With oral arguments soon to be heard in Amgen v Sandoz, what will be up for discussion?
Amgen has challenged the US Court of Appeals for the Federal Circuit’s decision that the ‘patent dance’ procedures are completely optional, and that the biosimilar applicant can decide not to provide a copy of its biosimilar application or engage in the other steps of the patent dispute resolution process.
According to Amgen, the information exchange and patent dance procedures were part of the quid pro quo of the Biologics Price Competition and Innovation Act (BPCIA) that balanced the rights of reference product sponsors against those of biosimilar applicants.
Permitting biosimilar applicants to opt out effectively lets them free-ride on the reference product sponsors’ approval and makes it difficult for reference product sponsors to enforce their patent rights.
Sandoz says that the BPCIA gives biosimilar applicants the option of participating in the patent dance or being subject to immediate patent infringement suit, in which case the reference product sponsor can obtain information about the biosimilar product through the usual discovery processes. The US agrees with Sandoz on this issue.
Sandoz has challenged the Federal Circuit’s decision that pre-marketing notice cannot be given until the biosimilar product has been approved.
It says that interpretation gives the “reference product sponsor” (the owner of the original brand name biologic) an extra 180 days of market exclusivity.
According to Amgen, since the purpose of the pre-marketing notice is to give the reference product sponsor a final opportunity to assert its patents, the notice should not be given before the biosimilar product is approved, because until then the characteristics of the biosimilar product and/or its method of manufacture may be subject to change. The US agrees with Sandoz on this issue.
How could a decision on either side change the patent dance system, and affect biosimilar applicants?
A Supreme Court decision upholding the Federal Circuit on the “pre-marketing notice” issue would continue to keep biosimilar products off the market for 180 days after FDA approval.
But a reversal would mean that biosimilar products could enter the market upon approval, as long as they are not under any injunctions (such as from pending patent litigation).
If the Supreme Court upholds the Federal Circuit on the patent dance issue, it could make it less likely that biosimilar applicants will engage in the patent dance, although some still may decide to do so to facilitate earlier resolution of patent disputes.
A reversal would mean all that biosimilar applicants must engage in the information sharing and other steps of the ‘patent dance’.
What sort of reaction has this case seen from industry players?
While companies developing biologics and biosimilars are interested in both issues, stakeholders on both sides are more interested in the pre-marketing notice issue, since that directly affects exclusivity periods, market entry dates, and competition in the marketplace.
How much of an influence will the US Department of Justice’s amicus curiae have on the final decision? What about the amicus curiae of the other parties?
While I hesitate to read the tea leaves, in this case I think the Supreme Court will give considerable weight to the position of the US, particularly since its views on both issues seem to support an interpretation of the BPCIA as a whole that promotes competition from biosimilar products.