In a unanimous opinion, the United States Supreme Court again reversed the Federal Circuit in Sandoz Inc. v. Amgen Inc., interpreting the meaning of key provisions of the Biologics Price Competition and Innovation Act of 2009. This decision permits competitors of an original, patented biologic drug to begin marketing a “biosimilar” (a biological product demonstrated to be highly similar to an FDA-approved product) earlier and deprives the owner of the patented FDA-approved product of a means to force disclosure of the method used to manufacture the biosimilar. This decision, while perhaps anticipated by many in the industry, weakens the hand of companies making patented, FDA-approved products.
In addition to expediting FDA approval of biosimilar products, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) provides a means to resolve patent disputes between the manufacturers of already licensed biologic products (sponsors) and the manufacturers of biosimilar products (applicants) earlier in the drug process. This case involved the drug filgrastim, a biologic used to stimulate the production of white blood cells. Amgen claims to hold patents on the manufacture and use of filgrastim, which it sells under the name Neupogen. Sandoz, the applicant, filed an application with the FDA seeking approval of a filgrastim biosimilar, Zarxio. This was the first time that the Supreme Court interpreted key provisions of the BPCIA. At issue in the case were two provisions of the BPCIA aimed at facilitating early resolution of patent disputes between the sponsor and applicant.
A Biosimilar Applicant May Provide Patent Owners with Earlier Notice. One issue presented to the Court was the timing of the notice required by the BPCIA to the sponsor. Under the BPCIA, the applicant “shall provide” notice of commercial marketing to the sponsor 180 days before the date of the first commercial marketing of the licensed biosimilar product. While the Federal Circuit held that the Applicant could not give notice until FDA approval, the Supreme Court concluded that only commercial marketing (and not notice to the patent owner) must wait for FDA authorization. This decision grants biosimilar manufacturers more flexibility regarding when they can begin marketing their product. Rather than waiting until six months after FDA approval, a drug maker can now provide notice months in advance of approval—allowing them to market and sell the product immediately after obtaining FDA approval.
A Patent Owner Cannot Compel Biosimilar Manufacturing Disclosures Under the BPCIA. The second issue was whether a court could compel disclosure of how the biosimilar is manufactured by injunction. The BPCIA states the applicant “shall provide” to the sponsor a copy of the application and information about how the biosimilar is manufactured. While Amgen asserted the disclosure requirement is enforceable by injunction, the Court disagreed. Instead, the Court held that when the applicant fails to turn over its application and manufacturing information, the sponsor may then immediately bring a declaratory-judgment action for patent infringement and proceed accordingly outside of the structure offered by the BPCIA.