On February 7, 2019, in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company, the Federal Circuit dismissed an appeal brought by a petitioner in an inter partes review (IPR) for lack of standing and mootness because the petitioner had ceased potentially infringing activities.
The Momenta decision follows the Federal Circuit's holding in RPX Corp. v. ChanBond LLC, No. 17-2346 (Jan. 17, 2018), that a membership organization that challenged patents but did not engage in any potentially infringing activity lacked Article III standing to appeal an IPR decision. RPX has petitioned for certiorari (No. 17-1686), and the Supreme Court invited the views of the Solicitor General regarding the petition. The Federal Circuit's decision in Momenta applies the holding in RPX to a pharmaceutical company involved in the potential development of a biosimilar.
Momenta petitioned for IPR to challenge the patentability of claims of U.S. Patent 8,476,239 related to the biologic drug Orencia® (abatacept). The Patent Trial and Appeal Board sustained the patentability of the challenged claims and Momenta appealed. Patent owner Bristol-Myers Squibb (BMS) moved to dismiss the appeal for lack of standing.
At the time it filed its IPR petition, Momenta was developing a potential biosimilar of Orencia, but that potential product subsequently failed its Phase I clinical trials. Op. at 3. Momenta later announced that it was discussing ceasing its participation in development of the product and ultimately confirmed in filings to the SEC that it had terminated a collaboration agreement with Mylan related to development of the potential biosimilar. Op. at 3-5.
Momenta argued that it had a sufficiently concrete and particularized interest in the appeal to convey standing because estoppel under 35 U.S.C. § 315(e) is an injury in fact to Momenta as an IPR petitioner and because there was a possibility Momenta would receive royalties if Mylan (its former collaboration partner) were to produce an Orencia biosimilar. The panel held that estoppel is not an injury in fact to Momenta because it was no longer "engaged in any activity that would give rise to a possible infringement suit." Op. at 8. It also held that possible future royalties should another company produce a biosimilar were too speculative to create standing. Op. at 8-9. It decided that "[o]n abandoning development of this product, Momenta has no legally protected interest in the validity of the '239 Patent, and there is no 'real need to exercise the power of judicial review.'" Op. at 7-8 (citations omitted).
Momenta also argued that it had standing because when it filed its petition, it had been working toward potentially infringing activity. The court held that "it is established that jurisdiction must exist throughout the judicial review, and an intervening abandonment of the controversy produces loss of jurisdiction." Op. at 10.
Following Momenta, potential IPR petitioners, including generic or biosimilar developers, should consider whether and when to initiate an IPR based on the status of their potentially infringing activity. The patent owner should consider on appeal whether the activities of the petitioner throughout the appeal are sufficient to create a substantial risk of future infringement.
WilmerHale represented amici curiae Pharmaceutical Research and Manufacturers of America and Biotechnology Innovation Organization.
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