TRIPS Waiver Compromise on COVID-19 Vaccines and Treatments Announcement Coming Soon?

The AIPLA and other IP organizations have issued a joint statement on a tentative TRIPS waiver compromise. On March 15, 2022, Adam Hodge, USTR spokesperson stated, in part:

Since last May, USTR has worked hard to facilitate an outcome on intellectual property that can achieve consensus across the 164 Members of the World Trade Organization to help end the pandemic. USTR joined informal discussions led by the WTO Secretariat with South Africa, India, and the European Union (EU) to try to break the deadlock.

The difficult and protracted process has resulted in a compromise outcome that offers the most promising path toward achieving a concrete and meaningful outcome. While no agreement on text has been reached and we are in the process of consulting on the outcome, the U.S. will continue to engage with WTO Members as part of the Biden-Harris Administration’s comprehensive effort to get as many safe and effective vaccines to as many people as fast as possible.

I wonder how Russia's invasion of Ukraine impacted the consensus building.  The Joint Statement provides:

JOINT STATEMENT ON TENTATIVE TRIPS WAIVER COMPROMISE

Written March 28, 2022

On March 24, AIPLA, along with the Intellectual Property Owners Association (IPO), Licensing Executives Society International (LESI), Licensing Executives Society USA & Canada, and the New York Intellectual Property Law Association (NYIPLA) issued a joint statement on the tentative TRIPs Waiver Compromise.  Our organizations are concerned by reports that the European Union, India, South Africa, and the United States have reached a tentative compromise on a proposed TRIPS waiver of intellectual property (IP) rights. We strongly support equitable, widespread and successful distribution of vaccines necessary to meet the challenges of COVID-19. However, the proposal currently being reported incorrectly portrays IP as a barrier to production and supply of COVID-19 vaccines. Our organizations know of no evidence to support that IP is such a barrier. In fact, the World Health Organization has stated: “[w]ith global vaccine production now at nearly 1.5 billion doses per month, there is enough supply to achieve our targets, provided they are distributed equitably. This is not a supply problem; it’s an allocation problem.”1 Solving the allocation problem is best accomplished by focusing on improvements to supply chain and distribution issues, rather than by concentrating on the red herring of intellectual property as an alleged barrier. Intellectual property has been critical to the development of technology that has enabled a global COVID-19 response and it continues to fuel efforts to more effectively distribute vaccines and advance other needed technology. We should not undermine our ability to respond to this and future pandemics.

Footnote 1:  See https://www.who.int/campaigns/vaccine-equity (accessed on 18 March 2022).

The U.S. Funding of the Moderna mRNA Technology and a Patent Dispute

Ana Santos Rutschman at Saint Louis University Law School has authored an interesting short article titled, "Why Moderna Won't Share Rights to the COVID-19 Vaccine with the Government that Paid for Its Development" in The Conversation.  The article basically outlines the U.S. government's technical and monetary contributions to the development of the mRNA technology and a dispute between Moderna and the U.S. government.  The article is available, here.  Moderna's stock has been falling overall, and I imagine this will not help as this is resolved. I've been worried about vaccine availability for some time, but I didn't realize so many would choose not to be vaccinated.  It appears COVID-19 mutation will continue relatively unabated.  

mRNA Vaccine Patents Study

Mario Gaviria and Burcu Kilic have published an interesting article titled, “A Network Analysis of Covid-19 mRNA Vaccine Patents.”  The article helpfully provides information concerning the relationship between entities, patents and licenses concerning mRNA vaccine patents.  Notably, the article identifies foundational patents from the University of Pennsylvania and the University of British Columbia and traces the relationship through various entities.  The article is available, here. KEI provides an analysis of potential U.S. government funding of some of those patents, here. 

