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Archived updates for Monday, September 12, 2005

EU to Extend Pediatric Drug Patent Term in Exchange for Testing

On September 7, 2005, The European Parliament approved amendments to a proposed regulation to enhance the development of pediatric medicines. Article 36 of the "proposal for a regulation of the European Parliament and of the Council on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/83/EC, and Regulation (EC) No 726/2004" offers drug makers an additional six months' patent protection on a given medicine, if they agreed to test its effects on children.

According to News.Telegraph, "that would extend patents for children's drugs to 15½ years, which could make companies an extra six £6 million, to offset the £2.7 million usually spent on clinical trials." French conservative deputy Francoise Grossetete, who guided the proposal through parliament, reportedly told Reuters that drug firms had wanted a 12-month patent extension. Although some EU member states, including Hungary and Poland, had argued for a shorter extension in order to support their generic drug manufacturers, parliamentary sources reportedly told the BBC that it was unlikely they would be able to organise a blocking minority, and that the regulation would probably have a smooth passage into law. Grossetete said she hopes the new rules will be in place by 2006.

Patent extension incentives for drug deveolpement are not a new idea. According to Dee Ann Divis writing for United Press International on September 1, 2005, the U.S. Congress will also be asked this fall to consider offering a "wild card patent extension" for a biodefense drug and vaccine manufacturers for a patent of their choice. Similar wild card extensions have also been proposed to spur development of new antibiotics in the U.S. and U.K.
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