Last week, several briefs were filed in Federal Circuit appeals relating to trastuzumab biosimilars: Trastuzumab IPR Appeals On September 3, 2019, the USPTO submitted responsive appellate briefs in Federal Circuit appeals from IPR final written decisions regarding two patents related to methods of treating HER2+ cancer with trastuzumab (Cases Nos….
On August 28, 2019, the District Court for the District of Delaware issued an opinion related to the validity of two of Amgen’s patents (U.S. Patent Nos. 8,829,165 and 8,859,741) covering its cholesterol-lowering drug Repatha® (evolocumab) and Sanofi’s Praluent® (alirocumab). After a jury found that two of the five asserted…
In February of this year, Amgen filed three petitions for inter partes review (IPR) of Alexion Pharmaceuticals’ U.S. Patent Nos. 9,725,504 (IPR2019-00739), 9,718,880 (IPR2019-00740), and 9,732,149 (IPR2019-00741). The claims of the challenged patents are directed to the monoclonal antibody eculizumab, which is the active ingredient in Alexion’s SOLIRIS, or methods…
On September 5, JHL Biotech announced that it has reached a settlement agreement with Genentech to resolve the parties’ lawsuit regarding JHL’s alleged misappropriation of trade secrets relating to Genentech’s Rituxan® (rituximab), Herceptin® (trastuzumab), Avastin® (bevacizumab), and Pulmozyme® (dornase alfa) products. As we previously reported, in October 2018, Genentech filed…
In August, the American College of Rheumatology released updated guidelines for the treatment of ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpA), the two types of axial spondyloarthritis. The new recommendations suggest that patients use TNF inhibitors (Humira, Cimzia and Enbrel) as first-line therapy, followed by IL-17 inhibitors (Cosentyx and Taltz)…
In recent weeks, several drug makers announced collaborations for the development, manufacture, and/or commercialization of a variety of biosimilars or follow-on biologics. Below are some highlights: On September 3, 2019, Polpharma Biologics and Sandoz announced that they have entered into a global commercialization agreement in connection with Polpharma’s proposed biosimilar…
As we previously reported, the parties in the follow-on Amgen v. Apotex BPCIA litigation concerning Apotex’s proposed biosimilars of NEUPOGEN (filgrastim) and NEULASTA (pegfilgrastim) informed the district court on August 8 that they were drafting a stipulation and unopposed motion that would substitute Apotex as a party with a then-unnamed…
This past May, in the Amgen v. Sandoz BPCIA litigation concerning Sandoz’s ZARXIO (filgrastim-sndz) biosimilar and proposed pegfilgrastim biosimilar, a Federal Circuit panel affirmed the district court’s judgment of non-infringement in favor of Sandoz. The panel found that Amgen could not prevail on its infringement claims under the doctrine of…
As we previously reported, AbbVie had appealed the PTAB’s final written decisions that the challenged claims of U.S. Patent Nos. 8,889,135, 9,017,680, and 9,073,987, directed to methods of using adalimumab, are unpatentable on obviousness grounds. These final written decisions stemmed from IPR petitions filed by Coherus against all three patents,…
On August 22, Amgen and Allergan announced positive top-line results from a clinical study (JASMINE) comparing the efficacy and safety of the biosimilar candidate ABP 798 (rituximab) to the reference drug Rituxan® in patients with CD20-positive B-cell non-Hodgkins lymphoma. As we reported in January, ABP 798 was previously found to…