In early March, BDR Pharmaceuticals International, a Mumbai-based company dealing in generic APIs and formulations, became the second company after Hyderabad’s Natco Pharma, to apply for a compulsory license (CL) for Bristol-Myers Squibb’s Sprycel (dasatinib), a blood cancer drug. This was the second bold move on BDR Pharma’s part, the first being its announcement that it would soon launch its generic version of Pfizer’s Sutent (sunitinib), a renal cancer drug.
Given that BDR Pharma is just under a decade old, it would be fair to say that the Davids of the pharma world are getting set to push the envelope as far as intellectual property (IP) rights of pharmaceuticals are concerned. BDR Pharma seems to have taken its cue from the decision of the IPAB to uphold Natco’s CL on Bayer’s kidney cancer drug Nexavar (sorafenib).
On cue, MNC pharma hit back with Pfizer’s Chief IP counsel Roy Waldron criticising India’s ‘protectionist’ IP regime in a March 13 US congressional hearing. Calling pharma companies like Natco Pharma and BDR Pharma “copiers” who want to obtain a “free ride or use the technology at a much-reduced cost”, he accused India of abusing the CL system.
Indeed, MNC pharma is leaning on governments to put pressure on their counterparts in developing countries via trade agreements. A case in point is the generalised system of preferences (GSP) between the US and India which is up for renewal in July. Médecins Sans Frontières (MSF) has also called attention to aggressive IP measures proposed by the US in the Trans-Pacific Partnership (TPP) Agreement negotiations with developing countries.
One proposed TPP provision, according to the MSF release, would require governments to grant new 20-year patents for modifications of existing medicines, such as a new forms, uses or methods, even without improvement of therapeutic efficacy for patients. Another provision would make it more expensive and cumbersome to challenge undeserved or invalid patents; and yet another would add additional years to a patent term to compensate for administrative processes.
As our market cover story analyses, such trade agreements could arm-twist governments of developing countries and could be the death knell for generics (‘Free trade or trade off?’, see page 15 in this issue).
Besides IP, patient safety is ironically the reason being cited for proposed regulations like the EU Falsified Medicines Directive. Our Management cover story, “Industry proposes, regulator disposes?” (see page 28) highlights the plight of API exporters who say that this Directive calls for repeat inspections for export consignments to the EU. Hence they are urging the Indian regulator to stand its ground and ask that the GMP certifications issued by India be considered equal to those of the EU. Given the hue and cry, one has to consider the possibility that such excessive regulations, under the guise of patient safety, are actually meant to stem the flow of affordable APIs from countries like India.
The IPAB’s backing of Natco Pharma’s CL has shown the way forward. Let us hope that other sections of the Indian regulatory mechanism also display the same steely resolve. For today, it is the ‘copiers’ who are the clear winners and saviours.
Viveka Roychowdhury
Editor
