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
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
In a new precedential decision issued August 13, 2024, the Court of Appeals for the Federal Circuit in Allergan USA. v. MSN Labs, 24-1061, held that a first-filed, first-issued parent patent that receives a patent term...more
In August 2023, the Federal Circuit in In re Cellect held that in evaluating unpatentability for obviousness-type double patenting (ODP) of a patent that has received patent term adjustment (PTA), the relevant date is the...more
The District Court for the District of Delaware recently held on summary judgment that a patent with 2,295 days of combined patent term adjustment (PTA) and patent term extension (PTE) was not invalid for obviousness-type...more
We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...more
ACI’s Advanced Summit on Life Sciences Patents is back in person on June 2–3 in New York City. Our reimagined 2022 conference will provide practical insights on how to implement bullet-proof patent prosecution tactics,...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
A Post-URAA Patent that Issues After but Expires Before a Related Pre-URAA Patent Is Not a Double-Patenting Reference Against the Pre-URAA Patent - In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc.,...more
Federal Circuit Summary - Before Moore, Chen, and Hughes. Appeal from the United States District Court for the District of Delaware. Summary: Obviousness-type double patenting does not invalidate an otherwise validly...more