Bayer, a German pharmaceutical company, currently manufactures and holds the patent to the drug sorafenib tosylate, known

as Nexavar. This drug is used to treat renal cancer and Bayer currently sells the drug for approximately U.S. $5700 or 285,000 rupees for one month's treatment. Indian drug manufacturer, Cipla, moved to create a generic version of the drug which could be sold at less than 28,000 rupees for one month's treatment--less than 1/10 the cost of the Nexavar. Cipla's application for generic drug approval caused Bayer to seek the creation of a patent-linkage system in India. Bayer sought to prevent Cipla from marketing a generic form of Nexavar and filed suit in the Delhi High Court in 2008. Bayer argued that the Drug Controller General of India (DCGI) should not grant approvals to generic versions of patented drugs while the patent is still in force. After a hearing on the merits, Justice Bhat rejected Bayer's petition for patent linkage (a system whereby the drug regulatory agency refuses to grant or delays marketing approval to a generic drug manufacturer for the production of a patented drug), holding that unpatented, generic drugs are not spurious drugs. Bhat previously noted that Bayer's petition was "a speculative foray; an attempt to tweak 'public policies' through court mandated regimes." On appeal before the Division Bench of the Delhi High Court, the Division Bench also rejected Bayer's claims and concurred with Justice Bhat. The Division Bench noted in its February 2010 decision that "This court cannot possibly read into a statute a provision that plainly does not exist" and that following Bayer's reasoning would result in a rejection of all generic drugs. Bayer appealed to the Supreme Court of India, but when the appeal was first listed in February 2010, the Court refused to stay the Delhi High Court's decision while the case remains pending. The Supreme Court of India will hear Bayer's appeal in August 2010. Cipla recently announced that it will launch its generic version of the cancer treatment despite the fact that the case remains pending before the Supreme Court of India. If the Court finds in favor of Bayer, Cipla will be forced to pay a fine--a risk Cipla is apparently prepared to take; in producing its generic treatment, Cipla is providing lower cost drugs not only for patients, but is also making the medicine more affordable for NGOs. Some have also speculated that Cipla's move might persuade judges to more greatly consider the public interest. Significantly, patent linkage does not even exist in the European Union (Bayer is a German company and Nexavar was invented by a German scientist). Scholars and patent experts assert that patent linkage is not only contrary to EU regulatory law but also beyond the scope of TRIPS. Furthermore, patent linkage undermines key public health safeguards. If patent linkage is, in fact, introduced to India, this system would seriously impact the availability of generic drugs in the market. Krista Cox