The Bayh-Dole Act provides that the federal government retains certain rights in inventions it funds. Many have sought to use those rights as a way to lower the cost of prescription drugs for consumers and for the federal...more
9/12/2025
/ Bayh-Dole Act ,
Biologics ,
Biosimilars ,
BPCIA ,
Drug Pricing ,
Federal Funding ,
Inventions ,
March-in Rights ,
National Institute of Health (NIH) ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Research and Development ,
Scientific Research
Inventions made in a particular country are generally first-filed in that country before entering the United States via a direct Paris Convention filing or, more commonly, a PCT national stage entry. Convenience, national...more
3/7/2025
/ Biologics ,
Biosimilars ,
Biotechnology ,
BPCIA ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Life Sciences ,
Paris Convention ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
On October 24, 2014, Amgen initiated the first litigation under the Biologics Price Competition and Innovation Act (“BPCIA”), asserting infringement of two patents. Over the last two calendar years, Amgen, Biogen, Genentech,...more
1/2/2025
/ Amgen ,
Biogen Idec ,
Biosimilars ,
BPCIA ,
Genentech ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regeneron
In an attempt to increase the availability of biosimilars, on July 11, 2024, the Senate passed the Affordable Prescriptions for Patients Act, which was introduced in the House on July 19, 2024. The bill sets a cap of 20...more
As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more
8/14/2024
/ Biologics ,
Coronavirus/COVID-19 ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturers ,
Patent Term Extensions ,
Patent Terms ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs