MUMBAI: The Madras High Court, which has been hearing a key patent appeal filed by Swiss drug maker Novartis AG, has shifted the case to the Intellectual Property Appellate Board (IPAB) with immediate effect. The move follows a Union government notification on 2 April setting up a patent cell at the IPAB to handle patent-related cases with the appointment of a technical member of patents in it.
With this, Novartis’ appeal on a decision by a Chennai patent office rejecting an application on its cancer drug Gleevec in India will no longer be handled by the court. Other patent cases are also likely to be heard by the IPAB.
The newly appointed technical member in the patent cell at IPAB is S. Chandrasekharan, formerly Controller General of Patents, Designs & Trademarks of India, under whose charge the Novartis patent was first rejected in May 2006.
“This reconstitution of IPAB is to expedite the disposal of matters related to appeals by patent applicants against the patent offices’ decision. With this body in effect now, it is expected that all existing patent appeals pending in courts will be transferred to it,” said a senior official at the Office of Controller General of Patents, Designs & Trademarks in New Delhi, who preferred to remain unnamed.
Mumbai-based drug maker Wockhardt has a similar litigation pending at the Bombay High Court. Wockhardt had, in December 2006, filed a case challenging a patent office rejection of its application for patenting a version of antibiotic drug nadifloxacin (branded Nadoxin), a drug molecule originally developed by Japan’s Otsuka Pharmaceuticals. Wockhardt claimed its version had an enhanced treatment efficacy.
But the patent office rejected Wockhardt’s application in August last year following oppositions filed by drug makers Cipla and Hetero Drugs, who have copycat generic versions of the drug in the market. An official from Mumbai Patent Office, who also did not wish to be quoted, said the Wockhardt patent litigation also would be likely shifted to the new appellate board with immediate effect. That patent was also rejected by patent offices in Chennai and Mumbai, when Chandrasekharan was the controller general.
“This is a step forward in creating a fully functioning patent system in India. However, we are concerned that this new development may further delay review of the Glivec (the name the drug is sold under in India) patent matter. The newly appointed technical member of the appellate board is the former Controller General of the Indian Patent Office who was responsible for the original decision on the Glivec patent in 2006 and is a party to the current case,” Svetlana Pinto, a Novartis spokeswoman, said in an emailed statement. Novartis is looking forward to wrapping up the case soon. “We look to the government of India to quickly develop procedures that allow us to explain our case clearly to an impartial board and in a manner that ensures transparency in the decision-making process,” Pinto added. Gleevec holds patents in China, Russia, Taiwan, and nearly 37 other countries.
Chandrasekharan couldn’t be reached and it was unclear if he will withdraw himself from hearing these two cases.
“Novartis’ patent appeal was the first of this kind to be shifted to the independent appeal committee from a high court,” said G. Gopakumar Nair, a lawyer representing Cipla which is arguing against Novartis, adding that it could come up for hearing soon.
The same lawyers could continue arguing the case before the panel. “The lawyers are entitled to represent the parties concerned in the new appellate body as well,” said Laxmi Kumaran, a lawyer who represented Ranbaxy Laboratories in the Novartis case.
Meanwhile, hearing on a petition on the same patent litigation filed by Novartis, challenging the compliance of Indian Patent rules with global trade laws, was completed in the high court and a judgment is awaited in a week, a lawyer for an Indian drugs company in the case said.
In May last year, Novartis had filed two cases, challenging both the patent office’s rejection of its application for Gleevec, and a rule—Section 3 D of the Indian Patents Law —which formed the basis of the patent office decision.
Gleevec is a cancer drug used in the treatment of myeloid leukemia, a rare cancer of the blood.
The drug is produced and marketed internationally by Novartis. In India, copies of the medicine—drug name: imatinib mesylate —has been manufactured and marketed by domestic drug makers such as Cipla, Hetero, Natco Pharmaceuticals and Ranbaxy at a tenth of the price that Novartis sells it at.
Gleevec, which costs an Indian patient Rs120,000 for a month’s treatment, is given away free to about 6,700 cancer patients in India not covered with insurance. Local versions of the drug are priced at about Rs8,000 to Rs12,000 a month.