The government of Taiwan will not need to resort to compulsory licensing to allow local manufacturers to make the influenza treatment Tamiflu (oseltamivir), according to the drug’s manufacturer Roche.
Taiwan had threatened the move after claiming that Roche had been unable to meet additional orders for Tamiflu, currently being stockpiled by countries around the world in case of a flu pandemic.
But Roche said it was surprised by the announcement, as it had already met with the government and committed to supplying the required Tamiflu order according to mutually-agreed delivery timelines. It will provide Taiwan with an additional 1.3 million doses of Tamiflu next year, taking the nation’s total order for pandemic use to 2.3 million treatments. It also notes that, during a recent visit to Taiwan, company officials had examined the manufacturing capabilities of a domestic firm with a view to issuing a voluntary license to produce the drug for local pandemic use.
“As a result of this review, it was clear that the local company could not produce the drug more rapidly or at lower cost than Roche,” said the company in a statement.
In addition, Roche said that it is still looking to identify companies which can contribute to manufacturing scale-up, in order to increase Tamiflu’s global availability for pandemic use without negatively affecting Roche’s own production capacity.
Specifically, it is looking for plants that can contribute to critical manufacturing steps such as biofermentation, azide chemistry and combined alcohol granulation/capsule filling; these could become potential toll manufacturers, as well as firms which believe they can fully produce Tamiflu in substantial quantities that could become either contract manufacturers or be issued with sub-licenses or de-blocking licenses.
Meanwhile, Roche has told the governments of Indonesia, the Philippines and Thailand that they are free to manufacture generic versions of Tamiflu because it is not under patented in these countries.
In Indonesia, the 90%-state-owned firm Kimia Farma will undertake Tamiflu production, starting in around five months. The country is planning to lay down enough supplies to treat a minimum of 10% of its total population of 220 million.
Indian generics manufacturer Ranbaxy has also reported that it has started exporting its version of Tamiflu to an undisclosed Southeast Asian nation. Roche has a patent pending for Tamiflu in India. It is already patented in China, another potential source of generic versions.
