Patentability of Covid-19 Vaccine

Introduction

Internationally, open access has been given by Excelrafor their Covid-19 Drug Repurposing Database[3]. Apart from this, an overview has been prepared by CAS for the purpose of published scientific information. CAS gives importance to patents in its content collection and emphasis has been laid on agents that were previously known to have fought other RNA viruses like SARS and MERS. One other initiative was that access would be provided to these patents by those making them for 1-year post the pandemic.[4]

Indian Position

According to a recent article[5], Drug makers from India have started developing ‘Remdisivir’ which has been termed as world’s best shot against COVID-19 virus. The patent has been granted to Gilead sciences which hold 3 patents for the drug since 2009 when it was first made to defeat Ebola. By virtue of the Bolar exemption under the Section 107A[6] of the Patents Act, pharma giants such as Cipla, Dr. Reddy and Glenmark have begun their research on the Remdisivir drug; however, these companies have not launched the drug due to the existing patent. The patent on Remdisivir has been granted very recently in February 2020, thus making it a patented good until 2035. Even though the Bolar exemption allows generic companies to conduct research on a drug that is patented, still the launch of generic medicines after the expiry of the patent depend on the success of the drug in eradicating or controlling the virus. The patent allows mere clinical trials of the drug but once that has been done; the drug cannot be marketed as per the regulations. Unfortunately, the drug has failed to perform in the first full trial.[7] A ray of hope in such a situation is the fact that clinical trials of old and existing molecules are not affected due to the patents because these molecules are already out of patent protection. Although Remdesivir and Favipiravir are two potential drugs for containment of the virus, the generic availability of these drugs for public use and clinical trials could be of great assistance.

An important suggestion in this case would be the use of compulsory or government license by the Government of India in order to arrange for a generic production of these drugs. As a response to the barriers in compassionate use due to the existence of a patent, Israeli and Chilean governments have issued compulsory licenses permitting the use of the patented drug and production of the same by generic pharmaceutical companies, without the permission of the patent holder. The Australian government can exploit the patented inventions of others under right of “crown use”[8]. In these cases, the patent holder is entitled to financial compensation from the government.[9] Apart from this, the patent laws in Germany have been amended in order to enable instant grant of the compulsory licenses. Also, in order to give power to the health minister to issue such government licenses, a resolution has been passed by the national assembly of Ecuador.

In spite of all these barriers, there are certain possibilities under which the exclusivity of a patent can be challenged. The primary and most widely used challenge is one that can be raised by any interested party when at any point of time it is claimed that the patent should not have been granted in the first place. The three requirements in order to grant a patent are Novelty, Inventive step and Industrial applicability as per rules under the Patents Act 1995. However, it would be extremely difficult to invalidate or put a stay on the patent that has already been granted as it would take a huge amount of time.

Another way of challenging patent exclusivity could be by the way of Section 84[10] of the Patents Act 1995. Under the Section 84, patent exclusivity can be subjected to compulsory license. Under the section, any interested party can file an application post 3 years of patent being granted to the Controller for the grant of compulsory license on any one of these grounds:

“(a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or

(b) that the patented invention is not available to the public at a reasonably affordable price, or

(c) that the patented invention is not worked in the territory of India.”

Here, as per the first ground, a vaccine for COVID-19 can be granted compulsory license due to the fact that the virus is widespread and has around 14 strains[11] in different regions of the globe. Hence, it cannot be possible to satisfy the reasonable requirements of all citizens everywhere in the world.

Under the second ground, it might not be possible for the patent holder to make the drug affordable to all because of the fact that the virus is spread all over the world. However, the price of the same cannot be predicted as of now. The last ground might not apply because the drug is most likely to be made available in India.

Even though the Section 84 of the Act suggests that an action can be taken only after 3 years of patent being granted, the Section 92[12] of the Act acts as a special provision whereby even if the 3 year mandatory period has not expired, still in case of a national emergency or any other circumstance of urgency, a compulsory license can be granted without the completion of 3 years. However such a circumstance should one of ‘extreme’ urgency. In such a case however, it must be seen that the patent holder gets a proper right to be heard and is paid his royalty charges as per proper regulations.

