December 7, 2018

Case Name: Novartis AG v. Ezra Ventures LLC, Fed. Cir. No. 2017-2284, 2018 U.S App. LEXIS 34459 (Fed. Cir. Dec. 7, 2018) (Circuit Judges Moore, Chen, and Hughes presiding; Opinion by Chen, J.) (Appeal from D. Del., Stark, J.) 

Drug Product and Patent(s)-in-Suit: Gilenya® (fingolimod); U.S. Patent No. 5,604,229 (“the ’229 patent”).

Nature of the Case and Issue(s) Presented: Gilenya is used to treat multiple sclerosis, and it is covered by two Novartis patents: the ’229 patent, which covers the formulation of the product; and U.S. Patent No. 6,004,565 (“the ’565 patent”), which claims a method for administering Gilenya. This suit originated when Ezra sought to manufacture and market a generic version of Gilenya and filed an ANDA application. Novartis then sued, alleging infringement of the ’229 patent.

35 U.S.C § 156 allows a patent owner attempts to account for the lengthy regulatory delays drugs face as they are brought to market. Under section 156, a patent owner may obtain an extension of five years to the term of a patent, provided that certain conditions are met. Section 156, however, is limited; it only permits a patent owner to extend the length of a patent term for a single patent directed to a particular drug.

Novartis sought and obtained a patent-term extension pursuant to section 156 for the ’229 patent, which caused it to expire after the ’565 patent. Ezra argued that this amounted to a violation of the single-patent limitation of section 156 because, by extending the term of the patent on the drug formulation, Novartis also extended the term of the ’565 patent, as a competitor would not be able to practice the method claimed in the ’565 patent without using the drug formulation claimed in the ’229 patent. Ezra moved for judgment on the pleadings on this ground. The district court disagreed, and allowed the suit to proceed. Ezra then appealed to the Federal Circuit, where the decision was affirmed on appeal.

Why Novartis Prevailed: The Federal Circuit recognized that, in a sense, Novartis had “effectively” extended the term of the ’565 patent when it elected to extend the term of the ’229 patent. The Federal Circuit, however, held that doing so was not a violation of section 156. It looked to the language of the statute, which did not provide any limitation or qualifier prohibiting “effectively” extending the term of an additional patent. Instead, the statute merely provides that only a single patent shall be entitled to a patent-term extension. This is exactly what happened here—the term of the ’229 patent was actually extended, while the term of the ’565 patent was not. Accordingly, the lower court ruled correctly, and the Federal Circuit upheld the determination.