Tussle Over Participation In India Compulsory Licence Hearing 14/03/2008 by Tatum Anderson for Intellectual Property Watch 2 Comments Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)By Tatum Anderson for Intellectual Property Watch Swiss pharmaceutical company Roche is expected to appear before the Indian Patent Office on 17 March to assert its right to attend a later meeting that could result in one of its drugs being copied, without its permission, by an Indian generic pharmaceutical company. The hearing is due to be held at the country’s patent office in Delhi and is the result of an application made to the Indian government by the domestic generic company Natco last September. Natco applied to the Indian Patent Controller for a compulsory licence, permission to copy two cancer drugs that are under patent in India, and export them to Nepal. One drug, called erlotinib, was patented in India last year by Swiss manufacturer Roche under the brand name Tarceva. The other is also a cancer drug called sunitinib and is sold by US manufacturer Pfizer under the brand name Sutent. Under WTO rules, compulsory licences can be issued without the authorisation of the patent holder if the country to which a drug is being exported is deemed to have no manufacturing capacity of its own and has declared a need for it. Such licences can be issued in special cases, such as during a national emergency or for government use, as deemed by the recipient government. If the patent office agrees to the application, it would be the first time such permission has been given in India and only the second time in the world. [Editor’s Note: This refers to compulsory licensing for export (see IPW, Developing Country Policy, 20 February 2008)]. The hearings on the applications were to have been held last month. However, when it emerged that one patent-holder, Roche, had been invited to attend the hearing on its drug, Natco filed a so-called interlocutory petition, an objection aimed at blocking Roche’s appearance. It did so because it believes that under Indian law, Roche should not be allowed to attend CL hearings. “There is no necessity for the patentee to come to the hearing,” said M Adinarayana, company secretary and general manager for corporate affairs at the Hyderabad firm. “The CL is between the patent office and the Natco. That is the reason why we objected.” It argued as such during a hearing at the end of February. For its part Roche, says it was invited to the compulsory licence hearing by the Indian government. “Originally, Roche was invited to attend the hearings by the Patent Controller of the Indian patent office,” said a spokesperson for Roche. The Indian Patent Office was not available for comment. On 17 March, Roche is expected to defend its right to appear at the eventual compulsory licence hearing, possibly occurring in the coming weeks. The company would not comment on the hearing, saying, “We are currently in the legal process of hearings with the Patent Controller and therefore cannot comment on the actions of our legal team.” However, observers including Natco, say that Roche will put forward an argument based one of the principles of the so-called natural justice philosophy, which is accepted in India. It is expected to argue the principle that proceedings should be conducted so they are fair to all the parties – expressed in latin audi alteram partem – essentially “hear the other side.” Some Lawyers Agree with Natco’s Assessment Tahir Amin, a lawyer at I-MAK, a US non-profit that specialises in combating IP obstacles for public health crises said: “I’m concerned about this talk of hearings to decide the compulsory licence request and allowing the patentee (Roche) to present a case at a hearing – which by the Indian Patent Act’s wording should not be permitted.” According to the Act, the patent office should grant a compulsory licence on the basis that the paperwork within an application is in order. Companies applying for a licence, in essence, require a written request from the countries with no capacity, ordering a particular quantity of drugs, he said. Indeed, a recently-issued draft of the patent office’s own “Manual on Practice” stresses that the compulsory licence should be granted immediately on request. Amin, who has seen the draft, said: “While the manual is only in draft, the nature and purpose of [the section] is such that it removes any opportunity for the patentee to oppose or challenge the granting of a compulsory licence for export.” Indeed, the patent office’s activities so far suggest it is in favour of Roche’s presence at the hearing on the application, when it finally takes place. “The current question mark is how is the Indian Patent Office going to handle these requests and what will be the procedure,” said Amin. “But this is the Indian Patent Office – so we don’t know how they are going to work it, especially if big pharma starts kicking up a fuss.” Other Lawyers Agree with Roche Krishna Sarma, managing partner at Corporate Law Group, a Delhi-based law firm which has represented Roche in the past but not in this particular case, said, “Calling a hearing is the incipient right of the Controller. If he thinks it is right, he can call for a hearing,” she said. “Roche should attend the hearings to get the facts right.” Curiously, one industry observer suggested Natco may find it difficult to present a compelling case for a compulsory licence at the hearing. That is because the letter sent by the Nepalese government to Natco requesting it to manufacture the drugs may not explicitly mention a public health crisis nor a lack of manufacturing capacity, according to the observer who claims to have knowledge of the letter’s contents. Nevertheless, once Roche has put forward its arguments, the Patent Controller will take a decision on whether the company can attend meetings in a matter of weeks. The hearing on the application for a compulsory licence – and probably the contents of the letter – will then follow. Tatum Anderson may be reached at firstname.lastname@example.org. 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