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Bayer Loses Nexavar Case in India; Could Open Door to Easier Generic Approvals

Bayer has lost an attempt in the high court in Delhi to link new drug approvals to the validity of patent exclusivity. Depending on your point of view, the ruling either potentially opens the door for Indian generic manufacturers like Cipla, Dr Reddy's and Ranbaxy to decimate the branded drug market there; or gives Indian patients quicker access to cheap drugs. The ruling allows Cipla to make a generic version of Bayer's Nexavar cancer treatment.

BNET noted in January that the case was controversial because Bayer and Bristol-Myers Squibb were attempting to persuade the Drug Controller General of India (the Indian FDA) to only approve new drugs if those drugs had a valid patent status.

The high court's ruling suggests that the DCGI should look only at safety and efficacy in granting approvals, and leave patents to the courts. DNA India:

The court not only dismissed Bayer's petition in a very keenly watched court battle, but also imposed a penalty on the drug maker in a judgment extremely scathing in tone.
The judge said Bayer's case was speculative:
... what may be characterised as a speculative foray [and] an attempt to 'tweak' public policies through court mandated regimes. ... the petitioner [Bayer] doubtless is possessed of vast resources and can engage in such pursuits ... these attempts, even unsuccessful in the ultimate analysis, achieve short term goals of keeping out competitors, through interim orders.
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