The patent linkage battle that has been going on between Bayer (Bayer Corporation and Bayer Polychem(India) Ltd. and the Drug Controller General of India(DGCI) has finally been put to rest by the Supreme Court. On 1st of December, 2010 the Supreme Court upheld the decision of the Delhi High Court dismissing Bayer’s application challenging the DGCI’s order granting marketing approval to CIPLA to manufacture a generic version of a drug for which Bayer holds the patent.

Patent linkage refers to a system wherein the drug regulatory authority of a country refuses permission to a generic drug manufacturer to market and sell an already patented drug. This sometimes delays the entry of cheap and affordable generic medicines into the market.

Bayer had earlier challenged the decision of the Drug Controller General of India (DGCI) granting approval to Cipla Ltd. to market and sell a generic version of the Bayer’s patented drug, by filing a writ petition before the Delhi High Court. This petition was dismissed by the Delhi High Court in February 2010. The Hon’ble High Court based its ruling on the fact that there was a clear distinction between the patent system and drug regulatory system in India and that granting marketing approval to generic versions of patented drugs was completely in accordance with Indian law.

The Supreme Court dismissed the special leave petition filed by Bayer and confirmed the Delhi High Court’s decision dismissing Bayer’s application challenging the DGCI’s authority to grant marketing approval to generic versions of patented drugs. The division bench comprising of Justice A Alam and Justice RM Lodha based their decision on the finding that it was incorrect to say that the DGCI did not have the authority to grant marketing approval to generic versions of patented drugs. The Supreme Court further observed that the issue of injunction sought by Bayer was to be decided in a suit for infringement under the patents act by the Delhi High Court.

For thoughts on this case go to our blog.