Double Patenting - Klarquist Patent DefensesKlarquist Patent Defenses

a) same invention

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). Where two patents issue on same invention, “the last, not the first, is void,” even when last to issue was first to be filed. Suffolk (U.S. 1865) (asserted patent was filed second but issued first). Matter of law defense.

b) obviousness-type (non-statutory)

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 (providing that an inventor shall obtain “a” patent for an invention) 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). See SawStop Cert. Petition (06/29/02) (arguing obviousness double patenting is ultra vires). Cf. Softview (Fed. Cir. 07/26/24) (USPTO had authority to interpret “patentably distinct” in 37 C.F.R. § 42.73(d)(3) (“A patent applicant or owner is precluded from taking action inconsistent with the adverse judgment, including obtaining in any patent: (i) A claim that is not patentably distinct from a finally refused or canceled claim….”) as having same meaning it has in obviousness double patenting context).
Applies Issued Claim-by-Issued Claim: Ortho Pharm. Corp. v. Smith, 959 F.2d 936, 942 (Fed. Cir. 1992) (“Where obviousness-type double patenting is recognized before issuance of a patent, the price extracted for obtaining the second patent is disclaimer of part of the term of protection for all claims in the patent, i.e., even those claims which standing alone would not run afoul of the rule against double patenting. …However, we conclude that this unitary treatment of the claims with respect to their term of protection does not carry over into an obviousness-type double patenting attack on the claims after the patent is issued. To do so would run counter to the requirement that validity of each claim must be evaluated individually as provided in 35 U.S.C. § 282 …. We conclude that the double patenting challenge must be evaluated, like any other ground of invalidity, against individual claims.”).
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). Applies to commonly owned patents even if inventive entities are different. In re Longi (Fed. Cir. 04/11/85). The relevant inventions need not have been co-owned at the time of invention. Immunex (Fed. Cir. 07/01/20) (2-1). “Where one of the rights transferred is the right to prosecute the patent at issue, identification of the effective “patentee” [under the “all substantial rights” test] is informative in evaluating whether the patents are ‘commonly owned’ for purposes of obviousness-type double patenting.” Immunex (Fed. Cir. 07/01/20) (2-1) (aff’g judgment that exclusive licensee did not have “all substantial rights” in asserted patents and thus its other patents (asserted as basis for double patenting defense) were not “commonly owned” with asserted patents). See SawStop Cert. Petition (06/29/02) (arguing obviousness double patenting is ultra vires). Cf. Softview (Fed. Cir. 07/26/24) (USPTO had authority to interpret “patentably distinct” in 37 C.F.R. § 42.73(d)(3) (“A patent applicant or owner is precluded from taking action inconsistent with the adverse judgment, including obtaining in any patent: (i) A claim that is not patentably distinct from a finally refused or canceled claim….”) as having same meaning it has in obviousness double patenting context).
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 Issuing Second May Be Double Patenting Reference For Earlier-Issued But Later-Expired Patent: “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 later priority date (because part of separate chain of applications by same inventors); 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 see Allergan (Fed. Cir. 08/13/24) (rev’g district court obviousness-type invalidity finding “A first-filed, first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date,” in view of “the purpose of the ODP doctrine, which is to prevent patentees from obtaining a second patent on a patentably indistinct invention to effectively extend the life of a first patent to that subject matter,” and because ruling otherwise would “effectively abrogate the benefit Congress intended to bestow on patentees when codifying PTA.”) [Note: no mention of Scott Paper (U.S. 11/13/1945) or consequences of the expiration of a patent.] Novartis Pharm. (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).
In Obviousness Double Patenting Analysis, Expiration Date Affected By Patent Term Adjustment (Section 154(b)) But Not By Patent Term Extension (Section 156): “While the expiration date used for an ODP analysis where a patent has received PTE is the expiration date before the PTE has been added, the expiration date used for an ODP analysis where a patent has received PTA is the expiration date after the PTA has been added” regardless of whether or not a terminal disclaimer has been filed. In re Cellect (Fed. Cir. 08/28/23) (aff’g obviousness double patenting rejection of “related patents that claim priority from the same application that … claim overlapping subject matter and that have different expiration dates only because of PTA,” in ex parte reexamination, not subject to terminal disclaimers, using PTA expiration dates to determine which patents expired later); 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).
