[Ip-health] CPAA responds to Novartis' Open Letter

[chan park]

--
[ Picked text/plain from multipart/alternative ]
Dear friends,

The Cancer Patients Aid Association has asked us to distribute the letter b=
elow, which responds to Novartis' open letter from last week.  Given that N=
ovartis has asked organizations to post its letter on your websites, the CP=
AA asks that you post this response as well, to clarify numerous factual an=
d 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 paten=
t law, and why Novartis thinks =93improving=94 patent law will benefit pati=
ents and society.  Given the numerous factual and legal inaccuracies contai=
ned in Novartis=92 letter, we, the Cancer Patients Aid Association, felt co=
mpelled 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 le=
ukaemia 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 p=
ay for it.  Although patents are by no means the only barrier to access to =
lifesaving medicines, it is undeniable that the monopolies created under th=
e patent system are a significant part of this problem.  The attempt by Nov=
artis, like so many other pharmaceutical companies, to distract attention a=
way from this problem by pointing out problems with =93infrastructure and d=
istribution networks=94 is utterly disingenuous.


Starting from our bedrock principle, we, as caregivers for those stricken w=
ith CML and other types of cancer, could not in good conscience sit idly by=
 when Novartis in 2003 obtained exclusive marketing rights (EMR) over imati=
nib mesylate and effectively prevented seven of nine Indian generic manufac=
turers from marketing their versions of the product that were priced some 8=
-12 times lower than Novartis=92 exorbitant price of USD 2600 per person pe=
r month.  Contrary to Novartis=92 claims that it has =93secured access to G=
livec both in India and globally,=94 many of our patients faced severe hard=
ships in obtaining free Glivec through Novartis=92 GIPAP programme.  These =
difficulties and other grave concerns about the GIPAP programme are describ=
ed in detail in the CPAA=92s separate letter to the Max Foundation.


As a result, the CPAA had no choice but to take action.  In addition to cha=
llenging the grant of the EMR all the way up to the Supreme Court of India,=
 we filed an opposition against Novartis=92 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 sever=
al grounds, only one of which is the provision that Novartis is currently c=
hallenging in court.  We firmly believe, as does the Patent Controller of I=
ndia, that the patent application for imatinib mesylate fails to meet even =
the basic patentability criteria, even without resort to the legal provisio=
n, 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 actual=
ly makes the drug more effective.  However reasonable this may seem to us, =
it is anathema to the multinational pharmaceutical companies, because it pr=
events them from being granted patents that serve no other purpose but to e=
xtend their monopolies beyond the 20 years already granted to them.  Such p=
atenting practices have nothing to do with creating incentives for research=
 and development or protecting genuine innovation.  Rather, it has everythi=
ng to do with protecting market share and keeping drug prices artificially =
high and out of reach for the majority of the world=92s poor.


It was shocking, then, to read Novartis claim that its actions in India wil=
l not hinder the supply of medicines to the poor.  The direct consequence o=
f Novartis=92 action of challenging 3 (d), if successful, will be to remove=
 a key public health safeguard designed to ensure that the grant of frivolo=
us patents would not prevent Indian generic companies from continuing to su=
pply low-cost essential medicines to the domestic population and throughout=
 the developing world.  The impact of Novartis=92 actions will stretch far =
beyond the realm of cancer and Gleevec, and negatively impact the accessibi=
lity and affordability of all essential medicines, including Anti-Retrovira=
ls.


When India amended its patent laws in 2005 to come into compliance with the=
 World Trade Organization=92s Agreement on Trade-Related Aspects of Intelle=
ctual 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 standa=
rd of health.  In interpreting its obligations under the TRIPS agreement, t=
he Doha Declaration instructed India that TRIPS =93should be interpreted an=
d implemented in a manner supportive of the WTO Members=92 right to protect=
 health, and in particular, to promote access to medicines for all.=94


In enacting the legal provision at issue, the Indian Parliament was mindful=
 of the competing interests between patent protection and public health, an=
d utilised the ample flexibilities inherent in the TRIPS agreement to do so=
.  Novartis=92 attempt to cloud the issue by claiming that the recent Mashe=
lkar Committee report =93proves=94 the invalidity of the provision is simpl=
y 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 v=
alidity of any of the existing provisions in Indian patent law.


Secondly, recent facts that have come to light that cast doubts on the cred=
ibility of the Mashelkar Committee report.  Significant portions of the rep=
ort have been plagiarised verbatim from a pro-industry submission funded by=
 Interpat, a coalition of multinational pharmaceutical companies of which N=
ovartis is a member, and the Indian chapter of which Novartis India=92s Man=
aging 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=92 involvement, if any, in the=
 timing and content of the report.


Novartis claims that it is pursuing a =93patient-focused=94 strategy in Ind=
ia.  We would ask how, exactly, does seeking to invalidate a legal provisio=
n that protects the supply of affordable drugs to millions qualify as =93pa=
tient-focused=94?  Novartis claims that no other Indian makers of generic m=
anufacturers offer access programmes for generic imatinib mesylate.  We wou=
ld ask why, then, does its own GIPAP website explicitly recognise the exist=
ence of Indian generic supplier Natco=92s access programme?  Novartis claim=
s that loose patentability criteria will be in the best interests of the In=
dian companies.  We would ask why, then, has the Indian Pharmaceutical Alli=
ance, representing 90% of the research and development expenditure in India=
, intervened to defend the validity of the provision that Novartis is chall=
enging?  Novartis claims that it supports TRIPS flexibilities.  We would as=
k why, then, does it persist in challenging a perfectly valid exercise of t=
hose flexibilities?
 Finally, Novartis claims that the denial of patents on medicines =93will n=
ot improve patient access to medicines.=94  We would ask how, then, did Ind=
ia=92s pharmaceutical companies become the largest supplier of affordable d=
rugs to the world=92s poor during a time when it did not recognise patents =
on medicines?


Novartis claims to seek =93an open dialogue with all groups, based on mutua=
l trust and tolerance.=94  So does the CPAA.  But we strongly feel that =93=
mutual trust and tolerance=94 is not engendered through public statements b=
y its CEO that accuses its opponent of being a puppet of the generic compan=
ies, nor through a public relations campaign that spreads verifiably false =
and misleading information about the facts and the law in an attempt to res=
tore its crumbling public image.  The only real way for Novartis to begin r=
estoring the general public=92s 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 N=
ovartis.


Sincerely,



Y.K. Sapru
Cancer Patients Aid Association



---------------------------------
Looking for earth-friendly autos?
 Browse Top Cars by "Green Rating" at Yahoo! Autos' Green Center.