India Patent

Section 3(d) of the Indian Patents Act, 1970 (as amended in 2005) is a specific restriction on pharmaceutical patentability that excludes from patent protection 'the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance.' The provision prevents patents on modifications of existing drugs — including new salts, polymorphs, hydrates, esters, metabolites, and other derivative forms — unless the applicant demonstrates that the new form shows significantly improved therapeutic efficacy. Section 3(d) was interpreted by the Indian Supreme Court in Novartis AG v. Union of India [2013] SCC — the Court rejected Novartis's patent on the beta crystalline form of imatinib mesylate (Gleevec/Glivec, a cancer drug) holding that improved bioavailability without demonstrated improved therapeutic outcomes was insufficient. Section 3(d) applies to pharmaceutical substances specifically — it is designed to prevent 'evergreening' of pharmaceutical patents through minor modifications that extend effective market exclusivity without providing genuine therapeutic advances. New chemical entities (NCEs) that are genuinely novel drug substances are not affected by Section 3(d) — the exclusion applies only when the claimed compound is a new form or derivative of a substance already known to have a certain property (typically, to have pharmaceutical efficacy). For pharmaceutical patentees filing in India: (1) NCEs face standard novelty/inventive step analysis — no Section 3(d) issue; (2) second-generation compounds (salts, polymorphs) require comparative efficacy data; (3) combination patents require evidence of synergistic effect beyond the individual components; (4) dosage form and formulation patents may be subject to Section 3(d) if the claimed formulation is a new form of a known substance.

Indian patent examination follows a process governed by the Patents Act 1970 and the Patent Rules 2003. Key steps: (1) Filing: application filed with CGPDTM (Controller General of Patents, Designs & Trade Marks) at one of four regional offices (Mumbai, Delhi, Chennai, Kolkata). Foreign applicants must use a registered Indian patent agent. (2) Publication: application publishes 18 months from priority date; early publication can be requested via Form 9. (3) Request for Examination (Form 18 or 18A): must be filed within 31 months of priority/filing date; if not filed, application is withdrawn. Fee: ₹4,000–₹20,000 depending on applicant type. (4) First Examination Report (FER): examiner issues objections typically 18–24 months after examination request. (5) Response deadline: 12 months from FER date to put application in order — strict, non-extendable; if not resolved, application is abandoned. (6) Hearing: Controller may hold a hearing before grant or refusal. (7) Grant and opposition: patent publishes in Patent Journal; pre-grant opposition (§ 25(1)) available to any person after application publication and before grant; post-grant opposition (§ 25(2)) available to any interested person within 12 months of grant. (8) Form 27: annual working statement required after grant. Average total pendency from filing to grant: 4–7 years for straightforward applications, longer if oppositions are filed. The CGPDTM has been reducing backlogs in recent years with increased examiner staffing and digital examination. India's patent office has been improving efficiency, but pharmaceutical applications facing Section 3(d) objections and pre-grant opposition can take significantly longer.

Form 27 is a mandatory annual statement required under Section 146 of the Indian Patents Act from every patent holder (and every licensee) for each granted patent in India. The statement must be filed by March 31 for the preceding calendar year. Form 27 requires disclosure of: (1) whether the patent was worked commercially in India during the year; (2) if worked: the extent of working — approximate value of products/services in India, quantity, whether licensed; (3) if not worked: the reasons why the patent was not worked and what measures are being taken or proposed to work the patent. Form 27 is a public document — anyone can access filed working statements. Failure to file Form 27 is punishable by a fine up to ₹10 lakh (approximately $12,000 USD). The working statement is significant for two reasons: (a) It creates a record that third parties can use to support compulsory license applications under Section 84 — a patentee who consistently files Form 27 showing 'not worked' provides evidence that the patent is not being worked to a reasonable extent, which is a ground for compulsory licensing; (b) It puts patent holders on notice that they must actively work their patents in India or face compulsory licensing exposure. For multinational companies: the standard response for a patent covering a marketed product sold in India is straightforward — report sales volume and revenue. The challenge arises for patents covering products that are sold globally but imported into India rather than manufactured locally — CGPDTM has sometimes considered importation insufficient 'working' in the Indian context, though the law does permit importation to satisfy the working requirement. Legal counsel should advise on appropriate characterization of working via licensed importation versus local manufacturing.

Yes — India has granted compulsory licenses for patents. The first and most prominent compulsory license in India was granted by the Controller of Patents in March 2012 in Natco Pharma Ltd. v. Bayer AG. Bayer had a patent on sorafenib tosylate (Nexavar), a cancer treatment drug. Natco Pharma applied for a compulsory license under Section 84 of the Indian Patents Act on three grounds: (1) the reasonable requirements of the public had not been satisfied; (2) the patented invention was not available to the public at a reasonably affordable price; and (3) the patented invention had not been worked in the territory of India. The Controller granted the compulsory license, finding that Bayer's patented drug was priced at approximately ₹280,000 per month while Natco proposed to sell the drug at ₹8,800 per month — less than 3% of the original price. The license required Natco to pay Bayer a royalty of 6% of net sales. Bayer appealed; the Intellectual Property Appellate Board upheld the compulsory license in March 2013; the Bombay High Court and then the Supreme Court of India upheld the decision. As of 2026, the Natco v. Bayer license remains the only compulsory license that has been formally granted and enforced in India under the post-2005 patent regime — but India's compulsory licensing provisions and working requirements remain active legal tools. Several other compulsory license applications have been filed but not granted or are pending. The COVID-19 pandemic renewed interest in potential compulsory licenses for vaccines and antivirals, but no licenses for COVID-19 vaccines or antivirals were formally granted in India as of 2026.

Software patentability in India is governed by Section 3(k) of the Patents Act, which excludes 'a mathematical or business method or a computer programme per se or algorithms' from patentability. The key word is 'per se' — meaning pure software (software as such) is not patentable, but software that is part of a system producing a specific technical application or physical effect may be. The CGPDTM has issued multiple revisions of its examination guidelines for computer-related inventions (CRI guidelines). The current approach (as refined post-2016) requires examiners to assess claims as a whole rather than in isolation, asking whether the claim is directed to a 'technical application' — something with a technical character and a concrete technical result. Software embedded in hardware systems, methods implemented in systems that achieve a specific technical improvement, and AI systems that produce physical technical outputs are more likely to be allowable than pure data processing or business method software. For AI inventions specifically: India does not have formal AI-specific patent guidelines as of 2026, but the general CRI approach applies — an AI model that improves a technical process (optimizes a manufacturing step, diagnoses disease from medical imaging, controls a physical machine) is more likely to be eligible than an AI model that generates text or analyzes business data without a defined technical effect. In practice, India's software patent landscape is more restrictive than the US post-2005 but has shown increasing flexibility through CGPDTM practice. The best drafting strategy for India includes: (1) anchoring software claims to a specific system or apparatus (method + system claims); (2) emphasizing the technical effect in the specification; (3) including concrete technical use cases; (4) avoiding pure data-processing claims without physical grounding.