How Novartis Extended ‘229 Patent: Federal Circuit Ruling

Extended '229 Patent

In a recent ruling, the Unified States Court of Appeals for the Federal Circuit upheld a district court decision affirming the validity, enforceability, and infringement of the ‘229 patent. The court granted an extension until February 2019, determining the five-year term extension under 35 U.S.C. § 156 as legitimate, despite its impact on a related patent. This landmark decision was in the case of Novartis AG v. Ezra Adventures LLC (No. 2017-2284, Dec. 7, 2018), with the opinion delivered by Circuit Judge Chen.

Background: Ezra’s ANDA and Novartis’ Lawsuit

Ezra filed a Shortened New Drug Application (ANDA) for a generic version of Novartis’ multiple sclerosis drug, Gilenya. Novartis initiated legal proceedings against Ezra, citing infringement of the ‘229 patent, which covers various compounds, including the active ingredient in Gilenya.

Patent Term Extension and Legal Battle

The ‘229 patent, filed before the Uruguay Round Agreement Act of 1994 (URAA), faced expiration on February 28, 2014. Novartis obtained a five-year Patent Term Extension (PTE) under 35 U.S.C. § 156, addressing regulatory approval delays for new drugs. Notably, Novartis extended the ‘229 patent’s term, ensuring its validity until February 18, 2019, in contrast to the ‘565 patent, which expired on September 23, 2017.

District Court Proceedings

Ezra, in the district court, raised two primary arguments: first, that Novartis effectively extended the term of the ‘565 patent along with the ‘229 patent, and second, that the ‘229 patent became invalid due to obviousness-type double patenting. The district court dismissed both arguments, emphasizing Section 156’s allowance for a single-patent extension.

Federal Circuit’s Verdict

On appeal, Ezra asserted three main points: Novartis violated Section 156, the ‘229 patent was invalid due to obviousness-type double patenting, and policy concerns regarding patent rights extension. The Federal Circuit rejected these claims, emphasizing that Section 156 permits a legal PTE for one selected patent. It clarified that the ‘229 patent’s extension did not violate Section 156, as Novartis satisfied all statutory requirements.

Addressing Obviousness-Type Double Patenting

The Court diverged from Ezra’s claim of obviousness-type double patenting, asserting that a patent term extension does not invalidate a patent otherwise valid under existing law. It referenced Merck and Co. v. Hi-Tech Pharmacal Co. (482 F.3d 1317, 2007), highlighting that a terminally disclaimed patent, when term-extended, retains its validity.

Policy Concerns and Conclusion

Ezra’s policy concerns, related to potential patent rights extension manipulation, were dismissed by the Court. It emphasized that the ‘229 patent, being the earlier-filed and earlier-issued patent, determined the later termination date. The Court concluded that Novartis was entitled to the full term of the ‘229 patent extension until 2019.

In summary, the Federal Circuit’s decision solidifies the validity and enforceability of the ‘229 patent, providing clarity on patent term extensions and their impact on related patents. This ruling holds significant implications for Law Services specializing in patent law, offering a clear precedent and guidance regarding the extension of patent terms and their legal ramifications.

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