The article reports on the recent development of a generic drug by Natco Pharmaceuticals, a leading Indian pharmaceutical company, which is expected to benefit patients suffering from Spinal Muscular Atrophy (SMA). SMA is a genetic disorder that affects the muscles, leading to progressive muscle weakness and paralysis.

The generic drug, called Nusinersen, is a biologic medication that has been approved by the US FDA for the treatment of SMA. Natco’s development of the generic version is expected to make the medication more affordable and accessible to patients in India, where SMA is a rare but debilitating condition.

However, patients and advocacy groups are calling for government intervention to ensure that the generic drug is made available to those who need it. The cost of treatment with Nusinersen is currently high, making it inaccessible to many patients in India.

The SMA patients’ community has welcomed Natco’s development of the generic drug, but has also expressed concerns that the medication may not be made available to all who need it due to lack of government support. The Indian government has been urged to take concrete steps to ensure that the medication is included in the National List of Essential Medicines (NLEM) and that the cost of treatment is subsidized or capped.

The patients’ community has also demanded that the government provide a sufficient quantity of the generic drug to the public sector hospitals and specialty clinics to ensure that patients have access to treatment. The SMA patients’ community has also urged the government to establish a dedicated registry for SMA patients to track their treatment and progress.

The development of the generic drug by Natco has generated hope among SMA patients and their families, who have been facing significant challenges in accessing treatment. The Indian government’s response to the situation will be crucial in determining whether the patients will be able to benefit from the generic drug or not.

The Indian court, Justice Mini Pushkarna, recently ruled against granting an injunction in favor of Roche, a pharmaceutical company, in a landmark case involving the patent dispute over the drug Risdiplam, used to treat Spinal Muscular Atrophy (SMA). The court’s decision was based on several crucial factors that challenged the validity of Roche’s patent. Firstly, the court found merit in NATCO’s arguments that Roche’s patent was vulnerable due to the similarity between its earlier Genus Patent (WO’916) and the Suit Patent for Risdiplam. Additionally, the court took note of statements made by Roche in foreign jurisdictions, such as its Patent Term Extension (PTE) applications in the US and Australia, which supported NATCO’s claims that Risdiplam was disclosed in the Genus Patent.

The court also concluded that the patented molecule, Compound 809, was an obvious modification of prior compounds, as described by “Grimm’s Hydride Displacement Law,” which made it a predictable adjustment for a chemist skilled in the art. Furthermore, the court highlighted the importance of making life-saving drugs accessible and the severe financial and medical burden imposed by Roche’s monopoly. The court recognized that many SMA patients in India could not afford Roche’s high pricing, and that NATCO’s commitment to manufacturing and supplying Risdiplam locally at significantly reduced costs would improve accessibility to the drug. Overall, the court’s decision prioritized public interest and the well-being of patients with SMA, ruling in favor of NATCO’s efforts to make the life-saving drug more accessible and affordable in India.

A Senior Executive at Natco Pharma Retires

Natco Pharma, a leading Indian pharmaceutical company, has announced the superannuation of Dr. Ramesh Dandala, the Executive Vice President of Technology Transfer, Intellectual Property Rights & Regulatory Affairs (API). Dr. Dandala’s retirement marks the end of an illustrious career, during which he played a crucial role in the company’s growth and success.

As the key executive responsible for overseeing Technology Transfer, Intellectual Property Rights, and Regulatory Affairs, Dr. Dandala successfully led the company’s efforts to develop and commercialize innovative products. His expertise in these areas was essential in navigating the complex regulatory landscape and ensuring compliance with global standards.

Throughout his tenure, Dr. Dandala was instrumental in securing numerous intellectual property rights, including patents, trademarks, and copyrights. His work also contributed significantly to the company’s technology transfer initiatives, enabling the development of new products and processes.

Under Dr. Dandala’s leadership, Natco Pharma has successfully commercialized a range of products, including APIs (Active Pharmaceutical Ingredients), intermediates, and other specialty chemicals. His efforts have greatly benefited the company’s growth and reputation, solidifying its position as a leading player in the global pharmaceutical industry.

Dr. Dandala’s retirement leaves a vacuum, and his successor will face the challenge of maintaining the high standards set by Dr. Dandala. However, his legacy will undoubtedly continue to shape the company’s approach to technology transfer, intellectual property rights, and regulatory affairs.

As Dr. Dandala hangs up his hat, Natco Pharma’s commitment to innovation, quality, and customer satisfaction will continue to be guided by his vision and leadership. While his retirement marks the end of an era, his contributions will be fondly remembered, and his expertise will be cherished for years to come.

In summary, the retirement of Dr. Ramesh Dandala, Natco Pharma’s Executive Vice President of Technology Transfer, Intellectual Property Rights & Regulatory Affairs (API), brings an end to a remarkable career. Dr. Dandala’s leadership was instrumental in shaping the company’s approach to technology transfer, intellectual property rights, and regulatory affairs, and his legacy will continue to influence the company’s future.

The Delhi High Court has ordered Natco Pharma to pause the launch of a generic version of Roche’s rare disease drug, Risdiplam, amid a patent dispute. The court has restrained Natco Pharma from launching the generic version of the drug, which is used to treat spinal muscular atrophy (SMA), a genetic disorder that affects the nervous system and causes progressive muscle weakness and loss of muscle mass.

Natco Pharma had earlier been granted permission by the court to manufacture and market the generic version of Risdiplam, but Roche had subsequently moved the court to block the launch, citing patent infringement. Roche had claimed that its patent for the drug was still valid, while Natco Pharma argued that the patent had expired.

The court has now allowed Natco Pharma to manufacture and market the generic version of Risdiplam, but has stayed its launch to allow for further proceedings. This decision is seen as a significant victory for Natco Pharma, as it will help to make the drug more affordable for patients in India, where access to healthcare is a major challenge.

The court’s decision is also seen as a setback for Roche, as it had hoped to maintain its monopoly on the market for the drug. However, the court’s ruling is in line with the Indian government’s efforts to increase access to affordable and essential medicines for patients in the country.

The decision is also seen as significant for the pharmaceutical industry, as it highlights the importance of intellectual property protection and the need to balance this with the need to ensure access to life-saving medicines. The case is likely to have implications for the industry as a whole, as it navigates the complex issue of patent protection and public health.

In a landmark ruling, the Delhi High Court has refused to grant an injunction to Roche, a pharmaceutical company, in a patent dispute over a cancer drug called Evrysdi (Risdiplam). The Court’s decision was guided by precedent, citing a previous case where an injunction was denied in a cancer drug case due to high pricing and limited availability. According to the Court, the approved drug Evrysdi, which is used to treat Spinal Muscular Atrophy (SMA), is not available at reasonably affordable prices in India. Therefore, the Court opined that if another party can manufacture the drug and make it available at an affordable price, the public interest would outweigh the need for an injunction.

The Court further noted that SMA is a debilitating disease with no cure, and Evrysdi is the only approved drug for treatment in India. The Court’s decision to deny the injunction ensures wider access to treatment for patients with SMA, while allowing Roche to seek damages if it ultimately prevails in the case.

In effect, the Court is encouraging the development of affordable alternatives to Evrysdi, which would benefit patients with SMA. By doing so, the Court is promoting the public interest in access to healthcare, particularly for rare and debilitating diseases like SMA. The ruling is seen as a significant step towards making complex and expensive treatments more accessible to the masses, paving the way for greater innovation and competition in the pharmaceutical industry. Overall, the Delhi High Court’s decision is a significant victory for patients’ rights and has the potential to set a precedent for future patent disputes in the country.