Top Ten Patent Cases * December 1, 2014

Transcription

1 Rank Top Ten Patent Cases * December 1, 2014 Top Ten No. (3) Bristol-Myers v. Teva: Whither Lead Compound Obviousness? see Bristol-Myers Lead Compound Prima Facie Obviousness (December 1, 2014)(lime bordered attachment). M = Sup. Ct. Merits Stage P = S. Ct. Petition Stage FC = Ct. of Appeals x Conf. Scheduled Case Name Issue Status 1 M Teva v. Sandoz Deference (Lighting Ballast) Awaiting decision 1a P Teva Clones Deference (Lighting Ballast) Held for Teva decision 2 P Commil v. Cisco 271(b) Scienter Awaiting Conference 3 P Bristol-Myers v. Teva Pandora s Box Petition due Jan FC Halo v. Pulse Seagate Willfulness Awaiting Pet. Reh g 5 FC BioSig v. Nautilus 112(b) Definiteness Awaiting decision 6 M Perez v. Mort. Bankers Interpretative Rules Argument Dec. 1 7 P Packard v. Lee Indefiniteness Petition due Dec. 2 8 M Hana Financial Jury Question Argument Dec. 3 9 FC Suprema v. ITC Induced Infringement/ITC Awaiting reh g en banc 10 M Hargis v. B&B Hardware Issue Preclusion Argument Dec. 2 P Consumer W dog v. WARF Standing Response due Dec. 4 P STC.UNM v. Intel Rule 19 Joinder Petition due Dec. 16 x P Kimble v. Marvel. Post-Expiration Royalties Conference Dec. 5 P Apple v. Ancora Nautilus Indefiniteness Awaiting Conference FC Cuozzo Speed Claim Construction Awaiting decision P Google v. Vederi Claim Construction Awaiting Conference P Sigram Schindler v. Lee Claim Construction Awaiting Conference x P Hoffmann La Roche Appellate Fact Finding Conference Dec. 12 P Allergan v. Apotex Appellate Fact Finding Awaiting Conference FC Reese v. Sprint Nextel Aukerman Laches Pet.for rhr g en banc FC SCA Hygiene Aukerman Laches Pet. for reh'g en banc P Glenmark Standing Awaiting Conference P Madstad First to File Response was due Dec. 1 P Yufa v. Lockheed Martin Evidence Resp.was due Nov. 19 * New Format February 2015; authorship responsibility, see the END NOTES.

2 Wegner s Top Ten Patent Cases [December 1, 2014] OCTOBER 2014 TERM Argument Session Non-Argument Session Conference Red / Blue Dates to Announce Certiorari Decisions: The Court notes grants and denials of certiorari as part of an electronic Orders List at 9:30 AM the date of the first session ( red or blue ) following the Conference considering the case, except that early in the Term a grant may be issued as part of an earlier, special Orders List. 2

3 Wegner s Top Ten Patent Cases [December 1, 2014] TOP TEN PATENT CASES Supreme Court Cases Yellow Highlighted. Circuit Court Cases Pink Highlighted. (1) Teva v. Sandoz Deference (Lighting Ballast) In Teva Pharms. USA, Inc. v. Sandoz, Inc., Supreme Court No , opinion below, 723 F.3d 1363 (Fed. Cir. 2013)(Moore, J.), petitioner challenges the Federal Circuit standard of appellate deference under Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998) (en banc), as most recently reaffirmed by the appellate tribunal in Lighting Ballast Control LLC v. Philips Electronics North America Corp., 744 F.3d (Fed. Cir. 2014)(en banc). Status: Awaiting decision before the end of the Term in June Decision unlikely until Argument was held October 15, Question Presented: Whether a district court's factual finding in support of its construction of a patent claim term may be reviewed de novo, as the Federal Circuit requires (and as the panel explicitly did in this case), or only for clear error, as Rule 52(a) requires. (1a) Teva Clones There is a growing list of Federal Circuit cases on petition to the Supreme Court where a District Court claim construction was reversed by the Federal Circuit under the Cybor de novo standard of review now before the Supreme Court in Top Ten No. (1) Teva v. Sandoz. Presumably, each of these cases will be held for a decision until after a merits decision in Teva v. Sandoz: 3

4 Wegner s Top Ten Patent Cases [December 1, 2014] Lighting Ballast Control LLC v. Universal Lighting Technologies, Inc. Supreme Court No , is the styling of the petition from review of the en banc decision of the Federal Circuit Lighting Ballast Control LLC v. Philips Electronics North America Corp.,, 744 F.3d 1272 (Fed. Cir. 2014)(en banc), that under a theory of stare decisis reaffirms the continued validity of appellate de novo claim construction under Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998) (en banc). (Lighting Ballast was scheduled for Conference on September 29, 2014, but no decision was reached.) Gevo, Inc v. Butamax Advanced Biofuels LLC, Supreme Court No (distributed for Conference of June 26, 2014, without any further action) ( This Court recently granted the petition for writ of certiorari filed by Teva Pharmaceuticals USA, Inc. raising the same question presented as the Federal Circuit's decision in this case. ) Shire Development, LLC v. Watson Pharmaceuticals, Inc., Supreme Court No. No (distributed for Conference of October 31, 2014)( This Court has already granted certiorari in the Teva Pharmaceuticals USA case, which presents the same question to the Court. The Court, therefore, may wish to hold this petition pending a decision by the Court in Teva. ). Takeda Pharmaceutical Co. Ltd v. Zydus Pharmaceuticals USA, Inc., Supreme Court No (Conference not yet set)( This case presents a question identical to the one the Court will consider in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., No : Does the Federal Circuit properly review all aspects of claim construction de novo, or is it bound by Federal Rule of Civil Procedure 52(a)(6) to defer to a district court's resolution of factual issues underlying the interpretation of a patent? ) Stryker Corporation v. Hill-Rom Services, Inc., Supreme Court No (Petition Response was due Oct. 27, 2014)(Because the same question is presented in this petition [and Teva v. Sandoz], Stryker requests that the Court hold this petition pending its ruling in Teva. If the Court decides that the Federal Circuit must apply a clear-error standard of review for factual findings supporting claim construction, the Court should grant this petition, vacate the Federal Circuit's order, and remand this matter to the Federal Circuit for a claim construction ruling consistent with the Court's decision. ) 4

5 Wegner s Top Ten Patent Cases [December 1, 2014] Apple Inc. v. Ancora Technologies, Inc., No , opinion below, 744 F.3d 732 (Fed. Cir. 2014)(Taranto, J.)(Response due Nov. 21, 2014)( Whether this petition should be held for disposition of Teva Pharmaceuticals USA, Inc. v. Sandoz Inc., No , which will address whether de novo review applies to a district court's ruling on the meaning of patent claims, because the Federal Circuit in this case expressly applied de novo review in reversing the district court's construction of a key claim term. ) Braintree Labs., Inc. v. Novel Labs., Inc., Supreme Court NO , opinion below, 749 F.3d 1349 (Fed. Cir. 2014)(Prost, J.)(additional opinions by Dyk, J., dissenting in part and concurring in the result; and Moore, J., dissenting)(response by Respondent waived)( petition presents the same question as is presented in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., No , currently pending before this Court[.] ) (2) Commil v. Cisco (b) Scienter In Top Ten No. (2) Commil USA, LLC v. Cisco Sys., Inc. Supreme Court No , Petitioner s challenge to the new Federal Circuit standard of scienter for active inducement under 35 USC 271(b) remains alive. The Court has taken no action on the petition and has yet to reschedule the case for a further Conference. Status: Awaiting Conference. (No action on the petition was taken at the Conference on November 25, 2014; as of December 1, 2014, the electronic docket sheet did not indicate when the case would be rescheduled for Conference.) Cisco Sys., Inc. v. Commil USA, LLC, Supreme Court No , is a conditional cross-petition for grant of review in the event that certiorari is granted in Commil v. Cisco. The cross-petition was denied in the Orders List for December 1, CVSG Brief Recommends Grant of Certiorari: The Government on invitation of the Court has filed a brief recommending grant of certiorari. First Question Presented: Whether the Federal Circuit erred in holding that a defendant s belief that a patent is invalid is a defense to induced infringement under 35 U.S.C. 271(b). 5

6 Wegner s Top Ten Patent Cases [December 1, 2014] A Deeply Fractured Federal Circuit: The proceedings below start with a divided panel opinion, Commil USA, LLC v. Cisco Sys., Inc., 720 F.3d 1361(Fed. Cir. 2013)(Prost, J)(Newman, J., dissenting), with further en banc proceedings denying rehearing, 737 F.3d 699, 700 (Fed. Cir. 2013)((Reyna, J., joined by Rader, C.J., Newman, Lourie, Wallach, JJ., dissenting from den. rh g en banc); id., 737 F.3d at (Newman, J., joined by Rader, C.J., Reyna, Wallach, JJ, dissenting from den reh g en banc). A Deeply Fractured Federal Circuit: The proceedings below start with a divided panel opinion, Commil USA, LLC v. Cisco Sys., Inc., 720 F.3d 1361(Fed. Cir. 2013)(Prost, J)(Newman, J., dissenting), with further en banc proceedings denying rehearing, 737 F.3d 699, 700 (Fed. Cir. 2013)((Reyna, J., joined by Rader, C.J., Newman, Lourie, Wallach, JJ., dissenting from den. rh g en banc); id., 737 F.3d at (Newman, J., joined by Rader, C.J., Reyna, Wallach, JJ, dissenting from den reh g en banc). (3) Bristol-Myers. v. Teva Pandora s Box A petition for certiorari is expected to be filed in Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., following the denial of rehearing en banc at the Federal Circuit, 769 F.3d 1339 (Fed. Cir. 2014)(Order den. reh g en banc), panel opinion, 752 F.3d 967 (Fed. Cir. 2014)(Chen, J.), where a witches brew of pharmaceutical obviousness issues are raised. Status: A petition for certiorari is due January 18, The Eisai Issue in this case which is not the focus on the holding is considered in detail in this author s paper (attached), Bristol-Myers Lead Compound Prima Facie Obviousness (December 1, 2014). Pandora s Box : Just as the petition in Bilski reopened patent-eligibility under 35 USC 101 in an area of seemingly settled precedent for the previous nearly thirty years, the petition, here, if granted, would open up the first Supreme Court challenge to the law of prima facie obviousness of synthetic organic chemicals, threatening more than a century of a rich fabric of case law in this area. A Fact-Based Holding: If certiorari is denied it will in be in major part because of the lack of a difference of opinion on the law amongst the several members of 6

7 Wegner s Top Ten Patent Cases [December 1, 2014] the en banc Court: In her concurrence with denial of rehearing en banc Judge O Malley painstakingly goes through the various specific issues raised in the en banc petition and then concludes that [the patentee] and the amici adopt a sky is falling approach to what is simply a fact dependent opinion. The opinion makes no dramatic changes to the law, closes no doors on what evidence may be considered in undertaking an obviousness inquiry, establishes no hard and fast tests for what results might be considered unexpected in a case involving a pharmaceutical compound, and does not improperly shift the burden of proof or denigrate the importance of objective indicia of non-obviousness. (footnote omitted). Double, double, Toil and Trouble: A large number of issues were raised by petitioner-patentee and its amici colleagues against the panel opinion. The internal disputes amongst the en banc Court fuel the possibility for grant of review. Bristol-Myers, 769 F.3d at (Dyk, Wallach, JJ., concurring with den. reh g en banc); Bristol-Myers, 769 F.3d at (O Malley, J., concurring with den. reh g en banc); Bristol-Myers, 769 F.3d at (Newman, J., joined by Lourie, Reyna, JJ., dissenting from den. reh g en banc); Bristol-Myers, 769 F.3d at (Taranto, J., joined by Lourie, Reyna, JJ.,dissenting from den. reh g en banc) Eisai, the Major Unaddressed Issue: Left untouched by the various voices raised in connection with the denial of rehearing en banc is the perpetuation of the rogue panel opinion in Eisai Co. Ltd. v. Dr. Reddy's Labs., 533 F.3d 1353 (Fed. Cir. 2008), that creates an entirely approach to prima facie obviousness of chemical compounds differing from long established precedent. This issue is considered in detail in Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness (December 1, 2014). Bristol-Myers thus breaks no new legal ground but merely follows a series of panel opinions that adopt the rationale of Eisai as happened earlier the same year in Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352 (Fed. Cir. 2011)(Rader, C.J.); see also Pfizer Inc. v. Teva Pharms. USA, Inc., 555 Fed. Appx. 961, (Fed. Cir. 2014)(citing Otsuka Pharm. Co. v. Sandoz Inc., 678 F.3d 1280, 1292 (Fed. Cir. 2012); Daiichi Sankyo Co. v. Matrix Labs., Ltd., 619 F.3d 1346, 1354 (Fed. Cir. 2010))( Mere structural similarity between a prior art compound and the claimed compound does not inform the lead compound selection. ). 7

