Linda MacDonald Glenn

Should intellectual property practitioners have a Hippocratic Oath? Should there be an equivalent of a standard of care for IP? Yes, and yes. In Intellectual Property (IP), especially patents, the conversation of quality and portfolio strength often centers around ensuring patents are valid, enforceable, and commercially valuable. Yet, despite the many tools and strategies available, a significant portion of patents provide little to no real market value. Why? IP with no value starts with a "bad idea" problem. The value of intellectual property (IP) is tied directly to the commercial relevance or economic potential of the underlying asset (e.g., a product, technology, or service) or the activity it enables (e.g., manufacturing processes, software applications, or business methods). If the underlying asset or activity generates significant revenue, provides a competitive edge, or enhances operational efficiency, the associated IP increases in value as a function of the asset or activity. If the idea has no commercial value, the IP instrument protecting it has zero value. I am not aware of a single professional who enters into IP who is not committed to generating a superior outcome for their employer or client. If they exist, please grab them, shake them by their shoulders, and let them know there is a better way. Any Hippocratic Oath for IP would include: 1. a commitment to innovation 2. a commitment to understanding the nature of the innovation AND an assessment of the ECONOMIC value of the innovation 3. personally owning the responsibility for the identification, curation, and appropriate protection of the innovation With patents, quality is mute without an accurate claim directed to the core economic value of the underlying asset. For me, the claim chart is my Weapon of Mass Accountability. If I do not know the tech or cannot assess the economic value of the innovation I am working on, I have failed point 2. If I cannot chart an asset, I have failed on point 3. If I fail on either of 2 or 3, I have failed in living up to point 1. In a way, this is the starting point for my "standard of care." What goes into your Hippocratic Oath of IP? What informs your standard of care? #intellectualproperty #innovationmanagement

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Are you curious about how the NIH patents and licenses its intellectual property? Bruce Goldstein from the NIH National Heart, Lung, and Blood Institute wrote an incredibly informative chapter on this topic, diving into the fundamentals of patents and the process for securing a patent, patents in the context of federal technology transfer, including how federal funding agreements affect patent rights, and how federal agencies (particularly the NIH) patent and license their own inventions, and closes by discussing transactional agreements other than patent licenses. You can find his chapter on Science Direct's website: bit.ly/4b6xOUa or browse through other technology transfer related texts written by NIH tech transfer professionals on our website: go.nih.gov/BbErTSa #WorldIPDay #IntellectualProperty #PublicHealth #BioTechnology

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Outstanding #AI #IP rights and #regulation panel at The Federalist Society's National Lawyers Convention. From L to R Microsoft Associate General Counsel Jordan Gimbel, Congressman Darrell Issa, Judge Paul Michel, FTC Commissioner Melissa Holyoak, and Judge Ryan T. Holte. Some takeaways: Ensure IP rights to encourage innovation and advancement, foster entrepreneurship and competition. Regulate with a light touch, trying to use existing rules and standards development. Regulatory Transparency Project

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🎉🌟💡The FAIR News! FAIR Advisor and Speaker focus! 🤩 Insightful Contributions from Dr. Allan McCay and Harikesh Pushpapathan on Neurotechnology and AI 🧠 Thought-provoking contributions from Dr. Allan McCay, a distinguished FAIR Speaker and FAIR Advisor and world-leading authority specialising in the intersection of law, neurotechnology, and ethics, recently featured on RNZ. In this enlightening interview, he discussed the groundbreaking implications of brain technology in the wake of Elon Musk's Neuralink clinical trials. Dr. McCay raises critical questions about whether neurotechnology will lead to societal transformation or introduce serious ethical dilemmas that we must address. In addition to his RNZ appearance, Dr. McCay authored an insightful article for LSJ Online. In this piece, co-authored with Harikesh Pushpapathan, also a FAIR Speaker, and Tara Hamilton, he delves deeper into the ethical, legal, and societal impacts of advancing neurotechnology. Their analysis offers a comprehensive overview of the challenges and opportunities posed by these innovations, setting the stage for meaningful dialogue at the upcoming FAIR Forum, The Convergence of Neurotech and AI: The Imperative Considerations. This forum, featuring both Dr Allan McCay and Harikesh Pushpapathan, promises an enriching exchange of ideas among thought leaders and industry experts and a pivotal discussion for anyone interested in the future of neurotechnology and its integration with AI. Read the full article: https://lnkd.in/gr38b7pM Listen to the RNZ interview: https://lnkd.in/gzX53Tw2 #SMEs #robotics #thefair2024mlb #executives #emergingtechnologies #AI #aiaustralia #brain #neuralink #neurotechnology

