INDIA Trends and Developments Contributed by: Pravin Anand, Vaishali R Mittal and Gursimran Singh Narula, Anand and Anand Advocates
Divisional patenting A division bench of the Delhi High Court in Syn- genta Limited v Controller of Patents and Designs clarified the Indian position on divisional patents, holding that a further application can be filed from the subject matter disclosed in provision - al or complete specification already filed. The Court held that the divisional claims need not be restricted to the parent application’s claims. Antibody patenting in India The Madras High Court in Genmab A/S v Assis- tant Controller of Patents set aside an order refusing a grant of a patent for antibody claims. The Patent Office had earlier rejected the grant of claims noting that the DNA and protein of claims were from homo sapiens as per the sequence listing. The High Court refused to apply Section 3(c), holding that the said provision is applica - ble only for the “discovery of a naturally exist - ing molecule/substance” and not for a synthetic version of a non-living substance, especially a monoclonal antibody. The Court held that the claimed invention concerns Daratumubab, a monoclonal antibody that binds to human CD38. It was held that the annotation homo sapiens indicated that the antibody was developed from a transgenic HubMab Mouse platform based on human germline sequence. The High Court also allowed a separate appeal by Immunas Pharma, Inc against the application of Section 3(c) for an invention titled “Antibody Capable of Binding Specifically to A-beta Oligomer and Use Thereof”. Patents for diagnostic methods The Madras High Court in The Chinese Univer- sity of Hong Kong v The Assistant Controller of Patents has clarified the law on patent ineligi - bility for diagnostic methods in India.The Court held that the patentability prohibition proposed by Section 3(i) of the Patents Act is limited to
inventions that are inherently and per se capa - ble of identifying the disease, disorder or condi - tion for treatment of the person. However, if the process cannot per se uncover the pathology, the same would not qualify as “diagnostic”. The Court held that the claimed invention relates to a method for determining a fractional concen - tration of fetal DNA in a biological sample taken from a pregnant female subject, which per se was incapable of identifying the existence of a disease, a disorder or a condition and further testing is required for such purpose and thus was not barred from patenting. Determining therapeutic efficacy for patentability The Madras High Court in Bristol Myers Squibb Company v Deputy Controller of Patents set aside a refusal order by the Patent Controller denying the grant of a patent for a new formula - tion under Section 3(d) of the Patents Act. The Court held that bioavailability is relevant for ther- apeutic efficacy but may not be the sole criterion for patentability. Therapeutic efficacy under Sec - tion 3(d) is a unique provision for India and has previously been debated. Post-filing of therapeutic efficacy data The Delhi High Court in Ischemix LLC v The Controller of Patents has permitted the patent applicants to rely on post-filing of clinical trial data to determine therapeutic efficacy. The deci - sion follows a similar position taken by the Cal - cutta High Court in Oyster Point Pharma Inc v The Controller of Patents and Designs and the Delhi High Court in AstraZeneca AB and Ors v Intas Pharmaceuticals . The Court reasoned that in the pharmaceuticals industry, the drug could be undergoing clinical trials for a new form at the time of filing of the patent application. Fur - thermore, given the complexities and lengthy nature of the process for drug development,
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