8 Wegner s Top Ten Patent Cases [December 1, 2014] (4) Halo v. Pulse Seagate Willfulness In Halo Elecs., Inc. v. Pulse Eng g, Inc., 769 F.3d 1371 (Fed. Cir. 2014) (O Malley, J., concurring), two members of the panel urge the Federal Circuit to reconsider en banc standards of willfulness. Status: A petition for rehearing en banc is due December 22, Discussion: The two members of the panel urge[ ] the full court to reevaluate our willfulness jurisprudence in light of the Supreme Court s decisions in Highmark [Inc. v. Allcare Health Management Systems, Inc., 134 S.Ct (2014)] and Octane[Fitness, LLC v. ICON Health & Fitness, Inc., 134 S.Ct (2014)]. Halo v. Pulse, F.3d at (O Malley, J., joined by Hughes, J., concurring). The concurrence specifically points to inconsistency between Federal Circuit precedent Bard Peripheral Vascular, Inc. v. W.L. Gore & Assocs., Inc., 682 F.3d 1003 (Fed. Cir. 2012), and In re Seagate Technology, LLC, 497 F.3d 1360 (Fed. Cir. 2007)(en banc) and the Supreme Court rulings in Highmark and Octane Fitness. (5) Biosig v. Nautilus 112(b) Indefiniteness In Biosig Instruments, Inc. v. Nautilus, Inc., on remand from the Supreme Court, Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct (2014)(Ginsburg, J.), prior opinion, Biosig Instruments, Inc. v. Nautilus, Inc., 715 F.3d 891, 900 (Fed. Cir. 2013)(Wallach, J.), the Federal Circuit must redefine a test for indefiniteness under 35 USC 112(b) to implement the holding of the Supreme Court: Status: Awaiting decision (Federal Circuit argument was held October 29, 2014, on remand from Supreme Court). Discussion: The Supreme Court stated According to the Federal Circuit, a patent claim passes the 112, 2 threshold so long as the claim is amenable to construction, and the claim, as construed, is not insolubly ambiguous. 715 F. 3d 891, (2013). We conclude that the Federal Circuit s formulation, which tolerates some ambiguous claims but not others, does not satisfy the statute s definiteness requirement. In place of the insolubly ambiguous standard, we hold that a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the 8

9 Wegner s Top Ten Patent Cases [December 1, 2014] invention. (emphasis added to show the holding). Guidance from Interval Licensing: The panel in BioSig does not write with an empty slate. In Interval Licensing LLC v. AOL, Inc., F.3d (Fed. Cir. 2014)(Chen, J.), as part of an affirmance of an invalidity holding in an inter partes Patent Office decision, a panel interpreted the standard of claim definiteness under what has become 35 USC 112(b) in the wake of the Supreme Court Nautilus decision. The Court states that [t]he claims, when read in light of the specification and the prosecution history, must provide objective boundaries for those skilled in the art. In support of this position, the panel cites to and quotes from Nautilus as indicating that there is an indefiniteness problem if the claim language might mean several things and if no informed and confident choice is available among the contending definitions[.] )(citation omitted). (6) Perez v. Mortgage Bankers Interpretative Rules In the concurrently granted petitions from the D.C. Circuit in Perez v. Mortgage Bankers Assoc., Supreme Court No , and Nickols v. Mortgage Bankers Assoc., Supreme Court No , consolidated for oral argument, the question is asked whether an Agency can issue an interpretative rule without notice-andcomment rulemaking. The Federal Circuit takes the position that notice-andcommenting is not required for Patent Office interpretative rules. Status: Certiorari was granted in both cases on January 16, The cases will be briefed over the summer; oral argument is expected in Fall 2014 with a decision before the end of the Term running through the end of June Perez Question Presented: The Administrative Procedure Act (APA), 5 U.S.C. 551 et seq., generally provides that notice of proposed rule making shall be published in the Federal Register, 5 U.S.C. 553(b), and, if such notice is required, the rulemaking agency must give interested persons an opportunity to submit written comments, 5 U.S.C. 553(c). The APA further provides that its notice-andcomment requirement does not apply * * * to interpretative rules, unless notice is otherwise required by statute. 5 U.S.C. 553(b)(A). * * * The question presented is: 9

10 Wegner s Top Ten Patent Cases [December 1, 2014] Whether a federal agency must engage in notice-and-comment rulemaking before it can significantly alter an interpretive rule that articulates an interpretation of an agency regulation. Nickols Question Presented: The Administrative Procedure Act, 5 U.S.C , established the maximum procedural requirements which Congress was willing to have the courts impose upon agencies in conducting rulemaking procedures. Vt. Yankee Nuclear Power Corp. v. Natural Res. Def. Council, Inc., 435 U.S.519, 524 (1978). Section 553 of the Act sets forth notice-and-comment rulemaking procedures, but exempts interpretative rules, among others, from the notice-and-comment requirement. 5 U.S.C. 553(b). The D.C. Circuit, in a line of cases descending from Paralyzed Veterans of America v.d.c. Arena L.P., 117 F.3d 579 (D.C. Cir. 1997), has created a per se rule holding that although an agency may issue an initial interpretative rule without going through notice and comment, [o]nce an agency gives its regulation an interpretation, it can only change that interpretation as it would formally modify the regulation itself: through the process of notice and comment rulemaking. Id. at 586. In this case, the D.C. Circuit invoked the Paralyzed Veterans doctrine which is contrary to the plain text of the Act, numerous decisions of this Court, and the opinions of the majority of circuit courts to invalidate a Department of Labor interpretation concluding that mortgage loan officers do not qualify for the administrative exemption under the Fair Labor Standards Act. The question presented is: Whether agencies subject to the Administrative Procedure Act are categorically prohibited from revising their interpretative rules unless such revisions are made through notice-andcomment rulemaking. Federal Circuit on Patent Office Interpretative Rules: The Federal Circuit says that interpretative rules for the Patent Office do not require notice-andcomment rulemaking. Animal Legal Defense Fund v. Quigg, 932 F.2d 920 (Fed. Cir. 1991); Cooper Technologies Co. v. Dudas, 536 F.3d 1330 (Fed. Cir. 2008). A thumbnail picture of the Federal Circuit view is set forth in Mikkilineni v. Stoll, 410 Fed. Appx. 311 (Fed. Cir. 2011)(per curiam). In Mikkilineni the court explains that [u]nder 553 of the APA, certain agency actions require prior public notice and comment. 5 U.S.C Generally speaking, substantive rules require notice and comment, while interpretive rules do not. 5 U.S.C. 553(b)(3)(A); Lincoln v. Vigil, 508 U.S. 182, (1993); Animal Legal Defense Fund v. Quigg, 932 F.2d 920, 927 (Fed. Cir. 1991). A rule is substantive 10

11 Wegner s Top Ten Patent Cases [December 1, 2014] where it causes a change in existing law or policy that affects individual rights and obligations and interpretive where it merely clarifies or explains existing law or regulations. Animal Legal Defense Fund, 932 F.2d at 927. Mikkilineni, 410 Fed. Appx. at 312. Earlier, the Court explained its position on interpretative rules in Cooper Technologies: By its own terms, section 553[, 5 USC 553,] does not require formal notice of proposed rulemaking for interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice. Id. 553(b)(3)(A); see also id. 553(d)(2) (exempting interpretive rules and statements of policy from publication more than thirty days before its effective date). The Patent Office's interpretation of original application was therefore not subject to the formal notice-and-comment requirements of section 553. See also Animal Legal Def. Fund, 932 F.2d at 931 (remarking that not every action taken by an agency pursuant to statutory authority [is] subject to public notice and comment because such a requirement would vitiate the statutory exceptions in 553(b) itself including the exception for interpretive rules). Though not required by section 553, the Patent Office's April 6, 2006 notice of proposed rulemaking expressly described the subjects and issues involved namely, the operation of the effective date provision of section See 65 Fed. Reg. 553(b)(3 at 18,155, 18, Moreover, the Patent Office received and acted on comments directly relating to the original application statutory language. See 65 Fed. Reg. at 76,763; see also 5 U.S.C. 553(c) (requiring that agency give interested persons an opportunity to participate in the rule making through submission of written data, views, or arguments with or without opportunity for oral presentation ). Cooper Technologies, 536 F.3d at (7) Packard v. Lee 112(b) Definiteness Packard v. Lee is the anticipated petition from In re Packard, 751 F.3d 1307 (Fed. Cir. 2014)(per curiam), where the panel created a new examination regime for indefiniteness under 35 USC 112(b). Status: Petition due December 2,

12 Wegner s Top Ten Patent Cases [December 1, 2014] Petition for Rehearing En Banc: The Panel created and decided this case on the basis of a new agency procedure a prima facie case procedure for indefiniteness. This was error. The Patent Office has not enacted any such procedure, and the Board did not rely on any such procedure in rejecting Mr. Packard s claims. [A]dministrative agencies are free to fashion their own rules of procedure. Vermont Yankee Nuclear Power Corp. v. Natural Res. Def. Council, Inc., 435 U.S. 519, 543 (1978). [A] fundamental rule of administrative law... [is] that a reviewing court, in dealing with a determination or judgment which an administrative agency alone is authorized to make, must judge the propriety of such action solely by the grounds invoked by the [ ] agency. Sec. & Exch. v. Chenery Corp., 332 U.S. 194, 196 (1947). (8) Hana Financial Jury Question In Hana Financial, Inc. v. Hana Bank & Hana Financial Group, Supreme Court No. No , opinion below, 735 F.3d 1158 (9th Cir. 2013)(Callahan, J.), the Court faces the issue as to whether a jury or the court determines trademark tacking. Whatever the Court decides may have an impact on jury vs. court decision in patent areas of the law. Status: Argument December 3, Question Presented: To own a trademark, one must be the first to use it; the first to use a mark has priority. The trademark tacking doctrine permits a party to tack the use of an older mark onto a new mark for purposes of determining priority, allowing one to make slight modifications to a mark over time without losing priority. Trademark tacking is available where the two marks are legal equivalents. The question presented, which has divided the courts of appeals and determined the outcome in this case, is: Whether the jury or the court determines whether use of an older mark may be tacked to a newer one? Discussion: The Federal Circuit has not addressed the jury vs. court issue of determination of tacking, but provides its understanding of the substantive law in this area Van Dyne-Crotty, Inc. v. Wear-Guard Corp., 926 F.2d 1156 (Fed. Cir. 1991)(Michel, J.). 12

13 Wegner s Top Ten Patent Cases [December 1, 2014] (9) Suprema v. ITC: Induced Infringement/ITC The Federal Circuit has granted two petitions for en banc review raising a total of five different questions for en banc review in Suprema, Inc. v. ITC, Fed. App x (Fed. Cir. 2014)(unpublished Order), vacating panel opinion, 742 F.3d 1350 (Fed. Cir. 2013)(O Malley, J.). In a nutshell, does the importation of a noninfringing component of a patented combination provide basis for an ITC exclusion order where there is infringement by customers in the United States who practice the patented combination? Status: Awaiting argument. (The Order granting rehearing en banc was issued May 13, 2014.) Panel Majority Denies Relief with only Post-Border Crossing Infringement: The panel majority, following the literal wording of the law, found no ITC liability for the post-border crossing infringement. The third member of the panel disagreed, presenting unique and bold theories that because the ITC is a trade law, the literal wording of the statute should be disregarded: My problem with the majority's opinion is that it ignores that Section 337 is a trade statute designed to provide relief from specific acts of unfair trade, including acts that lead to the importation of articles that will result in harm to a domestic industry by virtue of infringement of a valid and enforceable patent. To negate both a statutory trade remedy and its intended relief, the majority overlooks the Congressional purpose of Section 337, the long established agency practice by the Commission of conducting unfair trade investigations based on induced patent infringement, and related precedent by this Court confirming this practice. In the end, the majority has created a fissure in the dam of the U.S. border through which circumvention of Section 337 will ensue, thereby harming holders of U.S. patents. Suprema, Inc. v. ITC, 742 F.3d at 1372 (Reyna, J., dissenting-in-part) Plain Wording of the Statute vs. the Trade Law Intent of the Statute: The dissenting member s problem with the majority's opinion is that it ignores that Section 337 is a trade statute designed to provide relief from specific acts of unfair trade. Suprema, Inc. v. ITC, 742 F.3d at 1372 (Reyna, J., dissenting-inpart)(more fully quoted above). But, ased upon the wording of the statute, the panel majority in Suprema hold[s] that an exclusion order based on a violation of 13

