In April 2013, the Indian Supreme Court upheld a portion of India’s
patent law critical to preserving the nation’s generic drug industry
when it ruled that the Swiss pharmaceutical company Novartis
should not receive a patent for its leukemia drug Gleevec®. India
is the world’s largest producer of generic drugs and manufactures
more than 80 percent of the low-cost HIV medicines used to treat
HIV-positive individuals in low- and middle-income countries. The
patent lawsuit threatened that life-saving supply.
“The Supreme Court’s ruling will prevent companies from
further seeking unwarranted patents on HIV and other essential
medicines,” said Giten Khwairakpam, TREAT Asia’s project
manager for community and policy.
Novartis’s seven-year legal battle against India’s 2005 Patents
Act focused on one section of the act, Section 3(d), that prohibits
frivolous patent extensions for minor changes to existing drugs
that do not significantly improve their efficacy. This practice is
known as “evergreening” because it extends pharmaceutical
companies’ monopolies on drugs and prevents generic
production. The court’s decision affirmed that Gleevec is too
similar to a previous drug to warrant a new patent under Section
3(d), and rejected the company’s contention that the section
violates their intellectual property rights.
Loon Gangte of the Delhi Network of Positive People (DNP+)
called the decision, “A crucial victory for people living with HIV and other diseases who can continue to rely on India for access
to affordable treatment,” adding, “We have been filing several
oppositions to patent applications on ARV medicines on the
basis of Section 3(d).”
Novartis denounced the ruling as a symptom of “India’s
growing non-recognition of intellectual property rights that
sustain research and development for innovative medicines.”
Yet India has granted hundreds of patents since it enacted its
Patents Act to comply with international trade standards. The
only patents it does not grant are those considered to be cases
of evergreening, as opposed to real medical innovation.
Free trade agreements (FTAs) like the Trans-Pacific
Partnership (TPP) now threaten to thwart this progress towards
improved access to generic drugs. The U.S. and a number of
countries in Asia and the Pacific are currently negotiating the
TPP. As with many FTAs, current proposals require that member
nations adopt stringent intellectual property provisions similar
to those in the U.S. that would delay the availability of generic
medicines and decrease competition among generic drug
manufacturers. However, this competition caused the price of
first-generation HIV medicines to plummet from $10,000 per
person per year in 2000 to as low as $60 today. The price of free
trade could prove to be very high for those living in the world’s
poorer countries.