I-Mak Blog

US Government's Interference in India's Tenofovir Proceedings

Perhaps not quite the stuff of WikiLeaks' US Embassy Cables, but C.H Unnikrishnan of Livemint has revealed how the US Commerce Secretary, Gary Locke, has effectively lobbied India's Commerce Minister on Gilead receiving 'fair consideration' in its appeal over its tenofovir applications. Thanks to SpicyIP, a copy of the letter can be read here.

Readers may recall that Gilead's patent applications for tenofovir disoproxil (2076/DEL/1997) and tenofovir disoproxil fumarate (896/DEL/2002) were rejected following various pre-grant oppositions. The decisions of the Indian Patent Office (IPO) as relating to Cipla's and Intermed Lab's oppositions can be read here and here. Gilead has since filed an appeal to the Intellectual Property Appellate Board (IPAB). For an insight into the politics of how members of the IPAB are selected, see Spicy IP's views  here.

On the contents of the letter, one reading is that the US Commerce Secretary is simply asking that Gilead's applications get a fair and transparent hearing -- to ensure that India's IP laws provide the requisite business climate for spurring innovation and advancing the US-India bilateral commercial relationship. Nothing wrong with that, right?

That would be a overly generous reading of the letter. Firstly, why is Mr Locke 'particularly concerned' about Gilead's patents? Is this usual diplomatic practice to involve oneself in the patent application of a particular company? As D.G Shah, secretary general of the Indian Pharmaceutical Alliance has rightly said, the US would certainly not tolerate the Indian Government taking up such issues for a company and meddling in the affairs of the USPTO.

Second, Mr Locke mentions Gilead's 'innovative' business model, a so-called 'no-profit pricing approach' which entails technology transfer licenses to Indian companies who can then provide HIV/AIDS drugs to 95 of the world's poorest countries. This part of the letter is eerily similar to some of the press documents that Gilead itself has put out. Mr Locke conveniently forgets to mention Gilead does not have patents in any of the 95 countries, that it maintains control over the tenofovir API market through it's 'innovative' licensing model and continues to prevent the sale of finished products by licensees to middle income countries like Brazil.

Last but not least, Mr Locke feels it's acceptable to suggest that the IPO's decisions are not fair, not timely (considering it takes the USPTO around 6 years to examine an application to grant) and contrary to those of other patent offices, including the USPTO. Basically this means that India is not toeing the line that the US (and others like Japan and the EU) and their corporations want. In case he has forgotten, patents are national rights and countries have discretion on how to grant them.

The fact is, this isn't the first time that Gilead has attempted to influence the appeal of its patent applications. The last attempt we know of was its involvement in the George Washington University India project, where one of its employees gave a presentation in front of the head of the IPO and other government officials, on why tenofovir disoproxil and its fumarate salt meet the efficacy standard of s3d. The worrying part is that the US Government is now directly involved.

It is often considered conspiratorial to say that the politics of intellectual property is imperialistic, with western governments and corporations leaning on developing countries who are trying to set their own patent standards within the boundaries of TRIPS. In the light of this episode and the revelations coming out of WikiLeaks, it would seem that this is how business has been conducted all along. If that is the case, then it's all the more reason for stronger transparency and public opposition mechanisms within the patent system.


How to Search for Patents on Medicines

Continuing with the theme of my last post, public health actors regularly discuss the issue of how to search for patents on medicines. This includes NGOs, government bodies and procurement agencies. Very few organisations have the 'in-house' expertise on how to conduct such searches.

Given the absence of teaching materials on this subject, I have written a a step-by-step guide on how to conduct patent searches on medicines. The guide was written on behalf of the World Health Organization (South-East Asia and Western Pacific Regions).

Primarily written for beginners, the guide may also be useful for those who want to build on their basic understanding of the subject.

Using screenshots, live examples are provided on how to search for pharmaceutical product patents listed on the US FDA Orange Book and the Health Canada Patent Register. Based on this information, the guide demonstrates how to trace the corresponding patents in other countries.

Additionally, introductory techniques on how to expand on Orange Book/Health Canada patent searches are provided, including keyword and citation searching. Such techniques are important to find comprehensive information on the various patents covering a single product. Although by no means exhaustive, the guide attempts to provide as much information as possible on how to navigate currently available patent office databases and patent office journals.

The guide has now been published and can be downloaded here or here. Alternatively, if you would like a hard copy, send a request here.


HIV Drug Patent Landscape in China

One of the continuing problems in the access to medicines debate is the lack of transparency around patent information.

Access to patent information on medicines can be the difference between procuring more cost-effective generic drugs and paying higher prices for brand name versions. The outcome of such decisions can affect how many patients receive treatment.

To help redress this information gap, we will be making available patent information relating to medicines from as many countries as possible.

Given the various requests we recieve from public health actors working in the field of HIV/AIDS, we have started by concentrating on patents covering antiretrovirals (ARVs).

Our first landscape covers HIV drug patents filed and granted in China. The information provided in the landscape includes the applicant, Chinese patent application and grant numbers, the expected expiry date and a brief analysis of the claims of patents where translation permits. A summary and full version of the landscape report can be accessed here.

