Summary: The double patenting doctrine is a well-established facet of the United States patent law, having historic roots going back to the early 1800s. The purpose of the double patenting doctrine is to address the situation in which multiple patents (or applications and patents) claim patentably indistinct subject matter, but have some commonality that precludes any of them from being prior art as to the others. The original basis for the double patenting doctrine was to ensure that the inventor could not improperly extend the right to exclude granted in a patent by successively pursuing additional patents on indistinct subject matter.
The changes to patent term in the United States that took effect in 1995 as a result of the Uruguay Round Agreements Act (URAA),[i] which changed the patent term expiration date to be measured from the filing date of the application rather than the date the patent was granted, led to a questioning of the continued need for the double patenting doctrine. Nonetheless, the double patenting doctrine remains after this change in the patent laws, and the interplay of the double patenting doctrine and the 1995 change to patent term has led to interesting results that warrant close attention.
In addition, the relationships between inventors and companies and/or other organizations in developing and commercializing inventions is becoming increasingly complex. This in turn has led to questions concerning the degree of commonality required for double patenting to exist between patents and applications when there is partial but not complete overlap of inventorship, or of ownership, of the applications and/or patents at issue.
Introduction: Double patenting is a judicially-created doctrine emanating from the “may obtain a patent therefor” (i.e., a single patent) provision of 35 U.S.C. § 101.[ii] While the double patenting doctrine derives from 35 U.S.C. § 101, the patent code in title 35, United States Code, does not define double patenting (i.e., define what is double patenting or how or if it may be overcome) or even mention double patenting. The double patenting doctrine is essentially a judicial doctrine defined by case law, which has evolved since its early roots in the U.S. patent system. There are two reasons given for this doctrine: (1) the first is “to prevent unjustified timewise extension of the right to exclude granted by a patent no matter how the extension is brought about”; and (2) the second is to prevent multiple infringement suits by different assignees asserting essentially the same patented invention.[iii] The first reason—timewise extension of patent rights—was the primary force behind the development of this judicial doctrine,[iv] as this judicial doctrine developed when patent term expiration was measured from the date the patent was granted.
The more recent developments in the double patenting doctrine are the result of changes to the patent expiration date that took effect in 1995 as a result of the URAA, and of the increasingly complex relationships between inventors and companies and/or other organizations in developing and commercializing inventions. This article aims to review the evolution of the double patenting doctrine from its early roots and consider recent decisions dealing with the interplay of the double patenting doctrine and the 1995 change to patent term and the inventorship and/or ownership commonality necessary for double patenting to exist.
Historic Basis: The double patenting doctrine is rooted in several U.S. Supreme Court cases from the 1800s, leading to there being a “well-settled rule that two valid patents for the same invention cannot be granted either to the same or to a different party.”[v] These decisions are founded on the concern that if a patentee can successively take out additional patents for the same invention, the patentee could perpetuate its exclusive rights, defeating the patent bargain as the public would not be able to use the invention at the expiration of the term specified in the original patent.[vi] The Supreme Court answer to double patenting was to declare the second issued patent invalid.[vii]
The 1952 Patent Act,[viii] which codified the patents laws into title 35, United States Code, does not expressly mention the double patenting doctrine, but includes provisions that appear to address double patenting issues. One[ix] such provision is for terminal disclaimers, providing that “any patentee or applicant may disclaim or dedicate to the public the entire term, or any terminal part of the term, of the patent granted or to be granted.”[x] While the 1952 Patent Act and its legislative history do not connect this terminal disclaimer provision to double patenting, contemporaneous commentaries on the 1952 Patent Act suggest that its proponents thought it might be effective to address double patenting concerns.[xi]
Evolution of Double Patenting from Its Historic Roots: There are generally considered to be two types of double patenting: (1) the first is where the claims of the application or patent under consideration (target patent/application) are drawn to the “same invention” as the claims of a reference patent; and (2) the second is where the claims of the target patent/application are not drawn to the “same invention” as the claims of a reference patent, but are obvious over (or not patently distinct from) the claims of the reference patent.[xii]
Prior to 1970, the claims of the target patent/application were considered to be drawn to the “same invention” as the claims of the reference patent if they were substantially the same as those of the reference patent,[xiii] including claims directed to “mere colorable variations of the same idea.”[xiv] The distinction between these two types of double patenting is important because “same invention” double patenting is expressly prohibited by the “a patent” provision 35 U.S.C. § 101 and cannot be overcome by filing a terminal disclaimer.[xv]
In the 1970 U.S. Court of Customs and Patent Appeals (C.C.P.A.) decision In re Vogel,[xvi] “same invention” double patenting was confined to the situation in which the identical subject matter is being claimed twice. An example given in Vogel of the “same invention” condition being met is one claim reciting a length of “thirty-six inches” and the other claim reciting a length of “three feet” for an element, with all other limitations being identical (i.e., the identical item being described using different words).[xvii] An example given in Vogel of this “same invention” condition not being met is one claim reciting “halogen” and the other claim reciting “chlorine,” as halogen is broader than chlorine.[xviii] Vogel thus confined “same invention” double patenting to the rare situation in which the identical invention is being claimed twice, using either the same or different words.
