At ACI’s 23rd Advanced Summit on Life Sciences Patents, you can expect informational overviews and thorough discussion of every facet of the industry. In a time of major legislative, regulatory, and judicial change, you can't...more
We are excited to present the second edition of Sheppard Mullin’s “Year in Review” report, which provides a comprehensive summary of the key precedential Federal Circuit decisions related to patent law in 2024. Building on...more
The United States Court of Appeals for the Federal Circuit recently affirmed a district court ruling that a pharmaceutical dosing claim limitation was unpatentable due to obviousness-type double patenting. The court found...more
Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...more
The US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial & Appeal Board patentability determination, finding that the Board failed to consider the entire record regarding the prior art status of a...more
What You Need to Know: • Instead of filing multiple applications claiming different aspects of an invention but not sharing a single priority chain, patentees should strive to file highly comprehensive applications that...more
1. Background: ImmunoGen’s Patent Application & Dispute - In 2014, ImmunoGen, Inc. (Immunogen) filed U.S. Patent Application No. 14/509,809 (the ’809 application)....more
In this edition of The Precedent, we outline the decision in Regeneron Pharms., Inc. v. Mylan Pharms. Inc. In Regeneron Pharms., Inc. v. Mylan Pharms. Inc., the Federal Circuit affirmed the district court’s grant of a...more
Under U.S. law, most patents are limited to a term of 20 years from the earliest nonprovisional filing date. However, Patent Term Adjustment (PTA) and Patent Term Extension (PTE) can be used in certain circumstances to gain...more
2024 brought exciting developments at the Federal Circuit. The court issued its first en banc decision in a patent case in five years in LKQ, which significantly altered the standard for proving obviousness of a design...more
Unity of invention and double patenting law and practice in Canada can create challenges for patent applicants. For example, applicants may not expect a unity of invention objection to be raised, requiring claims to be...more
Addressing a preliminary injunction in patent litigation related to the Biologics Price Competition and Innovation Act (BPCIA), the US Court of Appeals for the Federal Circuit upheld the district court’s grant of a...more
Cabometyx® (cabozantinib (L)-malate) - Case Name: Exelixis, Inc. v. MSN Labs. Private Ltd., No. 22-228-RGA, 2024 WL 4491176 (D. Del. Oct. 15, 2024) (Andrews, J.) Drug Product and Patent(s)-in-Suit: Cabometyx®...more
On January 29, 2025, the CAFC issued opinions affirming the preliminary injunctions issued against biosimilars of Regeneron’s EYLEA® (aflibercept): Samsung Bioepis’s Opuviz™ (aflibercept-yszy) (CAFC Case Nos. 24-1965,...more
Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Appeal Nos. 2024-1965, -1966, -2082, -2083 (Fed. Cir. Jan. 29, 2025) Our Case of the Week is a 31-page decision that touches on a variety of issues, including...more
In Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 2024-1061 (Fed. Cir. August 13, 2024), the Federal Circuit reversed the District Court of Delaware’s invalidity determination of certain claims of U.S. Patent No....more
As 2025 begins and intellectual property (IP) strategies are being developed for the new year, it is a good time to reflect on what IP issues were prominent in 2024. According to many readers, hot IP topics included...more
Earlier this year, the U.S. Patent and Trademark Office (USPTO) proposed a sweeping set of rules imposing new requirements on terminal disclaimers filed to overcome obviousness-type double patenting (OTDP) rejections, and...more
Facing strong opposition from a rare alliance of the pharma and tech industries as well as past agency leaders, the U.S. Patent and Trademark Office (USPTO) has withdrawn a proposed new rule directed at Terminal Disclaimer...more
On May 10, 2024, the U.S. Patent and Trademark Office published a Notice of Proposed Rulemaking (NPRM) regarding terminal disclaimer practice. The proposed rule would have required any terminal disclaimer filed to obviate...more
The recent Patent Trial and Appeal Board (PTAB) decision Ex Parte Baurin reversed an Examiner rejection for obviousness-type double patenting (ODP) in U.S. Application No. 17/135,529 over the later-filed, later-expiring...more
The basis for obviousness-type double patenting (ODP) is found in 35 U.S.C. § 101, establishing an applicant is entitled to a single patent, “a patent” or the “first” patent, for an invention....more
The US Court of Appeals for the Federal Circuit issued its opinion in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061 (Fed. Cir. 2024), holding that “a first-filed, first-issued, later-expiring claim cannot...more
On August 13, the Federal Circuit, in Allergan USA, Inc. v. MSN Laboratories Private Ltd., held that a “first-filed, first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued, earlier-expiring...more
The Supreme Court denies Cellect LLC's petition for certiorari to consider whether patent term adjustment ("PTA") should be included in patent term for obviousness-type double patenting ("ODP") purposes....more