Pandemic, Patent Infringements And Public Interest Jurisprudence With Respect To Life-Saving Drugs
Ever since the global outbreak of Coronavirus, various countries across the globe have been constantly trying to come up with new drugs as well as vaccines that can cure the patients infected with the deadly viruses at large. With the Indian pharmaceuticals booming in the global market that manufactures 60% of the world’s vaccine, the Indian vaccine market reached a value of INR 94 Billion in 2019 as per a report by IMARC. Increased research and development in the area of public access to world-class healthcare at affordable prices has resulted in a tug-of-war situation between the need to reward innovators and the need to provide public access to patented products at affordable prices for the benefit of the general public. The significant amendments in the Patents Act, 1970 post signing the Trade-Related Aspects of Intellectual Property (TRIPS) ensured that lifesaving drugs are available to the public at affordable prices. However, due to the pandemic, there has been increased pharmaceutical patent litigation as a result, the courts are getting sensitive to hold the balance between upholding the rights of the patentees and consumers’ right to medication at a fair cost.
Covid-19, Life-Saving Drugs and Patients Right to Healthcare
The rapid surge of coronavirus has left many pharma companies to come up with medicines that can cure the infection caused due to the virus or prepare its vaccine to fight against the virus that spreads very quickly from one person to another. Though many of the lifesaving drugs (Remdesivir, Dexamethasone, Plaquenil, and Arlen etc.) have been put under the trial stage to prepare a vaccine, it is clear that no treatment has yet shown full efficacy in treating patients infected with the virus. As per Section 3(d) of the Patents Act, 1970, drugs that are already proven substances and are available in the public domain cannot be patented, but when they are developed as vaccines, they can be asserted as inventions qualified for patent protection. The present patent law protects the patentee’s right to exclude others from making the invention, unauthorized using, distributing, and even importing it as a result of which the drugs that are essential for medication become expensive and do not reach the consumers at an affordable cost.
The present patent law regards to the pharmaceutical patent is still emerging. The law has come to a long way post signing the TRIPS agreement. It has ensured that drugs which are essential for life should be available to the public at affordable costs that can be achieved through price controlling or compulsory licensing. The patent laws in India are often conceived as pro generic and anti-innovator following the judgment held by hon’ble Supreme Court of India in Novartis AG v. Union of India, where the SC refused to grant a patent on a drug that can cure cancer. This has left the innovators to rethink their strategies and take their woes arising due to presumed anti-innovator patent regime to courts on the issue of balancing public interest with their rights to grant injunctive reliefs in case of infringements. The right moves are being made to categorize intellectual property disputes as commercial disputes and there is a hope that commercial courts being the main ‘protectors of interests’ would balance the enforcement of statutory rights and socioeconomic interests.
Indian Courts and Public Interest Jurisprudence
‘Public Interest’ is a broad term that is subjectively used by courts depending on the individual facts and circumstances of the case. Its interpretation varies from case to case depending upon the scale of public interest involved. In pharmaceutical infringement cases, the thumb rule of public interest is taken into consideration before giving relief in way of injunction to any pharmaceutical company. Astonishingly, the public interest principle has been the cynosure in the ongoing pandemic.
In India, the judiciary follows a three-factor test to decide patent infringement cases and grant interlocutory relief by way of injunction to the party(s) involved. The first factor is whether there exists a prima facie case? Secondly, that if the application is not granted, irreparable and non-compensable harm would be caused to the applicant, and thirdly, that the balance of convenience ought to be in favor of the applicant. In addition to the three-factor test, a fourth factor is also considered when it comes to adjudicating patent infringement cases known as the ‘public interest’ principle.
Courts in India have repetitively stated from time to time that patent cases involving public health, access to life-saving medicines, and commercial interests should be expeditiously handled. Roche v. Cipla was the first major patent infringement case post the 2005 Indian patent regime. The Delhi High Court in the case had the occasion to balance the two competing public interest in which the one side of public interest was granting an injunction to affirm a patent in the middle of pendency of patent infringement action as opposed to the public interest in granting access to the life-saving, anti-cancer drug to the public. The court in the case held in favor of the latter concluding that damage or injury caused to the plaintiff can be recovered through monetary terms however, the injury will cause to the public in absence of the defendant’s product may lead to shortening the lives of humans which cannot be restored or re compensated by monetary terms. Thus, if the injunction sought is granted to the plaintiff, it would lead to an irreparable injury. This was the revolutionary case in the history of injunction jurisprudence where ‘public interest’ considered as a deciding factor for granting relief.
In the case of Novartis vs. Cipla, the court while upholding an interim injunction against the sale of Cipla’s copy of Novartis’s drug observed that public interest is a separate factor that should be kept in mind while considering for grant of an interim injunction even it has no role to play in the case. On a similar note, the Bombay High Court in Bayer v. Union of India stressed the importance of the public interest principle stating that life-saving drugs should be available to the general public in adequate numbers at a reasonable cost.
In the majority of cases, though the courts have given more importance to the public interest principle, there are instances where courts have even respected the interests of the patentee. In Glenmark Pharmaceuticals v. Merck Sharp & Dohme, the Hon’ble Supreme Court granted an injunction in favor of the patentee (Merch) by giving stay on operations of petitioners to sell existing stock of its generic product. Similarly, in the recent case of Indoco Remedies v. Bristol Myers Squibb, the High Court of Delhi refused to lift the injunction on Indoco Pvt. Ltd., as the court emphasized that supposed ‘public interest’ is not a sufficient ground to lift interlocutory injunction unless the order is unsustainable on prima facie merits. As per the court, Indico Remedies Ltd. have failed to provide any reasonable evidence that there was an actual shortage of drug and it was not affordable to the general public.
This particular case has widened the scope of public interest jurisprudence by showing that public interest cannot be subservient to patent rights either in relation to pharmaceutical patent infringement cases. Yet, it is still to perceive how this jurisprudence specifically for life-saving drugs would evolve considering the nature of the pandemic and its possible impact on medical industries as well as the general public in the coming years.
‘Public Interest’ has been one of the most important principles as it is about the common good and welfare of people at large. In the Indian context, the jurisprudence of public interest is still evolving as it is a complex concept that is ambiguous and dynamic. With each case, the courts have to strike a reasonable balance between the public’s right to healthcare and the innovator’s right to reward but considering the current pandemic, it is quite evident that public interest in life-saving drugs is outweighing the patentee’s exclusive rights. To maintain a healthy balance, compulsory licensing can be an effective tool for the government in times of “public health crises” to supply cost effective drugs to the public with generic version of patented drugs with simultaneously providing advantage to the patentees in form of fixed license fee. The government has also the option to grant voluntary licenses to the manufacturers to ramp up the affordable production of vaccines and drugs for common good.
Having said that, the genesis of the patent regime in India is in compliance with international standards and practices, public interest and access to healthcare will always remain a mainstay for the courts to grant any relief in form of an injunction. However, India being a country that thrives for innovation and creativity, protection of patents is pivotal for promoting economic growth and development. Let us see how the government and courts even after the pandemic respects the both stakeholders in the larger interest.
Unitedworld School of Law, Karnavati University