Top Ten Patent Cases (Supreme Court) *

Transcription

1 Top Ten Patent Cases (Supreme Court) * Merits Appeals (Certiorari Granted) highlighted in turquoise Rank Case Name Issue Status 1 Myriad. 101 Patent Eligibility Respondent s Brief due March 7 2 Bowman v. Monsanto. Seed Patent Exhaustion Argument Feb. 19 _ 3 FTC v. Watson ANDA Reverse Payments Argument Mar Merck (K-Dur) ANDA Reverse Payments Held [GVR?] 5 Gunn v. Minton Federal Circuit Jurisdiction. Awaiting decision 6 Kirtsaeng v. Wiley International Exhaustion Awaiting decision 7 Epic Systems v. McKesson Joint Infringement Response due Feb. 4 8 Limelight v. Akamai Joint Infringement Response due Feb. 1 9 U.S. v. Beer Judicial Pay Response due Feb Ninestar v. ITC Int l Patent Exhaustion Response due Feb. 4 Computer Packages 101 Patent Eligibility Conference Feb. 15 California v. Caldera.. Federal Circuit Jurisdiction. Conference Feb. 15 Allcare v. Highmark Cybor déjà vu Petition due March 4 Nokia [InterDigital]. ITC Domestic Manufacture. Petition due April 9 ` Byrne v. Wood et al. Federal Circuit Jurisdiction Held [GVR?] *About the List: Harold C. Wegner is solely responsible for this list. The author is a former Professor of Law at the George Washington University Law School and is 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. This list updated January 20, 2013.

2 Supreme Court October 2012 Term Red Day Sessions (arguments and sometimes decisions). The argument calendar is full until the final six red days beginning April 15, Blue Day Sessions (no arguments; decisions only): In addition to announcing decisions from the bench at the Session beginning at 10:00 AM, an Orders List relating to the previous Conference is published at 9:30 AM that announces certiorari (and other) decisions. Several additional blue days will undoubtedly be added in June that will be announced shortly before such sessions. Conferences ( Green Days ): Certiorari votes announced that day (for grants, if early in the Term) or the next red or blue day. 2

3 (1) Myriad 101 Patent-Eligibility The Myriad case, Association for Molecular Pathology v. Myriad Genetics, Inc., Supreme Court No , challenges the split 2-1 Federal Circuit confirmation of patent-eligibility under 35 USC 101 of claims to isolated DNA. Status: Respondent s brief due March 7, 2013; amici briefs supporting Respondent due April 6, Argument is expected in the last six days of arguments this Term (April and 22-24). The Petition raised three Questions Presented. Certiorari was granted only as to the first Question Presented: First Question Presented: Many patients seek genetic testing to see if they have mutations in their genes that are associated with a significantly increased risk of breast or ovarian cancer. Respondent Myriad [ ] obtained patents on two human genes that correlate to this risk, known as BRCA1 and BRCA2. These patents claim every naturally-occurring version of those genes, including mutations, on the theory that Myriad invented something patent-eligible simply by removing ( isolating ) the genes from the body. Petitioners are primarily medical professionals who regularly use routine, conventional genetic testing methods to examine genes, but are prohibited from examining the human genes that Myriad claims to own. This case therefore presents the following questions: 1. Are human genes patentable? *** (2) Bowman v. Monsanto Patent Seed Exhaustion In Bowman v. Monsanto Co., Supreme Court No , proceedings below, Monsanto Co. v. Bowman, 657 F.3d 1341 (Fed. Cir. 2011)(Linn, J.), Petitioner challenges the denial of patent exhaustion as to harvested seeds produced from patented plant technology, an issue discussed in Wegner, Post-Quanta, Post-Sale Patentee Controls, IV-B-1, Restrictions on Reproduced Bio-Products: The Quanta Loophole, 7 J. Marshall Rev. Intell. Prop. L. 682, (2008), available at 3

4 This case is considered in more detail in the Analysis section, Patent Exhaustion Issues of First Impression. Status: Argument February 19, Question Presented: Patent exhaustion delimits rights of patent holders by eliminating the right to control or prohibit use of the invention after an authorized sale. In this case, the Federal Circuit refused to find exhaustion where a farmer used seeds purchased in an authorized sale for their natural and foreseeable purpose - namely, for planting. The question presented is: Whether the Federal Circuit erred by (1) refusing to find patent exhaustion in patented seeds even after an authorized sale and by (2) creating an exception to the doctrine of patent exhaustion for self-replicating technologies? (3) FTC v. Watson (AndroGel) ANDA Reverse Payments In FTC v. Watson Pharms., Inc., Supreme Court No , opinion below, 677 F.3d 1298 (11th Cir. 2012), the Court is reviewing the AndroGel ANDA reverse payment settlement case. Justice Alito is recused. Status: Merits briefing. Argument March 25, Question Presented: Federal competition law generally prohibits an incumbent firm from agreeing to pay a potential competitor to stay out of the market. See Palmer v. BRG of Ga., Inc., 498 U.S. 46, (1990). This case concerns agreements between (1) the manufacturer of a brand-name drug on which the manufacturer assertedly holds a patent, and (2) potential generic competitors who, in response to patent-infringement litigation brought against them by the manufacturer, defended on the grounds that their products would not infringe the patent and that the patent was invalid. The patent litigation culminated in a settlement through which the seller of the brand-name drug agreed to pay its would-be generic competitors tens of millions of dollars annually, and those competitors agreed not to sell competing generic drugs for a number of years. Settlements containing that combination of terms are commonly known as reverse payment agreements. The question presented is as follows: Whether reverse-payment agreements are per se lawful unless the underlying patent litigation was a sham or the patent was obtained by fraud (as the court below 4

