Three Moments of Rescripting
First moment: in September 2012, the Delhi High Court passed a judgment
denying a patent to the Swiss phar maceutical com pany Hoffmann- La Roche
and the New York– based osi Phar maceuticals for their anticancer drug
erlotinib. Erlotinib is a human epidermal growth factor receptor that has
provided a major breakthrough in the targeted treatment of metastatic non–
small cell lung cancer. The verdict, issued by Justice Manmohan Singh, fol-
lowed the pre ce dent that was established by the Madras High Court in denying
a patent on Gleevec, in that it was an instance of an Indian court utilizing
the public health flexibilities that existed in its 2005 trips-compliant patent
legislation to impose limits on the extent and scope of intellectual property
rights in the cause of access to essential medicines. However, unlike Gleevec,
erlotinib had already been granted a patent, which the court proceeded to
revoke.
A patent application for erlotinib was jointly filed in 1996 by osi and
Pfizer.1 The drug was approved for market by the U.S. Food and Drug Admin-
istration (fda) in 2004 and by the Eu ropean Union in 2005. It was marketed
under its trade name, Tarceva, by Roche, which had entered into a licens-
ing agreement with osi in 2001 that allowed it to market and sell a number
of drugs covered by the agreement, including erlotinib. Roche introduced
Constitutions of Health, Responsibility, and Democracy
conclusion
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