USPTO Responds to GAO Report; Stewart Welcomes National Inventors Hall of Fame Inductees; CAFC Defines ‘Ground’ for IPR Estoppel Statute

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This week in Other Barks & Bites: the Federal Circuit issues several precedential decisions, including one ruling defining the “ground” that a patent validity challenger could have reasonably raised in IPR proceedings for purposes of the IPR estoppel statute; Nvidia announces that it will release a downgraded version of its H20 AI chip for the Chinese market; the U.S. Patent and Trademark Office notes that its challenges in balancing time, cost and quality in the patent examination context are “well-documented” following the GAO’s report on examination quality; the U.S. Trade Representative acknowledges that this week’s U.S.-UK trade deal will secure supply chains for U.S. pharmaceutical exports; Tesla’s “ROBOTAXI” trademark application is refused registration for being merely descriptive of the goods it will cover; an internal memo shared with news outlets shows that the government of India is thinking about reviewing copyright law within the artificial intelligence; and WHO announces a sublicensing agreement between the Medicines Patent Pool and a Nigerian diagnostics company that will increase manufacturing capacity in Africa. 

Bites

Secure Supply Chain for Pharmaceutical Products Part of U.S.-UK Trade Deal – On Thursday, May 8, government representatives from both the United States and the United Kingdom announced a trade deal between the two countries that removes longstanding barriers preventing U.S. exports from entering the UK market, including agricultural and chemical products, while leaving in place 10% reciprocal tariffs announced in early April. Although specific details from the trade deal remain unclear, the U.S. Trade Representative’s announcement of the agreement indicates that it establishes a secure supply chain for pharmaceutical products.

USPTO Acting Director Welcomes Latest National Inventors Hall of Fame Inductees – USPTO Acting Director Coke Morgan Stewart welcomed the 2025 class of inductees into the National Inventors Hall of Fame during the National Inventors Hall of Fame Illumination Ceremony on Wednesday, May 7. “This Gallery of Icons honors you — and every other inventor who has been inducted into the National Inventors Hall of Fame,” Stewart remarked. “It acts as a catalyst that prompts others to learn more about your legacies, and the many way you’ve left your mark on this world.”

CAFC Finds No Article III Standing for Incyte’s PTAB Appeal, Also Reverses Injunction – On Wednesday, May 7, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision finding that biopharmaceutical company Incyte did not establish an injury in fact for Article III standing to pursue its appeal of a post-grant review (PGR) proceeding filed at the Patent Trial and Appeal Board (PTAB) to challenge Sun Pharmaceutical’s patent claims, ruling that Incyte did not establish concrete plans to market a deuterated form of ruxolitinib at the dosage level claimed by Sun. In a concurrence, Circuit Judge Todd Hughes joined the majority’s decision because it was dictated by Federal Circuit case law, although he echoed sentiments Hughes has raised previously in other rulings that the CAFC’s Article III standing analysis in PTAB appeals is too narrow. In a separate ruling issued the same day, the Federal Circuit also reversed the District of New Jersey’s grant of injunctive relief preventing sales of Sun’s Leqselvi treatment for hair loss after finding that Incyte failed to show a likelihood of irreparable harm because its own deuterated ruxolitinib product was still in early development stages, thus the district court erred in finding that Incyte would be first to market.

CAFC Defines ‘Ground’ in IPR Estoppel Statute, Public Use Evidence Not Barred – On Wednesday, May 7, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in Ingenico Inc. v. IOENGINE, LLC affirming a District of Delaware jury verdict finding IOENGINE’s patent claims to portable devices with processors for network communications. In so ruling, the Federal Circuit for the first time defined a “ground” that a petitioner raised or reasonably could have raised in inter partes review (IPR) proceedings at the Patent Trial and Appeal Board (PTAB), finding that because arguments that an invention is on sale or is in public use are not permitted in IPR proceedings, such an assertion is permissible in district court proceedings even when the evidence of public use is duplicative of printed publications that could reasonably have been raised in parallel IPR proceedings.

CAFC Agrees With PTAB That Ad Traffic Reissue Claim Exceeds Scope of Original – On Tuesday, May 6, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in In re: Kostic affirming a decision by the Patent Trial and Appeal Board (PTAB) to sustain an examiner’s rejection of reissue patent claims covering methods of connecting websites with computer users for buying and selling click-through traffic including a trial conducted before a larger bidding and selling process. The Federal Circuit held that reissue claim 3, which recites a direct exchange of click-through traffic without a trial process, improperly broadened the scope of the original claims in violation of 35 U.S.C. § 251, affirming the PTAB’s decision below without reaching Kostic’s appeal of the PTAB’s separate obviousness determination.

