America’s biopharmaceutical and medical technology companies are focused like a laser in discovering therapies, vaccines, diagnostic and serology test kits, and scaling up their production to address the SARS-CoV-2 pandemic.  And they are doing it in record time.

On Tuesday, May 5, Pfizer and BioNTech announced the first participants in a Phase 1 and 2 clinical trial for a COVID-19 vaccine as part of their global effort to fight the disease.  This is the second clinical trial for a COVID vaccine in the U.S. and will determine the safety, immunogenicity (the ability to produce an immune response) and optimal dose for four vaccine candidates in a single study.  A similar vaccine clinical trial dosing occurred in Germany last month.  The two companies are now working to scale up to produce a global supply and Pfizer plans to activate its “extensive manufacturing network and invest at risk in an effort to produce an approved COVID-19 vaccine as quickly as possible for those most in need around the world.” 

The companies have been able to move from pre-clinical studies to human testing in four months, a remarkable accomplishment.  According to the Wall Street Journal, Pfizer will invest $500 million in vaccine research and development and $150 million to gear up manufacturing, with the hope of producing a vaccine for emergency use by the fall.  The concurrent research and production are being done before they even know if the vaccine will be effective and approved by the Food and Drug Administration (FDA).  This is an enormous financial risk, but those kinds of efforts are nothing new for research-based companies.

Unfortunately, there are growing numbers of elected officials within Congress that believe all sorts of things can be done for “free” and have no concept of the economic risk – or even care – what it takes to bring a leading-edge biopharmaceutical to the marketplace.  They believe that companies should release copious amounts of proprietary information concerning their research and development and demanding that after millions of dollars have been spent to produce a promising product and have it approved by the FDA, the company should just give it away.  

Efforts are under way by these big-government progressives to put their regressive ideas into legislation and voted on in the House in a future spending bill.  It would bring about an unprecedented disregard, and some would argue theft, of intellectual property and undermine incentives for biopharmaceutical research and development.  It could instantly dry up the cures that America and the rest of the world are depending on to move forward from the pandemic.  And it could open the door to similar takings of intellectual property in other industries.  

Citizens Against Government Waste pushed back against his dangerous proposal on May 7 with an Inside Sources op-ed and a coalition letter with other property rights defenders expressing opposition to this latest unwarranted attack on the private biopharmaceutical industry that is racing to provide urgently-needed therapies.

Major targets by the anti-property rights, big government crowd are companies that work with the National Institutes of Health or other federal agencies, like the Biomedical Advanced Research and Development Authority, to bring federally funded research to the marketplace.

Prior to 1980, 95 percent of all federally funded research sat deserted, but the Bayh-Dole Act opened up this research to for commercial development.  Patentable inventions that are a consequence of federal funding allow the research entity, like a university that made the discovery, to keep the patent and partner with manufacturers that would take the financial risk to develop and commercialize the discovery.  One would think big-government types would want this research to be utilized.  But, they not only attack research that started with government funds, they are after all biopharmaceutical research.

The federal government no longer funds a majority of basic research, according to a March 2017 Science article.  The pharmaceutical industry is the primary source of basic research, while universities and private foundations’ investments are increasing.  The legislation would deny “exclusivity for any COVID-19 vaccine, drug, or other therapeutic – whether it has been developed with U.S. taxpayer dollars and publicly funded, or not.”

More than 300 clinical trials are underway for COVID-19 treatments and vaccines.  If the intellectual property is going to be stolen and none of the money invested can be recovered, there will be a significant setback to these efforts.  At that point, it will be interesting to see where these so-called progressive members of Congress will go to find the cures for their constituents.