Tarceva: Following the Glivec path.

Following closely in the footsteps of the Novartis ‘Glivec’ battle, the validity of Section 3 (d) and the grant of compulsory licences seem the talk of town this time around in the Pharmaceutical industry. Our readers will remember the recent post on the Roche-Cipla Row.
Generating interest and raising several eyebrows, CIPLA’s latest move to ask the Court to revoke the 2007 patent granted to Roche’s TARCEVA, again hinges a great deal on the pricing of the drug as well as the availability of the several ailing lung cancer patients in India who have no access to the same. However, Mr. Jaitley arguing for the Swiss giant, stated that the patent was neither new nor involved an inventive step, and furthermore even failed the test for non-obviousness.

An excellent article by Bhuma Shrivastava in this regard is a must read for an insightful and concise analysis:

“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 copycat version of the Swiss firm’s lung cancer drug, erlotinib, sold under the brand name Tarceva.

Cipla has asked the court for the Tarceva patent, granted in February 2007, to be revoked—the first time such a request has been made on a patented drug.

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. According to the Indian Council of Medical Research, at least 90,000 men and 79,000 women are diagnosed with cancer of the lungs and bronchitis in India each year. Those living with lung cancer number some 100,000, estimates Y.K. Sapru, founder-president of Cancer Patients Aid Association, or CPAA, a patient group in Delhi.

The Mumbai drug maker 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). 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. Leena Menghaney, a drug access campaigner for Medecins Sans Frontieres, said the case will test “how courts and government make drugs available at affordable prices (and) tackle access issues after the drug is patented”. 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.
A patent expert said patient access and affordability issues should be addressed separately through government spending and financing mechanisms such as health insurance. “Will prices of patented drugs alone answer all the problems of access? When 65% of the population doesn’t have access to allopathic drugs, how can drug access be an exclusive problem of patented drugs. It applies to all drugs,” said Krishna Sarma, managing partner of Corporate Law Group, a New Delhi legal firm that has represented Roche to file patents in the past but is not connected with the Tarceva litigation.”

Compulsory licensing and Patent Litigation- who would have thought those would have been the buzz words in our Judiciary!

Leave a Reply

Your email address will not be published.