In what could be a definitive step towards ensuring availability of affordable drugs to the patients, India's Intellectual Property Appellate Board (IPAB) yesterday rejected the German drug major Bayer's request for a stay order against the grant of compulsory license on its anti-cancer drug Nexavar to Natco Pharma. This decision comes as a huge relief to the patients who will be able to access this drug at a far more cheaper rate than being offered by Bayer.

While rejecting the stay petition, D P S Parmar, technical member (patents) and Justice Prabha Sridevan, chairman, IPAB insisted that if the stay is granted, it will definitely jeopardise the interest of the public who need the drug at the later stage of the disease, since it is admitted that this drug improves the quality of life. “Therefore, the right of access to affordable medicine is as much a matter of right to dignity of the patients and to grant stay at this juncture would really affect them and further, it would in effect amount to deciding the main petition itself. The licence is granted subject to certain conditions which the licensee is bound to comply with and the order does not deserve to be stayed,” the IPAB decision stated.

In its appeal before the IPAB, Bayer had alleged that the CL decision of the Indian patent controller is illegal and unsustainable, and had filed for an immediate stay during the pendency of the appeal.

Earlier, on March 9 this year, Indian Patent Controller P H Kurian had issued the first-ever CL to Hyderabad-based Natco Pharma to manufacture an affordable generic version of sorafenib tosylate, the anti-cancer drug for which Bayer had obtained a patent IN215758 in India in 2008. Natco was also asked to pay Bayer a six per cent royalty on sales.

However, after the patent controller issued the CL to manufacture the Bayer's patented anti-cancer drug sorafenib tosylate (Nexavar), the German drug major had filed an appeal against the compulsory license order before the IPAB in Chennai and has in particular sought to have the operation of the CL order stayed till the appeal hearings are completed and IPAB passes its decision.

According to Leena Menghaney from the Médecins Sans Frontières' Access Campaign, "This decision rejecting the request for a stay on the CL, once again affirms that courts can and should act in the interest of public health in the case of pharma products. The high prices caused by patents in India is a growing problem that needs to be addressed with urgency.”

Giving example she informed that one year's treatment costs over $ 1700 for one of the newer HIV medicines that MSF use in their project in Mumbai, and this is the cost that they will be needing across the other developing world as well. “This proves that how important it is to bring the cost of this medicines down so that it can be accessible to the needy patients as well, who make the larger patient pool. Keeping this in mind we strongly support CL and hope that the routine use of compulsory licensing may be one way of making access to affordable medicines a reality in India,” she added.

MSF had welcomed the grant of a compulsory licence issued in March this year to allow a more affordable version of, sorafenib tosylate to be marketed. India’s first compulsory licence is seen as a prospective watershed for affordable access to patented medicines, by potentially opening the way for other life-saving drugs - such as the newest drugs used to treat HIV – now patented in India and priced out of reach to be produced by generic companies for use across the developing world at a fraction of the price.

In July 2011, NATCO had filed a CL application, proposing to market generic version of sorafenib tosylate at Rs. 8,800 per patient per month if the patent office grants it a compulsory license. The granting of CL has brought down the price of the medicine by 97 per cent lower than what Bayer is charging. Bayer currently markets the drug at an exorbitant price of approximately Rs. 2,80,000 per patient per month. This case is also important as it will test Section 84 of the Indian Patent Act, under which the CL mechanism kicks in when generic competitors request a CL.