‘Owning’ the Cure: Patent rights in the midst of an outbreak

As early as Dec. 31, 2019, the World Health Organization (WHO) was informed of the steadily increasing number of cases of pneumonia of unknown etiology detected in Wuhan City, Hubei Province of China. Over the next three weeks, researchers connected the spread of the outbreak to a market in Wuhan City and identified the cause of the contagious and potentially fatal respiratory disease to be a new type of coronavirus, which is now infamously known as the Novel Corona Virus (2019-nCoV).

As of Feb. 9, the WHO has reported over 812 deaths associated with 2019-nCoV, and 37,558 confirmed cases of 2019-nCoV worldwide with 37,251 confirmed cases in China alone. The first death reported outside of China was in the Philippines, a few days after the Philippine government confirmed the first case of 2019-nCoV in the country.

In a Feb. 4 statement, the Wuhan Institute of Virology confirmed that on Jan. 21 it applied for a patent in China for the use of Remdesivir, an experimental antiviral drug originally intended to treat the Ebola virus and developed by Gilead Sciences, Inc., an American pharmaceutical company.* The Chinese organization, in its statement, further claims that the patent application was filed out of national interest, and that it will not exercise its patent rights if “relevant foreign companies intend to contribute to China’s epidemic prevention and control.” Gilead Sciences, through its Chief Medical Officer Dr. Merdad Parsey, in its Jan. 31 Company Statement, stated that, although Remdesivir is not yet licensed or approved anywhere in the world and has not been demonstrated to be safe or effective for any use, Gilead Sciences is working closely with health authorities in China in conducting trials to test the efficacy of the drug in treating 2019-nCoV, especially considering that available data demonstrates that Remdesivir has shown activity against viral pathogens MERS and SARS, coronaviruses structurally similar to 2019-nCoV, in animal models.**

The legal requirements of patentability may vary in different jurisdictions but novelty, inventive step, and industrial applicability are basic conditions for an invention to be patentable. An invention, or in this case, particularly a drug or component thereof, may generally be considered novel if it is “not known to a body of existing knowledge in its technical field.” An invention must also be capable of industrial application or be useful “beyond mere theoretical phenomena.” The invention must also involve an inventive step or “that it could not be obviously deduced by a person having ordinary skill in the relevant technical field.”*** Thus, in order to be patentable, the patent application over the use of Remdesivir must satisfy the foregoing conditions and ultimately prove that use of the drug on the 2019-nCoV, which has shown activity against other coronaviruses, can be considered a new patentable use.

Although intellectual property rights like patent rights are territorial, patent registrations abroad can affect claims of novelty in other regions thus the local patent registration of the drug in China may affect pending and future patent applications involving the same drug in other jurisdictions. Moreover, the Wuhan Institute has clearly shown its intention to own the patent over the drug in other jurisdictions when it also stated that it will file patent applications for the use of Remdesivir under the Patent Cooperation Treaty (PCT) in other countries.

In the Philippine context, it is worth noting that regardless if a patent over any effective treatment of 2019-nCoV is obtained by any local or foreign entity, the Cheaper Medicines Act, amending the provision of Compulsory Licenses in the Intellectual Property Code, provides that the Director General of the Intellectual Property Office may grant a license to exploit a patented invention, even without the agreement or permission of the patent owner in favor of any person who has shown his capability to exploit the invention, under circumstances such as national emergency or other circumstances of extreme urgency, public interest, in particular, national security, nutrition, health or the development of other vital sectors of the national economy as determined by the appropriate agency of the Government, among others. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) as well as the Doha Declaration on TRIPS and Public Health also affirms the right of States in prioritizing access to essential medicines over patent rights.

Indeed, in the battle against a devastating viral disease, time is of the essence. It may be a while before we know whether or not the patent application will be granted and, if so granted, the full extent of the effects of the grant of such patent as to the free use of the drug in other jurisdictions, and even in the future entry of business from foreign pharmaceutical companies in China. In the meantime, at the very least, it seems that all parties are focused on finding a cure and in saving as many lives as possible.

* China Wants to Patent Gilead’s Experimental Coronavirus Drug (Feb. 5, 2020), Bloomberg News. Retrieved from https://www.bloomberg.com/news/articles/2020-02-05/china-is-trying-to-patent-gilead-s-experimental-coronavirus-drug

** Gilead Sciences Statement on the Company’s Ongoing Response to the 2019 Novel Coronavirus (2019-nCoV) (Jan. 31, 2020) Gilead Sciences Company Statements Retrieved from https://www.gilead.com/news-and-press/company-statements/gilead-sciences-statement-on-the-company-ongoing-response-to-the-2019-new-coronavirus

*** World Intellectual Property Organization, Frequently Asked Questions: Patents, Retrieved from https://www.wipo.int/patents/en/faq_patents.html#accordion__collapse__04

This article is for general informational and educational purposes only and is not offered and does not constitute legal advice or legal opinion.

Mary Erica D. Manuel is an Associate of the Intellectual Property Department of the Angara Abello Concepcion Regala & Cruz Law Offices (ACCRALAW).

8830-8000

mdmanuel@accralaw.com.