UNITED STATES COURT OF APPEALS

Case: 14-1294 Document: 71 Page: 1 Filed: 10/31/2014 NO. 2014-1294 IN THE UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT PURDUE PHARMA L.P., THE P.F. LABORATORIES, INC., PURDUE PHARMACEUTICALS L.P., AND RHODES TECHNOLOGIES, - vs - EPIC PHARMA, LLC, Plaintiff-Appellants, Defendant-Appellee. Appeal from the United States District Court for the Southern District of New York in No. 1:13-cv-00683-SHS, Judge Sidney H. Stein (Caption continued on inside cover.) BRIEF OF AMICI CURIAE DONALD E. KNEBEL AND MARK D. JANIS IN SUPPORT OF APPELLANTS PURDUE PHARMA L.P., ET AL. Mark D. Janis Center for Intellectual Property Research Indiana Univ. Maurer School of Law 211 S. Indiana Avenue 211 S. Indiana Avenue Bloomington, IN 47401-7001 Bloomington, IN 47401-7001 Donald E. Knebel* Center for Intellectual Property Research Indiana Univ. Maurer School of Law (812) 855-1205 (317) 231-7214 mdjanis@indiana.edu dknebel@btlaw.com *Attorney for Amici Curiae, Mark D. Janis and Donald E. Knebel In Support of Appellant Purdue Pharma, L.P.

Case: 14-1294 Document: 71 Page: 2 Filed: 10/31/2014 2014-1296 PURDUE PHARMA L.P., THE P.F. LABORATORIES, INC., PURDUE PHARMACEUTICALS L.P., AND RHODES TECHNOLOGIES, - v - Plaintiff-Appellants, MYLAN PHARMACEUTICALS INC. AND MYLAN INC., Defendant-Appellees. Appeal from the United States District Court for the Southern District of New York in No. 1:12-cv-02959-SHS, Judge Sidney H. Stein 2014-1306, -1307 PURDUE PHARMA L.P., THE P.F. LABORATORIES, INC., PURDUE PHARMACEUTICALS L.P., AND RHODES TECHNOLOGIES, AND GRÜNENTHAL GMBH - v - Plaintiff-Appellants, AMNEAL PHARMACEUTICALS, LLC Defendant-Appellee. Appeal from the United States District Court for the Southern District of New York in No. 1:11-cv-08153-SHS, Judge Sidney H. Stein (Caption continued.)

Case: 14-1294 Document: 71 Page: 3 Filed: 10/31/2014 2014-1311, -1312, -1313, -1314 GRÜNENTHAL GMBH, PURDUE PHARMA L.P., THE P.F. LABORATORIES, INC., PURDUE PHARMACEUTICALS L.P., AND RHODES TECHNOLOGIES, - v - Plaintiff-Appellants, TEVA PHARMACEUTICALS USA, INC. Defendant-Appellee. Appeals from the United States District Court for the Southern District of New York in No. 1:11-cv-02037-SHS and 1:12-cv-05083-SHS, Judge Sidney H. Stein

Case: 14-1294 Document: 71 Page: 4 Filed: 10/31/2014 CERTIFICATE OF INTEREST Counsel for the Amici Curiae certify the following: 1. The full name of every party or amicus curiae represented by me is: Donald E. Knebel and Mark D. Janis. 2. The name of the real party in interest (if the party named in the caption is not the real party in interest) represented by me is: same as above. 3. All parent corporations and any publicly held companies that own 10 percent or more of the stock of the party or amicus curiae represented by me are: none. 4. The names of all law firms and the partners or associates that appeared for the party or amicus curiae now represented by me in the trial court or agency or are expected to appear in this court are: Donald E. Knebel Center for Intellectual Property Research Indiana University Maurer School of Law 211 S. Indiana Avenue Bloomington, IN 47405-7001 Mark D. Janis Center for Intellectual Property Research Indiana University Maurer School of Law 211 S. Indiana Avenue Bloomington, IN 47401-7001 i