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📢 Major Antitrust Lawsuit Filed Against Leading Academic Publishers! On September 12, 2024, Lieff Cabraser Heimann & Bernstein, LLP and Justice Catalyst Law filed a federal antitrust lawsuit against six major academic journal publishers, including Elsevier, Wiley & Sons, and Wolters Kluwer, on behalf of a class of scientists and scholars. The lawsuit accuses these publishers of unlawfully appropriating billions of dollars that should have gone towards scientific research. Key Allegations in the Case: ✅ Unpaid Peer Review Labor: The lawsuit alleges that scholars are coerced into providing free peer-review services, with their unpaid work tied to their ability to get published in top-tier journals. ✅ Suppression of Competition: Publishers allegedly limit competition by requiring scholars to submit manuscripts to only one journal at a time, resulting in delayed reviews and slower publication of vital scientific research. ✅ Control of Intellectual Property: The complaint claims that once scholars submit their manuscripts, the publishers take control of the research, turning it into their property and charging exorbitant fees for access—despite the fact that much of the research is publicly funded. The lawsuit, filed in federal district court in New York, seeks to end these practices and secure fair compensation for scholars. It calls for injunctive relief and damages to rectify the harm done to the scientific community. 🚨 For scientists and scholars seeking more information or to join the case, contact Lieff Cabraser. ♻️ Share to raise awareness of the ongoing fight for fairness in academic publishing. 🔔 Stay updated on this important legal battle. #AcademicPublishing #AntitrustLawsuit #JusticeForScholars #FairScience https://lnkd.in/eDMas6va

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The Privacy-Preserving Data Sharing in Practice (PDaSP) program is accepting proposals from qualified researchers and multidisciplinary teams in the following tracks. Track 1: Advancing key technologies to enable practical PPDSA solutions: Projects are expected to be in the $500K - $1 million range for up to two years.  Track 2: Integrated and comprehensive solutions for trustworthy data sharing in application settings: Projects are expected to be in the $1 million - $1.5 million range for up to three years.  Track 3: Usable tools and testbeds for trustworthy sharing of private or otherwise confidential data: Projects are expected to be in the $500K - $1.5 million range for up to three years. Visit the site to register for upcoming informational webinars on either July 12 or July 23. PDaSP is led by the National Science Foundation (NSF) Directorate for Technology, Innovation and Partnerships in collaboration with the NSF Directorate for Computer and Information Science and Engineering, as well as Intel Corporation and VMware, as industry partners, and the Federal Highway Administration and U.S. Department of Commerce National Institute of Standards and Technology (NIST) as federal agency partners. #OpenData #Privacy #PETs #DemocratizingOurData https://lnkd.in/e_XiDb8U

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VIVV's patent application for the HIV drug Dolutegravir was recently rejected by the IPO, paving the way for affordable generics. The IPO, relying on the arguments from numerous oppositions, held that the application failed to demonstrate the therapeutic efficacy mandated under Section 3(d). Read Yukta Chordia’s post on this development below. https://lnkd.in/gA8_DiVP #HIV #AIDS #IPO #Patent #Evergreening #Opposition #Section3d #SpicyIP

