On May 10, 2024, the U.S. Patent and Trademark Office announced a proposed rule change to terminal disclaimer practice.[1] Unfortunately, the proposed change appears to further weaken issued patents in which terminal disclaimers have been filed and make obtaining robust patent protection more difficult and uncertain in the future.

Present Nonstatutory Double Patenting / Terminal Disclaimer Practice

One type of rejection a patent examiner can issue during pendency of a patent application is a nonstatutory double patenting rejection (sometimes called an "obviousness-type double patent rejection" or a "judicially created double patenting rejection").[2] These rejections are "based on a judicially created doctrine grounded in public policy and which is primarily intended to prevent prolongation of the patent term by prohibiting claims in a second patent not patentably distinct from claims in a first patent" and traditionally arise when a subsequent asset (e.g., a patent application) has claims that are, in the patent examiner's eyes, obvious over a prior asset (e.g., a prior patent).[3] Further, nonstatutory double patenting can be used after the fact (e.g., in litigation) as a grounds on which to invalidate a patent.

One way of overcoming nonstatutory double patenting rejections is by filing a terminal disclaimer.[4] The terminal disclaimer must include "a provision that any patent granted on that application . . . shall be enforceable only for . . . such period that said patent is commonly owned with the application or patent which formed the basis for the judicially created double patenting."[5] In other words, both the application in which the terminal disclaimer is being filed and the reference patent must permanently remain commonly owned. If they do not, any patent that issues from the application will essentially be rendered worthless. This is typically referred to as the "common ownership requirement" for terminal disclaimers.[6]

Proposed Change

In the proposed rule change to 37 C.F.R. § 1.321, the USPTO is considering adding another requirement for a terminal disclaimer to be used to overcome nonstatutory double patenting rejections (in addition to the common ownership requirement). Namely, under the proposed rule, the terminal disclaimer would also need to "include an agreement . . . that the patent in which the terminal disclaimer is filed, or any patent granted on an application in which a terminal disclaimer is filed, will be enforceable only if the patent is not tied and has never been tied directly or indirectly to a patent by one or more terminal disclaimers filed to obviate nonstatutory double patenting rejections in which: any claim has been finally held unpatentable or invalid as anticipated or obvious by a Federal court in a civil action or by the USPTO . . . or a statutory disclaimer of a claim is filed after any challenge based on anticipation or obviousness to that claim has been made."[7] According to the USPTO, the proposed rule is being made to "promote innovation and competition by allowing a competitor to avoid enforcement of patents tied by one or more terminal disclaimers to another patent having a claim . . . held unpatentable."[8]

Essentially, what this means is that, if a patentee has multiple patents tied together by terminal disclaimers, a competitor would only need to successfully invalidate one claim in one of those patents based on prior art in order to render all of the patents invalid. To highlight what a dramatic shift this represents, let's take an example. Assume the following (which represents a relatively common occurrence in a traditional patent family involving multiple assets):

1. Patentee owns Patent X, Patent Y, and Patent Z;
2. During prosecution of Application Y (now Patent Y), the examiner gave a nonstatutory double patenting rejection over Patent X, so the patentee filed a terminal disclaimer in Application Y (now Patent Y) over Patent X; and
3. Likewise, during prosecution of Application Z (now Patent Z), the examiner gave a nonstatutory double patenting rejection over Patent Y, so the patentee filed a terminal disclaimer in Application Z (now Patent Z) over Patent Y.

Under the current regime, a challenger would need to separately successfully challenge each of Patent X, Patent Y, and Patent Z (e.g., in district court or in an inter partes review or post-grant review before the Patent Trial and Appeal Board (PTAB)) in order to render each of Patent X, Patent Y, and Patent Z invalid. Under the proposed rule change, though, the challenger would only need to successfully demonstrate that just one claim of Patent X is invalid over the prior art in order to automatically render all claims of Patent Y and Patent Z unenforceable.[9] This is true even if the invalidated claim in Patent X is broader in all aspects than every claim in Patents Y and Z.

Commentary

This proposed change would substantially weaken a patent in which a terminal disclaimer is filed, since the patent's enforceability would be predicated entirely on the enforceability over the prior art of a separate patent over which the terminal disclaimer is filed. Such a fundamental change to the patent system would be problematic.

i) No Quid Pro Quo

First, this change lacks sufficient quid pro quo to be justified. One impetus provided from the USPTO for this proposed change is that, presently, "multiple patents tied by terminal disclaimers that are directed to obvious variants of an invention could deter competition due to prohibitive cost of challenging each patent separately in litigation or administrative proceedings."[10] While it is certainly true that, under the current terminal disclaimer regime, patents tied together by terminal disclaimers need to be challenged separately to render each of them invalid, it is also true that they need to be asserted separately. In other words, demonstrating that a defendant has infringed one patent does not automatically lead to a finding of infringement over a related patent simply because there is a terminal disclaimer in place between the two patents. Instead, the elements of the claims in each respective patent much be proved up separately against the putative infringer. Under this proposed change, the paradigm would shift to being imbalanced. While the burden would still be on the patentee to prove infringement in each and every patent separately, a purported infringer may only need to invalidate a single patent to automatically render an entire swath of patents unenforceable.

