A division bench of the Madras High Court today dismissed a challenge to section 3(d) of the Indian Patents Act, 1970 filed by Swiss pharmaceutical multinational Novartis AG and its Indian subsidiary, Novartis India . These petitions challenged the validity of a key provision in the Indian law, which seeks to prevent ever greening and which provided one of several grounds on which the Patent Controller rejected Novartis AG’s patent application for the beta-crystalline of Imatinib Mesylate, brand name Glivec (Gleevec).

In March 2005, with retrospective effect from 1 January 2005, the Indian Parliament amended its patent law to protect product patent protection. A significant and important provision was introduced to prevent every greening and granting of frivolous patents, section 3(d). Continue reading →

Daily News & Analysis, August 02 ,2007

Novartis has moved the Madras High Court on Wednesday against the Intellectual Property Appellate Boards (IPAB) decision in the Glivec case, in which the company is fighting the case to obtain a patent on its anti-cancer drug.

On July 20, IPAB shot down Novartis appeal to drop former controller general of the Indian Patent Office, S Chandrasekaran, as IPABs technical member for the Glivec case.As Chandrasekaran was responsible for the original rejection of the Glivec patent, Novartis believes that Chandrasekaran cannot act as an impartial member of the appellate board.

Novartis is optimistic about its appeal in the high court thanks to a recent Delhi High Courts decision against Chandrasekaran. In the case involving Magotteaux International, Delhi High Court said that Chandrasekaran cannot be a technical member on IPAB as he has earlier dealt with the matter under appeal.

Apart from this Glivec case, Novartis is also awaiting the final judgement from the Madras High Court for its second case. In the second case, the Swiss company has challenged constitution of Indian Patent Act.

The Economic Times 2 August 2, 2007

Triggering a fresh legal wrangle, Swiss drug major Novartis on Wednesday filed a writ petition with the Madras High Court contesting the Intellectual Property Appellate Board (IPAB)s decision to let former Patent Controller General S Chandrasekaran hear its appeal for Glivec.

Novartis had filed a petition with the IPAB last month insisting that the newly appointed technical member to the board had refused its patent for anti-cancer drug Glivec in the first place, and should therefore not hear its appeal. However, the IPAB dismissed Novartis objection.

The Madras Patent Office rejected Novartis patent application for Glivec in January 2006, arguing that the Basel-based drug makers innovation was obvious and did not meet the requirements of section 3(d) a legal clause specific to the Indian patent law, which stipulates that modifications of already-known medicines cannot be patented unless they make the drug significantly more effective.

While Glivec is a new medicine, patented in over 40 countries around the world, Novartis is seeking patent protection in India for a crystalline form of the drug, as the original molecule was invented prior to 1995, and is therefore not eligible for a patent in India.

Novartis has last year filed a petition with the Madras High Court challenging the constitutionality of Section 3(d).

Economic Times, July 21, 2007
The Indian Patent Appellate Board (IPAB) has dismissed Novartis objection to the appointment of S Chandrasekaran, former Patent Controller General India, to hear its appeal for Glivec.Novartis had filed a petition with IPAB last month, insisting that the newly appointed technical member to the board had in a different capacity refused its patent for anti-cancer drug Glivec.The dismissal of the Swiss giants protests could make Novartis take its case to the courts, triggering a fresh legal wrangle.

According to legal sources, IPAB has argued that Mr Chandrasekaran was serving in a different capacity with the Indian Patent Office and, therefore, though it was under his tenure that the patent for Glivec was rejected, he was not directly involved in the decision on Glivecs patent. Besides, the technical member to IPAB needs to have work experience of five years with the Indian Patent Office, which makes it difficult to appoint a new person to hear Glivecs case. Continue reading →