CURRENT INNOVATION CONCERNS
Elpidio V. Peria
8 February 2015
Shailly Gupta, Deputy Head of Medicin Sans Frontieres (MSF) in India circulated this past week a a post in an intellectual property and health e-group (IP-Health) indicating that the US and India is cooking up something in relation to US demands for India to change its patent law that will affect the production of generic medicines in India. She reports :
On January 27, 2015, even as Air Force One readies for take-off, bringing US
President Barack Obama’s three-day visit to India to an end, two seemingly
contradictory events occur – one in India and the other in the US – giving
reasons to believe that something is brewing between the two countries on
the issue of intellectual property rights. Equally important, if not more,
were there signs of a lack of transparency from the Indian side?
Consider this. On January 27, after meeting US Secretary of Commerce Penny
Pritzker, Commerce and Industry Minister Nirmala Sitharaman tells the media that the US was invited to comment on the draft National IPR Policy and India would “then see what we can do with it”.
Around the same time, miles away in the US, Michael Froman, the US Trade
Representative (USTR), is testifying at a Congressional hearing. He says
that the USTR has been able to “secure commitments from India in the 2014
Trade Policy Forum on a broad range of IP issues of concerns to the United
States and its stakeholders”. He goes on to say: “I believe we have a good
dialogue going with the new government on this issue and we are committed to
working to achieve concrete progress in this area.”
It is apparent that something is brewing on the IPR front from the nature of
apprehensions being raised.
For example, former UN Special Rapporteur Anand Grover’s mailer, shared by
an IPR expert with Business Today, says: “From inside sources it appears
that Prime Minister Modi is very keen to assure US President Barack Obama
and the 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’ and ‘Patent Linkage’.”
First timers on the issue would now ask : so why would we in the Philippines be concerned about what’s happening in India apparently succumbing to US pressure on the issue of patents on medicines, which is what this report is all about?
We in the Philippines should be concerned since our country could be the next country that may be lobbied or pressured by the US to change our law to relax our rules on patents on medicines, or the so-called Cheap Medicines Act, or Republic Act 9502, passed in 2008. The said law has some provisions that are patterned from what Indian patent law also provides concerning access to medicines and it is these provisions on which the US has the same concerns.
Back in 2011, the Philippine Daily Inquirer reported on the release by WIKILEAKS of unclassified cables dated Dec. 11 2006 from then US Ambassador to Philippines Kristie Kenney to Washington, who lobbied Sen. Manuel Roxas II and Quirino Rep. Junie Cua, sponsors of the controversial measure for some changes in the language of the bill which later became RA 9502, specifically on the issue of data exclusivity and new-use patents.
One particular exchange by the US Ambassador with Congressman Cua reported in the cable which very much reflects what’s happening today in India was when Cua noted that India’s new patent legislation does not protect new use patents and asked theoretically, ‘Is the US going to go to the mat with India over this issue?’”
On Dec. 4, 2006, the cable said Cua reported that “he was discussing the data exclusivity issue with House members and they had reached a consensus to change the language. He wanted to see again our recommended changes to explore whether they would be acceptable.”
“Cua called again on Dec. 8. He reported that the House committee on trade, which he presides, had amended the legislation partially, resolving our concerns on data exclusivity.
The law eventually passed, but with provisions on data exclusivity that are mainly text coming from the TRIPS Agreement, a specific intellectual property rights- related trade measure that was made part of the several agreements comprising the World Trade Organization (WTO) Agreement, which the Philippines ratified back in December 14, 1994.
That provision in the TRIPS Agreement, art. 39.3, which is what is now found in Cheap Medicines Act, which according to WIKILEAKS is a result of a strong US lobby, dealt with data protection, not data exclusivity, and if we are to be guided by Prof. Carlos Correa, an Argentinian legal expert now advising the South Centre, an intergovernmental organization based in Geneva of developing countries to which the Philippines is also a member, what he said about it in an old write-up (Recent Developments in the Field of Pharmaceutical Patents : Implementation of the TRIPS Agreement) back in 1998 found in the website of Health Action International was that :
The TRIPs Agreement obliged to protect confidential data submitted for the registration of new chemical entities (article 39.3), but it did not create exclusive rights on such data. The only protection conferred under the Agreement is against unfair commercial practices in the framework of unfair competition law. The granting of exclusive rights on the data would in practice amount to the granting of a patent prior to the expiration of the transitional period authorized by the TRIPs Agreement.
Once data on a new drug have been submitted, their use by a national health authority to study and approve a subsequent application on the basis of similarity, does not entail a violation of the confidentiality obligation under the Agreement.
It seems that back then, when the Cheap Medicines Act was being finalized, the US wants data exclusivity which is not what is even provided for in the TRIPS Agreement, as what is provided for in that Agreement is protection of test data submitted to drug regulatory authorities for registration of new chemical entities.
Usually, data exclusivity is a TRIPS-plus measure, as it is not found in the TRIPS Agreement, thus a country passing such measure adds on to what it has committed to implement under the TRIPS Agreement.
Fast-forward to the present time, looking at the US Trade Representative’s (USTR) Annual Special 301 Reports, the Philippines is no longer in the Watch List for 2014, but in 2013, the Philippines was included, and here is what the USTR has to say for the Philippines in that year :
The United States also remains concerned about amendments to the Patent Law that limit the patentability of certain chemical forms unless the applicant demonstrates increased efficacy. The United States encourages the Philippines to provide an effective system for protecting against the unfair commercial use, as well as unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approval for pharmaceutical and agricultural chemical products. The United States looks forward to continuing to work with the Philippines to address these and other issues.
Going back to 2012, here’s what the USTR reported for the Philippines:
The United States remains concerned about amendments to the Patent Law that limit the patentability of certain chemical forms unless the applicant demonstrates increased efficacy. The United States encourages the Philippines to provide an effective system for protecting against the unfair commercial use, as well as unauthorized disclosure, of test or other data generated to obtain marketing approval for pharmaceutical and agricultural chemical products’
The US wants protection of test data against unfair commercial use, which is an entirely different matter from data exclusivity that it is usually pushing in its bilateral trade agreements with various countries.
Nonetheless, given this regular pressure from the US through the Special 301 Reports which potentially subjects us to trade retaliation for our alleged infractions of what the US thinks what our intellectual property laws should be, it will not be a surprise if we will find out that our government agencies have responded to these constant needling and posturing by the US government by proposing changes to what is already in the law.
In his book A Matter of Honor : The Story of the 1990-91 RP-US Bases Talks, Dr. Alfredo R.A. Bengzon, the head of the Filipino negotiating panel, cited a World Bank official, Rosalie Dean, who spent many years working in Asia and she liked Filipinos more than any other people in Southeast Asia; we had a different spirit, she said and a joyfulness that she welcomed. But she added that she saw two flaws : “You Filipinos are forever trying to please foreigners, and you are always trying to be Americans.” She added, by way of contrast, “The Indonesians know who they are.”
If, indeed, this observation is true, then it is but a matter of time that we will succumb to US pressure, similar to what is currently happening in India.