Memo Shows Indian Government Mulling Changes to Copyright Law in AI Context – On Tuesday, May 6, news agency Reuters reported that it had received a memo reflecting that the government of India had set up an investigatory panel to determine whether the nation’s current copyright laws should be reshaped in the face of the advent of artificial intelligence (AI) technologies. This memo was reportedly developed in response to a copyright case against OpenAI’s ChatGPT AI platform filed by several Indian news outlets and book publishers arguing that ChatGPT has copied their works without permission.

Lumryz Injunction Falls at CAFC Due to Pre-Approval Research Harbor Under Hatch-Waxman – On Tuesday, May 6, the Federal Circuit issued a precedential decision in Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC reversing an injunction entered by the District of Delaware preventing Avadel from marketing its Lumryz treatment for idiopathic hypersomnia. The Federal Circuit found that Jazz Pharmaceuticals use of Avadel’s once-nightly formulation of sodium oxybate used to treat narcolepsy was a pre-approval research activity entitled to the safe harbor against patent infringement liability established by the Hatch-Waxman Act and codified at 35 U.S.C. § 271(e)(1).

Barks

WHO, MPP Sublicensing Agreement for Rapid Diagnostic Tests to Increase African Manufacturing – On Friday, May 9, the World Health Organization (WHO) and the Medicines Patent Pool (MPP) jointly announced a sublicensing agreement between MPP and Nigerian health technology company Codix Bio to begin manufacturing rapid diagnostic tests based upon technology transferred by South Korean diagnostics firm SD Biosensor, expanding manufacturing capacity in Africa for diagnostics technology that can be used to detect a wide range of diseases.

USPTO Announces 50K Trademark Registrations Cancelled Through Ex Parte Proceedings – On Thursday, May 8, the U.S. Patent and Trademark Office announced that 50,000 registrations had been removed from the trademark register through ex parte expungement and reexamination proceedings, most of which were initiated by the USPTO Director against registrations filed by entities linked to specimen farms, as part of the agency’s efforts to declutter the register.

USPTO Responds to GAO Report, Says Time-Cost-Quality Concerns are ‘Well-Documented’ – On Thursday, May 8, the USPTO published a response to the Government Accountability Office’s (GAO) recent report criticizing the agency for failing to maintain proper internal controls and manage its own initiatives regarding patent examination quality, noting that the issues of maintaining an “optimal balance between time, quality, and cost is a well-documented challenge that ubiquitously faces” the USPTO.

EPO and EIT Highlight Latest Innovation Efforts and Knowledge-Sharing Initiatives – On Wednesday, May 7, the European Patent Office (EPO) and the European Institute of Innovation and Technology (EIT) published a factsheet highlighting recent innovation initiatives jointly pursued by the two agencies as part of their on-going cooperation on knowledge-sharing initiatives dating back to memorandum of understanding signed in 2022.

Tesla’s “ROBOTAXI” Mark Refused Registration for Being Merely Descriptive – On Tuesday, May 6, the USPTO issued an office action refusing registration to a trademark application for “ROBOTAXI” filed by autonomous driving company Tesla after finding that the mark was merely descriptive of the automobiles and electric vehicles that the mark would cover in commerce.

EPO Announces List of 10 Young Innovators Honored as “Tomorrow Shapers” – On Tuesday, May 6, the EPO announced a list of 10 young inventors residing across five continents, including Neeka Mashouf and Leila Mashouf of the United States, who will be honored as Tomorrow Shapers during a ceremony live streamed from Reykjavik, Iceland, on June 18.

This Week on Wall Street

Nvidia to Release Downgraded Version of AI Chip to Continue Presence in China – On Friday, May 9, news reports indicated that American chipmaker Nvidia has developed plans to release a downgraded version of the company’s H20 chip for artificial intelligence and cloud computing providers in China, evading export restrictions impacting foreign exports of Nvidia’s original H20 chip.

Quarterly Earnings – The following firms identified among the IPO’s Top 300 Patent Recipients for 2024 are announcing quarterly earnings next week (2023 rank in parentheses):

• Monday: Alibaba Group Holding Ltd. (t-281st); Sharp Corp. (55th); Shimadzu Corp. (t-185th); Siemens AG (40th); Sony Group Corp. (11th); Tencent Holdings Ltd. (34th)
• Tuesday: Bayer AG (108th); Honda Motor Co., Ltd. (39th); Mitsubishi Chemicals Group Corp. (t-242nd); Nissan Motor Co., Ltd. (t-125th); Olympus Corp. (109th); Softbank Group Corp. (141st); Sumitomo Electric Industries (t-60th)
• Wednesday: Baidu, Inc. (131st); Cisco Systems, Inc. (32nd); Kyocera Corp. (57th); Ricoh Co. Ltd. (78th); Sumitomo Chemical Co. Ltd. (t-194th); Terumo Corp. (t-285th)
• Thursday: Konica Minolta, Inc. (t-217th); Merck KGaA (271st)
• Friday: None