Final Written Decisions

On August 20, 2019, a panel at the PTAB issued a Final Written Decision in Hunting Titan, Inc., v. DynaEnergetics GmbH & Co. KG that denied DynaEnergetics’s contingent motion to amend claims under the Motion to Amend PracticeIPR2018-00600, Paper 42 at 29.  The Panel explained that Hunting Titan met its burden to

In an April 11, 2019 order, Judge Andrews of the District of Delaware ruled that a Hatch-Waxman defendant’s obviousness defenses were precluded under 35 U.S.C. § 315(e)(2) even though the barring PTAB decision issued over a year after the court had held an obviousness trial.  Novartis Pharm. Corp. v. Par Pharm., Inc., No. 14-cv-01289 (D. Del. Apr. 11, 2019), Docket No. 198.  Read on for the details.
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In the chemical and biological arts, it is common for patent challengers to allege obviousness based upon prior art disclosures of ranges combined with “routine optimization” by one skilled in the art.  In E.I. du Pont de Nemours & Co. v. Synvina C.V., No. 17-1977 (Fed. Cir. Sept. 17, 2018), the Federal Circuit reversed the PTAB’s (“Board”) final written decision upholding Synvina’s U.S. Patent No. 8,865,921 (“’921 patent”) as non-obvious, in response to du Pont’s inter partes review (“IPR”) challenge on such grounds.  In particular, in E.I. du Pont, the Court found that the patentee failed to demonstrate that 1) the claimed range produced a new and unexpected result, different in kind and not merely in degree from the prior art, 2) the optimized parameter was not recognized as a result-effective variable, 3) the disclosure of broad ranges did not invite more than routine optimization, or 4) that the prior art taught away from the range.

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The Federal Circuit recently held that a product catalog distributed at a trade show was “publicly accessible,” and therefore qualified as prior art. In Nobel Biocare Services AG, v. Instradent USA, Inc., decided on September 13, 2018, the Federal Circuit affirmed the Patent Trial and Appeal Board’s (“PTAB”) finding that a catalog distributed at the International Dental Show (“IDS”) Conference in Cologne, Germany was publicly accessible. The court’s decision in Nobel hinged largely on the testimony of two declarants, one who went to the conference (Zvi Chakir), and another who Chakir gave the catalog to upon his return (Yechiam Hantman).
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On July 13, 2018, in Jazz Pharms., Inc. v. Amneal Pharms., LLC, (Case Nos. 2017-1617, -1673, -1674, -1675, -1676, -1677, -2075), the Federal Circuit affirmed the Patent Trial and Appeal Board’s (“PTAB”) holding that certain FDA advisory meeting minutes, transcripts, and slides were publicly available such that the materials constituted prior art.  We have previously discussed the PTAB’s public availability jurisprudence in Coalition for Affordable Drugs VIII, LLC v. The Trustees of the University of Pennsylvania, IPR2015-01835 where the PTAB held a presentation given to investors was not prior art. 
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Drug product labels (also known as prescribing information) are often asserted as prior art by patent challengers, both in front of the PTAB and in district court ANDA litigation.  Before the PTAB, using such prior art requires showing that it qualifies as a “printed publication” under 35 U.S.C. §§ 102 and 311(b).  Recently, the PTAB appears to be applying greater scrutiny to the use of such prior art when cited in invalidity grounds.  The Board’s analysis in such situations “involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.”  Sandoz Inc. v. AbbVie Biotechnology Ltd., IPR2018-00156, Paper 11 at *9 (June 5, 2018) (citing In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004)).  A pair of recent rulings identify some of the evidentiary issues catching the eyes of PTAB panels as they consider invalidity arguments that rely on product-label prior art.

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SAS Institute Inc. v. Iancu, 138 S. Ct. 1348 (2018), established a clear rule requiring institution on all challenged claims in future IPR proceedings. But the Supreme Court’s April 24 decision created immediate uncertainty regarding the hundreds of IPRs in which the PTAB had already instituted review or issued a final written decision on fewer than all claims and all grounds presented in the petition. The Federal Circuit’s immediately apparent interest in SAS transitional issues has led to swift action—the court’s precedential decision in PGS Geophysical AS v. Iancu explains that (1) SAS requires institution on all claims and all grounds presented in a petition for IPR, (2) the Federal Circuit can exercise appellate jurisdiction in pre-SAS cases where the Board granted only partial institution, and (3) parties can waive requests for SAS-based relief on appeal.
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In a final written decision in April 2017, the PTAB found that Petitioner did not satisfy its burden of proving claims of U.S. Patent No. 8,618,135 (“the ’135 patent”) were unpatentable in part because the PTAB found a slide deck presented to business persons was not prior art.  In Coalition for Affordable Drugs VIII, LLC v. The Trustees of the University of Pennsylvania, IPR2015-01f835, Paper No. 56 (PTAB March 6, 2017) Petitioner argued that the ’135 patent was unpatentable over a combination of prior art that included a slide deck prepared by Evan Stein, M.D., Ph.D., for PPD, Inc. (“Stein”).

Stein was presented during Analyst Day at PPD, Inc. live and via webcast, and a hyperlink was distributed.  Moreover, Stein was reported in Pink Sheet, a news webpage.  In asserting Stein was prior art, Petitioner alleged Stein was “targeted to financial analysts, investors, and skilled artisans interested in drug discovery and development.”  Petitioner also asserted that the presentation was publicized for weeks, and that skilled artisans would have taken great interest in it. 
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