[Ip-health] Section 3(d) pivots a health revolution

Lorraine Misquith lorrainemisquith at gmail.com
Tue Apr 7 03:53:21 PDT 2015

Apr 07, 2015 - Anand Grover / Y.K. Sapru / Loon Gangte

*The shrill opposition to India’s balanced patents law, particularly Sec.
3(d), hides the quiet revolution that the provision is inspiring across the
developing world. The Philippines introduced their version of Sec. 3(d) in

Ten years ago, on April 4, 2005, the President of India gave his assent to
the Patents (Amendment) Act, 2005. And with it, Section 3(d) came into
India’s law lexicon. Within six months, in September 2005, the Cancer
Patients Aid Association (CPAA) with legal aid and representation from the
Lawyers Collective, filed the first public interest pre-grant opposition
challenging Novartis’ patent application for a new form (beta crystalline)
of Imatinib Mesylate. Section 3(d) was a key argument in that challenge.
Little could anyone have known that this case and Section 3(d) would go on
to capture the imagination of the world and become the epicentre in the
global fight for access to affordable medicines.

Recognising the problems of patent evergreening (the practice of
pharmaceutical companies to file multiple, successive patents on known
medicines attempting to extend their monopolies), Section 3(d) allows
patents for new forms of known medicines only on the demonstration of a
significant increase in efficacy. On April 1, 2013, the Supreme Court held
that Novartis’ patent application failed the Section 3(d) standard. They
also rejected Novartis’ attempt to weaken its interpretation stating: “With
regard to the genesis of Section 3(d), and more particularly the
circumstances in which Section 3(d) was amended to make it even more
constrictive than before, we have no doubt that the “therapeutic efficacy”
of a medicine must be judged strictly and narrowly.”

Even as the Imatinib Mesylate case progressed through the courts, networks
of people living with HIV filed multiple patent oppositions; Section 3(d)
featured prominently as a majority of molecules used in first- and
second-line HIV treatment were invented before 1995. For newer molecules,
the provision features in challenges to ensure that the monopoly even if
granted is not extended.

At the time, Novartis’ challenge was considered the most serious threat to
Section 3(d). But the last few years have presented far greater challenges.
The US has ratcheted up its pressure on India’s patent regime; Section
3(d), their favourite whipping boy. In the Regional Comprehensive Economic
Partnership Agreement negotiations, Japan’s proposals reportedly include a
reversal of Section 3(d). An intense ongoing effort to introduce data
exclusivity would mean that medicines that remain off patent could,
nevertheless, be covered by a monopoly.

But the increasingly shrill opposition to India’s balanced patents law,
particularly Section 3(d), hides the quiet revolution that the provision is
inspiring across the developing world. The Philippines introduced their
version of Section 3(d) in 2008. Argentina introduced regulations in 2012
that improved on the spirit and intent of Section 3(d) through detailed
provisions prohibiting patents on new uses and new forms of known
substances. In Brazil, patent law reform proposals feature versions of
Section 3(d).

There is good reason for this. One that is immediately visible to those
working directly with patients. Since the judgment, CPAA has provided over
a 1,000 patients suffering from chronic myloid luekemia with generic
versions of Imatinib Mesylate free of cost. Section 3(d), along with other
provisions of India’s patent law, has been pivotal in the rejections or
withdrawals of patent applications on key first- and second-line HIV
medicines. It is increasingly being used in challenging patent applications
on medicines necessary to treat diabetes, cancer and hepatitis C treatment.
Every victory means that generic companies can freely manufacture and
supply generic versions of these critical medicines. Every victory means
one less hurdle for patients in India and developing countries in accessing
safe, effective and affordable generic medicines.

Every victory provides a chance to fight off the restrictive voluntary
licences that are increasingly binding generic production. Multinational
companies are luring India’s biggest generic manufacturers into deals that
may be sweet for their collective bottomlines, but that are creating
significant hurdles, including grave privacy violations for patients
accessing the drugs. For patients in countries excluded from these deals,
the future is bleak. In exchange for these unconscionable deals, generic
companies are shying away from or backing out of critical patent
oppositions. This leaves the burden of challenging questionable patent
applications squarely on the shoulders of patients and public interest
groups. Gilead’s voluntary licences on the critical hepatitis C treatment,
Sofosbuvir, is the worrying case in point. Multiple patent oppositions
based on Section 3(d), among other grounds, by people living with HIV and
hepatitis C, now pending before the patent office hope to stem the tide of
such devil’s bargains.

There are several other pro-public interest provisions in the patent law
amendments that were signed into effect 10 years ago. But for the
detractors of India’s balanced legal regime, for the supporters of
corporate monopolies and for the developed country governments lobbying for
even greater profits for their companies, Section 3(d) has been used as a
symbol of all that they argue is wrong with India’s approach to foreign
investment and innovation. But for many patients and public interest
groups, it is a symbol of all that is right with India’s approach in
balancing its international obligations to the WTO, its obligations to
patients in India and abroad and its obligations to push the research and
development world towards true innovations, away from minor tinkering with
existing molecules to extract the longest possible monopoly.

So this month, April 2015, we are celebrating 10 years of Section 3(d), 10
years of hope, 10 years of hard-fought and hard-won battles. We have a long
way to go and there are tough days ahead. Section 3(d) may not be the
perfect solution to the problem of patent evergreening and of the abuse of
the patent system, but in our books, it’s an efficacious one. And it is one
that we will defend, like our lives depend on it.

*Loon Gangte is with the Delhi Network of Positive People (DNP+). Anand
Grover is the former UN Special Rapporteur on Health and the director of
the Lawyers *

*Collective. Y.K. Sapru is the founder-chairman and CEO of the Cancer
Patients Aid Association.*


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