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Biotron Limited V. The Controller General of Patents & Designs & Anr.

The Calcutta High Court, in this case, set aside an order passed by the Assistant Controller of Patents & Designs (“Controller”), by way of which it had rejected Biotron Limited’s (“Appellant”) patent application on the grounds of lack of novelty and inventive step, insufficient disclosure, and for the subject matter being non-patentable.

The Appellant’s patent application focuses on innovative compounds for treating viral infections, such as HIV, HCV, and Dengue. The Appellant argued that cited prior arts did not impact the novelty of its invention and that they were also cited in other countries where the Appellant was able to overcome the objections and obtain patents. As regards insufficient disclosure, the Appellant submitted that it has disclosed the best methods for working of the subject invention in its application. Lastly, the Appellant also argued that the Controller’s order did not indicate the reasons for objection as regards non-patentability, and simply stated that the invention contains compounds which are derivatives of the compounds constituting the prior art.

The court, noting the inadequate consideration of the amendments made by the Appellant and the comparative studies submitted, stressed on the importance of justifying rejections and considering enhanced efficacy, especially in light of the Supreme Court’s decision in Novartis AG vs. UOI & Ors. [AIR 2013 SC 1311]. The court also observed that given the complexity of drug development, post-filing amendments are permissible and do not amount to a self-admission of lack of novelty. Additionally, the court underscored the order’s failure to discuss known substances or their efficacy and emphasized the obligation to consider the objections from foreign patent offices. Consequently, the court set aside the order and remanded the Appellant’s application back to the Patent Office for fresh adjudication.

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