On May 20, 2019, the PTAB denied a request for rehearing in Apotex Inc. v. Amgen Inc., Case IPR2016-01542 (Paper 67), but modified its Final Written Decision. In the Final Written Decision, the PTAB found claims 1-17 and 19-24 of U.S. Patent No. 8,952,138 (“the ’138 patent”) unpatentable. The ’138 patent is directed towards
Recently, in Adello Biologics LLC v. Amgen Inc., Case PGR2019-00001 (Paper No. 13) (PTAB Apr. 19, 2019), the PTAB instituted post-grant review of claims 1-30 of U.S. Patent No. 9,856,287 (“the ’287 patent”). The ’287 patent is the patent at issue in a pending litigation between Amgen and Apotex under the Biologics Price Competition
Earlier this month, Amgen initiated suit against Apotex in the Middle District of Florida, alleging infringement of U.S. Patent No. 9,856,287 (“the ’287 patent”). This is the third complaint that Amgen has brought against Apotex under the Biologics Price Competition and Innovation Act (the “BPCIA”), based on Apotex’s abbreviated biologic license applications (“aBLAs”) for biosimilars
Biologic drugs are large molecules, such as therapeutic proteins, DNA vaccines, monoclonal antibodies, and fusion proteins, that are typically derived from living cells and used in the treatment, diagnosis, or prevention of disease. Most biologics are produced by genetically engineering living cells to express the therapeutic proteins rather than through traditional chemical synthesis. As proteins
Several of the Federal Circuit’s initial decisions involving the Biologics Price Competition and Innovation Act (the “BPCIA”) focused on unpacking the contours of the statute. The Federal Circuit’s recently issued opinion in Amgen Inc. v. Apotex Inc., No. 2017-1010, Slip Op. Nov. 13, 2017, by contrast, involves standard principles of appellate review.
We previously
Introduction and Background
The Apotex filgrastim/pegfilgrastim biosimilar litigation was the first biosimilar litigation where the parties participated in the patent dance. As a result, important issues regarding the interpretation of the Biologics Price Competition and Innovation Act (the “BPCIA”) were raised, including whether a biosimilar applicant (“(k) applicant”) must give 180-days’ notice to the reference