July 11,2024
Mumbai: Swiss biotech giant Roche has sued Zydus, claiming the Indian drug maker infringed on their patents numbered IN 268632 and IN 464646. This lawsuit involves allegations of Perjeta’s (Pertuzumab) patent infringement, specifically targeting the ‘formulation’ and ‘process’ associated with an innovator’s ‘Reference Biologic Product’.
Roche contends that their suit patents are on the verge of being infringed upon by Zydus through the development of a ‘similar biologic product’. However, Dr Abhishek Manu Singhvi, Senior Counsel representing Zydus, pointed out that Roche does not have a patent registered for Pertuzumab in India.
Earlier, Roche had alleged that clinical trials conducted by Zydus for Sigrima (Perjeta’s biosimilar) might have been dubious as Zydus had procured Perjeta from an unofficial supply chain, potentially compromising the biologic’s nature. Zydus refuted the allegations, stating that all reference medicinal products were carefully tested before being submitted for clinical trials. The company also confirmed that all necessary study protocols and regulations in India were followed, with results submitted to the relevant authorities.
Interacting with ETPharma, an expert in the know-how of the ongoing legal battle based on anonymity highlighted that in terms of affordability and accessibility, the annual cost of Perjeta is Rs 47.6 lakh, which will be reduced to Rs 13.5 lakh with Sigrima—almost one-fourth of the cost. Within a week of its launch, over 200 patients were prescribed Sigrima. For patients needing both trastuzumab and pertuzumab, costs could reach Rs 80 lakh.
Refuting the cost of trastuzumab and pertuzumab combination, Roche’s spokesperson confirmed, “With PHESGO (which is the world’s first fixed-dose combination of pertuzumab and trastuzumab), the price is practically the same as what it is for pertuzumab alone. Also note that PHESGO is a subcutaneous injection, reducing hospital time by over 90 per cent. Patients don’t need any hospitalisation like in an intravenous procedure.
The interim injunction issued by the Delhi High Court on July 9, 2024, is based on significant concerns raised by Roche’s senior counsel. It was brought to the court’s attention that, amidst ongoing deliberations on the grant of an interim injunction [in IA 4196/2024], Zydus launched Sigrima, a biologic similar to Roche’s Perjeta, which comprises Pertuzumab. The senior counsel also noted that Zydus entered into a commercial licencing arrangement with Dr Reddy’s Laboratories for co-marketing their Sigrima product in India.
Under such circumstances, Roche sought injunctive relief against the sale and distribution of Sigrima through an application under Order XXXIX Rules 1 and 2, claiming it infringes the patents numbered IN 268632 and IN 464646.
Roche’s senior counsel emphasised that during hearings on I.A. 4196/2024, conducted on February 23, April 4, April 24, and May 13, 2024, concerns were repeatedly voiced regarding the potential launch of the impugned product by Zydus.
Considering fairness, equity, and the balance of convenience, the Court found compelling reasons to issue an injunction. Accordingly, until the next date of hearing, Zydus is restrained from marketing/selling Sigrima.
It should be noted that Roche has been entangled in various legal battles with Reliance Life Sciences, Biocon, Mylan, and Zydus over the approval and launch of another breast cancer drug, Vivitra (trastuzumab). The expert also highlighted, “There is no product patent in India for pertuzumab, as Roche never applied for it. Roche has a formulation patent, which Zydus has not infringed in any manner. Roche is deploying this tactic to delay the launch of biosimilars in India and thereby delay the affordability and accessibility that a biosimilar brings to Indian patients.”
He continued, “Scientifically, Roche cannot fight the case based on their patents; Indian authorities have been smart enough to prevent the ever-greening of patents. Hence, these additional barriers are created to prevent the availability of biosimilars.”
The expert mentioned that over 100,000 patients have benefited from Zydus’s Ujvira (trastuzumab) since its launch, highlighting that 300 patients are enrolled every month for Ujvira, whereas Kadcyla only enrols 30 patients each month on average, increasing access tenfold.
The expert noted that Perjeta served 2,000 patients last year, while Sigrima could serve 12,000 patients this year. When trastuzumab and pertuzumab are administered together, it is very expensive, which can be reduced by the launch of a biosimilar. A metastatic breast cancer patient can gain 16 months of additional life. The delay in the product launch will prevent thousands of patients from gaining access to these 16 months.
In terms of affordability and accessibility, the expert explained that the annual cost of Perjeta is Rs 47.6 lakh, which will be reduced to Rs 13.5 lakh with Sigrima—almost one-fourth of the cost. Within a week of its launch, over 200 patients have been prescribed Sigrima. For patients needing both trastuzumab and pertuzumab, costs could reach Rs 80 lakh. The expert questioned how many patients in India can afford this, highlighting that the safety and efficacy of Ujvira and Kadcyla were comparable.
Roche has been involved in several legal battles in India over the years. The expert expressed that this is done to prevent the launch of biosimilars, as their launch would hurt Roche’s market share. As long as it serves their commercial interests, they remain in the Indian market; when it no longer serves their interests, they exit. Such a scenario impacts patients the most, who are in dire need of more affordable and accessible alternatives. Legal battles like these once again raise the question: What about patient centricity? Are all innovator pharma companies only interested in higher profit margins?
Source: Pharma