J&J Secures Indian Patent for HIV Drug as Ranbaxy Joins Opposition to Roche's Valcyte

Ranbaxy Joins Valcyte Opposition

India drug major Ranbaxy Laboratories is opposing the grant of patent rights to Roche's anti-infective drug Valcyte (valganciclovir). According to Mint, Ranbaxy has "legally challenged" the decision of the Chennai Patent Office to grant the patent, highlighting that "the drug was not proved for enhanced efficacy than what is already known".' Ranbaxy joins two other strong opponents of the patent grant: the Lawyer Collective, which filed a pre-grant opposition for the drug that was rejected; and Indian drug-maker Cipla, which has stated its intention to contest the patent. However, as the source points out, it is still unclear whether Cipla has moved ahead yet. Valcyte is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS and for the prevention of CMV in kidney, heart, and kidney-pancreas transplant patients. The product was first patented in India in June 2007. The oppositions to the patent grant have come before the 12-month deadline under the amended patent rules in the Indian Patent Act for filing post-grant oppositions.

J&J's Intelence Patent

U.S. pharma major Johnson & Johnson (J&J) has scored a triumph in the Indian market by securing a key patent for its ARV drug Intelence (etravirine), making the drug the second ARV to gain exclusivity in the country after Maraviroc, the Economic Times reports. However, there is speculation over potential post-grant opposition from non-governmental organisations (NGOs) and consumer groups. The source notes that the drug, in combination with ARV agents, is indicated for the treatment of HIV Type 1 in adults who have developed resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs) and other ARV agents. The product received an FDA nod earlier this year. According to the report, J&J expects the approval to strengthen its position in the Indian market and potentially hopes to block any generic entry for the drug. With close to 2.5 million HIV-positive patients in India, the market potential for ARVs is growing and is expected to further increase as the government implements new plans to extend ARV coverage in the country.

Outlook and Implications

The two cases have clearly once again put the amended patent system back under the spotlight with a positive and negative development for multinational pharma firms operating in the country. For Roche, Ranbaxy's challenge poses yet more difficulties in relation to the Valcyte patent. Ranbaxy is toeing the general line of "known substance" prior to the 1995 cut-off year for seeking patent exclusivity in India. The danger is, however, that the intention to introduce a cheaper generic version of the drug, along with Cipla's announcement, could adversely affect Valcyte sales in the region. What has bolstered the initiative of the generic firms and non-profit organisation the Lawyers Collective is the emergence of documents from the U.S. Patent and Trademarks Office (USPTO) rejecting the Valcyte patent in 1994 on grounds that the drug had been in the public domain for three years. The other aspect is the scrutiny over why the pre-grant opposition was not heard by the regional patent office while examining Roche's application for the drug.

The issues regarding Valcyte will no doubt play to the strategy of the newest entrant, J&J, which secured its patent protection for Intelence. The drug-maker can anticipate post-patent grant oppositions in the forthcoming months as various stakeholders evaluate the option. However, so far the picture is mixed for ARV exclusivity in India. Although Pfizer has successfully secured a patent for Maraviroc, other pharma firms such as U.K. firm GlaxoSmithKline (GSK) and U.S.-based Gilead Sciences have chosen to withdraw their applications or in turn seek licensing agreements with Indian generic firms fearing regulatory intervention such as compulsory licensing for AIDS drugs in India. So far, the Indian government has not issued any compulsory licences but it is a threat that persists as the National AIDS Control Organisation (NACO) is on course to implement HIV/AIDS therapies to its 2.5 million patients.

Related Articles

• United States: 21 January 2008: J&J Secures FDA Approval for HIV Drug, Adds Contraceptive Warning
• India: 15 January 2008: Roche India Faces Trouble over Valcyte Patent, Seeks Compulsory Licensing for Tarceva
• India: 24 December 2007: Indian Patent Office Initiates Inquiry Over Roche's Valcyte Patent Grant
• India: 11 December 2007: Pfizer Wins Maraviroc Patent in India

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