Is an Applicant [generic biosimilar company] required by 42 U.S.C. § 262(l)(2)(A) to provide the Sponsor [reference biologic drug company] with a copy of its biologics license application and related manufacturing information, which the statute says the Applicant "shall provide," and, where an Applicant fails to provide that required information, is the Sponsor's sole recourse to commence a declaratory-judgment action under 42 U.S.C. § 262(l)(9)(C) and/or a patent-infringement action under 35 U.S.C. § 271(e)(2)(C)(ii)?
The Court's answer was unanimous:
If a subsection (k) applicant fails to provide the application and information required under paragraph (2)(A), the reference product sponsor, but not the subsection (k) applicant, may bring an action under section 2201 of Title 28, for a declaration of infringement, validity, or enforceability of any patent that claims the biological product or a use of the biological product.Under this rule, a reference biologic drug company whose FDA-licensed biologic drug entered the market first may seek declaratory judgment for infringement of its patent(s) by any would-be competitor generic biosimilar company failing to provide "its biologics license application and related manufacturing information", but may not seek federal injunctive relief to obtain that application and related information. Nevertheless, opting out of the patent dance does narrow the options available to a generic biologics company, largely letting the research biologic company decide when and how to initiate litigation.
The Court also addressed two other important issues. It left undecided questions about whether Amgen might be able to obtain injunctive relief under California state unfair competition law, though such availability might be federally preëmpted. However, contrary to Amgen's assertion that a generic biosimilar company must provide notice to a relevant research biologics company only after its product has been licensed by the FDA, the Court instead decided that "[a biosimilar drug] applicant may provide notice either before or after receiving FDA approval", suggesting that biosimilar drugs could reach market earlier than six months after licensure.
Perhaps the most important result of the Sandoz v. Amgen decision is clarification about the patent dance. Just as the whip and nae-nae is decidedly optional, so too, the Supremes have decided, is the patent dance.