India has high burden of rare and genetic diseases and large underserved patient population. In recent years cellular and gene therapeutic products incorporating genome editing technologies have transitioned from laboratory to commercially approved curative therapies. These therapies raising hope for millions of patients worldwide suffering from rare and genetic diseases. Recently, the world’s first gene therapy based on CRISPR gene editing “Casgevy” has been commercially approved in USA, EU and in many other countries for treatment of severe sickle cell anaemia (SCA) and transfusion-dependent beta-thalassemia (TDT). The therapy has proved the curative potential of genome editing technologies for treatment of rare and genetic diseases. But due to patents and high cost of manufacturing, the price of cellular and gene therapeutic products (CGTPs) Incorporating genome editing technologies are very high. Foundational patents on genome editing technologies like CRISPR-Cas9 are owned by handful of institutions. Due to foundational patents, developers and manufacturers requires licenses for developing CRISPR based therapies. The CRISPR based patents and increasing number of patent litigations have created a complex legal environment. The development of CRISPR based cellular and gene therapeutic products in India is in nascent stage. Recently India has announced its first indigenously developed gene therapy based on CRISPR editing technology named “BIRSA 101” for treatment of severe sickle cell anaemia. The therapy is entirely based on indigenously developed genome editing tools. The therapy may get regulatory approval in upcoming years. The therapy aims to make the treatment of sickle cell disease accessible and affordable. The Patents Act, 1970 allows patenting novel genome editing applications useful for treatment of human diseases but cellular and gene therapeutic products are subject to statutory exclusions. The 1970 Act specifically excludes “diagnostic, therapeutic or other treatment of human beings” from patenting. The article critically analyses the impact of Patenting Genome Editing Technologies and its Impact on Access to Human Cellular and Gene Therapeutic Products in India by analysing CRISPR based patents and patent litigations.
Krishnendu Roy Sarkar· Zenodo (CERN European Organi...· 0 citations
India has high burden of rare and genetic diseases and large underserved patient population. In recent years cellular and gene therapeutic products incorporating genome editing technologies have transitioned from laboratory to commercially approved curative therapies. These therapies raising hope for millions of patients worldwide suffering from rare and genetic diseases. Recently, the world’s first gene therapy based on CRISPR gene editing “Casgevy” has been commercially approved in USA, EU and in many other countries for treatment of severe sickle cell anaemia (SCA) and transfusion-dependent beta-thalassemia (TDT). The therapy has proved the curative potential of genome editing technologies for treatment of rare and genetic diseases. But due to patents and high cost of manufacturing, the price of cellular and gene therapeutic products (CGTPs) Incorporating genome editing technologies are very high. Foundational patents on genome editing technologies like CRISPR-Cas9 are owned by handful of institutions. Due to foundational patents, developers and manufacturers requires licenses for developing CRISPR based therapies. The CRISPR based patents and increasing number of patent litigations have created a complex legal environment. The development of CRISPR based cellular and gene therapeutic products in India is in nascent stage. Recently India has announced its first indigenously developed gene therapy based on CRISPR editing technology named “BIRSA 101” for treatment of severe sickle cell anaemia. The therapy is entirely based on indigenously developed genome editing tools. The therapy may get regulatory approval in upcoming years. The therapy aims to make the treatment of sickle cell disease accessible and affordable. The Patents Act, 1970 allows patenting novel genome editing applications useful for treatment of human diseases but cellular and gene therapeutic products are subject to statutory exclusions. The 1970 Act specifically excludes “diagnostic, therapeutic or other treatment of human beings” from patenting. The article critically analyses the impact of Patenting Genome Editing Technologies and its Impact on Access to Human Cellular and Gene Therapeutic Products in India by analysing CRISPR based patents and patent litigations.
Krishnendu Roy Sarkar· Zenodo (CERN European Organi...· 0 citations
New and advanced cellular and gene therapeutic (CGT) products using genome editing technologies have emerged in recent years as a curative treatment option for rare and genetic diseases. CGT products that edit the genome of human somatic cells are making it possible to treat the root cause of many rare and genetic diseases previously regarded as untreatable, and clinical trials of such products are under way worldwide. At present the only approved CGT product using genome editing is Casgevy, which is approved in the United States, the European Union and several other jurisdictions for the treatment of sickle cell disease and beta thalassaemia. In India a closely comparable therapy, BIRSA 101, has been developed indigenously for sickle cell disease and is expected to secure approval in the coming years. The Government of India has notified the New Drugs and Clinical Trials Rules, 2019 under the Drugs and Cosmetics Act, 1940 to accelerate the approval of CGT products. Under the 2019 Rules the Central Drugs Standard Control Organisation grants commercial approval of stem cell derived products and gene therapeutic products as new drugs. Alongside their curative potential, CGT products that edit the genome of human somatic cells carry additional risks, because they make permanent changes to the human genome and may produce off-target effects and other adverse events. The legal framework and the guidelines issued by the regulatory bodies must secure the safe and ethical application of these products, while timely approval is equally necessary if the unmet need for these lifesaving therapies is to be met. This article critically examines the legal framework and offers suggestions for addressing the challenges now facing India.
Krishnendu Roy Sarkar· International Journal of Law...· 0 citations
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