Novartis Decision: Is Beta Crystalline Form of Imatinib Mesylate the same as Glivec?

In my last two posts, I have blogged on the Novartis decision of the Supreme Court. Most of us have been using Glivec and Beta Crystalline form of Imatinib Mesylate interchangeably. Here’s Para 193 of the Supreme Court’s finding on the issue:

“193. Coming back to the case of the appellant, there is yet another angle to the matter. It is seen above 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.

194. 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.”

Now let’s examine the basis for this finding. The Supreme Court seems to have proceeded under the assumption that Novartis was obliged under law to mention the ‘beta-crystalline (BC)” form on its package, failing which, according to the Court, it was fair to assume that Imatinib Mesylate was being sold under the EMR granted for the BC form.

Before assuming thus and arriving at an adverse finding, it would have helped to undertake the following: 

1.  Branding of drugs is governed by Section 9 of the Drugs and Cosmetics Act, 1940 read with the manner of labeling prescribed under Rules 96 and 97 of the Drugs and Cosmetics Rules, 1945. Assuming that the Court deemed it relevant to address the issue of branding in a proceeding for grant of a patent, there appears to be no such discussion on the relevant provisions of the law. Unless these Drug Rules and their interpretation by Courts mandate mentioning the polymorphic form of the drug as part of the packaging, the patent applicant need not mention “beta crystalline form” as part of its package. 

2.  It would have also helped to understand the labelling practices prescribed by Indian Pharmacopoeia or the official pharmacopoeias in order to form an informed opinion on the facts of the case. 

3.  Tests could have been undertaken to check if what was being sold under the name of Glivec was Imatinib Mesylate or its BC form.

There is no discussion in the decision on the above aspects of the issue, and the Hon’ble Court seems to have proceeded on the basis of the packaging. Also, the packaging relied upon by the Hon'ble Court does not seem to state that its contents are the subject-matter of the impugned patent application.

I request better-informed readers to share with us their inputs to understand the issue better.