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CS Executive · Economic, Commercial and Intellectual Property Laws · Law relating to Patents

Kaveri Pharma modifies a known drug into a new crystalline polymorph. Tests show its efficacy is the same as the known drug, with no significant difference in properties. Under Section 3(d) and its Explanation, how is the polymorph treated?

The polymorph is not an invention. Section 3(d) excludes a new form of a known substance that does not enhance known efficacy, and its Explanation deems polymorphs to be the same substance unless they differ significantly in efficacy. Since efficacy is unchanged, the claim fails.

  1. AIt is patentable because a polymorph is a different physical form
  2. BIt is patentable if the manufacturing cost is lower
  3. CIt is treated as the same substance, and the mere new form without enhanced efficacy is not an inventionCorrect
  4. DIt is excluded only if the original drug was patented in India

Explanation

Section 3(d) excludes a mere new form of a known substance that does not enhance known efficacy. The Explanation treats polymorphs and similar derivatives as the same substance unless they differ significantly in properties with regard to efficacy. Here there is no difference, so it is excluded. Lower cost is not the test.

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