Gilead Sciences v. NATCO Pharma: Later Issued Patent May Invalidate Earlier Issued Patent Under Double Patenting, if First to Expire

Category: Double Patenting 
 By: Jesus Hernandez, Blog Editor/Contributor
TitleGilead Sciences, Inc. v. NATCO Pharma Ltd., No. 2013-1418 (Fed. Cir. April 22, 2014).
Issue[W]hether a later-issued patent can serve as a double patenting reference for an earlier-issued patent if the later one expires first.
Gilead Sciences, Inc. at *10.
HoldingWe […] hold that an earlier-expiring patent can qualify as an obviousness-type double patenting reference for a later-expiring patent under the circumstances here [where the ’483 patent and the ‘375 patent have substantially similar specifications, but are not related to each other (e.g., divisional, continuation, CIP)]. In cases where such obviousness-type double patenting is present, a terminal disclaimer can preserve the validity of the later-expiring patent by aligning its expiration date with that of the earlier-expiring patent. That disclaimer will most effectively enforce the fundamental right of the public to use the invention claimed in the earlier-expiring patent and all obvious modifications of it after that patent’s term expires.
Id. at *16 (text added).
Procedural HistoryGilead sued Natco Pharma Limited (“Natco”) for infringement of the ’483 patent after Natco filed a request with the Food and Drug Administration seeking approval to market a generic version of one of Gilead’s drugs that is allegedly covered by the ’483 patent. In response, Natco asserted that the ’483 patent was invalid for obviousness-type double patenting over Gilead’s ’375 patent. In Gilead’s view, the ’375 patent cannot serve as a double patenting reference against the ’483 patent because, even though the ’483 patent’s expiration date is twenty-two months after the ’375 patent’s expiration date, the ’375 patent issued after the ’483 patent. The United States District Court for the District of New Jersey agreed with Gilead and, pursuant to a stipulation, granted it final judgment on infringement. Natco appeals that judgment […].
Gilead Sciences, Inc. at *2.
Legal Reasoning (Chen, Prost)
375 and '483 Patent Unrelated, have Substantially Similar Spec.The ’375 and ’483 patents were issued to the same inventors and are commonly owned by Gilead. The inventions disclosed in both patents are related to the inhibition of viruses through selective interference with certain enzymes. The written descriptions of the patents are very similar and, in substantial parts, identical. Despite their similarities in content, however, the ’375 and ’483 patents are not part of the same family of patents and were not before the same patent examiner. Instead, Gilead crafted a separate “chain” of applications, having a later priority date than the ’375 patent family. That separate chain resulted in the issuance of the ’483 patent. Because the patents do not claim priority to any common application, they will expire at different times as governed by the provisions of the Uruguay Rounds Agreement Act [“URAA”].
Gilead Sciences, Inc. at *3 (text added).
Expiration DatesThe ’375 patent was filed on February 26, 1996, and claims priority to a regular utility patent application filed on February 27, 1995. It expires twenty years later on February 27, 2015, and issued on September 14, 1999. The ’483 patent was filed on December 27, 1996, and claims priority to a provisional utility patent application filed on December 29, 1995. Though filed after the application for the ’375 patent, it issued first, on June 9, 1998, and expires last, on December 27, 2016.
Id. at *3.
Terminal Disclaimer of ‘375, None for ‘483After the ’483 patent issued, Gilead filed a terminal disclaimer in the application that led to the ’375 patent. Through it, Gilead disclaimed any portion of the ’375 patent term that extended beyond the expiration date of the ’483 patent—which, absent abandonment, would not occur since, as explained above, the ’375 patent’s expiration date is before the ’483 patent’s expiration date. From the prosecution history records, that appears 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. No terminal disclaimer was filed for the ’483 patent.
Id. at *4.
legal standard: obviousness type double patentingThe scope of the bar against double patenting has also been well-established in patent law jurisprudence. Federal courts for over a century have applied the principles of the doctrine as a means to preserve the public’s right to use not only the exact invention claimed by an inventor when his patent expires, but also obvious modifications of that invention that are not patentably distinct improve- ments. See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 967 (Fed. Cir. 2001) (“The judicially-created doctrine of obviousness-type double patenting . . . prohibit[s] a party from obtaining an extension of the right to exclude through claims in a later patent that are not patentably distinct from claims in a commonly owned earlier patent.”).
