Posts in Government

Today, the U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) published a Patient Access Report profiling the many ways in which drug pricing controls, often enacted in the name of ensuring widespread access to low-cost medicines, actually result in less access to innovative medicines that are more widely available in free markets. The GIPC’s report comes at a time during which the Biden Administration has taken recent action on drug pricing provisions included in the Inflation Reduction Act passed into law last August, which could have deleterious effects on patient access in the United States.

For well over a year, Senator Elizabeth Warren (D-MA) and some members of Congress have engaged in a campaign to urge the Health and Human Services Secretary Xavier Becerra to break patents on pharmaceuticals to lower drug prices by invoking a century-old statute, Title 28 of the U.S. Code 1498. This is their “game plan”: HHS should contract with generic drug companies willfully to infringe pharmaceutical patents, thereby requiring any damages to be paid from public funds. This strategy took a new tack in early March 2023, when the Biden Administration’s Justice Department filed a surprise “Statement of Interest” in a private lawsuit on behalf  “the Government and its Department of Health and Human Services and the Department of Defense.” The case, filed in Delaware federal court, was initiated by Arbutus Biopharma and Genevant Sciences, which allege that that patents they own were infringed by Moderna in producing its version of the COVID-19 vaccine.

This week in Washington IP news, the Senate Committee on Health, Education, Labor, and Pensions will question the CEO of Moderna about the company’s potential price hike of the COVID vaccine. In the House, the Committee on Foreign Affairs will hear from Secretary of State Antony Blinken on competition with China. Elsewhere, the Hudson Institute is holding an event one day before the Supreme Court hears oral arguments in a case that could have big implications for trademark law.

Recently, ChatGPT (Generative Pre-trained Transformer), an artificial intelligence (AI) chatbot program developed by OpenAI, has become a popular topic, attracting much attention and discussion. Its applications in the fields of natural language processing and text analysis have been well documented and have aroused great interest. It can be used to generate various language models, such as natural language texts, dialogues, and question-answering. It is currently one of the most advanced and efficient technologies in the language field. ChatGPT has a wide range of applications. In fields like medical, financial, legal, and media, ChatGPT can also be used to generate and analyze text data, thereby improving work efficiency and accuracy. Recently, the technology has even been used in the realm of intellectual property, with some having used it to draft patent applications.

Whether or not the law recognizes a machine as the inventor-at-law, the facts are indispensable to determination of the true inventor-in-fact. In the case of Stephen Thaler’s attempt to obtain patent protection for a food container and light stick he says were independently invented by his AI machine, DABUS, the inventor-in-fact will be either Thaler or his machine. The procedural posture of Thaler v. Vidal caused the discourse to jump over the facts of how the food container and the light stick were invented by DABUS. These overlooked facts may reveal the true inventor, regardless of whether or not the type of inventor is recognized by the current law. 

The U.S. Copyright Office (USCO) has announced a new statement of policy on “Works Containing Material Generated by Artificial Intelligence” that will be published in the Federal Register tomorrow, March 16. The statement comes following several recent cases that have tested the bounds of copyright protection for works generated solely or in part by AI authors. Most recently, the USCO held in a case involving a graphic novel, Zarya of the Dawn, featuring AI-generated images that the copyright registration would be limited to the text of the novel, which was the product of human authorship. The Office there explained that the “the text of the graphic novel ‘as well as the selection, coordination, and arrangement of the Work’s written and visual elements’ are protectable under copyright law” but that the images themselves were not.

There was a slight uptick in district court filings last week after a slow January and February, with 43 new patent filings, including a design patent battle involving tumblers and multiple filings indicating an association with high-volume plaintiffs such as Jeffrey Gross and Leigh Rothschild. It was a busy week at the Patent Trial and Appeal Board (PTAB), with over 32 new challenges last week, with only one procedural denial on an institution decision—but that was not based on discretionary denial, which remains often briefed but rarely successful for the time being. Of course, the big news this week was that the Federal Circuit has revived an Administrative Procedure Act (APA) challenge to the Fintiv decision on discretionary denial itself as arbitrary agency action that skirted proper procedure and had an outsized impact on a broad swath of cases.