As this effort is work in progress, we welcome your comments on how we can improve the information provided. If you have any specific medicines you are interested in, please do not hesitate to contact us.


India Rejects Gilead's Tenofovir Patent Applications

Breaking news: the Indian Patent Office has refused Gilead's applications for tenofovir disoproxil (2076/DEL/1997) and tenofovir disoproxil fumarate (896/DEL/2002).

More to follow shortly...


The Treatment Timebomb

Continuing the previous post on this topic, the report of the All-Party Parliamentary Group (APPG) on Aids called 'The Treatment Timebomb' was released yesterday. A copy can be downloaded here.

The key messages from the Report were highlighted in the Guardian article, but some other interesting highlights are:

  • The idea of creating a patent pool is to mimic the situation in India before the new product patent regime kicked in.
  • GSK in its written evidence to the APPG believes that HIV is not a neglected disease and to improve access they have given out extensive voluntary licenses (including the royalty free license to the South African company Aspen to produce abacavir, which was coincidently announced yesterday - see report here). As a result GSK does not see the need for patent pools on HIV medicines.
  • The Report also encourages the Gilead model of voluntary licensing of tenofovir to 11 Indian companies - but recognises that despite voluntary licenses being in place for several years there are still signiifcant research gaps.
  • Patents are an important incentive for R&D, but do not drive investment into HIV medicines specifically needed by developing countries. Indeed, patents can sometimes hinder such research.
  • WIPO should be held accountable for the new development agenda and asked to demonstrate examples of how it is supporting developing countries implement TRIPS flexibilities.
  • The UK government should use its influence within the EC to halt TRIPS plus trade agreements that are currently being negotiated, as well as pushing for a reviews of the EC custom regulations that have recently allowed originator companies to seize generic medicines in transit to countries where there are no patents in force on the product or under the guise of counterfeiting.
  • Most fixed-dose combinations (FDC) of ARVs come from the generic sector in response to market demand and not patent incentives.
  • Patents can create barriers to new FDC's given the cost and complexity with three different patent holders. Also, overly broad rights result in patent thickets.
  • Patent pools have the advantage of creating much larger fields of competition, coming close to a free market, whilst preserving benefits for originator markets.
  • Generic competition has been central in reducing the price of ARVs.
  • Any investment in anti-retroviral treatments should go hand in hand with investment in common serious co-infections or opportunistic infectons, such as turberculosis and hepatitis-C, which are usually responsible for most of the deaths of people living with HIV/Aids.
  • Where the generic purchase of 2nd-line ARVs is not possible because of patents, prices can be upto 17 times the price of first line drugs.
  • It took political activism almost a decade ago to make life saving medicines available to the poor. Political activism is needed once more to ensure the next generation of drugs is available to the world's poorest in the future.

A few comments/thoughts on some of the points above:

GSK's comments on voluntary licensing and the lauding of Gilead's licenses to Indian generics needs to be put in context.

I wrote a research piece for Oxfam in 2007 on the role of voluntary licenses, available here. One of the things I noticed during the research was that a number of the companies that took licenses never actually brought any product to market. Indeed, as of April 2008 (almost two years after the licenses were entered into), only 1 of the 11 licensees for tenofovir had a product on the market, with a possible two more companies that were almost ready to launch at that time. The fact that Gilead claimed to have given a royalty free technology transfer was misleading as many of the generic companies that had entered into the license told us that the technology transfer was nothing more than what was publicly available in the patent specification. To read an analysis of Gilead's example licence agreement, see here.

Therefore, for GSK to claim that voluntary licenses take care of the HIV market needs or that the Gilead model should be encouraged is a tad misleading without looking at the full picture. For voluntary licensing to work more transparency and regulation around such licenses needs to happen.

With respect to patent pools, while they offer a possible solution, a number of questions remain on how the system will work.

For example, one wonders whether companies will be willing to give the crown jewels in their ARV patent portfolios to the pool e.g. Abbott and ritonavir? Will companies pool patents for opportunistic infections like hepatitis-c as recommended in the Report? Who will ensure that the pooled patents are merited patents so as to prevent originator companies earning rent where there should be none? What will the patentability standard be? Will the patent pool system detract from developing countries using TRIPS flexibilities - such as implementing tougher standards of patentability? What will the royalty rates be? If royalty rates are too high that generic companies won't cooperate, we could end up in a blame game and stalemate.

In sum, there's nothing particularly new coming out of this report that those involved in the debate didn't already know or haven't been saying for the past 4-5 years. To say that political activism is needed once more to ensure the next generation of drugs is available to the worlds poor does a bit of a disservice to those that have continued to work on these issues for the past 5-10 years. If it takes a single government body  this long to validate the ongoing problems with the patent system and access to medicines, one wonders how long it will take other governments. Still, it is good to see a developed country government body make inquiries and bring attention to the problems of access to ARVs and related illnesess.

On a separate but related note, for those of you who are not familiar with patent pools, the StopAIDSCampaign have launched this very useful animation explaining how they work: