Patent Issues around Swine Flu Threat

The drug Tamiflu so far is the most effective treatment for combating the threat of

Demand for antiviral increased in 2004 with the threat of the virulent bird flu, and so all 50 states and many other nations now have large enough  stockpiles of the drug for 220 million people. Roche has stated it could ramp up production to 400 million courses a year.

The Obama administration said it would seek $1.5 billion from Congress to combat the threat of a swine flu pandemic and is in talks with Roche about increasing production. Those with high fevers and consistent symptoms within 48 hours of illness are appropriate patients to receive the drug. Other vulnerable populations such as the elderly and home bound are also being considered candidates for the antiviral.

The flu sweeping Mexico and now appearing in several other countries is a strain never seen before by experts; it is a mix of genetic material from humans, birds and pigs. CDC officials told a Senate hearing Tuesday the agency was considering whether to develop a vaccine for just this strain of flu or a combination of flu viruses.

Gilead Sciences, Inc., Foster City, CA, is the patent holder, (Patent #5763483 for oseltamivir) having been assigned it by the five named researchers who invented this particular compound. Gilead Sciences’ patent on oseltamivir will not expire until December 26, 2016. Originally discovered by Gilead, Tamiflu was licensed to Roche for late-phase development and marketing. Roche produces and markets the anti-viral medication oseltamivir (as “Tamiflu®”)

Roche has made 5 million courses of Tamiflu available to the World Health Organization and has licensed other manufacturers to make the drug. Earlier this month, Gilead was denied patent protection for Tamiflu (formally known as oseltamivir) by India’s Patent Protection Office, and so the Indian pharmaceutical maker Cipla Ltd. has since moved its own version of the drug into production.

Similar issues arose with the 2005 avian flu threat, when Taiwan amidst a rising threat and frustrating negotiations with Roche, eventually moved forward with production of a generic version of Tamiflu. As a show of good faith, Taiwan’s National Health Research Institutes did not market the drug and  limited it to public use.  Arguments were that the NHRI could produce the drug more quickly and at lower cost, and being that negotiations fell apart they moved forward with their generic in the interest of their people. These past and present issues raise concern over the handling of these situations by the pharmaceutical Roche, still trying to strongly enforce patent rights abroad when threats are imminent. Only time will tell but let us hope that all parties involved handle the delicate situation and more delicate threat appropriately.