Goodwin attorneys and Big Molecule Watch editors Keith Zullow and Michael Cottler were recently published on Bloomberg Law.
Disputes often arise regarding what is required of a biosimilar applicant to comply with Subsection (l)(2)(A) of the BPCIA, a provision that kicks off the patent dance. Although this issue arises frequently in litigation, it is unclear whether courts will ever resolve it. Read the full article here.
The post INSIGHT: The Ongoing Debate About Disclosing Manufacturing Process Information in the Patent Dance appeared first on Big Molecule Watch.