Avian Flu Drugs: Patent Questions

Background. The two main products currently available to treat the flu virus are Tamiflu (oseltamivir) and Relenza (zanamivir). These are not vaccines, but a class of medicines called neuraminidase inhibitors, which work by limiting the spread of the influenza virus inside the body. Tamiflu has been highlighted because of its relative ease of use. As governments stockpile millions of doses of Tamiflu, widespread concerns have been raised about the capacity of Roche, the Swiss pharmaceutical company that manufactures and distributes the drug, to supply the need.

First, what is the difference between Tamiflu and oseltamivir?

They are the same drug. Oseltamivir is the generic name of the anti-viral drug which Roche markets under its trademark Tamiflu.

And Roche owns the oseltamivir patent?

No. A quick search of patent databases shows that the patents covering the invention of oseltamivir are owned by the California-based biopharmaceutical company, Gilead Sciences. (See e.g. U.S. patent no 5763483, for a "novel carbocyclic compound", filed in 1996 and in force in principle until at least 2016.) Rather than further develop and manufacture the drug within the company, Gilead opted in 1996 to license to Roche certain of the exclusive rights conferred by the patents.

What IP rights does the licensing agreement give Roche?

Gilead granted Roche a sole and exclusive license. Broadly speaking, this gives the legal right to Roche - and only to Roche - to undertake or sublicense the manufacture, sale and distribution of oseltamivir-based products covered by their patents. The text of the...