Drugs, lies and red tape
Compulsory licences to provide affordable medicines have been in limbo. Pharma industry pins hopes on a diabetes drug
Fcountry that has issued just one compulsoOR A ry licence (CL) for the manufacture of a patented drug, India has earned unwarranted notoriety. Ever since the Indian Patent Office granted a CL in 2012 to a Hyderabad-based generics company to manufacture an exorbitantly priced cancer drug at a fraction of the cost charged by the multinational pharmaceutical company that invented it, the CL issue has been trapped in a web of hyperbole, lies and fear. As India became the target of a vilification campaign by pharma mncs and the US administration as a country that does not protect intellectual property rights (iprs), the government beat a quiet retreat on CLs.
Readers of this column would know that a CL is a legal provision that allows countries to override patents without the consent of the patent owner to meet public health requirements. It is enshrined in the wto agreement on iprs as one of the flexibilities on patents and although its critics might claim that the CLs can be issued only in the case of a health emergency, this is not true. wto says clearly that “countries are free to determine the grounds for granting CLs”. However, such was the ferocity of the attacks on India that the Depatment of Industrial Policy and Promotion (dipp), the nodal agency for iprs,which was planning to issue CLs on three lifesaving drugs to treat various types of cancers,did an aboutturn in 2013.
Indian companies have also muddied the waters on CLs.In 2008,generics maker Natco attempted to get CLs for F Hoffman La Roche’s lung cancer drug,Tarceva,and Pfizer’s kidney cancer drug, Sutent, for supplying these medicines to Nepal.It invoked Section 92A of the Patents Act that allows export of patented pharma products to any country having insufficient or no manufacturing capaci- ty to meet its public health needs.That argument did not hold water with the Patent Office.
Natco got its act together to supply Bayer’s cancer drug, sorafenib tosylate, used to fight liver and kidney cancer, by slicing off 97 per cent of the cost—from
2.8 lakh for a month’s treatment to just 8,800.It sought a CL under Section 84(1) of the law which says licences can be issued if reasonable requirements of the public have not been met.This includes availability at a “reasonably affordable price”. That CL was granted.
However, the next application by bdr Pharmaceuticals in 2013 to make dasatinib, a blood cancer drug sold by its US inventor Bristol-Myers Squibb (bms) failed at the outset.Although bdr said it would supply the drug which retailed at
1.66 lakh for a month’s treatment at 8,100, the CL was rejected because the firm did not first seek a voluntary licence (VL) from bms as required by law.On June 29,the Delhi High Court,which was hearing a patent infringement suit on dastanib,upheld bms’s patent, raising questions about bdr Pharma’s odd strategy. Logically, the company should have re-negotiated a VL with bms and then applied again for a CL.
CLs have been in limbo for over three years.Now,after a long gap comes another CL application from Lee Pharma of Hyderabad for a CL to make a diabetes drug. Lee wants to make a generic version of saxagliptin,a drug to treat Type-2 diabetes.The drug, originally patented by bms in 2007, was transferred to AstraZeneca. Lee does not offer dramatic price reductions as in the case of cancer drugs,but it points out India has 66.84 million diabetics,of whom 60.15 million suffer from Type-2 diabetes mellitus which can only be managed through medication. Lee has strictly followed procedure and everyone is waiting with bated breath for the outcome.