Posts Tagged: "U.S. Chamber of Commerce"

On February 22, the U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) released the 2024 International IP Index, which provides an annual snapshot of the impact of legal developments in intellectual property (IP) on the innovation ecosystem in dozens of nations across the world. While this 12th version of the GIPC’s index noted some positive developments in national IP frameworks, stagnation among the recurring leaders of the IP Index is a major concern given growing efforts by governments to control prices in critical sectors of the economy, especially in pharmaceuticals.

Today, the U.S. Department of Health and Human Services (HHS) made its initial offers to pharmaceutical companies pursuant to the Biden Administration’s Inflation Reduction Act of 2022 (IRA), which allows the U.S. Government to “negotiate” Medicare drug prices under a set framework based upon the amount of time a drug has spent on the market. Opponents of the program, including the U.S. Chamber of Commerce, which is suing the government over the plan, argue it cannot be characterized as a voluntary negotiation since the affected companies would be subject to onerous excise taxes for refusing to participate and because it would have devastating consequences for patients if companies were to actually pull the affected drugs. The amounts of today’s initial offers were not revealed.

The U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) sent Freedom of Information Act (FOIA) requests on January 9 to the Department of Commerce and the National Institutes for Standards and Technology (NIST) regarding the Biden Administration’s recent Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights. The proposed framework was published in the Federal Register in December by NIST and the Department of Commerce and included suggestions on whether and when to exercise “march-in rights” under the Bayh-Dole Act that would arguably significantly broaden the criteria for compulsory licensing of patented technology developed with federal funding.

The U.S. Chamber of Commerce released a report today predicting that proposals by the Biden Administration to impose price controls on certain pharmaceuticals will reduce the number of clinical trials “by thousands across all categories of research examined and by up to 75% in some therapeutic areas,” eventually turning the United States into a “research desert.” The report comes on the heels of a Federal Register Notice last week that proposed a framework for expanding the use of march-in rights under the Bayh-Dole Act to circumstances in which qualifying drugs are priced too high.

The National Institute of Standards & Technology (NIST) and the Department of Commerce today published a draft version of a Federal Register Notice seeking comments on a proposed framework for deciding whether and when to exercise march-in rights under the Bayh-Dole Act that would significantly broaden the criteria for compulsory licensing of patented technology developed with federal funding. While Bayh-Dole contemplates march-in rights, the law strictly limits the situations in which they can be exercised and does not make any reference to pricing as a criterion for marching in. But under the proposed framework, an agency may consider “[a]t what price and on what terms has the product utilizing the subject invention been sold or offered for sale in the U.S.” and whether “the contractor or licensee [has] made the product available only to a narrow set of consumers or customers because of high pricing or other extenuating factors”.

On September 13, the Global Innovation Policy Center of the U.S. Chamber published its “IP Principles” paper declaring the Chamber’s “Beliefs about Intellectual Property.” It was promptly endorsed and signed by 32 external IP thought leaders, including the heads of nearly all major IP associations and organizations, and individual experts such as a former Director of the U.S. Patent and Trademark Office (USPTO), two retired judges (including myself), and leading IP academics…. In my view, the Chamber was exactly right to call for a “reset” in the policy debate over IP rights.

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.

On September 13, 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 maintain America’s global lead in innovation. Supported by a coalition of well-recognized individuals and trade organizations long supporting greater certainty in patent rights, the framework of IP principles is intended to serve as a guidebook for policymakers who want to address genuine issues currently facing the nation’s IP system.

In January of this year, the Federal Trade Commission (FTC) proposed a new rule that would ban employers from using noncompete clauses for their employees. In an announcement, the FTC said that the use of noncompete clauses is “a widespread and often exploitative practice that suppresses wages, hampers innovation, and blocks entrepreneurs from starting new businesses.” The agency estimated the new rule could increase wages by $300 billion a year, as firms would be encouraged to do more to keep their workers. The proposed rule change was opened for public comment in January, and the deadline for submissions was extended from March 20 to April 19 in early March. As of April 18, the Regulations.gov website indicated that 24,259 comments had been received and 14,946 posted. With the comment period coming to a close this week, the U.S. Chamber of Commerce has weighed in, urging April Tabor, FTC Secretary to withdraw the proposed rule.

The Global Innovation Policy Center (GIPC) of the U.S. Chamber of Commerce issued its 11th annual International IP Index today, striking what seems like a more dismal tone than usual compared with past reports. While 18 economies saw modest progress on IP protection improvements, 28 economies, including many of the high-scorers, like the United States and the United Kingdom, had a 0% change in score. Only two countries had a 0% change in the 10th edition of the Index. The Index covers 55 economies that represent “most of the global economic output, together contributing over 90% of global GDP.”

On November 10, a group of Democratic members of congress sent a letter to United States Trade Representative Katherine Tai expressing concerns about extending a waiver of intellectual property rights under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement to therapeutics and diagnostics for the treatment of COVID-19. The letter comes as talks are heating up at the World Trade Organization (WTO) about such an extension, with the technical deadline for a decision being December 19. The letter poses seven questions for Tai to consider and respond to as she formulates the U.S. position on waiver extension, including whether the current waiver of IP rights for vaccine-related technology has been effective, how “diagnostics” and “therapeutics” will be defined, and that she provide a list of countries that have expressed interest in gaining access to American IP for COVID-related diagnostics and therapeutics.

With the World Trade Organization’s (WTO’s) Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) set to meet informally on Monday, September 19, to discuss extending a waiver of IP rights for COVID-19 vaccine-related technology to diagnostics and therapeutics, the U.S. Chamber of Commerce and the Chamber’s Global Innovation Policy Center (GIPC) are urging the Biden Administration to oppose such a move in favor of “real solutions.” The GIPC’s President and CEO, David Hirschmann, and the Chamber’s Executive Vice President and Head of International Affairs, Myron Brilliant, sent a letter to U.S. Secretary of Commerce Gina Raimondo on Friday expressing confusion at the administration’s seemingly contradictory stances on intellectual property rights.

The U.S. Chamber of Commerce yesterday published a letter it sent to members of congress expressing strong support for both the “No Free TRIPS Act” and the “Protecting American Innovation Act.” According to the letter, if enacted, these bills “would prohibit the Administration from negotiating or concluding any modifications to the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property (TRIPS) agreement, without the explicit authorization of Congress.” The Chamber is concerned about the potential impact of the proposed waiver of patent rights for COVID-19 vaccine technology. The letter comes after the European Union, United States, India and South Africa reached a compromise on language for waiver terms last month.

The U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) today revealed its 2022 International IP Index, “Compete for Tomorrow,” which is now in its tenth edition. Last year, the report focused on the role of effective intellectual property (IP) frameworks in helping economies to combat and recover from the COVID-19 pandemic and identified several emerging economies that had made significant improvements. This year, the report analyzes ten years of data, which reveals that the global IP environment has steadily improved overall, including in the last two years of turmoil, and that emerging economies are particularly making a conscious decision to bolster their IP regimes.