The Federal Circuit will rehear en banc the appeal In re: Aqua Products, Inc., No. 2015-1177 to address whether the PTAB’s rules requiring the Patent Owner to demonstrate the patentability of proposed amended claims are consistent with the statute permitting claim amendment during an IPR challenge, 35 U.S.C. 316(d) and (e). A…
On August 5, Apotex filed a petition for an IPR on Patent No. 8,952,138, owned by Amgen. The ’138 patent is the same patent that is being challenged in the District Court for the Southern District of Florida, in a case in which the Federal Circuit affirmed a preliminary injunction enjoining…
A few BPCIA litigation updates to wrap up the week for our readers, looking ahead to next week: The Federal Circuit issued its formal mandate in Amgen v. Apotex yesterday. With the issuance of the formal mandate, the Federal Circuit has officially ordered that its July opinion in the case must now be…
In a study published on August 2nd, a team of scientists from Johns Hopkins Bloomberg School of Public Health in Maryland and Brigham and Women’s Hospital in Massachusetts conclude that preliminary evidence shows an interchangeability between biosimilars and their reference tumor necrosis factor-α (TNF-α) inhibitor counterparts. While this study only…
As we previously reported, on June 17, Janssen filed two complaints alleging infringement of claims in U.S. Patent No. 7,598,083, one against Celltrion and Hospira, and one against HyClone Laboratories, Celltrion’s supplier of cell culture media. On August 5th, HyClone filed a motion for injunctive relief to dismiss and to…
As we previously reported, on July 20, the Southern District of Florida granted Amgen’s motion for judgment on partial findings that the ’138 patent was not proven invalid on grounds of anticipation, lack of written description, indefiniteness and obviousness. The Court did not address lack of enablement, however, nor did…
Coherus Biosciences, Inc. announced submission to the FDA of its biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. Pegfilgrastim is used to prevent or treat neutropenia, a disorder wherein a patient is more susceptible to infection due to chemotherapy. Coherus supported its 351(k) application with similarity data…
Mylan N.V. and Biocon Ltd. recently announced that the European Medicines Agency has accepted Mylan’s Marketing Authorization Application for a proposed biosimilar version of Amgen’s Neulasta (pegfilgrastim). In Europe, Neulasta is indicated for the treatment of certain side effects associated with cytotoxic chemotherapy, including neutropenia. According to the two companies,…
We recently posted that Merck had announced “promising” results from Phase III studies evaluating MK-1293, an investigational follow-on biologic insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes. Late last week, Merck announced that the FDA had accepted for review its New Drug Application…
As we reported last week, on Thursday, August 4, AbbVie sued Amgen seeking an injunction to prevent Amgen from launching its biosimilar version of AbbVie’s Humira. The complaint alleges that Amgen’s biosimilar infringes 61 U.S. patents (and five pending U.S. patent applications that have since been allowed), but that AbbVie has…