14 Wegner s Top Ten Patent Cases [December 1, 2014] 1337(a)(1)(B)(i) may not be predicated on a theory of induced infringement where no direct infringement occurs until post-importation. Suprema, 742 F.3d at The holding is keyed to the wording of the statute that a patent-based exclusion order must be based upon importation * * * of articles that infringe a valid and enforceable United States patent[.] 1337(a)(1)(B)(i)( [T]he following are unlawful [methods of competition]. * * * The importation into the United States* * * of articles that infringe a valid and enforceable United States patent* * *. ) Thus, the articles must be an infringement of the patent. The third member of the panel jumps over the literal wording of the statute to look to the point that the ITC statute is a trade law : The jurist explains that [his] problem with the majority's opinion is that it ignores that Section 337 is a trade statute designed to provide relief from specific acts of unfair trade, including acts that lead to the importation of articles that will result in harm to a domestic industry by virtue of infringement of a valid and enforceable patent. To negate both a statutory trade remedy and its intended relief, the majority overlooks the Congressional purpose of Section 337, the long established agency practice by the Commission of conducting unfair trade investigations based on induced patent infringement, and related precedent by this Court confirming this practice. In the end, the majority has created a fissure in the dam of the U.S. border through which circumvention of Section 337 will ensue, thereby harming holders of U.S. patents. Suprema, Inc. v. ITC, 742 F.3d at 1372 (Reyna, J., dissenting-in-part)(emphasis added). The crux of this case, of course, is whether or not the definition of the specific acts of unfair trade should be interpreted in a manner that is broad enough to go outside the wording of the statutory definition of 1337(a)(1)(B)(i). [T]he remedy lies with the law making authority, and not with the courts : As explained by then-justice Rehnquist: "Laws enacted with good intention, when put to the test, frequently, and to the surprise of the law maker himself, turn out to be mischievous, absurd or otherwise objectionable. But in such case the remedy lies with the law making authority, and not with the courts." Griffin v. Oceanic Contractors, 458 U.S. 564, 575 (1982)(Rehnquist, J.)(quoting Crooks v. Harrelson, 282 U.S. 55, 60 (1930)). "Policy considerations cannot override our interpretation of the text and structure of [a statute], except to the extent that they 14

15 Wegner s Top Ten Patent Cases [December 1, 2014] may help to show that adherence to the text and structure would lead to a result so bizarre that Congress could not have intended it." Chamberlain Group, Inc. v. Skylink Techs., Inc., 381 F.3d 1178, 1192 (Fed. Cir. 2004)(quoting Central Bank, N.A. v. First Interstate Bank, N.A., 511 U.S. 164, 188 (1994)). A Limelight Domino : The decision fo the Supreme Court in Limelight that will take place in the coming weeks will have a domino impact on the Federal Circuit. Perhaps the first domino to fall will be Suprema: To the extent that the Supreme Court affirms the divided Federal Circuit in Limelight (that will be decided even before the briefing period has expired in Suprema) there is a stronger chance that the panel majority will be overturned. But, to the extent that the Supreme Court reverses in Limelight this may provide a strong indicator that the panel majority, here, should be sustained. The Five Questions Rasied in Two Petitions for Rehearing En Banc: Petitions of both the ITC and one of the parties were granted which cumulatively raise five questions: (i) The Commission s Petition asks four Questions: 1. Did the panel contradict Supreme Court precedent in [Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913 (2005),] and precedents of this Court [*] when it held that infringement under 35 U.S.C. 271(b) is untied to an article? 2. Did the panel contradict Supreme Court precedent in Grokster and this Court s precedent in Standard Oil [Co. v. Nippon Shokubai Kagaku Kogyo Co., 754 F.2d 345 (Fed. Cir. 1985),] when it held that there can be no liability for induced infringement under 35 U.S.C. 271(b) at the time a product is imported because direct infringement does not occur until a later time? 3. When the panel determined the phrase articles that... infringe in 19 U.S.C. 1337(a)(1)(B)(i) does not extend to articles that infringe under 35 U.S.C. 271(b), did the panel err by contradicting decades of precedent [*] and by failing to give required deference to the [ITC] in its interpretation of its own statute? 4. Did the panel misinterpret the Commission s order as a ban [on the] importation of articles which may or may not later give rise to direct infringement when the order was issued to remedy inducement of infringement and when the order permits U.S. Customs and Border Protection to allow importation upon certification that the articles are not covered by the order? 15

16 Wegner s Top Ten Patent Cases [December 1, 2014] [*] Beyond Grokster and Standard Oil, the ITC cites Crystal Semiconductor Corp. v. TriTech Microelectronics Int l, Inc., 246 F.3d 1336 (Fed. Cir. 2001); Young Eng rs, Inc. v. ITC, 721 F.2d 1305 (Fed. Cir. 1983); Vizio, Inc. v. ITC, 605 F.3d 1330 (Fed. Cir. 2010); and Enercon GmbH v. Int l Trade Comm n, 151 F.3d 1376 (Fed. Cir. 1998). (ii) The Cross Match Petition asks [w]hether the [ITC] has authority to find a Section 337 violation where it finds that an importer actively induced infringement of a patented invention using its imported articles but the direct infringement occurred post-importation. Cross Match cites Young Engineers and Vizio (also relied upon by the ITC) and Disabled Am. Veterans v. Sec y of Veterans Affairs, 419 F.3d 1317 (Fed. Cir. 2005). Professor Dennis Crouch provides a complete set of the petition documents as well as his own commentary. See Dennis Crouch, En Banc Federal Circuit to Review ITC s Power over Induced Infringement, PATENTLY O (May 15, 2014), available at (10) Hargis v. B&B Hardware Issue Preclusion In Hargis Indus. v. B & B Hardware, Inc., Supreme Court No , opinion below, B & B Hardware, Inc. v. Hargis Indus., 716 F.3d 1020 (8th Cir. 2013), issue preclusion is raised. Status: Merits argument at the Supreme Court December 2, Question Presented: Under the Trademark Act of 1946 (Lanham Act), a person generally may neither use nor register a mark that would be likely to cause confusion with an existing mark. If a person uses a mark that is likely to cause confusion with an existing registered mark, the owner of the registered mark may sue in federal court for trademark infringement. 15 U.S.C. 1114(1). If a person seeks to register a mark that is likely... to cause confusion with an existing registered mark, the owner of the existing registered mark may oppose the registration of the new mark before the Trademark Trial and Appeal Board (TTAB). 15 U.S.C. 1052(d); see id. 1063, 1067(a). In this case, petitioner B&B Hardware, Inc. (B&B), manufactures sealing fasteners and owns the registered mark SEALTIGHT. Respondent Hargis also manufactures sealing fasteners; it used and sought to register the mark SEALTITE. The TTAB held that Hargis's mark created a likelihood of confusion 16

17 Wegner s Top Ten Patent Cases [December 1, 2014] with B&B's mark. The questions presented are as follows: 1. Whether the TTAB's finding of a likelihood of confusion precludes Hargis from relitigating that issue in infringement litigation, in which likelihood of confusion is an element. 2. Whether, if issue preclusion does not apply, the district court was obliged to defer to the TTAB's finding of a likelihood of confusion absent strong evidence to rebut it. Discussion: A senior member of the intellectual property community well versed in both patent and trademark law and practice has explained that [this] is a trademark infringement case involving two federal practice and procedure issues, as well as one trademark law issue (which need not be reached if the Court s resolution of either of the two federal practice and procedure issues disposes of the case). The TTAB determined, in a USPTO opposition proceeding, that there was a reasonable likelihood of confusion between the trademark of the applicant (Hargis) and a previously registered trademark of the opposer (B&B) and, therefore, that Hargis was not entitled to register its trademark. Hargis did not file an appeal under 15 U.S.C. 1071(a) to the Federal Circuit (on the record in the USPTO) or, alternatively, file a civil action under 15 U.S.C. 1071(b) for a district court trial de novo of Hargis s entitlement to a registration. *** In B&B s trademark infringement suit against Hargis, B&B asserted that issue preclusion arising from the TTAB decision as to likelihood of confusion in the opposition precluded Hargis from asserting that it was not infringing B&B s registered trademark. A federal district court rejected B&B s issue preclusion argument and entered judgment in favor of Hargis after a jury determined, inter alia, that Hargis had not infringed B&B s trademark; and the Eighth Circuit affirmed. *** [There are] two independently dispositive issues of federal practice and procedure which are firmly rooted in Supreme Court precedent but which were not mentioned by either of the lower courts. *** 17

18 Wegner s Top Ten Patent Cases [December 1, 2014] ***[T]he Supreme Court may decline to discuss the two issues. *** [One] brief argues (1) that the Lanham Act reflects Congress s intent that collateral estoppel or issue preclusion should not arise from a TTAB decision and (2) that the rules and procedures before the TTAB in inter partes cases systemically prevent a full and fair opportunity to litigate the issues, which is a fundamental requirement for any application of collateral estoppel or issue preclusion. See, e.g., the repeated references to a full and fair opportunity to litigate the issues in Blonder-Tongue Laboratories, Inc. v. University of Illinois Foundation, 402 U.S. 313 (1971), as a central reason why Supreme Court permitted the (defensive) use of collateral estoppel for the first time without mutuality of the parties. (It is purely coincidental that that giant leap in the law of collateral estoppel happened to occur in a patent case.) The Supreme Court did not approve the offensive use of collateral estoppel without mutuality of the parties until almost eight years later and, once again, the Court relied on the full and fair opportunity to litigate the issues (as a sufficient safeguard). If the Supreme Court decides the B&B case on either of the grounds, the issue of issue preclusion arising from a TTAB decision will likely never arise again. Consumer Watchdog v. WARF Post-Grant Standing In Consumer Watchdog v. Wisconsin Alumni Research Foundation, Supreme Court No , proceedings below, 753 F.3d 1258 (Fed. Cir. 2014)(Rader, J.), the patent challenger-petitioner challenges the appellate court s dismissal of its patentability challenge on the basis of lack of standing. Status: Response due December 4, Question Presented: Does a statute that expressly provides a requester of agency action a right to appeal any dissatisfactory decision of the agency on her request to the courts provide sufficient Article III standing for the appeal, or must additional requirements be satisfied above and beyond the statute? Petitioner s Argument: Petitioner cites Lujan v. Defenders of Wildlife, 504 U.S. 555, 580 (1992)(Kennedy, J., concurring in part and concurring in the judgment)(a case discussed by the appellate panel below) but also relies upon cases that were not considered by the appellate panel, particularly NLRB v. Robbins Tire & Rubber Co., 437 U.S. 214, 221 (1978); and Public Citizen v. United States Dep t of Justice, 440 U.S. 440, 449 (1989). Petitioner argues that the normal standing rules 18