5 held), or instead are presumptively anticompetitive and unlawful (as the Third Circuit has held). (4) Merck (K-Dur)-- ANDA Reverse Payments Merck & Co., Inc. v. Louisiana Wholesale Drug Co., Inc., Supreme Court No , and Upsher-Smith Laboratories Inc. v. Louisiana Wholesale Drug Co., Inc., Supreme Court No. No , each involve ANDA reverse payment settlement decisions in conflict with No. (3) FTC. v. Watson, which will be argued in March or April with a merits decision by the end of June Status: It is apparent that both Merck and Upsher-Smith are being held for certiorari review following a merits decision in FTC v. Watson. If the decision in that case raises a conflict with Merck and Upsher-Smith, a GVR in each case may be anticipated. Question Presented in Merck: Whether the federal antitrust laws permit a brand name manufacturer that holds the patent for a drug to enter into a settlement of patent litigation with a prospective generic manufacturer, where the settlement includes a payment from the brand manufacturer to the generic manufacturer but does not exclude competition beyond the scope of the patent. Question Presented in Upsher: Whether the Third Circuit erred by holding, contrary to the Second, Eleventh, and Federal Circuits, that an agreement settling patent litigation that does not restrict competition outside the scope of the exclusionary right granted by the patent itself may presumptively violate the antitrust laws. (5) Gunn v. Minton Federal Circuit Jurisdiction In Gunn v. Minton, Supreme Court No , opinion below, Minton v. Gunn, 355 S.W.3d 634, 55 Tex. Sup. Ct. J. 196 (2011), Petitioner raises the same issue of exclusive Federal Circuit jurisdiction as in Byrne v. Wood, Herron & Evans, LLP. Status: Awaiting decision (argued January 16, 2013). 5

6 Question Presented: Did the Federal Circuit depart from the standard this Court articulated in Grable & Sons Metal Products, Inc. v. Darue Eng'g & Mfg., 545 U.S. 308 (2005), for arising under jurisdiction of the federal courts under 28 U.S.C. 1338, when it held that state law legal malpractice claims against trial lawyers for their handling of underlying patent matters come within the exclusive jurisdiction of the federal courts? Because the Federal Circuit has exclusive jurisdiction over appeals involving patents, are state courts and federal courts strictly following the Federal Circuit's mistaken standard, thereby magnifying its jurisdictional error and sweeping broad swaths of state law claims - which involve no actual patents and have no impact on actual patent rights - into the federal courts? Discussion: There is no conflict to resolve between the Texas Supreme Court and the Federal Circuit. Rather, the dissent in Byrne v. Wood, Herron & Evans relies upon the dissent in the Texas Supreme Court opinion to show why the Federal Circuit majority is wrong. The petition in Gunn v. Minton is reviewed by Professor Dennis Crouch, Federal Jurisdiction over Patent Malpractice Cases Supreme Court Shows Interest in Gunn v. Minton, Patently O (April 27, 2012). Focus on Byrne v. Wood, Herron & Evans, L.L.P.: A supplemental brief was filed focusing upon this Federal Circuit case decided after the petition was filed: In Byrne the Federal Circuit denied rehearing en banc on the issue of whether the court should revisit its jurisdictional rule that state law legal malpractice claims arising out of patent matters come within the federal courts' arising under jurisdiction. Two judges of the court dissented from the court's decision to deny rehearing en banc on the jurisdiction issue, because it is time we stop exercising jurisdiction over state law malpractice claims. The Federal Circuit, which created the jurisdictional morass at issue in this case, is split within itself regarding whether to abandon the misguided and overlybroad jurisdictional standard it articulated in Air Measurement Tech., Inc. v. Akin Gump Strauss Hauer & Feld, L.L.P., 504 F.3d 1262 (Fed. Cir. 2007) and Immunocept, L.L.C. v. Fulbright & Jaworski, L.L.P., 504 F.3d 1281 (Fed. Cir. 2007). Ten judges on the Federal Circuit voted to deny rehearing en banc and leave the court's jurisdictional standard in place, while two judges dissented. 6

7 The Byrne case thus illustrates two significant reasons why this Court should grant the petition in this case. First, the Federal Circuit is not going to correct the problem itself. The court's 10-2 split illustrates that the misguided Air Measurement standard will remain in place and continue to wreak havoc until this Court corrects it. Second, the dissenting opinion explains very starkly that the five years since Air Measurement was decided have proved just how misguided the Federal Circuit's jurisdiction standard is: Ultimately, even if it was unclear in 2007 that our case law would sweep an entire class of state law malpractice actions into federal court, our recent experience renders no doubts about that point. And extending jurisdiction over these cases has done little, if anything, to promote uniformity in patent law. (6) Kirtsaeng v. John Wiley: International Exhaustion Kirtsaeng v. John Wiley & Sons, Inc., Supreme Court No , opinion below, 654 F.3d 210 (2d Cir. 2011)(Cabranes, J.), has the same denial of international exhaustion as in Omega S.A. v. Costco Wholesale Corp., 541 F.3d 982 (9th Cir. 2008)(Smith, Jr., J.), where the Court accepted review but then left the issue in the air with a 4-4 tie vote affirmance, Costco Wholesale Corp. v. Omega, S.A., 131 S.Ct. 565 (2010)(per curiam without opinion). This case is considered in more detail in the Analysis section, Patent Exhaustion Issues of First Impression. Status: Awaiting decision; argument was October 29, Question Presented: This case presents the issue that recently divided this Court, 4-4, in Costco Wholesale Corp. v. Omega, S.A., 131 S. Ct. 565 (2010). Under 602(a)(1) of the Copyright Act, it is impermissible to import a work without the authority of the owner of the copyright. But the first-sale doctrine, codified at 109(a), allows the owner of a copy lawfully made under this title to sell or otherwise dispose of the copy without the copyright owner's permission. The question presented is how these provisions apply to a copy that was made and legally acquired abroad and then imported into the United States. Can such a foreign-made product never be resold within the United States without the copyright owner's permission, as the Second Circuit held in this case? Can such a 7

