Biden Trips Badly on Intellectual Property in TRIPS | Citizens Against Government Waste

Biden Trips Badly on Intellectual Property in TRIPS

The WasteWatcher

Less than two weeks after celebrating America’s commitment to the protection of intellectual property (IP) on April 26, World Intellectual Property Day, and claiming in a statement that the policies of his administration will continue to allow the U.S. to lead the world in innovation, President Biden undermined everything he said by agreeing to support a proposed waiver of COVID-19 patents under the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights (TRIPS).  While the purported intent of this effort is to increase the availability of vaccines, it will instead make that objective more difficult; give competitors like China and Russia access to valuable technology; make socialists in Congress like Sen. Bernie Sanders (I-Vt.)  and Rep. Alexandria Ocasio-Cortez (D-N.Y.) happy by undercutting intellectual property and starting a government takeover of the pharmaceutical and subsequently other industries; and turn the Biden administration into a nest of brazen pirates.

Citizens Against Government Waste (CAGW) strongly supports intellectual property (IP), not only because it is the only property right protected in the Constitution, but also because it encourages innovation and changes an intangible asset into property that can be traded and sold.  CAGW President Tom Schatz expressed his concern over the fragility of IP in an April 26 blog, “All Nations Must Respect and Protect Intellectual Property Rights,” and a wide international disrespect for it, in some cases attempted theft by other countries of IP, especially when it comes to life-saving vaccines and medicines that have played an important role in protecting people from COVID-19.  Never did CAGW think that a U.S. president would lead the charge in forfeiting valuable American patent rights and turning such technology over to global competitors.

TRIPS was created under the auspices of the WTO.  The 164 WTO member countries must follow specific agreements that have been established by the organization, including TRIPS, which requires minimum standards for protecting IP, including patents.  Prior to the TRIPS agreement, 40 countries did not grant patent protection for pharmaceuticals.  For patents, protection is for 20 years, although there are exclusions, and TRIPS does permit “governments to issue ‘compulsory licenses,’ which allow a competitor to produce the product or use the process under license without the owner's consent.  But this can only be done under specific conditions set out in the TRIPS Agreement aimed at safeguarding the interests of the patent-holder.”

In October 2020, India and South Africa (two of the worst countries in the world in protecting IP rights), eventually supported by 100 other countries, asked the WTO to waive provisions in TRIPS that would allow other countries to ignore the property rights of any developer of COVID-19 vaccines, medicines, diagnostics, or any medical technology during the COVID-19 pandemic.  In other words, allow others to steal the technology and produce the products, without compensation to the holders of the IP rights.  Their request states, “Given this present context of global emergency, it is important for WTO Members to work together to ensure that intellectual property rights such as patents, industrial designs, copyright and protection of undisclosed information do not create barriers to the timely access to affordable medical products including vaccines and medicines or to scaling-up of research, development, manufacturing and supply of medical products essential to combat COVID-19.”

The WTO has so far refused to agree to the proposal and the European Union, Japan, and Switzerland oppose the waiver, as did the U.S. up to yesterday.  These countries may feel pressure to follow suit thanks to the Biden administrations’ betrayal of fundamental Constitutional principles and critical IP rights.

A May 5 Inside Health Policy reported that President Biden has been pushed from progressive lawmakers and “civil society” groups for months to adopt the co-sponsors’ proposal.  Sens. Bernie Sanders (I-VT) and Elizabeth Warren (D-MA), along with eight other senators, wrote a letter to the president urging him to adopt the waiver.  Members of the House, like Speaker Nancy Pelosi (D-Calif) and Rep. Jan Schakowsky (D- Ill.), have also pressured President Biden to do the same in order to “ensure the most effective and efficient response to this once-in-a-lifetime global pandemic.”  But these demands are not new as they are consistent with their longstanding and damaging support for legislation that would denigrate and steal biopharmaceutical IP, like the provisions found in H.R. 3, the ”Elijah E. Cummings Lower Drug Costs Now Act.”  This legislation forces up to a 95 percent excise tax on biopharmaceutical companies if they do not accept to sell their product at whatever price the government demands, which is essentially a coerced taking of private property.

