CS(COMM) 567/2024, Delhi High Court.

Background

F. Hoffmann-La Roche AG (Roche) brought a Patent infringement case, at the Delhi High Court, against Natco Pharma Limited (Natco). The claim of Rochhe was based on infringement of its Patent for a compound Risdiplam marketed under the brand name EVRYSDI® used in the treatment of Spinal Muscular Atrophy (SMA). Risdiplam is an oral prescription medicine indicated for the treatment of SMA in patients two months of age or older. The note analyses the arguments of the parties, two intervenors that raised public interest issues and Court’s decision on interim injunction being sought by Roche.

Roche’s case and contentions

1. Admission of Infringement: Roche argued that Natco Pharma Limited admitted to the infringement by stating that they were in the process of launching Risdiplam.
2. Validity of the Patent: Roche emphasized that the patent in question is valid and has been granted in more than 60 countries without being revoked or invalidated in any jurisdiction. They also highlighted that the International Search Authority (ISA) found the patent to be novel and non-obvious.
3. Investment in Development: Roche pointed out the significant investment made in developing Risdiplam, which is the only oral drug for Spinal Muscular Atrophy (SMA) in the world. They argued that generic manufacturers like Natco Pharma bear minimal costs for research and development compared to the innovators.
4. Public Interest: Roche argued that there is an overwhelming public interest in protecting patents for rare diseases like SMA. They emphasized that the expenditure and time invested in research and development should be protected to encourage further innovation.
5. Price Reduction and Discounts: Roche mentioned that they have voluntarily provided heavy price reductions and discounts to the Government of India for the cause of SMA patients. They also highlighted their Patient Assistance Program, which aims to make the drug more affordable.
6. Habitual Infringer: Roche claimed that Natco Pharma is a habitual infringer with multiple lawsuits filed against them, where injunctions have been granted and damages paid in settlements.
7. No Evergreening: Roche argued that there has been no evergreening in this case, as Risdiplam is a new compound. They also stated that the International Genus Patent does not specifically disclose Risdiplam.
8. Obviousness and Anticipation: Roche contended that the defendant’s arguments regarding obviousness and anticipation are based on hindsight and reverse engineering. They argued that the International Genus Patent does not provide a basis for selecting Risdiplam.
9. Public Interest in Protecting Patents: Roche emphasized that protecting patent rights is crucial for encouraging companies to invest in research and development for new treatments. They argued that allowing generic manufacturers to produce the patented drug would dissuade companies from investing in innovation.

Natco’s case and contentions

1. Evergreening and Unlawful Patent Term Extension (PTE): Natco argued that Roche engaged in evergreening by applying for a species patent instead of an Indian Genus Counterpart to US’955/WO’916, which would have expired in 2033. By applying for a species patent in India, Roche secured an unlawful PTE of two years in India. Natco accused Roche of misrepresentation and material suppression before the Patent Office regarding the International Genus Patent.
2. Validity Challenge: Natco contended that the patent in question is vulnerable to revocation under the Patents Act. They argued that the patent does not enjoy presumptive validity and that the issue of patent validity can be raised even in a counterclaim to a suit for infringement.
3. Public Domain: Natco argued that due to the non-filing of the Indian Genus Patent, Risdiplam has fallen into the public domain in India, despite the grant of the Species Patent.
4. Foreign Admissions: Natco highlighted that admissions made by Roche in foreign jurisdictions regarding the International Genus Patent are relevant for assessing the validity of the Indian Species Patent.
5. Infringement Suit in the US: Natco pointed out that Roche filed a suit for infringement in the US against Natco, alleging infringement of the US Genus Patent, US’955, and US Species Patent, US’754, in respect of Risdiplam. This, according to Natco, validates their contention that the International Genus Patent can be asserted against third parties for the same product.
6. Coverage vs. Disclosure: Natco argued that there is no distinction between coverage or claim in the Species Patent and disclosure in the International Genus Patent. They contended that the species patent cannot be granted if the prior art discloses a species falling within the claimed genus.
7. Technical Advancement and Therapeutic Efficacy: Natco asserted that the species patent must disclose substantial advantage over the genus patent/prior art in the specification. They argued that the Suit Patent fails to disclose any such advantage over the International Genus Patent.
8. Non-Working of Patent in India: Natco claimed that Roche is not adequately working the patent in India, as they are not manufacturing Risdiplam in India but only importing it. Natco highlighted the significant price disparity between Roche’s drug and their proposed generic version, which would be nearly 80-90% cheaper.
9. Monetary Damages: Natco argued that the intent of Roche is to monetize the invention, and in such cases, monetary damages are adequate compensation. They contended that the drug is not accessible or affordable to regular patients.

