Sandoz v. Amgen: What The Court Settled, What It Didn ’t, And What Might Come Next

On June 12, the United States Supreme Court released a heavily anticipated decision relating to patent disputes between the developers of new biological medicines and the manufacturers of “biosimilar” copies of those medicines.  This was the Court’s first ruling on the patent provisions of the Biologics Price Competition and Innovation Act (BPCIA), enacted in 2010 as part of the Affordable Care Act. Biologics are typically complex, larger molecules that are derived from animals and microorganisms, in contrast to traditional, smaller-molecule drugs that are usually synthesized from chemicals. Biosimilars are akin to generic versions of traditional drugs, but, as the name implies, they are highly similar to the original medicine rather than identical. As an earlier Health Affairs Blog post explained, the BPCIA created a pathway for approval of biosimilars and a mechanism for early resolution of patent disputes relating to those biosimilars.  After enactment of the statute, however, the innovative biologic and biosimilar industries disagreed about how the patent mechanism was supposed to work.  In July 2015, the Federal Circuit (which is the court of appeals for patent issues) issued a ruling that left both sides unhappy.  Both companies involved in that litigation—biosimilar applicant Sandoz and innovator Amgen—asked the Supreme Court to review the decision.  Amgen wanted one aspect of the ruling reversed, and Sandoz wanted the other aspect reversed. Just...
Source: Health Affairs Blog - Category: Health Management Authors: Tags: Costs and Spending Drugs and Medical Innovation biologics Biologics Price Competition and Innovation Act biosimilars Food and Drug Administration Hatch Waxman Source Type: blogs