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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: …
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…
Last week, the Patent Trial and Appeal Board issued a final written decision in IPR2016-01771, filed by Hospira to challenge U.S. Pat. No. 7,622,115. The Board invalidated all 5 claims of the ’115 patent, which is directed to methods for treating cancer in a patient comprising administering an effective amount…
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…
As we’ve reported on previously, Allergan, Inc. assigned its rights to patents covering its Restasis® dry eye treatment to the St. Regis Mohawk Tribe (“Tribe”) and simultaneously licensed back those patents in exchange for the Tribe’s agreement to invoke tribal sovereign immunity in inter partes review (IPR) proceedings before the…
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…
On January 8, 2018, the Federal Circuit issued its en banc decision in Wi-Fi One, LLC v. Broadcom Corp., No. 2015-1944. The Federal Circuit originally held that due to binding precedent, a time-bar determination under 35 U.S.C. § 315(b) is final and nonappealable under 35 U.S.C. § 314(d). As we reported here,…