Pending in the Court of Appeals for the Federal Circuit in northern California is a case involving an effort to bring a biosimilar drug to market without making use of the “biosimilars pathway” included in the Biologics Price Competition and Innovation Act (BPCIA). Depending on the outcome, patients could soon be able to obtain less-expensive versions of an important drug for treating arthritis and psoriasis.
Sandoz would like to make a biosimilar version of Amgen’s drug Enbrel, but it wants to be sure that doing so does not violate Amgen’s patents. Accordingly, it sought a declaratory judgment from the courts that its drug would not infringe two Enbrel patents and that those patents are invalid and unenforceable. Sandoz filed the declaratory judgment proceeding prior to seeking FDA approval for the biosimilar drug. Amgen countered that the declaratory judgment proceeding contravened the BPCIA biosimilars pathway adopted by Congress which requires, among other steps, that the proposed biosimilar first be submitted to the FDA.
The district court in November 2013 sided with Amgen. However, Sandoz has filed an appeal. The worthy FDA Law Blog recently summarized the back and forth debate between the parties. In its opening brief, Sandoz argued “among other things, that the district court’s decision undermines the BPCIA’s purpose of advancing competition for biologic products because that decision ‘completely deprives federal courts of jurisdiction over any declaratory judgment action implicating a biosimilar product until after the FDA had already approved the product.’” In a 95-page reply brief, Amgen (and its co-party Roche) argued that Sandoz’s interpretation of the law would “eviscerate the statutory biosimilars patent dance framework.” But in its reply brief, Sandoz reiterated the “company’s points that the BPCIA is not the exclusive mechanism for resolving patent disputes involving biological products, and that the BPCIA in no way bars the company’s Complaint for Declaratory Judgment.”
The oral argument occurred before the Court of Appeals for the Federal Circuit on September 10, 2014. For those with an intense interest in the case, a recording of the oral argument is available. For others, a summary of the oral argument in the National Law Journal may be sufficient. According to the reporter, the “judges did not seem entirely convinced” by the Amgen argument. Judge Richard Taranto asked, “What would be the harm done to what Congress had in mind in creating this regime by allowing this [declaratory judgment] suit to go forward?” Amgen’s lawyer responded that “The litigation has to unfold according to the scheme laid out in the statute.” But another judge, Timothy Dyk, said “It’s not clear Congress thought about this situation.” Sandoz “argued that when Congress wrote the statute, it was thinking of the future, where patent challenges would likely occur during the 12-year exclusivity period granted the original drugmaker under the law,” but “In this case, Enbrel, which won FDA approval 16 years ago, is well past that point. The drug’s original patents expired in 2012 and early this year, but Amgen in 2011 licensed the rights to two new patents from Roche…that it claims will shield Enbrel from competition until 2029.”
The Court of Appeals decision in this case could have significance well beyond Enbrel. According to the FDA Law Blog, two additional declaratory judgment cases have been filed involving other biosimilars. We have written previously about how delays in bringing biosimilars to market are causing billions of dollars in wasteful, unnecessary drug spending. We have also discussed some of the efforts by biotech companies to impede cost-saving biosimilars. For the sake of patients and payers, we can only hope that the court will decide in favor of Sandoz.