Double Patenting—What We Know: With “same invention” double patenting being confined to the identical invention being claimed twice, almost all double patenting situations are now the second type of double patenting—obviousness-type double patenting (OTDP)[xix]—in which the claims of the target patent/application are not patentably distinct from the claims of the reference patent. Unlike “same invention” double patenting, OTDP can be overcome by filing a terminal disclaimer tying the expiration date and ownership of the target patent/application to the expiration date and ownership of the reference patent.[xx] By tying together the expiration date and ownership of the target patent/application and reference patent, all of the claims in both the target patent/application and reference patent are treated in effect as if appearing in a single patent.[xxi] A patentee (or patent applicant), however, cannot avoid double patenting by disclaiming the claims of the reference patent (disclaiming the reference patent).[xxii] In addition, if the reference patent has been disclaimed in this manner, a patentee (or patent applicant) may not thereafter terminally disclaim the target patent to expire at the time the reference patent would have expired had it not been disclaimed.[xxiii]
The Reference Patent: An OTDP reference patent does not normally qualify as prior art to the target patent/application; otherwise, the OTDP reference patent would be applied as prior art to the target patent/application under 35 U.S.C. § 102 or 103 and double patenting would not be an issue. Thus, the disclosure (written description and drawings) of an OTDP reference patent may not be used as prior art in the OTDP analysis.[xxiv] That being said, the disclosure of an OTDP reference patent may be used to interpret the meaning of terms in a claim and determine the coverage of the claim, as well as to determine whether a target patent/application claim is an obvious variant of the reference patent claim.[xxv] In addition, the disclosed uses in the written description or specification of the OTDP reference patent may be used to aid in determining the coverage of the reference patent claim.[xxvi] The portions of the disclosure of an OTDP reference patent unrelated to its claims, however, may not be used in the OTDP analysis.
The OTDP Analysis: The OTDP analysis varies from an anticipation or obviousness analysis under 35 U.S.C. § 102 or 103. A target patent/application patent claim is not patentably distinct from a reference patent claim if the target patent/application claim is obvious over, or anticipated by, the reference patent claim.[xxvii] The OTDP analysis may be analogous to an anticipation analysis when the reference patent claim falls within the scope of the target patent/application claim.[xxviii] This commonly occurs when the reference patent claim defines a species and the target patent/application claim defines a genus of that species.[xxix] The OTDP analysis also may be analogous to an obviousness analysis when the reference patent claim does not fall completely within the scope of the target patent/application claim, but is not patentably distinct from the scope of the target patent/application claim.[xxx] It is possible to consider other patents and publications in this obviousness determination, but those other patents and publications must themselves qualify as prior art under 35 U.S.C. § 102.[xxxi]
Two-Way Test: Genus and Species Patents: The genus/species situation where a first-filed but later issuing genus application is considered for OTDP over a later-filed but earlier issued species patent (i.e., the earlier genus application and later species application issue in reverse order) has resulted in particularized OTDP treatment. A species anticipates a genus, but a genus does not anticipate or necessarily even render obvious a species. The Federal Circuit provided for a “two-way” test for OTDP in certain situations in which genus and species applications issue in reverse order: the “two-way” test being that claims of the target patent/application must be obvious over claims of the reference patent, and claims of the reference patent must also be obvious over claims of the target patent/application.[xxxii] This led to numerous applicants contending that their situation also warranted application of the two-way test.[xxxiii]
The two-way test, however, has been applied sparingly in recent years, primarily due to a change to inventorship requirements in 1984 to allow joint inventors to file together in one application even if “each [inventor] did not make a contribution to the subject matter of every claim of the patent,”[xxxiv] which provided greater flexibility in filing applications involving joint inventors. The Federal Circuit subsequently clarified that the “two-way” test was a narrow exception that applied in unusual circumstances “‘to prevent rejections for obviousness-type double patenting 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.’”[xxxv]
The “two-way” test is also relevant to OTDP between a utility patent/application and a design patent. It is possible, though rare, for there to be OTDP between a utility patent/application and a design patent.[xxxvi] The Federal Circuit has also applied the “two-way” test when considering OTDP as between the utility patent/application and a design patent.[xxxvii]
Current Trends in Double Patenting: As a judicially created doctrine, OTDP is always evolving. Two such evolving areas are: (1) the amount of commonality of inventive entity and/or ownership there must be between the target patent/application and another patent for that other patent to be an OTDP reference patent; and (2) the interplay of OTDP and the twenty-year patent term provisions of the URAA, as well as both patent term extension for pre-marketing regulatory review (“PTE”) and patent term adjustment (“PTA”).[xxxviii]
Requirement for Common Inventive Entity or Ownership: One current issue is what amount of commonality (inventive entity or ownership) there must be between the target patent/application and the other patent for that other patent to be an OTDP reference patent. The U.S. Patent and Trademark Office (USPTO) indicates that OTDP may exist between an application and patent that share the same inventive entity, share at least one common (joint) inventor, share a common applicant, or share a common owner/assignee.[xxxix]
In In re Fallaux,[xl] the Federal Circuit noted the USPTO’s viewpoint, but stated that its opinion should not be read to decide or endorse the USPTO’s view on the issue. A few years later though in In re Hubbell,[xli] the Federal Circuit has held that complete identity of inventive entity or ownership is not a prerequisite to OTDP in the context of a target application and reference patent that had two common joint inventors (though different inventive entities and no common owners or assignees). It remains to be seen whether it will suffice for OTDP for there to be partial shared ownership if there are no inventors in common.
