Roche vs CIPLA Patent Litigation: An Update

An update on what is going on in this high ticket litigation that will set the tone for pharma patent litigation in India:

Apparently, Roche’s application for an ex-parte interim injunction did not even contain the complete specification of the patent!! They merely filed a copy of the patent certificate issued–as anyone familiar with patents knows, the certificate merely lists the title of the invention and the inventor’s name etc. It does not contain the “claims”, “description of invention” or other substantive details of the patent. How did Roche expect to get an ex-parte injunction without submitting this, we wonder?? Of course, CIPLA’s counsel immediately pointed to this, and on the next day of hearing, this complete specification was submitted. Bad foot to start off on, I think.

An order of ex-parte injunction is one where the other party (against whom the order is passed) is not even heard. Given the propensity of Indian courts to grant ex-parte orders in copyright and trademark cases, we wonder whether this tendency will extend to patent cases as well. I personally don’t think such orders ought to be passed by courts in “patent” matters. These are highly technical in nature and involve a detailed analysis of the scope of claims, and whether the allegedly infringing product falls within the scope of such claims.

Particularly when the subject matter of the patent involves complex chemistry!! Luckily, on the day that Roche moved the application for an ex-parte injunction, CIPLA’s counsel happened to be in court and asked that no order be passed without CIPLA being heard. The court obliged. On a related note, it turns out that CIPLA had not filed a caveat before the court, asking that it be issued notice, should proceedings be initiated by Roche. Again, given that CIPLA went about making press statements that it was going to infringe Roche’s patent, we wonder why?? Did it think that Roche would take this lying down and not initiate any action?

CH Unnikrishnan carries an update on this case in the Mint, which we carry below:

“The Delhi high court will on Tuesday take up the Roche Scientific Co. (India) Ltd’s petition seeking an injunction against a plan by Indian generic rival Cipla Ltd to market a copycat version of a lung cancer drug patented by Roche, even as at least one other local drug maker and a patient support group are planning to contest the patent.

The drug, known as erlotinib in chemical terms, was granted a patent in India in 2007. It is sold under the brand name Tarceva by Roche at about Rs4,800 a tablet here. As first reported by Mint on 11 January, Cipla had said it would launch a low-cost version of this drug in India, which it has done at Rs1,600 a tablet. “We are moving a post-grant opposition to Tarceva patent grant in India,” said a senior Cipla executive who did not want to be identified.

High speed: A tablet blister-pack machine at a Cipla plant which can process 7,000 tablets an hour. The company plans to market a copycat version of a lung cancer drug patented by Roche.
At the same time, Hyderabad-based cancer speciality company Natco Pharma Ltd, which unsuccessfully opposed the Tarceva patent application in India, had applied for a compulsory licensing for the drug as it wants to export it to Nepal.

Lawyers Collective, a Mumbai-based, NGO that fights for access to medicines, especially those for HIV/AIDS and cancer, is also likely to oppose the Tarceva patent in India.

Roche India managing director Girish Telang had earlier mentioned that “anyone can oppose the patent as the country’s patent law provides it, but launching a copy version now will infringe our patent and we will be forced to take necessary action immediately.”

At Tuesday’s hearing, attorney Arun Jaitley, a former Union law minister, will represent Cipla.
The Tarceva patent is held by Pfizer Inc. and another US firm, OSI Pharmaceuticals Inc., as they jointly invented the drug. The drug was globally licensed to F Hoffmann-La Roche Ltd, or Roche, which launched it in India in 2006.

While patient groups in India say that the patent granted to any product is to be respected, the high cost of these drugs blocks their access to poor patients.

Claiming the ground for a compulsory licensing by the government in such cases, Shamnad Basheer, a patent expert and an associate at the Oxford Intellectual Property Institute, UK, said: “The drug is not reasonably priced. A lung cancer patient could pay close to Rs1.5 lakh a month for treatment.”

Basheer pointed to an important provision in the Indian Patents Act that could give the Tarceva challengers ammunition in the case. “Local manufacturing is an essential condition for patented drugs though this is a highly controversial ground now in India. However, if this is invoked, I’m sure that at least 80% of all patented drugs by multinational companies, including Tarceva and the highly controversial Glivec, would be subjected to a compulsory licence here,” he said. But the clause can be invoked only three years after the grant of a patent.

Another patent expert said Roche has a strong case for now. “If a generic company launches a product patented by the inventor, it will be considered an infringement,” said Prabudha Ganguly, a patent consultant in Mumbai.

The inventor can secure an injunction as also claim damages from the violator, he added. According to the Indian Council of Medical Research, at least 90,000 men and 79,000 women are diagnosed each year in the country with cancer of the lung. Bhopal has the highest incidence of lung cancer at 14.5 per 100,000 men, followed by Mumbai at 14.3 and Delhi at 13.2.

Clinical trial data shows that Tarceva has demonstrated a striking survival benefit (42.5%) in advanced, non-small cell lung cancer, the most common form of the disease. The drug was approved in the US in 2004 and a year later in the European Union.”

Shamnad Basheer

Shamnad Basheer

Prof (Dr) Shamnad Basheer founded SpicyIP in 2005. He is currently the Honorary Research Chair of IP Law at Nirma University and a visiting professor of law at the National Law School (NLS), Bangalore. He is 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 Professor Basheer joinedAnand 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. Prof Basheer has published widely and his articles have won awards, including those instituted by ATRIP and the Stanford Technology Law Review. He is consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also serves on several government committees.

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