Case: 14-1294 Document: 71 Page: 5 Filed: 10/31/2014 TABLE OF CONTENTS Page INTEREST OF AMICI...1 ARGUMENT...2 I. This Court s Decisions in Abbott and Atlantic Thermoplastics Require That Courts Take Account of Process Limitations in Determining Whether Product-By-Process Claims are Valid....2 II. III. This Court Should Disavow Cases that Purport to Permit Courts to Ignore Process Limitations When Assessing the Validity of Productby-Process Claims....5 The District Court Applied the Incorrect Standard for Construing Product-by-Process Claims in its Obviousness Determination...9 IV. Conclusion...10 ii

Case: 14-1294 Document: 71 Page: 6 Filed: 10/31/2014 TABLE OF AUTHORITIES CASES Abbott Laboratories v. Sandoz, Inc., 566 F.3d 1282 (Fed. Cir. 2009)...2, 3, 5, 6, 7, 8, 9 Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340 (Fed. Cir. 2009)...5, 6, 7, 9 Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed. Cir.2003)...3 Atlantic Thermoplastics Co., Inc. v. Faytex Corp., 970 F.2d 834 (Fed. Cir. 1992)...2, 3, 4, 6, 7, 9 In re Brown, 459 F.2d 531 (C.C.P.A. 1972)...4 General Electric Co. v. Wabash Appliance Corp., 304 U.S. 364 (1938)...8 Greenliant System, Inc. v. Xicor LLC, 692 F.3d 1261 (Fed. Cir. 2012)...5, 6, 7, 9 In re Hughes, 496 F.2d 1216 (C.C.P.A. 1974)...8 Newell Cos., Inc. v. Kenney Manufacturing Co., 864 F.2d 757 (Fed. Cir. 1988)...7 Peters v. Active Manufacturing Co., 129 U.S. 530 (1889)...3 Polaroid Corp. v. Eastman Kodak Co., 789 F.2d 1556 (Fed. Cir. 1986)...4 Schering Corp. v. Geneva Pharmaceuticals, Inc., 339 F.3d 1373 (Fed. Cir. 2003)...3 Scripps Clinic & Research Foundation v. Genentech, Inc., 927 F.2d 1565 (Fed. Cir.1991)...2 In re Thorpe, 777 F.2d 695 (Fed. Cir.1985)...6, 7, 8, 9 Warner-Jenkinson Co., Inc. v. Hilton-Davis Chemical Co., 520 U.S. 17 (1997)...3 iii

Case: 14-1294 Document: 71 Page: 7 Filed: 10/31/2014 ADDITIONAL AUTHORITIES 5A Chisum on Patents 18.01 (2007)...3 Federal Rule of Appellate Procedure 32(a)(7)(B)...12 iv

Case: 14-1294 Document: 71 Page: 8 Filed: 10/31/2014 INTEREST OF AMICI Amici curiae are professors at the Center for Intellectual Property Research of the Indiana University Maurer School of Law. Neither the individual amici, the Center, nor Indiana University has any interest in the outcome of this case. However, the Center, as part of its mission, has a strong interest in the sound development and administration of patent law. As a result, the Center and these amici have previously filed amicus briefs in this Court and in the United States Supreme Court on matters of patent law. No one other than the undersigned wrote or funded any portion of this brief. Defendant-appellees Mylan Pharmaceuticals Inc. and Mylan Inc. have refused to consent to the filing of this brief. Accordingly, pursuant to Rule 29(b), amici have filed herewith a Motion for Leave to file this brief. 1

Case: 14-1294 Document: 71 Page: 9 Filed: 10/31/2014 ARGUMENT This appeal concerns the validity of product-by-process claims. 1 In particular, this appeal presents an important legal question about product-byprocess claims: whether courts may ignore the process limitations in product-by-process claims when determining obviousness. They may not. I. This Court s Decisions in Abbott and Atlantic Thermoplastics Require That Courts Take Account of Process Limitations in Determining Whether Product-By-Process Claims are Valid. This court ruled en banc in Abbott Laboratories v. Sandoz, Inc., 566 F.3d 1282, 1291 (Fed. Cir. 2009), that courts may not ignore process limitations in product-by-process claims when construing claims as a predicate to an infringement determination. Id. at 1291( This court takes this opportunity to clarify en banc the scope of product-by-process claims by imposing a requirement that courts construe[] product-by-process claims as limited by the process. ) The court stated explicitly that it was adopting the rule in Atlantic Thermoplastics and rejecting that in Scripps Clinic. Id., citing Atlantic Thermoplastics Co., Inc. v. Faytex Corp., 970 F.2d 834 (Fed. 1 Although the parties dispute whether some of the claims at issue should be construed as product-by-process claims, they stipulated that the asserted claims of the 800 Patent are product by process claims. A.55. Amici take no position on the parties claim construction dispute regarding the remaining claims. 2

