[Ip-health] Pharmalot/Stat News: Colombian government recommendation puts Novartis cancer drug patent at jeopardy

Zack Struver zack.struver at keionline.org
Mon Mar 7 11:44:30 PST 2016


Colombian government recommendation puts Novartis cancer drug patent at

MARCH 7, 2016

The tense battle between drug makers and patient advocates over patents and
access to medicines is moving to a new venue. The latest clash is taking
place in Colombia, where a government committee late last month recommended
that a compulsory license should be issued for the Gleevec cancer treatment
sold by Novartis.

A compulsory license allows a company to make a patent-protected product
without the consent of the patent holder.

In announcing its decision, the committee explained that doing so would be
in the public interest by widening access and saving health care dollars.
It added that the purpose in issuing a compulsory license would “restore
competition for this product in the Colombian market.” The health ministry,
however, must still make a final decision.

The annual cost of Gleevec is roughly $15,000, which patient advocacy
groups say is excessive in a country where the nation’s per capita gross
national income is about $8,000. “The public interest is obviously affected
when a patient or family is obligated to pay these prices, which
constitutes a violation of (a) fundamental right to health,” the groups
wrote in November 2014 petition to the government.

The dispute is the latest example of rising tension between the
pharmaceutical industry and some governments over the prices for
prescription medicines. In response, a growing number of countries have
been pressing drug makers for discounts or, in some cases, issuing
compulsory licenses.

Countries may grant such licenses to a generic drug maker, a right that was
memorialized in a World Trade Organization agreement known as Trade-Related
Aspects of Intellectual Property Rights, or TRIPS. According to WTO rules,
a country may cite a health emergency as a reason for issuing a license.

A few countries have issued compulsory licenses for patented medicines over
the past decade, although Colombia is not one of them. Consequently, the
licenses are a sore point for the pharmaceutical industry, which has argued
that governments may issue licenses inappropriately and, in the process,
violate intellectual property rights. This was one of the arguments
Novartis made in response to the recommendation by the Colombian committee.

“Novartis is concerned about the implications that disregarding
intellectual property rights might have for foreign investment.
Furthermore, the company believes that it damages industries like
pharmaceuticals that spend significant resources on research and
innovation, and negatively impacts the patients who benefit from their
innovative efforts,” a company spokeswoman wrote us.

She added that patients in Colombia are able to obtain Gleevec — which is
often called Glivec outside the United States – thanks to price
regulations. “Although Novartis respects and abides by the Colombian
regulatory framework, the company is concerned that the technical and
factual arguments presented before the authorities have not been taken into
account during the process,” she added.

Patient advocacy groups, however, argue that some efforts to enforce
intellectual property rights may come at the expense of patients who cannot
afford medicines.

“You don’t have ‘access to medicine for all’ unless the budget has enough
money to buy all the medicines that everyone needs. And when resources are
limited, prices can’t be unlimited. Providing universal access is, indeed,
in the public interest,” wrote Jamie Love of Knowledge Ecology
International, which focuses on access and patent issues, in an email.

In recent years, Thailand pursued compulsory licensing in order to lower
costs for different medicines and, more recently, India issued a license as
well. But the issue has become especially heated there since so many large
generic drug makers are based in the country, and global drug makers are
concerned the country has favored its domestic industry at their expense.

Two months ago, the Indian Patent Office rejected an application from a
domestic generic drug maker that sought a compulsory license to make a
generic version of the Onglyza a diabetes pill sold by AstraZeneca. The
decision was seen by some as a sign that the Indian government may alter
its approach toward protecting patent rights.​

Zack Struver, Communications and Research Associate
Knowledge Ecology International
zack.struver at keionline.org
Twitter: @zstruver <https://twitter.com/zstruver>
Office: +1 (202) 332-2670 Cell: +1 (914) 582-1428

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