Recent Pharma-Related Federal Circuit Opinions regarding DC and USPTO IPR Obviousness Decisions

BTG Int. Ltd. and Jannsen Biotech, Inc. et al. v. Amneal Pharmaceuticals LLC, et al.

May 14, 2019
Obviousness affirmed

PTAB IPR decision finding BTGs’s ZYTIGA® (abiratone) Orange Book ‘438 method of treatment patent invalid for obviousness affirmed (e.g., the ‘438 specification requires that “any definition of ‘treatment’ must encompass the full range of therapeutic agent’s effects disclosed; substantial evidence supports the PTAB’s obviousness findings including “a reasonable expectation that prednisone could be used as a therapeutic agent in the treatment of prostate cancer”).

Novartis Pharmaceuticals Corp. et al. v. West-Ward Pharmaceuticals Int. Ltd.

May 13, 2019
Nonobviousness affirmed

DC’s “ultimate determination that the challenged claims would NOT have been obvious” due to no reasonable expectation of success affirmed (e.g., DC “erred in applying this heightened standard” for a motivation to comine since the “law does not require that a particular combination must be the preferred, or most desirable combination described in the prior art in order to provide motivation for the current invention”, no clear error in the DC’s determination of NO reasonable expectation of success (POSA “would not make a determination or reasonable suggestion simply based in isolation upon whether a drug enters phase II”, “no dispute that more than seventy percent of oncology drugs failed at phase II”)).

Endo Pharm. Inc., Mallinckrodt LLC v. Actavis LLC et al.

May 3, 2019
Nonobviousness affirmed

DC holding that Endo’s claims to low “ABUK” oxymorphone were NOT shown to be invalid for obviousness affirmed (DC “did not clearly err” in finding no reasonable expectation of success in combining prior art; “FDA communications recite a goal without teaching how the goal is attained”; “the inventors of the ‘779 patent engaged in extensive experimentation, involving much failure, to ultimately produce the oxymorphone of the Asserted Claims”).

Neptune Genetics, LLC et al. v. Eli Lilly & Company

April 26, 2019
Nonobviousness affirmed

Board IPR decisions finding Lilly’s claims relating to administration of vitamin B12 with pemetrexed were NOT shown to be obvious affirmed (e.g., substantial evidence…that the art did not provide a motivation for a skilled artisan to administer an MMA lowering agent, such as vitamin B12, in addition to folic acid”; Lilly’s statements to the FDA “were made…more than five months after the critical date” (In re Copaxone, FC 2018 (“a patent owner’s own disclosures to the FDA may be considered in assessing the state of the prior art”); FDA’s skepticism weighed in favor of non-obviousness).

Grunenthal Gmbh et al. v. Alken Labs. Ltd., Hikma Pharm., Actavis et al.

March 28, 2019
Nonobviousness affirmed

DC decisions of NONobviousness of Grunenthal’s polymorph claims (e.g., no known or expected polymorphism, no evidence that ‘737 patent synthesis “results in any Form A”, and no guidance as to what conditions “were likely to result in Form A”), no induced or contributory infringement due to Section viii carve-out of “the neuropathic pain indication” and “substantial noninfringing uses for the accused product” (§ 271(c)), and specific utility of the claimed polymorph (as an analgesic) affirmed.

In re: Ikeda Food Research Co. Ltd.

January 29, 2019
Obviousness affirmed (Non-precedential)

Board decision affirming the rejection of claims directed to method for measuring blood glucose using a biosensor as obvious due to inherent disclosure by the prior art affirmed (e.g., while “inherency may supply a missing claim limitation in an obviousness analysis”, “the limitation at issue necessarily must be present[] or the natural result of the combination of elements explicitly disclosed by the prior art” (PAR Pharm., FC 2014), and that “the [US]PTO can require an applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied upon”).

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