Tagged as: IPR

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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IPR Updates: Trastuzumab, Rituximab, Abatacept

Below are a few recent updates in IPR proceedings concerning biologic-related patents: Today, the Board denied Samsung Bioepis’ petition for IPR of Genentech’s U.S. Patent No. 7,846,441 (IPR2017-00192), directed to cancer treatment methods using trastuzumab.  In its decision, the Board explained that it was exercising its discretion to deny the petition in…

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New IPR Petitions Filed Against GSK Vaccine Process Patents

Yesterday, Merck Sharp & Dohme Corp. filed four IPR petitions (IPR2018-01229,  IPR2018-01236, IPR2018-01234, and IPR2018-01237) against GlaxoSmithKline process patents – US Patent Nos. 8,753,645 and 9,265,839. The ‘645 and ‘839 Patents are directed towards a process of conjugating bacterial saccharides to protein carriers in order to improve the immunogenicity of…

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PTO Proposes Replacing Broadest Reasonable Interpretation Claim Construction Standard in IPR, PGR, CBM Proceedings

Today, the PTO announced proposed rulemaking to change the claim construction standard applied by the PTAB in IPR, PGR, and CBM proceedings.  In particular, the PTO proposes replacing the broadest reasonable interpretation standard for construing unexpired patent claims with the standard applied in federal district courts and ITC proceedings as…

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PTO Issues Guidance in Wake of SAS 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: …

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IPR Updates Relating to Adalimumab and Rituximab

Last week, the Patent Trial and Appeal Board (“Board”) instituted inter partes review of two patents directed to methods of administering adalimumab for the treatment of psoriasis, based on petitions filed by Sandoz: IPR2017-02105 (challenging U.S. Pat. No. 9,090,689) and IPR2017-02106 (challenging U.S. Pat. No. 9,067,992). Separately, the Board issued…

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Immunex Moves To Stay Dupixent® Patent Litigation Pending IPR

Last week, in the ongoing Immunex v. Sanofi patent litigation regarding Immunex’s claims of infringement against Sanofi and Regeneron’s Dupixent® (dupilumab) product, Immunex moved to stay the litigation pending resolution of two IPR proceedings the PTAB instituted on February 15, 2018 (IPR2017-01879 and IPR2017-01884) regarding the sole asserted patent: U.S. Patent No. 8,679,487….

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Biologics IPR Updates

Last week, the Patent Trial and Appeal Board (“Board”) denied institution of four IPR petitions on biologics-related patents.  First, the Board denied institution of IPR2017-01987 and IPR2017-01988, both filed by Sandoz Inc.  These IPRs sought to challenge U.S. Patent Nos. 8,911,737 and 8,974,790, respectively, both owned by AbbVie Biotechnology Ltd., and…

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