Posts Tagged: "innovation"

ITC Report on TRIPS COVID IP Waiver Extension Plays it Safe

The U.S. International Trade Commission (ITC) released a sprawling report on Tuesday analyzing market dynamics surrounding the question of whether to extend the waiver of IP rights for COVID-19 technologies under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to diagnostics and therapeutics. The report stopped short of making any recommendations, but ultimately did not find any definitive evidence that IP rights present a barrier to access in the context of COVID diagnostics and therapeutics. However, it largely amounts to a reiteration of talking points on both sides and seemingly does little to further the debate.

Is the Food and Drug Administration Killing Chevron Deference?

The U.S. Supreme Court on Friday added another case to its docket that challenges the Chevron Doctrine, a decades-old principle instructing lower courts to defer to federal agencies’ interpretations of ambiguous laws. The Court said it will hear Relentless, Inc. v. Dept. of Commerce in tandem with an almost identical appeal brought by Rhode Island herring fishers. Mark your bingo card if you had “Rhode Island herring fishers.”

This Week in Washington IP: IPWatchdog’s Life Sciences Masters, IP Competition with China, and Helping Women Entrepreneurs Protect Their Brand

This week in Washington IP news, Congress returns from its district work period with the House holding several meetings related to IP and innovation. The House Subcommittee on Courts, Intellectual Property, and the Internet holds a hearing on IP competition with China and another subcommittee discusses safeguarding data in the growing AI industry. Elsewhere, IPWatchdog is hosting its Life Sciences Masters™ program in Ashburn, VA, and the U.S. Patent and Trademark Office hosts a panel discussion for its ongoing Women’s Entrepreneurship (WE) program

How the U.S. Chamber’s IP Principles Can Reset the IP Debate: A Conversation with Patrick Kilbride

Last month, the U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) announced that it had joined with 30 other signatories to publish a framework of intellectual property principles designed to reshape the narrative around intellectual property (IP) rights and maintain America’s global lead in innovation. Broadly speaking, the principles focus on five primary goals to be achieved by American lawmakers and policymakers: 1) national security, 2) technological leadership, 3) fostering creative expression, 4) enforcing the rule of law, and 5) ensuring full access to the innovation ecosystem for all.

Biden Administration Moves Ahead with Its Unconstitutional Drug Pricing Regime That is Doomed to Fail

Last week, the White House announced that the manufacturers of all ten of the drugs singled out by the Centers for Medicare and Medicaid Services (CMS) and its drug price negotiation program (DPNP) have “agreed” to participate therein. The announcement concerns the manufacturers reluctantly agreeing to subject themselves to the sweeping drug price “negotiation” provisions of the Inflation Reduction Act (IRA), which was passed last year. Those provisions empower CMS to essentially dictate whatever price it pleases for a set of prescription drugs, the first ten of which were announced at the end of August.

U.S Manufacturing Requirement Changes the Landscape for Bayh-Dole Compliance Reporting

In recent months, two U.S. government executive initiatives have reshaped the landscape concerning intellectual property and the domestic production of products resulting from federally funded research. These initiatives are poised to bring substantial changes to the dynamics of academic-industry collaborations as inventions are brought to market.

Solving the Section 101 Conundrum: Examining Stakeholder Workarounds vs. Legislative Reforms

Judicial rulings have muddied the waters of patent eligibility, with judges themselves expressing uncertainty. In the case, Am. Axle & Mfg., Inc. v. Neapco Holdings LLC, U.S. Court of Appeals for the Federal Circuit judge Kimberly Moore openly shared the challenge of applying Section 101 consistently, explaining that “the majority’s blended 101/112 analysis expands § 101, converts factual issues into legal ones and is certain to cause confusion for future cases.” This haze has driven innovators to tread cautiously, often sidelining potential patents for fear of 101 rejections—stifling the American dream of groundbreaking innovation. Stakeholders craft tactics to dodge these pitfalls while lawmakers propose reforms.