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On July 2, 2024, the California State Assembly Judiciary Committee passed SB-1047, following its passage by the Senate on May 21, 2024. The bill aims to curtail the risk of novel threats to public safety and security that lie beyond our current AI landscape and follow in the footsteps of Colorado’s SB205, widely considered the first comprehensive AI legislation in the United States. #AI #California #Security

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#CMS Tries to Backfill for #DOJ in the Year 2 #IRA Guidance Sophistry: the use of “subtly deceptive reasoning or argumentation”. In defending the #inflationreductionact against manufacturer challenges, DOJ threw out there a novel argument that #drug makers aren’t “coerced to sell” under the IRA. The government represented to the court, in the #Janssen, #BMS, and #AstraZeneca cases, that the IRA doesn’t actually obligate a manufacturer to “sell” a #Medicare “fair price” drug. It was an argument that seemed to puzzle both the court and plaintiffs’ counsel, because it wasn’t a position that had been previously asserted by CMS. But in CMS’ most recent guidance, the agency tries to do some sophist “backfilling” for DOJ. The Guidance: Here’s what CMS said: “The Primary Manufacturer is obligated to provide access to the MFP for these dosage forms, strengths, and package sizes of the selected drug that are dispensed to MFP-eligible individuals, but is not obligated to make sales of the selected drug.” Echoing what DOJ argued in its hearing, this piece of “guidance” tries to make a distinction between, as the statute requires, “provid[ing] access” to the #MFP and actually “selling” at that price. Just Plain Silly: This is a wonderfully ridiculous piece of sophist lawyering—a distinction without a difference. It is absurd to say that one is obligated to “provide access” to pricing but not to make a sale. The “distinction” collapses into itself. What’s amusing about the government’s position is how inconsistent it is with its positions in multiple other contexts. Under the logic here, a manufacturer would be able to “offer” a #340b price, but never actually make any 340B sale at any time. A manufacturer could claim #MedicarePartB coverage for a drug, but never sell a drug at a #Medicaid rebated price. It could report an #FSS price, but never actually sell at that price to any federal agency. It’s also an argument built on an alternative reality. Manufacturers sell their drugs to multiple purchasers who provide services to patients, typically, regardless of their insurance coverage. There’s no practical way for a manufacturer to “provide access” to the MFP and then prevent a product from being used on a Medicare beneficiary. Sophistry, pure and simple. And It Shoudn’t Work, Either: Courts defer to agency interpretations of their authorizing statutes, if the statute is ambiguous. But the interpretation must reflect the “fair and considered judgment” of the agency. It cannot be a “‘post hoc rationalizatio[n]’ advanced by an agency” seeking to defend “past agency action against attack.” But that is exactly what CMS’s “backfilling” for DOJ is. And a reviewing court should see it for exactly what it is. #drugpricing

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DNA test results from a gun potentially carrying DNA from multiple contributors were excluded from trial in San Diego. Judge Curiel's ruling in US v. Ortiz sets a precedent on the limitations of probabilistic genotyping systems, emphasizing adherence to a lab's internal validation. This decision underscores the importance of establishing boundaries for such technologies, including estimations of NoC and suitability. There are too many labs running samples that can only be explained by a minimum of 5 contributors. #DNA #Forensics #LegalJustice

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Deep dive into the revolving door and how former FDA staff are helping Philip Morris, Juul, and other cig and vape manufacturers fight against FDA regulations. (I talked to author Kathryn Kranhold about the weakness of revolving door regulations.) Co-published by STAT and The Examination Free link to the Examination article here: https://lnkd.in/gWrhfbuY STAT article:

