A Delhi high court judgment, expected soon, promises to become the second test case in less than a year on the way Indian judiciary balances public health issues and patents owned by large multinational drug makers.
Basel-headquartered F Hoffman-La Roche Ltd is seeking an injunction against a move by India’s Cipla Ltd, ranked among the top three in the country by sales, to introduce in the local market a generic version of the Swiss firm’s lung cancer drug, Erlotinib.
Erlotinib hydrochloride (trade name Tarceva, Genentech/OSIP, originally coded as OSI-774) is a drug used to treat non-small cell lung cancer, pancreatic cancer and several other types of cancer. Cipla has asked the court for the Tarceva patent, granted in February 2007, to be revoked.
Cipla’s move, seen risky by some, hinges on the argument that the patented drug—costing Rs4,800 a tablet or nearly double an Indian’s per capita monthly income—is out of reach of most of this country’s citizens. Cipla sells its Erlotinib version at one-third of the Roche price.
The Roche-Cipla case follows a legal battle that Novartis AG is engaged in since early 2006 with the Indian authorities over the rejection of patent application for cancer drug Glivec (sold as Gleevac globally).
Imatinib is a drug used to treat certain types of cancer. It is currently marketed by Novartis as Gleevec (USA) or Glivec (Europe/Australia) as its mesylate salt, imatinib mesilate (INN). It was originally coded during development as CGP57148B or STI-571. It is used in treating chronic myelogenous leukemia (CML), gastrointestinal stromal tumors (GISTs) and a number of other malignancies.It is the first member of a new class of agents that act by inhibiting particular tyrosine kinase enzymes, instead of non-specifically inhibiting rapidly dividing cells.
Novartis’ challenge that a rule in the Indian Patents Act, 1970, is non-compliant with global trade laws has been rejected by the Madras high court and the company, also Swiss, is separately fighting the patent rejection at an appeal tribunal.
The New Delhi case, which has high profile lawyers fighting for Roche and Cipla, is keenly watched by the drugs industry, patient groups and patent attorneys.
“If Glivec was step one, then Tarceva will be step two. Glivec established the legitimacy of Section 3(D) (the patent rule that Novartis challenged), Tarceva will show what can the patent law do for public health and access to affordable drugs in the face of a patent protected drug,” said CPAA’s Sapru. Section 3(D) bars patenting of slight modifications on existing drugs without substantial increase in efficacy. Arguments in the Roche-Cipla case closed on 31 January.
In the court, Cipla, whose legal counsel is Arun Jaitley, also a politician representing the Bharatiya Janata Party in Parliament, contended that the Tarceva patent should be revoked under Section 3(D) as the drug is a mere derivative, or tweaked version, of an older drug. Cipla faces infringement charges and a claim of Rs1 crore in damages.
Tarceva, a new drug for Roche with revenues of about $1 billion (Rs3,960 crore), has the potential to be a moneyspinner. Indicated for non-small cell lung cancer and pancreatic cancer, it is approved in 87 countries for the second- and third-line treatment of patients with advanced lung cancer, says Roche website.
Mindful of the Glivec ruling, Roche’s legal counsel, Abhishek M. Singhvi, also a spokesperson for the Congress, stated in one of the hearings that they were not challenging Section 3(D), but just its application in erlotinib’s case. The managing director of the Swiss firm’s local unit, Roche Scientific Company (India) Pvt. Ltd, Girish Telang declined comment until the court verdict.
Roche has reported Rs13.91 crore of Tarceva sales since April 2006, when it first launched the drug in the country. The revenues of the Indian unit are not known as it is privately held and not mandated to publicly report financials.
Roche’s petition called Cipla’s actions as a brazen “infringement of the legal rights of the plaintiffs (Roche and OSI Pharmaceuticals Inc.)”. Its counsel Singhvi rebutted the Cipla claim that the drug is a derivative of quinazoline, a drug with a patent pre-dating 1995, the cut-off year for grant of patents in India.
Over the course of five hearings, Cipla’s counsel Jaitley argued the patent suffered from invalidity as it wasn’t new, obvious and didn’t involve an inventive step as it was a tweaked version of a pre-1995 drug, which is not eligible for a product patent in India. The specifications in the patent application didn’t sufficiently describe the invention or its claim to improved efficacy and didn’t disclose the drug was a mixture of two polymorphs, or drug derivatives, that qualifies it for rejection under Section 3(D), he contended.
Jaitley appealed for denial of the injunction, saying the patent was new and counterclaim serious. He also asked for a patient-friendly regime, where competition among drug makers could bring the price lower than even the Rs1,600 a tablet that Cipla charges and make affordable drugs available, especially when bulk of the medical costs are met not through insurance coverage.
