Patents serve as gateways to ground-breaking innovations that profoundly impact societal welfare, from life-saving pharmaceuticals to revolutionary technological advancements. It is critical to, therefore, balance the interests of patentees in being duly incentivised for their innovation with the public interest in ensuring broad accessibility to their innovations.

In India, the unique institutional context in which the Patents Act, 1970, came into force, serves as the backdrop for this balancing. Being sensitive to the unique ‘facilitating circumstances and precipitating conditions’ (this phrasing is taken from Laurence Helfer) that informed the formulation of modern Indian patent law can help us in arriving at concrete pathways for ensuring that the monopoly granted by patents does not impede the public interest.

The Ayyangar Committee report, which laid the groundwork for modern Indian patent law, boldly declared:

“Patent systems are not created in the interest of the inventor but in the interest of national economy… The precise provisions of the patent law, however, have to be designed with special reference to the economic conditions of the country, the state of its scientific and technological advance, its future needs and other relevant factors and so as to minimise if not to eliminate the abuses to which a system of patent monopoly is capable of being put.”

This makes it clear that a public-facing justification was the clear animating force that informed the determination of the extent to which patent protection should be granted.

Against this backdrop, a legal dispute currently brewing in the courts of Delhi assumes significance. The clash between Vifor International Limited and MSN Laboratories brings to the fore nuanced questions as to the scope and limits of a patent grant.

At issue are patent rights over the drug ferric carboxymaltose (FCM) – an intravenous intervention for patients affected by iron deficiency/anaemia when oral iron preparations are ineffective or cannot be used.

Vifor claimed that during routine online surveillance around December 2020, it discovered that MSN was planning to launch a generic version of FCM under the brand name ‘Feinj’, resulting in its lawsuit against MSN to stop the sale of Feinj. A key point of contestation was whether Vifor’s monopoly over FCM was confined to the process that it had followed for making FCM or would also extend to any other process for manufacturing FCM.

Vifor’s submission was that all processes for manufacturing FCM were covered within the remit of its patent grant (making it a patent over the product per se), while MSN argued that since it followed a different process for manufacturing FCM, Vifor could not stop it from doing so (making FCM’s patent a product by process patent).

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To understand why the seemingly insignificant distinction between product patents per se versus product by process patents matters, let us consider a couple of examples.

Assume that a pharmaceutical company develops a manufacturing process to produce a life-saving medication. Instead of patenting the medication itself, they patent the specific process used to create the medication. This allows the company to protect their innovative manufacturing method while enabling other companies to develop alternative processes to create the same medication.

In the same vein, assume that a company develops an innovative process to manufacture high-efficiency solar panels that generate more electricity than traditional panels. Instead of patenting the solar panels themselves, they patent the unique manufacturing process that enhances their performance. The patenting of the product through the given process rather than the product per se makes it possible for other researchers and manufacturers to explore similar techniques.

This is not to say that product patents are per se bad – an issue which in any event is academic, given that the Patents Act, since its amendment in 2005, expressly allows for the grant of product patents on pharmaceuticals.

The point we make is different. When a patentee only claims a particular process for manufacturing a particular product in its patent application, confining the scope of its patent to that process facilitates the manufacture of the same product by other processes by others, thus furthering the public interest.

This is not to say that the public interest, as an extraneous consideration, can override well-settled legal principles for how a court should read the claims in a patent. It is just to say that public interest should be amongst the calculus of factors that an Indian court should consider when deciding which amongst multiple plausible arguments it should subscribe to when adjudicating patent disputes.

In her comprehensive and well-reasoned judgment, Justice Jyoti Singh of the Delhi high court began her analysis by making the perceptive observation that

“In light of the [Ayyangar] report, one can safely state that the foundation of the patent system is on an edifice of “bargaining” and “public interest”, which means that in exchange for the monopoly rights over the inventions disclosed, the patentee gets a protection over the invention for a limited term and in turn public stands to benefit by the disclosure of newer technologies.”

On an exhaustive evaluation of the material furnished by the plaintiff while applying for the patent over FCM, as well as the claims in the patent application, she concluded that the plaintiff had applied for a minutely detailed process for producing FCM, and not a patent for producing FCM per se. She therefore held that this was a product by process patent.

A logical sequitur of this holding was that the defendant could be liable only if it used the patented process for manufacturing FCM. Since her finding was that this was not so, she held that the defendant was entitled to continue manufacturing the generic version of FCM.

Vifor challenged this decision before the Division Bench (DB), which stayed Justice Singh’s judgment. It principally held that the defendants were unable to dislodge the claim of novelty on the plaintiff’s patent over FCM as a product or establish that FCM was discoverable from the prior art. It further held that one of the claims by the plaintiff was for a product, while the others were for a process.

On this basis, it disagreed with the holding that the patent in question was over a product by process. Dr Reddy’s approached the Supreme Court against the DB’s judgment which was dismissed on August 22, as the high court had already listed the matter for final arguments on September 4.

When the DB hears final arguments in the matter, it is hoped that it will be alive to the fact that what is at issue is not the novelty of Vifor’s patent, but the question as to whether, in substance, what Vifor was claiming was a patent over manufacturing FCM based on the process set out in its claims and not a monopoly over the manufacture of FCM per se.

Further, if the court finds that there are two plausible constructions of Vifor’s claims, one that would extend its monopoly to the product and the other that would keep it confined to the manufacture of FCM through the given process, let us hope that the court will have an eye to the public interest in promoting access to affordable medicines and the unique institutional context of modern Indian patent law, to which Justice Singh exhibited attentiveness.

Rahul Bajaj is an Attorney at Ira Law and Yagya Kapoor is a fourth-year law student at the Vivekananda Institute for Professional Studies. Views are strictly personal.

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