India’s patent system on medicine
India’s patent system on medicine may be the new normal
There has been a lot of wailing amongst multinational pharma companies about India’s uniquely unfriendly attitude to patents. Now, it might be starting to look like the new normal.
The MNC’s are worried about three separate developments in India that they think will reduce incentives for innovation
- Compulsory licences where a local manufacturer is allowed to produce a low-cost version of a patented medicine that the government considers to be priced unreasonably. This may be allowed under a provision of the international agreement governing intellectual property rights (the TRIPS agreement) although the MNCs argue that this provision should only be used in unforeseen public health emergencies. India has only actually issued one CL although another is in the system. As Tapan Ray points out in a recent blog post, this is a much less aggressive attitude than has been taken in other fast growing economies such as Indonesia and Thailand (this piece is not entirely clear about the various different IP issues but remarkable because it comes from the Director General of the Organization of Pharmaceutical Producers of India, a group which represents only multinational pharma companies)
- Declaring patents to be invalid because they do not represent a real discovery. India’s courts recently did this to cancer drugs from Novartis and Roche (although in Roche’s case, the MNC case was weakened because the company had forgotten to file its patent renewal documents on time and depended on officials to allow it extra time). China has just used identical reasoning to declare that Gilead’s patent on tenofovir to be invalid. (We reported last year that Gilead was probably one of the major objectives of a new Chinese law permitting CLs). Tapan Ray also claims that the EU has done the same to Roche — he should know as the company is an OPPI member
- Not enforcing patent law. MSD / Merck & Co ran across this problem when state authorities in Sikkim licensed Glenmark Pharmaceuticals to produce a generic version of its diabetes drug Januvia (sitagliptin, Merck). No-one had suggested until that point that there was any problem with the Januvia patent in India (although some have suggested it since.) Merck’s application to stop Glenmark is wending its way through India’s complicated and often slow legal system and, in the meantime, Glenmark is selling. This problem is worse in most fast growing economies. As the US Patent and Trademark Office noted in a recent report this shouldn’t happen in China but, “the [Chinese] system has significant shortcomings that diminish if not eliminate its efficacy.”
The US government has shown itself to be unwilling or unable to shift India’s position significantly despite what five ex-US ambassadors to India called, “aggressive lobbying by US firms against India on business issues that has jeopardised bilateral ties lately.” (They were writing to President Obama, mostly about immigration but on a range of trade issues). There has been a vigorous exchange between some US lawmakers and the Indian ambassador to the US. India, though, is not giving in and the US doesn’t seem willing to offer a big enough political tit for tat.