Patent Office reverses Ruling

The US Patent and Trademark Office has reversed a March ruling that patent extensions available to innovator drugs under the Waxman-Hatch legislation would apply to products with either 17 years' patent life or the new 20-year patent life provided under the new General Agreement on Tariffs and Trade legislation (Marketletter June 5). Companies with existing patents may choose between having them run for 20 years from the date of filing, or 17 years plus any Waxman-hatch extensions. The ruling has appeared in the Federal Register.

Mylan Laboratories chairman Milan Puskar said the new PTO ruling was a "positive first step," but it has only partially resolved the problem. "There are still more than $2 billion in windfall profits for multinational brand-name drug companies that will come directly from consumers' pockets," he said. The new ruling revokes a decision which would have granted unearned patent term extensions for 94 out of 109 drugs. However, said Mr Puskar, the 15 remaining drugs are some of the most widely-prescribed on the market. Earlier this month, the Food and Drug Administration issued new rules, based on its interpretation of the language of the Uruguay Round Agreements Act, that still bars FDA approvals on generic versions of these 15 products.

Generics "Singled Out" Mr Puskar said it seemed obvious that the generic industry has been singled out as the only US industry which, if the FDA's position stands, will be denied the right to sell products under the URAA's transition language. "All this may just be coincidental, but it seems to me to be terribly convenient, from the perspective of certain brand-name companies, who will unjustly earn billions of dollars," he said.