The Biologics Price Competition and Innovation Act (BPCIA) has been considered overly complex and unclear as to many of its procedural requirements. The US Supreme Court is now considering the Federal Circuit Court’s decision in Amgen v Sandoz, which held that a biosimilar applicant could choose to opt out of the so-called patent dance and that the biosimilar’s notice of commercial launch may only be given after the FDA approves the biosimilar’s application. The Supreme Court’s decision in the case, expected by July, could set a precedent on whether the patent-dance exchange of patent and manufacturing information before FDA approval is necessary and whether biosimilar manufacturers must obey the provision specifying notice of commercial marketing, which effectively adds 6 months to the wait to market the drug after FDA approval.
One of the big questions biosimilar applicants have had to decide upon is whether to engage in the patent dance at all, and if so, for how long. The procedure takes approximately 6 months to complete, representing a significant delay in commercial launch. Another issue has been when to give the reference drug sponsor (RDS) the 180-day notice of commercial launch required by the BPCIA, which represents another 6 months of delay (and is the reason applicants have been trying different ways to give notice as soon as possible; see Amgen v Apotex below). RDSs have also been uncertain about these steps and whether they have the right to seek legal means of forcing biosimilar applicants to comply with the steps.
To date, companies have used 3 main strategies to address the patent dance, according to an analysis in Bloomberg Law Life Sciences Law & Industry Report.
- Opting out of the patent dance. In Amgen vs Sandoz, biosimilar maker Sandoz told Amgen, the RDS, that it wouldn’t do the patent dance, but it did attempt to provide notice of commercial marketing. Amgen filed a complaint in the US District Court for the Northern District of California compelling Sandoz to engage in the patent dance and asserting that Sandoz could not provide notice of commercial marketing until after the FDA approved its product. The Court ruled in favor of Sandoz on both counts, finding that the patent dance is not mandatory and that biosimilar applicants need not wait for FDA approval before providing notice. That judge called Amgen’s position “problematic” because it would add an additional 6 months of market exclusivity onto the 12 years they already had enjoyed. Amgen appealed the ruling to the Federal Circuit, which split on the issues, holding that the patent dance is not mandatory and said Amgen’s only remedy for Sandoz failing to engage in the patent dance was to file an infringement suit against Sandoz. The Federal Circuit also held that Sandoz was not allowed to provide notice of commercial marketing prior to FDA approval. This is the case that the Supreme Court is now considering.
- Partially completing 1 or more of the patent dance steps. Janssen vs Celltrion, which involves Celltrion’s infliximab-dyyb (Inflectra) biosimilar of Janssen’s infliximab (Remicade), is one such example of this strategy. In August 2014 Celltrion filed its biosimilar application with the FDA, which accepted it for review in October 2014. In February 2015, Celltrion provided Janssen notice of intent to market upon FDA approval. Celltrion provided Janssen with its application during the 20-day window to do so, including some, but not all, manufacturing information. Janssen asserted that Celltrion was obligated to give them additional manufacturing information and said Celltrion had not complied fully with the patent dance. Janssen sued Celltrion for infringement of 6 patents, seeking to enforce the patent dance. Four of these patents have been dismissed, but the suit proceeds on the other patent issues. The issue of remedies for alleged noncompliance has also arisen in the case. This case shows that the BPCIA provides “both flexibility and the possibility of litigation disputes over the issue of how much information the biosimilar applicant must disclose and when,” and shows that biosimilar applicants should consider the potential risk of losing the benefit of the damages limitation in the BPCIA when considering patent dance strategies, Bloomberg Law Life Sciences Law & Industry Report advises.
- Completing all of the patent dance steps. Amgen vs Apotex illustrates a case in which the biosimilar maker (Apotex) engaged in the entire statutory procedure of bringing its biosimilar of pegfilgrastim and filgrastim (Amgen’s Neulasta and Neupogen, respectively) to market and was sued because the biosimilar maker gave early notice of intent to market after FDA approval. Amgen filed a preliminary injunction seeking to prevent Apotex from giving notice until after Apotex gets FDA approval. Amgen’s position on notice was upheld by the District Court as well as the Federal Circuit Court on appeal. The trial proceeded on Amgen’s patent infringement claims, and the district court held that Apotex did not infringe on the asserted patents, a decision Amgen has appealed. Apotex petitioned the US Supreme Court on the notice provision but the Court denied the petition for review.
There are still many open questions in the area of biosimilars litigation that the Supreme Court and Federal Circuit Court will continue to weigh in on, and the answers they provide will have significant impact for biosimilar applicants going forward.