Inventor Profiles: Karikó, Weissman Earn Nobel Prize for Modifying mRNA and Paving Way for COVID-19 Vaccines

On October 2, the Nobel Assembly at Karolinska Institutet announced that Hungarian-American biochemist Katalin Karikó and American immunologist Drew Weissman were awarded the 2023 Nobel Prize in Physiology or Medicine for their discoveries related to modified messenger ribonucleic acid (mRNA) for use in vaccines. A critical part of the world’s response to the COVID-19 pandemic, mRNA vaccines were not an effective option until the pioneering work of these two scientists, one of whom faced considerable rejection while laying the foundation that answered one of the world’s greatest public health crises.

What the Patent Eligibility Restoration Act Means for Artificial Intelligence Inventions

PERA is no doubt an ambitious bill. In terms of its design, the proposed legislation attempts to deal with each of the Supreme Court’s decisions in Alice, Mayo and Myriad, plus all of their progeny applications thereafter engendered by the Federal Circuit, the Patent Trial and Appeal Board (PTAB), all the way down to the U.S. Patent and Trademark Office (USPTO) examining corp. In a nutshell, the bill, if passed, would return us to a time when Bilski was the law of the land, which will no doubt be welcomed by many innovators.

United States Slips Back to Third Place in WIPO’s Global Innovation Index 2023

On September 27, the World Intellectual Property Organization (WIPO) released the Global Innovation Index (GII) 2023, providing a snapshot of the relative performance of innovation economies across the world. While this year’s Index reflects mostly positive news about the state of global innovation, a slight drop in the United States’ overall ranking should encourage policymakers to advance efforts that would address issues with the country’s innovation engine.

Deadline for Comments on USPTO RFC on Standards and IP Extended

The U.S. Patent and Trademark Office (USPTO) has extended the deadline for comments on its joint request for comments (RFC) with the International Trade Administration (ITA) and the National Institute for Standards and Technology (NIST) on the agencies’ collaboration initiative concerning standards and intellectual property. In a Federal Register Notice (FRN) published today, the USPTO announced the new deadline will be November 6, 2023. The original deadline was September 29.

Brazilian Innovation in Extraction and Recycling Stages of EV Battery Technology

Brazil is among the countries currently in the spotlight in the automotive sector. The nation was ranked sixth, according to a survey published in January 2023 by Motor1, among the countries with the highest number of vehicles sold in 2022, and the market for electric vehicles (EVs) is emerging, as the number of EVs sold in Brazil increased by 58% in the first semester of 2023 compared to the same period last year..

Realtek Denied Mandamus Relief at CAFC in ITC Battle with AMD

The U.S. Court of Appeals for the Federal Circuit (CAFC) today denied a petition for writ of mandamus filed by Realtek Semiconductor Corporation seeking to direct the International Trade Commission (ITC) to vacate its ruling granting Advanced Micro Devices, Inc. (AMD)’s motion to strike Realtek’s witness from testifying at an upcoming evidentiary hearing.

Artificial Intelligence in Drug Development: Patent Considerations

Artificial intelligence (AI) is a field of computer science that creates software or models that mimic human reasoning or inference. Machine learning is a subset of AI which uses algorithms trained on massive amounts of data to allow the computer to learn with gradually improving accuracy without explicitly being programmed. The biopharmaceutical and healthcare fields produce massive amounts of data, including properties and characteristics of drug compounds, biological, genomic, and clinical data, efficacy of treatments, adverse events and risks, and electronic health records. The data may come from many sources, both public and proprietary. AI systems trained on such data can streamline and optimize the drug development process, including drug discovery, diagnosing diseases, identifying treatments and risks, designing clinical trials, and predicting safety and efficacy profiles, leading to increasing efficiency and reducing costs. 

Tips From In-House IP Counsel on Developing a ‘Rational IP Strategy’ at IPWatchdog LIVE

Legal professionals making corporate IP portfolio management decisions must have the ability to cut costs from underperforming assets while also making significant investments to protect market share. On Day 3 of IPWatchdog LIVE 2023, top legal officers for several companies currently navigating global markets offered their insights during a panel titled “The Hallmarks of a Rational IP Strategy.” While the panel discussion revealed no one-size-fits-all template for legal professionals to follow when building valuable IP portfolios, it underscored the need for IP attorneys to firmly grasp their clients’ business needs when determining which IP rights to obtain and where they should be leveraged.