In 2013, the
The BPCIA provisions regarding the timing and scope of patent infringement lawsuits are complex and differ drastically from those for ANDA litigations. As more and more BPCIA cases are filed, litigants and district courts tackle issues as they arise. The Federal Circuit has addressed a handful of provisions, and continues to be active in BPCIA-related appeals.
Yesterday, a unanimous Federal Circuit addressed another outstanding issue, related to the 180-day commercial marketing notice provision under § 262(l)(8)(A).
Background
By way of summary, the BPCIA specifies when and what actions are conducted between an aBLA Applicant and a Reference Product Sponsor (“RPS”) to identify patents which will be the subject of a patent infringement lawsuit triggered by the aBLA. This framework is colloquially referred to as the “Patent Dance,” and at a high level, the basic steps are:
- STEP 1: FDA notifies aBLA Applicant that its application is accepted for review;
- STEP 2: Applicant provides application/manufacture process information to RPS;
- STEP 3: RPS provides list of allegedly infringed patents;
- STEP 4: Applicant provides non-infringement, invalidity, unenforceability bases for patents;
- STEP 5: RPS provides infringement, validity, enforceability bases for patents;
- STEP 6: Parties engage in good faith negotiations to agree on patents for assertion or exchange list;
- § STEP 7: RPS must file a patent infringement action.
According to the Patent Dance, it is possible that an initial list of patents can be narrowed to (1) a group of patents upon which the RPS and Applicant agree will be asserted in the patent infringement action (Group A); and (2) a group of patents which will not be asserted in the action (Group B).
Second Phase of Litigation - Notice Issues
Even if the Applicant and the RPS engage in the Patent Dance to its conclusion, the Dance itself is not the only mechanism for patent infringement litigation. A second phase of litigation based on Group B patents can be triggered less than 180 days before the Applicant begins marketing its product. Relevant statutory provisions for the second phase of litigation include:
- 42 U.S.C. §262(l)(8)(A) — Applicant provides notice of intent to market its product to the RPS not less than 180 days before marketing of the product begins; and
- 42 U.S.C. §262(l)(8)(B) — For identified but not asserted patents (Group B), the RPS can seek a preliminary injunction based on such patents after the Applicant has provided notice of intent to market its product to the RPS.
Not surprisingly, Applicants do not want to be subject to a new patent infringement lawsuit, and the possibility of a preliminary injunction, less than 180 days before they launch their product(s). Accordingly, an issue has been whether or not the Applicant has to provide notice of intent to market to the RPS and, if so, when?
In early BPCIA litigation, Applicants argued that the 180-day notice can be provided early in the process to the RPS, and Applicants have even argued that they do not have to provide the 180-day notice at all under specific circumstances.
The
In the case at issue,
On appeal,
In its
This case correctly provides a straight-forward interpretation of the BPCIA, and provides a win for biosimilar makers, as they do not need to provide additional notice - and wait an additional six months - should they amend or supplement their application.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
Ms
Oblon, McClelland, Maier & Neustadt, L.L.P
Tel: 703413 3000
Fax: 703413 2220
E-mail: caskey@oblon.com
URL: www.oblon.com
© Mondaq Ltd, 2020 - Tel. +44 (0)20 8544 8300 - http://www.mondaq.com, source