China to license copies of patented medicines

Source: Aljazeera

9 June 2012

New law allows companies to produce generic versions during emergencies,
unusual circumstances, or in public interest.

Chinese intellectual property laws have been overhauled to allow the
nation’s drug makers to make less expensive copies of medicines still under
patent protection.

The move by China, considered a vital growth market for foreign
pharmaceutical companies, comes within months of a similar action by India.

The amended patent law allows Beijing to issue compulsory licenses to
eligible companies to produce generic versions of patented drugs during
state emergencies, unusual circumstances, or in the interests of the public.

For “reasons of public health”, eligible drug makers can also ask to export
these medicines to other countries, including members of the World Trade
Organisation (WTO).

“The revised version of Measures for the Compulsory Licensing for Patent
Implementation came into effect from May 1, 2012,” China’s State
Intellectual Property Office said in a faxed statement to the Reuters news
agency.

China is known to be looking at Gilead Sciences Inc’s Tenofovir, which is
recommended by the World Health Organisation as part of a first-line
cocktail treatment for AIDS patients, two sources with direct knowledge of
the matter told Reuters.

In March India granted a compulsory license to local generic drugs firm
Natco Pharma to manufacture Bayer’s cancer drug Nexavar, used for treating
kidney and liver cancer.

Key drug ingredients

China’s generic drug makers have been producing the key ingredients – or
active pharmaceutical ingredients (APIs) – in medicines for years, exporting
them to foreign drug makers, which then sell the patented finished products
back to China at prices which the average Chinese citizen often cannot
afford.

In particular, the government is struggling to provide newer HIV drugs, such
as Gilead’s Tenofovir, known by its brand Viread and which had worldwide
sales last year of $737.9m.

A difficulty that could only increase in 2013, when the Geneva-based Global
Fund to Fight AIDS, tuberculosis and malaria will no longer give grants to
China to fight HIV.

Although Gilead moved to share its intellectual property rights on its
medicines in a patent pool with generic drug makers from many countries last
July in return for a small royalty, China was excluded, which meant it had
to continue paying high prices for tenofovir.

Since the change in China’s patent law, Gilead has offered certain
concessions, including giving China a substantial donation of Tenofovir if
it continues to buy the same amount, said Paul Cawthorne, co-ordinator for
Medecins Sans Frontieres’ Access Campaign in Asia.

“This is all a negotiation game; this offer from Gilead came about once the
news that the Chinese was considering issuing a CL [compulsory license] came
out. The end game is okay, you get a better deal or you use the CL, it’s a
strategy that many countries use,” he said.

China had signalled interest in the idea from at least 2008-2009, when its
State Intellectual Property Office invited foreign experts to Beijing to
show Chinese officials how to prepare the legal grounds for issuing
compulsory licenses.

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