(Source: livemint.com)
Basel-headquartered F Hoffman-La Roche Ltd is seeking an injunction against a move by India’s Cipla Ltd, ranked among the top three in the country by sales, to introduce in the local market a generic version of the Swiss firm’s lung cancer drug, Erlotinib.
Erlotinib hydrochloride (trade name Tarceva, Genentech/OSIP, originally coded as OSI-774) is a drug used to treat non-small cell lung cancer, pancreatic cancer and several other types of cancer. Cipla has asked the court for the Tarceva patent, granted in February 2007, to be revoked.
Cipla’s move, seen risky by some, hinges on the argument that the patented drug—costing Rs4,800 a tablet or nearly double an Indian’s per capita monthly income—is out of reach of most of this country’s citizens. Cipla sells its Erlotinib version at one-third of the Roche price.
The Roche-Cipla case follows a legal battle that Novartis AG is engaged in since early 2006 with the Indian authorities over the rejection of patent application for cancer drug Glivec (sold as Gleevac globally).
Imatinib is a drug used to treat certain types of cancer. It is currently marketed by Novartis as Gleevec (USA) or Glivec (Europe/Australia) as its mesylate salt, imatinib mesilate (INN). It was originally coded during development as CGP57148B or STI-571. It is used in treating chronic myelogenous leukemia (CML), gastrointestinal stromal tumors (GISTs) and a number of other malignancies.It is the first member of a new class of agents that act by inhibiting particular tyrosine kinase enzymes, instead of non-specifically inhibiting rapidly dividing cells.
Novartis’ challenge that a rule in the Indian Patents Act, 1970, is non-compliant with global trade laws has been rejected by the Madras high court and the company, also Swiss, is separately fighting the patent rejection at an appeal tribunal.
The New Delhi case, which has high profile lawyers fighting for Roche and Cipla, is keenly watched by the drugs industry, patient groups and patent attorneys.
“If Glivec was step one, then Tarceva will be step two. Glivec established the legitimacy of Section 3(D) (the patent rule that Novartis challenged), Tarceva will show what can the patent law do for public health and access to affordable drugs in the face of a patent protected drug,” said CPAA’s Sapru. Section 3(D) bars patenting of slight modifications on existing drugs without substantial increase in efficacy. Arguments in the Roche-Cipla case closed on 31 January.
In the court, Cipla, whose legal counsel is Arun Jaitley, also a politician representing the Bharatiya Janata Party in Parliament, contended that the Tarceva patent should be revoked under Section 3(D) as the drug is a mere derivative, or tweaked version, of an older drug. Cipla faces infringement charges and a claim of Rs1 crore in damages.
Tarceva, a new drug for Roche with revenues of about $1 billion (Rs3,960 crore), has the potential to be a moneyspinner. Indicated for non-small cell lung cancer and pancreatic cancer, it is approved in 87 countries for the second- and third-line treatment of patients with advanced lung cancer, says Roche website.
Mindful of the Glivec ruling, Roche’s legal counsel, Abhishek M. Singhvi, also a spokesperson for the Congress, stated in one of the hearings that they were not challenging Section 3(D), but just its application in erlotinib’s case. The managing director of the Swiss firm’s local unit, Roche Scientific Company (India) Pvt. Ltd, Girish Telang declined comment until the court verdict.
Roche has reported Rs13.91 crore of Tarceva sales since April 2006, when it first launched the drug in the country. The revenues of the Indian unit are not known as it is privately held and not mandated to publicly report financials.
Roche’s petition called Cipla’s actions as a brazen “infringement of the legal rights of the plaintiffs (Roche and OSI Pharmaceuticals Inc.)”. Its counsel Singhvi rebutted the Cipla claim that the drug is a derivative of quinazoline, a drug with a patent pre-dating 1995, the cut-off year for grant of patents in India.
Over the course of five hearings, Cipla’s counsel Jaitley argued the patent suffered from invalidity as it wasn’t new, obvious and didn’t involve an inventive step as it was a tweaked version of a pre-1995 drug, which is not eligible for a product patent in India. The specifications in the patent application didn’t sufficiently describe the invention or its claim to improved efficacy and didn’t disclose the drug was a mixture of two polymorphs, or drug derivatives, that qualifies it for rejection under Section 3(D), he contended.
Jaitley appealed for denial of the injunction, saying the patent was new and counterclaim serious. He also asked for a patient-friendly regime, where competition among drug makers could bring the price lower than even the Rs1,600 a tablet that Cipla charges and make affordable drugs available, especially when bulk of the medical costs are met not through insurance coverage.
(Source: livemint.com)
