Introduction

Medical use claims constitute an important aspect of the pharmaceutical industry. Such claims comprise the use of known substances for the treatment of diseases or any other medical procedure. These types of claims may comprise the ‘first use’ or ‘subsequent use’ of the existing product or process. However, the Indian Patent Act does not allow patentability of such use claims.

This article explores the position of medical use claims under the Indian Patents Act and provides insights on how these claims can be modified to meet patentability criteria.

Position of Medical Use Claims under the Indian Patents Act

Section 2(1)(j) of the Indian Patents Act, 1970 defines an “invention” as “a new product or process involving an inventive step and capable of industrial application.” Thus, under this absolute definition, an invention must be either a product or a process. Use/application is not covered by the definition of invention of the Indian Patents Act. Thus, “use claims” are considered as non-patentable subject matter under the Indian Patents Act.

Furthermore, Section 3 of the Indian Patents Act also provides a list of the inventions which are not patentable. Section 3(d) states that the “mere discovery of any new property or new use of a known substance” is not patentable. Therefore, Section 3(d) also excludes the medical use claims from patent eligibility and creates a challenge for pharmaceutical companies attempting to secure patents for new therapeutic uses of existing substances. ¹

Thus, the above-stated two provisions of the Indian Patents Act bar medical use claims from patentability in India.

Compliance with TRIPS²

The exclusion of medical use claims from patentability in India, while restrictive for pharmaceutical companies, aligns with international intellectual property frameworks. Specifically, the TRIPS Agreement, which sets minimum standards for intellectual property protection among member states, allows flexibility in defining patentability criteria.

TRIPS does not prescribe specific patentability standards but instead, Article 1.1 empowers countries to craft their own legal frameworks, as long as they adhere to the agreement’s minimum requirements. This flexibility is critical in enabling member countries like India to balance intellectual property rights with public health priorities. Article 27.1 requires patents to be available for inventions in all fields of technology, provided they meet the criteria of novelty, inventive step, and industrial applicability. However, these criteria are not explicitly defined, allowing countries to interpret them in a manner suited to their socio-economic needs

Thus, the non-allowance of the “use claims” under the Indian Patents Act completely aligns with TRIPS, which allows the countries to exclude certain inventions for reasons of public order or morality. 

Should you file in India /How to Amend Medical Use Claims

If medical use claims are redrafted as composition claims by mainly focusing on specific formulations or combinations of components, they may qualify as patentable inventions, provided they meet the requirements of novelty, inventive step, and industrial applicability under the Act.

However, such claims must also comply with the provisions of Section 59 of the Act. The recent ruling by the Madras High Court in Starpharma Pty Ltd v The Assistant Controller of Patents ³ alongside precedents like Allergan Inc vs The Controller of Patents⁴ allows for broader amendments to patent claims than previously permitted compared to the traditionally rigid interpretations of Section 59. Furthermore, these rulings serve as a pathway for redrafting use claims into composition claims, as long as such amendments are supported by the original disclosure.

Redrafted composition claims should also comply with Section 3(e) of the Act, which mandates that the formulation or composition must have properties that are unique to the properties of the individual participating constituents and as a result, the end product has a more desirable effect in comparison to the individual constituents i.e. the component/ constituents of the composition should work interdependently to produce an unexpected effect. This is often referred to as a “synergistic effect,” where the combination results in an unpredictable change in the functions of the individual components.

If the specification contains proper experimental data, medical use claims can be redrafted into composition or formulation claims. Further, the Indian Patent Office has granted use claims when re-drafted into composition/product claims, provided the claims are supported by experimental data demonstrating technical advancement.

Examples of Redrafted Composition Claims Granted by the Indian Patent Office

Application No. 7503/DELNP/2007: Initially filed claims claimed “use of calcitonin and a glucocorticoid in the preparation of a medicament for treatment of an inflammatory disease.” The applicant amended the claims to “a pharmaceutical composition comprising calcitonin, a glucocorticoid, and a pharmaceutically acceptable carrier.” The amendment was allowed as it was supported by the specification and application was granted on the inventive merit over the prior art and support for the same was provided from experimental data.

Application No. 6627/DELNP/2013: Initially filed claims were related to the “use” claim for a viscoelastic fluid composition. The applicant amended the claim to define a viscoelastic fluid composition The claim was accepted after addressing technical objections raised in the First Examination Report (FER) as the composition claim was supported by the complete specification.

Comparative Analysis with the US and EP

The Indian Patents Act does not recognize the medical use claims as invention or patentable subject matter, but the United States and European Patent Office have different approaches to medical use patent claims.

In the U.S., “use” claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. Moreover, attempts to claim a process without setting forth any steps involved in the process generally raise an issue of indefiniteness under 35 U.S.C. 112(b). For example, a claim that read: “[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon” was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. ⁵

In Europe, Article 53(c) of the EPC excludes methods of treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body from patentability. However, this exclusion does not extend to products, particularly substances or compositions, intended for use in such methods. To address this limitation, the EPC permits the protection of “second medical use” claims, where novelty is derived from the intended therapeutic application of a known substance or composition.

Under Articles 54(2) and (3), substances or compositions included in the state of the art remain patentable for methods under Article 53(c), provided their use for such methods is novel. Specifically, Articles 54(4) and (5) recognize the novelty of a known substance or composition based on its new therapeutic application. This framework allows the European Patent Office (EPO) to support the patenting of critical medical innovations while adhering to the constraints of the TRIPS.

Conclusion

India’s approach to medical use claims, within the context of the TRIPS Agreement, reflects a careful balance between fostering innovation and addressing public health needs. The provisions of the Indian Patents Act impose certain restrictions on the patentability of certain subject matter, aiming to prevent the unauthorized exploitation of patented inventions and ensure that medicines remain affordable. 

However, to overcome the rejections of medical use claims, applicants can redraft their claims as formulation, composition, and combination claims while adhering to the criteria outlined in Section 2(1)(j) of the Indian Patents Act. Furthermore, robust experimental data showing technical advancements, synergistic effects, and enhanced efficacy can increase the likelihood of such claims being accepted.

References

1. N. Sohrabjit, K. Maloney, “Section 3(d) and Pharmaceutical Patents in India”, Journal of Intellectual Property Rights, Vol 25, May-July 2020, pp 65-73 (2020) ↩︎
2. B. Willis, “The Arguments For and Against the TRIPS Agreement”, E-International Relations (2013) ↩︎
3. (T) CMA (PT) No.22 of 2023 ↩︎
4. C.A.(COMM.IPD-PAT) 22/2021 ↩︎
5. PEP 2173.05(Q) “USE” CLAIMS Ninth Edition of the MPEP, Last Revised in November 2024  ↩︎