Gilead Sciences, Inc. v. Natco Pharma Limited
753 F.3d 1208
| Fed. Cir. | 2014Background
- Gilead owns two related antiviral patents, the '483 and '375, with different expiration dates due to separate priority chains; they are commonly owned but not in the same patent family or examiner track.
- Natco asserted the '483 patent is invalid for obviousness-type double patenting over the '375 patent; district court granted summary judgment for Gilead.
- URAA changed term calculation to 20 years from earliest effective filing date, affecting how double patenting is analyzed post-URAA.
- The district court held a later-issued but earlier-expiring patent cannot serve as a double patenting reference for an earlier-issued, later-expiring patent.
- The case centers on whether the '375 patent can serve as a double patenting reference for the '483 patent under URAA, and whether a terminal disclaimer can align expiration to avoid improper term extension.
- The Federal Circuit held that an earlier-expiring patent can qualify as a double patenting reference for a later-expiring patent under these circumstances, vacating and remanding.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Can an earlier-expiring patent serve as a double patenting reference for a later-expiring patent under URAA? | Gilead: later-expiring '483 cannot be blocked by earlier '375. | Natco: '375 can bar '483 under obviousness-type double patenting. | Yes, an earlier-expiring patent can serve. |
| What is the proper benchmark for double patenting analysis post-URAA? | Gilead argues issue date should govern. | Natco argues expiration date should govern. | Expiration dates control for post-URAA analysis. |
| Can terminal disclaimers align patent terms to uphold public use after expiration? | Disclaimers can be used to align terms. | Disclaimers are unnecessary if terms do not extend. | Yes; terminal disclaimer can align expiration to prevent improper term extension. |
| Should the district court have treated the '375 patent as an invalid reference for the '483 patent? | Gilead contends no improper term extension. | Natco argues '375 validly blocks '483. | District court erred; '375 can be a double patenting reference. |
Key Cases Cited
- Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955 (Fed. Cir. 2001) (obviousness-type double patenting principle applies to restrict extensions)
- Perricone v. Medicis Pharm. Corp., 432 F.3d 1368 (Fed. Cir. 2005) (double patenting policy and terminal disclaimer considerations)
- In re Longi, 759 F.2d 887 (Fed. Cir. 1985) (premise that public may use obvious variants after expiration)
- Robeson, 331 F.2d 610 (C.C.P.A. 1964) (terminal disclaimer as tool to align terms and avoid improper extension)
- Braithwaite, 379 F.2d 594 (C.C.P.A. 1967) (terminal disclaimer effect equating to one patent term)