For the first time in decades, the Supreme Court will consider patent law’s “enablement” requirement, in Amgen Inc. v. Sanofi. That requirement is often a key point in litigation when a patent claims a class of novel compounds or antibodies. In the oral argument on March 27, the Supreme Court…
Goodwin and the Big Molecule Watch team are looking forward to participating in the 41st Annual JP Morgan Healthcare Conference, bringing together industry leaders from across the country. If you are at the conference in San Francisco, we hope you will join the team on January 11, 2023 for the Goodwin + KPMG…
As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law as part of the Affordable Care Act on March 23, 2010, creating an abbreviated licensure pathway for “biosimilar” and “interchangeable” biological products. The BPCIA also introduced a new scheme to resolve…