Global U.S. Patent Standing Falls Due to Judicially-Created Patent Law

The United States is the only country in the world where the judiciary forces patent term truncation over unrelated patent families. In Europe, China, and most other nations, the patent laws provide a “novelty only” standard for patent applications filed before the publication of a different earlier filed patent application, and a “novelty and inventive step” standard for patent applications filed after the publication of an earlier filed patent application. The law in virtually every country outside the United States works well using this framework.

The United States is also the only country in the world where the judiciary forces patent applicants to submit a disclaimer of the terminal portion of its patent over another owned patent application or patent as an involuntary requirement to obtain patents either within a family that shares a priority date, or among those that do not share a priority date.

And the United States is the only major country in the world where the judiciary creates new patent law without statutory authorization. Two of the most damaging examples of this judicial legislation are the patent eligibility doctrine and the United States’ labyrinthine law on obviousness-type double patenting (ODP). ODP is a “judicially created (i.e., unauthorized by Congress and thus unconstitutional), non-statutory (i.e., unauthorized by Congress and thus unconstitutional), doctrine (i.e., Congress doesn’t pass doctrines, so this is not a Congressional law). To be accurate, we refer to this as “JCNSODP”. The U.S. judicial branch actually named the terminal disclaimer doctrine itself, which has been a massive admission against interest for the courts. (see e.g., In re Longi, 759 F.2d 887, 892 (Fed. Cir. 1985) “Obviousness-type double patenting is a judicially created doctrine grounded in public policy”; Novartis v. Ezra, 909 F.3d 1367, 1375 (Fed. Cir. 2018) and MPEP 804).

Global Indicators

The U.S. Chamber of Commerce Global Innovation Policy Center released the Fourteenth Edition of its International IP Index in March 2026, which is a major piece of work that we appreciate. The Chamber Index assessed 55 economies across 53 criteria in ten categories of IP, including patents. The patent category measures the strength of Patent Rights and Limitations over 9 indicators. Among the 9 categories relevant to this post are Term of Protection and Patentability Requirements. The United States received a 0.75 out of 1.0 on patentability requirements, and in the associated notes the Chamber referred to the judicial policies on patent eligibility as a cause for the less than stellar score. The Chamber Index patent indicators do not currently include a score for (i) whether the country’s judiciary follows its own country’s statutory patent laws in how it decides cases or whether it creates law; and does not include an indicator for (ii) whether the country’s patent office or judiciary truncates patent term based on non-statutory policy grounds. The United States would get a “0” in each of these indicators if accurately included. We recommend the Chamber consider adding these critical indicators to the 2027 Index, so that the U.S. patent regime can be more accurately assessed and compared. These indicators would demonstrate that the U.S. global patent standing is in fact below other major countries due to judicial patent law creation and patent term truncation.

Congress Attempts to Lower U.S. Global Patent Rankings

Under “Key Areas of Weakness” of the U.S. patent system, the Chamber Index mentions “Congressional bills seek to limit the number of patents a rights holder may assert in an infringement action; specifically targets biopharmaceuticals”. This is a forward-looking concern.

We all remember when, on June 8, 2022, former Senator Patrick Leahy (D-VT), Senators Richard Blumenthal (D-CT), Amy Klobuchar (D-MN), John Cornyn (R-TX), Susan Collins (R-ME), and former Senator Mike Braun (R-IN) sent a letter to the U.S. Patent and Trademark Office (USPTO), based on the now completely debunked I-MAK patent analysis that requested action on continuation practice and questioned whether terminal disclaimers should continue to be used to permit patents on what they assumed without evidence were “obvious variations” of existing inventions. The authors posted an IPWD article addressing this (“Let’s Do Something about the Unauthorized Doctrine of Non-statutory Judicially Created Obviousness-Type Double Patenting Doctrine; Sept. 6, 2022). The effort, correctly, did not proceed.

Then, the USPTO, in May 2024, under Director Kathi Vidal, published a Notice of Proposed Rulemaking (89 Fed. Reg. 40439) that would have forced draconian changes to terminal disclaimer regulations that would have caused immense damage to innovators. (See Knowles, “USPTO Steps in for Congress to Attempt to Legislate on Terminal Disclaimers”; IPWD May 14, 2024). This effort by Director Vidal died when she withdrew the Notice as she was leaving the USPTO.

Yet again, on May 8, 2025, Representatives Jodey Arrington (R-TX), Lloyd Doggett (D-TX), Darrell Issa (R-CA), Pramila Jayapal (D-WA), and August Lee Pfluger (R-TX) have now introduced the Eliminating Thickets to Increase Competition Act, or “ETHIC Act” to the House of Representatives (H.R. 3269). In July, Senators Peter Welch (D-VT), Josh Hawley (R-MO), and Klobuchar introduced the corresponding “ETHIC Act” in the Senate (S. 2276). The bill targets the purported negative effect on infringers of litigating patents that are terminally disclaimed over each other. Under this U.S. global ranking-sinking proposal, patents linked by terminal disclaimers would be treated as a single patent group for purposes of Hatch-Waxman and biosimilar litigation, substantially limiting the number of patents that could be asserted against generic and biosimilar infringers. The consequence would be to take away the property rights of inventors in their patents, based on laws that do not exist anywhere else in the world. It would severely weaken patent protection for pharmaceutical products in the United States by retroactively punishing innovators for involuntary compliance with JCNSOTP rejections. This bill is currently being debated by the House Judiciary’s Subcommittee on Courts, Intellectual Property, Artificial Intelligence, and the Internet. Now is the time to reach out to your representatives in Congress and yet again loudly oppose this effort. 

The USPTO Tries to Make Sense of the Nonsensical

The USPTO is again currently considering the scope of double patenting in view of the judicially created, more benign, Federal Circuit law in Allergan v. MSN. Several panels of Patent Trial and Appeal Board (PTAB) judges have interpreted the Allergan decision to limit JCNSODP rejections to situations where “an actual unjustified extension of time” would occur if the JCNSODP rejection was not raised. The Allergan decision rules that an application in the same family or in a later filed patent family cannot be used as a JCNSODP reference against an earlier patent because there is no “unjustified extension of time” in those situations. A representative PTAB decision that applied this framework, Ex parte Baurin, was recently selected for review by the Appeals Review Panel (ARP). This is only the third time the ARP has considered overturning a PTAB decision. The USPTO’s interest to address the scope of JCNSODP is further evidenced by the request for Amicus Briefs, which were due March 27, 2026 (See IPWD post “Amicus, Sanofi Urge USPTO Appeals Panel to  Uphold Ex Parte Baurin’s Approach to ODP”).

The Federal Circuit Continues to Create Law

When we initially began preparing this article, we expected the ARP decision to issue on or around June 3. That expectation was informed in part by the parallel timing of the Federal Circuit appeal in In re Ablynx which addresses a PTAB Panel’s decision on very similar facts as Ex Parte Baurin but instead reached the opposite conclusion, upholding a JCNSODP rejection even where there was “no unjustified extension of time”. The Director’s response brief in Ablynx was originally due on June 3, 2026.

That timeline has changed. On May 27, 2026, the USPTO filed an unopposed motion seeking a 65-day extension of time to file the Director’s brief, moving the due date from June 3, 2026, to August 7, 2026. While there is no requirement that the ARP decision and brief in Ablynx be coordinated, they address nearly identical facts, so the decision by the USPTO in one (for example to uphold the PTAB decision in Baurin) should directly influence the USPTO’s rhetoric in the other (for example to choose to not vigorously argue for expanded JCNSODP in Ablynx).

The Federal Circuit is collecting amicus curiae briefs on how they can further create or modify the unauthorized judicial law in Ablynx. Substantial deliberations will not occur until after the USPTO’s brief is submitted in August. The fact that the USPTO and the Solicitor’s Office has asked for an extension of time to submit its brief in Ablynx is not surprising given that there is no statutory law on the issues it is briefing, so the arguments by necessity have to try to comply with the judicial creation of law as it bobs and weaves. It would be very refreshing if the USPTO had the courage to state directly that these issues fall at the untethered whim of the Federal Circuit’s fancy.

