In The Supreme Court of the United States

Transcription

1 No In The Supreme Court of the United States TEVA PHARMACEUTICALS USA, INC., ET AL. Petitioners, v. SANDOZ, INC., ET AL. Respondents. ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT BRIEF OF AMICUS CURIAE FRESENIUS KABI USA, LLC IN SUPPORT OF NEITHER PARTY Ali I. Ahmed Fresenius Kabi USA, LLC Three Corporate Drive Lake Zurich, IL Lawrence M. Sung Counsel of Record A. Neal Seth Wiley Rein LLP 1776 K Street, NW Washington DC (202) LSung@wileyrein.com Attorneys for Amicus Curiae LEGAL PRINTERS LLC, Washington DC! ! legalprinters.com

2 i QUESTION PRESENTED 1. 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.

3 ii TABLE OF CONTENTS Page QUESTION PRESENTED... i TABLE OF CONTENTS... ii TABLE OF AUTHORITIES... v INTEREST OF THE AMICUS CURIAE... 1 SUMMARY OF THE ARGUMENT... 2 ARGUMENT... 4 I. The Experience of Amicus Curiae Fresenius Kabi USA, LLC, as a Global Leader in Medical Technology Innovation Suggests that a Departure From the Claim Construction Rubric This Court Set Forth in Markman v. Westview Instruments, Inc. is Unnecessary and Would Be Detrimental... 4 A. Medical Technology Patents Would Suffer Distinctly With a Shift Away From the Court of Appeals De Novo Review of a District Court s Claim Construction... 6

4 iii TABLE OF CONTENTS (Continued) Page 1. The Canon of Claim Construction to Interpret a Patent Claim So As to Preserve Validity Where Possible Subsumes Disclosure Issues Such as the Written Description, Enablement and Definiteness Requirements under 35 U.S.C. 112, Which Impact Inventions in Medical Technology More Than Other Technologies A Greater Number of Findings of Fact During the Claim Construction of Medical Technology Patents Would Work a Disproportionate Burden on Medical Technology Innovation Under a Clear Error Review of a District Court s Claim Construction by the Court of Appeals II. Should This Court Eschew the Claim Construction Rubric This Court Set Forth in Markman v. Westview Instruments, Inc. in Favor of a Clear Error Review of a District Court s Claim Construction by the Court of Appeals, the Enforcement of Patent Rights Generally Would Be Burdened by Greater Inconsistency and Less Efficiency... 13

5 iv TABLE OF CONTENTS (Continued) Page A. In Decades of Practice, the Court of Appeals De Novo Review of a District Court s Claim Construction Has Honored the Guidance That a District Court s Factual Findings Offer While Enabling the Federal Circuit s Expertise with Patent Claims to Benefit the Result B. Any Shift Away From the Court of Appeals De Novo Review of a District Court s Claim Construction Will Unduly Elevate Expert Testimony and Result in Lengthier and Costlier District Court Proceedings in Patent Cases Generally CONCLUSION... 15

6 Cases v TABLE OF AUTHORITIES Page(s) Alcon Research Limited. v. Barr Laboratories Inc., 745 F.3d 1180 (Fed. Cir. 2014) In re Bimeda Research & Development Limited, 724 F.3d 1320 (Fed. Cir. 2013) Carnegie Mellon University v. Hoffmann-La Roche, Inc., 541 F.3d 1115 (Fed. Cir. 2008)... 9 Cybor Corp. v. FAS Technologies., Inc., 138 F.3d 1448 (Fed. Cir. 1998) Enzo Biochem, Inc. v. Gen-Probe, Inc. 323 F.3d 956 (Fed. Cir. 2002)... 9 Generation II Orthotics, Inc. v. Medical Technology, Inc., 263 F.3d 1356 (Fed. Cir. 2001)... 8 GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., 744 F.3d 725 (Fed. Cir. 2014) Green Edge Enterprises, LLC v. Rubber Mulch Etc., 620 F.3d 1287 (Fed. Cir. 2010) Haemonetics Corp. v. Baxter Healthcare Corp., 607 F.3d 776 (Fed. Cir. 2010)... 4 Halliburton Energy Services, Inc. v. M-I LLC 514 F.3d 1244 (Fed. Cir. 2008)... 4