19 Wegner s Top Ten Patent Cases [December 1, 2014] do not apply for a statutory action which provides a right of appellate review of an agency decision. Discussion: The PTO in the decision below had denied the public interest patent challenger s attack in an inter partes reexamination. Although the patent challenger had a procedural right to appeal to the Federal Circuit, the Court dismissed the appeal on the basis of lack of standing: [W]here Congress has accorded a procedural right to a litigant, such as the right to appeal an administrative decision, certain requirements of standing namely immediacy and redressability, as well as prudential aspects that are not part of Article III may be relaxed. See Massachusetts v. E.P.A., 549 U.S. 497, (2007). However, the requirement of injury in fact is a hard floor of Article III jurisdiction that cannot be removed by statute. Summers [v. Earth Island Inst., 555 U.S. 488, 497 (2009)]. That injury must be more than a general grievance, Hollingsworth [v. Perry, 133 S. Ct. 2652, 2661 (2013)], or abstract harm, City of Los Angeles v. Lyons, 461 U.S. 95, 101 (1983). Implications for the America Invents Act Post-Grant Proceedings: Post grant proceedings under the Leahy Smith America Invents Act Inter Partes Review and Post Grant Review permit public interest groups to challenge patents. If the public interest group loses at the PTAB there is a statutory procedural right to appeal to the Federal Circuit just as there is for inter partes review that is the subject of the Consumer Watchdog case. STC.UNM v. Intel: Rule 19 A petition for certiorari is expected following STC.UNM v. Intel Corp., 767 F.3d 1351 (Fed. Cir. 2014)(Order)(per curiam), panel opinion, 754 F.3d 940 (Fed. Cir. 2014)where the Court denied en banc consideration of the panel s ruling that precludes a patent owner from using Rule 19 to join an indispensable party, effectively denying the right to enforce the patent. Status: A petition for certiorari is due December 16, Discussion: Plural opinions concurring and dissenting from the denial of rehearing en banc were issued, most notably one from the sharpest pen on the Court: 19

20 Wegner s Top Ten Patent Cases [December 1, 2014] The panel majority holds that the right of a patent co-owner to impede an infringement suit brought by another co-owner is a substantive right that trumps the procedural rule for involuntary joinder under Rule 19(a) of the Federal Rules of Civil Procedure. STC.UNM v. Intel Corp., 754 F.3d 940, 946 (Fed. Cir. 2014). It reaches this conclusion, however, without adequately explaining the legal footing upon which it is premised. It fails to ground its holding in either federal common law or the provisions of the Patent Act and ignores the mandatory nature of the Federal Rules of Civil Procedure. STC.UNM, 767 F.3d at ( O Malley, J., dissenting from den. reh'g en banc, joined by Newman, Lourie, Wallach, JJ.) Kimble v. Marvel Post-Expiration Royalties In Kimble v. Marvel Enterprises, Inc., Supreme Court No , opinion below, 727 F.3d 856 (9th Cir. 2013) (Callahan, J.), petitioner challenges the rule of Brulotte v. Thys Co., 379 U.S. 29 (1964), that a patentee s use of a royalty agreement that projects payments beyond the expiration date of the patent is unlawful per se. Status: Conference December 5, The Solicitor General has now filed a CVSG amicus brief in this case which argues that certiorari should be DENIED. The Solicitor General distinguishes this case from Brulotte v. Thys. Question Presented: * * * [B]ecause royalty payments under the parties contract extended undiminished beyond the expiration date of the assigned patent, Respondent s obligation to pay was excused under Brulotte v. Thys Co., 379 U.S. 29, 32 (1964), which had held that a patentee s use of a royalty agreement that projects beyond the expiration date of the patent is unlawful per se. A product of a bygone era, Brulotte is the most widely criticized of this Court s intellectual property and competition law decisions. Three panels of the courts of appeals (including the panel below), the Justice Department, the Federal Trade Commission, and virtually every treatise and article in the field have called on this Court to reconsider Brulotte, and to replace its rigid per se prohibition on postexpiration patent royalties with a contextualized rule of reason analysis. 20

21 Wegner s Top Ten Patent Cases [December 1, 2014] The question presented is: Whether this Court should overrule Brulotte v. Thys Co., 379 U.S. 29 (1964). Apple v. Ancora Nautilus Indefiniteness Apple Inc. v. Ancora Technologies, Inc., No , opinion below, 744 F.3d 732 (Fed. Cir. 2014)(Taranto, J.), petitioner challenges the ruling below on the alternate grounds that the appellate court decision did not correctly anticipate the indefiniteness ruling in Nautilus (the second Question Presented) and also asks the Court to hold this case for a decision on Cybor de novo appellate claim construction (the first Question Presented). Status: Awaiting Conference. (Response was filed November 21, 2014.) Second Question Presented: Whether this Court should grant, vacate, and remand for the Federal Circuit to reconsider whether, in light of Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct (2014), the patent claims are invalid for indefiniteness where the ordinary meaning of a key claim term is irreconcilable with the usage of the term in the patent's specification. (The first Question Presented is a piggyback petition listed earlier, keyed to the issue of Cybor appellate de novo claim construction: Whether this petition should be held for disposition of Teva Pharmaceuticals USA, Inc. v. Sandoz Inc., No , which will address whether de novo review applies to a district court's ruling on the meaning of patent claims, because the Federal Circuit in this case expressly applied de novo review in reversing the district court's construction of a key claim term. ) Cuozzo Speed Claim Construction In In re Cuozzo Speed Technologies, LLC, Fed. Cir , the Federal Circuit has an opportunity to review the procedures of the new Inter Partes Review proceedings, including the standard of claim construction. Status: Awaiting decision; argued November 3, 2014 (Newman, Clevenger, Dyk, JJ.) 21

22 Wegner s Top Ten Patent Cases [December 1, 2014] Discussion: A key issue is whether patent claims in a post-grant proceeding under the Leahy Smith America Invents Act be given the broadest reasonable construction as in ex parte patent proceedings at the Office and in reexamination, or should the standard of claim construction used in the District Courts in infringement litigation be used instead. Google v. Vederi Claim Construction In Google, Inc. v. Vederi, Supreme Court No , opinion below, Vederi, LLC v. Google, Inc., 744 F.3d 1376 (Fed. Cir. 2014)(Rader, C.J.), petitioner questions the Federal Circuit standard of claim construction keyed to disavowal of scope. Status: Awaiting Conference. Question Presented: When an applicant for patent amends a claim to overcome the Patent and Trademark Office s earlier disallowance of the claim, should a court (i) presume that the amendment narrowed the claim and strictly construe the amended claim language against the applicant, as this Court has held, or (ii) presume that the claim scope remained the same and require that any narrowing be clear and unmistakable, as the Federal Circuit has held? The Appellate Opinion below: Citing Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1369 (Fed. Cir. 2003), the court discerns no clear and unambiguous disavowal of spherical or curved images that would support the district court's construction. Vederi, 744 F.3d at More completely, the appellate court states that: [T]he prosecution history does not support the district court's construction. [The patent challenger] contends that the inventors of the Asserted Patents disclaimed the construction sought by [the patentee] in responding to a rejection over a prior art reference. Specifically, the application leading to the [ ] patent initially contained claims reciting images providing a non-aerial view of the objects. The Patent Office rejected those claims in view [the prior art patent to Levine]. The applicant responded by amending the claims to remove non-aerial view and add substantially elevations. The applicant also correctly noted that Levine was 22

23 Wegner s Top Ten Patent Cases [December 1, 2014] directed to map images, which may include names of streets, roads, as well as places of interest that a traveler could use to navigate through a geographic area. Therefore, Levine did not disclose images depict[ing] views that are 'substantially elevations of the objects in a geographic area' or acquired by an image recording device moving along a trajectory. Despite [the patent challenger s] protestations to the contrary, this court discerns no clear and unambiguous disavowal of spherical or curved images that would support the district court's construction. Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1369 (Fed. Cir. 2003). Vederi, 744 F.3d at 1384 (trial court citations omitted) Sigram Schindler v. Lee Claim Construction In Sigram Schindler Beteiligungsgesellschaft mbh v. Lee, Supreme Court no , opinion below, In re Teles AG Informationstechnologien, 747 F.3d 1357 (Fed. Cir. 2014)(Dyk, J.), petitioner challenges claim construction. Status: Awaiting Conference. On November 21, 2014, the docket sheet lists Rescheduled, thus cancelling this case from the November 25, 2014, Conference agenda that had previously been set. Question Presented: "Does the US Constitution, in legal decisions based on 35 USC 101/102/103/112, require instantly avoiding the inevitable legal errors in construing incomplete and vague classical claim constructions - especially for emerging technology claim(ed invention)s, ET CIs - by construing for them the complete/concise refined claim constructions of the Supreme Court's KSR/Bilski/Mayo/Myriad/Biosig/Alice line of unanimous precedents framework, or does the US Constitution for such decisions entitle any public institution to refrain, for ET CIs, for a time it feels feasible, from proceeding as these Supreme Court precedents require or meeting its requirements just by some lip-service and in the meantime to construe incomplete classical claim constructions, notwithstanding their implied legal errors?" 23

24 Wegner s Top Ten Patent Cases [December 1, 2014] The writer has no involvement with this case but in view of his firm s representation of a party no commentary is provided. Hoffmann La Roche Fact Finding In Hoffmann La Roche, Inc. v. Apotex Inc., Supreme Court No , opinion below, 748 F.3d 1326 (Fed. Cir. 2014)(Bryson, J.), following Icicle Seafoods, petitioner questions de novo appellate fact finding. Status: Conference December 12, Question Presented: In Pullman-Standard v. Swint, 456 U.S. 273 at 288, (1982) and Icicle Seafoods, Inc. v. Worthington, 475 U.S. 709, 714 (1986), this Court held that when a district court has failed to make findings of fact essential to a proper resolution of a legal question, the court of appeals (1) should remand to the district court to make those findings and (2) should not make the necessary findings in the first instance. As the Court explained in Icicle Seafoods, [t]he trial judge's major role is the determination of fact, and with experience in fulfilling that role comes expertise. Duplication of the trial judge's efforts in the court of appeals would very likely contribute only negligibly to the accuracy of fact determination at a huge cost in diversion of judicial resources. Id. (citation omitted). The question presented is as follows: Whether necessary factual inquiries underlying patent validity may be resolved in the first instance by the court of appeals (as the Federal Circuit did in this case under exercise of de novo appellate review), or must the Federal Circuit remand so that the necessary factual inquiries may be made in the district courts in the first instance, as this Court's precedent requires. The third member of the panel dissented: Hoffmann-LaRoche's once-a-month Boniva ibandronate medication for osteoporosis required twelve years of research and clinical testing and evaluation to demonstrate its efficacy when dosed once a month and its safety at this high monthly dosage. The prior investigations of intermittent dosing, and the publications describing protocols of lesser success, missed the protocol that produced this successful method. Indeed, this prior art 24

25 Wegner s Top Ten Patent Cases [December 1, 2014] weighs heavily against obviousness, for despite extensive exploration, this successful protocol was not discovered. Invalidation of this patent is not supported by clear and convincing evidence. The court's ruling of obviousness violates the principles of Graham v. John Deere Co., 383 U.S. 1 (1966) (all factors must be considered, including commercial success, failure of others, and long-felt need). The court's reasoning violates the guidance of KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) (the standard of obviousto-try requires a limited number of specified alternatives offering a likelihood of success in light of the prior art and common sense), this court instead invoking judicial hindsight to reconstruct the patented subject matter. Nowhere amid the many studies of bisphosphonate osteoporosis treatments over a wide range of dosages and conditions, did any reference show or suggest the Boniva combination of a single 150 mg dose and once-a-month administration. No reference suggested the effectiveness and safety of this combination. Nonetheless, my colleagues declare this treatment obvious to them. My colleagues' primary reason, that 150 mg is thirty times the daily dose of 5 mg, does not mention that the FDA refused to approve the 5 mg dose due to its toxic side effects. Surely this leads away from the obviousness of a single dose thirty times larger. Hoffmann La Roche, 748 F.3d at at 1335 (Newman, J., dissenting) Allergan v. Apotex Fact Finding In Allergan, Inc. v. Apotex Inc., , opinion below, 754 F.3d 952 (Fed. Cir. 2014)(Prost, C.J.), petitioner question de novo fact finding to support an obviousness ruling. Status: Awaiting Conference. (Responses waived.) Question Presented: May the Federal Circuit sitting in review of a district court bench trial on patent obviousness find facts that the district court never found or 25