It is also not certain what rights amount to ownership. In Immunex Corp. v. Sandoz, (Immunex)[xlii] the Federal Circuit indicated that where a party ultimately controls prosecution of both sets of patents, the “all substantial rights” test aids in determining whether the patents should be treated as commonly owned for purposes of OTDP. The Immunex court ultimately concluded that the party did not have “all substantial rights,” leaving open the question of when the “all substantial rights” test would lead to a determination that the patents should be treated as commonly owned for purposes of OTDP.
Double Patenting and the URAA: Another particularly uncertain area is the interplay between OTDP and the URAA.[xliii] The continued existence of the OTDP doctrine was questioned in view of the twenty-year patent term provisions of the URAA. The Federal Circuit answered this question stating that OTDP remains applicable after the URAA, observing that patents on overlapping subject matter will have different terms if the applications claim different priority dates, and that even applications claiming a common priority date may still result in patents having different terms due to the possibility of PTA.[xliv] The Federal Circuit issued a series of additional decisions that address the impact of the URAA’s patent term change on OTDP, as well as the interplay between OTDP and both PTE and PTA.
Gilead Scis., Inc. v. Natco Pharma Ltd. (Gilead)[xlv] involved two patents that did not have a common priority date. Both patents were filed after June 8, 1995, and thus both patents were under the twenty-year patent term provisions of the URAA (“URAA patents”), though one of the patents claimed benefit of an earlier “pre-URAA” application. In Gilead, the later-filed patent issued first, meaning that the earlier-filed (taking into account its priority date) but later issued patent had an earlier expiration date. Prior to the URAA, when patent expirations dates were connected to the patent issue date, OTDP looked to the later issued patent to see if its claims were not patentably distinct from the claims of an earlier issued patent. The Federal Circuit held that OTDP analysis was not so limited with the advent of the URAA, and in this situation looked to the patent expiration dates to determine if there was OTDP. The Federal Circuit specifically stated that under the circumstances of this case a patent that issues after but expires before another patent may qualify as an OTDP reference for that other patent.[xlvi]
Novartis Pharms. Corp. v. Breckenridge Pharm. Inc. (Novartis v. Breckenridge)[xlvii] involved two patents having a common priority date, but one patent was a pre-URAA patent and the other patent was a URAA patent. The change to patent term in the URAA resulted in the earlier issued pre-URAA patent having an “original”[xlviii] expiration date that was after the expiration date of the later issued URAA patent. The District Court applied Gilead and held that the URAA patent—issuing after the pre-URAA patent but expiring before the pre-URAA patent—qualifies as an OTDP reference for the pre-URAA patent. The Federal Circuit, however, distinguished the situation in Novartis v. Breckenridge (one pre-URAA patent and one URAA patent) from Gilead (both URAA patents), and held that traditional OTDP practices should apply to the pre-URAA patent, and thus the later issued URAA patent was not a proper OTDP reference for the pre-URAA patent.[xlix]
The USPTO has incorporated Gilead and Novartis v. Breckenridge into the Manual of Patent Examining Procedure (MPEP) with respect to double patenting, with Gilead being applicable when both the target patent/application and the reference patent are URAA and Novartis v. Breckenridge being applicable when at least one target patent/application or the reference patent are pre-URAA.[l] The USPTO, however, instructs examiners that that they should consult with a Technology Center Specialist if an otherwise appropriate OTDP rejection is not being made based upon Novartis v. Breckenridge.[li]
Novartis AG v. Ezra Ventures LLC (Novartis v. Ezra)[lii] involved two patents that did not have a common priority date. As in Novartis v. Breckenridge, one patent was a pre-URAA patent and the other was a URAA patent. In Novartis v. Ezra, however, the earlier issued pre-URAA patent had an original expiration date that was earlier than the expiration date of the later issued URAA patent, but the pre-URAA patent received PTE that resulted in the pre-URAA patent having an expiration date that was later than the expiration date of the later issued URAA patent. The patent challenger argued that the pre-URAA patent receiving PTE resulted in the URAA patent also receiving a longer patent term, which violated the PTE provision that only one patent be extended due to a regulatory review. The Federal Circuit held that OTDP does not cut off PTE[liii] and that the resultant impact on the URAA patent’s term did not violate the PTE provision that only one patent be extended due to a regulatory review.[liv] The USPTO has incorporated Novartis v. Ezra into the MPEP with respect to both double patenting and PTE.[lv]
In re Cellect, LLC (Cellect)[lvi] involved four URAA patents having a common priority date. The four patents were involved in a third party requested reexamination (target patents) and the USPTO rejected certain claims in each of the four target patents under OTDP over the claims in another patent (reference patent) sharing the common priority date with the four target patents. The patents would all have expired on the same date, except that the four patents under reexamination received varying amounts of PTA and the reference patent did not receive any PTA. Cellect argued that OTDP should be considered before adding any PTA, in which case the target patents and refence patents would have shared a common expiration date, analogizing the situation to PTE where OTDP is considered before adding any PTE. The Federal Circuit, however, distinguished PTE from PTA, noting that the PTA statute expressly accounts for terminal disclaimers where the PTE statute is silent with respect to terminal disclaimers.[lvii] The Federal Circuit rejected the argument that this provision speaks only to terminal disclaimers actually filed in a patent and not OTDP, treating terminal disclaimers and OTDP as two sides of the same coin.[lviii] Thus, while a terminal disclaimer does not cut off PTE (PTE is added to the end of the patent term as shortened by any terminal disclaimer), a terminal disclaimer cuts off any PTA. In essence, PTA may not extend the term of a patent beyond its term as shortened or limited by any terminal disclaimer actually filed or any terminal disclaimer necessary to address OTDP. The USPTO has incorporated Cellect into the MPEP with respect to terminal disclaimers.[lix]
Allergan U.S. v. MSN Labs. Private Ltd (Allergan) involved three URAA patents having a common priority date. The patents would all have expired on the same date, except that the first filed and first issued patent received PTA where the other two later filed and later issued patents did not receive any PTA. The patent challenger argued that under Cellect the first filed (and issued) patent extends beyond the expiration of the other patents, and thus the other patents are proper OTDP references to the first patent. The Federal Circuit in Allergan rejected this broad reading of Cellect, stating that Cellect only requires that the expiration date with the PTA addition be considered in the OTDP analysis and does not address under what circumstances a patent claim may serve as an OTDP reference.[lx] The Federal Circuit expressly stated in Allergan that 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.[lxi]
Practical Considerations in Double Patenting:
Make case-specific arguments: The law of double patenting is and will be ever-evolving. Decisions that appear to state categorical rules may be explained by and distinguished in subsequent decisions. Applicants should, if possible, contest double patenting rejections on the basis of the availability of the patent as an OTDP reference on case-specific grounds and the claim-to-claim obviousness analysis itself, rather than make broad-brush arguments that require the court to make a categorical holding.
