The Delhi High Court has allowed the Cancer Patients Aids Association (CPAA), an NGO working for the welfare and rights of thousands of cancer patients in India, as party to the on-going legal battle between the multinational pharma company Bayer and the Indian generic major Cipla over the Bayer's kidney cancer drug Nexavar (Sorafenib tosylate).

CPAA had filed an intervention application in the Delhi high court on January 17 this year so that patients' interest could also be represented before the court. In the hearing on January 19, the court admitted the intervention petition. The court order will allow CPAA to present its concerns regarding how the present case will introduce a TRIPS PLUS 'patent linkage' system in India. The CPAA will also present its concerns over the implication of the case on access to quality, low cost, generic medicines in future.

Bayer had sued both the government of India and the generic companies in the Delhi high court on the ground that the drug controller general of India (DCGI) has entertained Cipla's application for grant of marketing rights for the anti-cancer drug Nexavar for which it had obtained a patent in India. Bayer pleaded with the court that if marketing approval was granted to Cipla, its patent rights would be affected. Bayer had earlier requested the DCGI to reject Cipla's application as well as grant a hearing to Bayer prior to taking any decision in the matter. But, the DCGI did not reply, as marketing approval does not have anything to do with patent status of a medicine.

Meanwhile, the Delhi high court in its interim order on November 7, 2008 prohibited the DCGI from taking any decision on Cipla's application for marketing approval. Bayer's petition is a writ petition that asks for a writ prohibiting the DCGI from granting marketing approval to the generic version of the patented drug Sorafenib tosylate.

Experts are of the view that Bayer's litigation on Nexavar is significant because by seeking rejection of Cipla's application for marketing approval of the generic version of Sorafenib tosylate, Bayer wanted to link marketing approval to the drug's patent status. It will have serious implication as it means that the drug regulator should not allow approval to a generic version of a patented drug, irrespective of the legal status or validity of the patents.

Besides, by suing the government, Bayer is indirectly seeking higher intellectual property standards, than what is required under Trips agreement. It will also affect access to affordable generic medicines because patent linkages create barriers to the use of compulsory licenses, which are issued to generic producers if patented drugs are not available or affordable, or if countries that lack production capacity order drugs from countries like India, experts say.

This is likely to encourage other patentees to approach the court to prevent or at least delay marketing approval of more affordable versions of patented drugs.