26 Wegner s Top Ten Patent Cases [December 1, 2014] must the Federal Circuit remand to the district court for further fact finding consistent with Federal Rule of Civil Procedure 52(a)? Generic Disclosure too General to Support Obviousness Ruling: The third member of the panel in dissent notes the breadth of the prior art disclosure. This is not a situation in which there are a finite number of identified, predictable solutions. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). Rather, the single sentence in Johnstone actually proposes hundreds of thousands, or even millions, of variations on the alpha chain. Cf. Eli Lilly [& Co. v. Zenith Goldline Pharms., Inc.., 471 F.3d 1369, 1376 (Fed. Cir. 2006)] (prior art reference that disclosed millions of compounds did not spell out a definite and limited class of compounds that enabled a person of ordinary skill in the art to at once envisage each member of this limited class ). The compound in Johnstone could have a saturated bond at any position on the alpha chain, an unsaturated bond at any position, a triple bond at any position, or even a combination of any of these bonds. As a result, a person of ordinary skill in the art was not faced with a small or easily traversed number of options based on Johnstone. See Bayer Schering Pharma AG v. Barr Labs., Inc., 575 F.3d 1341, 1347 (Fed. Cir. 2009) ( [A]n invention would not have been obvious to try when the inventor would have had to try all possibilities in a field unreduced by direction of the prior art. ). In this instance, covering everything effectively tells us nothing. See Bayer, 575 F.3d at 1347 ( When what would have been obvious to try would have been to vary all parameters try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful an invention would not have been obvious. ) (internal quotations omitted). Allergan, 754 F.3d at (Chen, J., dissenting in part)(footnote omitted) 26

27 Wegner s Top Ten Patent Cases [December 1, 2014] Reese v. Sprint Nextel Aukerman Laches In Reese v. Sprint Nextel Corp., Fed. Cir. App. No , appellant challenges the Aukerman laches standard; the most recent filing is a petition asking the court to hear this case en banc. Status: Petition for en banc hearing filed October 29, Discussion: Petitioner argues that that this Court s decision in A. C. Aukerman Co. v. R. L. Chaides Constr. Co., 960 F.2d 1020 (1992) (en banc), was wronglydecided to the extent that it held that laches could bar legal relief for a claim of patent infringement. Id. at , This portion of Aukerman is contrary to the Supreme Court s recent decision in Petrella v. Metro-Goldwyn- Mayer, Inc., 134 S. Ct. 1962, 1967 (2014) ( To the extent that an infringement suit seeks relief solely for conduct occurring within the limitations period, however, courts are not at liberty to jettison Congress judgment on the timeliness of suit. ). SCA Hygiene Aukerman Laches In SCA Hygiene Prods. Aktiebolag v. First Quality Baby Prods., LLC, 767 F.3d 1339 (Fed. Cir. 2014)(Hughes, J.), petitioner seeks en banc review of Aukerman laches. Status: Pending petition for rehearing en banc; petition was filed October 15, From the Petition: Petitioner believe[s] this appeal requires an answer to one or more precedent-setting questions of exceptional importance: (1) Is the equitable defense of laches available to bar damages for patent infringement occurring within the six-year limitations period of 35 U.S.C. 286? (2) Should this Court continue to require a presumption of delay and prejudice in relation to acts of infringement occurring within the six-year limitations period of 35 U.S.C. 286? (3) Did the Panel err by contradicting settled precedent on the standard for establishing the nexus between delay and economic prejudice to support a finding of laches? 27

28 Wegner s Top Ten Patent Cases [December 1, 2014] From the Panel Opinion: We first turn to the issue of laches. As a preliminary matter, SCA argues that Petrella v. Metro-Goldwyn-Mayer, Inc., 134 S. Ct. 1962, 188 L. Ed. 2d 979 (2014), compels a finding that [Aukerman] is no longer good law. Notice of Supplemental Authority at 2, SCA Hygiene Prods. AB v. First Quality Baby Prods., No (Fed. Cir. May 27, 2014), ECF No. 51. In particular, SCA points out that the Supreme Court has never approved the application of laches to bar a claim for damages brought within the time allowed by a federal statute of limitations. Petrella, 134 S.Ct. at But Petrella notably left Aukerman intact. See id. at 1974 n.15 ( We have not had occasion to review the Federal Circuit's position. ). Because Aukerman may only be overruled by the Supreme Court or an en banc panel of this court, Aukerman remains controlling precedent. See, e.g., Tate Access Floors, Inc. v. Interface Architectural Res., Inc., 279 F.3d 1357, 1366 (Fed. Cir. 2002). Glenmark Standing In Glenmark Pharms., Inc. v. Sanofi-Aventis Deutschland GmbH, Supreme Court No , opinion below, Sanofi-Aventis Deutschland GmbH v. Glenmark Pharms., Inc., 748 F.3d 1354 (Fed. Cir. 2014)(Newman, J.), the petition raises an issue of standing. Status: Awaiting Conference. (Respondent waived Response.) Question Presented: The patent statute states that the patentee shall have a remedy for patent infringement ( 35 U.S.C. 281), and that an interest in a patent may be assigned by an instrument in writing. 35 U.S.C Here, the Federal Circuit held that the U.S. distributor of a patented product had standing to recover lost profits damages for infringement on the ground that it was an implied exclusive licensee, even though no written or oral agreement conveyed to that entity any interest in the patent in suit. The question presented is whether a distributor of a patented product, to which no interest in the patent has been assigned, has standing to recover damages for infringement. 28

29 Wegner s Top Ten Patent Cases [December 1, 2014] Madstad v. PTO First to File Constitutionality In Madstad Eng'g, Inc. v. United States PTO, Supreme Court No , opinion below, 756 F.3d 1366 (Fed. Cir. 2014)(O Malley, J.), Petitioner challenges the Leahy Smith America Invents Act of 2011 as unconstitutional insofar as the first-to-file provision is concerned. Status: Response due December 1, Questions Presented: 1. Whether the Federal Circuit's decision that Petitioners lack standing to challenge the First-Inventor-to-File provisions of the America Invents Act [AIA] conflicts with precedent of this Court and decisions in other circuits. 2. Whether the First-Inventor-to-File provisions of the AIA are unconstitutional under the Intellectual Property Clause of Article I, Section 8, Clause 8. Yufa v. Lockheed Martin Evidence In Yufa v. Lockheed Martin Corp., Supreme Court no , the petitioner challenges the evidence to support the decision. Status: Response to the Petition is due November 19, Questions Presented: 1. Whether the Federal Circuit has erred in affirming the District Court's summary judgment, holding that the non-movant of summary judgment did not supply evidence creating a genuine evidentiary dispute, without discussion or at least mention in the Federal Circuit decision of the clearly specified evidences on record, which create a genuine evidentiary dispute of the admissible triable evidentiary material facts, supplied by the non-movant for the Federal Circuit consideration. 29

30 Wegner s Top Ten Patent Cases [December 1, 2014] 2. Whether the Federal Circuit has erred in affirming the District Court's summary judgment, holding that the District Court applied the proper standards in granting summary judgment, without applying, discussion or at least mention in the Federal Circuit decision of the standards, supplied by the non-movant for the Federal Circuit consideration, and which must be performed in granting summary judgment. END NOTES Distribution of Top Ten Patent Cases after February 1, 2015: An updated List of recipients will be used to distribute patent information beginning in February. If you would like to be included in the new List please send an from the address you would like to have on the updated List, marking the subject line Updated List. Alternative Access: Access to Top Ten Patent Cases is also currently available (and after February 1st will continue to be available) through the Los Angeles Intellectual Property Law Association as Wegner s Writings, About the List Rankings: Cases where certiorari has been granted are ranked according to potential impact on patents. Rankings at the petition stage are based upon a blend focusing mainly on the likelihood of grant but also considering the impact of the case. Where certiorari has already been granted, then the main ranking criterion is importance of the outcome as to a potential change in the law. Case rankings for the numbered Top Ten cases are made under this set of criteria. Other cases are not necessarily ranked according to this guideline. Authorship: Harold C. Wegner is solely responsible for this list. He is a former Professor of Law at the George Washington University Law School and currently a partner in the international law firm of Foley & Lardner LLP. Any opinions or characterizations expressed in this paper represent the personal viewpoint of the author and do not necessarily reflect the viewpoint of any colleague, organization or client thereof. 30

31 BRISTOL-MYERS LEAD COMPOUND PRIMA FACIE OBVIOUSNESS * Harold C. Wegner * I. OVERVIEW 2 II. NCE PATENTABILITY REGIME PRIOR TO KSR 3 A. Structural Obviousness Rejections from Paper Chemists B. Papesch Rebuttal of a Failed Assumption B C. Papesch Showing versus the Closest Prior Art C III. KSR IMPACT ON MOTIVATION CASE LAW 11 A. KSR Tightened the Standard of Patentability B. KSR Standard of Motivation C. A Tightened Standard for Nonobviousness under KSR IV. PANEL LEAD COMPOUND FOCUS 13 A. Eisai Lead Compound Departure from Precedent B. Takeda v. Alphapharm Harmless Error C. Eisai Departure from Precedent D. Later Panels, Building upon Rogue Precedent V. POLICY CONSIDERATIONS 18 A. Federal Circuit Panels vs. the Supreme Court B. Patent Law Definition of a Lead Compound C. Commercial Realities divorced from Chemistry D. One Patent Law for All Technologies E. Confusion at the Patent Office F. A Fractured Anti-Harmonized Global Patent Regime G. Whither Binding Precedent VI. REACTION TO BRISTOL-MYERS 24 VII. CONCLUSION 27 ABOUT THE AUTHOR 29 * Author information and responsibility for this paper are explained at page 29. This version December 1, 2014

32 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness I. OVERVIEW An Order denying rehearing en banc in Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 769 F.3d 1339 (Fed. Cir. 2014)(Order den. reh g en banc), has drawn considerable attention due to the plurality of both concurring and, particularly, dissenting opinions which largely focus upon fact-specific issues that represented a reasoned basis for denial of the petition. This paper focuses upon panel deviations from precedent to create a brand new standard for prima facie obviousness of chemical compounds; the deviation started with Eisai Co. Ltd. v. Dr. Reddy's Labs., Ltd., 533 F.3d 1353 (Fed. Cir. 2008), but is now perpetuated in a series of panel opinions including Bristol-Myers. The starting point for this paper is a consideration of the law of structural obviousness or prima facie obviousness prior to KSR including the Supreme Court recognition of the doctrine in Brenner v. Manson, 383 U.S. 519 (1966). See II, NCE Patentability Regime Prior to KSR. Given that Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), is the only Supreme Court decision in the era of the Federal Circuit dealing with nonobviousness of an invention, the impact of KSR is necessarily considered. See III, KSR Impact on Motivation Case Law. A major problem exposed in Bristol-Myers is a bizarre interpretation of the law of prima facie obviousness based upon chemical structure that places an undue emphasis on the lead compound of the prior art when that lead compound is not the closest prior art. This is based first upon a most unfortunate choice of wording in Takeda Chem. Indus. v. Alphapharm Pty., Ltd., 492 F.3d 1350 (Fed. Cir. 2007), compounded by a misunderstanding of the case law in Eisai Co. Ltd. v. Dr. Reddy's Labs., 533 F.3d 1353 (Fed. Cir. 2008)). See IV, Panel Lead Compound Focus. 2

33 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness A variety of policy implications flow from the deviation from precedent. See V, Policy Considerations. Returning to the most recent case in the lead compound case law, the reaction to the Bristol-Myers case deserves attention. See VI, Reaction to Bristol-Myers. II. NCE PATENTABILITY REGIME PRIOR TO KSR The law of nonobviousness of a new chemical entity (NCE) falls within the framework of the patent law. A rich fabric of case law for NCE s has developed since the late nineteenth century starting with numerous chromophoric compounds often principally originating from the dyestuff laboratories on the Rhine and in Berlin. In the vast array of NCE s a small but important sliver is in the area of regulated chemical useful as medicines. American law relating to NCE patentability developed in with the laws of the United Kingdom, Germany, France and other European countries, and for the past several decades in Japan and other emerging countries of Asia. A. Structural Obviousness Rejections from Paper Chemists A patent law for NCE s presented a unique challenge essentially absent from most technologies because unlike a mechanical Widget which could be seen, analyzed and compared to the closest prior art Widget, a description of an NCE was often little more than a two dimensional structural formula reported together with physical data such as a melting point or a boiling point, often with a statement of a proposed usefulness of the compound but without comparative data relating to structurally similar compounds. Because the Patent Examiner is a paper chemist who had scientific books and journals (instead of the laboratory equipment of the wet scientist) often the 3

