Tuesday, July 05, 2016

CAFC interprets the Biologics Price Competition and Inn ovation Act of 2009 (Biologics Act or BPCIA ); Apotex loses

From the conclusion:

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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