Tuesday, July 05, 2016

CAFC interprets the "patent dance" of the Biologics Act (BPCIA ) in favor of patentees

Regulatory Affairs noted the importance of the case:

The ruling has major implications for when biosimilars can be launched and it follows the US Supreme Court’s request in late June that the solicitor general provide more information on whether the highest court in the US should review the terms of this so-called “patent dance,” the rules of which govern how biosimilar and reference product manufacturers must work out their patent issues as established by the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

From the conclusion of the CAFC decision:

Apotex would infer an outsize consequence from the
mere modesty of the role played by (9)(B)’s mention of
(8)(A). Apotex ’s proposed inference from (9)(B)
would implicitly make (8)(A) neither mandatory nor standalone,
despite (8)(A)’s language, and
would reintroduce the very problems
of rushed litigation —over patents the applicant
is empowered to prevent being litigated earlier
—that (8)(A) was enacted to avoid.

The inference that Congress
rendered unavailable direct injunctive enforcement of
(8)(A)’s plain terms is unwarranted.
We conclude that an applicant must provide a refer-
ence product sponsor with 180 days’ post-licensure
notice before commercial marketing
begins, regardless of wheth-
er the applicant provided the (2)(A) notice of FDA review.
Because the parties here stipulated to the remaining
preliminary-injunction factors, see
eBay Inc. v. Mer-
cExchange, L.L.C., 547 U.S. 388, 394 (2006), we affirm the
district court’s grant of a preliminary injunction
without addressing those factors.


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