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In Battle over Access to Biosimilars, U.S. Supreme Court Adopts Position of Zuckerman Spaeder Clients

June 12, 2017

Makers of biosimilars claimed victory on June 12, 2017, when the United States Supreme Court ruled in favor of Sandoz, Inc. in its legal battle against Amgen over how to interpret the Biosimilars Price Competition and Innovation Act (BPCIA). Zuckerman Spaeder partner Carlos Angulo filed two amicus briefs in the Supreme Court in support of Sandoz, including one for the Biosimilars Council, a division of the generic drug trade association (now known as the Association for Accessible Medicines (AAM)), urging the court to grant certiorari in the case, and one for America’s Health Insurance Plans (AHIP) at the merits stage of the case.

In agreeing with most of the arguments made by Mr. Angulo and his clients, the court’s decision allows biosimilar manufacturers to give 180-day marketing notice before FDA approval, which means their products can come to market faster. The court also held that federal law does not allow brand companies to obtain private injunctions forcing biosimilars makers to engage in the BPCIA’s expensive, time consuming “patent dance.” These landmark rulings should speed patients’ access to affordable versions of expensive biologic medicines and lower prescription drug costs for millions of Americans.

Mr. Angulo argued, and the Supreme Court agreed, that Congress did not intend for notice to cause an additional six-month delay in patients’ access to approved biosimilars and that allowing pre-approval notice was the only reading of the law consistent with the BPCIA’s intent. The U.S. Court of Appeals for the Federal Circuit had held that notice could only be given after FDA approval. The effect of this decision, had the Supreme Court not reversed it, would have been to delay the marketing of FDA-approved biosimilars by six additional months beyond the 12-year market exclusivity period adopted by Congress in the BPCIA. It would also have enabled the reference product sponsor to enforce this additional delay automatically in court.

Mr. Angulo also argued that an automatic injunction to enforce the “patent dance” provisions conflicts with the remedies Congress chose in the BPCIA. The amicus briefs argued that Amgen’s contrary position, which the Federal Circuit had also rejected, jeopardized Congress’ vision of enormous savings to the U.S. healthcare system from biosimilars.

In its opinion, the Supreme Court stated that Amgen’s interpretation of the marketing notice provision was “unpersuasive, and its various policy arguments cannot overcome the statute’s plain language.” Further, the Supreme Court ruled that violations of the BPCIA’s “patent dance” provision are not enforceable by injunction at the federal level, although the Court remanded the case to the Federal Circuit to determine whether an injunction remained available.

Mr. Angulo filed his first brief in the Supreme Court in this case for the Biosimilars Council in 2016, urging the court to review the Federal Circuit’s decision. He then filed a brief on behalf of AHIP in February 2017 on the merits of the case.

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