Case: 14-1294 Document: 71 Page: 10 Filed: 10/31/2014 Cir. 1992), and Scripps Clinic & Research Foundation v. Genentech, Inc., 927 F.2d 1565 (Fed.Cir.1991). However, the en banc court in Abbott left implicit the logical consequence of its ruling namely, that courts also may not ignore process limitations in product-by-process claims when determining validity. 2 This rule follows a fortiori from the well-established principle that claims must be construed the same way for both infringement and validity. See, e.g., Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1330 (Fed. Cir.2003) ( It is axiomatic that claims are construed the same way for both invalidity and infringement. ); 5A CHISUM ON PATENTS 18.01 (2007) (calling this principle [a] fundamental tenet of patent law ). It likewise aligns with two other bedrock principles of patent law: (1) the proposition that each limitation of a claim must be given effect in validity and infringement analysis, see, e.g., Schering Corp. v. Geneva Pharmaceuticals, Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (anticipation analysis); Warner- Jenkinson Co., Inc. v. Hilton-Davis Chem. Co., 520 U.S. 17 (1997) 2 Although the court did not expressly say that process limitations must be considered in making validity determinations, it said that this decision merely restates the rule that the defining limitations of a claim in this case process terms are also the terms that show infringement. 566 F.3d at 1293 (emphasis added). The word also can only mean that process terms are relevant in determining validity, as the Atlantic Thermoplastics case expressly held. 3

Case: 14-1294 Document: 71 Page: 11 Filed: 10/31/2014 (infringement analysis); and (2) the corollary proposition that a product that literally infringes if later, anticipates if earlier, see, e.g., Peters v. Active Manufacturing Co., 129 U.S. 530, 537 (1889); Polaroid Corp. v. Eastman Kodak Co., 789 F.2d 1556 (Fed. Cir. 1986). Indeed, the Atlantic Thermoplastics panel opinion had invoked these very principles in distinguishing between the PTO s treatment of productby-process claims and the court s treatment of those claims for infringement and validity purposes. Because the PTO construes claims under the broadest reasonable construction rubric, the PTO may assess whether product-by-process claims are patentable over the prior art based on the product itself even though that would mean ignoring limitations directed to the process. 3 Atlantic Thermoplastics, 970 F.2d at 845, citing In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985). But that rubric does not govern claim construction in litigation because the court treats claims differently for patentability as opposed to validity and infringement. Atlantic Thermoplastics, 970 F.2d at 846. As the Atlantic Thermoplastic court reasoned, whereas [t]he PTO s treatment of product-by-process claims as a 3 The court based this different treatment on the demands of the administrative process. Atlantic Thermoplastics, 970 F.2d at 846. In support of this conclusion, the court cited In re Brown, 459 F.2d at 535, which showed the PTO s administrative difficulty in evaluating productby-process claims 970 F.2d at 844. 4

Case: 14-1294 Document: 71 Page: 12 Filed: 10/31/2014 product claim for patentability is consistent with policies giving claims their broadest reasonable interpretation, that rule does not apply in validity and infringement litigation. Id. (emphasis added). That language disposes of the legal question that this brief addresses, one of the primary legal questions in this appeal. A court assessing obviousness of a product-by-process claim may not treat the claim as a mere product claim, ignoring the process limitations. II. This Court Should Disavow Cases that Purport to Permit Courts to Ignore Process Limitations When Assessing the Validity of Product-by-Process Claims. Unfortunately, when the en banc court in Abbott said that it was adopting the rule in Atlantic Thermoplastics, it could have stated more emphatically that it was adopting the entirety of the rule, applicable in both the validity and infringement contexts. Because it did not so state, the Abbott opinion has left room for uncertainty. For example, Judge Newman, dissenting in Abbott, assumed (incorrectly, we believe) that the en banc court was creating an anomaly by crafting a rule of construction for the infringement context that did not also apply in the validity context. Abbott, 566 F.3d at 1317-18 (Newman, J., dissenting). Worse yet, two of this court s panel opinions decided after Abbott have suggested that courts may ignore process limitations when construing product-by-process claims for 5

