Below is a brief summary of each of the U.S. patent litigations concerning a proposed or approved biosimilar product. Please also consult our BPCIA Litigation Summary Chart for additional details.
Below is a brief summary of each of the U.S. patent litigations concerning a proposed or approved biosimilar product. Please also consult our BPCIA Litigation Summary Chart for additional details.
On August 16, bioeq filed a petition for inter partes review of U.S. Patent No. 6,716,602, titled “Metabolic rate shifts in fermentations expressing recombinant proteins.” The patent is owned by Genentech and is directed to a method for increasing product yield of a polypeptide produced by recombinant host cells. We will…
As we previously reported, the district court in Janssen v. Celltrion (in which U.S. Patent Nos. 6,284,471 and 7,598,083 are at issue) began hearing oral argument on August 16 on Celltrion’s motion for summary judgment that all claims of the ’471 patent-in-suit are invalid for obviousness-type double patenting, as well…
The August, 2016, edition of the Journal of Managed Care & Specialty Pharmacy published the results of a survey designed to measure pharmacists’ view on biosimilar naming conventions. (See our previous posts here and here for more information regarding the naming of biosimilars.) The survey found that pharmacists would generally prefer…
According to a press release, Novartis AG has contracted Jacobs Engineering Group Inc. to provide engineering, procurement, and construction management services to expand monoclonal antibody (mAb) production capacity by 70% and to establish a purification system that would allow parallel manufacturing of multiple drugs at the Novartis Pharma S.A.A. Biotechnology…
Yesterday, Celltrion filed a petition for inter partes review of Biogen’s U.S. Patent No. 7,820,161, which is directed to the use of rituximab to treat rheumatoid arthritis. We will continue to monitor and report on updates for IPR2016-01614 and will post key documents on our IPR tracker page.
As we reported, in a litigation regarding Hospira’s planned biosimilar for Amgen’s epoetin alfa, sold under the brand names Epogen and Procrit, in May, 2016, the District Court (D.Del., J. Andrews) denied Amgen’s motion to compel Hospira to produce two contested categories of documents, finding that Amgen had not shown…
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…