The pharmaceutical industry, the drug regulatory officials and the patent experts in the country are eagerly waiting for the order expected to come out any time now from the Delhi High Court on the litigation Bayer vs Union of India, as the order is related to the much debated patent linkage system.

The writ petition filed by Bayer Corporation (USA) and Bayer Polychem (India) in November 2008 against the Union of India, the Drug Controller General of India (DCGI) and Cipla Ltd sought an order prohibiting the drug regulator from granting marketing approval to a generic version of Bayer's patented drug, Nexavar (sorefenib tosylate), used to treat advanced renal cancer.

The High Court, which has conducted the final hearing in the month of February by taking the views of Bayer, the Indian Government, the Cancer Patients Aid Association (CPAA) and the Indian Pharmaceutical Alliance (IPA), may issue the order any time now. However, the date of issuing the order is not known.

The case would have several implications in India's drug regulatory system and the wellbeing of the generic companies in the country, if the plea of Bayer is granted, according to regulatory sources. The major issue is related to the country's policy on patent linkages, a system whereby a drug regulatory authority is required to consider the patent status of a drug and refuse marketing approval to generic versions of a drug if the drug is patented.

Across the globe, patent linkage is the exception rather than the rule and the very idea is contrary to the World Health Organisation (WHO) report published in 2006, said Manoj Tongra, drug control officer, Rajasthan and a patent specialist.

"If Bayer's plea is upheld, it would be in violation of the Indian Patent Act. It may be recalled that the Indian parliament, while putting in place these safeguards had taken into account the very large mobilisation of people - in India as well as across the globe - demanding that India continue to function as a source for affordable generic medicines. So the Bayer case has implications for access, not just for patients in India, but for poor people in large parts of the world," he added.

Besides, the mere act of registering a medicine and getting a marketing approval does not constitute an infringement of a patent. If, after this step, the generic company were to market the drug, the patent holder has the right to sue the company for patent infringement and the matter is under the aegis of the patent office. Shamnad Basheer, a renowned intellectual property expert, agrees to the point.

"A mere grant of a drug regulatory approval by the DCGI to Cipla on the basis that its drug is safe and effective does not amount to an act of 'making, using, offering for sale, selling or importing' the petitioners' patented product," says Basheer. The patent infringement should be clearly established before the court of law and such an assessment is not under the statutory powers of the DCGI, he added.

In the three days of hearing on the February 17, 18 and 25, the Indian Pharmaceutical Alliance (IPA), the association of major Indian pharma companies, submitted their affidavit as an intervening party. The Alliance has opposed the views of petitioner through the affidavit, informed D G Shah, secretary general, IPA.

The association sought permission from the Court to be included as a party to the case on February 18. Justice Ravindra Bhat allowed the IPA to file its written submission in case it felt that any relevant argument had not been addressed by the parties.

Earlier, in November, 2008, the Delhi High Court (Justice Endlaw) granted an injunction to Bayer directing the DCGI not to grant a final order to Cipla for marketing sorefenib tosylate until a final order is passed in this matter.