First-filed, first issued patent: Allergan does expressly state that “a first-filed, first-issued, later-expiring claim” may not be “invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date.” Applicants should prosecute patent families in a manner that puts the most valuable claims—the claims for which the longest term is most desirable—in the first-filed, first-issued patent.
Restriction Requirements and the Safe Harbor: As discussed previously, 35 U.S.C. § 121 (third sentence) prohibits the use of a patent on a restricted application as a reference against any divisional application if the proper procedures are followed when filing and prosecuting the divisional application. A restriction requirement can be helpful in avoiding OTDP if the proper procedures are followed, but the procedures 35 U.S.C. § 121 must be strictly followed to take advantage of its safe harbor.[lxii] For example—
Properly state the relationship between patents/applications: The USPTO rules require that an applicant state the relationship between applications as continuation, divisional, or continuation-in-part of the prior-filed nonprovisional application. [lxiii] While the terms “divisional,” “continuation,” and “continuation-in-part” have been characterized as administrative labels, using (or failing to use) the term “divisional” in an application filed as the result of a restriction requirement has substantive effect in determining whether the safe harbor of 35 U.S.C. § 121 applies to that patent or application. Specifically, the Federal Circuit has held that the “safe harbor” of 35 U.S.C. § 121 applies only to divisional applications, and does not apply if the relationship between the target application/patent and the reference patent is only that of a continuation-in-part or continuation application.[lxiv] That being said, the “safe harbor” of 35 U.S.C. § 121 may also apply to continuations that descend from a divisional application filed as a result of a restriction requirement, and thus intervening continuation applications do not render a patent ineligible for the safe harbor of 35 U.S.C. § 121.[lxv]
Maintain “consonance” between applications: In general, an applicant must maintain the line of demarcation between the inventions that prompted the restriction requirement in the parent application in which the restriction was made. A divisional application that contains claims drawn to the invention set forth in the claims elected and prosecuted to patent in the parent application clearly violates this consonance requirement.[lxvi] An applicant though is permitted to pursue two or more non-elected inventions in the same subsequent divisional application without violating this consonance requirement.[lxvii] Maintaining consonance may be more challenging when filing multiple divisional applications to cover multiple non-elected inventions, as consonance in a divisional must be maintained with not only the parent application in which the restriction was made to avoid the parent application being used as an OTDP reference, but also as between sibling divisional applications to avoid a sibling application from being used as an OTDP reference.[lxviii]
Determine if any Terminal Disclaimer Already Filed is Unnecessary Before the Patent is Granted: The USPTO will consider petitions under 37 C.F.R. § 1.182 to withdraw an erroneously filed terminal disclaimer while an application is pending before the USPTO.[lxix] This does not mean the petition will be granted necessarily. The USPTO indicates that petitions seeking to reopen consideration of the OTDP rejection that led to the filing of the terminal disclaimer are not favorably considered.[lxx] However, an applicant who wishes to reopen consideration of the OTDP rejection that led to the filing of the terminal disclaimer may do so by filing a continuing application and abandoning the application in which the terminal disclaimer was filed.[lxxi] The continuing application will not be subject to the terminal disclaimer (unless one is filed in the continuing application), and the applicant may argue any OTDP rejection in the continuing application that results from there being no terminal disclaimer in that continuing application.
Once a patent is granted, the USPTO’s viewpoint is that the mechanisms to correct a patent, including certificate of correction (35 U.S.C. § 255), reissue (35 U.S.C. § 251), and reexamination (35 U.S.C. § 305), are not available to withdraw or otherwise nullify the effect of a recorded terminal disclaimer.[lxxii] The withdrawal or nullification of a terminal disclaimer through reissue has not been permitted as violating the requirement in 35 U.S.C. § 251 that a reissue patent be “for the unexpired part of the term of the original patent,” since the term of a patent subject to a terminal disclaimer does not include the disclaimed portion.[lxxiii] The Federal Circuit has also upheld the USPTO’s refusal to withdraw a terminal disclaimer from an issued patent when the reference patent and patent issuing from the target application were never commonly owned.[lxxiv]
Conclusion: The double patenting doctrine, being a judicial doctrine, is ever-evolving. It is said that there are “known knowns,” “known unknowns,” and “unknown unknowns.”[lxxv] What we know is that the Federal Circuit does not view the twenty-year patent term provisions of the URAA as having displaced the double patenting doctrine. We also know that the Federal Circuit does not confer the benefits of the 35 U.S.C. § 121 “safe harbor” on a divisional application unless that application strictly complies with the requirements of 35 U.S.C. § 121. The USPTO has also made clear that it will not remove a recorded terminal disclaimer in an issued patent. These are known knowns.
What is less known (a known unknown) is precisely under what circumstances a later issued patent may serve as a proper double patenting reference against an earlier issued URAA patent.[lxxvi] Thus, it is critical for patent applicants and patentees to avoid sweeping arguments regarding the URAA and PTA when contesting assertions of double patenting. In addition, another “known unknown” is the amount of shared ownership necessary, and what rights amount to ownership, for there to be sufficient commonality for double patenting to exist even in the absence of any common inventor.
Finally, there is always the possibility of review by the U.S. Supreme Court. Since the late 1990s, the Supreme Court has taken an interest in various aspects of the conditions of patentability.[lxxvii] While certiorari was sought and denied in Cellect, the Supreme Court granting certiorari in a double patenting case must be considered a possibility. That review, if it happens, could result in a decision that runs the gamut from abolishing the double patenting doctrine as unnecessary in view of the twenty-year patent term provisions of the URAA to holding the second or subsequent patent invalid in accordance with its decisions in Miller v. Eagle Mfg. Co. and Suffolk Co. v. Hayden. While decisions at the extremes may be unlikely, the Supreme Court issuing a “game-changing” decision in any area of patent law cannot be dismissed as an impossibility.
[i] Uruguay Round Agreements Act (URAA), Pub. L. No. 103-465, § 532(a), 108 Stat. 4809, 4983-85 (1994). The term of a U.S. patent was measured from the date of grant until 1995: it was not to exceed fourteen years from grant between 1790 and 1836; it was fourteen years from grant with a seven year extension between 1836 and 1861; and it was seventeen years from grant between 1861 and 1995. With the URAA, the term of U.S. patents on applications filed on or after June 8, 1995 is measured from the filing date of the application: specifically, the term of such a patent ends twenty years from its filing date, or the earliest filing date claimed under 35 U.S.C. § 120, 121, or 365(c).
[ii] Allergan U.S. v. MSN Labs. Private Ltd., 111 F.4th 1358, 1366-67 (Fed. Cir. 2024).
[iii] In re Hubbell, 709 F.3d 1140, 1145 (Fed. Cir. 2013) (quoting In re Van Ornum, 686 F.2d 937, 943-44 (C.C.P.A. 1982), and citing In re Fallaux, 564 F.3d 1313, 1319 (Fed. Cir. 2009)).
[iv] In re Fallaux, 564 F.3d 1313, 1318 (Fed. Cir. 2009) (explaining that the “unjustified patent term extension justification for obviousness-type double patenting has limited force” post-URAA).
[v] Miller v. Eagle Mfg. Co., 151 U.S. 186, 197 (1894).
[vi] Odiorne v. Amesbury Nail Factory, 18 F. Cas. 578, 579 (C.C.D. Mass. 1819) (No. 10,430) (Story, J.) (“if [the patentee] can successively take out at different times new patents for the same invention, he may perpetuate his exclusive right during a century, whereas the patent act confines this right to fourteen years from the date of the first patent. If this proceeding could obtain countenance, it would completely destroy the whole consideration derived by the public for the grant of the patent”).
[vii] Suffolk Co. v. Hayden, 70 U.S. (3 Wall.) 315, 319 (1866) (later-expiring patent held invalid for double patenting over an earlier-expiring patent, even though the patentee had applied for the later-expiring patent first).
[viii] An Act to revise and codify the laws relating to patents and the Patent Office, and to enact into law title 35 of the United States Code entitled “Patents,” Public Law 82-593, 66 Stat. 792 (1952).
[ix] Another provision is 35 U.S.C. § 121 (provides for restrictions), which states that “[a] patent issuing on an application with respect to which a requirement for restriction under [35 U.S.C. § 121] has been made, or on an application filed as a result of such a requirement, shall not be used as a reference . . . against a divisional application” if certain conditions are met. 35 U.S.C. § 121 (1952).
[x] 35 U.S.C. § 253(b).
[xi] P.J. Federico, Commentary on the New Patent Act, 35 U.S.C.A. 1, 49 (1954)(“its proponents contemplated that it might be effective in some instances, in combatting a defense of double patenting, to permit 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”); see also In re Zickendraht, 319 F.2d 225, 231 n.4 (C.C.P.A. 1963) (J. Rich, concurring).
[xii] In re Robeson, 331 F.2d 610, 614-15 (C.C.P.A. 1964) (distinguishing the situation in which the claims are directed to mere colorable variations of the same idea from the situation in which the claims are obvious variations of each other but more than mere colorable variations); see also In re Vogel, 422 F.2d 438, 441 (C.C.P.A. 1970).
[xiii] In re Robeson, 331 F.2d 610, 614 (C.C.P.A. 1964).
[xiv] In re Robeson, 331 F.2d 610, 615 (C.C.P.A. 1964) (citing Underwood v. Gerber, 149 U.S. 224 (1893)).
[xv] In re Robeson, 331 F.2d 610, 615 (C.C.P.A. 1964) (“[w]here the claims of a second application are substantially the same as those of the first patent, they are barred under 35 U.S.C. § 101) (citing Miller v. Eagle, and In re Ockert, 245 F.2d 467 (C.C.P.A. 1957); see also In re Vogel, 422 F.2d 438, 441 (C.C.P.A. 1970) (“35 U.S.C. § 101 forbids the grant of the second patent, regardless of . . . a terminal disclaimer”).
[xvi] In re Vogel, 422 F.2d 438, 441 (C.C.P.A. 1970). The U.S. Court of Appeals for the Federal Circuit (Federal Circuit) has adopted as precedent the decisions of the C.C.P.A. South Corp. v. United States, 690 F.2d 1368, 1369 (Fed. Cir. 1982).
[xvii] In re Vogel, 422 F.2d 438, 441 (C.C.P.A. 1970).
[xviii] In re Vogel, 422 F.2d 438, 441 (C.C.P.A. 1970).
[xix] Section 804 of the Manual of Patent Examining Procedure (MPEP) discusses double patenting in general, and uses the phrase “non-statutory double patenting” to refer to all double patent other than same invention (35 U.S.C. § 101) double patenting. The Federal Circuit, however, continues to use the phrase obviousness-type double patenting (or ODP or OTDP).
[xx] In re Robeson, 331 F.2d 610, 614 (C.C.P.A. 1964) (the terminal disclaimer results in the second patent expiring simultaneously with the first patent, leaving in place the right to fully utilize the patented discovery upon expiration of the first patent).
[xxi] The common ownership requirement was included in the USPTO’s regulations for a terminal disclaimer filed to overcome an OTDP rejection. As noted by the C.C.P.A. in Van Ornum, “‘[w]hen a terminal disclaimer causes two patents to expire together[,] a situation is created which is tantamount for all practical purposes to having all the claims in one patent.’” In re Van Ornum, 686 F.2d 937, 948 (C.C.P.A. 1982) (quoting In re Braithwaite, 379 F.2d 594, 601 (C.C.P.A. 1967)). The C.C.P.A upheld the common ownership requirement in Van Ornum as necessary to avoid the situation in which a patentee seeks to assign separate claims of the same patent to different parties, which was held impermissible in Pope v. Gormully,144 U.S. 248, (1892). In re Van Ornum, 686 F.2d 937, 948 (C.C.P.A. 1982).
[xxii] Eli Lilly & Co. v. Barr Laboratories, Inc., 251 F.3d 955, 968 n.5 (Fed. Cir. 2001).
[xxiii] Eli Lilly & Co. v. Barr Laboratories, Inc., 251 F.3d 955, 968 n.5 (Fed. Cir. 2001).
[xxiv] General Foods v. Studiengesellschaft Kohle, 972 F.2d 1272, 1281 (Fed. Cir. 1992); see also Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., 689 F.3d 1368, 1378-79 (Fed. Cir. 2012) (the focus of OTDP is on preventing a patentee from claiming an obvious variant of what it has previously claimed, not what it has previously disclosed); see also In re Braat, 937 F.2d 589, 594 n. 5 (Fed. Cir. 1991) (“The patent disclosure must not be used as prior art”); and In re Kaplan, 789 F.2d 1574, 1579 (Fed. Cir. 1986) (“In considering the question [of obviousness-type double patenting], the patent disclosure may not be used as prior art”).
[xxv] In re Basell Poliolefine, 547 F.3d 1371, 1378-79 (Fed. Cir. 2008).
[xxvi] Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 1387 (Fed. Cir. 2010) (citing Pfizer v. Teva Pharm, 518 F.3d 1353, 1363 (Fed. Cir. 2008), Geneva Pharmaceuticals v. Glaxosmithkline, 349 F.3d 1373, 1385-86 (Fed. Cir. 2003)).
[xxvii] Eli Lilly & Co. v. Barr Laboratories, Inc., 251 F.3d 955, 968 (Fed. Cir. 2001) (“A later patent claim is not patentably distinct from an earlier patent claim if the later claim is obvious over, or anticipated by, the earlier claim”).
[xxviii] In re Goodman, 11 F.3d 1046, 1053 (Fed. Cir. 1993) (OTDP applies where the claim of the target application or patent is generic to and thus “anticipated” by the species claim of the reference patent).
[xxix] Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1374 (Fed. Cir. 2005) (“the earlier species renders the later genus claims invalid under non-statutory double patenting”), and Eli Lilly & Co. v. Barr Laboratories, Inc., 251 F.3d 955, 968 (Fed. Cir. 2001) (citing In re Berg, 140 F.3d 1428, 1437 (Fed. Cir. 1998), as a case of OTDP where a patent application claim to a genus was anticipated by a patent claim to a species within that genus).
