Posts Tagged: "COVID IP waiver"

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.

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.”

Following four letters sent by Senator Thom Tillis (R-NC) to United State Trade Representative (USTR) Katherine Tai regarding the proposed waiver of intellectual property rights under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, Tai on November 8 replied to a July 14  letter sent by Tillis and Senator Tom Cotton (R-AR). That letter referred Tai and Commerce Secretary Gina Raimondo to a May 19 letter in which Tillis, Cotton and 14 other senators requested responses to 10 questions on the proposal to waive IP rights for COVID-19 related technology. The May 19 letter had requested Tai and Raimondo’s responses by July 19, 2021.

Last week, at a meeting of the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS), World Trade Organization (WTO) members had an opportunity to engage in small group and bilateral meetings to discuss the proposals by South Africa and India to waive patent and trade secret protections relative to COVID-19 innovations, as well as the proposal from the European Union regarding the use of current TRIPS compulsory licensing provisions during a pandemic. Some delegations believed the discussions were encouraging, while others expressed more skepticism, pointing out that a deal will not be achieved “unless delegations are able to make some real compromises.” See Members pursue convergence for IP COVID-19 response.

In the early days of the vaccination efforts, Americans were anxiously online trying to register for a COVID-19 vaccination appointment. Reports of success at 1:30 am and 2:30 am made the rounds as new appointments dropped onto websites. Also common were stories of vaccine elitism and discussions of which vaccine is “the best.”  News reports continue to show a steady uptick in the percentage of vaccinated Americans. Elsewhere in the world though, the story is very different, and a darker picture is emerging. In Africa, many countries have vaccinated less than 2% of their population. While vaccine distribution is difficult in many regions of the developing world, this is a hurdle that medical assistance groups, such as Doctors Without Borders, are accustomed to handling. The challenges are known. What is most difficult in combating COVID-19 is obtaining the vaccines in the first place. Some argue that IP rights are the key problem and should be waived, while others claim they are the only solution and that waiver would be catastrophic. This article suggests a third option, somewhere between voluntary vaccine donation and a full waiver of IP rights, that may offer a way forward.

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.”

While the discussions around waiving intellectual property (IP) rights set forth in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) are currently (and somewhat amorphously) limited to COVID-19 related drug and medical products, it is probably shortsighted to ignore the implications for other technologies critical to sustaining our environment and advancing a more healthful world. In fact, if we want to ensure continued investment in these technologies, we should be very concerned about the message conveyed by the international political tide: if you overcome a challenging scientific problem and your solution has the potential to save lives, be prepared to be subjected to intense political pressure and to potentially hand over your technology without compensation and regardless of the consequences.

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.”

The Office of the United States Trade Representative’s (USTR’s) 2021 Special 301 Report, published late last month, brought into sharp relief one of the ongoing issues the United States has with China. The country was again listed on its “Priority Watch List” in this annual review of the state of intellectual property (IP) protection and enforcement in the United States’ international trading partners, and the report explained that the United States remains unsatisfied with China’s failure to grant IP protection and enforcement to foreign rights holders. On the surface, very little is surprising about the USTR’s statement concerning China’s approach to the enforcement of IP rights. By now, China’s failures in the context of IP enforcement are a well-known refrain in the Western media. But dig beneath the surface, and the statement raises a multiplicity of issues that have gone unaddressed. Which IP rights are at issue? Whose IP rights are not being enforced? Should one country enforce the IP rights of the citizens of another country? If so, how and in what way does it do that? Last but not least, has the United States enforced the IP rights of the citizens of other countries?