The disputes threaten to require the Drug Controller to consider whether generic drugs infringe patents before it issues marketing approval.
In one case, which was argued today, German pharmaceutical company Bayer has sued Indian generic Cipla for patent infringement over the drug sorafenib. Sorafenib, which is marketed under the brand name Nexavar, is used in treating kidney and liver cancer.
Bayer has joined the Indian government to the suit, meaning it will have to abide by the decision.
In the other case, on December 18, the Delhi High Court granted an interim injunction to US drugs company Bristol-Myers Squibb that prevents Indian generic company Hetero Drugs from making, using or selling a product infringing BMS’s patent for the leukaemia drug dasatinib.
This decision has been criticised for creating so-called linkage between the DCGI and the India Patent Office.
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