Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
Synopsis: In a recently issued final written decision, the Patent Trial and Appeal Board (the “Board”) found all challenged claims of U.S. Patent No.11,572,334 (“the ’334 patent”) unpatentable.1 The Board’s decision centered...more
Patent owners generally look to secondary indicia to bolster their nonobvious defenses when prior art and/or knowledge of a person of ordinary skill in the art (“POSA”) seem to make the obviousness decision a close call. This...more
Case Name: Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd., No. CV 20-5426 (SRC), 2022 WL 17352334 (D.N.J. Dec. 1, 2022) (Chesler, J.) Drug Products and Patent(s)-in-Suit: Duobrii® (halobetasol...more
Case Name: Takeda Pharm. Co. Ltd. v. Norwich Pharms., Inc., No. 20-8966 (SRC), 2022 WL 17959811 (D.N.J. Dec. 27, 2022) (Chesler, J.) Drug Product and Patent(s)-in-Suit: Vyvanse® (1-lysine-d-amphetamine dimesylate); U.S....more
In the weeks preceding a recent Hatch-Waxman bench trial, a district court excluded portions of an expert’s opinion on obviousness that addressed internal documents and inventor testimony concerning the “inventors’ path” to...more
Case Name: Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., Case No. 2020-2106, 25 F.4th 1354 (Fed. Cir. Feb. 10, 2022) (Circuit Judges Newman, Prost, and Stoll presiding; Opinion by Stoll, J.; Dissenting Opinion by...more
[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more
Case Name: Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., No. 18-cv-734, 2021 WL 5323737 (D.N.J. Nov. 16, 2021) (Cecchi, J.) Drug Product and Patent(s)-in-Suit: Invega Sustenna® (paliperidone palmitate); U.S. Patent No....more
Biogen International GMBH, Biogen MA, Inc., v. Mylan Pharmaceuticals Inc. marks the Federal Circuit’s most recent interpretation of the 35 U.S.C. § 112 written description requirement in the Hatch-Waxman context. No....more
Case Name: Auxilium Pharms., Inc. v. FCB I LLC, Civ. No. 20-16456, 2021 WL 2802537 (D.N.J. July 6, 2021) (Vazquez, J.) - Drug Product and Patent(s)-in-Suit: Testim® (testosterone gel); U.S. Patents Nos. 7,320,968 (“the ’968...more
BECAUSE THE PRIOR ART TAUGHT OVERLAPPING PH RANGES AND STRUCTURALLY SIMILAR COMPOUNDS AS THOSE CLAIMED IN THE PATENT-IN-SUIT, THE FEDERAL CIRCUIT REVERSED SUMMARY JUDGMENT OF NON-OBVIOUSNESS. Case Name: Valeant Pharms...more
The Federal Circuit reversed a decision from the District Court for the District of Delaware invalidating three patents on anticipation grounds, finding the district court improperly relied on disclosures from multiple...more
PATENT CASE OF THE WEEK - Amgen Inc. v. Amneal Pharmaceuticals LLC, et al., Appeal Nos. 2018-2414, et al. (Fed. Cir. Jan. 7, 2020) - In this appeal from Markman and summary judgment opinions by the district court in a...more
The Situation: In a Hatch-Waxman litigation, a district court determined that the claims covering a method of using the drug everolimus to treat kidney cancers were not obvious. The court found a motivation to "pursue"...more
The Situation: In a Hatch-Waxman litigation, the claims recite oxymorphone with less than 0.001% of an impurity called 14-hydroxymorphinone. The prior art includes confidential communications from the FDA to oxymorphone...more
For the first time, on March 28, 2019, the Federal Circuit addressed obviousness of polymorph claims based on a known approach to polymorph screening, finding no reasonable expectation of success....more
This month, we highlight significant developments from July 2018, including the FDA’s Biosimilar Action Plan for “reducing gaming of FDA requirements or other attempts to unfairly delay competition” and the much anticipated...more
Berkheimer v. HP Inc., Appeal No. 2017-1437 (Fed. Cir. Feb. 8, 2018) - In Berkheimer v. HP Inc., the Federal Circuit reviewed the District Court’s summary judgment finding that certain claims of a patent were invalid as...more
In Merck v. Hospira, the only precedential case decided this week, a majority of the panel affirms a determination of obviousness, noting that despite the objective indicia supporting patentability, the claimed process was...more
The Hatch-Waxman Litigation and Life Sciences practice groups at Robins, Kaplan, Miller & Ciresi L.L.P. are pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the...more
When does a prior art disclosure of a concentration range of a medicament render obvious the use of a species that falls within that range, when that same use was also known in the prior art? After all, common sense should...more