[Commons-Law] CPAA responds to Novartis' Open Letter

[chan park]

Dear friends,

The Cancer Patients Aid Association has asked us to distribute the letter below, which responds to Novartis' open letter from last week.  Given that Novartis has asked organizations to post its letter on your websites, the CPAA asks that you post this response as well, to clarify numerous factual and legal inaccuracies contained in the Novartis letter.

Thanks

------------------------

Last week, Novartis issued an open letter detailing its reasons for pursing the legal action challenging a key public health safeguard in Indian patent law, and why Novartis thinks “improving” patent law will benefit patients and society.  Given the numerous factual and legal inaccuracies contained in Novartis’ letter, we, the Cancer Patients Aid Association, felt compelled to issue this response to set matters straight.  


As it always has been and always will be, our utmost concern is the health and welfare of the thousands of patients who suffer from chronic myeloid leukaemia and other forms of cancer in India and throughout the world.  It is our bedrock, non-negotiable position that no person should ever be denied access to a lifesaving medicine simply because he or she cannot afford to pay for it.  Although patents are by no means the only barrier to access to lifesaving medicines, it is undeniable that the monopolies created under the patent system are a significant part of this problem.  The attempt by Novartis, like so many other pharmaceutical companies, to distract attention away from this problem by pointing out problems with “infrastructure and distribution networks” is utterly disingenuous.


Starting from our bedrock principle, we, as caregivers for those stricken with CML and other types of cancer, could not in good conscience sit idly by when Novartis in 2003 obtained exclusive marketing rights (EMR) over imatinib mesylate and effectively prevented seven of nine Indian generic manufacturers from marketing their versions of the product that were priced some 8-12 times lower than Novartis’ exorbitant price of USD 2600 per person per month.  Contrary to Novartis’ claims that it has “secured access to Glivec both in India and globally,” many of our patients faced severe hardships in obtaining free Glivec through Novartis’ GIPAP programme.  These difficulties and other grave concerns about the GIPAP programme are described in detail in the CPAA’s separate letter to the Max Foundation.


As a result, the CPAA had no choice but to take action.  In addition to challenging the grant of the EMR all the way up to the Supreme Court of India, we filed an opposition against Novartis’ patent application for imatinib mesylate, claiming that the product was not patentable under Indian law.  The Patent Controller agreed with us, and denied Novartis a patent on several grounds, only one of which is the provision that Novartis is currently challenging in court.  We firmly believe, as does the Patent Controller of India, that the patent application for imatinib mesylate fails to meet even the basic patentability criteria, even without resort to the legal provision, called Section 3 (d), that Novartis is challenging.


Nevertheless, it is hard to understate the importance of 3 (d).  Simply put, the provision states that a drug company will not get a patent for making a modification to an already existing drug unless that modification actually makes the drug more effective.  However reasonable this may seem to us, it is anathema to the multinational pharmaceutical companies, because it prevents them from being granted patents that serve no other purpose but to extend their monopolies beyond the 20 years already granted to them.  Such patenting practices have nothing to do with creating incentives for research and development or protecting genuine innovation.  Rather, it has everything to do with protecting market share and keeping drug prices artificially high and out of reach for the majority of the world’s poor.


It was shocking, then, to read Novartis claim that its actions in India will not hinder the supply of medicines to the poor.  The direct consequence of Novartis’ action of challenging 3 (d), if successful, will be to remove a key public health safeguard designed to ensure that the grant of frivolous patents would not prevent Indian generic companies from continuing to supply low-cost essential medicines to the domestic population and throughout the developing world.  The impact of Novartis’ actions will stretch far beyond the realm of cancer and Gleevec, and negatively impact the accessibility and affordability of all essential medicines, including Anti-Retrovirals.  


When India amended its patent laws in 2005 to come into compliance with the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property (TRIPS), it was required to balance the obligation under the TRIPS agreement against the constitutional and international human rights obligation to ensure the right of citizens to the highest attainable standard of health.  In interpreting its obligations under the TRIPS agreement, the Doha Declaration instructed India that TRIPS “should be interpreted and implemented in a manner supportive of the WTO Members’ right to protect health, and in particular, to promote access to medicines for all.”  


In enacting the legal provision at issue, the Indian Parliament was mindful of the competing interests between patent protection and public health, and utilised the ample flexibilities inherent in the TRIPS agreement to do so.  Novartis’ attempt to cloud the issue by claiming that the recent Mashelkar Committee report “proves” the invalidity of the provision is simply false and misleading.  First and foremost, the question presented before the Mashelkar Committee was a separate issue, altogether from the question of whether the existing safeguards in Indian law are TRIPS-compatible.  The Committee was not asked, and did not offer any opinion whatsoever on the validity of any of the existing provisions in Indian patent law.  


Secondly, recent facts that have come to light that cast doubts on the credibility of the Mashelkar Committee report.  Significant portions of the report have been plagiarised verbatim from a pro-industry submission funded by Interpat, a coalition of multinational pharmaceutical companies of which Novartis is a member, and the Indian chapter of which Novartis India’s Managing Director, Ranjit Shahani, is Chairman.  These facts present some very serious and legitimate questions in our minds about the objectivity of the Mashelkar Committee report, and of Novartis’ involvement, if any, in the timing and content of the report.  


Novartis claims that it is pursuing a “patient-focused” strategy in India.  We would ask how, exactly, does seeking to invalidate a legal provision that protects the supply of affordable drugs to millions qualify as “patient-focused”?  Novartis claims that no other Indian makers of generic manufacturers offer access programmes for generic imatinib mesylate.  We would ask why, then, does its own GIPAP website explicitly recognise the existence of Indian generic supplier Natco’s access programme?  Novartis claims that loose patentability criteria will be in the best interests of the Indian companies.  We would ask why, then, has the Indian Pharmaceutical Alliance, representing 90% of the research and development expenditure in India, intervened to defend the validity of the provision that Novartis is challenging?  Novartis claims that it supports TRIPS flexibilities.  We would ask why, then, does it persist in challenging a perfectly valid exercise of those flexibilities? 
 Finally, Novartis claims that the denial of patents on medicines “will not improve patient access to medicines.”  We would ask how, then, did India’s pharmaceutical companies become the largest supplier of affordable drugs to the world’s poor during a time when it did not recognise patents on medicines?  


Novartis claims to seek “an open dialogue with all groups, based on mutual trust and tolerance.”  So does the CPAA.  But we strongly feel that “mutual trust and tolerance” is not engendered through public statements by its CEO that accuses its opponent of being a puppet of the generic companies, nor through a public relations campaign that spreads verifiably false and misleading information about the facts and the law in an attempt to restore its crumbling public image.  The only real way for Novartis to begin restoring the general public’s trust and tolerance would be for it to drop the case in India.  


We thank everyone around the world for their support in our fight against Novartis.  


Sincerely,



Y.K. Sapru
Cancer Patients Aid Association 


  
---------------------------------
Looking for earth-friendly autos? 
 Browse Top Cars by "Green Rating" at Yahoo! Autos' Green Center.  
-------------- next part --------------
An HTML attachment was scrubbed...
URL: http://mail.sarai.net/pipermail/commons-law/attachments/20070215/4f2f854f/attachment.html