The Office of the US Trade Representative placed India on its ‘Priority Watch List’, along with Algeria, Argentina, Chile, China, Indonesia, Pakistan, Russia, Thailand and Venezuela in its 2013 Special 301 Report.

The report states that ‘recent actions by the Indian Government … have raised serious questions about the innovation climate in India and risk hindering the country’s progress towards an innovation-focused economy.’ India’s Supreme Court recently rejected Novartis’ seven-year battle to gain patent protection for its cancer drug Glivec (imatinib mesylate) [1]. In another high profile case India’s High Court of Delhi also recently rejected Merck Sharp and Dohme’s (MSD’s) court case over the patent infringement of its diabetes drugs Zita (sitagliptin) and Zita Met (metformin/sitagliptin) [2].

Another reason stated in the report for India being placed under such scrutiny by the US includes the fact that the manufacture and distribution of pharmaceutical products bearing counterfeit trademarks is taking place in India. The country is also accused of having high tariffs on medicines and burdensome internal charges and regulatory challenges for pharmaceuticals and medical devices, hindering the Indian government’s efforts to promote increased access to healthcare products.

The report concludes by saying that India has made limited progress since 2012 in improving its weak legal framework and enforcement system for intellectual property and that some innovators are facing serious challenges in securing and enforcing patents in India.

Related articles

India may move away from compulsory licensing

India issues more compulsory licences

References

1.  GaBI Online - Generics and Biosimilars Initiative. Indian Supreme Court rejects Glivec patent [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 17]. Available from: www.gabionline.net/Policies-Legislation/Indian-Supreme-Court-rejects-Glivec-patent

2.  GaBI Online - Generics and Biosimilars Initiative. Indian high court allows sitagliptin generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 17]. Available from: www.gabionline.net/Policies-Legislation/Indian-high-court-allows-sitagliptin-generics

Permission granted to reproduce for personal and educational use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.