Biden Administration's Support of the So-Called WTO Waiver of COVID-19 Related IP

There’s been a lot of commentary going around regarding the Biden Administration’s support of South Africa and India’s proposed WTO waiver of COVID-19 related IP.  I thought I’d weigh in with maybe a bit of a slightly different angle [These are my personal views and certainly do not represent other folks on the blog.].  The Biden Administration’s support of the waiver is, mostly, about politics.  Many have written about how a WTO waiver of COVID-19 related IP under TRIPS, for a myriad of reasons, will not result in getting the vaccine or treatments to people in India or other countries who may need it.  For example, please see Professor Ana Rutschman’s excellent co-authored post, here, and Professor Jorge Contreras’ excellent post, here.  I don’t 100% agree with that general position because I frankly do not have enough information about the global patent landscape, particularly with respect to devices used to treat people with COVID-19, or global manufacturing and distribution capabilities.  I am also uncertain because some say it will help.  However, if I am in a position where I am unsure of a decision and millions of human lives are in the balance in a global pandemic, I am going to err on the side of saving human lives.  I think most Americans would agree with me.  I could be wrong. 

From a practical perspective, the patent waiver is, in my mind, political for at least two reasons.  First, the United States' standing in the world has sunk because of Donald Trump’s presidency.  In my humble opinion, he amplified some important issues, but took us down a path of challenging and alienating our allies.  Attempting to make COVID-19 treatments and vaccines available to people around the world is a great way for the United States to exercise so-called “vaccine diplomacy.”  And, let’s face it: the United States needs India on our side.  Biden is trying hard to prove that “America is back.”  That we don’t just give a crap about ourselves, but want to be there to support the rest of the world.

Second, I am doubtful the waiver will ever be adopted or fully implemented.  Why?  The United States' support for the waiver, in my mind, is about creating negotiation leverage.  The pharmaceutical industry will fight tooth and nail for every step protecting their business model, and one effective way to increase access is to create bargaining leverage through policy levers.  The United States has been dealing with a drug pricing crisis before COVID-19, and it hasn’t gone away.  Yes, I am very grateful to the pharmaceutical industry for the COVID-19 vaccines, but as others have pointed out, they have been well-compensated by the U.S. government and others who can pay.  The end result from all of this should be increased cooperation to manufacture and distribute vaccines and treatments, and the setting of a reasonable price for the vaccines and treatments.  Can you guess who is still going to make a lot (MORE) money?  Finally, do I think this is going to result in a world where people will no longer see human health innovation as something to be invested in without the potential of sufficient profits?  A world where patent protection will be waived all the time?  C’mon.  I seriously doubt it.

So, to sum up: Let’s save as many lives as we can and get the world economy back on its feet; Let’s continue to be a strong influence and partner supporting democracy and freedom throughout the world; and Let’s reach a compromise fast--protecting everyone's interests to the best extent possible--on how to move forward expeditiously to save lives.  

U.S. Office of Special Counsel finds Misuse of Funding for Vaccine and Emergency Preparedness

The U.S. Office of Special Counsel has found that the U.S. Department of Health and Human Services has misused funding allocated for vaccine preparation and emergency preparedness over the course of many years.  The funding was intended for use by the Biomedical Advanced Research and Development Authority (BARDA).  The press release notes that some apparently referred to the “Bank of BARDA.”  The press release of the Special Counsel states:

The U.S. Office of Special Counsel (OSC) today sent letters to the President and Congress alerting them that, over the last decade, the U.S. Department of Health and Human Services (HHS) misappropriated millions of dollars Congress intended to fund vaccine research and emergency preparedness for public health threats like Ebola, Zika, and COVID-19. A whistleblower alerted OSC to the misuse of funds appropriated to the Biomedical Advanced Research and Development Authority (BARDA) within HHS. OSC referred the allegations for investigation by the agency, which was conducted by HHS's Office of Inspector General (OIG). The investigation substantiated many of the allegations, finding that since at least fiscal year (FY) 2010, the Office of Assistant Secretary for Preparedness and Response (ASPR) misused funds appropriated for BARDA and failed to accurately report this mismanagement to Congress.   

The report contains evidence that ASPR used BARDA's research funds to pay for myriad unrelated expenses, including the removal of office furniture, administrative expenses, news subscriptions, legal services, and the salaries of personnel who did not work for BARDA. The report reveals that the practice of using BARDA funds for non-BARDA purposes was so common, there was even a name for it within the agency: “Bank of BARDA." HHS OIG determined that ASPR had “violated the Purpose Statute" and “potentially violated the Antideficiency Act."

