Open Forum
New Delhi, 10 April 2013
SC Verdict
BOOST TO HEALTHCARE
By Col
(Dr) PK Vasudeva (Retd)
Supreme Court’s recent dismissal of the Swiss drug
multinational Novartis’ petition for patent protection of its cancer drug
Glivec is vital for India’s
healthcare industry and the intellectual property regime which regulates the production
of important medicines.
This indeed is a landmark decision, which not only impacts
over 30 lakh cancer patients in the country but also ensures patients around
the world get access to cheap versions of lifesaving medicines as India is a
large exporter of its generic drugs in the developing world.
The apex court has rightly rejected the patent claim by the
Swiss pharma giant, Novartis, for an alternative chemical structure (‘beta
crystalline’) for a pre-existing chemical compound. The original invention
pertained to a compound, Imatinib, having anti-tumour properties and for which
Novartis was granted a US
patent in 1996 — when India
did not allow product-specific patents at all. Subsequently, it filed a patent
in India
for a ‘beta crystalline’ form of one particular ‘Mesylate’ salt derived from
Imatinib.
The Court verdict does not over-rule or discard the
principle of Patents. This patent applied is on a molecule originally patented
over 20 years ago. The current application is about a new process that creates
better consistency of the drug, which is in a different form that delivers
better results. It is not a new drug. The Court held that the increased
efficacy due to this process, for the patients, has not been proven. The pharma
and plant science sector has had many cases of patented molecules that didn't
commercialize till after patent expiry. Patents have not been renewed on those
products.
The basis of the apex Court's judgment was not the expensive
nature of the drug (its still going to cost a packet that's way beyond the
means of most Indians). It was on the principle of not endorsing “cosmetic”
changes that had little to do with novelty and effectiveness in use.
According to Novartis, the new product represented
significant technical advance and brought into existence a new substance, which
had superior therapeutic efficacy compared with Imatinib in its original ‘free
base’ form. The Court, however, has refuted this claim, basically stating that
the said product did not constitute a new chemical entity. A mere change of
form, which enables more effective administration of the underlying active
ingredient (Imatinib) as an anti-cancer drug to humans, cannot be the basis for
granting patents.
It is also a major victory for people around the world who
receive substantially cheaper drugs from India. The judgment underlined the
case of many western drug firms, which have sold their products in the country
at exorbitantly high prices, tweaking the provisions of the laws that govern
intellectual property. Novartis has been trying to secure a patent for an
amended form of Glivec since 2006. It has a patent for a cancer drug but has
claimed that Glivec is a new product, which needs patent protection.
It is standard practice of drug companies to claim patent
protection on the ground that the new drugs are based on new research and are
radically different from the patented drugs from which they are derived. The
cost of new research is most often marginal but the drug companies base their
prices on inflated costs and other expenses and sell the products at prices,
which are unaffordable to most people.
India’s intellectual property laws have
refused to grant patent protection to such drugs, which are only slightly,
changed versions of known compounds. The Supreme Court has now upheld this
position. Indian companies that can produce the drug on the basis of their
in-house research cannot be prevented from doing so. Since they can sell the
drug at drastically lower prices they also serve the public interest. The
judgment gives a big boost to them. The domestic drug industry has expanded in
a major way recently by catering to the needs of the large population. This has
helped to curb the exploitative practices of multinationals.
The decision can be considered part of the reform process to
ensure access and affordability to high cost drugs. Earlier this month, the
Intellectual Property Appellate Board (IPAB) upheld its decision by the Patent
Controller on India’s
first-ever compulsory licencing case which allowed Natco pharma to continue to sell
generic version of Bayers AG cancer drug. Last year it was Pfizer’s cancer drug
Sutent and Roche’s treatment drug lost their patented status in India. Surely,
this will influence other patent applications under scanner, which include
large MNCs.
Linked to this is the issue of the compatibility of the
Indian law on rejection of claims for patent, with the norms on intellectual
property rights or TRIPS of World Trade Organisation (WTO). The Supreme Court
has evidently been persuaded by the argument that the Indian law on patents
must be judged and interpreted on its own terms and not on the basis of certain
standards of the western world. Even so-called incremental inventions have to
involve modifications leading to substantially new attributes beyond what was already
present in the existing product. This, in a sense, strikes at the heart of
‘ever-greening’ of patents, wherein technology providers seek to pre-empt competition
by extending their exclusive rights through minor changes that are claimed as
new inventions.
Multinational firms, especially those in the pharma and
chemicals space, are bound to view the latest verdict negatively and project it
as inimical to innovation. But this amounts to an unfair reading of India’s patent
law, which, after all does give 20-years exclusive rights as per TRIPS
Agreement for firms or individuals to make commercial use of their inventions.
Moreover, patents today are also granted on products and not only on processes,
as in the past.
If the idea of bestowing such monopoly is meant to reward
innovation and encourage further research and development, it is only fair to
grant it to products embodying genuinely new knowledge. By charging prices that
make their drugs unaffordable to even ordinary folk, not supplying these in
adequate quantities and, on top of it, portraying Indian generic pharma
manufacturers as villains, the multinationals are causing damage to their own
long-term interests. There is enough in the current patent law for
multinationals to leverage their bona fide intellectual property strengths.
However, there is a caution for policy makers as well as
health activists’ group to not get complacent on these decisions, as the larger
issue of access and affordability has more to do with the country’s health
infrastructure, which also includes insufficient human resource and health
insurance and inadequate public spending in healthcare, which clearly needs a
greater push. ---INFA
(Copyright,
India News and Feature Alliance)
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