Unwrapping The BPCIA Patent Dance Riddle For Biosimilar Companies
By Lisa Mueller, partner and chair of Michael Best & Friedrich’s Life Sciences and Chemical Practice Group
In 2009, Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”). This act was passed to facilitate the entry of biosimilar drugs into the market by allowing for submission of an abbreviated Biologics License Application (“aBLA”) to a previously approved and licensed reference product (owned by a reference product sponsor). The BPCIA contains two parts. The first, found at 42 U.S.C. § 262(k), addresses the regulatory aspects of the new regime, and the second, found at 42 U.S.C. § 262(l), addresses certain patent resolution issues. This second part, often referred to as the “patent dance,” lays out the steps and schedule during which a biosimilar applicant and reference product sponsor exchange certain (confidential) information regarding the aBLA. This second part also highlights the patents that may be the subject of future litigation between the parties. The patent dance moves quickly, beginning 20 days after the biosimilar applicant receives notification from the Food and Drug Administration (“FDA”) that its aBLA has been accepted. Once the dance is completed, a potential exists for two-phases of litigation. In the first phase, the reference product sponsor can assert a certain subset of patents identified during the dance. In the second phase, the reference product sponsor can assert any remaining identified patents once it receives notice from the biosimilar applicant 180-days prior the date it intends to market its biosimilar product (referred to as the “Notice of Commercial Marketing”).
The first aBLA accepted by the FDA occurred on July 7, 2014, for Sandoz’ Zarxio, a proposed biosimilar of Amgen’s reference product Neupogen (filgrastim). On March 6, 2015, the FDA approved Zarxio for all proposed uses. After Sandoz notified Amgen of its aBLA filing, the companies disagreed on two fundamental aspects of the patent dance. The first was whether or not dancing was mandatory, and second, when, exactly, was Sandoz required to provide Amgen with the 180-day Notice of Commercial Marketing. As a result, in October 2014, Amgen sued Sandoz in the Northern District Court of California. Because the case involved the first interpretation of the BPCIA, it quickly reached the Federal Circuit. On July 21, 2015, in a split decision, the Federal Circuit held that the patent dance was not mandatory but that the 180-day Notice of Commercial Marketing was mandatory, at least for biosimilar applicants who opted out of the patent dance. Further, only notice given after FDA approved the aBLA would be effective to start the 180-day clock. In a footnote in the decision, the Court characterized the BPCIA as a “riddle wrapped in a mystery inside an enigma.” Not surprisingly, Sandoz appealed to the Supreme Court, which has not yet decided whether or not to hear the case.
What Questions Remain?
In the meantime, questions remain as to whether 180-day Notice of Commercial marketing is mandatory under the BPCIA. In fact, this issue is currently before the Federal Circuit in Amgen v. Apotex. In this case, Apotex filed an aBLA to market a biosimilar version of Amgen’s Neulasta (pegfilgrastim). However, unlike Sandoz, Apotex participated in the patent dance with Amgen. As a result, Apotex argued that it was not required to provide the 180-day Notice of Commercial Marketing upon receiving FDA approval. Judge Cohn in the Southern District of Florida disagreed and issued a preliminary injunction requiring Apotex to provide Amgen with at least 180-days notice of the date of the first commercial marketing upon FDA approval. On April 4, 2015, oral arguments in the case were heard at the Federal Circuit. Not only is this issue important for Apotex, but also for Celltrion whose aBLA for a biosimilar version of Janssen Biotech’s Remicade (infliximab) was approved on April 5, 2016. Celltrion has agreed not to launch until June 30, 2016. However, this date is rapidly approaching.
Considerations For Biosimilar Companies Facing “The Dance”
Given this past and current litigation, how do biosimilar companies minimize the potential for litigation under the BPCIA? For now, unless the Federal Circuit’s decision in Amgen v. Sandoz is overturned, biosimilar companies should remember that participation in the patent dance is optional. Given the amount of confidential information a biosimilar applicant has to provide to the RPS, biosimilar companies should carefully weigh whether the risks of disclosing such information outweighs the benefit of participating in the dance, particularly if the potential biosimilar product is a “biobetter”. Specifically, a biosimilar applicant should carefully consider the business risks of the reference product sponsor learning the biosimilar maker’s proprietary manufacturing and product development information via the patent dance. Additionally, a biosimilar applicant should consider whether the disclosure of confidential information could be used by the reference product sponsor to file (further) lawsuits against the biosimilar applicant and other third parties (such as a third party culture media supplier, etc.). Under these circumstances, the risks of participating in the patent dance might outweigh the benefits. However, biosimilar companies that choose not to dance should make certain to provide notice of commercial marketing within 180-days of approval of the biosimilar product by the FDA. As seen in the cases to date, failure to provide such notice will almost certainly result in litigation.
About The Author
Lisa Mueller is a member of the firm’s Management Committee and also serves as Chair of the Life Sciences and Chemical Practice Group. As a partner in the Intellectual Property Group, Ms. Mueller has extensive experience in the biotechnology, pharmaceutical, biopharmaceutical, diagnostic, specialty and renewable chemicals and plant areas. In her practice, Ms. Mueller advises clients in all areas of global intellectual property portfolio management, including patent and trademark prosecution, validity and infringement opinions, post-grant proceedings and regulatory issues. Ms. Mueller also has experience regarding FDA issues.