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European Biopharmaceutical Review

The Patent Dance

The state of biosimilars in the US has never been hotter; 2017 was the most active year to date for biosimilar drug manufacturers since the Biologics Price Competition and Innovation Act (BPCIA) was enacted by Congress. Recent decisions by the Supreme Court of the US and the US Court of Appeals for the Federal Circuit have indelibly altered the landscape of biosimilar litigation. Now, biosimilar applicants can eliminate the nearly eight-month information exchange process and/or collapse the two litigation phases into one single action − effectively expediting the litigation and potentially accelerating market entry.

Rounds of Disclosure

Enacted in 2010, the BPCIA created an abbreviated approval pathway for biosimilars (1). The BPCIA facilitates litigation during the period preceding FDA approval of the biosimilar so that the parties may attempt to resolve their patent disputes prior to commercial marketing (2). However, several key differences exist. Besides the absence of an Orange Book for patents covering biological products, the most notable distinction between the BPCIA and Hatch-Waxman schemes is how patent litigation can impact the approval and launch of a follow-on biologic. As set forth in 42 USC § 262 (l), a ‘patent dance’ is contemplated, consisting of several ‘rounds’ of disclosure and information exchange.

The first round of this dance starts rapidly. Within 20 days of the FDA’s acceptance of an Abbreviated Biologics License Application (aBLA), the BPCIA contemplates that a biosimilar applicant provides the reference product sponsor confidential access to its full aBLA application (2). Furthermore, the biosimilar applicant can provide the reference product sponsor detailed information concerning the biosimilar product’s manufacturing process (2). Sixty days after this initial exchange, the reference product sponsor must provide the biosimilar applicant with a list of unexpired patents for which a claim of infringement could reasonably be made, as well as any licensing offers (2). The biosimilar applicant then has another 60 days to provide detailed invalidity, unenforceability, and/or noninfringement contentions for each of the asserted patents (2). What follows next is an additional series of responses, culminating over an eight-month period, with the innovator bringing suit in a US federal court. However, if the biosimilar applicant fails to engage in this disclosure process, the reference product sponsor may file an immediate declaratory judgment action on any of those unexpired patents that could be reasonably asserted.

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Sanya Sukduang is a partner at Finnegan, Henderson, Farabow, Garrett & Dunner. He has a dynamic practice litigating matters concerning abbreviated new drug application challenges for brand drug manufacturers, diagnostic methods, biological products, and medical devices. Sanya has been the recipient of various awards and nominations, including Best Lawyers Under 40 by the National Asian Pacific American Bar Association.

Thomas J Sullivan is an associate at Finnegan. His practice focuses on complex patent litigation related to the pharmaceutical and biotechnology fields. He is actively involved in Hatch-Waxman litigation proceedings at the district court level and in appeals to the Federal Circuit.
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Sanya Sukduang
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Thomas J Sullivan
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