7 vi TABLE OF AUTHORITIES (Continued) Page(s) Karsten Manufacturing Corp. v. Cleveland Golf Co., 242 F.3d 1376 (Fed. Cir. 2001)... 8 Liebel-Flarsheim v. Medrad, 358 F.3d 898 (Fed. Cir. 2004)... 8 Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996)... passim Miller v. Fenton 474 U.S. 104 (1985)... 5 Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct (2014)... 4 Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336 (Fed. Cir. 2013) Rhine v. Casio, Inc., 183 F.3d 1342 (Fed. Cir. 1999)... 7 Synthes USA, LLC v. Spinal Kinetics, Inc., 734 F.3d 1332 (Fed. Cir. 2013) Takeda Pharmaceutical Co. v. Zydus Pharmaceuticals USA, Inc., 743 F.3d 1359 (Fed. Cir. 2014)... 11

8 vii TABLE OF AUTHORITIES (Continued) Page(s) Tobinick v. Olmarker, No , 2014 WL (Fed. Cir. May 19, 2014) Trading Technologies International, Inc. v. Open E Cry, LLC, 728 F.3d 1309 (Fed. Cir. 2013) Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir. 2004)... 9 Whittaker Corp. v. UNR Indus., Inc., 911 F.2d 709 (Fed. Cir. 1990)... 7 Statutes 35 U.S.C U.S.C passim Other Authorities Alison E. Cantor, Using the Written Description and Enablement Requirements to Limit Biotechnology Patents 14 HARV. J. LAW & TECH. 267 (2000) Dan L. Burk & Mark A. Lemley, Policy Levers in Patent Law 89 VA L. REV (2003)... 10

9 viii TABLE OF AUTHORITIES (Continued) Page(s) FED. R. CIV. P. 52(a) Giles Sutherland Rich, Extent of the Protection and Interpretation of Claims American Perspectives, 21 INT L REV. INDUS. PROP. & Copyright L. 497 (1990)... 4 Herbert A. Simon, MODELS OF BOUNDED RATIONALITY AND OTHER TOPICS IN ECONOMICS (1982)... 4 H.R. REP. No (1981)... 13

10 INTEREST OF THE AMICUS CURIAE 1 With the consent of the parties, this brief is filed by Amicus Curiae, Fresenius Kabi USA, LLC, which is a global leader in medical technology innovation. Amicus Curiae engages in the research and development, design, and manufacturing of medicines and medical products for use in the treatment of various conditions and diseases. Amicus Curiae s business operations include the medical technologies of intravenous specialty and generic pharmaceuticals, technologies for transfusion medicine and cell therapies, infusion systems, clinical nutrition, and related medical devices. Fresenius Kabi has no financial interest in the outcome of this case. Fresenius Kabi seeks an application of the patent laws in a manner that most effectively promotes innovation and most accurately reflects the intent of Congress. 1 Pursuant to Supreme Court Rule 37, no counsel for any party authored this brief in whole or in part, and no person or entity other than Amicus Curiae made a monetary contribution to the preparation or submission of the brief. Counsel of record for all parties were notified prior to filing and have consented to this filing. Letters of consent have been filed with the Clerk of the Court.