Case: 14-1294 Document: 71 Page: 13 Filed: 10/31/2014 validity purposes, even though those limitations must be taken into account for infringement purposes. Amgen Inc. v. F. Hoffmann La Roche Ltd., 580 F.3d 1340, 1366 67 (Fed. Cir. 2009); see also Greenliant Sys., Inc. v. Xicor LLC, 692 F.3d 1261, 1268 (Fed. Cir. 2012). In Amgen, the panel acknowledged that its approach to product-byprocess claims contravened the long-established principle that claims should be construed the same way for infringement as for validity, and the principle that a product that literally infringes if later, anticipates if earlier. Amgen, 580 F.3d at 1369-70. The court referred to Abbott and even invoked Atlantic Thermoplastics, but those decisions should have precluded the Amgen court from ruling as it did. Instead, the Amgen decision relied on the assertion that validity is determined based on the requirements of patentability. Amgen, 580 F.3d at 1370 n.14. However, as the Atlantic Thermoplastics decision correctly recognized, [t]his court already distinguishes treatment of claims for patentability before the PTO from treatment of claims for validity before the courts. 970 F.2d at 846, citing In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989). Patentability decisions by the PTO are based on giving the claims their broadest reasonable meaning, but validity decisions by courts are based on the construction of the claims that takes into account other 6

Case: 14-1294 Document: 71 Page: 14 Filed: 10/31/2014 considerations, including the written description and prosecution history. Atlantic Thermoplastics, 970 F.2d at 846. Greenliant, unfortunately, further propagated this misconception. There, the court relied primarily on Amgen, without reexamining Abbott or Atlantic Thermoplastics. Greenliant, 692 F.3d at 1268. The court also invoked In re Thorpe, notwithstanding the fact that the Atlantic Thermoplastics opinion had expressly limited Thorpe to the context of PTO determinations. Atlantic Thermoplastics, 970 F.2d at 846 ( The [In re Thorpe] rule, however, does not apply in validity and infringement litigation. ) The court should intervene to resolve the inconsistencies in the law regarding validity determinations for product-by-process claims. Any reading of Amgen and Greenliant that would allow a court to ignore process limitations in product-by-process claims would contravene this court s en banc decision in Abbott, which adopted the rule from Atlantic Thermoplastics, a prior panel decision. This court, of course, treats prior panel decisions as binding unless overturned en banc. Newell Cos., Inc. v. Kenney Mfg. Co., 864 F.2d 757, 765 (Fed. Cir. 1988). Moreover, where panel decisions are in direct conflict, the prior panel decision is treated as precedential. Id. Applying these principles, this court should disavow the 7

Case: 14-1294 Document: 71 Page: 15 Filed: 10/31/2014 approach to product-by-process claims suggested by Amgen and Greenliant that would allow courts to ignore process limitations in determining validity. It is especially important that the court resolve this inconsistency. In Abbott, this court stated: This court's en banc decision in no way abridges an inventor's right to stake claims in product-by-process terms. 566 F.3d at 1293. But the Amgen and Greenliant decisions severely undercut that right. If the process limitations in a product-by-process claim must be met for infringement, but can be ignored for validity determinations, there is nothing to be gained in pursuing such claims. An inventor would be better off simply omitting the process limitations and taking its chances on the product limitations being sufficiently novel to avoid invalidity. But it is precisely to avoid such situations that the Supreme Court has acknowledged that process limitations in product claims might be valuable. General Electric Co. v. Wabash Appliance Corp., 304 U.S. 364, 374 (1938). Avoiding such situations is also why the Court of Custom and Patent Appeals decided to allow broader use of product-by-process claims in In re Hughes, 496 F.2d 1216, 1219 (C.C.P.A. 1974) (Rich, J.), a decision cited as binding by the Abbott Labs court. 566 F.3d at 1291. In that case, the court imposed on the Patent Office the burden of showing that the claimed product is identical to that in the prior art so that an inventor could obtain 8

