The U.S. biotechnology and pharmaceutical industries are furiously mobilizing to develop vaccines and drug therapies against COVID-19, as rapidly as possible. As of May 12, more than 1,400 clinical trials were underway to evaluate potential COVID-19 drugs and vaccines.
Unfortunately, the fully privatized nature of U.S. biopharma research and production poses a major barrier that will slow development, despite the acute public health demand. This situation is a legacy of the biopharma companies’ 40-year history of aggressively seeking patent protection for their products in order to secure monopoly intellectual property rights, and thereby guarantee future profit margins. Moreover, as Truthout has reported, “top health officials coordinating the Trump administration’s COVID-19 response indicated to Congress … that they cannot guarantee universal access to vaccines for the highly contagious disease once they are developed.”
Millions of people have been spared the scourges of smallpox, polio, mumps, measles and influenza infections through vaccinations. The federally funded U.S. biomedical research system has led the world in opening up new avenues for understanding and treating viral infections. However, a disturbing feature of the otherwise extraordinarily productive biomedical public sector is the absence of pathways for manufacturing — as opposed to discovering — drugs or vaccines. Vaccine and therapy development and manufacturing are effectively reserved for the private sector.
Despite the effectiveness of vaccines, a recent report describes the limited investment of the biopharma industry in vaccine development. This follows from the difficulty in charging high prices to poor populations in need, such as in Africa, and that many effective preventive vaccines will not have large markets once the infection they are addressing is contained. This history highlights an enduring and troubling aspect of drug development in the U.S: private profit often takes precedence over the public good.
Drug and Vaccine Patents Impede Progress
Typically, biopharma scientists and companies neither share nor reveal their results until they have been able to file patents to protect their “investment.” They employ small armies of intellectual property lawyers to secure patents covering their products. A patent allows the owner to prevent others from using or benefiting from the patented invention, process or construct without compensating the holder.
When the patent covers a form of information, such as that encoded in genes, the holder can prevent others from using the information. For example, Myriad Genetics, which holds patents on human breast cancer gene sequences, regularly threatens clinical scientists with patent infringement if they offer an equivalent test to their patients.
The secrecy and nondisclosure agreements that dominate the relationships among biopharma firms follow from key features of U.S. patent law: once information has been publicly communicated, it loses patentability. Thus, corporate employees cannot report their results — either positive or negative — publicly, prior to patent filings. This secrecy leads to redundancy and inefficiency in research among different firms and slows progress.
The 20-year monopoly granted to the patent holders allows a company to prevent other efforts to produce or utilize the “invention,” even if for medical purposes or human welfare. Patents are routinely deployed to block the development of competing and potentially more effective products. Gilead, a corporate holder of the patents on the drug Remdesivir, is already in conflicts and international competition with Chinese COVID-19 efforts. As Juliana Broad reported for Truthout, the patenting of an Ebola virus vaccine by a U.S. firm — initially developed by Canadian public health scientists – delayed vaccine production.
Thomas Jefferson wrote many of the original U.S. patent laws. He understood clearly that patents were a form of limited monopoly. The new nation had come into existence in part out of resistance to the noxious aspects of monopoly practices imposed by the British. Jefferson believed the importance of the patent laws lay not in the generalized protection of private property, but in the limited and specific purpose of ensuring that creative and inventive individuals were able to make a living from their work, and thus continue to contribute to society. He wrote that whenever this monopoly was contrary to the public interest, the public interest would take precedence.
Most people associate patents with true inventions of machines, novel processes or chemical reactions. However, this changed in 1980 when the U.S. Supreme Court granted patent protection for genetically engineered Pseudomonas bacterium in Diamond v. Chakrabarty. This narrow 5-to-4 decision opened the door to other firms applying for patents on genetically modified organisms and cell lines.
During the same year, Congress passed the Bayh-Dole Act, which allowed patents to be taken on products of research that had been publicly funded without any compensation back to the funding agency or the U.S public.
Since then, U.S., British and European patent offices have issued thousands of patents on genetically modified genes, proteins, viruses, plants, animals and even human cell lines. Drug companies own patents on human cell lines and on thousands of human genes. Genentech owns patents on a variety of important human growth factors; Eli Lilly owns the patent on the human insulin gene.
The patents give corporate owners the legal right to prevent competitors or any other institutions — including nonprofit organizations — from making use of the patented information, including to produce viral proteins as candidate vaccines.
Thus, though the technology for isolating the human insulin gene from human cells is widely distributed, anyone trying to produce human insulin is subject to legal challenge by Eli Lilly. Hundreds of millions of dollars in such suits are brought regularly by the biopharma industry as companies jockey to control their protected markets. For many drugs, it is these patent monopolies that allow for the egregious overpricing of pharmaceuticals in the U.S. market.
Patent lawyers and biotech executives regularly put forward the specious argument that without patent protection, none of these drugs or vaccines would be developed. In fact, publicly funded scientists working without patent protections are largely responsible for developing nearly all the advances in molecular biology and genetic engineering that have provided the foundation of the biopharma industry. One has only to go back to Jonas Salk who, when asked why he didn’t patent the poliovirus, famously replied, “The people own the patent.”
The High Productivity of Public Sector Research
In contrast to privatized drug development, the extraordinary productivity of the U.S. public biomedical community arises from a set of values and practices in which almost all results are openly shared, and withholding results is the basis for being made a pariah among one’s peers.
Publicly funded scientists compete, but they compete to publish and communicate their results, not to hide them. The very absence of privatization and its coupled barriers to open communication is one of the main reasons that U.S. biomedical science is the most advanced and effective in the world. This was originally codified during WWII in the Public Health Service Act of 1944, a law that empowered Congress to appropriate public funds for grants to private individuals and institutions such as colleges and universities.
