Legal Experts Grapple With Implications of Sandoz v Amgen at the Summit on Biosimilars

News of the landmark Supreme Court ruling in the case of Sandoz v Amgen broke during the Monday session of the 8th Annual Summit on Biosimilars, a meeting of legal and pharmaceutical industry professionals convened in New York City. In a previously scheduled—and swiftly updated—discussion of the case, a panel of attorneys grappled with the ruling and its implications for the industry.

Hans Sauer, Deputy General Counsel for Intellectual Property at BIO, began by reminding attendees of the reasons that the so-called “patent dance” was so contentious to begin with; negotiations over the legal framework concerning biosimilars began roughly a decade ago, and at that time, Sauer said, the most important question on legislators’ minds was the 12-year period of data exclusivity for biologics. Clarifying the requirements of the patent dance was not a high priority in healthcare reform at the time. When the Biologics Price Competition and Innovation Act (BPCIA) was merged with the Affordable Care Act (ACA), its provisions surrounding the patent dance had not yet been refined or “cleaned up in the House.” In Sauer’s view, even when the BPCIA had been newly signed into law as part of the ACA, its language was generally understood to be ambiguous.

In sorting through the implications of the Sandoz v Amgen ruling, Irena Royzman, PhD, partner at Patterson Belknap Webb & Tyler LLP, described the verdict from an innovator’s point of view. Royzman explained that the Court’s ruling that biosimilar manufacturers need not engage in an exchange of information with innovators means that innovators will lack an informed path to litigation. These companies will no longer know whom to sue, which patents have been infringed upon, or even which patents to assert in protection of their products. Innovators will have to assert their full patent portfolios “blind,” Royzman said.

Looking ahead to the case of Amgen v Hospira, Royzman said its outcome may well be determined by this week’s ruling. In this case, Royzman explained, Hospira did not provide to Amgen the manufacturing information for its biosimilar product. In response, Amgen sued, though the company did not know whether a number of its patents had been infringed upon. When Amgen asked the court for discovery (a pre-trial procedure in which each party involved in a suit can obtain evidence from the other party), the judge in the case denied its request. As the BPCIA does not provide an independent basis for discovery, Amgen has not yet obtained—and may never obtain—evidence from Hospira.

Royzman suggested that the Supreme Court’s ruling provided a lesson for the US Congress: if legislators intend for remedies other than those provided under legislation to be available to parties whose patents have been infringed upon, then they must say so explicitly.

In discussing the ruling from the biosimilar manufacturer’s viewpoint, W. Blake Coblentz, co-chair of Hatch-Waxman & Biologics Litigation at Cozen O’Connor, suggested that the court’s decision will not signal a reduction in litigation. If a biosimilar applicant chooses to follow the information exchange pathway, Coblentz said, the end result of the process will still be litigation. If the applicant opts out of the information exchange, then the innovator will be free to sue the applicant immediately.

Nor does the ruling mean that all biosimilar manufacturers will forego the BPCIA pathway to litigation. If biosimilar applicants choose not to participate in the information exchange process, innovators would benefit. According to Coblentz, when immediate suits result from applicants’ opting out of the exchange of information under the BPCIA pathway, innovators will control the timing and the scope of litigation, disadvantaging biosimilar applicants. When applicants do engage in the information exchange, they benefit from temporary safe harbor from litigation, and also force innovators to identify their patents or forfeit the ability to sue for infringement later.

Many in the room, both on the panel and in the audience, suggested that the FDA should assist the industry and the courts in clarifying the remedies that an innovator might seek if it believes its patents have been infringed upon. One comment from the floor even suggested that the FDA could choose not to process a biologics license application on the basis of an applicant’s violation of law, though a number of others in the room suggested that the FDA has been unresponsive to such suggestions in the past.

Yet, the court itself signaled a need for the FDA to take up the matter; as Justice Breyer wrote in his concurring opinion, “if that agency (FDA), after greater experience administering this statute, determines that a different interpretation would better serve the statute’s objectives, it may well have authority to depart from, or to modify, today’s interpretation.”

It remains to be seen whether fresh leadership in the FDA—leadership that one attorney called “novel” in terms of FDA Commissioner Scott Gottlieb’s willingness to address such questions as drug pricing—might result in new precedents for the agency’s involvement in resolving these lingering questions.