34 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness most relevant inquiry to evaluate nonobviousness of an NCE was to compare the two dimensional label the structural formula against the parallel label for the prior art compound. An elaborate set of case law principles were developed in the first half of the twentieth century to determine whether a claimed compound was or was not nonobvious. A penumbra of structurally obvious variants developed in each area of chemistry. In a well developed and highly predictable area such as azo and anthraquinone dyestuffs many tens of thousands of compounds were synthesized and described in the German scientific literature already in the nineteenth century. The penumbra of structurally obvious variants was thus quite large. By contrast, when Nobel Laureate Dr. Bergstrom made his groundbreaking discovery of the activity of the prostaglandin nucleus, the penumbra was paper thin but then rapidly enlarged as numerous prostaglandin derivatives were synthesized with a variety of substituents such that it became more and more predictable how a prostaglandin derivative would behave based on such variations. The law of structural obviousness (later restyled as prima facie obviousness ) was crafted as a rich fabric of literally hundreds of decisions of the Patent Office Board of Appeals beginning not later than 1898 and many dozens of CCPA decisions. See Bender v. Hoffman, 1898 Commissioner s Decisions 262 (Com r dec. 1898). 4

35 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness As explained by the late Giles Sutherland Rich: The question of structural similarity in chemical patent cases has generated a body of patent law unto itself. [See generally Helmuth A. Wegner, Prima Facie Obviousness of Chemical Compounds, 6 Am. Pat. L. Assoc. Q. J. 271 (1978).] Particular types or categories of structural similarity without more have, in past cases, given rise to prima facie obviousness; see, e.g., In re Dillon, 919 F.2d 688, (Fed. Cir. 1990)(en banc)(tri-orthoesters and tetra-orthoesters) ; In re May, 574 F.2d 1082 (CCPA 1978) (stereoisomers); In re Wilder, 563 F.2d 457 (CCPA 1977) (adjacent homologs and structural isomers); In re Hoch, 428 F.2d 1341 (CCPA 1970) (acid and ethyl ester). *** [I]n any event, this court has previously stated that generalization is to be avoided insofar as specific structures are alleged to be prima facie obvious one from the other. In re Grabiak, 769 F.2d 729, 731 (Fed. Cir. 1985). In re Jones, 958 F.2d 347, (Fed. Cir. 1992)(Rich, J.) (footnote integrated into text in brackets). The Supreme Court in Brenner v. Manson explained in the context of the classic area of prima facie obviousness case law homology that knowledge of one member of the series provides basis for prediction as to the activities of the other members of the series: A homologous series is a family of chemically related compounds, the composition of which varies from member to member by CH 2 (one atom of carbon and two atoms of hydrogen).... Chemists knowing the properties of one member of a series would in general know what to expect in adjacent members." Manson, 383 U.S. at 522 n.3 (quoting In re Henze, 181 F.2d 196, (CCPA 1950), and also citing In re Hass, 141 F.2d 122, 125 (CCPA 1942); In re Norris, 179 F.2d 970 (CCPA 1950); In re Jones, 149 F.2d 50 (CCPA 1945)). 5

36 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness As explained in one of the cases cited by the Supreme Court in Manson, [i]t is well understood by chemists that the members of a homologous series of chemical compounds possess the same principal characteristics; that generally the chemical and physical properties of the individual members vary gradually from member to member; and that knowledge of the properties and chemical behavior of one of the members of the series suggests to the chemist the properties and chemical behavior of the other members of the series. Hass, 141 F.2d at 125. In essence, once a specific organic chemistry structure was identified and known to have a particular usefulness, a penumbra of obvious variants could then be identified that are structurally obvious. The breadth of the penumbra could be small or nonexistent in the case of a pioneer ring system where there was no experience in the art as to the impact of substituents on that ring system; generally, as a minimum, adjacent homologs and position isomers were considered to be within this penumbra of structural obviousness. As experience with the oncenewly discovered ring system develops and there are literally hundreds of known structural variations, predictability increases and the penumbra of structurally obvious compounds can grow quite large. The motivation to make a structurally obvious modification of a known compound is to find new compounds with the same usefulness as the prior art compound (with the hope that the new compound may have slightly better properties that may make the difference between commercial success and failure). The motivation to make structurally obvious variants is lacking when the prior art compound has no known utility: In that case under Stemniski the otherwise structurally obvious variants are unobvious. 6

37 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness Thus, the motivation to make a close structural analog of a known compound is provided by the quest by those skilled in the art to make similar compounds sharing the same utility. But, absent knowledge of utility of the prior art compound, there is no prima facie obviousness of structural analogs because there is no such motivation. In his first major opinion on the Federal Circuit shortly after joining the appellate body, Judge Lourie explained the significance of In re Stemniski, 444 F.2d 581 (CCPA 1971): Stemniski qualified [the established practice of rejecting closely-related compounds as prima facie obvious] by holding that a presumption is not created when the reference compound is so lacking in any utility that there is no motivation to make close relatives. In re Dillon, 919 F.2d 688, 697 (Fed. Cir. 1990)(en banc)(lourie, J.)(emphasis added). Throughout the history of the Patent Office, its chemical examiners have been paper chemists without laboratory facilities. Their initial examination of chemical compound nonobviousness has been based upon whether the claimed compound has an analogous relationship to a prior art compound: Does the claimed compound from the prior art by a substituent that is predictive that the claimed compound will share common properties with the prior art compound? The paper chemist has no way of known whether in fact the assumption of common properties is true or not. Rather, the examiner rejects the claims to the claimed compound on the assumption of common properties: This is structural obviousness or prima facie obviousness. 7

38 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness Historically, through most of the twentieth century it had been the practice of the Patent Office to deny claims to a compound, per se, when it was found to be structurally obvious, even though the three dimensional thing, the compound which is the subject of the patent claim, may well have a differing steric structure or other feature that makes the compound entirely different. For more than forty years since the landmark Stemniski case it is has been hornbook law that a condition precedent to reaching a conclusion of structural obviousness has been that there is motivation for a worker skilled in the art to make a structural variant. Such motivation comes from the expectation by a worker skilled in the art that the structural variant will have the same properties: But, if there is no property disclosed for a known compound, the motivation vanishes; there is no reason to make a structurally obvious compound of a useless prior art compound. B. Papesch Rebuttal of a Failed Assumption While an assumption could be made based upon paper chemistry that a homolog or isomer or other analog of a known compound would be expected to behave in a certain, predictable manner, the assumption all too often failed: The two dimensional structural formula was just that, a label that identified the carbon, nitrogen, oxygen and other elements of the compound but gave no hint or suggestion as to critical steric factors that particularly in pharmaceuticals made the difference between total success and failure. 8

39 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness More than fifty years ago in the Papesch case the late Giles Sutherland Rich devised a method for the paper chemist Patent Examiner to deal with the challenge of how to deal with a new compound that was actually different in its properties, running against the paper chemistry assumption that the structurally obvious variant would have the same properties: The landscape dramatically changed with the Papesch case that shifted the focus of the inquiry from the two dimensional label, the structural formula, to the actual thing that is claimed, the three dimensional compound with its various steric features and properties: From the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing. The graphic formulae, and the chemical nomenclature, the systems of classification and study such as the concepts of homology, isomerism, etc., are mere symbols by which compounds can be identified, classified, and compared. But a formula is not a compound and while it may serve in a claim to identify what is being patented, as the metes and bounds of a deed identify a plot of land, the thing that is patented is not the formula but the compound identified by it. And the patentability of the thing does not depend on the similarity of its formula to that of another compound but of the similarity of the former compound to the latter. There is no basis in law for ignoring any property in making such a comparison. An assumed similarity based on a comparison of formulae must give way to evidence that the assumption is erroneous. The argument has been made that patentability is here being asserted only on the basis of one property *** and that the compounds claimed and the compound of the prior art presumably have many properties in common. Presumably they do, but presumption is all we have here. The same is true of all of the compounds of the [cited] cases which were held patentable over compounds of the prior art, many of which must have had more in common by way of properties than the compounds here because the relationships, structurally, were even closer than here. In re Papesch, 315 F.2d 381, 391 (CCPA 1963)(Rich, J.)(emphasis added). 9

40 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness C. A Papesch Showing versus the Closest Prior Art It is axiomatic that to rebut a prima facie case of obviousness premised on the assumption that a structurally obvious compound has the same properties as the closest prior art compound that one must show that this assumption is incorrect, that the claimed compound in fact differs from the closest prior art: "When unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art." In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). An applicant relying upon a comparative showing to rebut a prima facie case must compare his claimed invention with the closest prior art. In re Merchant, 575 F.2d 865, 869 (CCPA 1978)(Markey, C.J.)(citing In re Malagari, 499 F.2d 1297, 1303 (CCPA 1974); In re Chapman, 357 F.2d 418, 423 (CCPA 1966); In re Albrecht, 514 F.2d 1389, 1394 (CCPA 1975)). A Rule 132 affidavit [to establish a difference in properties], to be effective, must compare the claimed subject matter with the closest prior art. In re Burckel, 592 F.2d (Fed. Cir. 1979)(Rich, J.)(citing In re Wright, 569 F.2d 1124 (CCPA 1977)). To be sure, a direct comparison with the closest prior art is not always necessary where the prior art points to superior properties for a structurally more remote compound. Indeed, a comparison of the prior art with a lead compound (not then nominated as such) was basis for overcoming a case of prima facie obviousness in the Fouche case where the prior art had established a marked pharmacological superiority for the commercial compound versus the closest prior art. See In re Fouche, 439 F.2d 1237, (CCPA 1971). See also Merchant, 575 F.2d at 869 n.8 (citing In re Blondel, 499 F.2d 1311, 1317 (CCPA 10

41 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness 1974)( Direct comparison with the closest prior art is not required in all cases. This court has found indirect comparisons persuasive of unobviousness. ). III. KSR IMPACT ON MOTIVATION CASE LAW There has never been a Supreme Court case that deals with the patentability of an NCE, yet the recent KSR case is helpful in providing general guidance. A. KSR Tightened the Standard of Patentability If anything, the standard for patentability was tightened in KSR. As to motivation, if anything, KSR provides an endorsement of the denial of patentability where there is implicit motivation as in Stemniski to go from the prior art to the claimed innovation: We note the [Federal Circuit] has since [its decision below] elaborated a broader conception of the [teaching, suggestion, motivation] test than was applied in the instant matter. See, e.g., ***Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1291 (Fed. Cir. 2006) ( There is flexibility in our obviousness jurisprudence because a motivation may be found implicitly in the prior art. We do not have a rigid test that requires an actual teaching to combine...) ". KSR, 550 U.S. at (original emphasis by the Court). 1 1 The more complete quotation from Alza: There is flexibility in our obviousness jurisprudence because a motivation may be found implicitly in the prior art. We do not have a rigid test that requires an actual teaching to combine before concluding that one of ordinary skill in the art would know to combine references. This approach, moreover, does not exist merely in theory but in practice, as well. Our recent decisions in Kahn and in Cross Medical Products 11

42 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness B. KSR Standard of Motivation In terms of the actual holding in KSR the case had nothing to do with the test for implicit motivation to modify a known chemical compound, but instead had everything to do with the motivation to combine known elements to make a combination invention: As is clear from cases such as [United States v. Adams, 383 U.S. 39 (1966)], a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art. Although common sense directs one to look with care at a patent application that claims as innovation the combination of two known devices according to their established functions, it can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does. This is so because inventions in most, if not all, instances rely upon building blocks long since uncovered, and claimed discoveries almost of necessity will be combinations of what, in some sense, is already known. * * * The obviousness analysis cannot be confined by a formalistic conception of the words teaching, suggestion, and motivation, or by overemphasis on the importance of published articles and the explicit content of issued patents. The diversity of inventive pursuits and of modern technology counsels against limiting the analysis in this way. In many fields it may be that there is little discussion of obvious techniques or combinations, and it often may be the case that market demand, rather than scientific literature, will drive design trends. Granting patent amply illustrate the current state of this court's views. See * * * Cross Med. Prods.[, Inc., v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1322 (Fed. Cir. 2005)] (reversing a district court ruling of nonobviousness and explaining that the motivation to combine need not be found in prior art references, but equally can be found in the knowledge generally available to one of ordinary skill in the art such as knowledge of a problem to be solved). 12

