Natco is examining various options including approaching Kolkatta High Court in continuation of its pursuit to challenge EMR granted to Novartis India by the Controller General of Patents and Trademarks for its drug Glivec(imatinib mesylate) in November 2003.

Natco had challenged the constitutional validity of the provisions of the Indian Patent Act before a Division Bench of the High Court at Delhi on the grant of EMR to Novartis. The petition was admitted by the Delhi High Court on December 23, 2003.

The company informed Pharmabiz that after hearing the parties on April 6, 2004 (after about three months of issuing notice to Novartis by Natco) the High Court without going into the merits of the case reached the opinion that the Court could not entertain the Writ Petition. While the full text of the judgement is awaited, Natco seems to be fully convinced that it has a strong case and would evaluate available options.

A breakthrough product in the treatment of cancer, Glivec is one of the first oncology drugs that validate rational drug design based on an understanding of how some cancer cells work.

As per the provisions of the Indian Patent Rules, exclusive marketing rights can be granted only in respect of patents/applications filed in a convention country after January 1, 1995. Natco feels that granting of EMR to Novartis is not correct and it has a strong case for asking for its revocation as the applications for patents with respect to imatinib mesylate were filed prior to 1995. The company feels that in respect of life-saving drugs such as imatinibi mesylate, the concerned authorities should look beyond commercial and legal considerations.

Granting of EMR to Novartis' Glivec by controller general of Patents and Trademarks of India is a gross violation of Indian Patents Act, as it is clearly mentioned in the Act that a drug will be worthy of an EMR only if its original discoverer has patented the product after 1995, the company sources said.

Novartis viewed that four conditions were required for an EMR grant. These are filing an application by the inventor for an EMR in India, product patent approval on the applied product from a convention country, marketing approval from a convention country and marketing approval from India. All these conditions have to be met with post 1995.

Novartis claimed to have applied for EMR in July 1998, received product patent from Australia in February 2002, received Australian marketing approval in August 2001 and received marketing approval in India in December 2001. Therefore there is no chance of any violation of law.

Dr. SN Maiti, controller general of patents, earlier stated that it was only after fully scrutinizing the matter that the EMR was granted to Novartis. It was verified that Novartis had filed an EMR application in 1998 and patent was granted to the product in 2002.