The competitive peer-reviewed grant system has been enormously successful since then. All of the historic breakthroughs in the identification of the genetic code; determination of the structure of DNA, RNA, proteins and viruses; and advances in cell biology and neuroscience were made without patent protection or related financial reward. The rewards of public recognition, research grants, academic appointments and the satisfaction of advancing human knowledge were apparently sufficient to motivate most scientists for decades.
In fact, the much hoped-for success of the biopharma industry in the COVID-19 vaccine effort relies on a foundation of public knowledge known as the “Protein Data Bank.” This is a repository of all known structures of proteins, viruses and nucleic acids accessible to any person on Earth who has access to a web browser connected to the internet. If you click on this link, you will be taken to the Protein Data Bank website, though a version more suitable for nonscientists is here.
The latest structural information on COVID-19 and its proteins critical for vaccine development is available at a first glance on the homepage. The structure of the spike protein that is now the major candidate for vaccine development is freely available. Every biopharma firm in the world working on developing a vaccine against the virus or its proteins uses this information for free.
Once they have made a certain amount of progress, they will file for patent protection for their “invention.” Prior to filing, they neither reveal nor share their results and most critical employees are required to sign explicit nondisclosure agreements.
This extraordinary human resource is the product of a decision made by protein crystallographers in 1971 at the Cold Spring Harbor meeting on protein structure to establish a public data bank. By 2003, crystallographers around the world had agreed to deposit their data establishing a Worldwide Protein Data Bank.
In contrast, when human genome sequencing was emerging, a major battle developed between the corporate interests who wanted to privatize the gene sequences through patenting, led by Craig Venter, founder of Celera Corporation, and the public genome sequencing effort led by Eric Lander, then at the Massachusetts Institute of Technology’s Whitehead Institute.
Every sequence that the public group released prevented Celera from applying for a patent on the sequence. Every sequence that Celera obtained before the public-sector releases became a candidate for a patent filing. This public/private tension was the underlying basis of the “race” that media outlets regularly reported on.
All of the factors described above that are influencing the development of COVID-19 vaccines also hold true for the development of therapeutic drugs, which are likely to act by blocking steps in the infectious process, or the intracellular replication or assembly of new viruses. For example, since Gilead already owns the patents on Remdesivir, effective against the SARS virus, other biopharma firms will not be pursuing closely related compounds that could possibly be effective against COVID-19.
A Reverse Manhattan Project
Moving as rapidly as is safely possible to develop a vaccine for COVID-19 requires initiating efforts on multiple, diverse scientific fronts, and at the same time, maintaining continued and open lines of communication and coordination. This process would allow scientists to abandon certain avenues of research as soon as evidence emerged that they were unproductive and to shift resources into more productive pathways.
This can only be done through a nationally coordinated project, unburdened by privatization and patent secrecy. Sen. Ed Markey, Massachusetts General Hospital President Peter Slavin and scientists have called for a Manhattan Project-scale response to the COVID-19 outbreak.
More accurately, we need a reverse Manhattan Project. In that original effort, hundreds of billions of dollars were drawn from the civilian economy to fund the A-bomb effort, over and above the funds needed for the ongoing war effort in Europe and in the Pacific.
To finance new COVID-19 vaccines and therapies requires shifting hundreds of billions from the bloated and nonproductive $738 billion Pentagon budget into a coordinated campaign in the public sector, over and above the enormous funds needed to protect the vulnerable sectors of the population from the economic downturn.
The lead agencies in this effort should be the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and the Biomedical Advanced Research and Development Agency (BARDA). The natural director would be National Institute of Allergy and Infectious Diseases Director Anthony Fauci. In fact, NIH Director Francis Collins has recently announced the formation of a new public-private initiative to speed vaccine development, but it’s only a small step compared to the need.
There are a variety of precedents to developing products and technologies outside of the patent system, but perhaps one of the most prominent is the Atomic Energy Act of 1946. This legislation established civilian control over atomic energy and atomic weapons and, for all practical purposes, prevented private patenting of developments in nuclear science processes and devices. (Though many patents were filed by individuals “in secret,” none were ever granted to the scientists.)
One step Congress could take would be to declare that COVID-19 vaccines and therapies are responding to a national emergency, and therefore cannot be the subject of patents. Biopharma companies would be compensated for their investments and expenditures, but could not use patents to ramp up prices or exclude potential competitors.
Given the muscle of the biopharma industry, as has been demonstrated in the unsuccessful efforts to control price-gouging or to limit intellectual property features or trade agreements, the above won’t be politically possible without a tough fight.
An easier solution could simply be to return to the pre-1960s environment that gave birth to the Salk vaccine, a period in which vaccines and drugs were developed in publicly funded laboratories and produced where needed through conventional contracts with biopharma labs to prevent price-gouging. This plan would involve increasing the NIH, CDC and BARDA budgets to cover the costs of production scale-up and organizing clinical trials.
President Trump’s budget proposals have called for funding cuts to these biomedical research agencies in order to release funds to increase the Pentagon budget. A good start on increasing federal investment on the public health front would be to take $75 billion from the worst aspect of the nuclear weapons budget, detailed in Senator Markey’s SANE Act, together with the $70 billion Overseas Contingency Operations Pentagon slush fund. These funds should be added to the further versions of the CARES Acts to prioritize vaccine and therapy development.
Let’s hope leadership emerges in the House or Senate to promote these critical reforms. Decreasing the time needed to develop effective vaccines or therapies could save hundreds of thousands of lives.