Perspectives on Hatch-Waxman Litigation
6 total results. Page 1 of 1.
This year brought us very significant changes in patent jurisprudence from the Supreme Court and Federal Circuit affecting Chemical & Life Sciences patent practice.
FDA Holds Public Meeting on Innovation in Drug Development and Accelerating Access to Generic Medicines
On July 18, 2017, FDA held a public meeting to address efforts to ensure a balance between innovation in drug development and accelerating the access of the public to lower-cost alternatives to innovator drug therapies is maintained under the Drug Price Competition and Patent Term Restoration Act.
On June 21, the Food and Drug Administration announced a Drug Competition Action Plan in order to attempt to address ways that the agency's rules have been, in the agency's view, “gamed” to create obstacles that delay generic drug approvals to reduce generic competition.
This week, the Supreme Court unanimously rejected the Federal Circuit’s broad reading of the patent venue statute for domestic corporations in TC Heartland LLC v. Kraft Foods Group Brands LLC, No. 16-341, 2017 WL 2216934 (U.S. May 22, 2017).
As in previous years, 2016 brought us a combination of both expected and unexpected holdings by the Supreme Court and the Federal Circuit.