The Delhi High Court recently addressed a significant case concerning the availability and affordability of drugs for rare diseases, emphasizing the importance of these factors when considering the grant of interim injunctions in intellectual property rights (IPR) disputes. Justice Mini Pushkarna, presiding over the matter, highlighted that ensuring public access to essential medications at economical and competitive prices is a crucial consideration during such legal proceedings.
The case involved a lawsuit filed by F. Hoffmann-La Roche AG against Natco Pharma Limited, alleging patent infringement. The patent in question, titled "Compounds for Treating Spinal Muscular Atrophy," pertains to the drug "Risdiplam," used in treating Spinal Muscular Atrophy (SMA), a rare neuromuscular disorder. F. Hoffmann-La Roche AG sought an interim injunction to restrain Natco Pharma from manufacturing and selling a generic version of Risdiplam, claiming it would violate their patent rights.
In its defense, Natco Pharma challenged the validity of the patent and highlighted its intention to produce the drug domestically, offering it at a price significantly lower than that of F. Hoffmann-La Roche AG. The company argued that their version of the drug would be approximately 80-90% cheaper, thereby making it more accessible to patients suffering from SMA in India. This assertion brought to the forefront the critical issue of drug affordability and availability for rare diseases within the country.
Justice Pushkarna, in her judgment, noted that while F. Hoffmann-La Roche AG had emphasized the absence of pre-grant or post-grant opposition to their patent, this factor alone did not establish the patent's validity unequivocally. The court observed that Natco Pharma had raised credible challenges regarding the patent's validity, particularly pointing to potential non-compliance with Section 8 of the Patents Act, which mandates full disclosure of information by the patent applicant. The determination of such compliance issues, the court stated, requires a thorough examination of evidence, which is only possible during a full trial.
A pivotal aspect of the court's decision was the consideration of public interest, especially concerning the affordability and accessibility of life-saving medications for rare diseases. Justice Pushkarna emphasized that when a drug is the sole treatment available in India for a rare condition, its accessibility at reasonable prices becomes a material factor in deciding whether to grant an interim injunction. The court recognized that F. Hoffmann-La Roche AG imports its drugs into India, whereas Natco Pharma proposed to manufacture the drug domestically, potentially reducing costs and increasing availability. This distinction played a significant role in assessing the balance of convenience between the parties involved.
Furthermore, the court took into account the pricing strategy of F. Hoffmann-La Roche AG, noting that the company had shared the pricing details of Risdiplam. The court inferred that the introduction of a more affordable generic version by Natco Pharma could substantially benefit patients who might otherwise be unable to afford the treatment. This consideration aligns with the broader objective of ensuring that essential medications for rare diseases are accessible to the public without imposing prohibitive costs.
In conclusion, the Delhi High Court dismissed the plea for an interim injunction filed by F. Hoffmann-La Roche AG, allowing Natco Pharma to proceed with the manufacture and sale of its generic version of Risdiplam. The court's decision underscores the judiciary's recognition of the paramount importance of drug availability and affordability, especially in the context of rare diseases where treatment options are limited. This ruling sets a precedent for future IPR disputes, highlighting that public interest considerations can outweigh the enforcement of patent rights in scenarios where access to essential medications is at stake.
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