Gilead Sciences, Inc. et al. v. Natco Pharma Limited et al.

Docket No. 2013-1418

April 22, 2014

Brief Summary: Earlier filed (earlier expiring) / later issued patent may serve as obviousness-type double patenting reference for later filed (later expiring) / earlier issued patent (URAA patents). Dissent argued Gilead should be entitled to later expiration date.

Summary: Natco appealed DC judgment that Gilead’s US 5,952,375 could not serve as an obviousness-type double patenting reference against US 5,763,483 because the ‘375 patent issued after the ‘483 patent, even though the ‘483 expiration date is 22 months after the ‘375 expiration date. The patents “disclose similar content [but] do not claim priority to a common patent application…[the patents] were issued to the same inventors and are commonly owned by Gliead.” During prosecution of the application of the ‘375 patent and after the later-expiring ‘483 patent issued, Gilead filed a terminal disclaimer for the application of the ‘375 patent disclaiming any term that would extend “beyond the expiration date of the ‘483 patent-which, absent abandonment, would not occur” (the TD appearing “to be the first time Gilead informed either the examiner of the ‘375 patent or of the ‘483 patent about the existence of the other patent application”). A terminal disclaimer was not filed for the ‘483 patent. The question here is whether “a patent that issues after but expires before another patent qualify as a double patenting reference for that other patent?” The opinion explains “under the circumstances of this case…it can”. This is based on the “bedrock principle of our patent system that when a patent expires, the public is free to use not only the same invention claimed in the expired patent but also obvious or patentably indistinct modifications of that invention” (citing Perricone, FC 2005). The opinion explained that under the URAA, “Congress clearly limited the one period of exclusivity an inventor can obtain for each of his inventions to twenty years from the filing date of the earliest application to which the inventor claims priority-with some limited exceptions…Permitting any earlier expiring patent to serve as a double patenting reference for a patent subject to the URAA guarantees a stable benchmark that preserves the public’s right to use the invention (and its obvious variants) that are claimed in a patent when that patent expires” (the use of terminal disclaimers creates one expiration date “which is tantamount…to having all the claims in one patent” (citing Braithwaite, CCPA 1967)). Since the public would not be free to use the invention claimed in the ‘375 patent upon expiration because the ‘483 patent had not yet expired (“if it does indeed claim obvious variants of the invention claimed in the ‘375 patent”), the DC judgment was vacated and remanded “for further proceedings consistent with this opinion.” Judge Rader’s dissent argued “this expansion is unwarranted” because “this case does not raise the policy concern regarding subsequent extensions of patent term” (“if the ‘375 patent had never issued, Gilead would certainly be entitled to the ‘483 patent’s 2016 expiration date”) and “this case does not involve the potential for harassment by multiple assignees asserting essentially the same patented invention” (through the terminal disclaimer, the ‘375 and ‘483 patents are only enforceable as long as they are commonly owned). The dissent argued that the real question was “whether Gilead’s conduct warrants the creation of a new rule proscribing its patent rights” (noting “[F]ederal courts do not site as councils of revision, empowered to rewrite legislation in accord with their own conceptions of prudent public policy….”)

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