While the report does not contain a specific estimate for total funds misappropriated, it contains evidence that as recently as FY 2019, approximately $25 million was taken from BARDA's Advanced Research and Development (ARD) programs and improperly provided to ASPR. Moreover, from FY 2007 to 2016, ASPR's reporting to Congress failed to account for $517.8 million in administrative expenditures. The report found that “ASPR is unable to demonstrate that the[se] BARDA funds were used for their appropriated purposes."

In response to the findings, HHS's Assistant Secretary for Financial Resources and Office of General Counsel have initiated an internal review of the agency's use of ARD funding for FY 2015 through 2019 to identify potential Antideficiency Act violations. The agency has also hired an outside accounting firm to audit the agency's use of ARD funding, both of which are estimated to be completed by the summer of 2021.

“I am deeply concerned about ASPR's apparent misuse of millions of dollars in funding meant for public health emergencies like the one our country is currently facing with the COVID-19 pandemic," said Special Counsel Henry J. Kerner. “Equally concerning is how widespread and well-known this practice appeared to be for nearly a decade, even garnering the nickname 'Bank of BARDA.' I urge Congress and HHS to take immediate actions to ensure funding for public health emergencies can no longer be used as a slush-fund for unrelated expenses."

Free Colloquium -- "Technological Progress, COVID-19 and the Future of Globalization"

VIT University Law School in Chennai, India is hosting a Zoom colloquium titled, “Technological Progress, COVID-19 and the Future of Globalization” on June 22 at 6:30 pm Indian Standard Time (6:00 am PST (California); 3:00 pm GMT+2 (Belgium) 9:00 pm GMT+8 (China)). The colloquium participants will offer their preliminary thoughts concerning issues ranging from intellectual property access to vaccine development and manufacturing to investment and the World Trade Organization.  Given the nature of the colloquium, we will not cover all potential issues.  However, a follow-up conference exploring these and additional issues in depth is tentatively scheduled for the Winter of 2020 or Spring of 2021 in Chennai. 

The participants in the Zoom colloquium include: Dean Gandhi Manimuthu (VIT Law); Mark Lemley (Stanford Law); Jim Chen (Michigan State Law); Martin Husovec (Tilburg University); Kirsten Schmalenbach (Univ. of Salzburg Law); Stephan Kirste (Univ. of Salzburg Law); Henrik Andersen (CBS Law); Liu Lina (Xi’an Jiaotong University); Prabash Ranjan (South Asian University); James Nedumpara (Indian Institute of Foreign Trade); Ana Rutchsman (St. Louis Law); Patrick Warto (Univ. of Salzburg Law); and Mike Mireles (Univ. of the Pacific, McGeorge Law).   If you are interested in participating via Zoom, please contact Mike Mireles at msmireles@gmail.com.  There are limited spots available.  Thank you!

U.S. Army Receives Remdesivir at No Cost

Back in March, the U.S. Army signed a deal with Gilead Sciences to receive Remdesivir at no cost to treat Covid-19.  This is especially important given the recent study demonstrating Remdesivir as a potential effective treatment for Covid-19.  The Military Times discusses the deal as well as work on a vaccine which started in January, here.  

Anthrax suicide would have benefited financially from patents

Today's Los Angeles Times has a chilling story about the Anthrax scientist Bruce Ivins who committed suicide after the FBI closed in on him as the perpertator of the Anthrax attacks in 1991. Wikipedia has chronicled his life here.

It seems that Bruce Ivins is co-inventor on two patents relating to the production of Anthrax Vaccine: US6387665 and US6316006 (he's also listed on the Espacenet website with two further patent applications which postdate the attacks).

The LA Tsime points out that a San Francisco based company VaxGen won the rights to produce the vaccine post the attacks. Part of the revenue would have been paid to the inventors, according to the report. However VaxGen could not produce the vaccine and the contract was terminated.

It has been recently reported that VaxGen has now sold the rights to the vaccine to competitor Emergent Biosolutions for USD 2 Million plus up to USD 8 Million in milestone payments. In an unfortunate coincidence of timing Emergent Biosolutions issues a press release on 31 July 2008 stating that they had submitted a proposal in response to the US Government's RFP for the developement and procurement of a recombinant protective antigen anthrax vaccine.