Drug Patent Linkage Is Subject Of Court Case, Dispute In India

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Should national drug control bodies grant marketing licences to generic medicine companies only if their products do not possibly infringe existing patent rights? Yes, German pharmaceutical company Bayer told the High Court of Delhi last week when the court heard arguments in an ongoing court case on patent linkage.

The company was scheduled to finish its arguments in court Wednesday.

Bayer filed a complaint against granting marketing approval to Indian generic drug manufacturer CIPLA. The complaint is against CIPLA, the Drug Controller General of India (DCGI) and the Union of India as the latter’s oversight body.

If CIPLA markets the anti-cancer drug Sorafenib, sold by Bayer under the name Nexavar, Bayer’s patent would be violated, said a spokesperson of Bayer in Germany. The patent is valid until 2020, she said, and when asked about patent linkage in other countries she pointed to the procedure of the United States Food and Drug Administration that does not grant marketing licences for drugs that are protected by patents.

Bayer’s lawyer, according to trial observers in Delhi, argued that CIPLA wanted permission to act illegally and that issuing marketing approval would amount to the “abetment of an illegal act” by the DCGI. One state authority (DCGI) cannot act against another one (the patents office), the lawyer said. The Delhi High Court issued an interim order mandating the DCGI stop the processing of CIPLA’s pending application.

Several non-governmental organisations are following the Bayer v CIPLA and India case closely. A mixing of patent law and the drug approval process would be “unfair”, said a spokesman of Médecins Sans Frontières (MSF). “While we do not take a legally dogmatic standpoint and also do not want to comment on the pending case, we are concerned about effects of patent linkage,” he said. “Everything that makes the grant of compulsory licensing more burdensome, threatens the life of our patients.”

Patent linkage could burden market access for generic drugs in several ways, according to MSF and several other NGOs. “Linking patent status and registration of medicines means that the drug regulatory authority is required to withhold marketing approval of a generic version of a patented drug regardless of whether the patent granted is valid or not,” the organisation said in an analysis. Getting market approval before a patent runs out also might help with a quick start for the generic versions of the patented drugs. The NGOs also warn that compulsory licences might become worthless if drug controllers withhold marketing approval.

The strategy to delay generic versions of drugs by patentees was confirmed recently in the preliminary report by the competition authorities of the European Union. DG Competition started a “pharmaceutical sector inquiry” last year and still is soliciting comments. The 400-plus page preliminary report states: “Based on the sample of medicines under investigation that faced loss of exclusivity in the period 2000 – 2007, representing an aggregate post-expiry expenditure of about €50 billion over the period (in 17 member states), the preliminary report estimates that this expenditure would have been about €14 billion higher without generic entry. However, the savings from generic entry could have been about €3 billion more, if generic entry had taken place without delay.”

In order to delay competition, originator companies had intervened before national authorities “other than patent offices” in a “significant number of cases,” the competition authorities found. “Originator companies claimed in their interventions that generic products were less safe, less effective and/or of inferior quality” and also argued that marketing authorisations could “violate their patent rights, even though marketing authorisation bodies may not take this argument into account.” The EU Directorate General for Competition also noted that “patent-linkage is considered unlawful under Regulation (EC) No 726/2004 and Directive (EC) No 2001/83.”

India is not obliged by international law to introduce patent linkage into Indian law, said NGO representatives. Yet there has been a debate of the Indian legislator and the Drug Controller General of India on the topic after a judgment asking for patent linkage last year. US drug company Bristol-Myers Squibb complained about the approval of an off-patent version of cancer medicine dasatinib for Hetero Drugs. This decision is now under appeal.

NGOs continue to call for respect for the so-called “Bolar provision” (Article 30) in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. Some countries allow “manufacturers of generic drugs to use the patented invention to obtain marketing approval – for example from public health authorities – without the patent owner’s permission and before the patent protection expires,” the WTO said on its webpage about TRIPS. Patent linkage would be TRIPS-plus, said MSF. It was introduced in some countries like Singapore, Chile, Morocco and Bahrain in free trade agreements with the United States.

Patent linkage in place in the US is accepted to have its limitations. The US Food and Drug Administration (FDA) did not have the expertise to review patent information, the FDA itself wrote a few years ago. The European Generic Medicines Association has argued for years that “just as the patent offices possess neither the legal competence nor the scientific expertise to assess the quality, safety and efficacy of medicines, the national medicines authorities do not have the mandate nor the expertise to judge and assess the validity of patents or confirm their status.”

The two systems’ patent offices and drug approval processes, according to an IP expert consulted by MSF in Bayer’s home market Germany, are systematically so different and on separate tracks that she questioned if Bayer’s complaint against the Union of India, the DCGI and CIPLA had been recorded correctly.

Michelle Childs, director of policy and advocacy at MSF’s Access to Medicines Campaign, said that it is no secret that pharmaceutical companies were favouring patent linkages. The timing of the ongoing Bayer case could result in a situation where the court decision might outrun the discussion on patent linkage started in India. Yet a final judgment is still up to three months away with several more hearing days coming up.

Bayer will finish its arguments on 25 February, then arguments of the Ministry of Health, CIPLA and several associations that joined the action like the Cancer Patient Aid Association and the Indian Pharmaceutical Alliance will be heard.

Monika Ermert may be reached at info@ip-watch.ch.

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