IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
Specify the Steps of Information Manipulation or Lose under § 101 - In Mobile Acuity Ltd. v. Blippar Ltd. Appeal No. 22-2216, the Federal Circuit held that patent claims that merely recite result-orientated, functional...more
On August 13, the Federal Circuit issued a precedential ruling in Allergan v. MSN Laboratories (Case No. 24-1061). This decision reversed the District of Delaware's application of the Federal Circuit precedent in In re:...more
Obviousness Analysis Does Not Consider Unclaimed Limitations - In Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals Usa, Inc., Appeal No. 22-1258, the Federal Circuit held that district court erred by adding unclaimed...more
On January 18, 2024, the USPTO rejected a "contingent" terminal disclaimer filed by Acadia Pharmaceuticals Inc. (Acadia) for a patent it owns that is being challenged in a pending litigation as invalid for obviousness-type...more
On December 27, 2023, Chief Judge Catherine Eagles of the U.S. District Court for the Middle District of North Carolina granted a motion for preliminary injunction by Natera Inc. enjoining NeoGenomics Laboratories Inc. from...more
This case addresses the legal framework for determining whether prior art anticipates a claimed range. The appropriate legal framework applies a different test depending on whether the prior art discloses a point within the...more
In an ANDA case in the District of Delaware, the court has rejected an obviousness challenge to a patented method of increasing survival in patients having prostate cancer. The court found that early clinical trial results...more
In its recent review of a district court decision the Federal Circuit characterized as "a thorough opinion," the Federal Circuit affirmed invalidation for obviousness of four claims from four different Orange Book-listed...more
We are excited to share Sheppard Mullin’s inaugural quarterly report on key Federal Circuit decisions. The Spring 2023 Quarterly Report provides summaries of most key patent law-related decisions from January 1, 2023 to March...more
The US Court of Appeals for the Federal Circuit upheld a district court’s findings of invalidity and noninfringement in a Hatch-Waxman case involving two sets of method patents directed to modulating dosages of pirfenidone, a...more
The Federal Circuit recently affirmed a district court judgment of invalidity for obviousness and for noninfringement for a series of patents challenged in ANDA litigation, in Genentech Inc. v. Sandoz Inc. In doing so, a...more
Case Name: Salix Pharms., Ltd. v. Norwich Pharms., Inc., C.A. No. 20-cv-430-RGA, 2022 WL 3225381 (D. Del. Aug. 10, 2022) (Andrews, J.) Drug Product and Patent(s)-in-Suit: Xifaxan® (rifaximin); U.S. Patents Nos. 7,612,199...more
Case Name: Tris Pharma, Inc. v. Teva Pharms. USA, Inc., Civ. No. 20-5212 (KM)(ESK) (D.N.J. Aug. 16, 2022) (McNulty, J.) Drug Product and Patent(s)-in-Suit: QuilliChew ER® (methylphenidate); U.S. Patents Nos. 9,545,399 (“the...more
In a crowded pharmaceutical art, the deficiencies thereof being so patent that the FDA encouraged industry to address and correct them, concerning a formulation developed to address the opioid crisis raging earlier in this...more
The US Court of Appeals for the Federal Circuit upheld a finding that patents covering Narcan, a naloxone-based intranasal opioid overdose treatment, were obvious despite evidence of long-felt need. Adapt Pharma Operations...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
There are some cases where the Federal Circuit makes its decision based on the eternal verities of patent law (insofar as there are any eternal verities in patent law). One such decision arose earlier this month when the...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
University of Strathclyde v. Clear-Vu Lighting LLC, Appeal No. 2021-2243 (Fed. Cir. Nov. 4, 2021) - In this week’s Case of the Week, the Federal Circuit reversed an inter partes review decision finding claims directed to...more
Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more
Imposition of liability under the equitable doctrine of inequitable conduct (as it has been variously defined) can result in a patent being held unenforceable; for this reason, former Chief Judge Rader called it the "atomic...more
In a terse, non-precedential opinion, the Federal Circuit affirmed a district court's judgment that Defendants Torrent Pharmaceuticals and Indoco Remedies Ltd. had failed to prove that the claims asserted by...more
[co-author: Kathleen Wills] Last year, the global COVID-19 pandemic created unprecedented challenges for American courts. By making several changes, however, the U.S. Court of Appeals for the Federal Circuit was able to...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 written description requirement has had a twenty-five year renaissance, particularly in the chemical and biotechnology arts as a way of restricting claim scope to what an inventor has actually invented (see Regents of the...more