BASICS: Same Invention Double Patenting: Sec. 101 prohibits an applicant from receiving multiple patents on the same invention. If one of the claims could be literally infringed without literally infringing the other, then not “same invention” double patenting. In re Vogel (CCPA 03/05/1970). Matter of law defense.
BASICS: Obviousness-Type (Non-Statutory) Double Patenting: Prohibits issuance of claims in a second patent on invention essentially the same as that claimed in a first issued patent. “Grounded in the text of” Sec. 101 and still needed despite 20-year terms from effective filing date. AbbVie (Fed. Cir. 08/21/14) (aff’g double patenting invalidity where continuation patent did not claim parent’s effective filing date and thus expired years later, and claimed an obvious species of the parent’s claimed genus; and citing patent-term adjustments under Sec. 154(b) as another circumstance where double patenting needed). Also matter of law. May not use earlier patent as prior art but may rely on earlier patent regarding unexpected results and other considerations related to obviousness. AbbVie (Fed. Cir. 08/21/14) (“a later expiring patent is not patentably distinct from an earlier expiring patent if it merely claims a disclosed utility of the earlier claimed invention.”) “In chemical cases, the double patenting inquiry is not whether a person of ordinary skill in the art would select the earlier compound as a lead compound, but rather whether the later compound would have been an obvious or anticipated modification of the earlier compound.” UCB (Fed. Cir. 05/23/18) (2-1) (aff’g no double patenting because insufficient prior art or other evidence of reasonable expectation of success as of priority date in modifying the earlier claimed compound to arrive at the later-claimed compound).
Applies Where Common Assignee And/Or At Least One Common Inventor: Applies where patents/applications have at least one inventor in common (even if never had a common assignee) and/or have a common assignee. In re Hubbell (Fed. Cir. 03/07/13) (2-1) (aff’g rejection of genus claims where prior issued (but not prior art) patent with some overlapping inventors claimed species).
Perhaps Not Apply To Patents Sharing Only One Common “Inventor”: In re Fallaux (Fed. 05/06/09) (taking no position on MPEP provision applying double patenting rejection where only one common inventor). Cf.In re Hubbell (Fed. Cir. 03/07/13) (2-1) (Applies where patents/applications have at least one inventor in common (even if never had a common assignee) and/or have a common assignee).
Whether One-Way Test Or Two-Way Test Depends On Whether Applicant’s Fault That Earlier-Filed Application Issued Second: Where later patent was filed later or on same day as the first patent, court will apply a one-way test: is the second patent’s claim patentably distinct from the issued claim? But, if first-filed application issues later than later filed app. through no fault of applicant, two-way test applies and claim is invalid only if each claim is not patentably distinct over the other. In re Basell Poliolefine Italia (Fed. Cir. 11/13/08); In re Janssen Biotech (Fed. Cir. 01/23/18) (aff’g PTAB double patenting unpatentability decision; “the two-way test is a ‘narrow exception to the general rule of the one-way test,’ and is only appropriate where (1) a second-filed application issues prior to a first-filed application, and (2) ‘the PTO is solely responsible for the delay’ in the issuance of the first-filed application.” Seeks to solve “unusual circumstances occur only ‘when the applicants filed first for a basic invention and later for an improvement, but, through no fault of the applicants, the PTO decided the applications in reverse order of filing, rejecting the basic application although it would have been allowed if the applications had been decided in the order of their filing.’”); In re Fallaux (Fed. Cir. 05/06/09) (delay not fault of PTO). Filing multiple CIPs triggers one-way test for double patenting because PTO not solely responsible for delay in issuance. Smith & Nephew (Fed. Cir. 12/02/09).
Not Same Test As Sec. 103 Obviousness: Although KSR makes it more likely to win a double patenting defense, there are differences, including: Obviousness compares claimed subject matter to the prior art; non-statutory double patenting compares claims in an earlier patent to claims in a later patent or application (but in construing scope of the earlier claim, court may look at earlier patent’s Spec.). Eli Lilly (Fed. Cir. 08/24/12) (both consider objective indicia); In re Hitachi (Fed. Cir. 03/17/15) (non-precedential) (Spec. may be consulted for claim construction and for determining what would be obvious variation). Cf.Tas (Fed. Cir. 09/29/15) (non-precedential) (aff’g declaration of interference where respective claims recite “result limitations that are a consequence of” method step recited in respective claims).
