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
3/20/2025
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Patent Litigation ,
Patent Reissue Applications ,
Patent Term Extensions ,
Patent Terms ,
Patents ,
Pharmaceutical Industry ,
USPTO
On January 29, 2025, the Federal Circuit issued paired decisions addressing Samsung Bioepis’s (“SB”) and Formycon AG’s (“Formycon”) appeals of preliminary injunctions entered in ongoing aflibercept biosimilar litigations with...more
1/31/2025
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Biosimilars ,
Food and Drug Administration (FDA) ,
Foreign Corporations ,
Generic Drugs ,
Hatch-Waxman ,
Life Sciences ,
Marketing ,
Patent Litigation ,
Personal Jurisdiction ,
Pharmaceutical Patents ,
Preliminary Injunctions
Last year, the Federal Circuit surprised many observers of patent law in In re Cellect LLC, 81 F.4th 1216, 1228–29 (Fed. Cir. 2023) when—for the first time—it affirmed a U.S. Patent & Trademark Office decision cancelling an...more
Federal funding is a huge boon for companies, universities, and research institutions conducting innovative research. However, it comes attached with requirements that can become a stumbling block, especially for emerging and...more
3/6/2023
/ Bayh-Dole Act ,
Contractors ,
Emerging Technology Companies ,
Federal Funding ,
Filing Requirements ,
Innovation ,
Innovative Technology ,
Intellectual Property Protection ,
Inventions ,
Patent Ownership ,
Reporting Requirements ,
Research and Development
On September 27, 2022, Judge Richard Andrews of the District of Delaware granted Novartis’s motion to dismiss declaratory judgment (“DJ”) counterclaims raised by two generic drug manufacturers in the ongoing litigation...more
In April of 2021, we provided a three-part series relating to the IP and Competitive Landscape for the mRNA market. In this post we provide a 2021 year in review update on mRNA pioneers and key players and offer additional...more
On October 15, 2021, the U.S. Food and Drug Administration (“FDA”) approved Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm), the first interchangeable biosimilar to AbbVie’s blockbuster immunosuppressant Humira®...more
Following the successful development (and financial success) of its mRNA vaccine, biotech company Moderna is now looking to expand into the gene editing field. During a second-quarter earnings call on August 5, 2021, Moderna...more