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Employee Empowerment

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Patent for Imatinib had already been obtained by Novartis on April 2, 1993. Novartis claimed that this invention involved two aspects:

1. Selecting an example from the Zimmermann patent and then choosing methane sulphonic acid addition salt of the free base Imatinib, which was called Imatinib Mesylate.
2. Making the invention suitable for oral consumption and use. This led to the formation of the beta-crystalline form of the above drug.
Opponents of the patent filed by Novartis charged saying that the first invention had merely been picked up from the Zimmermann patent and couldn’t actually be classified as an invention and that the claims by Novartis were false[3].

Hence, the SC had to first determine the veracity of the claims made by the company. For this, the bench studied the relevant clauses of the Zimmermann patent in detail. It was found that Novartis had indeed disclosed both Imatinib and Imatinib Mesylate in the Zimmermann patent and had also directed Natco Pharma to stop selling their drug Veenat, in Europe [4]. Veenat involved the use of Imatinib Mesylate and was infringing upon their European equivalent of the Zimmermann patent[4].

Hence, the court declared that only the second invention of the formation of the beta-crystalline form could be actually termed as an “invention”.

Once this was done, Novartis had to pass the bar of calling its invention a “patent”. Section 3(d) of the Act clearly states that discovery of a new form of a known substance must result in some enhancement in efficacy. Unless accompanied by an enhancement in efficacy, it cannot be classified as a patent.

Novartis claimed that the known substance in this case was Imatinib as disclosed in the Zimmermann patent and not Imatinib Mesylate. However, the Court rejected these claims as they contradicted the oral and written statements given by Novartis and concluded that…...

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