Tagged as: IPR

Hoffman-La Roche Disclaims Patent Claims in Response to IPR

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…

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Federal Circuit Solicits U.S. Attorney General’s Views on Constitutionality of Subjecting Pre-AIA Patents to Inter Partes Review

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….

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Mylan Files Ten Additional IPR Petitions Challenging Sanofi's Lantus Patents

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…

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BMS and Momenta File Additional Letters Regarding Standing in Orencia IPR Appeal

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…

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Federal Circuit Rules No Tribal Immunity in IPRs

This morning, the Federal Circuit issued its much anticipated decision in St. Regis Mohawk Tribe v. Mylan Pharmaceuticals.  A panel of the court, consisting of Judges Dyk, Moore, and Reyna, held that “tribal sovereign immunity cannot be asserted in IPRs.”  Relying on the Supreme Court’s decisions in Oil States and SAS Institute,…

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Proposed Amendment to Hatch-Waxman and BPCIA Could Curb IPRs by Generic and Biosimilar Applicants

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…

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