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…
As we previously reported, currently pending before the Federal Circuit are consolidated appeals from five final written decisions of the Patent Trial and Appeal Board (Board) in inter partes review (IPR) proceedings finding the claims of AbbVie’s U.S. Patent Nos. 8,889,135, 9,017,680, and 9,073,987 unpatentable for obviousness in view of…
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…
As we previously reported, Pfizer filed a petition for IPR of certain claims of Hoffman-La Roche’s U.S. Patent No. 8,314,225 (IPR2018-01219). According to the petition, the challenged claims “purport to claim nucleic acid sequences that encode the C-terminal part of a human immunoglobulin heavy chain and a method for improving the expression…
Genentech recently submitted two opening appellate briefs to the Federal Circuit in connection with its appeals from the Board’s final written decisions in Hospira’s IPRs, IPR2016-01771 and IPR2016-01837, which found that the challenged claims of U.S. Patent Nos. 7,622,115 and 7,807,799, respectively, were unpatentable in view of the prior art….
As we reported here, on June 9, 2017, Mylan filed two IPR petitions challenging Sanofi-Aventis’s U.S. Patent No. 7,476,652 (IPR2017-01528) and U.S. Patent No. 7,713,930 (IPR2017-01526), related to Sanofi’s Lantus® (insulin glargine injection). Both petitions were instituted on December 13, 2017, as reported here. On September 10, 2018, Mylan filed ten additional…
As we reported here, Momenta is appealing a PTAB decision upholding the patentability of BMS’s U.S. Patent No. 8,476,239 (“the ’239 patent”), which relate to BMS’s Orencia® (abatacept) product. Momenta has not yet filed an aBLA for its abatacept biosimilar candidate, M834, so one of the key issues on appeal is whether Momenta has Article III standing…
As we previously reported, Sandoz appealed the PTAB’s decision not to institute an IPR regarding AbbVie’s U.S. Patent No. 9,512,216, which relates to a method for treating moderate to severe chronic plaque psoriasis using adalimumab. Last month, the Federal Circuit ordered Sandoz to show cause why the appeals should not be dismissed for lack…
As we previously reported, a panel of the Federal Circuit in St. Regis Mohawk Tribe v. Mylan held that “tribal immunity cannot be asserted in IPRs.” The Federal Circuit’s decision, if upheld, means that Allergan’s sale and license-back of patents covering its branded product Restasis to the Tribe was ineffective in shielding the…