A two-year battle between the US Patent and Trademark Office (USPTO) and biopharma over a much-contested set of patent rules ended yesterday (October 8) when the USPTO rescinded the rules altogether.

"These regulations have been highly unpopular from the outset and were not well received by the applicant community," said David Kappos, director of the USPTO, in a statement. "In taking the actions we are announcing [October 8], we hope to engage the applicant community more effectively on improvements that will help make the USPTO more efficient, responsive, and transparent to the public."

The rules, released by the USPTO in 2007 to streamline the patent-approval process, limited the number of times an applicant could file a continuation application, which adds claims to an existing patent. In addition, inventors could include only one request for a continued examination, which they file after the patent office has rejected their patent application. The new rules also limited the number of claims included in a single patent submission to 25. Under the current rules, there are no limits to the number of continuation requests and the number of claims a single patent can include.

The biopharma community objected that these limitations would make it more difficult to protect intellectual property in the life sciences, because the scope of biological discoveries so often expands with additional research.

"By the PTO's own numbers, biotech relies to a greater extent than other industries on so-called continuing patent applications and a variety of patent claims, all of which would have been constrained by the proposed rules," Hans Sauer, associate general counsel for intellectual property for the Biotechnology Industry Organization, told GenomeWeb Daily News. "Accordingly, biotech always felt particularly impacted by these rules."

The new rules were supposed to take effect on November 1, 2007, but GlaxoSmithKline filed an 11th-hour lawsuit on the grounds that the USPTO did not have the authority to institute them. A district court ruled in favor of the company in April, 2008. The USPTO appealed, and in March of this year, a federal court panel ruled that the agency did have the authority to make the rules; this summer, the court scheduled further hearings on the case. Now, though, GSK and the USPTO say they will file a joint motion for the case to be dismissed.


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Glaxo stalls new patent rules
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Big pharma sues USPTO
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New patent rules hurt biotech?
[21st August 2007]