Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017:
5. In January 2017, the FDA released a draft guidance on biosimilar interchangeability, entitled “Considerations in Demonstrating Interchangeability With a Reference Product.” The guidance provides an overview of scientific considerations for demonstrating the interchangeability of a biosimilar product to its reference product. As we previously reported, over 50 public comments were filed in response to the draft guidance, including multiple biopharma industry organizations, several groups representing physicians, and numerous biopharma companies. According to the Regulatory Affairs Professional Society (RAPS), the FDA expects the first interchangeable biosimilars to become available in the U.S. market within the next two years. The FDA is currently reviewing the public comments and expects to issue either a revised draft guidance or final guidance.
4. On the legislative front over the past year, more states enacted laws regarding the substitution of biosimilars for prescribed biological products. These new laws allow pharmacists to substitute biosimilars for prescribed biological products unless the prescriber expressly prohibits substitution. The laws also require that the patient or the patient’s representative is informed of the substitution and that the prescriber be notified.
3. In September 2017, a Delaware federal jury found that Hospira infringed one of Amgen’s Epogen® (EPO) patents (the ‘298 patent), and awarded Amgen $70 million in damages. The jury agreed with Amgen in finding that 21 of Hospira’s biosimilar EPO batches were produced to create a stockpile of commercial product, and not protected by the safe harbor of 35 U.S.C. § 271(e)(1), which exempts from infringement use of a patented invention for the purpose of gaining FDA approval. As we previously reported, the fight is not yet over, despite the jury verdict. Hospira filed a post-trial motion for judgment as a matter of law that the accused batches were protected under the safe harbor, the asserted claims of the ’349 and ’298 patents were not infringed, the asserted claims of the ’298 patent are invalid, and damages can be no greater than $1.5 million per batch, if sold. Amgen also filed its own post-trial motion, arguing that Hospira infringed claims 1-7 of the ‘349 patent, which the jury found that Hospira did not infringe. The Delaware court has not yet ruled on the post-trial motions.
2. In November 2017, a Federal Circuit panel affirmed the district court’s judgment that Apotex’s pegfilgrastim and filgrastim biosimilar candidates do not infringe Amgen’s protein refolding method patent. As we previously reported, Amgen’s time for filing a petition for panel rehearing or rehearing en banc of last month’s panel decision expired on December 13, without Amgen filing a petition. On December 20, 2017, the Federal Circuit issued its formal mandate, certifying its judgment in favor of Apotex. Amgen has until February 13, 2018 to file a petition for certiorari with the U.S. Supreme Court. In the absence of a successful certiorari petition, the Federal Circuit’s judgment will mark the final resolution of the case.
1. On June 12, 2017, the Supreme Court issued a unanimous decision in Sandoz v. Amgen (filgrastim), holding that notice of commercial marketing may be given prior to FDA approval, siding with Sandoz and reversing the Federal Circuit on that issue. As we previously reported, the Court also held that no injunction is available under federal law to force compliance with the patent dance. However, the Court stated that an injunction might be available under state law, but left open the possibility that such a state-law injunction might be preempted by federal law. On remand, the Federal Circuit held that federal law preempts any such state-law theory. The Federal Circuit’s decision appears to close the door to any state-law attempt to enforce the steps of the patent dance with an injunction or to penalize noncompliance.