8 foreign-made product sometimes be resold within the United States without permission, but only after the owner approves an earlier sale in this country, as the Ninth Circuit held in Costco? Or can such a product always be resold without permission within the United States, so long as the copyright owner authorized the first sale abroad, as the Third Circuit has indicated? (7) Epic Systems v. McKesson Joint Infringement (8) Limelight v. Akamai Joint Infringement In both Epic Systems Corp. v. McKesson Technologies, Inc., Supreme Court No , and Limelight Networks, Inc. v. Akamai Techs., Inc. v. Limelight Networks, Inc., Supreme Court No , opinion below in each case, Akamai Techs., Inc. v. Limelight Networks, Inc., 692 F.3d 1301 (Fed. Cir. 2012)(en banc)(per curiam), Petitioner questions whether there can be third party infringement liability in the absence of any direct infringement by any party under 35 USC 271(a). Status: Petitions were filed in each case on December 28, 2012; the Supreme Court docket sheet shows responses are due on February 4, 2013 in Epic Systems and February 1, 2013, in Limelight. Question Presented in Epic Systems: Whether a defendant may be held liable for inducing infringement of a patent that no one is liable for infringing. Question Presented in Limelight: [The patent claims] a method involving redirecting requests for Internet content and selecting optimal servers. The Federal Circuit acknowledged that neither [the accused infringer] nor customers using [the accused infringer's service directly infringe [the] patent under 35 U.S.C. 271(a) because no one performs all the steps of the patented method. The Federal Circuit nevertheless held that [the accused infringer] could be liable, under 35 U.S.C. 271(b), for inducing infringement if (1) it knew of [the] patent; (2) it performed all but one of the steps of the method; (3) it induced its customers to perform the final step of the claimed method; and (4) the customers performed that step. The question presented is: 8

9 Whether the Federal Circuit erred in holding that a defendant may be held liable for inducing patent infringement under 35 U.S.C. 271(b) even though no one has committed direct infringement under 271(a). Epic Systems Argument: This Court should grant review for the reasons that the five dissenting judges below articulated in the sharpest possible terms. A scant majority of that Court (Newman, J., dissenting), has significantly [b]roaden [ed] liability for patent infringement, thereby effectuating a sweeping change to the nation's patent policy, (Linn, J., dissenting). The majority concluded that a party may be held liable for inducing patent infringement when the conduct it induced would not itself be actionable as infringement. This approach is contrary to both the Patent Act and to the Supreme Court's longstanding precedent that if there is no direct infringement of a patent there can be no contributory infringement. (quoting Aro Mfg. Co. v. Convertible Top Replacement Co., 365 U.S. 336, 341 (1961) ( Aro I ); citing, inter alia, Deepsouth Packing Co. v. Laitram Corp., 406 U.S. 518, 526 (1972)). Simply put, the Federal Circuit's new rule is not in accordance with statute, precedent, and sound policy. It raises new issues unrecognized by the majority, and contains vast potential for abuse. (Newman, J., dissenting). These are compelling reasons for this Court's review. Limelight s Argument: The Federal Circuit's holding that [the accused infringer] may be liable, under 35 U.S.C. 271(b), for inducing infringement of [the] patent even though no party directly infringed the patent under 271(a) conflicts with this Court's holding, repeatedly reaffirmed, that if there is no direct infringement of a patent there can be no [indirect] infringement. Aro Mfg. Co. v. Convertible Top Replacement Co., 365 U.S. 336, 341 (1961) ( Aro I ) (referring to principle as a fundamental precept of patent law); see Global-Tech Appliances, Inc. v. SEB S.A., 131 S. Ct. 2060, 2065 (2011); Deepsouth Packing Co. v. Laitram Corp., 406 U.S. 518, 526 (1972); Aro Mfg. Co. v. Convertible Top Replacement Co., 377 U.S. 476, 483 (1964); see also Dawson Chem. Co. v. Rohm & Haas Co., 448 U.S. 176 (1980); Mercoid Corp. v. Mid-Continent Inv. Co., 320 U.S. 661, 677 (1944) (Frankfurter, J., dissenting). A Deeply Fractured Federal Circuit: The senior member of the Court explains: This en banc court has split into two factions, neither of which resolves the issues 9

