3. About of CIPLA & ROCHE
CIPLA: Cipla limited is an Indian multinational pharmaceutical and
biotechnology company, headquartered in Mumbai, India, Belgium
and Florida in the United states.
It was founded by Dr. Khwaja Abdul Hamied as 'The Chemical,
Industrial & Pharmaceutical Laboratories' in 1935 in Mumbai.
ROCHE: Roche is a leader in research-focused healthcare with
combined strengths in pharmaceuticals and diagnostics,
Headquartered in Basel, Switzerland.
Roche is the world’s largest biotech company, with truly
differentiated medicines in oncology, immunology, infectious
diseases, ophthalmology and neuroscience.
Roche is also the world leader in in vitro diagnostics and tissue-
based cancer diagnostics, and a frontrunner in diabetes
management.
4. Background
Delhi High court has been the battleground for a
pharmaceutical war between Roche and Cipla, over Roche’s
patent for anticancer drug Erlotinib sold by Roche as TARCEVA.
On 24 April 2009, the division bench of Delhi high court
dismissed Roche's appeal against the refusal of a single judge to
grant an injunction restraining Cipla from manufacturing,
offering for sale, selling and exporting its generic version of
Erlotinib hydrochloride.
This case is regarded as a very important case in a series of high
profile patent battle between multinational pharmaceutical
companies and Indian generic drug companies.
5. Facts of the Case
In February 2007, Roche with Pfizer (as a joint applicant),
claimed that it had been granted a patent for Erlotinib.
The patented product, which Roche introduced to the Indian
market was marketed under the brand name TARCEVA.
In December 2007 and January 2008, Indian news paper
reported Cipla’s plan to launch a generic version of erlotinib.
Soon after that, Roche commenced patent infringement
proceedings.
6. Cipla’s Defence and counter claim
Roche’s patent was invalid because erlotinib is a
derivative of quinazolin which is used in cancer
treatment. According to Indian patent act a derivative
of known compound is not valid.
The huge difference in price between Roche’s drug
should be taken into account whether to grant or not
intrim injuction.
7. Conclusion
In September 2012 Cipla limited won landmark
patent case against Swiss drug maker F Hoffmann-
La Roche Ltd.
It had been scientifically proven that Cipla’s generic
version was a polymorph B variant of Roche's
patented drug and it didn’t infringe any patent in
India.