Answer By law4u team
Yes, medicine formulas can be patented in India, but there are important restrictions and conditions under the modern Indian patent framework, particularly under the Bharatiya Nyaya Sanhita (BNS) provisions on intellectual property and related pharmaceutical regulations. Here’s a detailed explanation: 1. Patentability Criteria in India For a medicine formula to be patented, it must meet the general criteria of patentability: Novelty: The formula should be new, i.e., not disclosed in any prior publication or publicly known before the filing date. Inventive Step (Non-Obviousness): The formula must involve an inventive step, meaning it is not an obvious development for someone skilled in the field. Industrial Applicability: The formula should have a practical application, such as treating a disease or improving drug delivery. Full Disclosure: The applicant must provide a complete description of the formula and its preparation, enabling others to replicate it (without copying the invention). 2. Restrictions on Patentability of Medicines Under modern Indian law, especially reflecting BNS and BNSS principles for public health, there are specific restrictions: Section on “Exclusions”: Some substances are not patentable in India, even if new, including: Formulations that are already known in traditional medicine systems like Ayurveda, Unani, or Siddha. Simple mixtures of known substances that do not enhance efficacy in a novel way. New forms of known drugs without improved therapeutic efficacy (for example, a new tablet form of an existing drug may not be patentable unless it shows enhanced effect). Section on Public Health: India has safeguards to ensure medicines remain affordable and accessible. If a patent would restrict access to essential medicines, authorities can: Refuse the patent if it is not sufficiently innovative Grant compulsory licensing later, allowing others to produce the medicine if needed for public health 3. Types of Patentable Medicine Formulas New chemical entities (NCEs): Completely new drugs with unique chemical structures. New combinations: If two or more existing drugs are combined in a novel way that improves efficacy or reduces side effects. New dosage forms with enhanced effects: For example, a slow-release tablet of a known drug that significantly improves therapeutic results. New methods of treatment: Some processes of using a drug in a novel way can also be patented. 4. Non-Patentable Examples A simple herbal mix that has been traditionally used in India cannot be patented. A known drug in a different salt form that does not improve therapeutic efficacy cannot be patented. Mere discovery of a new property of a known drug without significant application is not patentable. 5. Patent Term and Protection If a medicine formula is successfully patented in India: The patent term is generally 20 years from the filing date. The patent holder has exclusive rights to manufacture, sell, or license the formula. Others cannot legally produce or sell the patented medicine without the holder’s permission, unless a compulsory license is issued. 6. Practical Implications India allows patents for genuine pharmaceutical innovations, balancing innovation incentives with public access to medicines. Many multinational companies file for patents in India, but the law prevents evergreening (patenting minor modifications of old drugs to extend monopoly). For traditional medicine or herbal formulas, India encourages publication and protection through trademarks or traditional knowledge registries, but not standard patents. In summary: Yes, medicine formulas can be patented in India if they are new, inventive, and industrially applicable. India does not allow patents for minor modifications, known substances, or traditional remedies unless they demonstrate enhanced efficacy. The SDM is not involved in patent matters; patents are granted by the Indian Patent Office under BNS/BNSS regulations.
