Novartis Patent issue : is government killing innovation?

Comments (0)

Novartis India is the Indian arm of the Swiss multinational pharmaceutical company “NOVARTIS INTERNATIONAL AG"  which ranks 2nd worldwide in terms of sales. It was fighting for patent protection of its anti-cancer drug Glivec. It argued in favour that Glivec contains Mesylate salt of imatinib –a new form of Imatinib salt, as an ingredient. Since it is developed by Novartis, it should be provided with the new patent for Glivec.

issues Involved

1. Degree of innovation involved in research : Supreme Court in its decision has stated that drug had failed in "both the tests of invention and patentability" under Indian law.

2. Public dimension related to such patents (need of cheap drugs in Indian society) – imatinib is used for making anti-cancer drugs. Generic version of same drug is 10 times less costly than its original version of Novartis.

3. Will such judgements will decrease innovation in pharma sector?

Novartis Pharma’s Stand

Jurg Zimmerman , in 1996, was granted patent (on behalf of Novartis) for Imatinib Derivatives by USA & EU but he didn’t say anything about how to make “mesylate salt” of imatinib (which is new according to them). Novartis has taken special effort for making such form of imatinib which also promises an improved efficacy. So a new patent can be issued for such innovation and production of generic versions should be stopped in India.

Government’s Stand : Government conceded that Zimmerman had not told about the way to manufacture mesylate salt of imatinib but he knew at that time about it and the information related to it was also published in the Cancer research & nature, 1996. A patent can only be granted when there is sufficient amount of innovation. There is nothing innovative about the new form of imatinib & argued that efficacy mentioned in section 3(d) of Indian Patent Act is about therapeutic efficacy and not just physical efficacy.

Section 3(d) of Indian Patent Act

Section 3(d) if Indian Patent Act states that inventions that are mere "discovery" of a "new form" of a "known substance" and do not result in increased efficacy of that substance are not patentable. It is the exact statement which was used by solicitor general of India to defend Indian government in Novartis Case.

  • How “imatinib” does fit in the category of not-patentable under Section 3(d) of Indian Patent Act? : Imatinib’s mesylate salt is not a “discovery”. It is just a changed form of original imatinib. It’s not a new form altogether. Also mesylate salt of Imatinib was known to Zimmerman (original patent holder for derivaties of imatinib) which he mentioned in the journal Cancer research & nature, 1996.

Will this new judgement of SC will hamper innovation ?

It has been argued that such judgements will discourage the spirit of innovation among pharma players on the ground that whatever they will innovate after spending millions of dollars in research will not be given patent by Indian government. However these apprehensions donot hold much ground as :

  • in India Patent law is strict & government of India grants particular patent only if it is really innovative (i.e. not just some changes in the original patent already present).
  • SC didn’t give this judgement because many poor people will loose access to anti-cancer drug if Novartis wins. SC gave this judgement after looking into the innovation degree of Novartis. It was found that Novartis didn’t actually made any innovation & had made some minor changes in its original patent to have hold on anti-cancer drug patent for more of the coming years to make big profits.
  • SC has now set the threshold up to which a particular innovation should reach to qualify as patentable.

Infact it is the mal-intentions of big Pharma giants which lead them to tweak original products for minor changes so as to continue hold patent to monopolize and make profit, while in reality they may have not made any innovation. This judgement will set the precedent where by they would not get patent unless it is innovative and therefore actually incentivizing “REAL INNOVATIONs”.

Evergreening of patents

Its a practice in which corporate sector, in order to extend the expiry of their existing patent (to make more profits through royalty), make some minor changes in the existing patent & claim for new patent.

RELATED SUBJECTIVE QUESTIONS :

1. Discuss the issues involved in Novartis Patent Case?
2. Do you  think that the recent judgement of SC related to Novartis Patent issue will discourage innovation in India?
3. Why was section 3(d) of Indian Patent Act in news recently?
4. Analyze the Indian Patent Act for its definition of “not-patentable”.
5. What is imatinib?
6. Write Short note on mesylate salt of imatinib.
7. What is evergreening of patents ?

Practice Questions
Q1
Q.no:-1/5