As we have previously reported, in April the Supreme Court will hear arguments regarding the Federal Circuit’s interpretation of the BPCIA’s notice of commercial marketing requirement and patent dance provisions. As we reported last week, several amicus briefs in support of Sandoz were filed last week.
The amicus brief, filed by Pharmaceutical Care Management Association, National Association of Chain Drug Stores, and Healthcare Supply Chain Association, makes three primary arguments. First, the amici submit that the Federal Circuit’s interpretation of 42 U.S. § 262(l)(8)(A) conflicts with Congress’ intent to create a “biosimilar pathway balancing innovation and consumer interests.” The six months additional exclusivity, the amici argue “imposes significant costs throughout the drug supply chain that ultimately harm consumer interests and are not necessary to safeguard patent rights and encourage innovation.” The amici also contend that the cost associated with six months of additional exclusivity for reference biologics will “increase insurance premiums paid by all consumers, and negatively affect those consumers’ ability to afford healthcare.”
Second, the amici state that the plain language reading of 42 U.S.C. § 262(l)(8)(A) requires only that the aBLA applicants provide notice 180 days before commercial marketing. The brief contends that the plain language does not limit how early notice may be sent but rather is explicitly limited to the latest time notice may be sent. The amici state that “the text of § 262(l)(8)(A) states that a BLA ‘applicant’ is to provide notice at least 180 day prior to marketing” and such language is dispositive. The Federal Circuit’s interpretation would require a “post-licensure sponsor, which is not an applicant, but is a sponsor, or holder, of an approved application.” Had Congress intended to require FDA licensure before notice is given they would have expressly used the term “holder of an approved application.” The amici also rebut the Federal Circuit’s reasoning that “Congress must have intended licensure as the start of a notice period because it otherwise would have used the phrase the ‘biological product that is the subject of the application’ as it did elsewhere in the BPCIA.” The amici argue that this reasoning suggests § 262(l)(8)(A) be read “notice … not later than 180 days before the first commercial marketing of the biological product that is the subject of the application.” The amici argue this implies the “absurd idea” of potential commercial marketing of an as-yet-unlicensed product.
Third, the amici state that the Federal Circuit’s determination ignores the larger context of the notice requirement. The amici contend that § 262(l) sets out a procedure for the reference product sponsor to enforce its patent rights and that § 262(l)(8)(A) exists as a safeguard to ensure that the reference sponsor has enough time to seek an injunction if need and not as an additional period in which to make patent litigation decisions. The brief submits that the BPCIA provides consequence for failure to provide timely notice. Under § 262(l)(9) the reference sponsor can bring a declaratory infringement action against the aBLA applicant. The amici argue that the “Federal Circuit’s reading, however, imposes additional consequences on those who comply in the form of a mandatory automatic 180-day stay on marketing.”
Stayed tuned to Big Molecule Watch for more coverage of the amicus briefs filed in Sandoz v. Amgen.