Celgene Incapable of Dismissing Lawsuit in First Written REMS Opinion

In a closely watched case, a federal judge has denied Celgene’s motion to dismiss a lawsuit alleging the brandmaker engaged in anticompetitive conduct by refusing to turn over product samples for ANDA bioequivalence testing.

The New Jersey District Court federal judge ruled late last month that Mylan could proceed with claims that Celgene’s actions willfully excluded the generics maker from the market. The judge did, however, dismiss Mylan’s claims alleging a conspiracy by Celgene and its distributors to deny testing samples of its cancer therapies Thalomid (thalidomide) and Revlimid (lenalidomide).

The ruling appears to be the first written opinion in the case that could help settle the dispute over the brand industry practice of using REMS protocols to block access to sample drugs that generics need to prepare their applications, legal experts say.

Other REMS cases have been dismissed or settled out of court, Hyman, Phelps & McNamara attorney Kurt Karst said. The case between Mylan and Celgene stands to be the first to go to a final decision at trial, which could set a significant legal precedent for other generics makers seeking to circumvent REMS barriers to product samples, Karst toldDID.

Mylan expressed satisfaction with the ruling, calling it an important step in the firm’s efforts to bring generic versions of the two therapies to market.

Court documents trace the dispute between the two firms to 2003, when Mylan first requested Thalomid samples from Celgene for bioequivalence testing. Celgene balked at the request, citing product safety protocols meant to carefully limit distribution of drugs that are prone to abuse.

The two companies entered protracted negotiation that stretched into 2009, with Celgene continuously pushing back on Mylan’s requests. Finally, after attempting to engage with Celgene for almost five years to procure samples, Mylan recognized that further engagement with Celgene would be fruitless, the judge said in her ruling.

A similar squabble emerged over Mylan’s efforts to acquire Revlimid samples in a series of requests and countered protocol requirements that stretched from 2009 to 2012, according to the documents.

The FTC this summer sided with Mylan in an amicus brief, and has weighed in on similar cases, arguing that in the individual instances, refusal to sell sample batches amounted to anticompetitive behavior that threatened to stifle generic competition.

Celgene has argued that it is free to determine with whom it does business. Brandmakers in similar instances have voiced fears they could be held liable for noncompliance with their REMS protocols.

Nearly 40 percent of all new drugs now come with REMS restrictions, and generics makers say these protocols are often abused by brandmakers to hinder bioequivalence testing and head off potential competition. A bill was introduced in the last Congress aimed at prohibiting such conduct. The FDA also recently issued draft guidance codifying its longstanding practice of issuing letters to generics makers certifying them to be REMS compliant in their bid for samples. — Bryan Koenig