Switzerland’s Roche has waved a white flag in the face of international pressure and, this morning, said it would be willing to enter into discussions for compulsory licensing of its oral influenza drug, Tamiflu (oseltamivir), after cases of bird flu crept into Turkey and Greece, causing widespread panic and upping the scrutiny on governments to secure sufficient stockpiles and prevent an outbreak from extending its reach further.
Scientists have warned that this strain of flu, H5N1, which can jump from birds to humans, could prove deadly if it mutates into a form that is easily transmissible. Tamiflu has shown activity against the virus and, because it can be taken orally, has seen its sales skyrocket after what had been a low period for the drug: revenues are now expected to more than double in 2005 to 800 million Swiss francs, up from 330 million francs last year [[02/02/05a]].
With researchers ever more convinced that a flu pandemic is just around the corner, Roche has faced growing pressure to allow compulsory licensing of Tamiflu, whereby governments can override a company’s intellectual property and order third-party manufacturers to produce the drug. Meanwhile, others are looking to sidestep its patents as well, and India’s Cipla has said it will immediately start production of a generic version of Tamiflu for the developing world, where patents are absent or difficult to enforce [[17/10/05a]].
Roche has previously stressed it would not consider outsourcing production of Tamiflu – which has a 12-month lead-time - stressing that it expected to increase its manufacturing capacity eight-10 fold by mid-2006 [[13/10/05b]]. It has just been granted approval of an additional manufacturing site in the USA – part of a network of more than one dozen facilities worldwide, including third-parties – but now says it is “prepared to discuss all available options, including granting sub-licenses, with any government or private company who approach us to manufacture Tamiflu or collaborate with us in its manufacturing.”