10 of divided infringement. A scant majority of the court adopts a new theory of patent infringement, based on criminal law, whereby any entity that advises, encourages, or otherwise induces, or causes, urges, encourages, or aids the infringing conduct, is liable for the infringing conduct. The majority further holds that only the inducer is liable for divided infringement, and that the direct infringers are not liable although the patent rights are plainly being violated by the actors' joint conduct. These are dramatic changes in the law of infringement. On this new inducement-only rule, the inducing entity is liable on greatly enlarged grounds, such as merely advising or encouraging acts that may constitute direct infringement. This new rule is not in accordance with statute, precedent, and sound policy. It raises new issues unrecognized by the majority, and contains vast potential for abuse. Akamai, 692 F.3d at 1319 (Newman, J., dissenting). The second senior-most member of the four dissenting judges (who has himself now taken senior status) explains the former majority viewpoint: [T]his court assumes the mantle of policy maker. It has decided that the plain text of 271(a) and (b) fails to accord patentees certain extended rights that a majority of this court's judges would prefer that the statute covered. To correct this situation, the majority effectively rewrites these sections, telling us that the term infringement was not, as was previously thought, defined by Congress in 271(a), but instead can mean different things in different contexts. The majority's approach is contrary to both the Patent Act and to the Supreme Court's longstanding precedent that if there is no direct infringement of a patent there can be no contributory infringement. Aro Mfg. Co. v. Convertible Top Replacement Co., 365 U.S. 336, 341 (1961); Deepsouth Packing Co. v. Laitram Corp., 406 U.S. 518, 526 (1972) (quoting Mercoid Corp. v. Mid Continent Co. ( Mercoid I ), 320 U.S. 661, 677 (1944) (Frankfurter, J., dissenting on other grounds)); see also Joy Techs., Inc. v. Flakt, Inc., 6 F.3d 770, 774 (Fed.Cir.1993) ( Liability for either active inducement of infringement or for contributory infringement is dependent upon the existence of direct infringement. ); C.R. Bard v. Advanced Cardiovascular Sys., Inc., 911 F.2d 670, 673 (Fed.Cir.1990) (same). Akamai, 692 F.3d at 1337 (Linn, J., joined by Dyk, Prost, O Malley, JJ.). Two Critical Votes by the Two Newest Members of the Federal Circuit: The Federal Circuit is a court in transition. What was once was an apparent solid 10

11 majority for the viewpoint of what became the dissent in the opinion below was swung to a 6-5 per curiam majority thanks to the votes of the two newest members of the Court, Wallach, Reyna, JJ. With the possible exception of the senior member of the Court, the penultimate member of the Court has the highest ratio of separate opinions concurring, dissenting (or concurring dubitante) versus majority opinions of any member of the Court. Both have taken a positive attitude to become deeply involved with the most important matters of the Court, a sharp departure from a generation ago when newer members of the Court were reluctant to vote for en banc consideration of cases; it was then very difficult to obtain review of clear conflicts within the Circuit. This was perhaps best manifested by the conflict between Scripps Clinic & Research Found. v. Genentech, Inc., 927 F.2d 1565 (Fed.Cir.1991), and Atlantic Thermoplastics Co. v. Faytex Corp., 970 F.2d 834 (Fed.Cir.1992). The Court repeatedly refused to resolve this conflict through an en banc proceeding, e.g., SmithKline Beecham Corp. v. Apotex Corp., 453 F.3d 1346 (Fed. Cir. 2006)(Order den. reh g en banc). The conflict was only finally resolved seventeen (17) years after Atlantic Thermoplastics in Abbott Laboratories v. Sandoz, Inc., 566 F.3d 1282 (Fed. Cir. 2009)(en banc)(rader, J.) (9) United States v. Beer Judicial Pay In United States v. Beer, Supreme Court No , opinion below, Beer v. United States, 696 F.3d 1174 (Fed. Cir. 2012)(en banc)(rader, C.J.), the Department of Justice questions the en banc decision of the Federal Circuit that determined that members of the Federal Judiciary are entitled to cost of living pay adjustments. Status: Response to Petition due February 4, Questions Presented: 1. Whether the Compensation Clause prohibited Congress from disallowing certain annual increases in judicial salary contemplated by the Ethics Reform Act of 1989, Pub. L. No , when the statutes disallowing those increases were enacted into law before the increases were scheduled to take effect. 11

12 2. Whether, under the Act of Nov. 28, 2001, Pub. L. No , 625, amending Pub. L , 140, Congress's failure in 2007 and 2010 to pass specific legislation authorizing judicial salary increases prevented increases for those years from taking effect. Discussion: While this case has absolutely nothing to do with intellectual property law, the case may be the highest profile Federal Circuit case at the Supreme Court in terms of the attention of the federal judiciary at all levels because it deals with Congressional denial of cost of living pay adjustments. (10) Ninestar v. ITC -- International Exhaustion Ninestar Technology Co., Ltd. v. International Trade Com'n, Supreme Court No , opinion below, 667 F.3d 1373 (Fed. Cir. 2012) (Newman, J.), challenges the Federal Circuit s denial of international patent exhaustion. Status: Responses to Petition are due February 4, 2013 (extended period). Discussion: This case is considered in more detail in the Analysis section, Patent Exhaustion Issues of First Impression. Question Presented: The longstanding doctrine of patent exhaustion provides that the initial authorized sale of a patented item terminates all patent rights to that item. Quanta Computer, Inc. v. LG Elecs., Inc., 553 U.S. 617, 625 (2008). In Holiday v. Mattheson, 24 F. 185, 185 (C.C.S.D.N.Y. 1885), the court held that foreign sales authorized by U.S. patentees exhaust U.S. patent rights. That decision was followed for more than a century. In Jazz Photo Corp. v. International Trade Commission, 264 F.3d 1094, 1105 (Fed. Cir. 2001), however, the Federal Circuit concluded that foreign sales do not exhaust U.S. patent rights. The question presented is: Whether the initial authorized sale outside the United States of a patented item terminates all patent rights to that item. Argument for Grant: For over a century, courts consistently held that authorized sales abroad exhaust U.S. patent rights. In Jazz Photo Corp. v. International Trade Commission, 264 F.3d 1094, 1105 (Fed. Cir. 2001), however, the Federal Circuit reversed course. That decision the operative portion of which was two sentences in length did not acknowledge the preexisting law. 12

