Madras High Court restrains patent board in Novartis case

Chennai, Aug 9 (IANS) Swiss pharma major Novartis had some relief Thursday in its legal battle in India as the Madras High Court restrained the Intellectual Property Appellate Board (IPAB) from hearing its appeal contesting the rejection of its patent application for a blood cancer drug. The same high court had thrown out Novartis's challenge to the Indian patent laws Monday.

A division bench of the Madras High Court comprising Chief Justice A.P. Shah and Justice P. Jyothimani Thursday granted an interim stay for four weeks on another Novartis petition questioning the IPAB's order.

The board had rejected the firm's demand that technical member S. Chandrasekharan withdraw from hearing its appeal as he was part of the process of rejection of its application before the Patents Office here.

Following the rejection of its plea for a patent for the beta-crystalline form of imatinib mesylate, marketed under the brand name Glivec, by the Assistant Controller of Patents, Chennai, in January 2006, Novartis had initially filed the writ petition. The matter was transferred to the board after the central government constituted a bench of the IPAB.

The IPAB had on July 21 rejected the plea by Novartis to exclude the technical member from the bench.

Novartis raised objections to the presence of Chandrasekharan on the IPAB since he had originally taken a stand against the company.

The IPAB comprising chairman M.H.S. Ansari and Chandrasekharan had rejected the plea by saying that Chandrasekharan had earlier made his submissions in his official capacity as a statutory authority, but now he was an adjudicator.

Novartis moved the high court against this order of the IPAB.

The high court bench also issued notices to the central government and others Thursday and adjourned the hearing till Sep 10.

Novartis' patent claims Dismissed by Madras HC

Chennai, Aug 6 (IANS) In a major victory for Indian pharma firms, a Madras High Court bench Monday dismissed a controversial claim by Swiss pharmaceutical giant Novartis that it should be given the right to patent life-saving drugs and prevent their generic manufacture in India.

Justice R. Balasubramanian and Justice Prabha Sridevan summarily rejected Novartis' challenge against the constitutional validity of Section 3 (d) of the Indian Patents Act. The division bench also declined the multinational company's plea to declare the statue as non-compliant with the Trade Related Aspects of Intellectual Property Rights (TRIPS), the global intellectual property treaty.

The bench noted that TRIPS itself provided for a Dispute Settlement Board to adjudicate all issues relating to the treaty.

"As the participating nations themselves had created a dispute settlement mechanism, we see no reason at all why we must disregard it," the court said.

Nationally, the judgement is a major victory for campaigners who say MNCs try to patent life-saving drugs by merely producing new forms of existing compounds, or by twisting the intellectual property law by a process dubbed "ever-greening" - indefinitely perpetuating patent protection by passing off variants and derivates as fresh inventions.

Globally, the judgement is set to be welcomed a millions of patients, particularly in the poorest countries of the world, for whom Indian generic drugs often mean the difference between life and death.

Novartis had moved the court when the Assistant Controller of Patents, Chennai, rejected its application for a patent for the beta-crystalline version of its drug, imatinib mesylate, which is sold under the brand name Glivec and is used in the treatment of blood cancer.

In January 2006, the assistant controller had invoked Section 3(d) of the Indian Patents Act to deny the company's claims of discovery of a new form of a known substance because it had not resulted in "enhancement of its known efficacy".

Novartis challenged the controller's decision - its appeal is pending before the Intellectual Property Appellate Board (IPAB), Chennai - and questioned the validity of the relevant section, which was introduced in the Patents Act, 1970, through an amendment in 2005.

Novartis counsels argued that the section was vague, arbitrary and ambiguous and gave unbridled power to the authority to use or misuse it.

The bench upheld the contention of the central government, the Cancer Patients' Aid Association of India, Mumbai, and several other rival pharmaceutical companies which stressed that the section was neither vague nor arbitrary. The global pharmaceutical giant could not pretend to be unaware of what it meant by "enhancement of known efficacy".

"We reiterate that the amended section, along with its explanation, is capable of being understood and worked out in a normal manner not only by the patent applicant, but also by the patent controller. In other words, the patent controller would be guided by various relevant details, which every patent applicant is expected to produce before him, showing that the new discovery has resulted in enhancement of known efficacy and that the derivatives differ significantly in properties with regard to efficacy," the court pointed out.

The company's argument that the provision violated Article 14 of the constitution (right to equality before law) and its claim that it had been discriminated against were also turned down.

The right of Indian citizens to have easy access to life-saving drugs could not be denied, the bench added.

Apex court slams Tamil Nadu government over MBBS Admissions

New Delhi, July 19 (IANS) The Supreme Court Thursday criticised the Tamil Nadu government for making last-minute changes in its admission rules for state-run medical colleges, thereby depriving some students who were studying in other colleges from taking admission.

A bench headed by Chief Justice K.G. Balakrishnan pulled up the state government while staying a July 10 order of the Madras High Court order banning over 400 students, who were pursuing professional courses in other colleges of the state from participating in the counselling for admissions to medical colleges for the new academic year.

The high court passed the order after the state's advocate general said that the government would strike down the rule allowing these students to compete for admissions.

Upset by the government's approach on the issue, an irate chief justice went said that the government's action was tantamount to "stifling the education" in the state.

"By doing this you are stifling the education," said the chief justice adding: "Everyone has the right to get admission in a medical college. How can you deny this right?"

"There is a huge disparity between the fee of the government colleges and private colleges, particularly for medical courses. How can you deprive the students of their chances in a government college?" he asked.

"Don't stretch the provision of the constitution too far to deny the rights of the citizens," he snapped.

The bench, which also had Justice R.V. Raveendran and Justice Dalveer Bhandari on it, allowed the affected students to participate in the second round of counselling for admission from Monday.

The bench, however, said that the students already admitted to medical colleges after the first round of counselling between July 9 and 16 will not be affected by its order.

The apex court's order follows a petition by eight Tamil Nadu students, who had taken admission last year in other private colleges after they failed to get admission in state-run medical colleges.

When the state began admissions for 2007-08, the students again took the entrance test.

Out of around 1,500 students who made it to the merit list in the entrance test, around 400 were those who had taken admission in professional courses in other colleges.

Some students who had taken the entrance test for the first time moved the Madras High Court saying that by admitting students who had already taken the test a year ago and were pursuing courses elsewhere to the new session, the seats in the other colleges vacated by them would go waste.

Allowing their petition, the high court had asked the government to change the rule to deny the old students admission to the state-run medical colleges.