Following three days of hearings in Janssen v. Celltrion, the District Court for the District of Massachusetts (J. Wolf) today issued a memorandum order summarizing the Court’s rulings on several pending motions in the case. The Court granted Defendants’ Motion for Summary Judgment of Invalidity of the ’471 patent on both…
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…
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…
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…
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…