Nature of the Case
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Facts
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) governs a type of drug called a biosimilar, which is a biologic product that is highly similar to a biologic product that has already been approved by the FDA. Under §262 (l), an applicant that seeks FDA approval must provide its application materials and manufacturing information to the manufacturer of the corresponding biologic within 20 days of the date the FDA notifies the applicant that it has accepted the application for review. The applicant then must give notice to the manufacturer at least 180 days before marketing the biosimilar commercially. The BPCIA enables the parties to bring infringement actions at certain points in the application process, even if the applicant has not yet committed an act that would traditionally constitute patent infringement. The mere submission of a biosimilar application constitutes an act of infringement. §§271(e)(2)(C)(i), (ii). This is called an “artificial” infringement. Section 271(e)(4) provides remedies for artificial infringement, including injunctive relief and damages. When the FDA accepts an application for review, it notifies the applicant, who within 20 days “shall provide” to the sponsor a copy of the application and information about how the biosimilar is manufactured. §262(l)(2)(A). The applicant also “may provide” the sponsor with any additional information that it requests. §262(l)(2)(B). These disclosures enable the sponsor to evaluate the biosimilar for possible infringement of patents it holds on the reference product (i.e., the corresponding biologic). §262(l)(1)(D). Within 60 days of receiving the application and manufacturing information, the sponsor “shall provide” to the applicant “a list of patents” for which it believes it could assert an infringement claim if a person without a license made, used, offered to sell, sold, or imported “the biological product that is the subject of the [biosimilar] application.” §262(l)(3)(A)(i). The sponsor must also identify any patents on the list that it would be willing to license. §262(l)(3)(A)(ii). Within 60 days of receiving the sponsor’s list, the applicant may provide to the sponsor a list of patents that the applicant believes are relevant but that the sponsor omitted from its own list, §262(l)(3)(B)(i), and “shall provide” to the sponsor reasons why it could not be held liable for infringing the relevant patents, §262(l)(3)(B)(ii). The applicant must also respond to the sponsor’s offers to license particular patents. §262(l)(3)(B)(iii). Then, within 60 days of receiving the applicant’s responses, the sponsor “shall provide” to the applicant its own arguments concerning infringement, enforceability, and validity as to each relevant patent. §262(l)(3)(C). In the first phase, the parties collaborate to identify patents that they would like to litigate immediately. The second phase is triggered by the applicant’s notice of commercial marketing and involves any patents that were included on the parties’ §262(l)(3) lists but not litigated in the first phase. In the second phase of litigation, either party may sue for declaratory relief. Under §262(l)(9)(C), if an applicant fails to provide its application and manufacturing information to the sponsor, the sponsor, but not the applicant, may 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.” Section 271(e)(2)(C)(ii) facilitates this action by making it an artificial act of infringement, with respect to any patent that could have been included on the §262(l)(3) lists, to submit a biosimilar application. When an applicant provides the application and manufacturing information but fails to complete a subsequent step, §262(l)(9)(B) provides that the sponsor, but not the applicant, may bring a declaratory-judgment action with respect to any patent included on the sponsor’s §262(l)(3)(A) list of patents (as well as those it acquired later and added to the list). As noted, it is an act of artificial infringement, with respect to any patent on the §262(l)(3) lists, to submit an application to the FDA. See §271(e)(2)(C)(i). Amgen (P) marketed a filgrastim product called Neupogen and claims to hold patents on methods of manufacturing and using filgrastim. Sandoz (D) filed an application with the FDA seeking approval to market a filgrastim biosimilar under the brand name Zarxio, with Neupogen as the reference product. The FDA informed D on July 7, 2014, that it had accepted the application for review. One day later, D notified P both that it had submitted an application and that it intended to begin marketing Zarxio immediately upon receiving FDA approval, which it expected in the first half of 2015. D did not intend to provide the requisite application and manufacturing information under §262(l)(2)(A) and informed P that P could sue for infringement immediately under §262(l)(9)(C). In October 2014, P sued D for patent infringement. P also asserted two claims under California’s unfair competition law. P alleged that D engaged in “unlawful” conduct under state law when it failed to provide its application and manufacturing information under §262(l)(2)(A), and when it provided notice of commercial marketing under §262(l)(8)(A) before, rather than after, the FDA licensed its biosimilar. P sought injunctions and D counterclaimed for declaratory judgments that the asserted patent was invalid and not infringed and that it had not violated the BPCIA.
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