In 2013, the U.S. enacted the Biologics Price Competition and Innovation Act (“BPCIA”), 42 U.S.C. § 262 to allow for abbreviated biologics license applications (“aBLA”) to be filed for complex products which are biosimilar to/interchangeable with FDA-licensed biologics.
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).
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 Supreme Court clarified that, while it is mandatory, the 180-day noticemay be provided to the RPS either before or after the Applicant has received approval of its product from the FDA. Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664, 1677-78 (2017).
Genentech v. Immunex and Amgen
In the case at issue, Genentech filed an emergency motion and restraining order with the district court on the premise that Amgen had not complied with the notice of commercial marketing provision of 42 U.S.C. § 262(l)(8)(A) because it had filed supplements to its application. The district court disagreed, siding with Amgen that the approved product remained the same. Upon receipt of that decision, Amgen launched its Mvasi™ product.
On appeal, Genentech argued that although Amgen served a notice of commercial marketing in 2017, Amgen was required to provide a new notice because it subsequently filed supplements to its approved application. Genentech argued that because Amgen failed to provide a second (and even further) notice(s), Amgen was legally barred from commercially marketing its biosimilar until 180 days after it served such notice.
In its July 6, 2020 decision, the Federal Circuit sided with Amgen, holding that its first notice satisfied Section 262(l)(8)(A). The Court concluded that despite later supplements to add a manufacturing facility and change the drug label, the biological product itself did not change. Thus, notice with respect to the biological product was met, and there was no need for the biosimilar maker to provide additional notice for each supplemental application concerning the same biological product. The Court also detailed how its interpretation was consistent with the statutory language itself.
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.
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