Fed Circuit dismisses Momenta appeal in BMS suit
The US Court of Appeals for the Federal Circuit yesterday dismissed an appeal by Massachusetts-based biotech Momenta Pharmaceuticals in a case involving a rheumatoid arthritis drug.
On February 7, the Federal Circuit held that Momenta lacked standing to appeal against a Patent Trial and Appeal Board (PTAB) decision which had affirmed the validity of a BMS-owned patent.
BMS’s US patent number 8,476,239, called “Stable protein formulations”, describes and claims specific fluid formulations of the protein molecule CTLA4Ig, an immunosuppressive agent used in treatment of immune system disorders such as rheumatoid arthritis.
The product has the chemical name “abatacept” and the BMS brand name Orencia.
In July 2015, Momenta submitted a petition for inter partes review of the patent. At the time, Momenta was reportedly attempting to develop a biosimilar counterpart of Orencia.
The PTAB instituted review and sustained patentability of the ‘239 patent, a decision Momenta filed an appeal against.
BMS then moved to dismiss the claim, alleging that Momenta didn’t have standing as its biosimilar product had failed its Phase 1 clinical trials and had been withdrawn.
In response, Momenta claimed that it hadn’t abandoned its intent to produce a counterpart of the Orencia product and that the ‘239 patent was an obstacle to its activities.
Then, in October last year, Momenta filed a press release with the court, which stated that the biotech company had initiated discussions with its collaboration partner Mylan to exit its participation in the development of five biosimilar programmes including M834, a proposed biosimilar to Orencia.
BMS claimed that this information confirmed Momenta’s lack of standing to appeal.
Later that month, following no further communication from Momenta, the Federal Circuit issued an order which required Momenta to show why the appeal should not be dismissed as moot.
Momenta responded, claiming that the decision of whether or not to progress with the programme rested on the outcome of its appeal.
Today, the Federal Circuit found that Momenta does not have standing and that the appeal was mooted by Momenta’s discontinuance of any potentially infringing activity.
“On 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,” said the court.
Circuit judge Pauline Newman, on behalf of the court, added that Momenta’s argument that it might, at some future time, receive a royalty from Mylan, if Mylan should produce an
Orencia biosimilar, had no support in precedent.
Momenta also claimed that as it was engaged in infringing activity when the proceedings began, it had not lost its standing to complete the review.
“However, even though Momenta may have been working in pursuit of potentially infringing activity, it is established that jurisdiction must exist throughout the judicial review, and an
intervening abandonment of the controversy produces loss of jurisdiction,” said Newman.
The court concluded that the cessation of potential infringement meant that Momenta no longer had the potential for injury, thereby mooting the enquiry.
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