Below is a summary of recent updates in biosimilar-related proceedings before the Patent Trial and Appeal Board of the United States Patent and Trademark Office. Trastuzumab: Last month, the Board issued two Final Written Decisions in IPRs of U.S. Patent No. 7,892,549, which is directed to methods for the treatment…
On October 23, 2018, we previously reported that the Federal Circuit ordered Momenta to show cause as to why Momenta’s appeal of a PTAB decision upholding the patentability of BMS’s U.S. Patent No. 8,476,239, relating to BMS’s ORENCIA® (abatacept) product, should not be dismissed as moot. Pursuant to Fed. R. App. P….
The USPTO announced a proposal today to change the procedures for amending claims in post-grant proceedings. Even though the AIA specifically provides for claim amendments in IPRs, claim amendments have been rare in actual practice. USPTO Director Andrei Iancu stated that the new procedures are being proposed to allow patent…
As we have previously reported, Momenta appealed a PTAB decision upholding the patentability of BMS’s U.S. Patent No. 8,476,239, relating to BMS’s ORENCIA® (abatacept) product. On October 1, 2018, Momenta informed the Court of a press release stating that it “has initiated discussions with its collaboration partner, Mylan, to exit its participation…
As we previously reported, following the Federal Circuit’s ruling in St. Regis Mohawk Tribe v. Mylan that “tribal immunity cannot be asserted in IPRs,” Allergan and the Tribe petitioned for rehearing en banc. The petition was first referred to the panel that heard the appeal as a petition for rehearing, and was then…
Today, the PTO announced that it has published a final rule changing the claim construction standard applied during IPR, PGR, and CBM proceedings before the PTAB. The final rule replaces the “broadest reasonable interpretation” standard with the claim construction standard that is used to construe claims in civil actions in…
On June 13, Senator Orrin Hatch (R-UT), co-author of the Drug Price Competition and Patent Term Restoration Act (aka the “Hatch-Waxman Act”), proposed an amendment in the Senate Judiciary Committee to modify the inter partes review (IPR) process for pharmaceuticals. The amendment, titled the Hatch-Waxman Integrity Act of 2018, would require aBLA…
Last week, the Federal Circuit issued a decision in Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, in which the court held that Altaire had standing to appeal the PTAB’s final written decision in a post-grant review (“PGR”) of Paragon’s U.S. Patent No. 8,859,623 and reversed-in-part and vacated-in-part the PTAB’s Final Written Decision….
As we reported earlier this week, the Supreme Court held in SAS Institute Inc. v. Iancu that when the PTAB institutes an IPR, it must decide the patentability of all challenged claims. The U.S. Patent and Trademark Office yesterday issued guidance on the impact of SAS. The guidance explains that going forward: …