11 2 SUMMARY OF THE ARGUMENT The standard that a district court s claim construction receives plenary review on appeal effectuates the goals set forth by this Court in Markman v. Westview Instruments, Inc. of correctness and uniformity in defining the scope of patent rights. The principle of bounded rationality that underpins placing claim construction responsibility with the judge rather than the jury also militates for Court of Appeals de novo review of the trial court s claim construction. By declining to cabin the Court of Appeals review, this Court remains most faithful to the legislative mandate of promoting patent law uniformity by preserving the Court of Appeals exclusive intermediate appellate authority. Moreover, a departure from existing practice may bring unintended consequences. The interpretive canon that claims should be construed so as to sustain their validity if possible subsumes disclosure issues such as the written description, enablement and definiteness requirements under 35 U.S.C. 112, which impact inventions in medical technology more than other technologies. Because these issues can be fact intensive, medical technology innovation companies will suffer a disproportionate burden under a clear error appellate review. Furthermore, a new, clear error standard for appellate review of claim construction will unduly elevate expert testimony and result in lengthier and costlier district court proceedings in patent cases

12 3 generally. This Court should uphold plenary Court of Appeals review of claim construction, including any supporting factual findings.

13 4 ARGUMENT I. The Experience of Amicus Curiae Fresenius Kabi USA, LLC, as a Global Leader in Medical Technology Innovation Suggests that a Departure From the Claim Construction Rubric This Court Set Forth in Markman v. Westview Instruments, Inc. is Unnecessary and Would Be Detrimental. The proper interpretation of a patent claim is paramount in patent cases. See Giles Sutherland Rich, Extent of the Protection and Interpretation of Claims American Perspectives, 21 INT L REV. INDUS. PROP. & COPYRIGHT L. 497, 499 (1990) ( To coin a phrase, the name of the game is the claim. ). Despite its critical significance, patent claim construction can be problematic. As this Court knows from its recent consideration in Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct (2014), claim construction may be implicated by certain patent validity considerations, such as the definiteness requirement under 35 U.S.C. 112, which pose additional complexities. See Haemonetics Corp. v. Baxter Healthcare Corp., 607 F.3d 776, 783 (Fed. Cir. 2010) ( [B]ecause claim construction frequently poses difficult questions over which reasonable minds may disagree, proof of indefiniteness must meet an exacting standard. (quoting Halliburton Energy Servs., Inc. v. M I LLC, 514 F.3d 1244, 1249 (Fed. Cir. 2008))). In his 1982 book, MODELS OF BOUNDED RATIONALITY AND OTHER TOPICS IN ECONOMICS, U.S. Nobel Laureate Herbert A. Simon proposed that decision

14 5 makers (irrespective of their level of intelligence) work under three unavoidable constraints: (1) only limited, often unreliable, information is available regarding possible alternatives and their consequences, (2) the human mind has only limited capacity to evaluate and process the information that is available, and (3) only a limited amount of time is available to make a decision. Therefore, even individuals who intend to make rational choices are bound to make satisficing (rather than maximizing or optimizing) choices in complex situations. The cognitive heuristic of satisficing searching through available alternatives for a satisfactory solution rather than the optimal one applies no less in patent claim construction. This understanding was manifest in this Court s holding in Markman v. Westview Instruments, Inc., 517 U.S. 370, 388 (1996) that patent claim construction is within the exclusive province of the trial judge. This Court recognized that the categorization of patent claim construction as a question of law or mixed question of fact/law would not suffice alone to guide the fashioning of an appropriate analytical rubric. In this regard, this Court noted: We said in Miller v. Fenton, 474 U.S. 104, 114 (1985), that when an issue falls somewhere between a pristine legal standard and a simple historical fact, the fact/law distinction at times has turned on a determination that, as a matter of the sound administration of justice, one judicial actor is better positioned than another to

15 decide the issue in question. So it turns out here, for judges, not juries, are the better suited to find the acquired meaning of patent terms. Id. This Court thus reasoned that the path forward was to focus on placing the inquiry in the hands of the person best equipped through experience and insight to render a proper claim interpretation. 6 This wisdom extrapolates to plenary appellate review of patent claim construction. Without the constraint of deference to the district court s factual findings on claim construction, the Court of Appeals is better able to employ its considerable experience and insight to reach the most correct claim interpretation. Moreover, the Court of Appeals has the advantage of a keen facility with the interplay between claim construction, validity, enforceability and enforcement to ensure uniformity in the overall application of the patent laws. These considerations support upholding plenary Court of Appeals review of claim construction, including any supporting factual findings. A. Medical Technology Patents Would Suffer Distinctly With a Shift Away From the Court of Appeals De Novo Review of a District Court s Claim Construction. In an attempt to better inform this Court s understanding of the various medical technologies that may be affected by creating a new, clear error standard for appellate review of claim construction, Amicus Curiae respectfully offers its perspective drawn from composite experiences of Amicus Curiae

