2013 (4) TMI 348 - SC - Indian Laws

Supreme Court rules against Novartis on Imatinib patent, reinforcing standards to prevent patent evergreening

Novartis AG Versus Union of India and others

The Supreme Court dismissed the appeals filed by Novartis AG, holding that the beta crystalline form of Imatinib Mesylate did not qualify as an invention ... Patent application rejected - Does the product for which the appellant claims patent qualify as a “new product” which comes by through an invention that has a feature that involves technical advance over the existing knowledge and that makes the invention “not obvious” to a person skilled in the art? - In case the appellant’s product satisfies the tests and thus qualifies as “invention” within the meaning of clauses (j) and (ja) of section 2(1), can its patentability still be questioned and denied on the ground that section 3(d) puts it out of the category of “invention”? - whether the appellant is entitled to get the patent for the beta crystalline form of a chemical compound called Imatinib Mesylate which is a therapeutic drug for chronic myeloid leukemia and certain kinds of tumours and is marketed under the names “Glivec” or “Gleevec” - Held that:- Fundamental that for grant of patent the subject must satisfy the twin tests of “invention” and “patentability”. The subject product, the beta crystalline form of Imatinib Mesylate, does not qualify the test of Section 3(d) of the Act but that is not to say that Section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances. It will be a grave mistake to read this judgment to mean that section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Parent Act. That is not said in this judgment. Section 2(1)(j) defines “invention” to mean, “a new product or …”, but the new product in chemicals and especially pharmaceuticals may not necessarily mean something altogether new or completely unfamiliar or strange or not existing before. It may mean something “different from a recent previous” or “one regarded as better than what went before” or “in addition to another or others of the same kind”. However, in case of chemicals and especially pharmaceuticals if the product for which patent protection is claimed is a new form of a known substance with known efficacy, then the subject product must pass, in addition to clauses (j) and (ja) of section 2(1), the test of enhanced efficacy as provided in section 3(d) read with its explanation. Also as seen that in the US the drug Gleevec came to the market in 2001. It is beyond doubt that what was marketed then was Imatinib Mesylate and not the subject product, Imatinib Mesylate in beta crystal form. It is also seen above that even while the appellant’s application for grant of patent lay in the “mailbox” awaiting amendments in the law of patent in India, the appellant was granted Exclusive Marketing Rights on November 10, 2003, following which Gleevec was marketed in India as well. On its package the drug was described as “Imatinib Mesylate Tablets 100 mg” and it was further stated that “each film coated tablet contains: 100 mg Imatinib (as Mesylate)”. On the package there is no reference at all to Imatinib Mesylate in beta crystalline form. What appears, therefore, is that what was sold as Gleevec was Imatinib Mesylate and not the subject product, the beta crystalline form of Imatinib Mesylate. If that be so, then the case of the appellant appears in rather poor light and the claim for patent for beta crystalline form of Imatinib Mesylate would only appear as an attempt to obtain patent for Imatinib Mesylate, which would otherwise not be permissible in this country. In view of the findings that the patent product, the beta crystalline form of Imatinib Mesylate, fails in both the tests of invention and patentability as provided under clauses (j), (ja) of section 2(1) and section 3(d) respectively, the appeals filed by Novartis AG fail and are dismissed with cost. The other two appeals are allowed. Issues Involved:1. Interpretation of Section 3(d) of the Patents Act, 1970.2. The interplay between Section 3(d) and Clauses (j) and (ja) of Section 2(1).3. Patentability of the beta crystalline form of Imatinib Mesylate.4. Compliance with international treaties and obligations.5. Impact on public health and access to life-saving drugs.Detailed Analysis:1. Interpretation of Section 3(d) of the Patents Act, 1970:The central issue was the interpretation of Section 3(d) of the Patents Act, 1970, which aims to prevent the 'evergreening' of patents by disallowing patents for new forms of known substances unless they result in enhanced efficacy. The Court noted that Section 3(d) was amended to set a higher standard for patentability, particularly for pharmaceutical products. The amendment was intended to strike a balance between encouraging genuine innovation and preventing the extension of patent monopolies on trivial grounds.2. The Interplay Between Section 3(d) and Clauses (j) and (ja) of Section 2(1):The Court examined whether the beta crystalline form of Imatinib Mesylate qualified as an 'invention' under Clauses (j) and (ja) of Section 2(1). It was determined that for a product to qualify as an invention, it must be new, involve an inventive step, and be capable of industrial application. The inventive step must entail a technical advance over existing knowledge or have economic significance, making the invention non-obvious to a person skilled in the art.3. Patentability of the Beta Crystalline Form of Imatinib Mesylate:The Court found that Imatinib Mesylate was a known substance from the Zimmermann patent, and its pharmacological properties were already known. The beta crystalline form of Imatinib Mesylate did not exhibit enhanced efficacy over the known substance, Imatinib Mesylate. The Court emphasized that the properties such as better flow, stability, and lower hygroscopicity, while beneficial, did not qualify as enhanced therapeutic efficacy under Section 3(d).4. Compliance with International Treaties and Obligations:The Court acknowledged India's obligations under international treaties like the TRIPS Agreement but emphasized that the Indian patent law must be interpreted on its own terms. The TRIPS Agreement and the Doha Declaration allow member states to adopt measures necessary to protect public health. The Court noted that the Indian patent law, as amended, was fully TRIPS compliant and aimed to balance international obligations with public health considerations.5. Impact on Public Health and Access to Life-Saving Drugs:The Court highlighted the importance of ensuring that life-saving drugs remain accessible to the public. It was noted that the introduction of product patents for pharmaceuticals could potentially put essential medicines beyond the reach of many, particularly in developing and underdeveloped countries. The Court emphasized that the legislative intent behind Section 3(d) was to prevent the extension of patent monopolies on frivolous grounds and to ensure that genuine innovations that enhance therapeutic efficacy are encouraged.Conclusion:The Supreme Court dismissed the appeals filed by Novartis AG, holding that the beta crystalline form of Imatinib Mesylate did not qualify as an invention under the Patents Act, 1970, and failed the test of Section 3(d). The judgment underscored the importance of maintaining a high standard for patentability to prevent the evergreening of patents and ensure access to affordable medicines.