The Critical Analysis of Novartis V Cipla Case Verdict by Supreme Court.
In a landmark judgment that has the potential to change the direction of
India's pharmaceutical business, The Supreme Court denied that the drug Glivec
manufactured by the pharma giant Novartis is qualified for getting patent in
India.
A Brief about the Facts in Issue
Novartis a Swiss based pharmaceutical company filed a patent application
in the year 1997 to grant patent to its drug named Glivec which was a critical
drug used for the treatment of leukaemia on the ground that it invented the
beta crystalline salt form (imatinib mesylate) of the free base, imatinib.
However at that time India was not in a position to grant patent to pharmaceutical
products and agrochemical products, In the year 2005 in compliance with the TRIPS
agreement India thereon started to grant patents in pharmaceutical drugs. Parliament
introduced a significant and important provision to prevent ever greening and
granting of frivolous patents— section 3(d).
Subsequently the matter of Novartis was taken up by the patent
controller, CPAA and other generic companies filed pre-grant oppositions
against Novartis patent application for imatinib mesylate, claiming, among
other things, that Novartis alleged “invention” lacked novelty, was obvious to
a person skilled in the art, and that it was merely a “new form” of a “known
substance” that did not enhance the substance’s efficacy, and was thus not
patentable under section 3(d).
Novartis was already granted Patent for the salt imatinib in the year
1993 in United States itself and the present application was based on one of
the specific compound of the already invented salt.
The Application was rejected by the patent controller as the invention
failed to comply with condition laid down by section 3(d) of the patent act.
This meant that the generic manufacturers were now free to manufacture
the generic version of the drug.
But Novartis challenged the decision of patent controller in Madras High
court in the year 2006 by filing number of writ petitions. Challenging to the
constitutional validity of section 3(d) was that the use of the term “efficacy”
in section 3(d) is vague and ambiguous, and therefore violates the equality
provision (Article 14) of the Indian Constitution.
While dismissing Novartis’ writ petitions, the Madras High Court held:
“We have borne in mind the object which the Amending Act wanted to achieve
namely, to prevent ever greening; to provide easy access to the citizens of
this country to life saving drugs and to discharge their Constitutional
obligation of providing good health care to it’s citizens”.
Also held that the term “efficacy” was known in the pharmaceutical field
to mean “therapeutic efficacy”. Therefore rejected the contention that
it was vague.
After this the next phase of Litigation started in IPAB an appellate
body of patent controller.
However IPAB overturned the Patent Controller’s findings on novelty and inventive
step and held that the beta-crystalline form of imatinib mesylate was new and
involved an inventive step.
But refused to grant patent as the Novartis failed to establish beta-crystalline
form of imatinib mesylate exhibited significantly enhanced therapeutic efficacy
over imatinib mesylate, the known substance .In contravention to section
3(d) of the act.
Challenging the IPAB’s order, Novartis approached
the Supreme Court directly by filing a special leave petition challenging the
IPAB’s interpretation and application of section 3(d) to its patent
application. Subsequently, CPAA and Natco filed cross-petitions challenging the
IPAB’s findings on other issues including novelty and inventive step.
Supreme Court Observations
The main question before the Supreme Court was that
1. Whether the invention qualifies the section 3(d) of the patent act?
2. Interpretation of section 3(d) of patent act?
3. Whether the invention qualifies for the test of novelty and inventive
for the alleged product?
The main contention of Novartis was that IPAB admitted that the
substance is an invention in its impugned order and then applied section 3d of
the act, It was contended that if it is admitted that the product is an
invention then section 3d would not be applicable as section 3d is applicable
to incremental inventions or discovery and not on new invention.
It was also contended that ‘efficacy‘ test is only applied on known
substance but not in the case of beta-crystalline form of imatinib mesylate
which is a new substance.
The approach of Supreme Court was simple in this case-:
1. Court observed that the product was a new form of substance not an
entire new substance. It has always existed in the original amorphous
form. The product thus qualifies for the test laid by section 3d of the patent
act.
2. This section says that just discovering a new form of a substance is
not enough to grant a patent, if it does not enhance its "known
efficacy".
3. On interpretation of section 3d of the act, Novartis tried to argue
that the physico-chemical properties of the polymorph form of the imatinib
molecule, i.e. better flow properties, better thermodynamic stability and lower
hygroscopicity, resulted in improved efficacy. The Supreme Court firmly
rejected this contention holding that in the case of medicines, efficacy means
"therapeutic efficacy" and these properties while they may be
beneficial to some patients do not meet this standard. The Supreme Court also
held that patent applicants must prove the increase in therapeutic efficacy
based on research data in vivo in animals.
4. Simply if the invention does not qualify the test of Therapeutic
efficacy the invention can’t be granted patent, Thereby the true intention of
the section 3d of patent act is fulfilled by stopping the concept of ever
greening in critical sectors, moreover the supreme court held the strict view
that patent in the field of medicine specially in the cases of life saving drug
must be granted with
full caution so that larger interest of the masses are not affected to
an extent that they lose right to live.
Conclusion
The SC judgement is a big relief for those people who can’t afford the lifesaving
drugs manufactured by profit guzzling big pharma giants, there is a simple
sense of humanity which needs to be preserved by the human race only. I say
what is the purpose of an invention when
it is not affordable to the masses and cannot do good for mankind. Here we are
talking about a drug which is a life saving drug priced way above the per
capita income of the country. The Company in the name of patent prohibits those
generic firms who are selling the generic version at an affordable rate, These
Pharma big giants are corporates and claimed to have already made billion
dollars and are becoming selfish thereby prohibiting people to buy the cheaper
version and leaving only option to die because of the fact they are poor as if
these Big pharma giants have a patent rights over their lives. I agree with the
fact that patent is necessary to preserve one’s invention but that invention
must be available to all at a rate reasonable to the masses then only the
purpose of the invention would be fulfilled.
On the other hand the companies like Novartis, are doing just tweaking a
single molecule call that whole thing as an invention and thus trying to obtain
the monopoly over the lives of millions of masses.
The Supreme Court was clear that India is a developing country and cheap
medicines are an essence for healthcare of 1 billion people. The Supreme Court has
taken a right step and thereby prohibited the liberal approach in granting
patents and thus filtering the genuine inventions with frivolous inventions. which
allows these companies to make huge amount of inventions
Regarding the investment in innovation in India, This decision is a huge
setback to the investors who are interested in investing in India for R&D,
I say that they must be cautious that whatever they are inventing should be as
per the Indian market conditions or else they will face great amount of dissatisfaction
as in the cases of Novartis, Bayer etc. Indian patent environment is not like
US and the EU, Rather it is more society dependent than inventor dependent which
is exactly the way should be. Following the judgement Novartis had withdrew all
its investments of research in India.
By-:
Nitish Banka