The Pharmaceutical Research and Manufacturers of America stated, “In the midst of a deadly pandemic, the Biden Administration has taken an unprecedented step that will undermine our global response to the pandemic and compromise safety.  This decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines.  This change in longstanding American policy will not save lives.  It also flies in the face of President Biden’s stated policy of building up American infrastructure and creating jobs by handing over American innovations to countries looking to undermine our leadership in biomedical discovery.  This decision does nothing to address the real challenges to getting more shots in arms, including last-mile distribution and limited availability of raw materials.  These are the real challenges we face that this empty promise ignores.”

Other leaders in the effort to improve global health, like Bill Gates, were also critical of the decision.  He said, “There’s only so many vaccine factories in the world and people are very serious about the safety of vaccines.  The thing that’s holding things back in this case is not intellectual property.  There’s not, like, some idle vaccine factory with regulatory approval that makes magically safe vaccines.  You’ve got to do the trials on these things and every manufacturing process has to be looked at in a very careful way."

Clete Williams, a former attorney at the Office the U.S. Trade Representative, said, "This is a huge misstep by the Biden Administration that will do nothing to increase vaccine distribution and will endorse China's ability to piggyback on US innovation to further its vaccine diplomacy aims.”  As the House Republican Study Committee tweeted, “America invents it, America makes it, and #China gets to own it.”

The claim that compulsory licensing will speed up vaccine production and distribution is false.  It will take time for the WTO to reach agreement on the waiver’s language and for other countries to scale up production. In addition to violating fundamental principles of IP protection and opening the door for additional “waivers” for other industries and products should the WTO agree to this waiver, vaccines are not easy to manufacture and production mistakes can be easily made.  The Biden administration admits their uncertainty that the waiver will speed up production because of the unique and complicated mRNA technology used in the Pfizer and Moderna vaccines, which took years to develop.  And it is precisely this technology over which countries like China and Russia are salivating to have.  This action will help China reach its 2025 goal:  beating the U.S. in biotechnology.

The waiver is not only dangerous, it is also superfluous, because Johnson & Johnson, Moderna, and Pfizer are already producing tens of millions of doses of vaccines and gearing up to produce more, and all have plans to distribute them around the world without any need for the WTO to intervene or allow their IP to be stolen.

Moderna stated on April 26 that it was working with Sanofi to produce 200 million doses by September 2021 and announced on May 3 a supply agreement with Gavi (the Vaccine Alliance that supplies vaccines to the COVAX Facility) to make up to 500 million doses to help end the pandemic in the lowest income countries.  Moderna is also working with the World Health Organization for the emergency use of their vaccine and UNICEF to help with distribution of vaccines.  Pfizer is in the process of delivering 200 million doses in the U.S. by July 31, 2021 and stated on May 2 it would be shipping 4.5 million doses of its COVID-19 vaccine to South Africa by June.  While the company is still waiting for India to register its COVID-19 vaccine (making it highly suspicious that the waiver is simply an attempt to steal the patents since it would be faster to finalize approval), Pfizer is already sending other free medicines to assist their public hospitals in fighting COVID-19.  Johnson & Johnson, in spite of some setbacks, resumed production on April 23 and had administered 6.8 million single-shot doses. 

It is important to remember the development and clinical testing of all the vaccines have occurred in less than a year and these companies have been preparing for months to scale up their production.  When they received emergency use authorization from the Food and Drug Administration, they were ready to start shipping the first doses.  Normally it takes several years to research and develop a vaccine.

Just as President Biden is stealing from future generations by proposing massive spending bills costing trillions of dollars, he is allowing the theft of U.S. funded biomedical research, permitting our worse adversaries, China and Russia, to take advantage of the situation.

Instead of acting like a pirate by leading the effort to steal intellectual property, kowtowing to leftist politicians that produce nothing but bad speeches, bad laws, and bad regulations that stifle U.S. ingenuity and have a naïve idea that pharmaceuticals can be magically produced from a Handy Andy Junior Chemistry Lab kit, President Biden should be praising and protecting the intellectual property rights of U.S. innovators that have done a magnificent job in developing life-saving vaccines in record time and are getting them out to U.S. citizens and the rest of the world as safely, quickly, and as efficiently as they can.