by Green Griffith | Jan 3, 2019 | IP News
The Bill (H.R. 7251) would require companies desiring to launch a generic or biosimilar product to choose between an IPR and the Hatch-Waxman/BPCIA framework. Members of the US House and Senate, on December 11, 2018, jointly introduced the Hatch-Waxman Integrity Act...
by Green Griffith | Nov 11, 2018 | IP News
The United States Patent and Trademark Office (USPTO) has discarded the “broadest reasonable interpretation” claim construction standard for PTAB proceedings effective for petitions filed on or after November 13, 2018. The USPTO, in a final rule (a copy of...
by Green Griffith | Nov 7, 2018 | IP News
A Delaware District Court has determined that drug substance batches manufactured pursuant to a continued process verification program for a biosimilar product were not protected under the “safe harbor” defense. The Biologics Price Competition and Innovation Act of...
by Green Griffith | Oct 29, 2018 | IP News
The Federal Circuit recently confirmed that its own framework, which creates a presumption of obviousness in overlapping range cases, governs in IPR proceedings. Under Federal Circuit precedent, a presumption of obviousness typically exists when numerical ranges...
by Green Griffith | Oct 26, 2018 | IP News
The Federal Circuit recently confirmed that factors such as operation of a manufacturing plant capable of infringing a patent confer standing on a petitioner to appeal an IPR Final Written Decision. In a September 17, 2018, decision (E.I. DuPont de Nemours v....
by Green Griffith | Oct 16, 2018 | IP News
The Supreme Court may review the Federal Circuit’s dismissal of an appeal from an adverse PTAB decision on the basis that the appellant has no risk of being sued for infringement—and thus has no standing on appeal. The Supreme Court recently ordered briefing from the...