13 The court relied solely on Boesch v. Graff, 133 U.S. 697, (1890), but, as lower courts and commentators alike have noted, the Federal Circuit s reading of Boesch was wrong. Any uncertainty about international patent exhaustion should have been put to rest by this Court s decision in Quanta Computer, Inc. v. LG Electronics, Inc., 553 U.S. 617, 625 (2008). There, the Court indicated that products sold abroad exhaust U.S. patent rights. Yet the Federal Circuit has refused to reconsider Jazz Photo in light of Quanta, and it continues to apply Jazz Photo s rule, as it did in this case. This Court should grant review to settle the rule governing international patent exhaustion. Not only is Jazz Photo wrong, but it has substantial and baleful practical implications for global trade. The U.S. import market for patented goods sold abroad is enormous, and barring importation of these goods causes U.S. consumers to pay inflated prices. The rule of Jazz Photo also restricts growth of the domestic remanufacturing industry, which relies on imports of patented goods suitable for repair. Yet more troubling, the rule encourages U.S. patent holders to move production facilities overseas. And Jazz Photo has been shown to restrict innovation. A GVR, Return to the Federal Circuit: Given that both Kirtsaeng (argued October 29, 2012) and Bowman v. Monsanto (to be argued this Term) have an exhaustion issue, a strong likelihood exists that the Court will defer a vote on certiorari in Ninestar until after a decision in either or both cases. To the extent that the Court concludes that exhaustion is present in either Kirtsaeng or Bowman v. Monsanto, a substantial chance exists that the Court will grant, vacate and remand (GVR) in Ninestar in light of the merits decision in either Kirtsaeng or Bowman v. Monsanto. Petitioner expressly asks that the case be held for such a GVR as an alternative to the outright grant of certiorari: Alternatively, the Court should hold this petition pending resolution of Kirtsaeng v. John Wiley & Sons, Inc., No [argued October 29, 2012], and Bowman v. Monsanto Co., No (cert. granted Oct. 5, 2012), two cases that present questions bearing some relationship to the issue here. 13

14 Computer Packages 101 Patent-Eligibility In Computer Packages, Inc. v. Whitserve, LLC, Supreme Court No , opinion below, Whitserve, LLC v. Computer Packages, Inc., 694 F.3d 10 (Fed. Cir. 2012)(O Malley, J.), a fractured panel procedurally denied consideration of a Section 101 invalidity issue that was not briefed before the Federal Circuit. The petition takes up the view of the dissent, Whitserve, 694 F.3d at (Mayer, J., dissenting), that reached the merits and argued that the standards of Section 101 are not met. Status: Conference February 15, Questions Presented: 1. Whether 35 U.S.C. 101, which defines the subject matter that is eligible for a patent, is a jurisdictional statute. 2. Whether a federal court must address whether a patent claims abstract ideas or mental steps, outside the scope of patentable subject matter defined by 35 U.S.C. 101, whenever the issue comes to the court's attention. 3. Whether Respondents' [four patents], which patent looking up due dates and notifying clients of them, claim unpatentable abstract ideas or mental steps under 35 U.S.C The Merits Dissent Below: There can be no infringement of [the WhitServe patents] because they are invalid. The WhitServe patents are barred at the threshold by [35 U.S.C.] 101, Diamond v. Diehr, 450 U.S. 175, 188 (1981), because they are directed to the abstract idea that it is useful to provide people with reminders of approaching due dates and deadlines. See Mayo Collaborative Servs. v. Prometheus Labs., Inc., U.S., 132 S.Ct. 1289, 1303 (2012) (explaining that section 101 performs a vital screening function ); Bilski v. Kappos, U.S., 130 S.Ct. 3218, 3225 (2010) (noting that whether claims are directed to statutory subject matter is a threshold test ). Whitserve, 694 F.3d at 39 (Mayer, J., dissenting). The Procedural Dissent Below: [A] court may consider an issue antecedent to... and ultimately dispositive of the dispute before it, even an issue the parties fail to 14

15 identify and brief. See U.S. Nat'l Bank v. Indep. Ins. Agents, 508 U.S. 439, 447 (1993) (citations and internal quotation marks omitted). It is appropriate to take up an issue not specifically raised by the parties where there have been significant changes in applicable law since the trial court's decision. See Hormel v. Helvering, 312 U.S. 552, 558 (1941); see also Kamen v. Kemper Fin. Servs., Inc., 500 U.S. 90, 99 (1991) ( When an issue or claim is properly before the court, the court is not limited to the particular legal theories advanced by the parties, but rather retains the independent power to identify and apply the proper construction of governing law. ). When it was before the trial court, Computer Packages [ ] unsuccessfully sought to obtain a declaratory judgment that the WhitServe patents were invalid under section 101. See Joint App'x 136, 142. Although [Computer Packages] did not include a discussion of section 101 when it filed its appeal briefs here, we can take it up because the Supreme Court's Mayo decision, which issued after [Computer Packages]'s briefs were filed, makes clear that the Whit Serve patents disclose no inventive concept, 132 S.Ct. at 1294, that would even arguably confer patent eligibility. See Forshey v. Principi, 284 F.3d 1335, 1356 (Fed.Cir.2002) (en banc) ( [D]ecision of an issue not decided or raised below is permitted when there is a change in the jurisprudence of the reviewing court or the Supreme Court after consideration of the case by the lower court. ). The majority errs in refusing to address the question of whether the WhitServe patents meet section 101's eligibility requirements and in requiring [Computer Packages] to return to the trial court to relitigate the appropriate measure of damages for its alleged infringement of plainly invalid claims. See Bradley v. Sch. Bd. of Richmond, 416 U.S. 696, 711 (1974) ( [A] court is to apply the law in effect at the time it renders its decision, unless doing so would result in manifest injustice or there is statutory direction or legislative history to the contrary. ); Hormel, 312 U.S. at 557 ( Rules of practice and procedure are devised to promote the ends of justice, not to defeat them. A rigid and undeviating judicially declared practice under which courts of review would invariably and under all circumstances decline to consider all questions which had not previously been specifically urged would be out of harmony with this policy. ). Whitserve, 694 F.3d at (Mayer, J., dissenting). 15

