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Indian Court Permits Manufacture of Generic Version of Lung Cancer Drug

by Gopalan on  April 26, 2009 at 1:40 PM Medico Legal News   - G J E 4
Indian Court Permits Manufacture of Generic Version of Lung Cancer Drug
The High Court of Delhi has permitted Cipla, a leading Indian pharmaceutical firm, to manufacture and market the generic version of lung cancer drug 'Erlotinib,' originally turned out by Swiss pharma Hoffman La Roche.
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 A bench headed by chief justice AP Shah vacated its interim order by which Cipla was restrained from exporting the drug to other countries in which La Roche had patent rights. The court also imposed a cost of Rs 5 lakh on the Swiss company for suppressing material facts. Roche has around 90 days to appeal to the Supreme Court now.

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The move is a big relief to cancer patients who depend on generic versions of the drug, which is priced much lower than the patented drug.

Nearly 1,60,000 people in the country are estimated to be suffering from the disease, which has a high fatality rate, according to sources with patient groups.

The tyrosine kinase inhibitor erlotinib (Tarceva) has demonstrated encouraging activity with relatively tolerable side effects in elderly, previously untreated patients with advanced non-small cell lung cancer according to researchers from Boston, it was reported back in 2005.

 Cipla had launched its generic version Erlocip in December 2007 at Rs 1,700 per tablet as against Roche's price of over Rs 4,000 per pill.
   Roche was awarded a product patent for the drug, which it has been selling as Tarceva in India since 2006. Cipla launched its generic version, Erlocip, in India in January last year, challenging the monopoly rights of Roche.

 HC dismissed the plea of the Swiss company, which argued that Cipla should be restrained from manufacturing and selling the generic drug till the issue of patent rights was decided through litigation.
   Roche had approached the division bench of the High Court after a single bench had dismissed its plea to restrain Cipla.
    The bench also said public interest was predominant and it required that patients get access to cheap cancer medicines in the country. Advocate Pratibha Singh, appearing for Cipla, pleaded that the company should not be restrained from manufacturing the lifesaving drug at cheaper price.

"I think this judgement is really fantastic for cancer patients because there is no injunction against Cipla to sell the drug. But in all likelihood, they (Roche) may appeal to the SC because their whole approach has been very litigatory. They are missing the point that the issue is to the benefit of patients," said Amar Lulla, joint managing director of Cipla.

When contacted, Roche India managing director Girish Telang, said he had not seen the judgement yet, and would only be able to see it next week. "I am aware of the judgement and the cost of Rs5 lakh. In any case, the judgement will be studied by our headquarters in Switzerland. They will study it properly and then decide what the next course of action should be. I cannot take that decision from here." 

  "This will certainly go down as a landmark ruling," Shamnad Basheer, an expert with the ministry of Human Resources and Development, said.

"In view of the existence of gefatinib, an earlier known molecule, the court appears to suggest that erlotinib, Roche's patented molecule may not be inventive," Basheer said.

 Roche had filed for two patents in India, one for gefatinib (polymorph A+B) and another for erlotinib (polymorph B). In its patent for erlotinib, it had said that gefatinib had an ingredient that was unstable for tablet form. The patent office had granted it a patent for gefatinib.

"...the court is conscious that the defendant (Cipla) has been able to demonstrate prima facie that the plaintiffs (Roche) do not hold a patent yet for Tarceva, which is the polymorph B form of the substance for which they hold a patent. Secondly, the defendant has raised a credible challenge to the validity of the patent held by the plaintiffs. In such circumstances, the public interest in greater public access to a life-saving drug will have to outweigh the public interest in granting an injunction to the patent holder," the judgement said.

India's patent law allows companies to oppose patents both before and after grant. Natco, another Indian drug maker, filed an unsuccessful pre-grant opposition against Roche's application for erlotinib.

It has to remembered that Section 3(d) of India's Patent Act, which was challenged by Novartis in the courts last year, was also the feature in the case. Section 3(d) restricts what can be patented. In particular, the section states that salts and other derivatives of known substances "shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy".

In the case of Novartis, patent was first granted for its Glivec, blocking the generic version, but the ruling was reversed, three years later. Patients who could not afford the huge cost of the patented drug would have suffered enormously in the intervening period, it is pointed out.

Now the Delhi court has laid down a rule of caution, adjuring fellow judges against presuming that all patents are valid and hence generic versions could be blocked as a matter of course.

Source: Medindia
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