[xxx] Eli Lilly & Co. v. Barr Laboratories, Inc., 251 F.3d 955, 968 (Fed. Cir. 2001) (citing In re Longi, 759 F.2d 887, 896 (Fed. Cir. 1985), as a case of OTDP where the claims at issue were obvious over the subject matter of the claims in the first patent); see also Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280, 1297 (Fed. Cir. 2012) (unless the earlier claim anticipates the later claim, the question whether the two claimed compounds are patentably distinct implicates the question of obviousness, which in the chemical context requires identifying some reason that would have led a chemist to modify the earlier compound to make the later compound with a reasonable expectation of success”) (quoting In re Longi, 759 F.2d 887, 892 (Fed. Cir. 1985), and citing Takeda Chemical v. Alphapharm, 492 F.3d 1350, 1357, 1361 (Fed. Cir. 2007)).
[xxxi] In re Longi, 759 F.2d 887, 893 (Fed. Cir. 1985) (in an OTDP analysis, the relevant inquiry is “whether the claimed invention in the application for the second patent would have been obvious from the subject matter of the claims in the first patent, in light of the prior art”).
[xxxii] In re Braat, 937 F.2d 589, 594 (Fed. Cir. 1991) (citing In re Borah, 354 F.2d 1009 (C.C.P.A. 1966), and In re Stanley, 214 F.2d 151 (C.C.P.A. 1954), among other decisions).
[xxxiii] See, e.g., In re Hubbell, 709 F.3d 1140 (Fed. Cir. 2013), In re Fallaux, 564 F.3d 1313 (Fed. Cir. 2009), In re Basell Poliolefine, 547 F.3d 1371 (Fed. Cir. 2008), In re Berg, 140 F.3d 1428 (Fed. Cir. 1998), In re Emert, 124 F.3d 1458 (Fed. Cir. 1997), and In re Goodman, 11 F.3d 1046 (Fed. Cir. 1993).
[xxxiv] In re Emert, 124 F.3d 1458, 1461 n.1 (Fed. Cir. 1997) (quoting 35 U.S.C. § 116 as amended by the Patent Law Amendments Act of 1984, Pub. L. No. 98-622, 98 Stat. 3383 (1984)).
[xxxv] In re Basell Poliolefine, 547 F.3d 1371, 1375-76 (Fed. Cir. 2008) (quoting In re Berg, 140 F.3d 1428, 1432 (Fed. Cir. 1998)).
[xxxvi] In re Thorington, 418 F.2d 528 (CCPA 1969), In re Phelan, 205 F.2d 183 (CCPA 1953), In re Barber, 81 F.2d 231 (CCPA 1936), and In re Hargraves, 53 F.2d 900 (CCPA 1931); see also MPEP § 804(II)(B)(7).
[xxxvii] Carman Industries, Inc. v. Wahl, 724 F.2d 932, 940 (Fed. Cir. 1983)( “the test is whether the subject matter of the claims of the patent sought to be invalidated would have been obvious from the subject matter of the claims of the other patent, and vice versa”).
[xxxviii] Despite similar names, PTE and PTA are completely separate grounds for extending the term of a patent. PTE compensates for patent term effectively lost due to a requirement for pre-marketing regulatory review and approval (35 U.S.C. § 156). PTE was enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act). About 80-150 patents receive PTE each year. PTA compensates for patent term lost due to certain delays and proceedings within the USPTO (35 U.S.C. § 154(b)). PTA was enacted as part of the American Inventors Protection Act of 1999. Currently, over fifty percent of patents of the 300,000 plus patents issued each year receive PTA.
[xxxix] See MPEP § 804(I)(A). This MPEP section, as well as MPEP §§ 804(V) and (VI), provide guidance on the situation in there is “deemed” common ownership for OTDP purposes due to the disqualification of a reference patent as prior art under 35 U.S.C. § 102(c) on the basis of a joint research agreement.
[xl] In re Fallaux, 564 F.3d 1313, 1315 n.1 (Fed. Cir. 2009).
[xli] In re Hubbell, 709 F.3d 1140, 1146-47 (Fed. Cir. 2013).
[xlii] Immunex Corp. v. Sandoz, 964 F.3d 1049, 1059 (Fed. Cir. 2020).
[xliii] Uruguay Round Agreements Act, Pub. L. No. 103-465, 108 Stat. 4809 (1994).
[xliv] Abbvie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Trust, 764 F.3d 1366, 1373-74 (Fed. Cir. 2014) (recounting, and rejecting, patentee’s arguments that the OTDP doctrine should be discarded due to the URAA).
[xlv] Gilead Scis., Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014).
[xlvi] Gilead Scis., Inc. v. Natco Pharma Ltd., 753 F.3d 1208, 1217 (Fed. Cir. 2014).
[xlvii] Novartis Pharms. Corp. v. Breckenridge Pharm. Inc., 909 F.3d 1355 (Fed. Cir. 2018).
[xlviii] The pre-URAA patent also received a five-year (the maximum) PTE, but this was not an issue in the decision. The phrase “original expiration date” means the expiration date before any PTE is applied.
[xlix] Novartis Pharms. Corp. v. Breckenridge Pharm. Inc., 909 F.3d 1355, 1366 (Fed. Cir. 2018).
