By Tatum Anderson for Intellectual Property Watch

One of the most vocal voices for the interests of cancer patients in India says it will use the courts to force the Indian government to declare cancer a national emergency, in an attempt to make cancer drugs affordable to sufferers.

The Cancer Patients Aid Association (CPAA) wants the Indian government to issue permits, called compulsory licences, for a number of drugs it has deemed unaffordable. Such permits would allow generic pharmaceutical companies to manufacture the drugs instead of the patent holders. It believes that the prices would then drop considerably.

Under Indian patent law, no one can apply for a compulsory licence for the first three years after a patent has been granted, unless the government declares one of four emergency criteria: a national emergency, extreme urgency, a case for public non-commercial use or a patentee has employed anti-competitive practices. (After three years anyone can apply for a licence under much broader set of criteria.)
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Times Of India

MUMBAI: The Novartis cancer drug patent case has taken a new turn with an online petition urging doctors and medical professionals to boycott the multinational. The Swiss pharma giant may plan to switch hundreds of millions of dollars in planned investments from India to other locations, primarily China, in response to a court ruling, but an Indian, non-government organisation has decided to clamour for the firm’s boycott.

The Drug Action Forum, Karnataka, has initiated the online petition since Novartis continues to fight a case in the Chennai high court, though the firm lost out an earlier verdict on Section 3 (d). The forum has said that if public opinion and pressure is not brought on the company, “then this single case that is currently in the court may have long term implications on access to medicines to people all over the world”.

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THE HINDU, 13 August 2007

All further proceedings on the statutory appeals filed by Novartis, challenging the rejection of its patent application, pending before the Intellectual Property Appellate Board (IPAB) were stayed by the Madras High Court on Thursday.

The First Bench comprising Chief Justice A.P. Shah and Justice P. Jyothimani granted the interim relief on a writ petition filed by Novartis AG stating that the IPAB had erred in dismissing its plea to exclude its Technical Member S. Chandrasekaran from hearing its statutory appeals.

The Bench has posted the matter to September 10 for further proceedings.

Novartis application to patent the beta crystalline form of imatinib mesylate was rejected by Chennai Patent Office in January 25, 2006. In April 2007, the High Court transferred the statutory appeals to the IPAB after a Technical Member was appointed and the Board became functional.

When the IPAB took up the appeal for hearing, Novartis sought to exclude Mr. Chandrasekaran from the Bench, on the ground that he had filed a counter-affidavit in support of the Union of India and the Controller-General of Patents and Designs and hence he would be biased against Novartis. In July 2007, the IPAB rejected the objections. The present writ petition challenges the rejection of its objections.

Describing the timing of appointment of Mr. Chandrasekaran as significant, the company said the IPAB had erred in rejecting its plea to request the Centre to appoint another member in lieu of Mr. Chandrasekaran.

The January 25, 2006 order rejecting Novartis patent application was passed by the Assistant Controller under the aegis of the erstwhile Controller-General Chandrasekaran, the petitioner said, adding that he had deposed an affidavit against Novartis in High Court before becoming a Technical Member of the IPAB. It said he would suffer from a prejudiced mindset and would not be able to apply his mind in an independent fashion. It said, It is well nigh impossible to expect that a person with an indelible mindset will be able to serve as an unbiased Technical Member (Patent).

It sought to quash the IPAB order and consequently direct the Board to remove Mr. Chandrasekaran from acting as a Technical Member (Patent) to hear the appeal and direct the Centre to appoint another Technical Member in his place.

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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).
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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).

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