16 7 as a global leader in medical technology research and development, design, and manufacturing of medicines and medical products for use in the treatment of various conditions and diseases. These initiatives include intravenous specialty and generic pharmaceuticals, technologies for transfusion medicine and cell therapies, infusion systems, clinical nutrition, and related medical devices. These experiences reflect the extraordinary breadth of technology in this industry sector and foreshadow the importance of recognizing the grave potential consequences, unintended or otherwise, of any change in claim construction methodology for medical technology and health care. Fresenius Kabi s products are used to treat critically and chronically ill patients. Fresenius Kabi is part of Fresenius SE, a century old group of health care companies based in Germany and with employees and customers in six continents. 1. The Canon of Claim Construction to Interpret a Patent Claim So As to Preserve Validity Where Possible Subsumes Disclosure Issues Such as the Written Description, Enablement and Definiteness Requirements under 35 U.S.C. 112, Which Impact Inventions in Medical Technology More Than Other Technologies. Interpretive canons have been fashioned to facilitate proper patent claim interpretation. One such canon is that claims should be construed so as to preserve validity where possible. See Rhine v. Casio, Inc., 183 F.3d 1342, 1345 (Fed. Cir. 1999) (quoting Whittaker

17 8 Corp. v. UNR Indus., Inc., 911 F.2d 709, 712 (Fed. Cir. 1990) ( [C]laims are generally construed so as to sustain their validity, if possible. ); but cf. Generation II Orthotics, Inc. v. Med. Tech., Inc., 263 F.3d 1356, 1365 (Fed. Cir. 2001) ( [C]laims can only be construed to preserve their validity where the proposed claim construction is practicable, is based on sound claim construction principles, and does not revise or ignore the explicit language of the claims. ); Liebel-Flarsheim v. Medrad, 358 F.3d 898, 911 (Fed. Cir. 2004) ( [U]nless the court concludes, after applying all the available tools of claim construction, that the claim is still ambiguous, the axiom regarding the construction to preserve the validity of the claim does not apply. ). Even where this canon of patent claim construction is not explicitly applied, the district courts remain mindful of the doctrinal intersection between proper claim interpretation and issues of validity. See Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1384 (Fed. Cir. 2001) ( The jurisprudence of claim construction reflects the difficult balance between a patentee s exhortation that courts should read the claims broadly and unlimited to the specific embodiments shown in the specification, and the rule that claims should be construed sufficiently narrowly to preserve their validity. ). In addition to the conditions for patentability of statutory subject matter, utility, novelty and nonobviousness under 35 U.S.C , the patent laws set forth the disclosure requirements of written description, enablement, and definiteness under 35 U.S.C The adequacy of a patent applicant s disclosure is a prerequisite to the patent

18 9 grant. See, e.g., Carnegie Mellon Univ. v. Hoffmann- La Roche, Inc., 541 F.3d 1115, 1122 (Fed. Cir. 2008) ( The written description serves a quid pro quo function in which the public is given meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time. (citing Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 922 (Fed. Cir. 2004) (quoting Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970 (Fed. Cir. 2002)))). More particularly, the disclosure requirements of written description, enablement, and definiteness under 35 U.S.C. 112 provide meaningful limitations on the scope of the patent grant by establishing standards against which the patent claims are measured for support. To this end, these considerations under 35 U.S.C. 112 are often subsumed into the claim construction analysis even while they constitute separate and distinct bases for the determination of patent validity. Given this interrelationship, assessing the impact of any modification of the claim construction rubric implicates how district courts address 35 U.S.C. 112 issues. And for the reasons infra, a change in the current appellate review of district court claim constructions will affect medical technology patents to a greater extent. With medical technology inventions, the written description requirement, for example, is often implicated due to the pioneering nature and/or complex nomenclature that innovation in this field of endeavor entails. The inconsistent doctrinal application across different technologies has long

