There is a race for a COVID-19 cure, and a race to patent it. A U.S. Patent offers a long period of exclusivity. When a drug company owns the patent on a cure, vaccine, or successful drug, and/or the drug gets "orphan status," from the FDA, the price of that product is set by that company and driven by demand. For COVID-19, the demand is not just worldwide, it is the world.
In 1955, Dr. Jonas Salk, whose polio vaccine was announced as safe, effective and potent, was asked who owned the patent on it. He famously replied, "The people." He said, "There is no patent. Could you patent the sun?" Whether he meant there was a moral duty not to own the cure for a pandemic, or he meant it is not patentable, or both, the same principle faces the U.S. Patent and Trademark Office today regarding COVID-19. So far, the answer seems to be yes, a cure, vaccine, or drug to fight COVID-19 is patentable.
There are examples of patented drug prices drugs soaring when demand rises. Several are currently impacting COVID-19 treatment in the U.S.
Sofosbuvir (owned by Gilead Sciences) is a drug used to treat Hepatitis C. It might also be a treatment for COVID-19. It costs $5 to make. In the United States, the current list price for a 12-week course is more than $84,000. Pirfenidone (owned by Roche) is a drug used for lung fibrosis. It costs about $31 for a 28-day treatment course. In the US, a course is priced at $9,606.
Manufacturers say they invest billions in research and development, on many fronts, most of which will never result in a success. They say they deserve to recoup their investments.
But sometimes huge investments of taxpayer dollars in public research and grants have assisted in the R&D, and as with COVID-19, the entire world needs the cure. FDA Orphan status bestows development incentives on the drug sponsor such as valuable tax benefits for clinical testing.
There are conflicts of public interest intersecting with politics. Remdesivir, currently the only drug thought to shorten the duration or lessen the severity of COVID-19, is also made by Gilead Sciences. A member of the White House Coronavirus Task Force was a former lobbyist for Gilead. Gilead offered emergency access to Remdesivir, and the drug is conditionally authorized by the FDA for compassionate use. In March, 2020, the U.S. FDA granted Remdesivir “orphan” drug status, giving Gilead seven years exclusive rights to profit from the sale of Remdesivir. When Gilead said it was ceasing emergency access to Remdesivir, it came under heavy criticism, and then announced it would donate its current stockpile of the drug to the U.S. (size of stockpile not disclosed) and to scale up production. Gilead reportedly received $79 million in US taxpayer funding to help develop it.
A patent period of exclusivity is granted in return for "open science," investors disclosing their inventions to the public, to spur further downstream development and increase the pool of prior disclosed art. Patent pools and international collaboration of experts with no personal financial investments encourage free exchange of ideas for the public good.
Other countries grant their own patents. China's government-run Wuhan Institute of Virology and its military pursued a patent in China over Gilead's product, even though Gilead applied for its own Chinese patent over the drug three years ago.
In March 2020, United States Patent and Trademark Office (USPTO) granted a patent to a Tel Aviv University's professor at the School of Molecular Cell Biology and Biotechnology, for his innovative design for a vaccine for the corona family of viruses.
Also in March, 2020 there was an unsubstantiated rumor that Bill Gates, the Gates Foundation, and/or the Pirbright Institute may own a vaccine for COVID-19.
The European Union recently held an online summit with 40 countries participating. It pledged $8 billion for a COVID-19 vaccine. The United States, however, chose not to participate. It was reported that the current U.S. administration had financial motives for not pooling with other countries, because it thinks U.S. companies will get there first.
“There has been a long history of big pharmaceutical companies charging unnecessary and unwarranted high prices for medications, even if they actually spent very little on research and development for that medication.”