As the world continues to tremble under the weight of COVID-19 outbreak, with the numbers of fatalities and those infected continually increasing, new and urgent needs for diagnostics, medical supplies and treatment arise. Shortages of supplies and care-givers are putting medical personnel and those infected in a life-threatening position. Given this, some countries are considering to take strong measures to ensure affordable access to medical supplies including respirators, ventilators, diagnostic tests and any drugs or vaccines to protect public interest and ensure national and economic stability. Those supplies that people so desperate need are protected by valuable patent rights. How can public necessity during emergency outweigh otherwise valuable patent rights? And what is the response from patent owners?
On 17th March, the parliament of Chile declared a resolution that the pandemic outbreak of COVID-19 justifies the use of compulsory licensing to facilitate access to vaccines, devices, drugs, diagnostics and other goods and technologies for surveillance, prevention, detection, diagnosis and treatment of people infected with the virus in Chile. Two days later, Israel issued compulsory patent license related to drug (brand name Katetra), medicine primary used for the treatment of HIV, which is currently being tested for effective treatment of COVID-19. Full text can be found here.
Compulsory licensing is when a government allows someone else to produce a patented product or process without the consent of the patent owner or plans to use the patent-protected invention itself. It is one of the flexibilities in the field of patent protection included in the WTO’s agreement on intellectual property — the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement. TRIPS allows each country to limit the circumstances and causes of their issue. TRIPS also stipulate that the proprietor of the patent must be adequately paid for copies of the product.
In the past compulsory licensing was used in Israel, South Africa, Colombia,.. Chile and Malaysia are also an example of countries that passed regulatory exclusivity waivers for cases of compulsory licensing. United States, however has two laws on the statue enabling it to override patent rights. ”The 1980 Bayh-Dole Act which confers federal agencies with “march-in rights” to compel the granting of a licence for the use of a patented technology that was developed with the help of federal funding. This can be done if “action is necessary to alleviate health or safety needs”. Given the role of the federal government in funding several candidate COVID-19 medicines, this should be widely applicable to Coronavirus-related patents.”
In Europe all European Patent Convention member states have national laws allowing governments to compulsorily license of use patents in the interest of public health, such as when life-saving inventions are at stake, as long as reasonable compensation is paid. Grounds for grant for compulsory license may differ between countries as this depends on the national civil or administrative procedure. If you are interested in specific European country and its justifications and conditions for compulsory licensing, full text in English is available on here.
But it is not solely government’s that exercise its compulsory licensing rights, but in some cases, so it seems- benevolence of companies, that open inventions and usage of patents to the public.
One such case is drug manufacturer AbbVie, which excluded enforcement of its global patent rights on the HIV medication, Kaltera, while the drug is being tested as a efficient medication for the treatment of COVID-19. What does that mean? It means that the generic version of Kaltera can be made by others without threat of being sued of patent infringement. If found to be an effective treatment, Kaltera can be more easily brought to market and alleviate possible drug supply shortages.
On the other hand, research-based biopharmaceutical company Gilead Science Inc. was granted orphan drug status, due to restrictions issued by the company for drug called Remdesivir. Restrictions have been made due to overwhelming demand according to Gilead. Under the Orphan Drug Act, Remdesivir, being one of the most promising medications in treatment of COVID-19 cannot be supplied by generic drug manufactures.
Emergency that we are currently facing, is also encouraging the potential rise of 3D printing. For instance in Italy engineers designed the digital version of a patented valve used for life-saving treatments of COVID-19 patients. They were soon threatened to be sued for patent infringement. Although, strongly needed move by engineers, which resulted in 10 saved lives and has the potential to save more lives, example is shedding a light on 3D printing as indirect patent infringement. In our next video we are going to explain what is exactly indirect infringement and how does EU legal framework differ from the one in USA regarding indirect infringement.
Gilead Science Inc. is one of many patent owners that takes advantage of
patent system’s exclusionary rights, whether this is morally legitimate one can
judge on its own, but one thing is certain. With an urgent need for global
collaboration, and increasing demand of medical supplies etc., this decision
needs to be done quickly. Whether the decision will be made by patent owners