Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co.
The Bristol-Myers Squibb (BMS) patent, entitled “Stable Protein Formulations,” describes and claims specific fluid formulations an immunosuppressive agent used in the treatment of immune system disorders such as rheumatoid arthritis. The product has the common name “abatacept” and the brand name Orencia®. Momenta sought Inter Partes Review of the Patent under the America Invents Act, 35 U.S.C. 311. Momenta was attempting to develop a biosimilar counterpart of Orencia®. The Patent Trial and Appeal Board sustained patentability of the patent claims. Momenta filed an appeal under 35 U.S.C. 319. BMS moved to dismiss for lack of standing because Momenta’s proposed product had failed its Phase 1 clinical trials and had been withdrawn. Momenta responded that it had not abandoned its intent to produce a counterpart of the Orencia® product and filed various exhibits concerning its intentions, ultimately submitting a form that was filed with the Securities and Exchange Commission in December 2018, indicating termination of Momenta’s collaboration agreement with respect to the development of a proposed biosimilar to ORENCIA®. Momenta did not withdraw its appeal. The Federal Circuit dismissed the appeal for lack of standing as moot. The cessation of potential infringement means that Momenta no longer has the potential for injury, thereby mooting the inquiry. View "Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co." on Justia Law