[Ip-health] Novartis press release

[Jean Blaylock]

 This is the press release issued by Novartis, at
http://www.novartis.com/newsroom/index.shtml


06/08/2007, 2007, 10.59 AM CET

Novartis concerned Indian court ruling will discourage investments in innov=
ation needed to bring better medicines to patients

    * Court dismisses Novartis petition challenging constitutionality of Se=
ction 3(d); defers to World Trade Organization (WTO) to resolve question on=
 TRIPS compliance
    * WTO recently urged India to improve its intellectual property system =
during Trade Policy Review
    * Glivec patent appeal not decided; Intellectual Property Appellate Boa=
rd (IPAB) review continues as separate proceeding


Mumbai, India, August 6, 2007 - A decision issued today in an Indian court =
will have long-term negative consequences for research and development into=
 better medicines for patients in India and abroad.

The High Court in Chennai dismissed the writ petition challenging the const=
itutionality of Section 3(d), and deferred to the World Trade Organization =
(WTO) forum to resolve the TRIPS compliance question. The full text of the =
Court's decision is not yet issued.

"We disagree with this ruling, however we likely will not appeal to the Sup=
reme Court. We await the full decision to better understand the Court's pos=
ition," said Ranjit Shahani, Vice-Chairman and Managing Director, Novartis =
India Limited. "Our actions advanced this essential debate in India; now lo=
cal and international leaders in both industry and academia recognize the i=
nadequacies of Section 3(d) and are raising serious concerns about the defi=
ciencies of the Indian patent system."

Novartis brought this case forward because it firmly believes this was the =
right thing to do for patients. Effective patent systems ensure incentives =
are in place that stimulate long-term research and development efforts crit=
ical for medical progress.

"It is clear there are inadequacies in Indian patent law that will have neg=
ative consequences for patients and public health in India," said Paul Herr=
ling, Ph.D., Head of Corporate Research at Novartis. "Medical progress occu=
rs through incremental innovation. If Indian patent law does not recognize =
these important advances, patients will be denied new and better medicines.=
"

WTO recently urged India to improve its intellectual property system
Unlike other WTO member countries, India has a unique provision in its pate=
nt law, Section 3(d). This provision excludes important developments in the=
 form of incremental innovation, and ignores the importance of side effects=
, ultimately denying patients in India new and better medicines.

During the India Trade Policy Review in late May 2007, the WTO urged India =
to strengthen its intellectual property rights system. It commended India f=
or taking steps to align its national standards with international requirem=
ents but added that "effective implementation of IPR-related legislation wo=
uld be in the interest of India itself."

Novartis originally filed the appeal in India because the Indian patent off=
ice rejected the Glivec patent application. "Because the patent rejection w=
as based on Section 3(d), we challenged this specific provision in India," =
said Shahani. "We had hoped to resolve this question on Section 3(d) locall=
y in order to receive a patent for Glivec."

Glivec patent appeal not yet decided
Still at issue is why a patent for Glivec - granted in nearly 40 countries,=
 including Russia, Taiwan and China - was denied in India in 2006. The Gliv=
ec patent appeal will be decided separately by the newly-operational Intell=
ectual Property Appellate Board (IPAB).

At present, Novartis is petitioning the High Court for a new technical memb=
er because the current technical member is the former Controller General of=
 the Indian Patent Office, responsible for the original rejection of the Gl=
ivec patent.

"We expect the appellate board to conduct an independent and impartial revi=
ew of our appeal and ensure transparency of the decision-making process," s=
aid Shahani.

Novartis cares about patients and access to medicine
Through the Glivec International Patient Assistance Program (GIPAP), Novart=
is provides Glivec free of charge to 99% of patients in India prescribed th=
e medicine for as long as they need it.

The Glivec patent case has generated much debate on global access to medici=
ne. "Some groups have speculated that changing India's patent law will impa=
ct access to medicine. However, eliminating Section 3(d) will not hinder th=
e supply of medicines from India to poor countries given the safeguards in =
international agreements," said Herrling. "In addition, medicines are made =
available through tiered pricing solutions, public-private partnerships, sh=
ared contribution models and donation programs."

Improving access to medicine is an integral component of the Novartis busin=
ess strategy and global social responsibility commitment. The Group's acces=
s-to-medicine projects reached over 33 million patients worldwide in 2006, =
with contributions totaling USD 755 million.

Further information on Glivec India case and patient testimonials
For more information about the Glivec India case, including testimonials fr=
om Glivec patients in India, please visit www.novartis.com.

About TRIPS
The WTO Agreement on TRIPS outlines minimum standards for intellectual prop=
erty rights, requires member countries to create mechanisms to safeguard in=
tellectual property, and provides flexibility for governments to regulate i=
ntellectual property rights in the way that best serves society. For pharma=
ceutical patents, the flexibilities have been clarified and enhanced by the=
 2001 Doha Declaration and the 2003 decision on TRIPS and Public Health, wh=
ich enabled countries that cannot make medicines themselves to import pharm=
aceuticals made under compulsory license.

About Novartis
Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect =
health, cure disease and improve well-being. Our goal is to discover, devel=
op and successfully market innovative products to treat patients, ease suff=
ering and enhance the quality of life. We are strengthening our medicine-ba=
sed portfolio, which is focused on strategic growth platforms in innovation=
-driven pharmaceuticals, high-quality and low-cost generics, human vaccines=
 and leading self-medication OTC brands. Novartis is the only company with =
leadership positions in these areas. In 2006, the Group's businesses achiev=
ed net sales of USD 37.0 billion and net income of USD 7.2 billion. Approxi=
mately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzer=
land, Novartis Group companies employ more than 100,000 associates and oper=
ate in over 140 countries around the world. For more information, please vi=
sit http://www.novartis.com.





--------------------------------------
Jean Blaylock
Trade Campaign Officer
- Ecumenical Advocacy Alliance
- Alliance oecum=E9nique agir ensemble
- Alianza Ecum=E9nica de Acci=F3n Mundial
- Globales =D6kumenisches Aktionsb=FCndnis
+41 (0)22 791 6080
jblaylock@e-alliance.ch
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