supreme court’s patent dance decision: victories ... · he u.s. supreme court’s recent ruling...
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June 2017
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The U.S. Supreme Court’s recent ruling in a landmark biosimilars case represents two victories for biosimilar applicants. 1) The conclusion that the information-sharing requirements of Section 262(l)(1)-(2) are effectively optional, at least
under federal law, is an advantage for biosimilar applicants because it provides additional strategic options under the BPCIA. And 2) The Supreme Court’s holding that a biosimilar applicant may provide effective 180-day notice of commercial marketing before FDA licensure is also a win for biosimilar applicants.
While this landmark Supreme Court decision in Amgen v. Sandoz is an overall positive development for biosimilar applicants, it should not be viewed as final or conclusive, since the question of whether state law may provide an equitable remedy for the RPS to compel sharing of information has yet to be decided by the Federal Circuit.
In view of the Supreme Court’s decision, biosimilar applicants should:
• Consider filing the 180-day notice of commercial marketing at the earliest possible opportunity and at least 180 days prior to the end of the RPS exclusivity period, to reduce or eliminate lag to market.
• Until the Federal Circuit further weighs in, consider newly available strategic options for participating in all, part, or none of the patent dance.
Similarly, RPS companies should prepare diligently for the possibility of a biosimilar application by developing a robust patent portfolio, and watching for opportunities to license-in patents that complement the portfolio.
Decision Details
On June 12, the Supreme Court interpreted the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), and in particular, Section 262(l) of the BPCIA that
June 2017
In this Issue:
Decision Details .......................... 1
Biosimilars Background ............. 2
Industry Implications ................. 2
Authors .............................................. 3
For More Information ....................... 4
Biosimilars
Supreme Court’s Patent Dance Decision: Victories & Uncertaintiesby Morgan Kirley, Tara Nealey, Tim Worrall, and Gary Hood
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biosimilar applicants must give reference product sponsors (RPS’s) notice of commercial marketing 180 days prior to marketing their products.
The BPCIA provides at Section 262(l)(1)-(2) a procedure for the biosimilar applicant to provide its biosimilar application and biosimilar manufacturing information to the RPS no later than 20 days after the FDA accepts the application for review. The BPCIA also provides a procedure for exchanging information on the patents that could reasonably be asserted regarding the biosimilar application, used to determine grounds for an infringement action by the RPS. The exchange of information and the associated timeline for legal action is often collectively referred to the patent dance. Section 262(l)(9)(C) of the BPCIA further provides that an RPS may bring a declaratory judgment action upon the biosimilar applicant’s failure to provide this information.
Industry Implications
In the present legal dispute, Sandoz obtained the first biosimilar approval for Zarxio® under the BPCIA in March 2015, for which Amgen was the RPS for Neopogen® (filgrastim). Amgen initially sued Sandoz in October 2014 for, among other things, Sandoz’s failure to provide information that Amgen argued was required by BPCIA Section 262(l)(8)(A), and for premature and ineffective notice of commercial marketing, which was initially provided before FDA licensure of Zarxio® and later through a “further notice” in March 2015 following grant of FDA licensure. According to its June 12, 2017 decision, the U.S. Supreme Court upheld in part the Federal Circuit’s earlier interpretation of the BPCIA to permit a biosimilar applicant to not share its application and manufacturing information, subject to the consequences of Section 262(l)(9)(C). Reversing the Federal Circuit, the Supreme Court held that a biosimilar applicant may provide the 180-day notice of commercial marketing either before or after FDA approval (i.e., before obtaining a license to market the product), and is not required to wait until approval, which would effectively have extended Amgen’s market exclusivity for six months.
The Supreme Court did not, however, provide finality to all of the outstanding legal issues. The Court remanded
details an intricate patent infringement litigation resolution process commonly known as the “patent dance.” The Court focused on two questions: (i) whether Sandoz (the biosimilar applicant in this case), could file the required 180-day Notice of Commercial Marketing before its biosimilar competitor of Amgen’s branded filgrastim product was approved by the FDA; and, (ii) whether Amgen, the reference drug sponsor (“RPS”) of the branded filgrastim product Neupogen®, could obtain an injunction under federal law against Sandoz for failing to provide information on Sandoz’s filgrastim biosimilar product application. As to the latter question, to roughly analogize, the Supreme Court considered what remedy is available to Amgen under the BPCIA if Sandoz decided not to follow the detailed steps of the patent dance outlined in the BPCIA.
The Court’s answers: (i) the BPCIA does not require the biosimilar applicant to wait until its biosimilar application has been approved by the FDA to file its 180-day Notice of Commercial Marketing; and, (ii) Section 262(l)(2)(A) of the BPCIA is not enforceable by injunction under federal law, but the Court remanded to the Federal Circuit to address whether an injunction under state law (in this case, California law) may be available if not pre-empted by federal law. While an injunction is not one of the remedies provided by the BPCIA under federal law, the Court reiterated that Section 262(l)(9)(C) of the BPCIA allows an RPS such as Amgen to bring a declaratory judgment action upon the biosimilar applicant’s failure to provide information on the biosimilar product application.
Biosimilars Background
Biosimilars, or “generic biologics,” are a rapidly emerging area of the pharmaceutical industry. The Biologics Price Competition and Innovation Act (BPCIA), enacted in 2009, is somewhat similar to the Hatch-Waxman Act in its goals of balancing innovation and consumer interests. The biosimilar applicant may rely in part on the approved license of a reference biologic product if it can show that its product is “highly similar.” To provide reference products some protection, the BPCIA provides for twelve years of exclusivity for the reference drug from the date of reference product licensure, even upon loss of patent protection. Additionally,
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to the Federal Circuit to consider whether an injunction—while not available to the RPS under the BPCIA—may yet be available to the RPS under state law, to enforce Section 262(l)(9)(C) of
J. Morgan Kirley Shareholder | Practice Vice Chair 312.873.3624 [email protected]
Authors:
Gary E. Hood Shareholder | IP Division Chair 816.360.4128 [email protected]
Tara A. Nealey Shareholder 314.622.6630 [email protected]
Timothy A. Worrall Principal 720.931.1198 [email protected]
the BPCIA, if not pre-empted by federal law. In particular, the question left unaddressed is whether Amgen may seek an injunction under California state unfair competition law.
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For More Information
For questions regarding this alert or to learn more about how it may impact your business, please contact one of the authors, a member of our Biosimilars practice, or your Polsinelli attorney.
To learn more about our Biosimilars practice, or to contact a member of our Biosimilars team, visit http://www.polsinelli.com/services/biosimilars or visit our website at polsinelli.com.
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June 2017 Biosimilars | Newsletter