Gilead Sciences, Inc. v. Natco Pharma Limited
Appeal from the United States District Court for the District of New Jersey in Nos. 11-CV-1455 and 11-CV-4969, Judge Susan D. Wigenton (2014)
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Rule of Law:
For patents subject to the Uruguay Round Agreements Act (URAA) term, the expiration date, not the issuance date, is the determinative factor for an obviousness-type double patenting analysis. An earlier-expiring patent can serve as an invalidating reference against a later-expiring patent, even if the earlier-expiring patent issued later in time.
Facts:
- Gilead Sciences, Inc. owns two patents, U.S. Patent No. 5,763,483 ('483 patent) and U.S. Patent No. 5,952,375 ('375 patent), which list the same inventors and disclose similar antiviral compounds.
- The two patents were prosecuted in separate application chains and do not claim priority to a common application.
- The '375 patent's application was filed on February 26, 1996, and it expires on February 27, 2015.
- The '483 patent's application was filed later, on December 27, 1996, giving it a later expiration date of December 27, 2016.
- Due to differences in prosecution time, the '483 patent issued first on June 9, 1998, while the '375 patent issued second on September 14, 1999.
- This created a situation where the first-issued patent ('483) expires 22 months after the second-issued patent ('375).
- Natco Pharma Limited filed an Abbreviated New Drug Application seeking FDA approval to market a generic version of a Gilead drug allegedly covered by the '483 patent.
Procedural Posture:
- Gilead sued Natco in the U.S. District Court for the District of New Jersey for infringement of the '483 patent.
- Natco asserted as a defense that the '483 patent was invalid for obviousness-type double patenting in light of the '375 patent.
- The district court granted summary judgment for Gilead on the double patenting defense, ruling that a later-issued but earlier-expiring patent cannot serve as a reference.
- After Natco conditionally stipulated to infringement, the district court certified its summary judgment ruling for appeal.
- Natco (appellant) appealed the district court's judgment to the U.S. Court of Appeals for the Federal Circuit, where Gilead was the appellee.
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Issue:
Can a patent that issues later but expires earlier serve as a reference for an obviousness-type double patenting challenge against a patent that issued earlier but expires later?
Opinions:
Majority - Circuit Judge Chen
Yes, a patent that issues later but expires earlier can serve as an obviousness-type double patenting reference. The core principle of the double patenting doctrine is to prevent an inventor from extending their right to exclude the public from practicing an invention and its obvious variations beyond the expiration of the patent term. Before the URAA, a patent's issuance date was a reliable proxy for its expiration date, but this is no longer the case. The critical date for the analysis is the expiration date. In this case, when the '375 patent expires, the public should be free to practice the claimed invention and its obvious variants. However, Gilead's later-expiring '483 patent improperly blocks the public from doing so for an additional 22 months. Relying on issuance dates would invite gamesmanship in patent prosecution. The proper analysis focuses on patent expiration dates to preserve the public's right to use the invention after the first patent term ends.
Dissenting - Chief Judge Rader
No, a later-issued, earlier-expiring patent should not invalidate a first-issued, later-expiring patent. The majority improperly expands a judicially-created doctrine where neither of its underlying policy concerns—preventing improper term extension and preventing harassment by multiple assignees—are present. The later-issued '375 patent does not extend the term of the earlier-issued '483 patent; had the '375 patent never issued, Gilead would still be entitled to the '483 patent's full term. Gilead followed the statutory scheme by forfeiting an earlier priority date for the '483 patent in exchange for a later expiration date, subjecting it to more intervening prior art. The majority's new rule is based on the flawed assumption that the public gains an absolute right to practice an invention upon a patent's expiration, ignoring that other overlapping patents can still block such practice.
Analysis:
This case significantly clarifies the application of obviousness-type double patenting for all patents whose terms are calculated under the post-URAA framework (20 years from filing). The decision firmly shifts the focus of the inquiry from the patent's issuance date to its expiration date. By establishing that the earliest expiration date is the controlling benchmark, the court prevents patentees from using strategic prosecution to obtain extended monopoly periods for obvious variations of an invention. This holding makes it more difficult to 'evergreen' a patent portfolio through serial applications and strengthens the public's right to use an invention and its obvious variants as soon as the first patent protection expires.
