Today, in the Immunex v. Sandoz BPCIA litigation, a District of New Jersey judge held that U.S. Patent No. 8,063,182, related to “the fusion protein etanercept, the active ingredient in Immunex’s product Enbrel®” and U.S. Patent No. 8,163,522, related to Enbrel®’s method of manufacture, are not invalid. As we previously reported,…
On July 31, the United States Patent and Trademark Office (USPTO) issued a Notice of Proposed Rule Making (NPRM) outlining proposed increases in patent fees in a number of categories. In particular, America Invents Act (AIA) fees are subject to a 26% increase, substantially more than the 5% increase in…
As we previously reported, Genentech has appealed the Delaware district court’s denial of its preliminary injunction motion that sought to bar sales of Amgen’s KANJINTI (trastuzumab-anns) biosimilar in the United States. In conjunction with its appeal, Genentech also asked the Federal Circuit (1) to issue an injunction against Amgen pending…
On July 31, the U.S. Department of Health and Human Services (HHS) announced a Safe Importation Action Plan (“Action Plan”) created with the Food and Drug Administration (FDA) to “allow the importation of certain prescription drugs originally intended for foreign markets,” particularly Canada. According to the HHS Secretary Alex Azar, “[the…
In a precedential decision last week, the U.S. Court of Appeals for the Federal Circuit held that the use of IPR proceedings for patents issued prior to the enactment of the America Invents Act (AIA) was not an unconstitutional taking under the Fifth Amendment to the U.S. Constitution. In that July 30,…
As we previously reported, Amgen commercially launched two biosimilars in the United States earlier this month: KANJINTI™ (trastuzumab-anns), a biosimilar to Herceptin®; and MVASI® (bevacizumab-awwb), a biosimilar to Avastin®. Amgen’s launch announcement on July 18, 2019 came shortly after a Delaware federal district court denied Genentech’s requests for a temporary…
Mylan N.V. and Pfizer Inc. recently announced that Mylan and Upjohn, Pfizer’s off-patent branded and generic business, will combine to form a new company. According to the press release, each Mylan share would be converted into one share of the new company. Pfizer shareholders will own 57% of the combined new company,…
On July 29, Sandoz filed a response to Amgen’s petition for rehearing en banc of the Federal Circuit’s decision affirming summary judgment of non-infringement of Amgen’s U.S. Patent No. 8,940,878 (“the ‘878 patent”). The ‘878 patent concerns a protein purification method that is allegedly used in the manufacture of Amgen’s NEUPOGEN…
On July 23, 2019, the FDA approved Pfizer’s aBLA for RUXIENCE (rituximab-pvvr), a biosimilar of Genentech’s RITUXAN. According to its approved package insert, RUXIENCE is indicated for the treatment of certain types of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener’s Granulomatosis), and microscopic polyangiitis. RUXIENCE is the twenty-second…
As we previously reported, last year Amgen appealed a Delaware district court’s decision dismissing Amgen’s patent infringement complaint under the BPCIA against Coherus on the ground that Coherus’s biosimilar of NEULASTA (pegfilgrastim) could not be found to infringe Amgen’s patent under the doctrine of equivalents (Amgen’s only asserted basis for…