The Indian subsidiary of German family-owned drug major Boehringer Ingelheim has urged drug authorities to put in place a system that will inform patent holders whenever an application is filed by local drugmakers for generic versions of patented molecules. The company said currently, the burden is on the innovator to first get the patent then keep a check for any infringement.
The demand from the company comes at a time when concerns are growing over patent infringements and copyright violations. A senior company official said patents are granted in India after intense scrutiny and that it takes years to secure a patent in the first instance.
The period of exclusivity that follows after the patent is granted needs to be respected, said the official, adding generic companies in India, however, appear to be keen to launch their drugs during that time.
Patent linkage and any notification filed by a generic company on patented molecules needs to be made mandatory, said the official, adding that state governments can approve and allow any generic company to produce and launch the generic versions of the molecule in four years time.
Boehringer Ingelheim had obtained two separate interim injunctions last year against Indian drugmakers MSN Laboratories and Dr Reddy’s Laboratories (BSE: 500124), who had launched cheaper, generic versions of their anti-diabetic drug empagliflozin.
Boehringer Ingelheim holds a patent for empagliflozin under the trade name Jardiance in India till 2025, the company said.
However, at the end of last month, the Himachal Pradesh high court issued an interim injunction restraining Dr Reddy's Laboratory from manufacturing and selling generic versions of Jardiance.
Also of note, Boehringer Ingelheim lost its patent exclusivity on its respiratory drug Spiriva (tiotropium bromide) in India in 2015, with the Indian patent office agreeing with Cipla that Boehringer’s Spiriva patent was obvious and was not an invention under India’s patent laws.
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