U.S. Supreme Court Rules 180-Day Delay Will Not Be Required for Biosimilars After FDA Approval
On June 12, 2017, the U.S. Supreme Court unanimously ruled that biosimilar applicants will no longer be required to wait for an additional 180 days to launch their biosimilar product once the U.S. Food and Drug Administration (FDA) has granted regulatory approval. Furthermore, the decision is likely to provide biosimilar applicants the option of not participating in the patent notification procedure (i.e. the disclosure of data relating to a biosimilar’s biologic license application and manufacturing process), often referred to as the “patent dance”, outlined in the Biologics Price Competition and Innovation Act (BCPIA).
In March 2015, Sandoz’s Zarxio (filgrastim-sndz), a biosimilar of Amgen’s Neupogen, was the first biosimilar to receive FDA approval, having been filed via the abbreviated 351(k) pathway which was established within the amended Public Health Service Act. Sandoz refused to take part in the patent dance with Amgen at the time of the FDA accepting Zarxio’s filing (July 2014), stating that the procedure was not mandatory. Moreover, Sandoz argued that a required notice period after FDA approval would provide Amgen with a further six months of market exclusivity, in addition to the 12 years already provided to them under law. Sandoz stated these issues in a letter sent to Amgen, which Sandoz believed served as the start of their 180-day notice of commercialization. This provoked Amgen to file a suit against Sandoz in October 2014, with Amgen requesting a preliminary injunction in an attempt to prevent Sandoz from launching Zarxio until the matter could be clarified by the Courts. In July 2015, the U.S. Court of Appeals for the Federal Circuit ruled that it was mandatory for biosimilar sponsors to provide the 180-day notice of commercialization specified by the BCPIA, and that this could only be provided after FDA approval – prompting Sandoz to petition the case to the U.S. Supreme Court.
The U.S. Supreme Court’s ruling on June 12, 2017 aimed to address two questions. One of the questions related to the interpretation of 42 U. S. C. §262(l)(8)(A) of the BCPIA, and whether it is required for a biosimilar applicant to provide the reference product sponsor a 180-day notice of commercialization prior to FDA approval. Although the Federal Circuit had previously concurred with Amgen’s interpretation of the BCPIA’s stature, that the 180-day notice period could only be given after a biosimilar’s FDA approval, all nine judges of the U.S. Supreme Court have now reversed the decision, commenting that Amgen’s “arguments are unpersuasive, and its various policy arguments cannot overcome the statute’s plain language,” and that “a biosimilar applicant may provide notice either before or after receiving FDA approval.” This ruling will be viewed as a pivotal moment for the U.S. biopharmaceutical industry for both types of stakeholders; reference product sponsors and biosimilar applicants. The Court’s decision on the 180-day premarketing notice means that biosimilar applicants can market a biosimilar as soon as they receive FDA approval, provided that there are no preliminary injunctions or on-going patent litigations; thus accelerating the time new biosimilars can enter the U.S. market. In turn, this may encourage more biosimilar developers to invest in the growing U.S. biosimilar space.
The other question considered by the U.S. Supreme Court related to the issue of the “patent dance”, stated in 42 U.S.C §262(l)(2)(A) of the BCPIA, and whether a biosimilar applicant will need to provide information to the reference product sponsor on their biosimilar’s application and manufacturing data. The Federal Circuit previously agreed that the patent dance was only optional for biosimilar applicants, but not participating may risk the legal action from the reference product sponsor for potential patent infringements. The U.S. Supreme Court partly supported this decision, and ruled that under Federal Law, biosimilar applicants are not obliged to enter the patent dance process. However, the Court did not rule out that a reference product sponsor could seek an injunction under State-law. This issue of the patent dance has now been remanded back to the Federal Circuit to reconsider.
In summary, the U.S. Supreme Court’s rulings now provides biosimilar applicants with a greater level of autonomy on how, and when, they wish to address any patent issues. A biosimilar applicant can either choose to resolve any patent litigations earlier in the development process, by sharing information on their biosimilar candidate with the reference product sponsor; or they could choose not to share this information at all, potentially delaying any inevitable patent issue(s). However, a reference product sponsor will still be able to file a patent lawsuit without being provided any information from the biosimilar applicant, and would be able to delay this until closer to the biosimilar’s approval date – when any possible patent infringements are likely to be more certain, and could hinder a biosimilar’s launch.