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DRUGS

Indian minister defends Novartis drug ruling

An Indian court was fully justified to reject a patent bid by Swiss drug giant Novartis last week, India's trade and industry minister said in Geneva on Monday, defending the country's generic drug business.

Indian minister defends Novartis drug ruling
Indian Trade Minister Anand Sharma in Geneva. Photo: Fabrice Coffrini/AFP

"The reasons for the denial . . . are absolutely justified under the law," Anand Sharma told reporters following a ceremony marking his country's accession to the Madrid Protocol, an international trademark system.
   
Novartis had fought a seven-year legal battle to gain patent protection for 
an updated version of its blockbuster leukaemia drug Glivec, arguing the compound was a significant improvement because it is more easily absorbed by the body.
   
India's Supreme Court however fell in line with three previous court 
rulings and found that the compound "did not satisfy the test of novelty or inventiveness" required by Indian legislation.
   
"Our law does not accept evergreening," Sharma pointed out, referring to 
India's law restricting pharmaceutical companies from seeking fresh patents for making minor modifications.
   
Speaking at the World Intellectual Property Organization in Geneva, he 
emphatically stressed the independence of India's judiciary and insisted the government had nothing to do with last week's ruling, which enables generic drugmakers to continue copying Glivec, and which was harshly criticised by Novartis.
   
That company and other global drugmakers say India's powerhouse generics 
industry and strict patent filtering reduce commercial incentives to produce cutting-edge medicines.
   
Sharma meanwhile pointed out that Novartis is the third largest beneficiary 
of registered patents in India, behind Roche and Sanofi, with 147 patents to its name in the country.
   
"Why are we not being respected for having granted the 147 patents to the 
same company rather than (discussing how) the Indian judiciary has denied one?" he asked.
   
Sharma insisted his country was "committed to protecting intellectual 
property," pointing out that patent applications in the country had more than doubled in the past five years.
   
The country's decision to join the Madrid trademark system Monday was also 
"a very strong reaffirmation of India's commitment . . . not only to trademark protection but also to intellectual property protections," he said.
   
But he made no apologies for his country's booming generic drug trade, 
which he pointed out has helped dramatically slash the cost and increase the availability of life-saving drugs to combat diseases like AIDS and cancer.

"The right balance has to be found … to ensure the common good," he said.

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NOVARTIS

Switzerland’s Novartis to help make Pfizer-BioNTech Covid vaccine

Swiss pharmaceuticals giant Novartis said Friday it had signed an initial agreement to help produce the Pfizer-BioNTech vaccine against Covid-19, as countries scramble to boost supplies.

Switzerland's Novartis to help make Pfizer-BioNTech Covid vaccine
Novartis will help manufacture Pfizer vaccine. Photo by AFP.

The rare act of cooperation — in an industry usually marked by cut-throat competition — comes after French pharma group Sanofi announced earlier this week that it would also team up with rivals Pfizer and BioNTech to help produce 125 million doses of their jab.

The two-dose vaccine, which is based on mRNA technology, has been shown to be around 95 percent effective and has been approved for use by the World Health Organization and in some 50 countries.

But it is in limited supply as nations around the world race to immunise their populations against the coronavirus, which has killed nearly 2.2 million people in just over a year.

Novartis said in a statement that it would use its sterilised manufacturing facilities at its site in Stein, Switzerland to help produce the Pfizer-BioNTech jabs.

Under the agreement, the company said it would “take bulk mRNA active ingredient from BioNTech and fill this into vials under aseptic conditions for shipment back to BioNTech for their distribution to healthcare system customers around the world”.

Once a final agreement is reached, Novartis said it expected to begin production in the second quarter of the year, with initial shipment of finished product expected in the third quarter.

Steffen Lang, Head of Novartis Technical Operations, stressed that the company was “committed to leverage our manufacturing capabilities to help support the supply of COVID-19 vaccines and therapeutics around the world”.

“We expect this to be the first of a number of such agreements,” he said in the statement.

Novartis said it was already in “advanced discussions” with a number of other companies about with other production tasks, including of mRNA, therapeutic protein and raw material production for Covid vaccines and therapeutics. 

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