The coronavirus outbreak has swept the world swiftly and violently, becoming a global pandemic and affecting many millions, currently with no treatments or vaccine. To best deal with this health crisis and fight the pandemic off, the world should work together to provide medical care for those in need: tests and diagnostic tools, medical devices, technologies, medications and vaccines, as soon as possible. This may not seem like the right time to worry about intellectual property rights. But intellectual property is part of new and existing medical technologies and treatments, and medical innovations use the patent system for protection. In an effort to save lives and rid the world of this pandemic, how can we balance intellectual property protection and quick medical help?
What is a patent?
A patent is a property right. Patent protection gives owners the right to exclude others from making, using, selling, distributing, offering for sale or importing the claimed invention without the patent owner’s consent. This right exists for a limited time and is territorial, meaning the protection is granted only in the territory that granted patent rights.
Why offer patent protection in the health industry?
Medical research is often costly, lengthy, and high-risk. Patent protection was constructed for a reason: to give incentive for investment of knowledge, time and money toward medical innovation and further research and development. Our hope is that patent protection will result in better medical care and ultimately, better health.
Existing patents and COVID-19
Existing biomedical patents may result in delays or obstructions during a health crisis. One such example is a company called Labrador Diagnostics that attempted to block the production of COVID-19 test kits due to “patent infringement”. Following media coverage and public response, Labrador Diagnostics announced that it will offer to grant royalty-free licenses to third parties to use its patented technology in COVID-19 tests.
A company that currently holds an essential patent, may cause delays. Even if this patent-holding company makes efforts to manufacture, sell and distribute quickly during the pandemic, it is likely to be too slow to meet demand. This creates a tension between IP protection and health. Should patent protection stop patients from getting the help they need due to shortages of essential medical equipment?
The past few months have seen doctors doing their best to treat patients and find solutions for essential medical equipment. A team of doctors in Italy faced shortages of valves needed to give life supporting oxygen to patients, since the Italian company holding the patent on the valve was not able to meet the surging demand. Engineers were able reverse engineer the valve and used a 3D printer to make their own. Making the valves constitute an infringement on the rights of the company that owns the IP rights for the valves. However, in this case the company clarified that it wasn’t going to sue.
The race for new patents
Government funds, government agencies, the scientific community and R&D companies around the world are racing to develop a vaccine for COVID- 19. Some are looking into existing vaccines that were developed for other viruses. Others attempt to develop a vaccine based on new technology. In the United States, the FDA is looking to fast track approval for a COVID-19 vaccine. Dr. Anthony Fauci, the head of the National Institute of Allergy and Infectious Disease, noted that “this is the fastest we have ever gone from a sequence of a virus to a trial,” but an FDA-approved product will not be available before next year.
The patent system during the crisis
To fight the corona virus, governments may use the tool of IP suspension. This means that the vaccine, treatment or equipment will be public domain at least for some time, allowing for large-scale manufacturing and lower prices.
As a result of the coronavirus outbreak, Germany’s parliament extended powers to suspend patent rights, a tool last used in the country in 1949, although it was not invoked immediately. Israel invoked an emergency patent-suspension clause in its 1967 code for the first time, allowing it to import a generic version of a drug which has the potential to be helpful with coronavirus. In the U.K., the government has the power to suspend protections that it would normally grant a patent holder.
In the United States, $3 billion out of the recently-signed $8.3 billion bill to fund the response to the coronavirus outbreak is assigned to new vaccine research and development. A new vaccine developed with government funding is likely to raise questions of ownership and pricing for both the health system and individuals. Under the Bayh-Dole Act (the Patent and Trademark Law Amendments Act) the government can retain ownership rights in some patents for inventions arising from federal government-funded research. In the past, the U.S. government guarded the principle of free market and did not attempt to override intellectual property rights regarding pharmaceutical products developed using public grants and funding, but this case may be different.
Options for patent protection
To help with the effort to fight COVID-19, many countries offer public funds and grants to support COVID-19 vaccination research programs. This raises various questions, including the question of intellectual property protection and ownership for the developed vaccine. Patent protection for coronavirus vaccine depends on who develops the treatment and in what circumstances.
IPWatchdog listed scenarios that may affect ownership and use of IP rights related to a coronavirus vaccine in the U.S.:
(1) Coronavirus IP is owned by U.S Government
If a U.S. government researcher develops the vaccine as part of her or his work, the U.S. government owns its employees’ work. Patent application is likely to be filed by the agency they work for, and an industry partner can license the IP.
(2) Coronavirus IP is funded by U.S. Government which holds a license
Under the Bayh-Dole Act, if federal funds were used to develop the vaccine, the company or university must elect to retain possession of its IP rights and undertake disclosures to the government. In return, the government would have a non-exclusive, irrevocable license to practice the invention, if needed.
(3) Coronavirus IP is funded by U.S. Government which uses compulsory license
In case the funded company fails to bring the product to market, or where “action is necessary to alleviate health or safety needs,” the government has a right to force the funded company to license its rights to a third party to bring the patented invention to market.
This procedure has never been used in the pharmaceutical industry before.
(4) Coronavirus IP is not funded by U.S. Government which uses compulsory license
Even if the government has no rights to ownership of the intellectual property, it can get involved. If the company does not provide the vaccine to the U.S. market, the government can order another company to manufacture it in the name of the public good, and provide “reasonable” compensation to the patent holder.
According to IPWatchdog, there are other regulatory exclusivities that could limit the ways that the U.S. government can get an FDA-approved vaccine to market.
Wiser Patent Protection
The coronavirus pandemic unites people and governments globally in the search for safe and effective treatments. This is an unusual situation in which governments are likely to play an active role in IP rights associated with COVID-19, even if only temporarily.
The quest to protect your patent normally does not involve the government but instead unscrupulous companies who attempt to infringe on your protected rights.
Wiser Market’s advanced monitoring system and team of experts provide full online coverage and end-to-end service that together achieve an exceptionally high success rate in online IP protection at all times.
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