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.
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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