16 California v. Caldera Federal Jurisdiction In Regents of the Univ. of California v. Caldera Pharm., Inc., Supreme Court No , opinion below, Caldera Pharm., Inc. v. Regents of the Univ. of Cal, 205 Cal. App. 4th 338, 140 Cal. Rptr. 3d 543 (2012), the Court is asked whether there is exclusive federal jurisdiction over a patent license dispute. Status: Conference February 15, Discussion: This case may very well be held for a certiorari decision until after a merits decision in Gunn v. Minton. Questions Presented (per Petitioner): 1. Are a patent licensee's contract and tort claims against its licensor claims that arise under federal patent law such that they are within the exclusive jurisdiction of the federal courts when: a. those claims depend upon proof of infringement of a claim of a licensed patent or patent application; b. the patent license measures the allegedly breached obligations by reference to provisions of the federal patent laws and regulations governing practice before the United States Patent and Trademark Office; or, c. the licensee's claims seek to impose duties upon licensed practitioners conducting patent prosecution before the United States Patent and Trademark Office? 2. In determining whether a patent license dispute arises under federal patent law and is within the exclusive jurisdiction of the federal courts, should the court consider the license and actual elements of proof necessary for the plaintiff to prevail on its claims? Questions Presented (per Respondent): Did the California Court of Appeal properly determine that exclusive federal jurisdiction pursuant to 28 U.S.C. 1338(a) does not apply to a case alleging counts for breach of contract, fraud, and breach of the implied covenant of good faith and fair dealing? 16

17 Allcare v. Highmark: Cybor Déjà vu Allcare Health Mgmt. Sys., Inc. v. Highmark Inc., is the anticipated certiorari petition from the denial of rehearing en banc in Highmark Inc. v. Allcare Health Mgmt. Sys., Inc., F.3d (Fed. Cir. 2012), panel opinion, 687 F.3d 1300 (Fed. Cir. 2012), where the en banc petitioner unsuccessfully sought review of the de novo standard of review for a fact-based determination, here, an exceptional case determination under 35 USC 285. Status: The petition for certiorari is due March 4, A Deeply Fractured En Banc Panel: Plural dissenting opinions were issued dissenting from denial of rehearing en banc, including a principal opinion by Moore, J., joined by Rader, C.J., O Malley, Reyna, Wallach, JJ., dissenting from the denial of the petition for rehearing en banc. This is only the latest episode in a thirty year struggle by the Court to deal with FRCP 52(a) deferential standard of review of trial court fact findings. Rule 52(a) has troubled the Federal Circuit since its inception. The issue was squarely raised by the Supreme Court in its intervention in Dennison Mfg. Co. v. Panduit Corp., 475 U.S. 809 (1986). Here, the controversy first bubbled up into widespread public attention in the context of the factual underpinnings for an obviousness determination under 35 USC 103. The current dispute is capsulized by the main dissent in Highmark by Judge Moore: Our court system has well-defined roles: the trial court makes factual findings and the appellate court reviews those findings with deference to the expertise of the trial court. An exceptional case determination under 35 U.S.C. 285 has traditionally been one of the questions of fact determined by the trial court that is review-able only for clear error. Contrary to our precedent, the divided Highmark panel decided that a district court s exceptional case finding based on its determination that the infringement claims asserted at trial were objectively baseless is entitled to no deference and should be reviewed de novo. 17

18 Highmark,[687 F.3d at ]. Because Highmark * * * invades the province of the fact finder, and establishes a review standard for exceptional case findings in patent cases that is squarely at odds with the highly deferential review adopted by every regional circuit and the Supreme Court in other areas of law, I dissent from the denial of rehearing en banc. * * * We need to avoid the temptation to label everything legal and usurp the province of the fact finder with our manufactured de novo review. We have done it with claim construction, see Cybor[Corp. v. FAS Techs., Inc., 138 F.3d 1448, (Fed. Cir. 1998) (en banc)], with willfulness, see Bard [Peripheral Vascular, Inc. v. W.L. Gore & Assocs., 682 F.3d 1003 (Fed. Cir.2012)], and now with the exceptional case, see Highmark. When we convert factual issues, or mixed questions of law and fact, into legal ones for our de novo review, we undermine the uniformity and predictability goals this court was designed to advance. CCPA Genesis of the Rule 52(a) Controversy: Throughout its thirty year history the Federal Circuit has had great difficulty coming to grips with FRCP 52(a) deferential review of factual determinations in patent matters. The dean of the Federal Circuit early on explained that the predecessor CCPA had a lax standard of review of Patent Office decisions: One of the things that changed in the transition from CCPA to CAFC is much greater emphasis in the new court on standard of review. Giles S. Rich, Thirty Years of this Judging Business, Giles S. Rich 139, 148 (1986). The Supreme Court Speaks in Dennison: The first open confrontation with the Supreme Court occurred four years after creation of the Federal Circuit in Dennison: The Federal Circuit [in its obviousness ruling] did not mention Rule 52(a), did not explicitly apply the clearly-erroneous standard to any of the District Court's findings on obviousness, and did not explain why, if it was of that view, Rule 52(a) had no applicability to this issue. We therefore lack an adequate explanation of the basis for the Court of Appeals' judgment: most importantly, we lack the benefit of the Federal Circuit's informed opinion on the complex issue of the degree to which the obviousness determination is one of fact. 18

