USPTO Proposes To Close Gap In Terminal Disclaimer Practice

06 January 2021 PharmaPatents Blog
Authors: Courtenay C. Brinckerhoff

The doctrine of obviousness-type double patenting is one of the most complicated and most confounding aspects of U.S. patent law. Although a Terminal Disclaimer can overcome most obviousness-type double patenting rejections, Terminal Disclaimers are not permitted in all circumstances where obviousness-type double patenting may arise. In a Federal Register Notice dated December 30, 2020, the USPTO published proposed rule changes that would close one gap in Terminal Disclaimer practice related to inventions made pursuant to joint research agreements.

Terminal Disclaimer Practice

Obviousness-type double patenting may arise when a later-expiring patent/application claims subject matter that is deemed to be an obvious variation of subject matter claimed in an earlier-expiring patent/application with the same or overlapping inventorship or ownership. To avoid an “unjust timewise extension of the right to exclude” and “the risk of multiple infringement suits by different parties,” U.S. patent law prohibits the granting (or enforcement) of the later-expiring patent/application unless a Terminal Disclaimer is filed that aligns its expiration date with that of the earlier-expiring patent/application.

The doctrine of obviousness-type double patenting is a judicially-created doctrine. Thus, the rules governing Terminal Disclaimers (set forth in 37 CFR § 321) primarily are based on Federal Circuit decisions and USPTO policies. A typical Terminal Disclaimer is filed by an entity who owns both patents/applications at issue, disclaims “the terminal part of the statutory term of any patent granted on the [subject] application which would extend beyond the expiration date of the [cited patent/application],” and includes “a provision that any patent granted on [the subject application] … shall be enforceable only for and during such period that said patent is commonly owned with the or patent which formed the basis for the judicially created double patenting.” See 37 CFR § 321(c).

Pursuant to rules implemented under the CREATE Act, patents/applications owned by different entities that raise obviousness-type double patenting issues for an invention made pursuant to a joint research agreement can be overcome by a Terminal Disclaimer that includes “a provision waiving the right to separately enforce” the patents/applications at issue and providing that any patent granted on the subject application “shall be enforceable only for and during such period that [the patents/applications at issue] are not separately enforced.” See 37 CFR § 321(d). However, the current version of that rule only applies where the patent/application cited as the obviousness-type double patenting reference “was disqualified as prior art” under the joint research agreement prior art exception (e.g., 35 USC § 102(c)). It does not apply where the cited patent/application at issue would not otherwise qualify as prior art, such as where the subject application has the same or an earlier effective filing date, or where the patents/applications have the same inventorship.

According to the Federal Register Notice, the USPTO has granted 22 petitions to waive the prior art requirement of Rule 321(d), but now seeks to change the rule itself “to avoid the unnecessary costs and delays incurred by users with the current petition process.”

The Federal Register Notice warns that the proposed changes do not eliminate “the requirement in pre-AIA 35 U.S.C. 103(c) or in 35 U.S.C. 102(c) that the claimed invention of the application or patent in which the terminal disclaimer is filed was made as a result of activities undertaken within the scope of the joint research agreement.”

The Proposed Revisions To The Terminal Disclaimer Rules

In addition to closing the joint research agreement gaps discussed above, the USPTO is proposing other changes to Rule 321 to reflect that a Terminal Disclaimer may be filed prospectively (not only in response to an obviousness-type double patenting rejection), may only be filed by the owner(s) of the whole interest in the patent/application at issue (with Terminal Disclaimers by owners of sectional interests being subject to approval by petition under Rule 182), to separately set forth requirements applicable based on an application’s filing date (including who may sign a Terminal Disclaimer), and make other changes. The text of the proposed revised rule is set forth below:

321. Disclaimers in a patent or an application by owner of the whole interest.

(a) Disclaimer of any complete claim or claims in a patent. A patentee owning the whole interest in a patent may disclaim any complete claim or claims in a patent. A notice of the disclaimer is published in the Official Gazette and attached to the printed copies of the specification. To be effective and recorded under this paragraph, the disclaimer must:

(1) Be signed by the patentee or a patent practitioner of record;
(2) Identify the patent and the complete claim or claims being disclaimed;
(3) State the present extent of the disclaimant's ownership interest in the patent. The disclaimer must be made by the owner of the whole interest in the patent;
(4) Be accompanied by the fee set forth in § 1.20(d); and
(5) Include a provision that the disclaimer is binding upon the disclaimant and its successors and assigns.

(b) Disclaimer or dedication to the public of the entire term or any terminal part of the term of a patent or any patent to be granted on an application—

(1) Terminal disclaimers or dedications filed by a patentee. A patentee owning the whole interest in a patent may disclaim or dedicate to the public the entire term, or any terminal part of the term, of the patent granted. A notice of the disclaimer is published in the Official Gazette and attached to the printed copies of the specification. To be effective and recorded under this paragraph, the terminal disclaimer must:

(i) Be signed by the patentee or a patent practitioner of record;
(ii) Identify the patent and the term of the patent that is being disclaimed. The terminal disclaimer must disclaim the entire term or any terminal part of the term of the patent;
(iii) State the present extent of the disclaimant's ownership interest in the patent. The terminal disclaimer must be made by the patentee owning the whole interest in the patent;
(iv) Be accompanied by the fee set forth in § 1.20(d); and
(v) Include a provision that the disclaimer is binding upon the disclaimant and its successors and assigns.

