Patents on pharmaceuticals are a contentious issue for many countries around the world, for the obvious reason that the average person in most countries can’t afford to pay for brand-name drugs. The patent battle over Glivec is, needless to say, bitter and complicated.
The argument for providing a patent to glivec (imatinib mesylate), a drug made by Swiss pharmaceuticals major Novartis began on 11th September 2012. Novartis is on one side and the government, four Indian firms and the Cancer Patients Aids Association are on the other side.
The case is the appeal made by the Novartis against IPAB (Intellectual Property Appellate Board) decision of not granting patent to the medicine.
Counsel of the company Gopal Subramanian stated that company had faced a lot of criticism at the hands of many organization who says that the price of the drug which is placed at 1.20lakhs per month is too high. He also told to the court that company is running a patient assistance scheme in which company provides free medicine to 80% of the blood cancer patients.
Glivec is a tyrosine kinase inhibitor that treats chronic myelogenous leukemia (CML), a rare cancer that is slow-growing but fatal. Glivec targets a malfunctioning enzyme that is the product of a genetic abnormality present in more than 95% of patients with CML. For almost all patients with CML, Glivec or its second- or third-generation counterparts enable people with CML to live a normal, healthy life (and lifespan) with minimal, if any, side effects.
In 2003, Cipla, Indian pharma company produced generic version of Glivec, which cost around Rs 8000 per month but, Novartis rejected to this and in 2006 filed a petition in Indian Patent Office. The petition was rejected on the grounds that generic companies are in their own limits as guaranteed by Indian Patents Act, 2005 to manufacture generic versions. Subsequently the case was rejected in Chennai high court and than in IPAB.
IPAB rejected the plea stating that the plea is against Section-3(d) of Indian Patents Act,2005 and promotes ever greening of patents.
What is Section-3(d) and ever greening?
According to section 3(d) of Indian Patents 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 a concrete proof that yes there is an increase in the therapeutic efficacy of the substance and the change is prominent.
Pharma companies reintroduce same drugs in new forms to keep renewing there patents because patents are given only for a specific period of time after which, they can be manufactured by anyone. This whole process of renewing the same drug with some alterations in structure to get more patents is termed as ‘ever greening”. It is like old wine in new bottle without much change in taste.
Many pharmaceuticals giants use the method of ever greening and gets more and more patents, and when they introduce the medicines in market, they charge heavily from the patients. This is not a good practice and a check should be kept over this issue, so that the medicine should be available to all and not only to rich people because each and every citizen of a country have the right to get treated properly. High cost of drugs should never be a reason for no treatment of poor.
Thus, for this case Supreme Court should give a decision against Novartis or if they give a decision in favor of the company than they should be asked to slash the prices to that extent that each and every person can afford to buy the medicine. Also company should be made to provide treatment to a specific amount of patients every year and a check should be maintained on the workings of the company.
Supreme Court held an important decision in this case as with the judgement of this case, it will also make it clear that what is the proper meaning of Section 3(d). This decision is being watched upon by all the pharma giants because there were some patent applications that have been rejected on the basis of Section-3(d) in past.