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Posts Tagged: "Biden administration"

FDA Resists FOIA Request for Vaccine Approval Info as Biden Administration Offers to Share it with the World

From the “one hand doesn’t know what the other hand is doing” category, believe it or not, the Food and Drug Administration (FDA) is effectively refusing to release documents it possesses relating to the approval of the Pfizer-BioNTech COVID-19 vaccine. More precisely, Public Health and Medical Professionals for Transparency (PHMPT), a group of doctors and scientists, submitted a Freedom of Information Act (FOIA) request for documents relating to the approval of the Pfizer COVID-19 vaccine. After the FDA denied a request by the PHMPT to expedite release of the documents, a lawsuit was filed. In response to that lawsuit, the FDA proposed to release 500 pages per month, which would allow the agency time to redact material as necessary. Given that there are 329,000 pages responsive to the PHMPT request, at the proposed FDA rate of 500 pages per month it would take 55 years for the FDA to fully release the Pfizer COVID-19 vaccine documents.

Iancu, Locke and Kappos Slam Biden Administration’s Support for COVID IP Waiver in New White Paper

Former U.S. Patent and Trademark Office (USPTO) Directors Andrei Iancu and David Kappos, and former Secretary of Commerce Gary Locke, today released a White Paper calling the Biden Administration’s decision to support a waiver of intellectual property protections for COVID-19-related technologies under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) “strategic folly.” The report was produced by the Center for Strategic and International Studies (CSIS). In the paper, titled “The Shot Heard around the World”, the three officials, two of whom served under the Obama Administration, explained that the United States must indeed ramp up its efforts to improve vaccine diplomacy and to distribute more vaccines globally, but that “[w]aiving IP protections would not lead to the manufacture of a single additional dose of a vaccine.” Instead, they proposed a number of alternative solutions to solve the “real problems.”

Jonathan Kanter Responses to Senate Provide Insight on Approach to Antitrust-IP Nexus

On July 20, President Joe Biden nominated Jonathan Kanter as Assistant Attorney General, a position that would place him at the head of the Antitrust Division at the Department of Justice. Kanter is an antitrust lawyer with over 20 years of experience. He is currently a partner at The Kanter Law Group LLP, which is a boutique antitrust law firm that advocates in favor of federal and state antitrust law enforcement. Prior to founding the The Kanter Law Group, he was Co-Chair of the antitrust practice at Paul, Weiss, Rifkind, Wharton, and Garrison LLP. Kanter also served as an attorney for the U.S. Federal Trade Commission’s Bureau of Competition. 

A Pandemic Can’t Stop Bayh-Dole—But Politicians Might

What would you say about a technology commercialization system that kept on performing even through the worst pandemic in over a century? How about if it improved its performance over the previous year and was a critical factor in developing desperately needed therapies to protect people around the world? Would it seem reasonable that this was something that all of us should highly value and want to protect? You might think so, but some in Washington apparently don’t agree.

Biden Executive Order’s Approach to SEPs Sells Out American Small Businesses and Innovators

President Joe Biden’s recent executive order was billed as “promoting competition in the American economy,” but is a prime example of why one should always read the fine print. Rather than boosting the technology and innovations that spur American competitiveness in the global marketplace, the Biden administration is pushing a directive that reinforces the dominance of technology giants like Apple and Google. Part of the executive order addresses the complex but essential way we protect those who develop standard technology – such as the shared technologies that make mobile communication possible across multiple networks. Standards enable critical technologies such as 5G, the Internet of Things, video transmission, artificial intelligence, and autonomous vehicles. Nations that develop these technologies and the standards they are based on will have a significant advantage in gaining the lead in the next industrial revolution.

Emerging Anti-IP Policies the Focus of Heritage Foundation Event

At today’s Heritage Foundation event in Washington, D.C., titled Restoring American Leadership in Patent Law and Innovation Policy, former U.S. Patent and Trademark Office Director (USPTO) Andrei Iancu began by lamenting the failure of decision makers to make the connection between intellectual property and innovation. Increasingly, policy makers think innovation just happens, Iancu explained, with too many believing monetization happens after the fact, rather than driving innovation. “Without IP, the free market does not participate, or does not participate to scale,” Iancu told the Heritage audience. Laurie Self, Senior Vice President and Counsel, Government Affairs, Qualcomm, agreed with Iancu and added that, without a strong patent system, there is no opportunity to maintain a strong innovation leadership position. Presumably alluding to developments such as the Biden Administration’s support for waiving IP rights under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) related to COVID-19 inventions and the recent Executive Order on Competition, Self said: “We are seeing a series of policies that if implemented would undermine our system… this cognitive dissonance is a threat.”

The Biden Executive Order’s Restraint on Freedom of Contract: Regulation by Anecdote May Lead to Unintended Consequences

Capping months of anticipation, President Joe Biden on July 9 unveiled his Executive Order on Promoting Competition in the American Economy, which he argues will “lower prices for families, increase wages for workers, and promote innovation and even faster economic growth.” To achieve these lofty goals, the order prescribes regulatory interventions that interfere with property and contract rights in industry after industry. Undergirding the order is the premise that “competition has weakened in too many markets, denying Americans the benefits of an open economy and widening racial, income, and wealth inequality.” The White House offers only a handful of anecdotes to justify this sweeping conclusion, which remains highly disputed. In fact, few sectors of the U.S. economy are especially concentrated, and many markets that have become concentrated at the national level have become less concentrated at the local level, as national chains open up in more areas.