Intervenors arguments

The two intervenors in this case were permitted to submit their arguments. And they presented their arguments primarily focusing on the public interest and accessibility of the drug Risdiplam for patients suffering from Spinal Muscular Atrophy (SMA).

• Ms. Purva Mittal:
  • Ms. Purva Mittal, a patient diagnosed with SMA, argued that the price of Risdiplam is exorbitant and unaffordable for many patients in India. She highlighted that the average cost for one year’s treatment is around ₹1,48,00,000 (One Crore Forty-Eight Lakhs), i.e., approx. US $ 173,000 per year.
  • She emphasized the importance of public interest in making life-saving drugs affordable and accessible. She pointed out that the plaintiffs’ Patient Assistance Program (PAP) was inadequate, as it only made Risdiplam available to 75 patients in India in 2023.
  • Ms. Mittal argued that if a generic manufacturer like the defendant could produce the drug at a lower cost, it would significantly benefit the public.
• Ms. Seba P.A.:
  • Ms. Seba P.A., another patient living with SMA, argued that the high cost of Risdiplam makes it inaccessible to many patients. She mentioned that the drug is not easily accessible due to the patent monopoly held by the plaintiffs, which allows them to charge an exorbitant price1.
  • She shared her personal experience, stating that the Kerala Government procured 18 bottles of Risdiplam for her under the National Rare Disease Policy, but this was insufficient for her long-term treatment1.
  • Ms. Seba P.A. emphasized that public interest in terms of availability and accessibility of the drug should be a relevant factor in deciding whether to grant an injunction1.
  • She also highlighted that the price under Roche’s Patient Support Program in India is still unaffordable for many patients.

Court’s Decision

• Prima Facie Case: The court found that the defendant, Natco Pharma Limited, raised a credible challenge to the validity of the plaintiffs’ patent. The court noted that the patent was vulnerable to revocation on several grounds, including anticipation by prior publication, obviousness, and misrepresentation1.
• Balance of Convenience: The court determined that the balance of convenience did not favor the plaintiffs. The plaintiffs were importing the drug into India, making it highly expensive, whereas the defendant intended to manufacture the drug locally at a significantly lower cost. This would make the drug more accessible to patients suffering from Spinal Muscular Atrophy (SMA). Additionally, the court noted that the plaintiffs’ Patient Assistance Program is limited to an exceedingly small number of patients compared to the number of patients actually suffering from SMA in India. Even if the plaintiffs provide the drug at their proposed price, it would not be a viable proposition in economic terms for the patients who are not enrolled in the program.
• Irreparable Damage/Prejudice: The court determined that the plaintiffs could be compensated with damages if they were successful at the conclusion of the trial. The plaintiffs’ primary intention was to monetize the drug, and therefore, monetary compensation would be adequate.
• Public Interest: The court emphasized the importance of public interest in making life-saving drugs affordable and accessible. The high cost of the plaintiffs’ drug made it inaccessible to many patients in India. The court noted that the defendant’s proposal to manufacture the drug locally would significantly reduce its cost and benefit the public.

In conclusion, the court denied Roche’s request for an interim injunction, allowing Natco Pharma Limited to continue its plans to manufacture and distribute the drug at a lower cost.

Our comment

The extensive discussion in this case revolved on the impact of an injunction, if granted, on the public. Thus, public interest and affordability of drugs is an important factor for Patent holders to consider when brining infringement action in India. More so, considering there is a large income disparity and significantly low health insurance penetration in India. The Court remarks in this context are noteworthy “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 interim injunction. Besides, the plaintiffs can be compensated by way of damages. However, there exists no right for the public to lessen or compensate itself”.