Id. at *8.
legal standard: terminal disclaimers[…] 35 U.S.C. § 253’s terminal disclaimer provision provided patent owners a remedy against a double patenting charge by “permit[ting] the patentee to cut back the term of a later issued patent so as to expire at the same time as the earlier issued patent.” […] Relying on that understanding of the purpose of terminal disclaimers permitted by the new § 253, the court concluded that a terminal disclaimer could negate a double patenting rejection in some instances.
Id. at *9.
Patent Term ExtendedThe ’375 patent expires on February 27, 2015. Thus, come February 28, 2015, the public should have the right to use the invention claimed in the patent and all obvious variants of that invention. [...] That was the condition upon which the ’375 patent was issued to the inventors. [...] But the public will not be free to do so. The ’483 patent does not expire until December 27, 2016, and it (we assume for this appeal) covers obvious modifications of the invention claimed in the ’375 patent. The ’483 patent, therefore, extends the inventors’ term of exclusivity on obvious variants of the invention claimed in the ’375 patent for an additional twenty-two months past the expiration of the ’375 patent.
Gilead Sciences, Inc. at *11-12 (internal citations omitted).
First Issued is Not Necessarily First to Expire[F]or double patenting inquiries, looking to patent issue dates had previously served as a reliable stand-in for the date that really mattered—patent expiration. But as this case illustrates, that tool does not necessarily work properly for patents to which the URAA applies, because there are now instances, like here, in which a patent that issues first does not expire first. Therefore, in light of the principles reflected in our prior case law as explained above, it is the comparison of Gilead’s patent expiration dates that should control, not merely the issuance dates.
Id. at *13.
Expiration Date greater weight in double patenting inquiry than Issuance Date[W]e see little import here in the fact that the ’483 patent issued first. Gilead cites cases that describe the double patenting bar as applicable to the “second” or “later” issuing patent. [...] But those cases dealt with patents to which the URAA did not apply and, critical to a double patenting analysis, to patents for which the expiration date was inextricably intertwined with the issuance date. […] As discussed above, the primary ill avoided by enforcement of the double patenting doctrine is restriction on the public’s freedom to use the invention claimed in a patent and all obvious modifications of it after that patent expired. Thus, the focus on controlling the patent term of later issued patents in those cases makes perfect sense: before the URAA, later issued patents expired later.
Id. at 12-13 (internal citations omitted).
[T]he district court erred in concluding that the ’483 patent could not be invalid for double patenting because the ’375 patent could not qualify as an obviousness-type double patenting reference. We therefore vacate the judgment of the district court and remand for further proceedings consistent with this opinion.
Gilead Sciences, Inc. at *16-17.
RADER, Chief Judge, dissenting. Gilead Sciences, Inc., Rader, CJ Op. at *1.
General Grounds for DissentToday the court expands the judicially-created doc- trine of obviousness-type double patenting. The court holds that a later-issued, but earlier-expiring patent can invalidate a first-issued, but later expiring patent—even where the patents are subject to a requirement of common ownership. Because this expansion is unwarranted, I respectfully dissent.
Gilead Sciences, Inc., Rader, CJ Op. at *1.
Underlying Basis for Obviousness Type Double Patenting has changed[B]ased on changes implemented as part of the GATT and URAA, the term of a patent is now generally limited to 20 years from its filing date or the earliest claimed filing date under 35 U.S.C. §§ 120, 121 or 365(c). 35 U.S.C. § 154(a)(2). With this change, successive continuations generally do not result in any additional patent term. Rather, the filing date of the earliest member of a patent family limits the rest of the related patents. Id. Thus a primary motivation behind the doctrine— preventing the effective extension of patent term—is largely no longer applicable. […] That being said, the doctrine of obviousness-type double patenting is also predicated on a second underlying policy concern—preventing multiple infringement suits by different assignees asserting essentially the same patented invention. […] [I]n this case, neither policy concern justifies an extension of double patenting.
Id. at *2 (internal citations omitted).
Actions are Self-CorrectingUnder 35 U.S.C. § 154(b) a patentee may not maintain its earliest possible priority date while seeking to extend the expiration date of subsequent patent claims. Rather, to obtain a longer patent term, a patentee must forfeit its earlier claim to priority and subject any new patent to intervening prior art. Gilead followed that precise approved course. Instead of claiming priority to the ’375 patent family, Gilead filed the application that ultimately issued as the ’483 patent as a separate family. In the process, Gilead gave up roughly 10 months of priority. Consequently, the ’483 patent is subject to roughly 10 months of intervening prior art.
Id. at *4.
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