Public health over patent rights

We will begin with a standout paragraph in a recent judgment on a case involving access to life-saving medicines. Public health, it said, is not something that should be dealt with lightly. As such, “A drug which is the only one available for treatment in India, for a rare disease, its availability to the public at large at very economical and competitive prices, is a material factor which a Court will consider at the time of dealing with an application for an interim injunction.” For emphasis, the judge noted that “the plaintiffs can be compensated by way of damages. However, there exists no right for the public to lessen or compensate itself.”

This was Justice Mini Pushkarna of the Delhi High Court in her ruling on March 24, while dismissing the patent infringement suit filed by Swiss pharma giant Hoffman La Roche against Natco Pharma of Hyderabad. Few judgements in recent years have foregrounded public health concerns as this while dealing with patent infringement suits. In this instance, Roche had sought an injunction against Natco, which was developing a generic version of its risdiplam, a prohibitively expensive drug used in the treatment of spinal muscular atrophy (SMA) patients. SMA is a rare genetic disease that affects motor nerve cells in the spinal cord and impacts muscles used for breathing, eating, crawling and walking. There is no cure for this progressive condition that requires lifelong treatment.

SMA patients who intervened in this suit have given startling figures of how expensive risdiplam, sold as an oral solution, Evrysdi, is. Seba P A, in her intervention application, has stated that risdiplam costs around Rs 6 lakh per bottle. For a patient weighing over 20 kg, one bottle is enough for just 12 days, which means that a patient would require approximately 30 bottles per year, costing Rs 1.8 crore. Another intervener, Purva Mittal, who is undergoing treatment at Lok Nayak Jai Prakash Hospital, New Delhi, told the court she has been recommended risdiplam, but is unable to start treatment since it is “completely unaffordable”.

The judge noted “the predicament of the persons suffering from SMA and their inability to purchase the only approved drug in India on account of its exorbitant cost”. Quite often in such patent infringement cases, Big Pharma innovators claim that their patient assistance programmes (PAPs), where they provide subsidised medication to a limited number of patients, solve the concern over drug accessibility. This is a good public relations exercise that sometimes sways court sentiment by presenting a caring façade. Roche did the same in its suit. However, Justice Pushkarna did not buy its argument, pointing out that the plaintiff’s patient programme was far too limited to resolve the issue of accessibility for SMA patients. Even if the plaintiffs provided the drug at a subsidised rate—the proposed price was indicated in a sealed cover given to the court—it would not be a viable proposition for SMA patients, she noted. Besides, the proposed price would only cover patients enrolled in the PAP, “leaving a broad space” for the unenrolled.

The company’s proposal to provide the drug to the National Rare Diseases Committee as part of pap would also be of limited consequence because of the paucity of funds under the National Policy for Rare Diseases (NPRD). Therefore, the court finds the proposed price reduction does not offer the plaintiffs any leverage for the grant of an injunction in their favour, she ruled. The court’s remark on NPRD is a realistic observation of the government’s ability to look after patients with rare diseases. An August 2024 press release gives a clear idea of the constraints. It says financial support of up to Rs 50 lakh per patient is provided under the policy, but so far, only 1,118 patients have benefited from it, although 63 rare diseases have been notified.

While the balance of convenience—a test used by courts to determine whether to issue a preliminary injunction against a defendant’s allegedly infringing or unfair practices—is in favour of the defendant, Justice Pushkarna clarified that in case the plaintiffs ultimately succeed in the trial, Natco shall be liable to pay damages to the plaintiffs.

Few judges have been as forthright in their observations on the affordability of life-saving drugs as Justice Pushkarna, although many have refused to pass injunctions on generic companies in patent infringement suits. One case that comes to mind is the Roche suit filed against Cipla in 2008 for a permanent injunction for infringing its patent onthe cancer drug erlotinib. Roche claimed it was a breakthrough drug (marketed as Tarceva), but Cipla claimed the patent had been granted under “suspicious circumstances” and was liable to be revoked since it only made improvements from an existing compound. The cost was a consideration in the refusal of an injunction, with the court noting that a month’s dose of Tarceva cost around Rs 1.4 lakh against Rs 48,000 for Cipla’s generic Elrocip. The balance of convenience was held to be in Cipla’s favour.

Natco is battling Roche on another front. In the US, where Natco has filed an abbreviated new drug application—better known as ANDA— with the US Food and Drug Administration for the approval of its generic risdiplam, it faces an infringement suit along with other generics makers who are trying to be first in the queue to release their competitively priced alternatives. Risdiplam is a money spinner and is expected to do better when it comes in tablet form. Although it is a rare disease drug, which means the patients are limited in number, sales in the US have grown sharply by 18 per cent to $1.8 billion in 2024. Similar drugs by competitors are not doing as well because they are injected into the spinal area.

In India, the patent dispute hinges on the fact that Roche had filed an earlier international genus patent at the World Intellectual Property Organization, but has only a species patent on risdiplam in India. A genus patent is broad and covers not just one specific chemical but a group of related chemicals, while a species patent is more specific to an invention. The species patent in India is valid till 2035, two years after the international genus patent expires. Natco claims it is a ploy to prolong the term of the patent, which it says is invalid in any case because risdiplam was disclosed in the genus patent. Roche has come under fire for misrepresentation in other territories. The outcome is important because it is the first test on the affordability of a rare disease drug. DTE

Views expressed are personal