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Pharmaceutical

Federal Court Throws Out Patent Rules

April 02, 2008
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The Associated Press is reporting that recently, a federal district court sided with GlaxoSmithKline PLC and struck down new patent rules the British drug maker argued were a threat to innovation.

Glaxo sued in October to block the implementation of the U.S. Patent and Trademark Office rules, charging that they would jeopardize about 100 of the company''s pending patent applications.

The rules, issued in August 2007, were intended to streamline the application process by limiting how many times patent applicants can tweak existing applications and how many claims they can make about an invention.

But Glaxo argued the limitations would harm pharmaceutical companies that frequently change the scope of their applications as research and testing uncovers additional applications for a drug.

Jennifer Rankin Byrne, a spokeswoman for the PTO, said the agency is disappointed with the decision and is considering its next steps.

The Biotechnology Industry Organization, which filed court papers in support of Glaxo, said the rules would have made it harder to get financing for new products.

The U.S. District Court for the Eastern District of Virginia, based in Alexandria, Va., ruled that the PTO had overstepped its authority when it issued the regulations. The rules made substantive changes to the patent application process, Judge James Cacheris wrote, and the PTO doesn''t have the authority to make such changes.

The rules were intended to go into effect Nov. 1, but the court blocked their implementation Oct. 31 pending the outcome of the case.
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