This is a very common pattern. As medical researchers become successful and develop new drugs that are treatments or effective treatments, there are calls for patents to expire.
This is currently happening with COVID-19 vaccines, therapies and antiviral treatments.
Some public health advocates believe the World Trade Organization, which oversees the protection and enforcement of intellectual property around the world through a complex international trade agreement known as TRIPS, has extended the rights of COVID-19 drug patent holders. should be “abandoned”.
This means that the WTO should allow the use of COVID-19-related patents without the consent of the patent owner.
This is a bad idea, with little short-term gain and huge negative impacts on public health and innovation in the medium to long term.
To understand how a WTO waiver would be a disastrous policy choice, it is important to understand what patents do and why.
What is a patent?
A patent is essentially a government license granted to an inventor to preclude others from making, using, or selling his invention for a period of time.
In the United States, patents last only 20 years. If you find a cure for cancer or a solution to global warming, you own the intellectual property you create for just 20 years.
In the United States, patents last only 20 years.
This means that in 20 years, you will be able to copy and use whatever complicated recipe you create, no matter how expensive or time consuming it may be.
In fact, inventions are patented as soon as they are discovered, so before they are perfected or ready for sale, the actual patent life for most drugs is well below 20 years.
Compare patents and copyrights. If you wrote the great American novel, it would give you the exclusive right to sell, reproduce, make derivative works of, distribute copies of, and perform your novel for the rest of your life and his 70 years. You will be taken!
Patents Drive Innovation
Patent holders are granted 20 years of exclusivity to encourage innovation.
It takes over 12 years and about $2.8 billion to bring a new drug from a laboratory concept to an FDA-approved drug. And most pharmaceutical concepts fail halfway through lab or clinical trials.
It takes more than 12 years and about $2.8 billion to take a new drug from a lab concept to FDA approval.
Only 1 in 1,000 new drug candidates make it onto pharmacy shelves.
Who would put so much time and money into something so risky? What if, if successful, someone could get hold of that recipe and produce the drug without paying for R&D, just at manufacturing costs?
Successful drugs make a profit, but that profit goes to all R&D—the few that succeed and the many well-intentioned and well-designed projects that don’t.
Patent enabled COVID vaccine, treatment
Biopharmaceutical companies have reallocated and mobilized R&D resources (scientists, laboratories, clinical trial infrastructure) from many other projects to tackle COVID-19 in record time.
In less than a year, a safe and effective vaccine was developed and, importantly, produced in large quantities and distributed widely.
Biopharmaceutical companies have reallocated and mobilized R&D resources from many other projects to tackle COVID-19 in record time.
Additionally, COVID-19 therapeutics and antiviral drugs have been developed, many of which have therapeutic value for diseases and conditions other than COVID-19.
The next time an unknown pathogen threatens us, will biopharmaceutical researchers divert their research budgets to combat new pathogens if they can give away the IP they develop?
Abandoning WTO patents is unwise
Unfortunately, this is exactly what the WTO decided.
In June, after much lobbying by developing countries, notably India, the WTO decided to waive certain rights of COVID-19 vaccine IP patent holders, allowing access to patented COVID-19 technology. I agree with
The European Union, Switzerland, and the United Kingdom vehemently opposed it, citing its impact on innovation.
Exemption turned out to be unnecessary for several reasons.
The U.S. initially opposed it, but the Biden administration has since relented on the grounds that the abandonment would be a one-off policy adjustment to address the alleged COVID-19 vaccine shortage.
Exemption turned out to be unnecessary for several reasons.
Low vaccination coverage in many developing countries has often been attributed to vaccine reluctance. And by the time the waiver was issued, the biopharmaceutical industry voluntarily shared his IP, resolving supply issues where its manufacturing and distribution expertise existed.
Expanding WTO exemptions makes even less sense
The logic behind the June waiver was flawed, but the WTO is now considering extending the patent waiver to COVID-19 diagnosis and treatment.
Industry advocates, including the CBIA’s Bioscience Growth Council, are speaking out against it.
There is no shortage of supply, so the proposed expansion of the exemption will be a giveaway.
With no shortage of supply, the proposed waiver expansion is a freebie for manufacturers in developing countries.
The benefits they enjoy are dwarfed by the devastating impact of such policies on innovation.
Paul Pescatello is Executive Director of the CBIA’s Bioscience Growth Council and Chair of the We Work for Health Connecticut. follow him on twitter @CTBio.
