Tagged as: PTAB

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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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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Trastuzumab IPR Updates

Last month, the PTAB issued decisions on two petitions, IPR2017-02063 and IPR2018-00016, filed by Pfizer against one of Genentech’s Herceptin® (trastuzumab) patents, U.S. Patent No. 7,846,441 (“the ‘441 patent”). The ‘441 patent has claims directed to methods of treating a malignant progressing tumor or cancer characterized by overexpression of ERBB2 receptor. IPR2017-02063…

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PTAB Denies Institution Of IPR On Two Humira Patents

The PTAB has denied institution of inter partes review of two Abbvie patents that relate to HUMIRA (adalimumab). On February 9, 2018, the PTAB denied Sandoz’s IPR2017-01824 on U.S. Patent No. 9,512,216, which is directed to a method of treating plaque psoriasis by subcutaneously administering a claimed regimen of adalimumab. On the same day, the PTAB…

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