19 In the absence of an opinion clearly setting forth the views of the Court of Appeals on these matters, we are not prepared to give plenary consideration to petitioner's claim that the decision below cannot be squared with Rule 52(a). Instead, we grant the petition for certiorari, vacate the judgment, and remand the case to the Court of Appeals for further consideration in light of Rule 52(a). Dennison Mfg. Co. v. Panduit Corp., 475 U.S. 809, 811 (1986). Judge Rich took to the pages of the AIPLA Quarterly Law Journal to respond to the Supreme Court: [The CCPA] did not act like the Circuit Courts of Appeal. We have been breaking that habit. Meanwhile, the criticism I hear of the [Federal Circuit] most often is that we have been doing de novo fact finding and delving into the record on our own when we should not. I am probably one of the offenders. But I have to say that I do not know how one can decide whether a finding of fact is clearly erroneous without delving into the record, and surely we have the right to make such a decision. I also must say that I have great difficulty in determining the distinction between an alleged fact being wrong and being clearly erroneous, and I seem to remember a learned colleague saying It doesn't matter; if you want to upset the fact finding, you just have to use the magic words. Rich, 14 AIPLA Q. J. at 149. Nokia ITC Domestic Manufacture In the Nokia case, opinion below, InterDigital Communications, LLC v. International Trade Com'n, F.3d (Fed. Cir. 2013)(on panel reh g), vacated panel opinion, 690 F.3d 1318 (2012), the expected certiorari petition will challenge ITC jurisdiction to consider patent infringement without domestic manufacture. Status: The Court denied rehearing en banc, paving the way for a Supreme Court petition by Nokia by April 9, From the Majority Opinion below: [S]ection 337 makes relief available to a party that has a substantial investment in exploitation of a patent through either engineering, research and development, or licensing. It is not necessary that the party manufacture the product that is protected by the patent, and it is not necessary that any other domestic party manufacture the protected article. As long 19

20 as the patent covers the article that is the subject of the exclusion proceeding, and as long as the party seeking relief can show that it has a sufficiently substantial investment in the exploitation of the intellectual property to satisfy the domestic industry requirement of the statute, that party is entitled to seek relief under section 337. InterDigital, F.3d at. From the Dissenting Opinion: My colleagues depart from the statutory text and purpose, in holding that the statutory requirement of domestic industry does not require domestic manufacture. The statute says, twice, that there must be articles protected by the patent, 1337(a)(2), (a)(3), whether produced by the patentee, or under license from the patentee. The domestic industry requirement is not met by foreign manufactures. InterDigital, F.3d at (Newman, J., dissenting). GSK v. Classen 271(e)(1) Safe Harbor In GlaxoSmithKline v. Classen Immunotherapies, Supreme Court No , proceedings below sub nom Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011)(Newman, J.), on remand from the Supreme Court upon Order granting, vacating and remanding in light of Bilski, 130 S.Ct (2010), earlier Federal Circuit opinion, 304 Fed.Appx. 866 (Fed. Cir. 2008)(Moore, J.), petitioner questions the Federal Circuit limitation of the safe harbor of 35 USC 271(e)(1) to exclude from infringement uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs to activities prior to regulatory approval. This case represents an opportunity for the Court to further refine its interpretation of the safe harbor in Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005), discussed in Harold C. Wegner, Post-Merck Experimental Use and the Safe Harbor, 15 Fed. Cir. B.J. 1 (2005). Status: Certiorari is likely to be denied in the Orders List of January 14, 2014, given that the Conference was held January 11, 2013 and no decision was issued that day. Only Question Presented: Congress has created a statutory safe harbor from patent-infringement liability for otherwise-infringing conduct that is reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs. 35 U.S.C. 271(e)(1). In this case, the Federal Circuit concluded that this safe harbor is limited to activities 20

21 conducted to obtain pre-marketing approval of generic counterparts. The question presented is: Whether the Federal Circuit's interpretation of 271(e)(1), which arbitrarily restricts the safe harbor to preapproval activities, is faithful to statutory text that contains no such limitation, and decisions of this Court rejecting similar efforts to impose extra-textual limitations on the statute. The Unasked Question not Presented to the Court: The principal issue addressed by the split Federal Circuit panel focused on the patent-eligibility of claims that the patentee in his petition that the patentee summarizes as including a risk evaluation step (I). * This raised issues of patent-eligibility under 35 USC 101 which were the principal focus of the opinion below, and which might be considered basis for a GVR in view of Mayo v. Prometheus, if there had been a relevant Question Presented. Discussion: Petitioner argues that post-regulatory approval testing that is required for submission to the FDA is included within the wording of the safe harbor of 35 USC 271(e)(1). The Legislative History: Patentee relies upon the legislative history that does not support the Petitioner s viewpoint. It is, indeed, clear that the legislative history of the safe harbor is focused upon pre-approval testing that is mutually exclusive from the activities under consideration in this appeal. The patentee does makes a convincing case that the legislative history is entirely focused on pre-approval testing. There is no dispute, however, that the post-approval testing involved in the instant case is within the literal wording of the statutory safe harbor. The * Classen Response to the Petition. More completely, Respondent states: The '139 and '739 patents include a total of 183 claims [which] cover a routine method of therapeutic use and are directed to immunizing a mammalian subject. They recite two method steps: (I) screening two or more immunization schedules; and (II) immunizing according to the lower risk schedule. The '790 Patent has 213 claims directed to methods of immunization and compositions therefor, which provide for substantially preventing or reducing the symptoms of at least one infectious disease and at least one chronic immune mediated disorder, and recite three method steps: (I) considering the association between an immunization schedule and one or more chronic immune-mediated disorder, (II) screening one or more potential recipients, and (III) immunizing according to the lower-risk schedule. 21