Under Section 100[13] of the Patents Act, the government is empowered to use any patented good for its own purpose and also sell it for non-commercial basis. Such rights given to the government are called ‘march-in rights’ and the government can exercise this right while keeping in mind the remuneration to be paid to the patentee. Similarly, under Section 66 of the Act, the government has right to revoke any patent for the public good and in public interest. Powers have been given to the Central Government to revoke a patent if the patent in itself or the mode in which it is exercised is mischievous to the State or generally prejudicial to the public or for the “security of the State”[14]. However, in general practice, this option is used as a last resort and must be used sparingly by the Government.

Conclusion

In research based industries like the pharmaceutical industry and those related to biologics, patents are usually in the form of innovations and such patents also inspire individuals to collaborate as well as to come with newer innovations. In case of diseases such as the COVID-19 virus, patents tend to be an important instrument and also a source for further knowhow. As it can be seen, the COVID-19 virus has impacted countries globally and this increases the probability of it occurring more than just once. This increases the scope of research due to recurrence and due to that there might be a rise in patent filings. It is most likely that the virus will bring in another kind of PIP-type or other long term open source program which would result into a boost in contractual licensing of intellectual property in the form of innovations in exchange for access to specialized expertise or important biological data.

The best way to counter the COVID-19 virus, nations should give prime importance to the betterment of the citizens of the world and any vaccine or treatment that might help curb the effect of the virus must be let out for compassionate usage. Intellectual property rights must be seen in light of basic human rights and a balance must be made between economic and social aspects.

[1]Philippidis A, “Vanquishing the Virus: 160 COVID-19 Drug and Vaccine Candidates in Development” (GENMay 24, 2020) <https://www.genengnews.com/a-lists/vanquishing-the-virus-160-covid-19-drug-and-vaccine-candidates-in-development> accessed June 5, 2020.

[2]“Let’s Share Intellectual Property to Fight COVID-19” (Open Covid Pledge) <https://opencovidpledge.org/> accessed June 6, 2020.

[3]Pearce J and Kenny H, “Contribute to Open Source Healthcare Projects for COVID-19” (Opensource.com) <https://opensource.com/article/20/3/volunteer-covid19> accessed June 6, 2020.

[4]Dailymail.com JPF, “Scientists and Tech Companies Open-Source Patents to Help Researchers Studying COVID-19” (Daily Mail OnlineApril 9, 2020) <https://www.dailymail.co.uk/sciencetech/article-8206471/Scientists-tech-companies-open-source-patents-help-researchers-studying-COVID-19.html> accessed June 6, 2020.

[5]Chandna H, Gupta S and Yadav J, “Indian Drugmakers Begin Developing Remdesivir, ‘World’s Best Shot’ against Covid-19” (ThePrintApril 22, 2020) <https://theprint.in/india/indian-firms-begin-developing-remdesivir-for-covid-19-research-hope-to-land-licensing-deal/406432/> accessed June 6, 2020.

[6] Patents Act 1955, s 107A.

[7]Boseley S, “First Trial for Potential Covid-19 Drug Shows It Has No Effect” (The GuardianApril 23, 2020) <https://www.theguardian.com/world/2020/apr/23/high-hopes-drug-for-covid-19-treatment-failed-in-ful.l-trial> accessed June 6, 2020.

[8]“Crown Use” (ALRC) <https://www.alrc.gov.au/publication/genes-and-ingenuity-gene-patenting-and-human-health-alrc-report-99/26-crown-use-and-acquisition/crown-use/> accessed June 6, 2020.

[9]Stoianoff N, “Whoever Invents a Coronavirus Vaccine Will Control the Patent – and, Importantly, Who Gets to Use It” (The Conversation May 29, 2020) <https://theconversation.com/whoever-invents-a-coronavirus-vaccine-will-control-the-patent-and-importantly-who-gets-to-use-it-138121> accessed June 6, 2020.

[10] Patents Act 1955, s 84.

[11]Ries J, “COVID-19 Will Mutate – What That Means for a Vaccine” (HealthlineMay 5, 2020) <https://www.healthline.com/health-news/what-to-know-about-mutation-and-covid-19#The-new-coronavirus-is-mutating,-but-very-slowly> accessed June 6, 2020.

[12] Patents Act 1955, s 92.

[13] Patents Act 1955, s 100.

[14] Patents Act 1955, s 157A.