Novartis' Sandoz unit has scored another legal victory set to shape the budding biosimilars field. After a June victory at the Supreme Court, the biosim developer once again prevailed against branded drugmaker Amgen over a question about the famed "patent dance."
In the new decision, the Federal Circuit Court of Appeals ruled that branded drugmakers can't use state law to force biosim developers to disclose patent information under the Biologics Price Competition and Innovation Act (BPCIA).
The development follows a decision by the Supreme Court that violations of the "patent dance" established under the BPCIA aren’t enforceable by an injunction at the federal level. The Supreme Court further found that biosim makers can provide marketing notice ahead of an FDA approval—meaning they can launch sooner after winning an official nod—and remanded part of the case back to the appeals court for a decision on whether California law would find violations of a part of BPCIA unlawful.
Established in 2009, the BPCIA set up a process for biosim developers and branded drugmakers to interact to determine whether new biosimilars infringe on patents covering existing medications. The process is dubbed the “patent dance." After hearing the arguments, the appeals court ruled that states shouldn't get involved in biosimilar patent law, partly because that could create an unreasonable barrier for biosim companies. Now, with two victories for biosim makers and no recourse under federal biosims law for branded drugmakers, it seems unlikely biosim companies will voluntarily offer up information about their applications.
Reacting to the new decision, Locke Lord intellectual property chair Alan Clement wrote to FiercePharma that the "Federal Circuit has closed the door on what remedies remained available to a brand biologic company in terms of a biosimilar applicant who is refusing to engage in the 'patent dance' under the BPCIA … after the Supreme Court ruling."
But Clement wrote that Amgen "can still maintain their normal patent infringement rights outside the BPCIA and, in fact, there is a current case pending.” For his part, Mark Waddell, co-chair of Loeb & Loeb's life science patent group, said the decision will create more patent litigation.
After the Supreme Court decision, McDonnell Boehnen Hulbert & Berghoff partner Kevin Noonan told FiercePharma the court ruled in a way that would allow branded drugmakers and their lobby to ask Congress to tweak the BPCIA to be clearer. But that was when Republican lawmakers were aggressively pursuing healthcare reform, so it may be tougher to change the law given recent failed attempts at repealing or changing the Affordable Care Act.