Denial or grant of injunction in a patent infringement dispute in Indian courts or elsewhere on the ground of public interest is not a new trend. In fact, the trend of considering public interest in motion for preliminary injunction as the fourth element, in US courts, was earlier set in Pfizer v. Teva, 429 F.3d 1364 (Fed. Cri. 2005). In this case, the Court was caught between the elements of two competing public interests, viz., lower cost and public policy of patent grants. The Appeal Court found that granting the injunction was in the public interest, as the injunction would further the public policy inherent in patent laws, outweighing Ranbaxy’s contention that the public interest favoured denying the preliminary injunction because the statutory framework under which Ranbaxy filed its ANDA makes low-cost generic drugs available to the public through increased competition.
It was further consolidated by the Federal Court in Sanofi v. Apotex, 488 F.Supp.2d 317 (S.D.N.Y. 2006), where the appeals court ruled that the public interest in lower-priced drugs is balanced by a significant public interest in encouraging the massive investment in research and development that is required before a new drug can be developed and brought to market. In both cases, the grant of an injunction favoured the patentee; however, it is not always a rule. The Courts in the US and elsewhere, including India, consider other public interest aspects, such as non-availability, large-scale market disruption, customer inconvenience, and lower cost, to consider denying the injunction at the preliminary stage of the dispute.
Position In India
The first case where the Delhi High Court considered public interest as the fourth factor for denying injunction was in a patent dispute between F. Hoffmann-LA Roche Ltd. and Cipla Ltd., 2009 (40) PTC 125 (Del). In this appeal, the High Court considered the general public access to life-saving drugs to assume great significance and the adverse impact on such access which the grant of an injunction may have, and affirmed that:
’81. This Court is inclined to concur with the learned single Judge that in a country like India where question of general public access to life saving drugs assumes great significance, the adverse impact on such access which the grant of injunction in a case like the instant one is likely to have, would have to be accounted for. Erlocip is the Indian equivalent produced by the defendant in India as a generic drug manufacturer. It is priced at Rs. 1600 per tablet. Even if this does not make it inexpensive, the question of greater availability of such a drug in the market assumes significance.’
Soon after the Roche vs Cipla ruling, it became a trend to raise public interest as an instrument to gain a denial of injunction in many infringements in Indian courts. Interestingly, this public interest argument raised to seek denial of injunction by the Indian courts did not find favour as a rule. The courts in India did not take this ruling as precedent to deny injection, especially those involving pharmaceutical products. For instance, in Merck Sharp & Dohme Corporation & Anr. vs Glenmark Pharmaceuticals Ltd. (October 7, 2015), the Delhi High Court recognised the public interest in favour of the applicant and granted an injunction. The Court in this case looked into the two competing public interests, viz., lower cost and public policy of patent grants and ruled that:
“Merely because defendant, who is manufacturing generic version, is selling a tablet at a lower price than that of plaintiffs cannot be made ground to decline injunction against the defendant, who has been found to have been infringing the invention of the plaintiffs, is as much as, a competitor of the plaintiffs.”
In this case, the Court, without mincing words, held that selling the drug at a lower price than that of the plaintiffs cannot be grounds for declining the injunction against the defendant, who has been found to have infringed the invention. Selling at a low price does not give a license to infringe. In this case, without saying so, the Court favoured a public policy of patent grant.
Public Policy of Grant of Patent
Raising a public interest issue at the preliminary stage for objecting to injection in patent infringement disputes is now well established in Indian jurisprudence as well. The Courts in India, like those in the US, considered public interest in granting an injunction or denying it if access to drugs is an important facet of the case. We may note that courts in India do not, as a routine, deny an injunction merely based on a supposed public interest, like a lower price. The courts may not grant a preliminary injunction, unmindful of the existence of the public policy of granting a patent inherent in the patent law.
Injection Denied Based on Public Interest
With a series of injunctions granted even after the Cipla ruling, it was believed that the public interest element may not play a primary role in denying the preliminary injunction in patent disputes. The courts also considered other elements to grant the injunction. For example, in the BMS v. Hetero case, the Delhi High Court granted an ex parte injunction citing imminent drug launch and risk of irreparable market disruption as the decisive element.
However, in a recent case F. Hoffmann-La Roche AG (Roche) vs Natco Pharma Limited (Natco) (CS(COMM) 567/2024) Delhi High Court denied Roche’s request for an injunction against Natco’s production of Risdiplam, an oral drug for Spinal Muscular Atrophy (SMA) recognising the critical need for affordable SMA treatment as a public interest element weight in favour of denying injunction. Additionally, the Court found that Roche’s patent was vulnerable due to potential prior disclosures and a lack of inventive steps. Curiously, the Court examined all the elements necessary to balance the convenience before denying the preliminary injunction to Roche.
Lesson Learnt
In patent infringement disputes, seeking an ex parte injunction is not a cake walk. The bar for grant or denial of injunction in patent disputes has been raised even higher with the addition of the fourth element of public interest to the traditional well-settled three-pronged test, viz., requiring the establishment of (i) a prima facie case, (ii) irreparable harm, and (iii) a balance of convenience. The courts considered judiciously how each claimed element is satisfied, right up to the very last element. Without this level of scrutiny, the interim injunctive relief is unlikely to be granted. Like in other jurisdictions, Indian courts have considerably raised the parameters for awarding preliminary injunctions.
The courts in India are effectively balancing the rights of the patentee, the defendants’ interests, the public interest and the public good. The Indian courts are alive to balance the convenience scale, where both the plaintiff and defendant raise public good cards, especially in pharma infringement disputes. In such situations, the courts invariably seek the patentee to demonstrate that public interest aligns with the injunction and ensures that the grant of the injunction will not harm consumer access or pricing. If in the CIPLA case the Court denied an injunction to Roche as the Court found that the grant of an injunction may harm consumer access or pricing, in the Roche case, the Court denied an injunction, citing public access to the drug and a credible challenge to the Roche patent.
In many other cases, courts have allowed injunctions, as Indian courts are increasingly scrutinising every element with detail to decide whether an equitable relief should be granted where the balance of convenience and public interest is contested in patent infringement disputes. The grant or denial of a preliminary injunction in a patent case is not as easy as it appears. The Court in India expects the patentee to break down each element and demonstrate how each claim element is satisfied, right up to the very last element. Similarly, defendants cannot expect the Court to deny injunctions just by citing the element of public interest.
The good news for the patent owners who seek to enforce their patent rights effectively is that the ex-parte injunctions are indeed still a viable and swift court-sanctioned route in India to deter the infringer. Similarly, for defendants, if anything shows that public interest must align with the injunction, the Court may favour its denial to meet the public good. As the case may go either way, expert advice may be useful to get favourable results. Lastly, for Indian courts, both competing public interests, viz., accessibility at lower cost and public policy of patent grant matters, are considered in deciding the contested injunctive relief cases.
