Bayer Urges India to Link Patents and Drug Approvals to Stymie Generics Producers
Bayer has placed itself at the forefront of an international lobbying campaign by the pharmaceutical industry to link patents and marketing approval in foreign countries. On Monday, the Delhi High Court will hear a case in which Bayer wants a ruling that will legally link marketing approval for drugs to their patent status. Such a rule would prevent India's massive generic drug industry from getting approval to sell drugs without bothering with patents, according to the Times of India.
The grounds of Bayer's petition are that the drug controller entertained Cipla's application for grant of marketing rights to generic version of its anti-cancer drug, 'Nexavar', for which it has obtained a patent in India. If marketing approval were granted, its patent rights would be affected, it says.Bayer is not the only company wanting the Indians to prevent approvals without patents. As BNET noted a few days ago, Bristol-Myers Squibb is trying to do the same thing. Linking product approvals to patent status is controversial because it seems unfair that governments should approve drugs for companies that did not go to the expense of patenting their drugs. But bodies like the Drug Controller General of India and the US FDA are ill-equipped to do the legal research on patent statuses prior to making approvals.
The Times says:
This is one of rare instances an [multinational] suing the Indian government to introduce higher intellectual property standards, than what is required under Trips agreement (trade-related aspects of intellectual property rights), experts say.Bayer's move is part of an international lobbying effort to strengthen patent-approval ties and to keep generic drug industry's in developing countries in their place:
During last year multinational pharmaceutical companies lobbied with the drug controller to reject marketing approval to generic companies on patented drugs.
Proposals to link registration of drugs with their patent status are not new and have been promoted by MNCs and their associations. Several developing countries have faced pressure to introduce patent linkages. In 2001, a group of companies took the South African government to court to prevent it from importing cheaper AIDS medicines, and more recently, Pfizer sued the Philippine government.