By : Madhushree Paul
Confirmed COVID-19 cases in India have crossed 30 Lakh as this article is being written. Various pharmaceutical companies are aiming to create the vaccine needed to fight the infector virus as this article is being written. In fact, two Indian vaccine candidates- Bharat Biotech International Limited in collaboration with the Indian Council of Medical Research and ZydasCadila Healthcare Limited- have been approved by the Drug Controller General of India (DCGI) for the second phase of clinical trials already as this article is being written.
Not only in India, but the race to develop a vaccine has been going on all throughout the world. Nearly 160 vaccine candidates are either in pre-clinical or clinical trials.
Russia and China have jumped most mandatory tests, and have approved human trials (and they are being criticized for that) but who knows, their actions might as well be rewarded with success.
But, the one thing that will surely take some time and scrutiny (months after this article is written) is the pathway of COVID-19 Vaccine into the Indian market. And that stimulates the following question into the minds-
Will intellectual property rights be used to bridge the gap between the availability and affordability of the vaccine to the public?
Or will it be used as a barrier to encouraging commercialization to take the steering in these difficult times?
Enters… Indian Patents Act, 1970.
To understand the concept of patents and how is it related to COVID-19 Vaccines, let’s take the famous example of patented drugs in India:
The Gilead Diaries.
Back in April 2017, Gilead Incorporated naming their innovation “Compounds for treating Filoviridae virus infections” had filed a patent application in the Indian Patent Office. This was developed to fight viruses like the Ebola virus, the Marburg virus, and the Cueva virus. The patent got approved in February 2020.
How is this news important?
Well, Remdiviser is one of Gilead’s drugs patented by numerous other countries including India. It is currently being evaluated as a potential treatment against the SARS-CoV2 virus.
And with the patent, Gilead basically has the exclusive rights to prevent any third parties from “the act of making, using, selling or importing that product to India” as provided under Section 48 of the Indian Patent Act, 1970.
Thankfully, Gilead had the senses to not stay put holding its rights and has entered a Non-Exclusive Voluntary Licensing Agreement with 127 countries including India.
In fact, the U.S. Food and Drugs Administration (USFDA) has issued an Emergency Use Authorization (EUA) for the use of Remdiviser in urgent cases of COVID-19 patients.
But what if the case scenario was a teensy bit different? Had there been ways in which the Patentee (Gilead for example, and other upcoming vaccines as a matter of fact) could have scored?
None actually. The Indian Patents Act, though secures the rights of an inventor also has provisions to make sure the well-being of the public in general. Literally, no one can commercial their products with money-driven intentions at the stake of public health.
Had Gilead not agreed to enter this non-exclusive voluntary licensing agreement (basically letting numerous pharmaceutical companies to manufacture its drugs and making it accessible ad affordable at the same time) it would’ve faced numerous challenges that, in certainty, wouldn’t have secured its patents rights. Gilead would’ve lost its credibility.
There are robust safeguards when it comes to public well-being effectively not considered essential. These restrictive obligations making the patentees cater to public health in difficult times, such as now.
With the 2002 amendment of the Indian Patents Act, the provision for “Compulsory Licensing” was introduced whereby the government can authorize the manufacturing of a patented product without the consent of the patentee.
Section 84 – A Compulsory License can be obtained by any interested person by filing an application to the Controller of Patents, after expiry of three years from the date of grant of the patent, on the grounds that:
a. Reasonable requirements of the public with respect to the patented invention have not been satisfied, or
b. The patented invention is not available to the public at a reasonably affordable price, or
c. The patented invention is not worked in the territory of India.
The Patentee effectively doesn’t make a score here if its only intention is to commercialize the products and prevents it from reaching specific classes of the society.
Take Naxavar drug (used to treat liver and kidney cancer) for example. The Supreme court Bench comprising of Justices Ranjan Gogoi and RF Nariman decided that Hyderabad-based Natco can continue selling a copy of the drug, despite Bayer holding the patent. The local company’s version of sorafenib, the chemical name of the drug, costs just a fraction of the original product’s price which was at INR 2,80,428/-.
Compulsory License can also be granted in case of “national emergency” or in circumstances of “extreme urgency” or in case of “public non-commercial use” the Central Government may not follow the elaborate procedures (generally required to be followed through) for the grant of compulsory licensing. This provision has been laid down under Section 92 of the Indian Patents Act, which again safeguards public interest. In such a case both the sides of the bridge are satisfied since the patent holder is granted with reasonable remuneration for the usage of its patent rights and the common people get the products at much affordable rates. The patentee, to be clear, less satisfied since it has to accept whatever remuneration is being offered to him.
In both cases, if the Patent holder pushes further down the road, there are chances that the patentee holder might lose his exclusive rights altogether.
Further, Section 100 of the Indian Patents Act, 1970, allows the Central Government to authorize any third party to use the invention for the purposes of the Government. The Central Government can pay remuneration to the patentee for use of its patents. Patent laws in India also allow the Central Government, if it deems necessary for a public purpose, to acquire a patent under Section 102 of the Indian Patents Act, 1970
India doesn’t have a reason to panic as such. The Indian Patent Act has more or less got all the loopholes covered through which an inventor otherwise could’ve misused his rights.
Although, the intension should be, from the very beginning – Ethical.
The reality is that when such intensions become money-driven is when harsh decisions are needed to be taken. And “Desperate times call for desperate measures.”
An example is the legal fight by about 40 US pharmaceutical firms with the South African government that started in February 1998 to prevent the country from manufacturing low-cost generic antiretroviral medicines used to treat HIV. Even with millions of lives at stake, public health had taken a backseat to intellectual property. The fight continued till September 1999, until the United Nations intervened, and the lawsuit was dropped.
There’s no saying that delay in bringing forth the vaccine to the public won’t happen, because it will. Probably because of corruption that has roots in any economy you can name. Nothing is certain in that regard. But what is certain is the fact that the whole world is trying, and the vaccines will be out for everyone.
Accessible and affordable.
The interesting aspect would be to see if the Indian Government actually has to use its power grantedby the Indian Patents Act, to look afterall Indiancitizens and fight this pandemic.