Case: 14-1294 Document: 71 Page: 16 Filed: 10/31/2014 product-by-process claims that recite his novel process of manufacture as a hedge against the possibility that his broader product claims might be invalidated. In re Hughes, 496 F.2d at 1219. III. The District Court Applied the Incorrect Standard for Construing Product-by-Process Claims in its Obviousness Determination. The district court in the present case fell prey to this uncertainty. The district court relied on In re Thorpe to conclude that it could not take account of the 8α limitations in the product-by-process claims at issue when assessing obviousness. A.48. As the court explained: For the purposes of validity, the Court considers only the product limitations of a claim, not process limitations or source limitations that add no patentable significance to the end product. See In re Thorpe, 777 F.2d 695, 697 ( Fed. Cir.1985). The asserted claims of the 799, 072, and 800 Patents are product by-process claims. Therefore, the Court assesses the validity of the low ABUK oxycodone API product -- and its various purity and oral dosage form limitations -- not oxycodone API with 14 hydroxy obtained from 8α. Id. The court also cited Amgen and Greenliant for its conclusion that [a] court determines the obviousness of a product by process claim without reference to its process limitations. A55. This was error. The court instead was bound to follow the standard set out in this court s en banc ruling in Abbott, incorporating Atlantic Thermoplastics, which requires that the process limitations be taken into account both for infringement and for validity. 9

Case: 14-1294 Document: 71 Page: 17 Filed: 10/31/2014 Following the incorrect legal standard led the district court to an incorrect conclusion that the asserted claims, all of which included limitations based on the use of 8α, were invalid. The court found as a fact that the prior art did not disclose the existence of 8α or teach that it converts to 14 hydroxy and therefore the patents in suit make claims based on the 8α limitations that the prior art did not. A37. Notwithstanding the absolute novelty of the claimed invention, the court found those claims invalid because of its view that the decisions of this court precluded it from considering the 8α limitations. A48. IV. Conclusion. The decisions of this court relied upon by the district court in finding the asserted claims invalid are all inconsistent with this court s earlier Atlantic Thermoplastics case, adopted en banc in the Abbott Labs case. These amici therefore support the appellants to the extent they seek reversal because of the district court s failure to consider the 8α limitations in determining the validity of the asserted claims. 10

Case: 14-1294 Document: 71 Page: 18 Filed: 10/31/2014 Respectfully submitted, /s/donald E. Knebel Donald E. Knebel Mark D. Janis Center for Intellectual Property Research Indiana Univ. Maurer School of Law 211 S. Indiana Avenue Bloomington, IN 47401-7001 11

Case: 14-1294 Document: 71 Page: 19 Filed: 10/31/2014 CERTIFICATE OF SERVICE I hereby certify that on October 14, 2014, a copy of the Brief of Amici Curiae Donald E. Knebel and Mark D. Janis in Support of Appellants Purdue Pharma, L.P., et al. was filed via operation of the Court s CM/ECF system. Copies of the Brief were served on counsel of record via electronic means on this day, October 14, 2014. /s/donald E. Knebel Donald E. Knebel 12

Case: 14-1294 Document: 71 Page: 20 Filed: 10/31/2014 CERTIFICATE OF COMPLIANCE 1. This brief complies with the type-volume limitation of Federal Rule of Appellate Procedure 32(a)(7)(B). The brief contains 2,082 words, excluding the parts of the brief exempted by Federal Rule of Appellate Procedure 32(a)(7)(B)(iii). 2. This brief complies with the typeface requirements of Federal Rule of Appellate Procedure 32(a)(5) and the type style requirements of Federal Rule of Appellate Procedure 32(a)(6). The brief has been prepared in a proportionally spaced typeface using Microsoft Word 2010 and Times New Roman font set at 14pt font size. Dated: October 14, 2014 /s/donald E. Knebel Donald E. Knebel 13