Likewise, an issued patent only confers protection against infringement of what is claimed, but notably does not confer protection against infringement of all obvious variations of the claims.[11] Instead, to obtain protection of an obvious variation, a patentee must pay to file, prosecute, and have issued another patent with a different set of claims (not to mention paying maintenance fees on the subsequent patent). Why, then, should an opponent be able to invalidate a patent without also having to address each patent on its own terms (rather than simply challenging the weakest link in the chain)? As pointed out by some commentary previously provided to the USPTO, this raises some real concerns regarding the patentee's due process rights.[12]

ii) The Issues are Compounded by Recent Changes in Jurisprudence and Other Proposed Changes by the USPTO

Obviously, this proposed change does not occur in a vacuum, but is accompanied by everything else swirling around in the world of patent law. Two other recent issues are also worth noting here. First is the recent Federal Circuit decision in In re Cellect and second is the recent fee changes proposed by the USPTO.

This blog has recently provided some insight on (and discussed the issues with) the In re Cellect decision.[13] I also recently wrote a piece about practice steps that patentees / applicants can take to protect themselves against the fallout of the decision.[14] To briefly summarize the primary result of that case, post In re Cellect, patentees can be put in the situation where patents with the same effective filing date can be used as prior art against one another for nonstatutory double patenting purposes based on the amount of patent term adjustment (PTA) awarded. To be as safe as possible, and as I proposed in my post referenced above, patentees may want to consider filing proactive and/or bespoke terminal disclaimers. This already seemed unduly onerous on the patentee (especially given that later-issued patent may result in invalidation of a prior-issued patent based solely on PTA, meaning that the patentee may need to retroactively file a terminal disclaimer in the prior-issued patent).

However, this situation gets even worse when compounded with this proposed rule change from the USPTO. Now, assuming two patents are even arguably obvious variations over one another, the patentee will be given a "Sophie's choice." On one hand, the patentee can choose to file a terminal disclaimer of the patent with additional PTA over the patent with less PTA, which will protect them against the In re Cellect issue but will expose them to the vulnerabilities resulting from this proposed new terminal disclaimer rule (should the patent with less PTA be deemed invalid). On the other hand, the patentee can refrain from filing a terminal disclaimer in the patent with additional PTA so as not to risk the vagaries of this new terminal disclaimer rule, but the patentee then will then risk invalidation based on PTA differences under In re Cellect should the patent with additional PTA be determined to be an obvious variant of the patent with less PTA. This is effectively a lose-lose decision.

Additionally, the USPTO recently proposed a set of fee changes.[15] There are many changes proposed by the PTO therein, but I merely wish to highlight the proposed changes to the terminal disclaimer fee structure. The fees for filing a terminal disclaimer are proposedly increasing by anywhere from 18% (if an applicant files a terminal disclaimer prior to a first action on the merits) to 724% (if an applicant files a terminal disclaimer in an issued patent). This quite clearly indicates the USPTO's desire to encourage applicants / patentees to file terminal disclaimers proactively and early in prosecution. It presents an interesting dichotomy that the USPTO is simultaneously encourage applicants to file terminal disclaimers early and often (with the proposed fee changes) while also severely increasing the risk associated with filing terminal disclaimers (with this proposed change). Further, even if an applicant ultimately does decide to file a terminal disclaimer, the applicant is clearly paying more (in terms of raw fees) and getting less (in terms of the value of the terminally disclaimed patent in light of the new risks invited by this rule change).

iii) Practical Implications

Lastly, I'd like to highlight some practical implications that are created as a result of this new rule change. As a result of the risks posed by terminally disclaimed patents under the new rule, applicants are likely to seek other ways of addressing nonstatutory double patenting rejections (rather than filing terminal disclaimers almost as a matter of course for expediency, as many applicants do currently). The USPTO even provides some ways applicants might do so.[16] The suggestions provided by the USPTO range from self-evident ("cancel[] or amend[] any conflicting claims in the application or in the other application containing the conflicting claims that formed the basis of the nonstatutory double patenting") to unhelpfully thermonuclear ("fil[e] a reissue application of the patent whose claims formed the basis of the nonstatutory double patenting in order to add canceled conflicting claims from the application into the reissue application, provided that the added claims do not introduce new matter into the reissue application").

