Novartis Update 30.03.07

The Novartis appeal resumed today, with Bhushan resuming his critique of the IIT and IICT studies that were submitted by Natco to show that the ß-crystalline form invariably formed when the mesylate salt was produced. He pointed to Example 1 of the Indian specification, which showed how to create the a-crystal form. He then showed that one of the experiments conducted by IICT was essentially identical to the example cited in the Indian specification. He concluded from this that the imatinib free base that Natco had supplied to IICT must have been contaminated with ß-crystal seeds, thus inevitably resulting in the ß-crystal. He alleged that Natco must have reverse engineered the imatinib free base from the ß-crystal form, thus resulting in the contamination.

In this context, he again discussed an affidavit submitted by Novartis’ expert, who concluded that the ß-crystal form must have been attained through contamination.

Bhushan then pointed to Hetero’s pending application for the amorphous form of imatinib mesylate, and claimed that this proved that, contrary to Natco’s allegations, the ß-crystalline form is not obtained invariably. He also pointed to Natco’s own admissions which showed that Natco, Cipla and other companies had applied for and received marketing approval on the a-form of imatinib mesylate. He further cited to other references to show that forms other than the ß-form were known and being used by the generic companies.

Bhushan then read out the Order of the Patent Controller in which he dealt with Novartis’ argument that it was entitled to a selection patent, to show that the Controller had not applied his mind on the issue of selection patents. Bhushan pointed out that Novartis had specifically raised the issue of selection patents, but that the issue was never dealt with in the Order.

Bhushan then argued that on the issue of claiming wrong priority, first that the relevant law to be applied in this case was the current law, which presumes all countries to be convention countries unless otherwise specified. Even if wrong priority had been claimed, Bhushan argued that this was not a ground for rejection, because this would only serve to change the priority date to July 1998. He claimed that nothing had been published between 1997 and 1998 that would affect the patentability of the subject application.

With this, Bhushan closed his arguments.

The Court adjourned early for the weekend. The matter will likely resume on Monday. We will continue our updates then.

In solidarity,

The Lawyers Collective HIV/AIDS Unit Team
Anand
Chan
Julie
Prafulla