In patent law, there is a constant tug of war between the importance of incentivizing innovators and the need to ensure that consumers have access to innovations. The law reflects this tussle as well. But this constant striving to balance the rights between patentees and consumers is essential for the patent system to function and be meaningful to society. Some laws are perceived as pro-patentee, i.e., favouring the innovators, whereas some laws are perceived to ensure that the public benefits from the innovations.
Public interest in India
Courts in India follow a three-factor test to determine whether interlocutory relief is to be granted in patent infringement cases by way of injunctions. The elements of this test are: firstly, that there exists a prima facie case; secondly, that if the application is not granted, the applicant will suffer irreparable and non-compensable harm; and thirdly, that the balance of convenience lies in the favour of the applicant.
In pharmaceutical patent infringement cases, besides this three-factor test, a fourth factor is usually also considered, i.e., the public interest principle. The thumb rule is that the public must have affordable and adequate access to patented products.
The first major discussion on public interest in pharmaceutical patents took place in the case of Roche v. Cipla.1 Here, the Delhi High Court had occasion to discuss the balance between the public interest in granting an injunction to affirm the patent while the infringement action was ongoing, and the public interest in granting access to the public to a life-saving, anti-cancer drug. In such circumstances, the court held, the balance is tilted in the favour of the latter. The court concluded that the damage or injury that would be caused to the patent-holder could be assessed in monetary terms. However, the damage or injury caused to the public as a result of having no access to the drug could lead to the shortening of lives of several people who were not parties to the suit. This harm could not be compensated in monetary terms, thus making it non-compensable and irreparable. This was a path-breaking decision for it set Indian patent law heading down a new path, which had been unexplored until then.
In Bayer v. Union of India,2 the Bombay High Court emphasized the importance of the public interest principle by ruling that the anti-cancer drug, Nexavar, should be made available to society in adequate numbers and at a reasonable price. In Glenmark Pharmaceuticals v. Merck Sharp & Dohme,3 the Supreme Court stressed that the primary focus was on balancing the interests of the patentee on one hand, and public interest on the other.
But the public interest argument does not always succeed in pharmaceutical cases. In Novartis v. Cipla,4 the Delhi High Court said that merely providing publications and articles that demonstrate the requirement of a particular drug does not imply that the drug is in short supply.
‘Overwhelming’ public interest during the pandemic?
Unsurprisingly, the ongoing pandemic has been a major testing ground for the public interest principle in India. In the recent case of Indoco Remedies v. Bristol Myers Squibb,5 the Delhi High Court granted an interim injunction, finding that Indoco’s drug ‘Apixabid’ infringed Bristol Myers’s patented drug associated with ‘Apixaban.’ After the injunction was issued, Indoco approached the court on the grounds of public interest, requesting permission to sell 58,000 strips of their drug, since they had manufactured them before the injunction order came about. Indoco also argued that the pandemic conditions necessitated a higher demand for the drug, since it was necessary for Covid-19 treatment. They also argued that applying for a compulsory license under Section 84 of the Indian Patents Act, 1970, would have been time consuming given the circumstances.
The Delhi High Court was not sympathetic to Indoco’s arguments, and refused to lift the injunction. According to the Court, Indoco had not provided enough evidence to demonstrate that there was an actual shortage of ‘Apixaban’ in India, or that it was reasonably unaffordable. The court specifically said that the material placed before them did not show any ‘overwhelming’ public interest. It also clarified that ‘perceived’ or ‘supposed’ public interest is an insufficient ground for lifting an injunction, unless the injunction order is prima facie unsustainable on merits. This is, arguably, a new dimension to the public interest principle that has been proposed by the Delhi High Court and opens up many possibilities as to what constitutes ‘overwhelming’ public interest. It is to be seen how jurisprudence on this evolves over the years.
This case also highlights that the court still retains a great deal of discretion in dealing with matters purportedly involving ‘public interest.’ While the ground of public interest can still be invoked, the court has raised the bar considerably on when it can be invoked.
‘Public interest’ is a broad and subjective term, and its interpretation varies from case to case, where courts need to define the application, scope as well as limitations of the term, depending on the individual facts of the case. Although it is the duty of the courts to maintain a balance between the rights of patentees and the public, the interests of the public, especially when life-saving drugs are involved, tend to outweigh the necessity to incentivise innovators.
The jurisprudence on public interest in connection with patents on life-saving drugs in India is still evolving, however. Courts are constantly prising open many possibilities with every interpretation of the term. With the pharmaceutical industry itself involved in much frenetic activity particularly due to the ongoing pandemic, surely, newer and more exciting questions relating to public interest are likely to emerge for patent law to grapple with.
1 148 (2008) DLT 598.
2 W.P. No.1323 of 2013.
3 SLP (C) No. 9220 of 2015.
4 CS (OS) 3812/2014.
5 CM APPL. 602/2020.