The PTAB decision at issue in Ablynx (Ex parte Baumeister, Appeal 2026-000193) relied on old judicial case law that dealt with fact patterns that largely cease to exist in modern patent practice. For example, the PTAB panel extensively relied on in re Fallaux which allegedly contains “a similar fact pattern to the instant case.”  But the Fallaux decision is largely focused on whether the two-way or one-way test should be applied for the ODP rejection of the Fallaux claims and not whether, under even their own judicially created law, the reference patents were an appropriate basis for an JCNSODP rejection. In re Fallaux, 564 F.3d 1313, 1319 (Fed. Cir. 2009). Notably, the two-way test is not at issue in the JCNSODP rejections of Baumeister, Baurin or Allergan. Additionally, to the extent that Fallaux is inconsistent with Allergan it is Allergan judicial law that at least controls the Federal Circuit. Articles carefully dissecting these old OTDP cases should be published to help the Federal Circuit with its own unauthorized judicial lawmaking to reach a conclusion in Ablynx that at least supports innovation in the U.S.

Major Increase in JCNSODP Rejections at the USPTO

Meanwhile, JCNSODP rejections, especially across different patent families, are increasing so quickly during U.S. patent prosecution in the pharma and biotech sectors that it appears orchestrated. One explanation for this increase might be a USPTO policy of growing integration of artificial intelligence.

On August 14, 2025, the USPTO announced that SimSearch “another USPTO AI-assisted examination tool” was “ready for prime time”. SimSearch has been in use at the USPTO since September 2022 and it and related tools in the Patents End-to-End (PE2E) Search Tool review application text to generate an AI search query and provide ranked search results. The Search Tool is getting increasingly broad at identifying related applications with overlapping claims because by use of AI, the tool is constantly becoming more robust (but not necessarily better). Originally, use of SimSearch and related tools was optional, but on October 24, 2025, the USPTO issued an internal communication announcing that Examiners are now required to use similarity searching for patent examination. The USPTO memo states that the use of AI searching will be noted in Examiner search results, but we have not seen widespread adoption of this notice. Instead, many Office Actions now include search history queries where 6+ lines of searches are generated and ran in minutes and often the searches center first on Inventor and Applicant name and then on prior art related queries. While these search strings are not marked “AI Generated” it seems unlikely that examiners are routinely typing 6+ complex search strings within minutes. The initial focus on Inventor and Applicant names instead of chemical structure for a chemical invention is also telling. We expect the increased trend towards issuing 10+ pages of JCNSODP rejections to continue until meaningful policy change is made.

The USPTO open data portal also currently lacks a function to filter patents and applications with JCNSODP rejections in the Office Action. Determining the number of JCNSODP rejections in each OA, whether the JCNSODP reference is within the same patent family or different patent family and whether additional references are cited in JCNSODP rejections still require manual review so is hard and cumbersome to track. In 21 randomly chosen pharma Office Actions, we noted an average of 67%, or two-thirds, of the pages of the Office Actions were directed to JCNSOPD rejections. Of these 21 Office Actions, 62% included at least one JCNSODP rejection to a patent (application) not in the same patent family, and 29% include at least one ODP rejection combined with other art.

Let’s Protect Our Innovators, not Infringers

As we approach the 250^th birthday of our country, it is time to reflect on the basic structure of government embedded in the Constitution as it pertains to our patent system as a motivator of progress. The fact that the well-meaning Patent Eligibility Restoration Act (PERA) was used to sneak in a quiet Section 4(a) as an indirect ratification of judicially created non-statutory double patenting law confirms even Congress knows that JCNSODP as it currently stands is unauthorized by Congress. While PERA has been considered a potential thank-you to Senator Thom Tillis (R-NC) for solid work on IP while in office, if PERA does not advance, Senator Tillis may have fortunately escaped the opposite legacy of being responsible for ratifying a doctrine that does not exist anywhere else in the world and that would have cemented the United States’ position in a patent race to the bottom. The authors applaud Senator Tillis’ and others’ work advancing patent eligibility reform and hope that PERA is amended and then passed without Section 4(a).

The concerns raised by this article are not academic. We stand at a crossroad on JCNSODP and we must make our voices heard to change course and improve America’s competitive edge. Congress, the Federal Circuit and the USPTO are all considering policies that can reduce the United States’ global patent ranking. Please celebrate the semiquincentennial anniversary of the United States, the greatest country ever in the authors’ opinion, by defending innovation and inventors, who collectively made this country what it is.