43 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness protection to advances that would occur in the ordinary course without real innovation retards progress and may, in the case of patents combining previously known elements, deprive prior inventions of their value or utility. KSR, 550 U.S. at C. A Tightened Standard for Nonobviousness under KSR If there is anything instructive in the quoted text for the obviousness inquiry for an NCE it is that any change in the standard of patentability should be tightened and not loosened: Granting patent protection to advances that would occur in the ordinary course without real innovation retards progress and may ***deprive prior inventions of their value ***. KSR, 550 U.S. at 419. IV. PANEL LEAD COMPOUND FOCUS Although there is but one patent law for all technologies, and, a fortiori, one patent law for nonobviousness of NCE s whether a dyestuff, pesticide, pharmaceutical, monomer or any compound in any other field the renegade panels in disregard of both precedent and the tighter standard of patentability of KSR have remarkably loosened the standard of patentability for pharmaceutical compounds. Previously, a known chemical compound with a known utility was basis for an assumption that a penumbra of surrounding, novel compounds are structurally obvious. Now, under a lead compound theory, the assumption of obviousness is applied only to a penumbra of novel compounds surrounding a known lead compound, greatly broadening the sphere of compounds that are now free from an assumption of structural obviousness. 13

44 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness A. Eisai Lead Compound Departure from Precedent Recent panel precedent focuses upon the nonobviousness of a claimed compound versus a lead compound, a term never used by the Supreme Court nor the regional circuit courts of appeal nor ever specifically defined even by the Federal Circuit: Recent panel opinions have shifted the focus of the rebuttal of the Papesch presumption that a claimed compound is assumed to have the same properties as the closet prior art to a focus on a comparison with the lead compound. In the post-ksr case law, some panel opinions have markedly shifted from precedent that denies a patent to a new chemical entity that is prima facie obvious versus the closest prior art, absent a Papesch showing of unexpected properties. B. Takeda v. Alphapharm Harmless Error Confusion between a lead compound and the closest prior art may be traced to a harmless error by Alphapharm s counsel who discussed the obviousness inquiry in terms of a comparison of the claimed invention versus a lead compound in Takeda Chem. Indus. v. Alphapharm Pty., Ltd., 492 F.3d 1350 (Fed. Cir. 2007). 2 The mistake was noticed only late in the opinion drafting process but was harmless in the context of that case. Takeda v. Alphapharm, 492 F.3d at 1357 n.3 (Fed. Cir. 2007)( The parties do not dispute that [this compound] was the closest prior art compound. Thus, the legal question is whether or not the claimed subject matter would have been obvious over that compound. ) For whatever reason, the Court failed to change the draft and left the language 2 To be sure, the term lead compound, without definition of the term, was used as early as Yamanouchi Pharmaceutical Co. v. Danbury Pharmaceutical, Inc., 231 F.3d 1339 (Fed. Cir. 2000)(Rader, J.). 14

45 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness untouched. Id. ( We will, however, use [the patent challenger] s terminology of lead compound in this opinion[.] ). Perhaps given that Takeda v. Alphapharm was authored by the only pharmaceutical chemist on the Court who also authored the en banc opinion in Dillon, usage of a lead compound analysis may have gained credence. C. Eisai Departure from Precedent Shortly after Takeda v. Alphapharm, the leading case with departure from precedent in this area is the Eisai analysis which introduced the concept of a lead compound as the centerpiece for the obviousness inquiry of a pharmaceutical NCE: Obviousness based on structural similarity thus can be proved by identification of some motivation that would have led one of ordinary skill in the art to select and then modify a known compound (i.e. a lead compound) in a particular way to achieve the claimed compound. See Takeda Chem. Indus. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1356 (Fed. Cir. 2007). But, it is not any known compound but the closest prior art that was the focus of the inquiry in Takeda v. Alphapharm. (It would have been appropriate in the quotation in Eisai to refer to modi[fication of] a known compound (e.g. a lead compound) but not modi[fication of] a known compound (i.e. a lead compound) ) The mistake is repeated when the panel in Eisai says that [i]n other words, post-ksr, a prima facie case of obviousness for a chemical compound still, in general, begins with the reasoned identification of a lead compound[,] Eisai,

46 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness F.3d at Instead, the relevant inquiry is a reasoned identification of the closest prior art compound; this is explained in the previously quoted footnote in Takeda v. Alphapharm which referred to lead compound in the context of being the closest prior art compound. 3 The predicate for the statement quoted in Eisai is as follows: In KSR, the Supreme Court noted that an invention may have been obvious [w]hen there [was]... a design need or market pressure to solve a problem and there [were]... a finite number of identified, predictable solutions. 127 S. Ct. at 1742 (tense changes supplied to clarify, as the Court stated and as per 35 U.S.C. 103, that the obviousness inquiry must rely on evidence available at the time of the invention, see Takeda, 492 F.3d at 1356 n.2). The Supreme Court's analysis in KSR thus relies on several assumptions about the prior art landscape. First, KSR assumes a starting reference point or points in the art, prior to the time of invention, from which a skilled artisan might identify a problem and pursue potential solutions. Second, KSR presupposes that the record up to the time of invention would give some reasons, available within the knowledge of one of skill in the art, to make particular modifications to achieve the claimed compound. See Takeda, 492 F.3d at 1357 ( Thus, in cases involving new chemical compounds, it remains necessary to identify some reason that would have led a chemist to modify a known compound in a particular manner to establish prima facie obviousness of a new claimed compound. ). Third, the Supreme Court's analysis in KSR presumes that the record before the time of invention would supply some reasons for narrowing the prior art universe to a finite number of identified, predictable solutions, 127 S. Ct. at In Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc., 520 F.3d 1358, 1364 (Fed. Cir. 2008), this court further explained that this easily traversed, small and finite number of alternatives... might support an inference of obviousness. To the extent an art is unpredictable, as the chemical arts often are, KSR's focus on these identified, predictable solutions may present a difficult hurdle because potential solutions are less likely to be genuinely predictable. Eisai, 533 F.3d at

47 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness D. Later Panels, Building upon Rogue Precedent In Bristol-Myers the panel perpetuates the reasoning of Eisai that [g]enerally, an obviousness inquiry concerning [ ] known compounds focuses on the identity of a lead compound. Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 973 (Fed. Cir. 2014)(Chen, J.),subsequent proceedings, 769 F.3d 1339 (Fed. Cir. 2014)(Order den. reh g en banc)(quoting Eisai, 533 F.3d at 1359). A lead compound is a compound in the prior art that would be a natural choice for further development efforts. " Bristol-Myers, 752 F.3d at 973 (quoting Altana Pharma AG v. Teva Pharms. USA, Inc., 566 F.3d 999, 1008 (Fed. Cir. 2009)). But, what, precisely is a natural choice? Is a compound a natural choice because it is commercially solid from a patent standpoint, or from a standpoint of its properties or both? Renegade panel opinions include Unigene: A prima facie case of obviousness in the chemical arts is often based on a known compound, called a lead compound, which serves as a starting point for a person of ordinary skill developing the claimed invention. Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352, 1361 (Fed. Cir. 2011)(Rader, C.J.)(citing Eisai Co. Ltd. v. Dr. Reddy's Labs., 533 F.3d 1353, 1357 (Fed. Cir. 2008)). Despite its departure from precedent, the lead compound analysis persists to the present day: Mere structural similarity between a prior art compound and the claimed compound does not inform the lead compound selection. Pfizer Inc. v. Teva Pharms. USA, Inc., 555 Fed. Appx. 961, (Fed. Cir. 2014)(citing 17

48 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness Otsuka Pharm. Co. v. Sandoz Inc., 678 F.3d 1280, 1292 (Fed. Cir. 2012); Daiichi Sankyo Co. v. Matrix Labs., Ltd., 619 F.3d 1346, 1354 (Fed. Cir. 2010)). Against the backdrop of a well defined body of prima facie obviousness case law, there have now been several renegade panel opinions which have deviated from precedent where the claimed invention is measured for obviousness (at least in the regulated pharmaceutical industry) based upon the lead compound of the prior art. See IV, Panel Lead Compound Focus V. POLICY CONSIDERATIONS Eisai and its progeny open a Pandora s Box of questions. A. Federal Circuit Panels vs. the Supreme Court It is remarkable that panel opinions have invoked the KSR opinion as basis for panel opinion liberalization of the standard of patentability, a 180 degree turn from what actually happened in KSR. To open up for patenting novel compounds that up until now have been assumed to be obvious is, if anything, antithetical to the Supreme Court decision in KSR. 18

49 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness B. Patent Law Definition of a Lead Compound Lead compound is now a key point for NCE patentability in pharmaceuticals, but the metes and bounds of the term for patent law have never been defined! Nowhere, in any context does either the Supreme Court or the Federal Circuit provide a definition of the metes and bounds of this terminology. C. Commercial Realities divorced from Chemistry To the extent that the lead compound however it is defined is based upon superior properties of that compound versus other candidate compounds, then there is no harm in this panel departure from precedent. But, often the choice of the lead compound is based upon commercial realities having nothing to do with the properties of the selected compound. Thus, if a major pharmaceutical company has, say, thirty promising candidates to undergo regulatory approval testing at a cost of several hundred millions of dollars, a first consideration is whether there is an existing generic (blocking) patent in any of the United States, Germany, Japan, the United Kingdom, France and perhaps several further countries. If there is a blocking patent in any of these territories for a particular candidate for lead compound the cost of obtaining a license for all territories must be considered and a license successfully negotiated before the floodgate to hundreds of millions of dollars of regulatory testing is opened. 19

50 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness A second consideration is whether a potential lead compound has an exclusive patent position in the same countries of the world. Particularly in the case of potential pharmaceutical candidates licensed from an academic institution there are often weak spots in the global patent portfolio based upon the institution s reliance on the first inventor system where a publication during the grace period has fatally destroyed overseas patent rights. If there are compounds without this defect in the running or selection as a lead compound, clearly such globally patent-protected candidates will be favored. D. One Patent Law for All Technologies The problem of obviousness arises under section 103 of the Patent Act. It is a problem of patent law and not of chemistry. In re Papesch, 315 F.2d 381, 386 (CCPA 1963). Thus, the requirement of unobviousness in the case of chemical inventions is the same as for other types of inventions. In re Johnson, 747 F.2d 1456, 1460 (Fed. Cir. 1984)(Nichols, J.). The problem is more than theoretical: Many NCE s have dual utilities either as a regulated pharmaceutical i.e., a lead compound or other utilities that are not regulated where lead compound has no meaning. But, a compound is or is not prima facie obvious if obvious for any technology. 20

51 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness E. Confusion at the Patent Office The Office has had understandable difficulty in providing clear guidance as to how to deal with the lead compound case law, first in a Federal Register notice in 2010 and then in the Manual of Patent Examining Procedure. The notices speak for themselves. First, in the Federal Register the Office explains that: Office personnel are cautioned that the term lead compound in a particular opinion can have a contextual meaning that may vary from the way a pharmaceutical chemist might use the term. In the field of pharmaceutical chemistry, the term lead compound has been defined variously as a chemical compound that has pharmacological or biological activity and whose chemical structure is used as a starting point for chemical modifications in order to improve potency, selectivity, or pharmacokinetic parameters; [a] compound that exhibits pharmacological properties which suggest its development; and a potential drug being tested for safety and efficacy. See, e.g., accessed January 13, 2010; accessed January 13, 2010; and biotechnology.com/glossary4.php, accessed January 13, The Federal Circuit in Eisai makes it clear that from the perspective of the law of obviousness, any known compound might possibly serve as a lead compound: Obviousness based on structural similarity thus can be proved by identification of some motivation that would have led one of ordinary skill in the art to select and then modify a known compound (i.e. a lead compound) in a particular way to achieve the claimed compound. Eisai, 533 F.3d at Thus, Office personnel should recognize that a proper obviousness rejection of a claimed compound that is useful as a drug might be made beginning with an inactive compound, if, for example, the reasons for modifying a prior art compound to arrive at the claimed compound have nothing to do with pharmaceutical activity. The inactive compound would not be considered to be a lead compound by pharmaceutical chemists, but could potentially be used as such when considering obviousness. Office personnel might also base an obviousness rejection on a known compound that pharmaceutical chemists would not select as a lead compound due to expense, 21

