Roche Sues CIPLA Over Tarceva Patent


As predicted, Roche files a suit against CIPLA before the Delhi High Court. In an earlier post, we touched upon this foolhardy “infringement” strategy by CIPLA.

CIPLA went around announcing to the press that it was hell bent on infringing the patent. Making such announcements doesn’t leave one with much of leeway when arguing that the patent owner should not be granted a favourable injunction. As one knows, a temporary injunction is a discretionary relief, and the judge looks into factors like “balance of convenience” etc.

By its press statements, CIPLA has ensured that a judge does not look too favourably upon its valiant attempt to bring down the price of cancer drugs. It clearly needs better legal advise!! No injunction has issued as yet–and I believe that the matter will be heard on Tuesday.

Here is a report from Jyothi Datta of the Hindu Businessline:

Roche files patent suit against Cipla over Tarceva

P.T. Jyothi Datta

“After Novartis’ cancer drug Glivec, it is Roche’s lung cancer drug Tarceva that has run into litigation, with Roche filing a patent infringement suit against Cipla in the Delhi High Court.

Roche’s patent infringement suit comes after Cipla launched its generic version of Tarceva in the Indian market. The case came up for its first hearing on Friday. Roche India’s Managing Director, Dr Girish Telang, confirmed the development, but did not want to comment on the case.

Cipla’s Chief Executive Officer, Mr Amar Lulla, told Business Line that the generic version of Tarceva had been launched in the domestic market at Rs 1,600. Roche reportedly sells Tarceva at Rs 4,800 per tablet, amounting to over Rs 1 lakh per month, as the medicine is taken once a day.

Erlotinib is the generic version of Tarceva and is being viewed by patient groups and patent experts as the next Glivec. Roche has been granted a patent on Tarceva, which means the company should have a 20-year sales monopoly on the drug. But with Cipla going ahead and launching the drug, the development is being viewed by Roche as a patent infringement.

Cipla, however, believes that it has a strong case to oppose the Tarceva patent, even after it has been granted in India. In fact, another Indian drug-maker, Natco had opposed Roche’s patent application, before the patent was granted by the Patent Controller’s office.

At present, though, Natco is seeking a compulsory licence on Tarceva to export the drug to Nepal. Natco is believed to have offered a royalty payment to Roche and the issue would now have to be sorted out by the patent office in Delhi.

Patent lawyers point out that the developments around Tarceva are assuming similar contours as Novartis’ Glivec case. With the price difference being steep between Glivec and its generic versions made by local drug companies, Novartis’ patent application on the drug drew attention from local and international patient groups, besides a slew of litigation.”

Shamnad Basheer

Prof. (Dr.) Shamnad Basheer founded SpicyIP in 2005. He's also the Founder of IDIA, a project to train underprivileged students for admissions to the leading law schools. He served for two years as an expert on the IP global advisory council (GAC) of the World Economic Forum (WEF). In 2015, he received the Infosys Prize in Humanities in 2015 for his work on legal education and on democratising the discourse around intellectual property law and policy. The jury was headed by Nobel laureate, Prof. Amartya Sen. Professional History: After graduating from the NLS, Bangalore Prof. Basheer joined Anand and Anand, one of India’s leading IP firms. He went on to head their telecommunication and technology practice and was rated by the IFLR as a leading technology lawyer. He left for the University of Oxford to pursue post-graduate studies, completing the BCL, MPhil and DPhil as a Wellcome Trust scholar. His first academic appointment was at the George Washington University Law School, where he served as the Frank H Marks Visiting Associate Professor of IP Law. He then relocated to India in 2008 to take up the MHRD Chaired Professorship in IP Law at WB NUJS, a leading Indian law school. Later, he was the Honorary Research Chair of IP Law at Nirma University and also a visiting professor of law at the National Law School (NLS), Bangalore. Prof. Basheer has published widely and his articles have won awards, including those instituted by ATRIP, the Stanford Technology Law Review and CREATe. He was consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also served on several government committees.

2 comments.

  1. Anonymous

    I saw this article in Hindu Businessline and got curious to know more about similar litigations. Does Cipla stand a chance in still marketing the product in India ? Will the cost difference could be a vaild point to be considered by the court to grant a permission to market without the patent ? what is your take on it ?

    Am a budding entrepreneur who wants to bring a generic medical device to indian market at 10% the cost of innovator product. But am sure I wont get a patent protection in India. what would be your advice on this end ? will you be able to help me on this regard ?

    Shesh
    [email protected]

    Reply
  2. Shamnad Basheer

    Dear Shesh,

    Thanks for the comment. It is not a defense in a patent infringement litigation to argue that the price of the patented product is high. As long as the patent is valid and in force, any manufacture/sale of the generic is an infringement. If the price is high, the generic could ask for a compulsory license–however, this comes into operation only after 3 years of the patent grant.

    Reply

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