19 10 been the focus of scholarly debate. See, e.g., Dan L. Burk & Mark A. Lemley, Policy Levers in Patent Law, 89 VA. L. REV. 1575, (2003) ( In biotechnology, however, the doctrine has been applied as a sort of super-enablement requirement, forcing biotech patentees to list particular gene sequences in order to obtain a patent covering those sequences. The written description doctrine as currently applied is a macro policy lever. The Federal Circuit has applied the doctrine to biotechnology cases in a way that would be inconceivable in other industries, such as software. The effect is to narrow the scope of biotechnology patents or at least DNA patents rather dramatically. ); Alison E. Cantor, Using the Written Description and Enablement Requirements to Limit Biotechnology Patents, 14 HARV. J. LAW & TECH. 267, 313 (2000) ( If courts are strengthening the written description and enablement requirements in order to limit biotechnology patents, this fact raises concerns about creating special standards for particular areas of technology. If it is the courts that impose these standards, pioneering scientists in a new field will be unable to determine, when applying for patents, to what standard their patents will eventually be held when they are litigated. ). Moreover, a disproportionate number of patent cases where a dispute exists over the written description requirement under 35 U.S.C. 112 involve medical technology patents. Indeed, an unscientific survey of the nine most recent precedential patent decisions of the Court of Appeals involving a written description requirement issue reveals seven of those cases pertaining to a medical technology invention. See

20 11 Tobinick v. Olmarker, No , 2014 WL (Fed. Cir. May 19, 2014) (pharmaceutical); Alcon Research Ltd. v. Barr Labs. Inc., 745 F.3d 1180 (Fed. Cir. 2014) (pharmaceutical); GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., 744 F.3d 725 (Fed. Cir. 2014) (pharmaceutical); Takeda Pharm. Co. v. Zydus Pharms. USA, Inc., 743 F.3d 1359 (Fed. Cir. 2014) (pharmaceutical); Synthes USA, LLC v. Spinal Kinetics, Inc., 734 F.3d 1332 (Fed. Cir. 2013) (medical device); Trading Techs. Int l, Inc. v. Open E Cry, LLC, 728 F.3d 1309 (Fed. Cir. 2013) (software); In re Bimeda Research & Dev. Ltd., 724 F.3d 1320 (Fed. Cir. 2013) (pharmaceutical); Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336 (Fed. Cir. 2013) (biotechnology). Therefore, in practice, where a medical technology patent is involved, the claim construction often implicates the written description requirement of 35 U.S.C. 112 in an effort to guide the interpretation according to the canon of construction to preserve validity if possible. Whether a claim satisfies the written description requirement is a question of fact. See Alcon, 745 F.3d at In this regard, the interplay with the invalidity issue of adequate written description will necessitate related factual findings for medical technology patent claim construction purposes.

21 12 2. A Greater Number of Findings of Fact During the Claim Construction of Medical Technology Patents Would Work a Disproportionate Burden on Medical Technology Innovation Under a Clear Error Review of a District Court s Claim Construction by the Court of Appeals. Similar to the illustration supra with the written description requirement under 35 U.S.C. 112, the other disclosure requirements of enablement and definiteness arise more often with medical technology patents than with those of other technologies. Both enablement and definiteness engender factual determinations. See Green Edge Enters., LLC v. Rubber Mulch Etc., 620 F.3d 1287, 1299 (Fed. Cir. 2010) ( Definiteness, under 35 U.S.C. 112, paragraph 2, and enablement, under paragraph 1, are both questions of law with underlying factual determinations. ) (referring to the pre-america Invents Act statutory provisions, now 35 U.S.C. 112(b) and 35 U.S.C. 112(a), respectively). As with the invalidity issue of adequate written description, the interplay with the invalidity issues of enablement and definiteness will necessitate related factual findings for medical technology patent claim construction purposes. Therefore, to the extent this Court creates a new, clear error standard for appellate review of claim construction, medical technology patents would be disproportionately impacted.

