The Royal Society of Chemistry IP Law Case Seminar: 2017 in the U.S.

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1 Finnegan, Henderson, Farabow, Garrett & Dunner, LLP The Royal Society of Chemistry IP Law Case Seminar: 2017 in the U.S. Anthony C. Tridico, Ph.D

2 Agenda U.S. Supreme Court news 2017 U.S. Court of Appeals for the Federal Circuit highlights Interesting decisions and news from the USPTO Patent Trial and Appeal Board 2

3 Judge Gorsuch joins U.S. Supreme Court Long-serving Supreme Court Justice Antonin Scalia died on February 13, President Donald Trump nominated Judge Neil Gorsuch of the Court of Appeals for the Tenth Circuit to replace. No patent opinions by Gorsuch, but... Gorsuch known for skepticism about delegating judicial decision-making to executive agencies (see, e.g., Gutierrez-Brizuela v. Lynch, 2016). 3

4 U.S. Supreme Court Patent Cases Life Technologies Corp v. Promega Corp. infringement for the export of a component of a patented invention for later combination SCA Hygiene Products Aktiebolag v. First Quality Baby Products, LLC laches as a defense against claims brought within the statutory limitations period TC Heartland LLC v. Kraft Foods Group Brands LLC venue requirements for domestic corporate defendants Impression Products v. Lexmark International patent exhaustion; international sales All four decisions reversed the Federal Circuit 4

5 U.S. Supreme Court Patent Cases Several cases pending for the fall 2017 term. Oil States vs. Greene s Energy Group, et al. The Supreme Court will address the constitutionality of having an Article I tribunal extinguish patent rights. The Question: Whether inter partes review an adversarial process used by the Patent and Trademark Office (PTO) to analyze the validity of existing patents violates the Constitution by extinguishing private property rights. Past Precedent? In 1898 in McCormick Harvesting Mach. Co. v. Aultman & Co., 169 U.S. 606 (1898), the Supreme Court held that once a patent is granted it is not subject to be revoked or canceled by the president, or any other officer of the Government because [i]t has become the property of the patentee, and as such is entitled to the same legal protection as other property. Oral Argument November 27,

6 Court of Appeals for the Federal Circuit 1. Helsinn Healthcare SA v. Teva Pharmaceuticals i. Post-AIA public sales may be prior art, even without disclosing the invention 2. Soft Gel Technologies, Inc. v. Jarrow Formulas, Inc. i. Obviousness only requires a reasonable expectation of success, not absolute predictability 3. Millennium Pharmaceuticals v. Sandoz, Inc. i. Teaching of a process does not render obvious a claim for a new compound formed by the process in a manner that achieves unexpected results 4. Enzo Biochem Inc., v. Applera Corp. i. DoE does not cover structures or elements specifically excluded from the claim scope 6

7 Court of Appeals for the Federal Circuit 5. In re Stepan i. Prior art combinations of the same materials with different ratios that fail to achieve desired results are relevant evidence of non-obviousness 6. Novartis v. Noven i. PTAB may reach conclusions different from district court and Federal Circuit 7. Eli Lilly and Company, v. Teva Parenteral Medicines, Inc., i. Product literature directed to physicians, such as dosage, instructions, and warnings about the importance and reasons for treatment may establish intent for inducing infringement 8. The Medicines Company v. Mylan, Inc. i. A product claim is limited to a method of manufacture if the method is included in the product s definition within the specification 7

8 Court of Appeals for the Federal Circuit 9. Cumberland Pharmaceuticals v. Mylan i. Prior art that teaches that a substance is required in a solution does not render obvious claims directed to the solution without that substance 10. Mylan Institutional LLC v. Aurobindo Pharma Ltd. i. A substantiality of the differences test may be more appropriate for analysis of a chemical compound under the DoE than the function-way-result test 11. Shire Development, LLC v. Watson Pharmaceuticals, Inc. i. There can be infringement of a consisting of Markush group by a product having an additional, unlisted component if the additional component is irrelevant to invention 12. Novartis AG, Mitsubishi Pharma Corp. v. Torrent Pharmaceuticals Limited i. References not cited in a petition to institute an IPR can be used by the PTAB to support an obvious determination if the patent owner has sufficient notice 8

9 Millennium Pharmaceuticals v. Sandoz, Inc., , , , , , (Fed. Cir. 2017) Consolidated infringement actions against 18 pharmaceutical companies that filed ANDAs to produce a generic of Millenium s cancer drug, Velcade Relying on expert testimony, the District Court invalidated 4 claims of the Velcade patent covering lyophilized versions of the compound Once a liquid formulation proved unsuccessful, the obvious next step was to attempt lyophilization. Focused on process, even though result was unexpected 9