I think that the most realistic course of action an applicant will take will be to either amend their claims in a fashion that gets around the nonstatutory double patenting rejections or argue the nonstatutory double patenting rejection on the merits. The former option is, at the very least, undesirable. The latter option, on the other hand, puts applicant in the unenviable position of being forced to characterize their own reference on the record. Ideally, under the new rule, examiners would put more effort into determining whether or not a nonstatutory double patenting rejection should apply (so that applicants aren't unnecessarily forced to make such a touch decision). However, I have not seen any evidence from the USPTO indicating that they will adjust how they instruct examiners to identify and issue nonstatutory double patenting rejections as a result of this proposed change.

Conclusion

This proposed rule change strikes me as counterproductive to the exact purposes the USPTO is purporting to advance with it (namely, to "promote innovation"). The Federal Circuit, itself, has said that a terminal disclaimer does not give rise to the presumption that two patents are patentably indistinct.[17] Given all this, it seems like an incredibly bold and unnecessary step for the USPTO to promulgate this rule change. Between the issues inherent with this proposed rule change and the result in In re Cellect, it may be time for Congress (rather than the judicial branch and the executive branch) to weigh-in substantively on nonstatutory double patenting rejections and terminal disclaimer practice.

Comments on this proposed rule change are being accepted by the USPTO until July 9, 2024.[18] It will certainly be interesting to see how the public responds and what the USPTO does about it.

[1] Full text of the proposed rule change can be found at https://www.federalregister.gov/public-inspection/2024-10166/terminal-disclaimer-practice-to-obviate-nonstatutory-double-patenting.

[2] See the following for a full discussion of nonstatutory double patenting rejections -- https://www.uspto.gov/web/offices/pac/mpep/s804.html.

[3] M.P.E.P. § 804

[4] 37 C.F.R. § 1.321

[5] 37 C.F.R. § 1.321(c)(3)

[6] The "common ownership requirement" is obviously in addition to the inherent effect of a terminal disclaimer that limits any term of the disclaimed patent that would extend beyond the term of the patent over which it is disclaimed.

[7] https://www.federalregister.gov/documents/2024/05/10/2024-10166/terminal-disclaimer-practice-to-obviate-nonstatutory-double-patenting. In addition to the substantive changes, it might be of interest to some that the USPTO is also proposing changing the C.F.R.'s wording from the phrase "judicially created double patenting" to "nonstatutory double patenting." This change, at least, is a positive in my view, as it brings the terminology of the C.F.R. into better conformance with the terminology of the M.P.E.P.

[8] https://www.federalregister.gov/documents/2024/05/10/2024-10166/terminal-disclaimer-practice-to-obviate-nonstatutory-double-patenting

[9] This example of cascading unenforceability is similar to Example 2 discussed in the proposed rule change. It illustrates so-called "direct tying" under the proposed rule change between Patent X and Patent Y and "indirect tying" under the proposed rule change between Patent X and Patent Z. Note, however, that the rendering of unenforceability remains unidirectional, even under the proposed new rule. In other words, under this hypothetical, it wouldn't be sufficient to demonstrate that Patent Z is invalid in order to render Patent X or Patent Y unenforceable. See, e.g., https://www.federalregister.gov/documents/2024/05/10/2024-10166/terminal-disclaimer-practice-to-obviate-nonstatutory-double-patenting ("As is the case under current practice, a terminal disclaimer under the proposed rule would be unidirectional, encumbering only the patent with the terminal disclaimer and not the conflicting patent.")

[10] https://www.federalregister.gov/documents/2024/05/10/2024-10166/terminal-disclaimer-practice-to-obviate-nonstatutory-double-patenting

[11] A patentee does ostensibly get protection of a slightly broader range of things than is literally described in the claims under the Doctrine of Equivalents. See, e.g., Warner-Jenkinson Co. v. Hilton Davis Chemical Co. (1997). However, the coverage under Doctrine of Equivalents is certainly not so broad as to cover all obvious variants (and, instead, only covers "insubstantial" differences relative to the claimed invention).

[12] See Request for Comments on USPTO Initiatives To Ensure the Robustness and Reliability of Patent Rights, 87 FR 60130 (October 4, 2022); https://www.federalregister.gov/documents/2024/05/10/2024-10166/terminal-disclaimer-practice-to-obviate-nonstatutory-double-patenting.

[13] https://www.patentdocs.org/2023/10/overcoming-the-consequences-of-in-re-cellect.html

[14] https://www.mbhb.com/intelligence/snippets/living-with-cellect-three-best-practices/

[15] https://www.federalregister.gov/documents/2024/04/03/2024-06250/setting-and-adjusting-patent-fees-during-fiscal-year-2025

[16] https://www.federalregister.gov/documents/2024/05/10/2024-10166/terminal-disclaimer-practice-to-obviate-nonstatutory-double-patenting

[17] SimpleAir, Inc. v. Google LLC (Fed. Cir. 2018).

[18] Comments may be submitted at https://www.regulations.gov/.

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