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MIT loses EU court bid to extend cancer drug patent

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The Massachusetts Institute of Technology lost a bid at the European Union's highest court to extend a patent on a brain cancer drug.

"This is a blow" to the research-based drug industry, Robert Anderson, an intellectual property partner at Lovells in London, said in a telephone interview.

The European Court of Justice in Luxembourg ruled today that Germany was correct to reject a patent extension for two ingredients used in a tumor-treatment drug. MIT licenses the patent to Guilford Pharmaceuticals Inc., a U.S. biotechnology company owned by MGI Pharma Inc.

Drug companies try to extend patent protections to delay competition from generic drugs. The longer the patent lasts, the more a drug company can recoup its investment.

Under EU rules, drugmakers can apply for a "Supplementary Protection Certificate." The certificate, granted for a maximum of five years, aims to compensate drug companies for the time lost from when a company first applies for a drug patent to its authorization. In many cases, the delay can be as long as 15 years. Patents expire after 20 years.

In an eight-page ruling, the EU tribunal said companies can't receive patent extensions covering the combination of two substances when only one is an active ingredient and the other controls the release of the first, such as the MIT treatment.

New treatments

The European Federation of Pharmaceutical Industries and Associations, which represents 28 national industry groups and 44 drugmakers, said it was "disappointed" in the ruling. The court took too narrow a view of EU law, Ann Robins, manager of legal affairs for the EFPIA, said in an e-mail.

"We would have favored a wider interpretation based on the fact that a substance which does not have a therapeutic effect of its own may nonetheless render a pharmaceutical form possible, which contributes to new treatments," Robins said.

MIT had asked Germany for the patent extension for Gliadel, which is used to treat recurrent brain tumors. The German patent office rejected the application. MIT appealed to a German court, which referred the case to the EU court.

Gliadel is implanted in the skull after brain surgery. The coin-sized wafer dissolves slowly, releasing the active substance, Carmustine, a potent anticancer drug, controlled by a biodegradable polymer to delay the recurrence of the tumor. This ensures the release of a steady flow of the drug without any possibility of a sudden chunk being released and potentially causing an overdose, according to MIT.

The court's ruling means that only a combination of active ingredients can be granted patent extensions.

Lovells's Anderson said some drugmakers will find it difficult to convince authorities that their patents should be given extra protection following the ruling.

"It hasn't sunk the ship on supplementary protection certificates, but it's knocked a bit of a hole in it," he said.

The case is C-431/04 Massachusetts Institute of Technology.

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