Supreme Court Clarifies Biosimilar Legislation in Sandoz

On June 12, the Supreme Court also handed down another patent-related opinion in Amgen Inc. v. Sandoz Inc., a case dealing with the Biologics Price Competition and Innovation Act, a small 17-page subchapter contained within the Affordable Care Act (“Obamacare”). This subchapter deals with generic “biologics,” very-large-molecule drugs typically synthesized from biological sources such as recombinant DNA technology. The biologic at issue in this case is filgrastim, a G-CSF glycoprotein.

Typically, when patent protection on a drug expires, the producer of a generic drug can enter the market with an exact copy of the formerly-patented drug, which greatly simplifies the process of FDA approval. However, in the case of biologics, the generic drugs are not always exact copies, and may instead be “biosimilars” that are slight variations on the original drug, and which originally required separate FDA approval. The law at issue here (the BPCIA) was intended to streamline the FDA approval process for biosimilars.

This case dealt with certain regulatory requirements set forth in the BPCIA for new biosimilars. Subsection (l) of the law establishes a process by which an applicant for a biosimilar license can exchange information with the company that originally obtained FDA approval for the drug. One of the first requirements of this process is that the new applicant “shall provide” to the original company “a copy of the application submitted [to the agency],” so that the original company can evaluate the biosimilar for possible infringement of any of its unexpired patents.

In the present case, the new applicant, Sandoz, did not provide a copy of the application it had filed to the original company or “sponsor,” Amgen. This created a question of whether the sponsor was entitled to obtain a copy of the application filed by the applicant.

The Supreme Court, like the Federal Circuit before it, determined that Amgen was not entitled to a federal injunction to force Sandoz to turn over the application (though the two courts used different reasoning). The BPCIA establishes that the filing of a biosimilar application allows the sponsor to immediately bring an action for “a declaration of infringement, validity, or enforceability of any patent that claims the biological product or a use of the biological product.” On this basis, other injunctive relief is foreclosed, and Amgen would need to sue Sandoz for patent infringement and seek discovery on the application in order to obtain it.

A separate requirement of the BPCIA requires the applicant to provide notice to the sponsor that it is going to market a generic biosimilar, no later than 180 days before it plans to do so. In this case, Sandoz had provided notice before the FDA approved the biosimilar, so that it would be able to market the biosimilar immediately after approval. This created a question of whether Sandoz needed to wait until after the biosimilar had actually been approved before providing this notice.

The Supreme Court determined that there was no requirement for Sandoz to wait for the FDA to approve the biosimilar, and that the statute only set forth a single timing requirement (i.e. marketing can be made 180 days after notice) and not two timing requirements (i.e. marketing can be made 180 days after notice and after FDA approval). The Federal Circuit had come to the opposite conclusion.

The main effect of this case is to accelerate the marketing of biosimilars. Generic drug manufacturers may be able to market biosimilars immediately, or very soon after, FDA approval (provided FDA approval takes more than 180 days) rather than needing to wait an extra half-year to market the drug. This can often bring in hundreds of millions of dollars in extra revenue for the generic manufacturer.

The different reasoning used by the Supreme Court as to the question of injunctive relief also means that sponsoring drug companies may be able to seek injunctive relief in state court. While the Federal Circuit had ruled that the Patent Act, 35 U.S.C. § 271(e)(4), prevented Amgen from obtaining an injunction, the Supreme Court instead ruled that a section of the BPCIA did so, and determined that this did not cut off state law remedies.