Patentability of beta crystalline Imatinib Mesylate failed because the claimed form lacked proven enhanced therapeutic efficacy.

The statutory scheme distinguishes "invention" from patentability, and a claimed product must satisfy novelty, inventive step and industrial applicability, while a new form of a known substance must also show enhanced efficacy under section 3(d). On the materials, Imatinib Mesylate was already disclosed in the prior Zimmermann patent, and the beta crystalline form was only a new form of that known substance. The asserted advantages in flow, stability, hygroscopicity and bioavailability did not amount to enhanced therapeutic efficacy, and no comparison with the immediately preceding substance was shown. Patent protection was therefore refused.

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Issues: Whether the beta crystalline form of Imatinib Mesylate was a patentable invention under the Patents Act, 1970; whether it was barred by section 3(d) as a new form of a known substance without enhanced efficacy; and whether the appellant was entitled to patent protection on the facts.

Analysis: The statutory scheme, after the 2005 amendments, treats "invention" and "patentability" as distinct concepts. A product must satisfy novelty, inventive step and industrial applicability under section 2(1)(j), section 2(1)(ja) and section 2(1)(ac), and in the case of a new form of a known substance, section 3(d) requires proof of enhanced efficacy. On the materials relied upon, Imatinib Mesylate was already disclosed in the prior Zimmermann patent and its pharmacological properties were known. The beta crystalline form was only a new form of that known substance, and the asserted advantages of flow, stability, hygroscopicity and increased bioavailability did not amount to enhanced therapeutic efficacy. The record also did not establish a comparison of efficacy with the substance immediately preceding the claimed form.

Conclusion: The claim for patent on the beta crystalline form of Imatinib Mesylate failed both the invention test and the section 3(d) test, and patent protection was rightly refused.

Final Conclusion: The appellant's patent appeals were dismissed, while the connected appeals succeeded to the extent indicated by the judgment.

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