Data Exclusivity Patent

Worrying Developments in Indo-US IP negotiations – Data Exclusivity and Patent Linkages


War is peaceIn a deeply worrying development, Senior Advocate and former UN Special Rapporteur Anand Grover reports in an email alert that “From inside sources it appears that PM Modi is very keen to assure the US President Barack Obama and US multinational companies (MNCs) that India will agree to the changes proposed by them. Inside sources also reveal that two issues likely to be worked upon are Data Exclusivity[1] and Patent Linkage[2].

We have covered the recent developments in the Indo-US dialogue on India’s IP regime in multiple posts. There were a stream of developments with regards to USTR’s problems with India’s IPR regime last year, which have been covered in posts here, here, and here. A lot of the concerns with regards to how India would react to the pressure being put on it to change its laws came to the fore around the time of Prime Minister Modi’s visit to the United States, as detailed in Rupali’s post here, but these worries have only compounded over the past few months with the joint statement released by US-India Trade Policy Forum, and the announcement by PM Modi on January 27th that he was ‘more than happy to accept the suggestions of the Joint High Level Working Group on IP between US and India’, which Anubha has written about here.

As Anubha has noted, one of the biggest problems with the ‘suggestions’ was that they had not been made public. This is the first specific piece of news that we have had in this regard – and with that itself, the ball is headed outside the ballpark.

Data Exclusivity

We have quite a few excellent posts on the issue of data exclusivity, starting with Prashant Sir detailed post here (and his paper mentioned here), followed by Shamnad Sir’s reply to the same. To summarise quickly, the concept of data exclusivity gives the original manufacturer of a drug the right to keep data regarding their clinical trials confidential for an extra five to ten years. As access to this data is crucial for manufacturers of generic drugs to create the generic (and cheaper) drugs, this means that the entry of cheaper drugs into the market is delayed. And at the same time this also means that there is a duplication of effort from competitors in the market aiming to create the same (or equivalent) drug. India’s lack of a data exclusivity regime is part of what makes the Indian generic drug market robust.

Patent Linkages

The concept of ‘Patent Linkages’ also has similar functions. It refers to a legal system by which a country links a company’s approval for marketing a drug to the status of the patent of the originator’s product. The position of Indian law in this regard is summarised extremely well by Shamnad Sir’s post here. The lack of this provision, again, plays an important role in getting a generic drug into the market quickly.

The Draft IPR Policy

It is crucial to note here that Patent Linkages, as has been confirmed by the Delhi High Court are a part of TRIPS plus policies. Moreover, the position of ‘Data Exclusivity’ as a part of TRIPS is heavily contested to say the least. In fact, the US and EU’s requests to other GATT signatories to include ‘Data Exclusivity’ provisions within the TRIPS clauses during the 1988 negotiations had specifically not been accepted as it failed to reach consensus. This is all the more relevant as the Draft IPR Policy released by the government’s IPR Think Tank had itself noted that “In future negotiations in international forums and with other countries, India shall continue to give precedence to its national development priorities whilst adhering to its international commitments and avoiding TRIPS plus provisions.

Furthermore, under section 3.6 ‘Objective 3: Legal and Legislative Framework’ of the Draft Policy, which talks about important areas of study and research for future policy development, it is specifically stated that such research would focus on “Protection of undisclosed information not extending to data exclusivity”.

And this is why the recent reports are troubling. As the email notes, it is the existing patent structure which allowed the Indian generic pharmaceutical industry to become the dominant international force that it currently is. It goes on to mention the fact the current regime is entirely TRIPS compliant, and that the measures noted above are not legally mandatory, and would be for the benefit of the profits of pharmaceutical companies. The email also notes the multiple negative consequences of such strong exclusivity measures, such as delays in the entry of generic medicines and a huge upshot in the costs of non-generic medicines, and the consequent harm to access to medicines required by patients. The full email is reproduced below.

*High Alert:* Indian Prime Minister announces change in the IP regime! 

– Former UN Special Rapporteur Mr. Anand Grover’s note on the Indian Prime Minister’s announcement on change in the IP regime.

Under the recent pressures from the United States the Indian government headed by Prime Minister Mr.   Narendra Modi has announced possible changes in India?s IP regime, which might adversely affect access to medicines.

From inside sources it appears that PM Modi is very keen to assure the US President Barack Obama and US multinational companies (MNCs) that India will agree to the changes proposed by them. Inside sources also reveal that two issues likely to be worked upon are Data Exclusivity[1] and Patent Linkage[2].

India is the largest provider of generic high quality medicines at affordable rates to patients in India as well as other developing countries. This was possible because in the 1970s, faced with patents owned by rich MNCs and medicines? prices which were amongst the highest in the world, India introduced significant changes in its patent law. In particular, it did away with product patents and only preserved process patents. This, along with the industrial policy, gave a huge boost to the Indian generic industry. From being a minor partner to the Western pharmaceutical companies, the Indian generic industry became a dominant force in the market and the pharmacy of the poor across the globe.

India signed on to the TRIPS Agreement because it allowed flexibilities which it could use fully. In particular, it has used patentability criteria, opposition procedures (i.e. pre and post grant oppositions, revocations and counterclaims) and compulsory licenses. All these flexibilities are now under attack by the US government at the behest of their industry. Not only do they want to dismantle India?s existing IP regime but also introduce TRIPS-plus and other measures.

Prime Minister Modi has come to power on the promise of development, which he seeks to achieve by providing sops to corporate giants in India as well as the US and EU, all of whom have one aim ? pursuit of profits. With the US pressure to change the IP laws after the PM?s recent visit to the US, the PM has set up an IP Think Tank to come up with a national IP policy as well as a high-level bilateral IP Working Group to see what could be agreed to in terms of the demands of industry.

During President Obama?s visit to India the PM has announced that IP would be protected with strong indications that measures related to data exclusivity and patent linkage are in the offing. An Oxfam study in Jordan reveals that after Data Exclusivity was introduced, owing to the absence of generic substitutes, certain medicines costed over a *1000 per cent more* in Jordan than in its neighbouring country Egypt.

Both Patent Linkage and Data Exclusivity delay the entry of generic medicines thus allowing monopolistic pricing to thrive even if this means that patients across the world are denied access to affordable medicines. If Prime Minister Modi succeeds in bringing about these two measures he would only be emboldened to dismantle the very core of the Indian IP regime, which is what the US IP industry wants.

We are sending this email to all of you to apprise you of the worrying developments regarding the changes proposed to India?s IP regime. Kindly circulate this message widely to your network of contacts inviting them to call upon Prime Minister Modi to resist dismantling India?s pro-public health laws at the behest of the US!

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