As we have previously reported, the Supreme Court will later this year hear arguments in Sandoz v. Amgen regarding the Federal Circuit’s interpretation of the BPCIA’s notice of commercial marketing requirement and patent dance provisions. Several amicus briefs in support of Sandoz were filed last week.
One brief was filed by AARP, AARP Foundation, Citizens Against Government Waste, the UAW Retiree Medical Benefits Trust, the National Health Law Program, and the Coalition to Protect Patient Choice. In their brief, the amici discussed spending on prescription drugs and the disproportionate effect that high drug costs have on older Americans. In particular, biologic drugs are more expensive than traditional prescription medications, and even as the cost of traditional drugs has decreased in recent years, biologic costs have been increasing. The amici explained that the availability of more biosimilar products will result in lower cost and greater access to lifesaving medications, as has already been the experience in European markets. On the merits, the amici argued that the notice of commercial marketing and the patent litigation provisions of the BPCIA are separate and were intended to run parallel to each other. In other words, “Congress did not intend to penalize biosimilars manufacturers for their readiness to bring their products to market immediately upon their approval by FDA.” In short, the amici argued that the statute provides for only twelve years of marketing exclusivity, which in itself was the result of a contentious legislative negotiation, and does not provide an additional 180 days of exclusivity under the notice provision.
America’s Health Insurance Plans (“AHIP”) also submitted an amicus brief last week. Similar to AARP’s brief, AHIP provided a detailed discussion of drug cost and spending and made similar arguments in support of Sandoz’s position based on the text, structure, and history of the relevant provisions of the BPCIA. AHIP in particular noted the pediatric exclusivity provision, arguing that where Congress wanted to provide an exclusivity period beyond twelve years, it did so explicitly. Unlike AARP’s brief, however, AHIP also took a position on Amgen’s cross petition. AHIP argued that the Federal Circuit’s decision below was correct and that the biosimilar applicant’s sharing of its application with the RPS is optional. AHIP noted that the biosimilar applicant’s choice not to disclose its application under 42 U.S.C. § 262(l)(2)(A) is specifically contemplated by 35 U.S.C. § 271(e)(2)(C)(ii), which provides that such a choice not to disclose creates an act of infringement allowing for immediate litigation. AHIP further argued that requiring the biosimilar applicant to disclose its application would frustrate the purpose of the statute, which provides a range of patent dispute resolution options. AHIP also argued that a reversal of the Federal Circuit’s interpretation would lead to the absurd result of requiring the biosimilar applicant to dance even when there is no dispute to be resolved, such as when, for example, “there are no relevant, unexpired patents … when the application is submitted.”