Patent That Expires First May Be Double Patenting Basis For Later Expiring Patent Even If Issued Second: “A patent that issues after but expires before another patent [may] qualify as a double patenting reference for that other patent.” Gilead (Fed. Cir. 04/22/14) (2-1) (earlier issued patent expired later because had different priority date; the principle that a patent’s expiration allows the public to practice the invention “is violated when a patent expires and the public is nevertheless barred from practicing obvious modifications of the invention claimed in that patent because the inventor holds another later-expiring patent with claims for obvious modifications of the invention.”). But seeNovartis Pharma. (Breckenridge) (Fed. Cir. 12/07/18) (rev’g double patenting decision; where later-filed, later-issued, earlier-expiring patent expired earlier than first-filed patent with same effective filing date, because subject to 20-years-from-priority-application term, while first-filed, first-issued patent was subject to 17-year patent term, there is no double patenting “because a change in patent term law should not truncate the term statutorily assigned” to the first-filed patent.); Novartis AG (Ezra) (Fed. Cir. 12/07/18) (aff’g that obviousness double patenting does not invalidate a patent term extension where patent owner had two patents covering product/method subject to regulatory review and, as permitted, selected one for a five year extension of term, so expires 22 years after issue date, and after the second, later-filed patent.)
Claiming Use Of Compound Disclosed In Earlier Patent Claiming That Compound: “Obviousness-type double patenting encompasses any use for a compound that is disclosed in the specification of an earlier patent claiming the compound and is later claimed as a method of using that compound.” Sun Pharm. (Fed. Cir. 07/28/10); cf.Eli Lilly (Fed. Cir. 08/24/12) (distinguishing Sun Pharm. where prior patent claimed intermediate used in producing what is claimed in later patent).
Claims Reciting Narrower Range May Be “Obvious” Over Prior Claims Reciting Broader Range. Boehringer (Fed. Cir. 03/16/20) (aff’g obviousness double patenting (and obviousness) of claims reciting “2.5 mg and 5 mg dosages” over claims reciting, apparently, “1–100 mg range,” where routine to do dosage ranging studies and start at lower dosages).
Relevance Of Written Description To Double Patenting: Four Fed. Cir. judges would have reheard this issue en banc, arguing that written description is irrelevant to double patenting. Sun Pharm. Order (Fed. Cir. 11/01/10).
KSR Applies In Double Patenting Context: a claim to an active pharmaceutical ingredient is invalidated by an earlier claim to a three-element composition that included the active compound; omitting the known elements would have been obvious under KSR. In re Metoprolol Succinate Patent Litig. (Fed. Cir. 07/23/07) (citing with approval).
Patent On Product And Patent On Method Of Making Product: patentably distinct (and thus no obviousness-type double patenting) if materially different process existed—at time of filing the second application—for making the product. Takeda (Fed. Cir. 04/10/09). But, if patent owner relies on different process available post effective filing date, that opens door to alleged infringer to also look to double-patenting-obviousness evidence post effective filing date. Amgen (Fed. Cir. 09/15/09).
Two “Comprising” Claims Reciting Different Subcombinations But Encompassing Same Combination: ABC was old. Spec. disclosed improvements X and Y and XY together. First patent’s claim recited ABCX, in a comprising claim. Second app., with same applicant, claimed ABCY and ABCXY. As each claim covered effectively ABCXY, it violated non-statutory double patenting. In re Schneller (CCPA 06/27/1968); accordIn re Metoprolol (Fed. Cir. 07/23/07). [Note: USPTO limits Schneller to its facts.]
c) terminal disclaimer
Terminal Disclaimer Avoids Obviousness Double Patenting Only If Patents Commonly Owned: Terminal disclaimer overcomes obviousness double patenting only if patents/applications are commonly owned. Gilead (Fed. Cir. 04/22/14) (2-1).