On March 13, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision in Intel Corp. v. PACT XPP Schweiz AG reversing a final written decision of the Patent Trial and Appeal Board (PTAB) that found Intel had failed to show that PACT’s patent claims were invalid for obviousness. In reversing, the Federal Circuit ruled that the PTAB improperly rejected Intel’s “known technique” rationale supporting a motivation to combine prior art references under the flexible analysis set out by the U.S. Supreme Court’s landmark 2007 obviousness ruling in KSR v. Teleflex.

The USPTO was actively working behind the scenes to revise sections of the Manual of Patent Examining Procedure pertaining to the subject of its recent Request for Comments, including policies and procedures relating to restriction, continuation, divisional, double patenting and terminal disclaimer practice. Three days after the RFC response period ended, the USPTO announced publication of a revised version of the MPEP in the Federal Register. The revised MPEP (Ninth edition, revision 07.2022) was made retroactive to July 2022…. An analysis of the revised MPEP reveals that it contains multiple changes that not only fail to address the President’s and Senators’ concerns [patent thickets], but instead actively facilitate more “restriction thickets”.

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Monday said that Apple has standing to pursue its claim that the U.S. Patent and Trademark Office (USPTO) Director’s instructions to the Patent Trial and Appeal Board (PTAB) regarding discretionary denial practice under Apple Inc. v. Fintiv, Inc. were made without proper notice-and-comment rulemaking. The CAFC affirmed the district court’s ruling on two other challenges brought by Apple, Cisco, Intel and Edwards Lifesciences, but said that at least Apple had standing to present the challenge that the discretionary denial instructions were improperly issued and reversed on that ground. The appeal relates to Apple’s and the other companies’ challenge of the Fintiv instructions governing the PTAB’s discretion to deny institution of inter partes review (IPR) proceedings based on their contention that they will result in too many denials.

This week in Washington IP news, the Senate Judiciary Committee is considering several nominations, including for the U.S. Court of Appeals for the First Circuit. The United States Patent and Trademark Office (USPTO) is hosting a workshop about women’s mentorship in innovation and the best practices for women to overcome hurdles. Additionally, the USPTO is hosting staff from the National Medal of Technology and Innovation who will discuss the nomination process and the importance of the award.

The quality of issued patents drives the entire patent system. Valid patents fuel innovation, but invalid patents often have the opposite effect. Well-searched claims with clear boundaries, detailed disclosures with understandable teachings, and alignment with the proper statutes, rules and regulations, all contribute to a high-quality patent that an inventor can rely on and that appropriately apprises competitors and the public of the scope of the invention. Although the U.S. patent system overall is still arguably the best in the world, there is room to do things better. Instead of leading the world in issuing robust and reliable patents, we are at risk of being surpassed by China in the innovation arena. It is incontestable that many improvements to drafting and prosecuting of patent applications can be made by both the applicants and examiners to provide more certainty to the validity of issued patents.

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Thursday upheld a decision of the Trademark Trial and Appeal Board (TTAB) affirming an examiner’s refusal to register the mark OXIPURITY for chemical products. The court agreed with the TTAB that OXIUPURITY is likely to be confused with the previously registered mark, OXYPURE, for ““hydrogen peroxide intended for use in the treatment of public and private potable water systems and supplies.”

U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal has been on a tear recently, reviewing sua sponte a number of Patent Trial and Appeal Board (PTAB) decisions and designating others precedential. Many of those decisions have helped to make America Invents Act (AIA) proceedings more rigorous and fair, such as the Director’s decisions correcting the PTAB for relying on conclusory expert statements and putting at least some teeth in the real parties in interest requirement. Her most recent interventions in Commscope Technologies v. Dali Wireless IPR2022-01242 and AviaGames, Inc. v. Skillz Platform, Inc., IPR2022-00530 however, add more confusion than clarity to the Fintiv analysis, and more work for parties and the Board, without improving fairness or efficiency.