[Ip-health] BMJ: Leena Menghaney: India’s patent law on trial

Joanna Keenan-Siciliano joanna.l.keenan at gmail.com
Fri Sep 28 00:47:17 PDT 2012

BMJ Blog
Leena Menghaney: India’s patent law on trial

27 Sep, 12 | by BMJ Group

This month, two critical legal battles between multinational pharmaceutical
companies and the Indian government are taking center stage in an ongoing
struggle over India’s medicines patent law. The potential consequences
could be dire for governments and people in developing countries that rely
on affordable, quality generic medicines produced in India. For example,
more than 80% of antiretrovirals (ARVs) used by donor funded HIV treatment
programmes globally between 2003 and 2008 were sourced from generic
manufacturers in India. [1]

At stake are public health safeguards within India’s patent law that allow
India to provide life saving drugs at affordable prices. One case goes to
the heart of what merits a patent. The other addresses what countries can
do when patented life saving medicines are priced out of reach for the vast
majority of patients.

India’s 1970 Patents Act was a watershed law designed to encourage the
development and production of low-cost generic medicines. Over time, it
helped India become the “pharmacy of the developing world,” with generic
manufacturers competing for markets and thereby dramatically driving down
prices of medicines that were patented elsewhere. For example, the cost of
first generation HIV treatment dropped from over $10,000 per patient per
year in 2000 to $350 by 2001. Today, improved first line treatment costs
roughly $120 yearly. [2]

By joining the World Trade Organization in 1995, India became obligated to
start granting pharmaceutical patents within a decade. But in 2005, the
country adopted a strict medicines patent law that, while ensuring patent
protection for new pharmaceutical compounds, makes it tougher to get a
patent on new forms of existing medicines. The law was designed with the
social objective of stopping drug giants from indulging in “evergreening,”
a common abusive patenting practice in the pharmaceutical industry aimed at
filing and then obtaining separate patents relating to different aspects of
the same medicine.

This tougher patentability standard—Section 3d of India’s patent law—is at
the crux of Swiss company Novartis’ six year legal battle against the
Indian government, which has now reached India’s Supreme Court. Novartis is
contesting the Indian patent office’s and appellate body’s decision to
reject the company’s application for a secondary patent on the salt form of
imatinib, a life saving drug for treating chronic myeloid leukemia. (The
basic research that led to the original drug was conducted largely in
publicly funded US research institutions. [3])

Novartis is arguing that the interpretation of Section 3(d) as applied by
the courts and patent office is narrow and should be broadened, in this
case, for example, to allow patenting of the mesylate salt form of imatinib
on the basis of a 30% increase in bioavailability. But this reasoning is
flawed, according to patient and public interest groups. Selecting a
particular salt of an active ingredient as a means of improving
bioavailability is a common practice within the pharmaceutical industry,
and should not be considered patentable.

A win for Novartis would set a dangerous precedent, severely weakening
India’s legal norms against evergreening and inevitably leading to patents
being granted far more widely in the country. Filing patent applications
covering simple changes in the chemistry or formulation of existing
pharmaceutical products is a lucrative game for the pharmaceutical
business, but also a deadly one for patients: it would prevent generic
competition for these products and allow pharmaceutical companies to
continue charging high prices, which can mean the difference between life
and death.

The second case now playing out in India’s courts revolves around the issue
of “compulsory licensing,” a legal mechanism sanctioned by international
trade law that allows governments to authorise production of a medicine by
a company other than its patent holder, in the interest of public health.
In March 2012, India’s Patent Controller took the unprecedented step of
issuing a compulsory license to an Indian generic manufacturer: with German
pharmaceutical company Bayer charging $5,500 per person per month in India
for a kidney and liver cancer medicine (sorafenib tosylate, marketed as
Nexavar), the Indian government deemed this price unaffordable and granted
a compulsory license to generic manufacturer Natco. As a result, a generic
version is now available for 97% less ($175/month).

India has faced political backlash from the US for this landmark move, one
which health advocates and patients worldwide hope will set a precedent for
other life-saving medicines deemed unaffordable. For example, unlike
first-generation ARVs, several of the newest HIV medicines—needed by
patients who have become resistant to their drug regimens—are patented in
India, preventing generic competition. One of them is the integrase
inhibitor raltegravir, which Médecins Sans Frontières (MSF) uses in its
Mumbai clinic to treat people who developed resistance to two drug
regimens, at a cost of $1,750 per person/year—for just one drug of a needed
triple drug cocktail.

Bayer has appealed India’s granting of a compulsory license, and the case
is now with the country’s Intellectual Property Appellate Board—and may,
like the Novartis case, eventually reach India’s highest court. The world
is watching closely, as these cases could have a profound impact on access
to life saving medicines for millions of people worldwide.

Leena Menghaney is a lawyer and India manager of the Access Campaign at
Médecins Sans Frontières.

[1] Waning B, Diedrichsen E, Moon S. A lifeline to treatment: the role of
Indian generic manufacturers in supplying antiretroviral medicines to
developing countries. Journal of the International AIDS Society 2012. 13:35
[2] Untangling the Web of Antiretroviral Price Reductions. Médecins Sans
Frontières Access Campaign. 15th Edition. July 2012.
[3] Don’t abuse patents: scientists. Op-ed by Dr Brian Druker.
LiveMint.com, Wall Street Journal. 15 August 2007.

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