Posts Tagged: "innovation"

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.

In a significant milestone for the preservation of biodiversity, Decree 11,865/2023, published in the Official Gazette on 12/28/2023, enacted the Nagoya Protocol in Brazil. The protocol, providing for access to genetic resources and the fair sharing of benefits arising from their use, is part of the renowned Convention on Biological Diversity (CBD). The Nagoya Protocol, in force since October 12, 2014, relates to the international commitment of 140 countries, including Brazil, to implement the objective of the CBD on the fair and equitable sharing of benefits from the use of genetic resources and the traditional knowledge associated with them (TK).

The remarkable story that inventor Alan Nelson shared last week at the 7th Annual Intellectual Property Awareness Summit held by CIPU at Northwestern University was revealing in many ways. Dr. Nelson related how he overcame numerous obstacles to commercialize a landmark technology for detecting cervical cancer in the 1990s. Using artificial intelligence (AI) while at the University of Washington, Dr. Nelson automated and vastly improved how early and accurately cervical cancer is identified — he and his team invented a machine to read Pap smears. 

Did you know that Brazil’s medical device market is experiencing a surge, attracting billions in imports annually? This boom, however, is attracting not only legitimate businesses but also those looking to exploit loopholes. On average, more than US$6.7 billion worth of products are imported annually, with around 14,000 new products being introduced every year. One example is the increase in sales of equipment for endoscopic surgeries, given the rise in the number of bariatric surgeries, which already exceeds 70,000 procedures per year.

The U.S. Supreme Court’s flimsy eligibility jurisprudence offers the U.S. Court of Appeals for the Federal Circuit (CAFC) several “softball pitches” to avoid a patent bloodbath. To date, the Federal Circuit has struck out at preserving the patent system — at least twice without really even taking a swing! The first softball pitch appears in the High Court’s initial decision to exalt judge-made “exceptions” over the 200-year-old statutory rule, namely, Mayo v. Prometheus.

A number of individual consumers have filed suit against Apple, Inc. in California and New Jersey courts, piggybacking on the U.S. Department of Justice’s (DOJ’s) March 21 complaint accusing Apple of “broad-based, exclusionary conduct” amounting to monopolization of the smartphone market. The DOJ’s sweeping complaint included a number of U.S. states as plaintiffs and charged Apple with “thwart[ing] innovation” and throttle[ing] competitive alternatives via its practices around the iPhone platform.

I have been critical of certain National Institute of Standards and Technology (NIST) proposals to alter the regulations related to the Bayh-Dole Act, in 2021 (Notice of Proposed Rulemaking, NPR), and specifically, the NIST “Framework” published for comments in December, 2023.  My Comments submitted in February addressed numerous legal infirmities, ranging from construction analysis to demonstrated ambiguity problems of the Request for Information/Comments (RFI) itself. 

It’s rare that a federal policy inspires fierce opposition from both sides of the aisle. But the Biden administration’s recent proposal to gut the Bayh-Dole Act is doing exactly that. Bayh-Dole is a pivotal and successful bipartisan law, but Biden’s proposal would effectively allow federal agencies to tear up patent licensing agreements signed between federally funded universities and private businesses. The economic consequences would be dire. Individuals from across the political spectrum, including former Obama administration officials, have warned the proposal would threaten America’s small businesses and inventors.

After a year-long process involving 38 state organizations and dozens of individual representatives, IP rights has been selected as the topic for the 2024-2025 debate competition by The National Federation of State High School Associations (NFHS). “Should the U.S. strengthen intellectual property rights” was chosen over “Nuclear Weapons Reduction” by a 25-17 vote in the final balloting process. In addition to NHFS and state debate associations, those who helped to determine the outcome included the National Speech and Debate Association, the National Catholic Forensic League, the National Association for Urban Debate Leagues and the Nation Debate Coaches Association.

The Supreme Court has never quite grasped the distinction between patent eligibility and patentability. Eligibility involves entire subject matter categories or fields of inventive enterprise, like the categories “process, machine, [article of] manufacture, or composition of matter.” 35 U.S.C. 101. Ascertaining eligibility should therefore require little more than checking the patent title and ensuring that, in the words of the venerable Judge Giles Rich, “[the invention] produces a useful, concrete and tangible result.”  State Street Bank v. Signature Fin. Group, 149 F. 3d 1368 (Fed. Cir. 1998). In simple terms, Section 101 requires little more for eligibility than a showing that an invention has applied natural principles to achieve a concrete purpose within the expansive categories articulated by Thomas Jefferson in 1793. Patentability, on the other hand, proceeds as a detailed claim-by-claim, feature-by-feature examination of “the conditions and requirements of this title.” 35 U.S.C. 101. Ironically this fundamental distinction that eludes the Supreme Court is explicit in the statutory language of 35 U.S.C. 101 itself.