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
Since the America Invents Act (“AIA”) established a new venue for hearing patent disputes, the Patent Trial and Appeal Board (“PTAB”), much ink has been spilled regarding the impacts of this forum on patent litigation and the...more
12/27/2024
/ America Invents Act ,
Article III ,
Burden of Proof ,
Declaratory Judgments ,
Fees ,
Filing Deadlines ,
Innovation ,
Patent Ownership ,
Patent Trial and Appeal Board ,
Patent Validity ,
Patents ,
Small Business ,
Standing ,
Transparency ,
USPTO
The United States Patent and Trademark Office (USPTO) announced today the finalized fee increases taking effect on January 19, 2025. While applicants can still expect significant increases in certain areas, some proposed fee...more
11/20/2024
/ Applications ,
Corporate Counsel ,
Disclaimers ,
Duty to Disclose ,
Fees ,
Information Disclosure Statement ,
Patent Applications ,
Patent Ownership ,
Patent Term Adjustment ,
Patent Term Extensions ,
Patentability Search ,
Patents ,
USPTO
Heading into 2025, patent applicants should prepare for significant fee increases at the United States Patent and Trademark Office (USPTO). These fee increases can significantly impact patent applicant behavior, leading...more
Biosimilars are becoming increasingly important in healthcare as they offer a lower-cost alternative to biologic drugs, which can be expensive for patients, governments, and insurers. These biologic medicines, which are...more
3/1/2023
/ Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Care Providers ,
Healthcare ,
Insurance Industry ,
Interchangeability ,
Marketing ,
Patients ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Proposed Legislation ,
USPTO
The United States Patent and Trademark Office (USPTO) issued updated guidance on the duty of candor and duty to disclose in relation to submissions made to other government agencies, particularly the Food and Drug...more