The Federal Circuit held in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., 23-2254 that a reissued patent receives patent term extension (PTE) based on the issue date of the original patent, not the reissue patent,...more
In the mid-2000s, the U.S. Patent Office (USPTO) determined that reexaminations would be more consistent and legally correct if performed by a centralized set of experienced and specially trained Examiners. As a result, the...more
Merck Sharp & Dohm B.V. v. Aurobindo Pharma USA, Inc. et al (Fed. Cir. March 13, 2025) - The Hatch-Waxman Act seeks to strike a balance in the pharmaceutical industry by incentivizing drugs makers to develop innovative...more
Addressing the calculation of patent term extensions (PTEs) under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit affirmed a district court decision that under the act the issue date of the original...more
Early last year, Aurobindo, one of the Defendants* in ANDA litigation against Merck, advanced the proposition that in cases where a patent had been reissued patent term extension ("PTE") under 35 U.S.C. § 156 should be...more
On March 13, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed a five-year patent term extension (“PTE”) for Merck’s sugammadex patent, holding that the district court had correctly calculated PTE based on the...more
On March 13, 2025, the Federal Circuit decided in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. (No. 2023-2254) how patent term extensions (PTEs) apply to reissued patents under the Hatch-Waxman Act....more
The Federal Circuit heard oral argument in Auribundo's appeal of the district court's decision in favor of plaintiff Merck, in a case captioned In re Sugammadex (alternatively, Aurobindo v. Merck Sharp and Dohme). The issue...more
For branded drugmakers, the development of a pharmaceutical product approved by the Food and Drug Administration (FDA) all but assures generic competition. As discussed during the first installment of our Hatch-Waxman series,...more
Case Name: In re Sugammadex, No. 20-CV-2576 (CCC/LDW), 2023 WL 3966146 (D.N.J. June 13, 2023) (Cecchi, J.) Drug Product and Patent(s)-in-Suit: Bridion® (sugammadex sodium); U.S. Patent No. RE44,733 (“the ’733 patent”)....more
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more
The USPTO will be hosting a “public listening session” on January 19, 2023, focusing on USPTO-FDA collaboration initiatives proposed pursuant to President Biden's Executive Order on “Promoting Competition in the American...more
The USPTO has issued proposed rules to make permanent a Covid-19-related change in the manner in which applications for patent term extension under 35 USC § 156 are to be filed. While the Covid-19-related changes permitted...more
Allele v. Pfizer – The Basics. On April 23, 2021 Pfizer, Inc., BioNTechSE, and BioNTech US, Inc. (“Pfizer and BioNTech”) filed a joint reply supporting of their previously filed motion to dismiss a patent infringement...more
Patent term extension (PTE) is available under the 1984 Drug Price Competition and Patent Restoration Act, also known as the Hatch-Waxman Act (The Act). The Act allows the extension of the term of a patent claiming a product...more
On 6 July, China’s National People’s Congress (NPC) published additional amendments to its draft patent law, which was first released in January 2019. As we reported at that time here, the proposed Chinese Patent Law...more
In Biogen International GmbH v. Banner Life Sciences LLC, the Federal Circuit construed language of the Hatch-Waxman patent term extension statute in a manner Biogen argued was inconsistent with the “active moiety” focus of...more
In a recent decision, the issue before the Federal Circuit was the meaning of the term “product” in a patent term extension statute. Biogen Int'l GmbH v. Banner Life Scis. LLC, 956 F.3d 1351 (Fed. Cir. 2020). Section 156 of...more
Case Name: Biogen Int’l GmbH v. Banner Life Sciences LLC, No. 18-2054-LPS, 2020 U.S. Dist. LEXIS 3639 (D. Del. Jan. 7, 2020) (Stark, J.)....more
The coronavirus global pandemic has ushered in extraordinary roadblocks for the pharmaceutical industry. To help you carve out a path forward, in-house senior executives and industry leaders will convene virtually at ACI’s...more
BIOGEN INTERNATIONAL GMBH v. BANNER LIFE SCIENCES LLC - Before Lourie, Moore, and Chen. Appeal from the U.S. District Court for the District of Delaware - Summary: If a claimed product is not the active ingredient of...more
In 1984, Senator Orrin Hatch (R-UT) and Rep. Henry Waxman (D-CA) shepherded a grand legislative compromise through Congress that balanced the rights and solved inefficient regulatory consequences for both branded and generic...more
This month we highlight two Federal Circuit obviousness-type double patenting decisions. CASES - Federal Circuit - Section 156 Patent Term Extension and Obviousness-Type Double Patenting - Novartis AG v. Ezra...more