Momenta Pharmaceuticals

On January 3, 2018, Momenta and Mylan announced their development plan for a proposed biosimilar to Regeneron’s Eylea® whose active ingredient is aflibercept, a recombinant fusion protein. Eylea® was first approved as an intravitreal injection indicted for the treatment of patients with neovascular (wet) age-related macular degeneration. Eylea® is now also indicated for macular edema

On December 5, 2017, the Federal Circuit held oral argument in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company, 17-1694. The case comes on appeal from an IPR decision where the Board declined to find U.S. Patent No. 8,476,239 (“the ʼ239 patent”) unpatentable as obvious. The ʼ239 patent covers Bristol-Myers Squibb’s (“BMS”) Orencia® product, a