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On April 17, Colorado Governor Jared Polis signed HB 1058 into law, which means it is time to update our chart comparing the various definitions of sensitive data in consumer data privacy laws. Here's some more context: 1️⃣ HB 1058 amends the Colorado Privacy Act to add biological data (and through it neural data) as a category of sensitive data in the Colorado Privacy Act. 2️⃣ The true impact of the amendment is debatable as the definition of biological data states that the data must be "used or intended to be used, singly or in combination with other personal data, for identification purposes." 3️⃣ Colorado is the first state to add biological/neural data to its state privacy law. This continues the trend over the last two legislative sessions of state lawmakers expanding the types of data covered as sensitive data. Given the constant expansion, at some point it may be easier to define what is not sensitive data rather than what is. 4️⃣ California is also considering a bill to add neural data to the CCPA's definition of sensitive personal information. 5️⃣ Colorado isn't done. The legislature is still considering two other bills to amend the Colorado Privacy Act, dealing with the treatment of biometric data and minor's data. 6️⃣ Here's a link to the Colorado bill for those interested: https://lnkd.in/gE7KPyY9

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California's recent legislation protecting brainwave data is a crucial advancement in consumer privacy, particularly as it relates to neural data, which encompasses information generated by measuring the activity of an individual's central or peripheral nervous system. This law recognises the sensitive nature of such data, which can reveal thoughts, feelings, and intentions, and classifies it alongside other protected personal information like genetic and biometric data. The new law empowers users to control their neural data by allowing them to opt out of sharing, access their information, and request corrections or deletions. This is a significant victory for consumers, especially those with mental health conditions who may benefit from neurotechnology while needing assurance that their mental privacy is safeguarded. However, while California's initiative is commendable, it underscores the urgent need for comprehensive federal or global legislation to ensure consistent protections for neural data across all jurisdictions. The fragmented state-level approach could leave individuals vulnerable to exploitation as neurotechnology continues to evolve. Protecting brainwave information is not just about privacy; it’s about respecting fundamental rights in an age where technology increasingly intersects with our most intimate experiences. #technologylaw #dataprotection https://lnkd.in/dMU7Pge7

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Sharing lessons learned and insights from the Athena project, two short articles were published on Biovox: - https://lnkd.in/egs6M4kp - https://lnkd.in/e_r7CsD3

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Interesting read. #patentprosecution #USPTO #techlawyer

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Experts are concerned as rapidly rising levels of #trifluoroaceticacid, or #TFA -- a class of "#foreverchemical" believed to harm #fertility and #childdevelopment -- are being discovered in #drinkingwater, #blood and #rainwater #worldwide. #PFAS #SustainabilityMatters #ConsumerProducts #HealthMatters #PublicHealthMatters #FGases #CFCs #Refrigeration #AirConditioning #AC #AerosolSprays #HeatPumps #Pesticides #Dyes #Phamaceuticals #Germany #China #UnitedStates #NorwegianGeotechnicalInstitute #NorwegianUniversityOfScienceAndTechnology #TapWater #Montreal #EuropeanChemicalsAgency #Reprotoxic #Denmark #UnitedKingdom #UK #England #EnvironmentAgency #Environment #Policy #Regulations #HumanHealth #ReverseOsmosis #EnvironmentalProtectionAgency #EPA #FederalGovernment #UnitedStatesOfAmerica #USA #Americans #UniversityOfAlberta #GreenSciencePolicy #NGOs #Fidra #GermanEnvironmentAgency #Pollution #WaterPollution #WaterQuality #TheGuardian

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Oh really?! Look at point (1) of the complaint PhDs: "The defendant publishers are Elsevier, Wolters Kluwer, John Wiley & Sons, Sage Publications, Taylor and Francis, and Springer Nature. In the suit, filed by the Lieff Cabraser law firm and co-counsel at Justice Catalyst Law, the plaintiffs claim the defendants engaged in a three-part “scheme” to: (1) Lower labor costs by agreeing not to compensate scholars for performing their peer review services; (2) Reduce competition by requiring scholars to submit their manuscripts to only one journal at a time; and (3) Control access to scientific information by prohibiting scholars from freely sharing their research while their manuscripts are under peer review." ....Which publishers are missing from this PhDs? How much longer will the academic-publishing complex last do you think? #phd #jobsearch

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