[l] MPEP § 804(I)(D) (“[w]here both the [target patent/application ] and the reference patent are post-URAA, ‘an earlier-expiring patent can qualify as an obviousness-type double patenting reference for a later-expiring patent’” (citing Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208, 1217 (Fed. Cir. 2014), as well as the explanation of Gilead in Novartis Pharms. v. Breckenridge Pharm., 909 F.3d 1355, 1360 (Fed. Cir. 2018), “[h]owever, where at least one of the [target patent/application] or the reference patent is pre-URAA, the patent with the earlier issuance date is available as a reference against a patent with a later issuance date ‘because, under the law pre-URAA, the expiration date of the patent was inextricably intertwined with the issuance date.’” (citing Novartis Pharms. v. Breckenridge Pharm., 909 F.3d 1355, 1362 (Fed. Cir. 2018)).
[li] MPEP § 804(I)(D).
[lii] Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367 (Fed. Cir. 2018).
[liii] The Federal Circuit previously held that PTE (35 U.S.C. § 156) may apply to a patent subject to a terminal disclaimer. Merck Co., v. Hi-Tech, 482 F.3d 1317, 1324 (Fed. Cir. 2007).
[liv] Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367, 1373 (Fed. Cir. 2018).
[lv] MPEP §§ 804.05 (double patenting) and 2751(I) (PTE).
[lvi] In re Cellect, 81 F.4th 1216 (Fed. Cir. 2023).
[lvii] 35 U.S.C. § 154(b)(2)(B) (“No patent the term of which has been disclaimed beyond a specified date may be adjusted under this section beyond the expiration date specified in the disclaimer”).
[lviii] In re Cellect, 81 F.4th 1216, 1228 (Fed. Cir. 2023) (“ODP [obviousness-type double patenting] and terminal disclaimers are ‘two sides of the same coin: the problem and the solution.’”) (quoting the USPTO Patent Trial and Appeal Board (PTAB) decision in Cellect).
[lix] MPEP § 1490(II).
[lx] Allergan U.S. v. MSN Labs. Private Ltd., 111 F.4th 1358, 1368-69 (Fed. Cir. 2024).
[lxi] Allergan U.S. v. MSN Labs. Private Ltd., 111 F.4th 1358, 1366 (Fed. Cir. 2024)
[lxii] Geneva Pharmaceuticals v. Glaxosmithkline, 349 F.3d 1373, 1382 (Fed. Cir. 2003) (“Given the potential windfall such [a] patent term extension could provide to a patentee, this court applies a strict test for application of [35 U.S.C] § 121”).
[lxiii] 37 C.F.R. § 1.78(d)(2).
[lxiv] Pfizer v. Teva Pharm, 518 F.3d 1353, 1362 (Fed. Cir. 2008) (stating in a continuation-in-part that “the protection afforded by section 121 . . . is limited to divisional applications”), and Amgen v. F. Hoffmann-La Roche, 580 F.3d 1340, 1353 (Fed. Cir. 2009) (stating in a continuation that 35 U.S.C § 121 “on its face applies only to divisional applications, and a continuation application . . . is not a divisional application”).
[lxv] Amgen v. F. Hoffmann-La Roche, 580 F.3d 1340, 1353-54 (Fed. Cir. 2009).
[lxvi] Gerber Garment Tech., Inc. v. Lectra Sys., Inc., 916 F.2d 683, 687 (Fed. Cir. 1990).
[lxvii] Boehringer Ingelheim Int’l GmbH v. Barr Labs, Inc., 592 F.3d 1340, 1350 (Fed. Cir. 2010).
[lxviii] St. Jude Med., Inc. v. Access Closure, Inc., 729 F.3d 1369, 1379-80 (Fed. Cir. 2013).
[lxix] MPEP § 1490(VIII)(A).
[lxx] MPEP § 1490(VIII)(A).
[lxxi] See MPEP § 1490(VIII)(A)(“The filing of a continuing application other than a CPA, while abandoning the application in which the terminal disclaimer has been filed, will typically nullify the effect of a terminal disclaimer”).
[lxxii] See MPEP § 1490(VIII)(B).
[lxxiii] In re Yamazaki, 702 F.3d 1327 (Fed. Cir. 2012).
[lxxiv] See In re Dinsmore, 757 F.3d 1343 (Fed. Cir. 2014). The MPEP formerly included a provision indicating that correction of a terminal disclaimer that inadvertently transposed digits of the reference patent number may be permitted. MPEP 1490(VIII)(B) (9th ed., 07-2015). This provision was removed in the next revision of the MPEP, apparently in response to the Federal Circuit’s decision in Dinsmore.
[lxxv] From a response by former U.S. Secretary of Defense Donald Rumsfeld to a question at a U.S. Department of Defense news briefing (“We also know there are known unknowns; that is to say we know there are some things we do not know. But there are also unknown unknowns—the ones we don’t know we don’t know.”).
[lxxvi] Federal Circuit expressly stated in Allergan that 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. Allergan U.S. v. MSN Labs. Private Ltd., 111 F.4th 1358, 1369 n.6 (Fed. Cir. 2024).
[lxxvii] KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) (35 U.S.C. § 103: obviousness); Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014), Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Bilski v. Kappos, 561 U.S. 593 (2010) (35 U.S.C. § 101: subject matter eligibility); Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014) (35 U.S.C. § 112(b): definiteness); Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., 586 U.S. 123, (2019), Pfaff v. Wells Electronics, Inc., 525 U.S. 55 (1998) (35 U.S.C. § 102: on-sale bar); Amgen Inc. v. Sanofi, 598 U.S. 594 (2023) (35 U.S.C. § 112(a): enablement).
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