Terminal Disclaimer Must Be Filed Before Earlier Patent Expires: although terminal disclaimer may be filed during litigation and even after double patenting found, it must be filed before first patent expires, to be effective. Boehringer (Fed. Cir. 01/25/10).
Terminal Disclaimer May Prospectively Revive Otherwise Invalid Patent, Even After Issuance: Even post-issuance, a terminal disclaimer will prospectively revive a patent found invalid for double-patenting. Perricone (Fed. Cir. 12/20/05) (noting that terminal disclaimer can prospectively overcome double patenting invalidity, but refusing to determine the retrospective effect).
Patent Term Subject To Terminal Disclaimer May Be Extended Under Sec. 156: A patent term extension under Sec. 156 runs from the expiration date created by the terminal disclaimer. Merck (Fed. Cir. 03/29/07).
Terminal Disclaimer Is Not An Admission That Claims Are Patentably Indistinct, But Is A Strong Clue: “A terminal disclaimer is a strong clue that a patent examiner and, by concession, the applicant, thought the claims in the continuation lacked a patentable distinction over the parent. But … that strong clue does not give rise to a presumption that a patent subject to a terminal disclaimer is patentably indistinct from its parent patents.” Simpleair (Fed. Cir. 03/12/18) (vacating dismissal based on claim preclusion due to district court’s erroneous over reliance on terminal disclaimer.)
d) safe harbor for “divisionals”
Divisionals May Be Protected From Double Patenting Invalidity: 35 U.S.C. § 121 “safe harbor” protects divisional applications (only to extent required by a PTO restriction requirement) from double patenting invalidity. Bristol-Myers (Fed. Cir. 03/17/04) (Vacating denial of Summ. J. that Sec. 121 bars the asserted double patenting defense. “Bristol-Myers is entitled to invoke the [Sec. 121] statutory prohibition against the use of the ’707 patent ‘as a reference’ against the divisional application that resulted in the ’927 patent only if the divisional application was filed as a result of a restriction requirement and is consonant with that restriction requirement.” Here, the earlier restriction requirement was not repeated in the later continuation application and thus Sec. 121 does not protect the patent owner.). Question of law. In re Janssen Biotech (Fed. Cir. 01/23/18) (aff’g ex parte reexamination rejection of claims for double patenting and ruling that claims not protected by Sec. 121 safe harbor).
Sec. 121 Safe Harbor Does Not Protect Continuations Or CIPs, Unless Continuation Of Divisional: Sec. 121 does not protect CIPs, Pfizer (Fed. Cir. 03/07/08); or a reissue on an application originally filed and issued as a CIP with new matter even if later “corrected” to be called a “divisional”, G.D. Searle (Fed. Cir. 06/23/15); or a patent issued as a CIP (with new matter) re-designated during reexamination to be a “divisional,” even if the patent owner did not benefit from its CIP designation, In re Janssen Biotech (Fed. Cir. 01/23/18) (aff’g ex parte reexamination rejection of claims for double patenting and ruling that claims not protected by Sec. 121 safe harbor; not deciding whether re-designation to divisional before patent issued would invoke safe harbor); or continuations, unless they descend from an application designated as a “divisional,” Amgen (Fed. Cir. 09/15/09).
Sec. 121 Safe Harbor Does Protect Divisional Of Divisional: It does protect a divisional of a divisional, even one claiming multiple “inventions” that the restriction requirement had found to be distinct and there was no restriction requirement repeated in the first divisional. Boehringer (Fed. Cir. 01/25/10) (rehearing en banc denied, with dissenting opinion (05/07/10)).
Both Patents Must Derive From Same Restriction Requirement: Challenged and referenced patent must derive from the same (perhaps reinstated or otherwise continued) restriction requirement. D. Searle (Fed. Cir. 06/23/15).
Sec. 121’s Consonance Requirement: Sec. 121 consonance requirement “requires that the challenged patent, the reference patent, and the patent in which the restriction requirement was imposed (the restricted patent) do not claim any of the same inventions identified by the examiner.” St. Jude Med. (Fed. Cir. 09/11/13) (consonance lacking, but fact specific).
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