Obviousness Double Patenting Doctrine May Invalidate Patent Based On Otherwise Proper Patent Term Adjustment (Section 154(b)): “While the expiration date used for an ODP analysis where a patent has received PTE is the expiration date before the PTE has been added, the expiration date used for an ODP analysis where a patent has received PTA is the expiration date after the PTA has been added” regardless of whether or not a terminal disclaimer has been filed. In re Cellect (Fed. Cir. 08/28/23) (aff’g obviousness double patenting rejection of “related patents that claim priority from the same application that … claim overlapping subject matter and that have different expiration dates only because of PTA,” in ex parte reexamination, not subject to terminal disclaimers, using PTA expiration dates to determine which patents expired later).
But, PTA Giving First-Filed And First-Issued Patent A Later Expiration Date Than Child Patents With Same Priority Date Cannot Invalidate Patent Under Obviousness-Type Double Patenting: “A first-filed, first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date,” in view of “the purpose of the ODP doctrine, which is to prevent patentees from obtaining a second patent on a patentably indistinct invention to effectively extend the life of a first patent to that subject matter,” and because ruling otherwise would “effectively abrogate the benefit Congress intended to bestow on patentees when codifying PTA.” Allergan (Fed. Cir. 08/13/24) (rev’g district court obviousness-type invalidity finding and distinguishing Cellect as not addressing this question of law at least in part because no party had presented it, and distinguishing Gilead (holding that “a later-issued but earlier-expiring patent can qualify as a ODP reference to invalidate an earlier-issued but later-expiring patent” because that involved a separate chain of applications with priority dates)).
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) (non-precedential) (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 With Reference Claims’ Elements Treated As If They Were Prior Art: 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). Elements of a reference patent’s various claims may be treated, for purposes of the “patentably distinct” analysis, as if they were elements in the prior art in a KSR analysis. See Softview (Fed. Cir. 07/26/24) (not an obviousness double patenting context) (aff’g PTAB finding that reexamination claims were not “patentably distinct” from claims cancelled in an IPR proceeding, where Board found reexamination claims were “merely a combination of limitations that had previously been invalidated on obviousness grounds in the IPR [and] “the limitations in combination ‘merely perform as they did in each sub-combination,’ such that “the Board evaluated whether the combination of the canceled claim limitations—all of which are individually in the prior art— made them anything more than the obvious sum of their parts,” consistent with KSR).
Inherency May Supply A Missing Claim Element In An Obviousness Double Patenting Analysis: In re Institut Pasteur (Fed. Cir. 12/13/23) (non-precedential) (aff’g rejection of claims for obviousness double patenting where the limitation “without inducing pharmacodependence or tolerance in the patient” was inherent in earlier patent).
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); accord In 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: A terminal disclaimer overcomes obviousness double patenting, In re Robeson (CCPA 05/14/64), but 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). Cf. In re Yamakazi (Fed. Cir. 12/06/12) (terminal disclaimer like disclaimer of claim is treated as being part of original patent so terminal disclaimer, here entered before patent issued, affects original term of patent, and cannot be revoked in reissue).
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); Gerber Garment (Fed. Cir. 10/10/90) (aff’g Summ. J. obviousness double patenting of patent issuing indirectly from an application filed as a result of a restriction requirement because amendment adding an element to the claims “crossed back over the line of demarcation between the ‘cutting apparatus’ claims and ‘work holding means’ claims drawn by the examiner in the restriction requirement … render[ing] claims 15 and 16 non consonant with those not elected in its response to the restriction requirement”).
TIPS: