Novartis is a behemoth in pharma industry – its net profit was about $9 billion in 2011. This Swiss multinational pharmaceutical company ranks second in sales in the world. In spite of making hell lot of profit, since 2006 it is fighting a legal battle in Indian courts to stop Indian companies from producing affordable version of one of its drugs.
A final hearing is due on August 22, 2012 by the Supreme Court of India, which would decide the fate of millions of cancer patients worldwide.
BACKGROUND
In 2003, Cipla, Indian pharma company produced generic version of Glivec, (a brand name for imitinib mesylate) which is an anti- cancer drug used for treating chronic myeloid leukaemia (CML) which is popularly known as blood cancer. This drug is the invention of Novartis and it costs Rs 1,20,000 per month which has to be taken life long. Whereas, Indian generics of the same product cost Rs 8000 per month – which is affordable for millions of patients.
In 2006, Novartis challenged this in Indian patent’s office. The case was rejected on the basis that generic companies were within their rights as guaranteed by Indian patents act 2005 to manufacture such generic versions.
Subsequently the case was rejected in Chennai High Court and then in Intellectual Property Appellate Board. Novartis moved Supreme Court and the case is scheduled to be heard in late August 2012.
Patent office rejected Novartis’ claim on the basis of section 3(d) of the Indian patents act 2005 – which prohibits ‘evergreening‘ of the drug by original manufacturers.
EVERGREENING AND SECTION 3(d)
Pharma companies resort to a the trick of reintroducing same drugs in new ‘forms’ to keep renewing their patents as there will be a time limit on a patented drug beyond which it can be manufactured by anyone. This method is called as ‘evergreening‘. It is like old wine in new bottle without much change in taste.
To avoid misuse of ‘evergreening’ by the companies, Indian Patents act introduced safeguards in the act in the interest of public health.
According to section 3(d) of Indian Petents Act, 2005:
“the mere discovery of a new form of a substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy“
Section 3(d) requires stringent evidence of proof of significantly enhanced therapeutic efficacy if a company wants to continue holding patent rights for a product. So far Indian courts have not been convinced with the argument of Novartis and are aware of catastrophic consequences of their negative ruling for the patients worldwide.
India is the leader in the manufacturing of life saving generic drugs. Africa and South America import 90% of low cost drugs used for treating AIDS from India.
INDIAN PATENTS ACT,2005
This act is an amended version of original Indian Patents Act 1970, which was hailed as most progressive patents act anywhere in the world.
Until 1995 – when India became member of WTO and agreed to abide its rules – India gave patents to only processes of production, unlike for products which is being practiced by West and elsewhere.
This enabled Indian companies to manufacture popular medicines cheaply using new processes.
But after 1995, WTO rules bound India to change its patents act to allow product patent regime.
In accordance with TRIPS (trade related intellectual property rights) agreement of WTO, India amended patents act thrice in 1993, 2002 and 2005.
The 2005 act has safeguards in the form of section 3(d) and compulsory licensing clauses to protect interests of patients.
This amended act has enabled Indian companies to continue to be world leaders in producing affordable generic drugs which have saved millions of lives all around the world.
NOVARTIS MUST NOT WIN THE CASE
If Novartis wins the case, it will be a death knell for millions of patients, especially poor patients in developing and under developed countries which are relying on Indian generics for survival.
pharmaceutical companies like Bayer, GSK, Novartis and many other giant MNCs sell their drugs at exorbitant costs which poor can not afford.
The lives of so many cancer patients rests on the Supreme Court judgement, which we hope upholds the rights of ordinary people for good health.
