Are Biosimilar Development Efforts Enough?

In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co. (here), the Federal Circuit was poised to explore the level of biosimilar legwork that could satisfy Article III standing for appeal from an adverse Patent Trial & Appeal Board (PTAB) decision. But, business developments of Momenta since the 2017 oral argument have now spoiled all of the fun.

The question as to how much investment/business exploration is enough in the biosimilar context for Article III standing remains an open question.

Bristol-Myers Squibb (“BMS”) holds a patent related to abatacept (Orencia®), a drug for immune system disorders like rheumatoid arthritis. Momenta, which had invested resources in developing a biosimilar product, filed an IPR petition against BMS’s patent, but the PTAB upheld the challenged claims. When Momenta appealed, BMS argued that Momenta lacked Article III standing to appeal because the FDA had not approved Momenta’s product, and Momenta’s Phase I trials failed. Momenta countered that it did have standing because it invested millions of dollars in its product and would be harmed by estoppel under § 315(e) based on the invalidity grounds it raised in the IPR.

The Federal Circuit (Newman, Dyk, and Chen) heard argument in December 2017. In the fall of 2018, Momenta notified the court that it “initiated discussions with its collaboration partner, Mylan, to exit its participation in the development” of certain biosimilars, including abatacept. The court issued an order to show cause why the appeal should not be dismissed for mootness. Momenta argued that it could still receive royalties if Mylan eventually develops the product. Then, in December 2018, BMS filed another notice with the Federal Circuit, noting that Mylan’s public SEC filings stated that Momenta terminated its collaboration with Mylan.

Given these intervening events, the court held today that Momenta now lacks standing, and the dispute is moot: “On abandoning development of this product, Momenta has no legally protected interest in the validity of the ’239 Patent.” Following its precedent, it also rejected Momenta’s argument that IPR estoppel creates injury because there is no potentially infringing activity.

While the court was initially poised to rule on interesting questions about standing to appeal IPRs in relation to the BPCIA and FDA approval process for biosimilars, by waiting 14 months to issue a decision, it avoided those issues thanks to Momenta’s intervening business developments.

Scott A. McKeown is an author of the Patents Post Grant