10 Millennium v. Sandoz Federal Circuit reversed, finding that utilizing lyophilization to produce a stabilizing compound would not be obvious to someone of ordinary skill in the art Prior art contains no teaching or suggestion of this new compound, or that it would form during lyophilization. Federal Circuit found that prior art discouraged POSITA from using lyophilization because several different types of compounds could be formed Therefore, production of the right stabilizing compound was unexpected, and therefore, nonobvious 10

11 Novartis AG v. Noven Pharmaceuticals Inc., , (Fed. Cir. 2017) At district court, Noven lost its obviousness argument. But, in an inter partes review, Noven won the very same obviousness argument. In an inter partes review, must the PTAB take into account a final district court determination of non-obviousness of the same claims, based on the same prior art? 11

12 Novartis v. Noven No. The Federal Circuit affirmed the PTAB s finding of obviousness, but rejected the PTAB s reasoning. The PTAB had concluded that a prior court decision need not be considered since the record was different at the PTAB (though, admittedly, substantively the same ). The Federal Circuit instead reasoned that: because the petitioner in an IPR must meet a preponderance of the evidence rather than a clear and convincing evidence standard... the PTAB properly may reach a different conclusion based on the same evidence. Follows the Supreme Court in Cuozzo. 12

13 Cumberland Pharmaceuticals v. Mylan, , (Fed. Cir. 2017) ANDA litigation between patentee Cumberland and Mylan. Mylan asserted that Cumberland s pre-aia patent was anticipated by or obvious in light of a suggestion from the FDA during regulatory approval. FDA had requested justification for the inclusion of drug stabilizing agent EDTA. Cumberland then discovered they did not need to use EDTA. District Court sided with Cumberland: No one at the FDA had conceived of the invention. No expectation of success for making this kind of formulation lacking EDTA. Mylan infringed. 13

14 The Federal Circuit affirmed. Cumberland Pharmaceuticals v. Mylan "[a] request for justification of the inclusion of EDTA, supported by data, is not the same as a suggestion to remove it, let alone to remove it and not replace it with another chelating agent. The kind of general research suggestion at issue here, whatever its role in an obviousness analysis, does not establish the conception required for derivation. Mylan s obviousness argument failed because it was the prevailing skilled-artisan view that chelating agents like EDTA were necessary to prevent degradation of acetylcysteine. 14

15 Patent Trial and Appeal Board (PTAB) 1. Trustees of the University of Pennsylvania v. Coalition for Affordable Drugs Presentations with the wrong audience can be disqualified as prior art. 2. Reactive Surfaces LTD., LLP v. Toyota Motor Corp. Declarants used for preliminary response, but no longer relied upon, must be made available for cross examination as routine discovery. 15

16 Trustees of the University of Pennsylvania v. Coalition for Affordable Drugs, IPR (PTAB Mar. 6, 2017) The Board determined that Petitioner Coalition failed to demonstrate that claims of the patent-in-question, directed to treating hyperlipidemia and hypercholesterolemia were obvious. Petitioner failed to show that the alleged prior art qualified as a printed publication. The alleged prior art was a slide set and presentation for an investor event, also available on a webcast. Petitioner failed because it did not provide any evidence establishing the expertise of the target audience as being ordinary artisans in the relevant field. Nothing in the press release for the presentation indicated that the topic of the presentation would interest persons of ordinary skill in the field. 16

17 Finnegan s Latest PTAB Statistics (through May 1, 2017) 17

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20 Questions? Anthony C. Tridico, Ph.D. Practice includes patent office trials and appeals, patent prosecution management, IP due diligence, and litigation. Focus on post-grant proceedings, appeals and oral hearings at the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO), as well as European Patent Office (EPO) opposition and appeal procedures. Experienced in a variety of technical areas including biologics, immunology and biotechnology, chemical and pharmaceutical sciences, polymers and adhesives, food sciences, medical devices, and diagnostics and instrumentation. Finnegan, Henderson, Farabow, Garrett & Dunner, LLP 16 Old Bailey London, United Kingdom EC4M 7EG Tel +44 (0) anthony.tridico@finnegan.com 20

21 Disclaimer These materials are public information and have been prepared solely for educational and entertainment purposes to contribute to the understanding of U.S. intellectual property law. These materials reflect only the personal views of the authors and are not a source of legal advice. It is understood that each case is fact specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, the authors and Finnegan, Henderson, Farabow, Garrett & Dunner, LLP cannot be bound either philosophically or as representatives of their various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorneyclient relationship with the authors or Finnegan, Henderson, Farabow, Garrett & Dunner, LLP. While every attempt was made to ensure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed. 21