Posts Tagged: "innovation"

The U.S. Patent and Trademark Office (USPTO) recently released new guidance for practitioners using artificial intelligence (AI)-based tools. The guidance primarily serves as a reminder of longstanding requirements and best practices for patent and trademark practitioners. For example, patent practitioners have a duty of candor and good faith to the USPTO and a duty of confidentiality to their clients. The guidance does not announce any new law or rule regarding practicing before the Office;  rather, it provides some insight into how the Office expects practitioners to operate when incorporating AI-based tools into their practice.

On April 30, the Federal Trade Commission (FTC) announced that it was expanding its campaign against allegedly improper patent listings in the U.S. Food & Drug Administration’s (FDA) Orange Book. In letters to 10 pharmaceutical companies, the FTC disputed the relevancy of more than 300 patents protecting aspects of drugs that have received market approval from the FDA. While the FTC claims that such action is necessary to improve Americans’ access to affordable prescription drugs, pharmaceutical industry representatives have questioned the propriety of this enforcement campaign given two decades of requests from industry stakeholders for greater clarity on Orange Book listings.

The U.S. Senate Judiciary Committee’s Subcommittee on Intellectual Property met today to hear from six witnesses about a recently-proposed bill to curb unauthorized uses via artificial intelligence (AI) of an individual’s voice and likeness.   The “Nurture Originals, Foster Art, and Keep Entertainment Safe Act of 2023” (NO FAKES Act) was introduced in October 2023 by Senator and Chair of the IP Subcommittee Chris Coons (D-DE) and Senators Marsha Blackburn (R-TN), Amy Klobuchar (D-MN), and Thom Tillis (R-NC). The goal of the bill is to “protect the voice and visual likenesses of individuals from unfair use through generative artificial intelligence (GAI).”

President Biden issued an executive order (EO) on artificial intelligence on October 30, 2023,  announcing a series of agency directives for managing risks related to the use of AI technologies. Now, the Department of Commerce (DOC) has announced several new actions aimed at implementing that order. On Monday, April 29, the DOC said the National Institute of Standards and Technology (NIST) has released four draft publications on improving safety and security of AI technologies and also launched a program that will help to distinguish between content produced by humans and content produced by AI. Additionally, the U.S. Patent and Trademark Office (USPTO) today published a request for comment (RFC) on “how AI could affect evaluations of how the level of ordinary skills in the arts are made to determine if an invention is patentable under U.S. law.”

When the Center for Strategic and International Studies recently hosted a forum on IP, innovation, national security and geopolitical competition, there was an active discussion about the role of IP – intellectual property – in achieving those other outcomes. An interesting debate emerged over the words that describe those IP functions, suggesting that policy can be ill-served by some habitually used, but perhaps not descriptively accurate, vocabulary. The upshot: words matter.  

GlaxoSmithKline filed a four-count civil action for patent infringement in the United States District Court for the District of Delaware late last week seeking damages for Pfizer and BioNTech’s infringing manufacture, use, sale and marketing of both the original “monovalent” and “bivalent” Comirnaty COVID-19 vaccines. The COVID-19 vaccine was quickly rolled out compared to other vaccines in the past and many pharmaceutical companies benefited financially. However, GSK contends their competitors, Pfizer Inc. and Pharmacia & Upjohn Co. LLC (collectively Pfizer) and BioNTech SE, BioNTech Manufacturing GMBH and BioNTech US Inc. (collectively BioNTech) developed their vaccines with GSK’s patented inventions created about a decade earlier.

Late last year, , the United States International Trade Commission (ITC) announced that it would issue a limited exclusion order (LEO) and cease and desist order (CDO) against Apple, Inc. prohibiting Apple from importing and selling its Apple Watch (Series 6 and 7) products in the United States. The case was Certain Light-Based Physiological Measurement Devices and Components Thereof, Investigation No. 337-TA-1276 (“Light-Based Physiological Measurement Devices”), a “Section 337” patent infringement investigation before the ITC that was initiated by Masimo Corporation. Adding insult to injury, the ITC refused to stay these remedial orders pending appeal, putting at immediate risk continued sales of the Apple Watch in the United States. These decisions sent shock waves across both the tech industry and the legal community.

The World Intellectual Property Organization (WIPO) established World IP Day (WIPD) 19 years ago to celebrate the day on which the WIPO Convention entered into force: April 26, 1970. And this year, WIPO has set as the theme for World IP Day 2024, “IP and the SDGs: Building our common future with innovation and creativity.” According to WIPO’s website, in order to reach the United Nations’ Sustainable Development Goals (SDGs), “we need to re-think how we live, work and play.” Intellectual property is, of course, a major part of this as the engine for “innovative and creative solutions that are so crucial to building our common future.”

On April 19, the World Health Organization (WHO) released an updated draft proposal of an international agreement on the global response to future pandemics. While the WHO pandemic agreement has been met with widespread support from many of the international agency’s member nations, including the United States, it retains provisions limiting intellectual property (IP) rights that have encouraged opposition from lawmakers and pharmaceutical innovators alike.

As the hit sitcom Young Sheldon comes to an end next month, a look back at the series offers an opportunity for young inventors to learn about inventorship. The coming-of-age show centers around a boy genius, Sheldon, who has run the gamut of growing up in expedited fashion—experiencing high school, college dorm life, and even a first (failed) kiss (attempt), all before being eligible to drive. Another milestone in Sheldon’s life—his first inventorship dispute—shows that it doesn’t take a boy genius to become a young inventor.

On April 16, the U.S. Department of Commerce announced that the Biden Administration had issued a notice of funding opportunity (NOFO) earmarking $54 million in funds available under the CHIPS and Science Act to fund advances in measurement technologies critical to semiconductor production. These funds, administered via grant through the Small Business Innovation Research (SBIR) program, are expected to improve U.S. leadership in computer chip manufacturing by mitigating production defects and increasing production yields.

On April 9, Knowledge Ecology International (KEI), the Union for Affordable Cancer Treatment (UACT) and Universities Allied for Essential Medicines (UAEM) sent a letter to Chiquita Brooks-LaSure, Administrator for the Centers for Medicare and Medicaid Services, requesting that CMS use alleged statutory authority to allow companies to make and sell generic versions of the blockbuster prostate cancer drug, Xtandi®. The letter comes two months after the Department of Health and Human Services (HHS) denied an appeal of a decision not to march in on the drug under 35 USC §203.

The U.S. Patent and Trademark Office (USPTO) today announced guidance for practitioners and the public regarding the use of artificial intelligence (AI) in the preparation of filings for submission to the Office. The guidance comes two months after the Office issued a guidance memorandum for the Trademark and Patent Trial and Appeal Boards (TTAB and PTAB) on the misuse of AI tools before the Boards that clarified the application of existing rules to AI submissions.

Independent Presidential candidate Robert F. Kennedy, Jr’s Vice-Presidential running mate, Nicole Shanahan, a mercurial patent analyst, intellectual property lawyer and incidentally rich entrepreneur, is in the position to influence declining patent reliability and increasing copyright abuse. But will she? This column is not intended to opine on Shanahan’s merits as an independent Vice-Presidential candidate, but to attempt to understand her motivation for running and its potential impact on IP rights, creators and assignees.