The New Biden Executive Order: Undermining Bayh-Dole is Like Shooting Ourselves in the Foot—Let’s Not Go There

Late Friday, the Biden Administration unveiled what must be one of the longest Executive Orders in history, titled “Promoting Competition in the American Economy.” In 31 pages, it covers everything from agriculture, shipping and railroads to the internet. The aim is to promote a “fair, open and competitive marketplace” against the threats of “excessive market concentration.” Among the intended beneficiaries are entrepreneurs, who will receive “space to experiment, innovate, and pursue the new ideas that have for centuries powered the American economy and improved the quality of life.” Unfortunately, tucked away on page 28 is a directive to the Secretary of Commerce that could threaten to undermine the Bayh-Dole Act, which allows entrepreneurs to commercialize federally-funded inventions. The law has spurred the impressive formation of academic spin-out companies and resulted in approximately 70% of these discoveries being licensed to small companies. It’s also critically important to our economic growth and continued well-being.

Waiving IP Rights: The Wrong Path to the Right Goals

Waiving intellectual property (IP) protections for COVID-19 vaccines will hinder rather than further three meritorious objectives of the current U.S. Presidential Administration: ending the pandemic as soon as possible, leveling the IP playing field with China, and pursuing a worker-centric trade policy. Ensuring equitable, widespread, and successful distribution of vaccines across the globe to meet the challenges of COVID-19, ending the erosion of U.S. IP at the hands of China, and putting Americans back to work are goals that most of us in the U.S. share. An examination of the facts, however, demonstrates that waiving IP rights in the name of COVID-19 relief undermines each of these three U.S. government goals.

The DOJ Antitrust Division: Regulatory Capture at the Expense of U.S. Interests

Historically an esoteric area of law, in recent years, antitrust policy is drawing broader attention as a tool to curb the exercise of monopolistic market power, especially by big tech behemoths. Congressional reports on both Democratic and Republican sides of the aisle, multiple legislative initiatives to reform U.S. antitrust law, and a recent book by Senator Amy Klobuchar (D-MN), Chair of the Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights, are some indicators of this trend. Along these lines, broad outcry broke out against rumored Department of Justice (DOJ) Antitrust Division leadership appointments of candidates representing big tech interests, such as Karen Dunn (Apple, Amazon), Renata Hesse (Google, Amazon), Susan Davies (Facebook), and against Deputy Attorney General Lisa Monaco’s (Apple, Google) involvement in deliberations over the nomination of a DOJ Assistant Attorney General (AAG) for Antitrust.

Biden is Missing an Opportunity at the USPTO

Intellectual property (IP) made modern vaccines possible. It took billions of dollars in private and public investments in research and development to be able to create, in record time, multiple viable vaccines to fight the COVID-19 pandemic. The entire world should be celebrating the innovators that continue to push forward with new solutions to problems we will face in the future. This pandemic will end, but there will be another. We should be eternally grateful to have companies like Pfizer, Moderna and Johnson & Johnson that have the capability to create and manufacture vaccines at large scale…. It has been over four months since President Biden’s inauguration. As of yet there has not been a nomination for the Under Secretary of Commerce for Intellectual Property and Director of the U.S. Patent and Trademark Office (USPTO). In addition to running the USPTO, the Director is responsible for advising the President on intellectual property issues. I believe that President Biden would have benefitted from an experienced voice knowledgeable about the dangers of supporting the erosion of property rights during the discussions on whether to support India and South Africa’s proposal to the World Trade Organization to waive IP protections under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Republican Senators Demand Answers from Biden on ‘Disastrous Decision’ to Support COVID IP Waiver

A group of 16 Republican senators sent a letter on Wednesday to U.S. Department of Commerce Secretary Gina Raimondo and U.S. Trade Representative (USTR) Katherine Tai denouncing the Biden Administration’s “disastrous decision” to support a proposal at the World Trade Organization (WTO) to waive intellectual property (IP) rights for COVID-19-related inventions and products.  The letter explains that the waiver is not limited to vaccines and “will do nothing to end the pandemic,” but will instead “undermine the extraordinary global response that has achieved historically remarkable results in record time and our nation’s global leadership in the technologies, medicines, and treatments of the future.”

Stop Tripping Over TRIPS

The petition by South Africa and India at the World Trade Organization (WTO) to waive most of the protections in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement was all but dead. It failed in October, December, January, March, and May. Then, after the Biden Administration expressed in the most neutral terms is was “considering” and “discussing” the proposal, U.S. Trade Representative Katherine Tai yesterday announced U.S. support for text-based negotiations that “will take some time.” IP rights are not the barrier to rapid production of vaccines advocates think they are, the waiver would cause more harm than possible good. The WTO would do much better to discuss removing obstacles to the trade of COVID-19 related items than removing intellectual property rights. There are 191 trade restriction measures on COVID-19 related supplies.  

Tai Says United States Will Back India-South Africa Proposal to Waive IP Rights Under TRIPS

Bloomberg first reported today that U.S. Trade Representative Katherine Tai said that the United States will back a proposal by India and South Africa last year to waive intellectual property protections under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. The proposal calls for the suspension of international protections for patents, copyrights, industrial designs, trade secrets and proprietary materials, “in relation to the prevention, containment, or treatment of COVID-19 until widespread vaccination is in place globally and the majority of the world’s population has developed immunity.” Tai reportedly said “We are for the waiver at the WTO, we are for what the proponents of the waiver are trying to accomplish, which is better access, more manufacturing capability, more shots in arms.”

Biden Announces Intent to Nominate Tiffany Cunningham to Federal Circuit

President Joe Biden today announced 11 judicial candidates – 10 for federal circuit and district court judge positions, including Tiffany Cunningham as nominee for the United States Court of Appeals for the Federal Circuit (CAFC). Cunningham would replace Judge Evan J. Wallach, who announced earlier this month that he will retire from active service and assume senior status as of May 31, 2021, after 10 years of service with the court.