52 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness handling issues, or other business considerations. However, there must be some reason for starting with that lead compound other than the mere fact that the lead compound merely exists. See Altana Pharma AG v. Teva Pharmaceuticals USA, Inc., 566 F.3d 999, 1007 (Fed. Cir. 2009) (holding that there must be some reason to select and modify a known compound ); Ortho-McNeil Pharmaceutical, Inc. v. Mylan Labs, Inc., 520 F.3d 1358, 1364 (Fed. Cir. 2008). Examination Guidelines Update: Developments in the Obviousness Inquiry After KSR v. Teleflex, 75 Federal Register 53643, (Sept )(Notice) Then, in the Manual of Patent Examining Procedure it is explained that: In the chemical arts, the cases involving so-called lead compounds form an important subgroup of the obviousness cases that are based on substitution. The Federal Circuit has had a number of opportunities since the KSR decision to discuss the circumstances under which it would have been obvious to modify a known compound to arrive at a claimed compound. *** Office personnel are cautioned that the term lead compounds in a particular opinion can have a contextual meaning that may vary from the way a pharmaceutical chemist might use the term. In the field of pharmaceutical chemistry, the term lead compounds has been defined variously as a chemical compound that has pharmacological or biological activity and whose chemical structure is used as a starting point for chemical modifications in order to improve potency, selectivity, or pharmacokinetic parameters; [a] compound that exhibits pharmacological properties which suggest its development; and a potential drug being tested for safety and efficacy. See, e.g., accessed January 13, 2010; accessed January 13, 2010; and accessed January 13, *** [O]ffice personnel should recognize that a proper obviousness rejection of a claimed compound that is useful as a drug might be made beginning with an inactive compound, if, for example, the reasons for modifying a prior art compound to arrive at the claimed compound have nothing to do with pharmaceutical activity. The inactive compound would not be considered to be a 22

53 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness lead compound by pharmaceutical chemists, but could potentially be used as such when considering obviousness. Office personnel might also base an obviousness rejection on a known compound that pharmaceutical chemists would not select as a lead compound due to expense, handling issues, or other business considerations. *** It should be noted that the lead compound cases do not stand for the proposition that identification of a single lead compound is necessary in every obviousness rejection of a chemical compound. For example, one might envision a suggestion in the prior art to formulate a compound having certain structurally defined moieties, or moieties with certain properties. If a person of ordinary skill would have known how to synthesize such a compound, and the structural and/or functional result could reasonably have been predicted, then a prima facie case of obviousness of the claimed chemical compound might exist even without identification a particular lead compound. As a second example, it could be possible to view a claimed compound as consisting of two known compounds attached via a chemical linker. The claimed compound might properly be found to have been obvious if there would have been a reason to link the two, if one of ordinary skill would have known how to do so, and if the resulting compound would have been the predictable result of the linkage procedure. Manual of Patent Examining Procedure 2143, Examples of Basic Requirements of a Prima Facie Case of Obviousness, B, Simple Substitution of One Known Element for Another To Obtain Predictable Results [R ](downloaded November 26, 2014). F. A Fractured Anti-Harmonized Global Patent Regime Creating a unique American patent regime in the pharmaceutical global village unnecessarily fractures the global pharmaceutical marketplace. It is unthinkable to create a unique American patent marketplace divorced from Europe, Japan and other leading countries. Given the hundreds of millions of dollars for regulatory approval costs for a pharmaceutical NCE it is imperative that the corporate entity funding the regulatory testing have the promise of a unified global 23

54 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness marketplace to provide maximum incentive based upon a worldwide patented product to justify the hundreds of millions of dollars for regulatory approval costs. G. Whither Binding Precedent [O]vertly conflicting decisions will repose in the official reporters, I suppose some day to be resolved, but meanwhile to place this law in disarray. This does not serve the public, or litigants, or trial judges, who are entitled to know how the Federal Circuit will interpret [the patent law], without depending on the luck of the draw of the appellate panel. Hon. Pauline Newman * VI. REACTION TO BRISTOL-MYERS The recent denial of rehearing en banc in Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 769 F.3d 1339 (Fed. Cir. 2014)(Order den. reh g en banc), panel opinion, 752 F.3d 967, 973 (Fed. Cir. 2014)(Chen, J.), in one sense is much ado about nothing: One member points out that she write[s] to assuage [petitioner] s and the amici's fears that this panel decision has rewritten the test for obviousness for pharmaceutical patents. In [her] view, the concerns expressed are unjustified and mischaracterize the opinion. * Atlantic Thermoplastics Co. v. Faytex Corp., 974 F.2d 1279, 1282 (Fed. Cir. 1992)(Newman, J., joined by Rich, Lourie, JJ., dissenting from den. reh g en banc). 24

55 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness This case does not forge new ground or set down immutable principles. It simply decides that, on the record before it, the district court did not err in finding the asserted claim invalid as obvious. Bristol-Myers, 769 F.3d at (O Malley, J., concurring in the denial of reh g en banc). * In another sense, the denial of rehearing is huge because of the multiple opinions that in particular perpetuate and emphasize deviation from precedent particularly in the area of the lead compound analysis. Once again, the Federal Circuit in its denial of rehearing en banc was badly split. Beyond the brief opinion of Circuit Judge O Malley explaining why the case is not fit for en banc review, there were several further opinions that may well gain the attention of the Supreme Court. See Bristol-Myers, 769 F.3d at (Newman, J., joined by Lourie, Reyna, JJ., dissenting from den. of petition for reh g en banc); Bristol-Myers, 769 F.3d at (Taranto, J., joined by Lourie, Reyna, JJ., dissenting from den. of petition for reh g en banc); Bristol-Myers, 769 F.3d at (Dyk, J., joined by Wallach, J., concurring in the den. of reh g en banc). While two of the newer members of the Court have shown support for a more liberal grant of en banc review (Reyna, Wallach, JJ.), perhaps more interesting is the viewpoint of the most experienced Supreme Court lawyer on the * The jurist painstakingly goes through the various specific issues raised in the en banc petition and then concludes that [the patentee] and the amici adopt a sky is falling approach to what is simply a fact dependent opinion. The opinion makes no dramatic changes to the law, closes no doors on what evidence may be considered in undertaking an obviousness inquiry, establishes no hard and fast tests for what results might be considered unexpected in a case involving a pharmaceutical compound, and does not improperly shift the burden of proof or denigrate the importance of objective indicia of non-obviousness. (footnote omitted). 25

56 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness court who would have granted en banc review even without a conflict in precedent. * Adding fuel to the fire in BMS v. Teva is the broad industry opposition to the panel opinion but without regard as to the issue of the lead compound : As pointed out by the senior active member of the Court, [t]his case has aroused extensive commentary, particularly in the chemical and pharmaceutical fields; the request for rehearing en banc is supported by much of the nation's research-based industry, which has filed briefs as amici curiae to point out the disincentives and uncertainties flowing from the court's rulings. Bristol-Myers, 769 F.3d at (Newman, J., joined by Lourie, Reyna, JJ., dissenting from den. reh g en banc). The dissent quotes from an amicus brief by a leading intellectual property organization that makes no mention of the lead compound issue: * Bristol-Myers, 769 F.3d at (Taranto, J., joined by Lourie, Reyna, JJ., dissenting from den. of petition for reh g en banc)( Although I am not confident of the answers, I think that the ruling raises questions about core aspects of the widely used approach to obviousness analysis particularly, the proper meaning of the related elements, reasonable expectation of success and unexpected results. Those questions would benefit from plenary consideration. In panel review, case-specific applications on complex facts necessarily consume almost all of the space of parties' briefs, and attention is focused almost exclusively on this court's own precedents. En banc review would allow a focus on and full analysis of the doctrinal issues, considering the language of section 103 (what it resolves and what it leaves open); the role of section 103 in the statute as a whole (which places a premium on early filing); Supreme Court precedents elaborating on the policy of section 103; our own precedents; congressional actions in light of those precedents; and pertinent, reliable information that may bear on assessing the real-world consequences of one answer or another in an industry where research is especially expensive and uncertain. The widened inquiry seems to me worthwhile. ) 26

57 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness [The panel] decision introduces substantial uncertainty into what appeared to be a clear legal standard; allowing this uncertainty to fester would affect countless pending and future cases. Obviousness is an issue in most patent examinations, litigations, and administrative proceedings. Particularly in unpredictable chemical and pharmaceutical fields, unexpected results evidencing differences and objective considerations can tip the balance between obviousness and non-obviousness. Patent owners would benefit from the certainty of an en banc ruling on when and how later-discovered differences between an invention and prior art may be considered in the obviousness analysis. Id. (quoting Brief of Amicus Curiae Intellectual Property Owners Association in Support of Rehearing En Banc at 6-7). VII. CONCLUSION Unnecessary unpredictability has been woven into the fabric of the law of chemical compound nonobviousness, first by a careless reference to a lead compound instead of the closest prior art in Takeda v. Alphapharm which was then compounded by a restyled standard of prima facie obviousness keyed to the lead compound in Eisai. The chaotic departure from precedent in Eisai is shown by the complex gyrations shown in the prima facie obviousness analysis in Altana Pharma AG v. Teva Pharms. USA, Inc., 566 F.3d 999 (Fed. Cir. 2009)(Ward, J.). Under a classic Stemniski analysis, the simple conclusion of prima facie obviousness is reached quite promptly. Instead, a more complex Eisai analysis is problematic: 27

58 Wegner, Bristol-Myers Lead Compound Prima Facie Obviousness [T]o establish a prima facie case of obviousness in cases involving new chemical compounds, the accused infringer must identify some reason that would have led a chemist to modify a known compound in a particular manner. See Yamanouchi Pharm. Co., Ltd. v. Danbury Pharmacal, Inc., 231 F.3d 1339, 1344 (Fed. Cir. 2000). This standard is consistent with the legal principles announced in the Supreme Court's decision in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). See Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1356 (Fed. Cir. 2007); Eisai, 533 F.3d at 1359 ( In other words, post-ksr, a prima facie case of obviousness for a chemical compound still, in general, begins with the reasoned identification of a lead compound. ). Obviousness based on structural similarity may be proven by the identification of some motivation that would have led one of ordinary skill in the art to select and modify a known compound in a particular way to achieve the claimed compound. Eisai, 533 F.3d at The requisite motivation can come from any number of sources and need not necessarily be explicit in the art. Id. (citing Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293, 1301 (Fed. Cir. 2007)). Instead, it is sufficient to show that the claimed and prior art compounds possess a 'sufficiently close relationship... to create an expectation,' in light of the totality of the prior art, that the new compound will have 'similar properties' to the old. Id. (quoting In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990) (en banc)). Altana, 566 F.3d at As manifested by Altana, an Eisai analysis for prima facie obviousness is neither simpler than nor consistent with the classic prima facie analysis that has stood the test of time and under the precedent of the still remains the law. 28

59 ABOUT THE AUTHOR HAROLD C. WEGNER has announced his retirement from Foley & Lardner LLP effective at the end of next month, which follows his recent twentieth anniversary with the firm. Prof. Wegner will continue to participate in academic events both domestically as well as in Asia and Europe. Prof. Wegner s patent career commenced with service at the U.S. Department of Commerce as a Patent Examiner. His academic involvement started with a three year period in Munich and Kyoto, first as a Wissenschaftliche Mitarbeiter under the late Professor Friedrich-Karl Beier at what is today the Max Planck Institute for Innovation and Competition, followed by studies as a Kenshuin at the Kyoto University Law Faculty in collaboration with the late Dr. Zentaro Kitagawa. After eight years on the adjunct faculty at the Georgetown University Law Center, Prof. Wegner commenced a twenty year affiliation with the George Washington University Law School; at GW he was Director of the Intellectual Property Law Program and Professor of Law. His involvement with other academic institutions has included service as a Visiting Professor at Tokyo University. Prof. Wegner holds degrees from Northwestern University (B.A.) and the Georgetown University Law Center (J.D.). contact: hwegner@foley.com This paper represents the author s personal views and does not necessarily reflect the views of any colleague, organization or client thereof. 29