22 13 II. Should This Court Eschew the Claim Construction Rubric This Court Set Forth in Markman v. Westview Instruments, Inc. in Favor of a Clear Error Review of a District Court s Claim Construction by the Court of Appeals, the Enforcement of Patent Rights Generally Would Be Burdened by Greater Inconsistency and Less Efficiency. In Markman, this Court recognized the legislative mandate of the Court of Appeals, stating: Congress created the Court of Appeals for the Federal Circuit as an exclusive appellate court for patent cases observing that increased uniformity would strengthen the United States patent system in such a way as to foster technological growth and industrial innovation. Markman, 517 U.S. at 390. (citing H.R. REP. No , at (1981)) (internal citations omitted). The reasoning supporting this Court s decision then to hold that claim construction is better decided by the judge than the jury applies with equal force almost two decades later. A change to require deference by the Court of Appeals to factual findings of the district court in claim construction belies this special legislative status. Moreover, the reason for change is unclear whereas the cost of such a change is certain. For the reasons set forth supra, this cost would be borne by medical technology patent holders disproportionately.

23 14 A. In Decades of Practice, the Court of Appeals De Novo Review of a District Court s Claim Construction Has Honored the Guidance That a District Court s Factual Findings Offer While Enabling the Federal Circuit s Expertise with Patent Claims to Benefit the Result. In his concurring opinion in Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998) (en banc), Circuit Judge William C. Bryson stated: While I join the opinion of the court without reservation, I think it important to note that our adoption of the rule that claim construction is an issue of law does not mean that we intend to disregard the work done by district courts in claim construction or that we will give no weight to a district court s conclusion as to claim construction, no matter how the court may have reached that conclusion. Simply because a particular issue is denominated a question of law does not mean that the reviewing court will attach no weight to the conclusion reached by the tribunal it reviews. Id. at This sentiment captures the practical reality of claim construction de novo review by the Court of Appeals, which addresses the concern that the district courts guidance is ignored. Furthermore, a change to a clear error standard of review will place a greater burden on district court judges in patent cases.

24 15 B. Any Shift Away From the Court of Appeals De Novo Review of a District Court s Claim Construction Will Unduly Elevate Expert Testimony and Result in Lengthier and Costlier District Court Proceedings in Patent Cases Generally. In Markman, this Court noted that its own experience with document construction leaves us doubtful that trial courts will run into many cases in which a simple credibility judgment would suffice to choose between experts whose testimony was equally consistent with a patent s internal logic. Markman, 517 U.S. at 389. A new, clear error standard for appellate review of claim construction, however, would increase the chances of this scenario. Under a more deferential standard of review, parties would be encouraged as a strategic consideration to rely more heavily on expert testimony before the district courts given the enhanced likelihood that any resulting factual findings will be upheld on appeal. Furthermore, the district courts will be required to provide more specific findings of fact to create a record amenable to review pursuant to FED. R. CIV. P. 52(a). The unfavorable result of such a change would be lengthier and costlier district court proceedings in patent cases generally. CONCLUSION For the foregoing reasons, Amicus Curiae respectfully submits that a departure from the claim construction rubric this Court set forth in Markman v. Westview Instruments, Inc. is unnecessary and would be detrimental, placing a disproportionate

25 16 burden on medical technology patents and raising the prospect that the development of critical lifesaving medical technology will be impeded. This Court should uphold plenary Court of Appeals review of claim construction, including any supporting factual findings. Respectfully submitted, Ali I. Ahmed Fresenius Kabi USA, LLC Three Corporate Drive Lake Zurich, IL Lawrence M. Sung Counsel of Record A. Neal Seth Wiley Rein LLP 1776 K Street, NW Washington DC (202) LSung@wileyrein.com Attorneys for Amicus Curiae Fresenius Kabi USA, LLC