(2) Terminal disclaimers or dedications in applications filed under 35 U.S.C. 111(a), 363, or 385 on or after September 16, 2012. An applicant owning the whole interest in an application may disclaim or dedicate to the public the entire term, or any terminal part of the term, of a patent to be granted. To be effective and recorded under this paragraph, the terminal disclaimer must:

(i) Be signed by the applicant or a patent practitioner of record. A juristic entity who is the applicant may sign the terminal disclaimer;
(ii) Identify the application and the term of the patent to be granted that is being disclaimed. The terminal disclaimer must disclaim the entire term or any terminal part of the term of the patent to be granted;
(iii) State the present extent of the disclaimant's ownership interest in the application. The terminal disclaimer must be made by the applicant owning the whole interest in the application;
(iv) Be accompanied by the fee set forth in § 1.20(d); and
(v) Include a provision that the terminal disclaimer is binding upon the disclaimant and its successors or assigns.

(3) Terminal disclaimers or dedications in applications filed under 35 U.S.C. 111(a) or 363 before September 16, 2012. An applicant and/or assignee of record owning the whole interest in an application may disclaim or dedicate to the public the entire term, or any terminal part of the term, of a patent to be granted. To be effective and recorded under this paragraph, the terminal disclaimer must:

(i) Be signed: (A) By the applicant where the application has not been assigned; (B) By the applicant and an assignee of record where each owns an undivided part interest in the application; (C) By the assignee of record of the whole interest in the application; or (D) By a patent practitioner of record;
(ii) Identify the application and the term of the patent to be granted that is being disclaimed. A terminal disclaimer must disclaim the entire term or any terminal part of the term of the patent to be granted;
(iii) State the present extent of disclaimant's ownership interest in the application. A terminal disclaimer must be made by the owner of the whole interest in the application;
(iv) Be accompanied by the fee set forth in § 1.20(d); and
(v) Include a provision that the disclaimer is binding upon the disclaimant and its successors and assigns.

(c) Terminal disclaimer with common ownership enforcement provision to obviate nonstatutory double patenting. Except as provided for in paragraph (d) of this section, a terminal disclaimer may be filed in a patent, in a reexamination proceeding, or in a patent application to obviate nonstatutory double patenting or potential nonstatutory double patenting of a claimed invention based on a reference patent or application. To be effective and recorded under this paragraph, the terminal disclaimer must:

(1) Comply with the provisions of paragraph (b)(1), (2), or (3) of this section as applicable; and
(2) Include a provision that the patent or any patent granted on the application for which the disclaimer is filed shall be enforceable only for and during such period that the patent or any patent to be granted on the application for which the disclaimer is filed is commonly owned with the reference patent or any patent granted on the reference application whose claim(s) formed or may form the basis for the nonstatutory double patenting.

(d) Terminal disclaimer with a joint research agreement enforcement provision to obviate nonstatutory double patenting. This paragraph is only applicable for patents granted on or after December 10, 2004, reexamination proceedings of patents granted on or after December 10, 2004, and for applications pending on or after December 10, 2004.

(1) Subject to paragraph (d)(2) of this section, a terminal disclaimer may be filed in a patent, in a reexamination proceeding, or in a patent application to obviate nonstatutory double patenting or potential nonstatutory double patenting of a claimed invention based on a reference patent or application where the reference patent or application and the claimed invention are not commonly owned but are subject to a joint research agreement as defined by 35 U.S.C. 102(c) in effect on March 16, 2013 or 35 U.S.C. 103(c)(2) in effect on March 15, 2013. To be effective and recorded under this paragraph, the terminal disclaimer must:

(i) Comply with the provisions of paragraph (b)(1), (2), or (3) of this section as appropriate; and
(ii) Include a provision waiving the right to separately enforce the patent or any patent granted on the application for which the disclaimer is filed and the reference patent or any patent granted on the reference application whose claim(s) formed or may form the basis for the nonstatutory double patenting, and agreeing that the patent or any patent granted on the application for which the disclaimer is filed shall be enforceable only for and during such period that the patent or any patent granted on the application for which the terminal disclaimer is filed and the reference patent or any patent granted on the reference application are not separately enforced.

(2) A terminal disclaimer may be filed under paragraph (d)(1) of this section if the requirements of paragraph (d)(2)(i) or (ii), as applicable, have been met.

(i) For applications or patents subject to 35 U.S.C. 102 in effect on March 16, 2013.

(A) The applicant or patent owner provides, or has provided, a statement to the effect that the subject matter of the reference patent or application was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement, within the meaning of 35 U.S.C. 100(h) and § 1.9(e), that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and

(B) The application for patent, or the patent, for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement in accordance with § 1.71(g).

(ii) For applications or patents subject to 35 U.S.C. 102 in effect prior to March 16, 2013.

(A) The applicant or patent owner provides, or has provided, a statement to the effect that the subject matter of the reference patent or application and the claimed invention were made by or on behalf of the parties to a joint research agreement, within the meaning of 35 U.S.C. 100(h) and § 1.9(e), that was in effect on or before the date the claimed invention was made, and that the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and

(B) The application for patent, or the patent, for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement in accordance with § 1.71(g).

(e) Submission of a disclaimer during an interference under subpart E of part 41 or a proceeding under part 42. A disclaimer of a complete claim or claims, or a disclaimer of the entire term or terminal part of the term (terminal disclaimer) under this section, of a patent involved in an interference under subpart E of part 41 of this chapter or a proceeding under part 42 of this chapter may not be entered into the official file or considered, or if inadvertently entered, will be expunged unless a motion requesting to file the disclaimer under §§ 41.121(a)(2), 41.121(a)(3), or 42.20 of this chapter has been granted.

That sure simplifies things, doesn’t it?

Portal For Submission of Public Comments

According to the Notice, the USPTO only will consider comments “submitted through the Federal eRulemaking Portal at https://www.regulations.gov” with reference to docket number PTO-P-2020-0015. Comments must be posted by March 22, 2021.

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