Right now, everybody is watching India with great interest, says Buchanan. In January 2005, the final amendments necessary for full compliance with TRIPS were made to Indias patent law. The January amendments put everything on the books that made Indian intellectual property laws ready for serious product development. But, Buchanan cautions, on the books is different from in practice. Pharmaceuticals have only been patentable in India since January 2005.
India is interested in intellectual property issues, asserted Callahan, who conducts regular IP seminars in India and says companies want to be active pharmaceutical ingredient manufacturers to the world. Based on the questions he receives during the seminars, Indian pharmaceutical companies are keenly interested in strategies to design around patents (particularly U.S. patents, as the U.S. represents the largest market). They are less interested in obtaining their own patents at this time, although they do obtain some, Callahan adds.
To become a player, India must respect intellectual property and is taking steps in that direction, Callahan says. Therefore, Id be surprised if India allowed a compulsory license, in the case of Roche. Indian courts have a reputation for transparency, ensuring the rule of law. But, Callahan adds, The courts are notoriously slow, and results may take five to ten years.
There is plenty of time for debate, particularly given the built-in ambiguity of the compulsory license component of Indias patent law. It extends to the manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector, in order to address public health problems. That sounds fine, except that neither public health problem nor insufficient capacity are defined, and the products extend beyond medications to include diagnostic kits and ingredients.
The provisions are somewhat more ambiguous than those of other developing nations, Callahan says, but some still find fault with Indias new patent laws. The Indian Pharmaceutical Alliance, in a letter to the Group of Ministers, reiterated its opposition to patent applications that would delay the commercialization of generic pharmaceuticals.
The decision to support, rather than deny, Roches patent application will delay entry of generic versions of oseltamivir unless Roche reaches a sub-licensing agreement with Ranbaxy, Cipla, or some other company. Although the laws have been in effect for pharmaceuticals for about one year, The letter could affect the progress of the patent applications, Callahan speculates.
The WHO says avian flu is in phase three, the warning stage, of its development. There is time for countries to prepare, and there is time for the virus to mutate. The extent of oseltamivirs effectiveness against a mutated strain of H5N1 remains to be seen, but it is acknowledged as the only effective therapy to date.
With the global death toll less than 100 persons, the rush toward oseltamivir may seem premature, but the cost of ignoring the threat could be devastating. As Samant says, We need to stockpile oseltamivir and have distribution channels set up, before a pandemic ensues. Countries are fully justified in doing what they need to do, he says, to ensure the health and safety of their populations.