IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
Tradjenta® (linagliptin) - Case Name: Boehringer Ingelheim Pharms. Inc. v. Apotex Inc., Civ. No. 23-685-CFC, 2025 WL 71979 (D. Del. Jan. 10, 2025) (Connolly, J.) Drug Product and Patent(s)-in-Suit: Tradjenta® (linagliptin);...more
Simbrinza® (brinzolamide / brimonidine) - Case Name: Alcon Inc. v. Padagis Israel Pharms. Ltd., Civ. No. 22-1422-WCB, 2025 WL 457119 (D. Del. Feb. 5, 2025) (Bryson, C.J.) Drug Product and Patent(s)-in-Suit: Simbrinza®...more
AZURITY PHARMACEUTICALS, INC. v. ALKEM LABORATORIES LTD. Before Murphy, Moore, and Chen. Appeal from the United States District Court for the District of Delaware. Arguments and amendments made during prosecution of a parent...more
While a Miranda warning isn’t given prior to starting substantive examination, perhaps it should be. In Azurity Pharmaceuticals, Inc. v. Alkem Laboratories, Ltd., a precedential decision issued on April 8, 2025, the Federal...more
Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd., No. 2023-1977 (Fed. Cir. (D. Del.) Apr. 8, 2025). Opinion by Murphy (sitting by designation), joined by Moore and Chen. Azurity owns a patent directed to non-sterile...more
The US Court of Appeals for the Federal Circuit affirmed a district court’s noninfringement determination, finding that the presence of a disclaimed compound in the accused product precluded infringement. Azurity Pharm., Inc....more
Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd., Appeal No. 2023-1977 (Fed. Cir. Apr. 8, 2025) In our Case of the Week, the Federal Circuit affirmed that defendant Alkem’s proposed generic antibiotic did not...more
Novartis markets and sells a combination therapy of valsartan and sacubitril under the brand name Entresto® for the treatment of various forms of heart failure. MSN submitted an Abbreviated New Drug Application seeking...more
The Federal Circuit recently reversed a district court decision that found a patent that did not describe after-arising technology failed to satisfy the written description requirement. In so doing, the Federal Circuit...more
Minocin® (minocycline) - Case Name: Melinta Therapeutics, LLC v. Nexus Pharms., Inc., Civ. No. 21-2636, 2024 WL 4799896 (N.D. Ill. Nov. 15, 2024) (Kness, J.) Drug Product and Patent(s)-in-Suit: Minocin® (minocycline);...more
Exeltis USA, Inc. and other parties (Exeltis) recently prevailed against Lupin Ltd. and Lupin Pharmaceuticals, Inc. (Lupin) in a patent infringement suit brought in the District of Delaware. After a three-day bench trial, the...more
CloudofChange, LLC v. NCR Corp., Appeal No. 2023-1111 (Fed. Cir. Dec. 18, 2024) In our Case of the Week, the Federal Circuit addressed the question of divided infringement in the context of system claims. In its...more
In a recent precedential opinion, the Court of Appeals for the Federal Circuit vacated an infringement judgement against Mylan (Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., No. 2022-1889, Fed. Cir. Nov. 6,...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
Case Name: AstraZeneca AB v. Mylan Pharms., Inc., No. 22-cv-35, 2022 WL 2707729 (N.D.W.V. July 12, 2022) (Bailey, J.) Drug Product and Patent(s)-in-Suit: Symbicort® (budesonide and formoterol); U.S. Patent No. 11,311,558...more
On January 3, in Novartis Pharmaceuticals Corporation v. Accord Healthcare, Inc., the Federal Circuit found written description support for a negative claim limitation, even though the negative claim limitation did not have...more
Vacating a stipulated infringement judgment based on an incorrect claim construction, the US Court of Appeals for the Federal Circuit explained that it is improper to isolate claim language from the intrinsic evidence when...more
The use of the word “about” in a patent claim as part of a numeric range might permit the patent holder to preclude competitor formulations falling outside the approximate range, as illustrated in a fairly recent decision Par...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
Stipulating to infringement after a contrary claim construction is a conventional stratagem for a losing party to have a final judgment that can be challenged before the Federal Circuit. The risk of course, is that if the...more
Precedential Federal Circuit Opinions: In Re NITRO FLUIDS L.L.C. [ORDER] (2020-0142, 10/28/28) (REYNA, WALLACH, and CHEN) - Reyna, J. The Court considered a petition for a writ of mandamus seeking transfer from the...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
Transitional terms in patent law (conventionally, "comprising," "consisting of," and the more arcane "consisting essentially of") have their own provenance and meaning, denoting limitations that are "open" (comprising) or...more
The PTAB Cannot Approve or Deny Certificates of Correction - In Honeywell International, Inc. v. Arkema Inc., Arkema France, Appeal Nos. 2018-1151, -1153, the Patent Trial and Appeal Board (“Board”) does not have the...more
PATENT CASE OF THE WEEK - Nalpropion Pharmaceuticals, Inc. v. Actavis Laboratories, FL, Inc., Appeal No. 2018-1221 (Fed. Cir. Aug. 15, 2019) - This week’s Case of the Week focuses on issues relating to written...more