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.