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Polsinelli Polsinelli - Hatch-Waxman Litigation and Opinion

July 2016


New Guidance on Mandatory Notice in the Biosimilar ‘Patent Dance’


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Gary E. Hood


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Khurram Naik


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Patrick C. Woolley


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The Federal Circuit’s recent decision in Amgen Inc. v. Apotex Inc., No. 16-1308, provides new guidance on the timeline of biosimilar approval and the impact to commercial marketing.

The ruling weighed in on a key provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), deciding that biosimilar applicants must provide reference product sponsors with notice 180 days before commercial marketing.

In the decision, the Federal Circuit affirmed the district court’s grant of Amgen’s motion for a preliminary injunction. As a result, Apotex must provide its notice of commercial marketing, and delay commercial marketing for 180 days from the date of that notice. Additionally, the Federal Circuit’s decision may effectively extend by six months the 12-year exclusivity that prevents approval of biosimilar applications.

The BPCIA defines the so-called “patent dance,” a set of procedures for adjudicating which patents may be asserted against biosimilar applicants by a reference product sponsor. These procedures are initiated by disclosures from the biosimilar applicant to the sponsor. Among those procedures, the BPCIA states that an applicant shall provide notice at least 180 days before beginning commercial marketing subsequent to approval of a biosimilar application. In relevant part, certain provisions of the BPCIA provide for declaratory judgment actions by sponsors and applicants, depending on whether the applicant provides notice of commercial marketing. The BPCIA also amended 35 U.S.C. § 271 to add infringement causes of actions and provide “the only remedies” available based on the parties’ participation in the patent dance.

This case involves Apotex’s application for a biosimilar to Amgen’s anti-infection drug Neulasta. Apotex complied with the notice requirements of the BPCIA and proceeded with the patent dance with Amgen, agreeing on which patents would be asserted against Apotex. Amgen moved for a preliminary injunction enjoining Apotex and specifically requiring that it provide its notice of commercial marketing if and when it received a license, as well as delaying commercial marketing for 180 days from the date of that notice. Apotex stipulated to all preliminary injunction factors except the likelihood of success. The district court granted Amgen’s motion.

The Federal Circuit concluded that the 180-day notice of commercial marketing was mandated by the BPCIA. The Court’s analysis of the statutory language relied on its 2015 opinion Amgen v. Sandoz, which held that the BPCIA’s commercial marketing provision was a “standalone notice” provision, not contingent on the disclosure process Apotex participated in here. The Amgen decision further explained that the commercial marketing notice provision serves the purpose of creating a defined statutory window in which a court and parties can fairly and efficiently resolve the parties’ rights before launch of the subject biosimilar.

The Federal Circuit did not view this notice requirement as conflicting with the exclusivity provision that prevents biosimilar approval and runs 12 years from the reference product sponsor approval date (Biologic exclusivity), as the 12-year provision is only an earliest date that an application may be approved, not a deadline. The Court presumed that there will be fewer extensions of exclusivity beyond the 12-year Biologic exclusivity, as more biosimilar applicants submit their application at the expiration of the 4-year window that blocks application submissions following approval of sponsor products, given that this is well in advance of the 12-year Biologic exclusivity. For such applications, the Court opined that the FDA could issue licenses before the 11.5-year mark, and deem the license to take effect on the 12-year date.

Finally, the Court rejected Apotex’s contention that the declaratory judgment provisions of the BPCIA provide the sole remedies where applicants do not provide notice of commercial marketing, and that such applicants may not be enjoined and required to provide such notice. The Court simply found no basis in the statute to conclude those declaratory judgment provisions controlled over the 35 U.S.C. § 271 provisions describing the “only remedies” available to sponsors, and found no express language otherwise limiting sponsors’ remedies to those declaratory judgment provisions.

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