22 patentee does not provide a detailed discussion as to why the Court should depart from its view that had disregarded the legislative history in Merck v. Integra. The Plain Meaning of the Statute: The Court in Merck v. Integra first of all noted the broad scope of the statute, particularly as first interpreted by the Court in 1990: [I]t is apparent from the statutory text that 271(e)(1)'s exemption from infringement extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the FDCA. Cf. Eli Lilly[& Co. v. Medtronic, Inc., 496 U.S. 661, (1990)], (declining to limit 271(e)(1)'s exemption from infringement to submissions under particular statutory provisions that regulate drugs). * * * There is simply no room in the statute for excluding certain information from the exemption on the basis of the phase of research in which it is developed or the particular submission in which it could be included. Merck v. Integra, 545 U.S. at 202 (footnote omitted). Thus, Congress did not limit 271(e)(1)'s safe harbor to the development of information for inclusion in a submission to the FDA; nor did it create an exemption applicable only to the research relevant to filing an ANDA for approval of a generic drug. Rather, it exempted from infringement all uses of patented compounds reasonably related to the process of developing information for submission under any federal law regulating the manufacture, use, or distribution of drugs. See Eli Lilly, 496 U.S. at 674. We decline to read the reasonable relation requirement so narrowly as to render 271(e)(1)'s stated protection of activities leading to FDA approval for all drugs illusory. Id., 545 U.S. at Respondent s Constitutional Law Argument: If Petitioner's and Amicus PRMA's interpretation of 271(e)(1) were adopted by this Court, it would completely eviscerate the patent right enshrined in the United States Constitution in the field of pharmaceutical and medical device patents. Since, as pointed out by Petitioner and Amicus PRMA, there are many statutory and regulatory requirements for pharmaceutical drug and medical device manufacturers to comply with after FDA marketing approval for a drug or device has been obtained, extending 271(e)(1) to encompass uses of a patented invention to comply with those requirements would provide pharmaceutical and medical device 22

23 manufacturers with a complete defense to a claim of patent infringement that would last throughout the life of the patent or the life cycle of the drug or device, whichever expired first. The Solicitor General Suggests Denial of Certiorari: The Solicitor General in his CVSG brief agrees with Petitioner s view that the wording of 271(e)(1) covers post-approval testing, but in essence says that subsequent to the CVSG briefing order, the Federal Circuit corrected its mistake in the majority opinion in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348, (Fed. Cir. 2012)(Moore, J.) (To be sure, the panel in Momenta was fractured, with a vigorous opposing view to the holding in that case, Momenta Pharmaceuticals, 686 F.3d at (Rader, C.J., dissenting)(distinguishing Merck v. Integra).) In essence, the Solicitor General said that while the Government disagrees with what the Federal Circuit said in the opinion below, because the Federal Circuit has issued the Momenta opinion that repudiates statements in the opinion below, it is not worthwhile for the Court to invest its time in granting review in this case: [A]fter the Court invited the Solicitor General to express the views of the United States in this case, the Federal Circuit issued its decision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (2012). In Momenta, a divided panel ruled that the plain language of [Section 271(e)(1)] is not restricted to pre-approval activities. Id. at The panel concluded that post-approval studies that are reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs' fall within the scope of the [Section] 271(e)(1) safe harbor. Id. at In so holding, the court of appeals in Momenta distinguished its decision in this case as standing only for the proposition that Section 271(e)(1)'s safe harbor does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained. 686 F.3d at (quoting Pet. App. 27a). According to the Momenta majority, the court of appeals' decision in this case did not turn on any artificial distinction between pre- and post-approval 23

24 activities. Id. at Chief Judge Rader, dissenting in Momenta, argued that the panel had misconstrued the reasoning of its prior decision in this case and had come out the exact opposite way. Id. at On November 20, 2012, the Federal Circuit denied rehearing en banc in Momenta. See Docket entry No. 86. *** The [Federal Circuit] erred in stating that Section 271(e)(1)'s safe harbor encompasses only activities undertaken to obtain the FDA's pre-marketing approval of generic products. Congress not only contemplated that drug manufacturers would conduct post-approval scientific studies and clinical trials, but specifically authorized the FDA to require such, studies in a variety of circumstances. If such post-approval studies involve the use of patented inventions solely for uses reasonably related to the development and submission of information to the FDA, the plain language of Section 271(e)(1) precludes any claim for patent infringement. Nevertheless, there is no longer any practical need for this Court's intervention in light of the Federal Circuit's subsequent decision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (2012). The court in Momenta adopted a narrowing construction of the ruling below and held that postapproval studies performed for the FDA fall within the scope of the [Section] 271(e)(1) safe harbor, id. at In addition, this case would provide a poor vehicle for the Court to consider the application of Section 271(e)(1) to postapproval activities, both because it is unclear whether Section 271(e)(1) applies to patented research methods, and because petitioner is not entitled to the safe harbor even under a proper reading of that provision. Further review therefore is not warranted. W.L. Gore v. C.R. Bard Joint Inventorship In W.L. Gore & Associates, Inc. v. C.R. Bard, Inc., Supreme Court No , opinion below, Bard Peripheral Vascular, Inc. v. W.L. Gore & Assocs., Inc., 670 F.3d 1171 (Fed.Cir.2012)(Gajarsa, J.), mod'f on petition for reh g, 682 F.3d 1003 (2012), Petitioner challenges joint inventorship standards in this case, stated to be in conflict with General Electric Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242 (1945). The standards move away from the statutory revision for joint 24