New Patent Rules on Hold
Drug Discovery & Development - November 05, 2007
New rules designed to improve patent quality and the effectiveness and efficiency of patent examination scheduled to go into effect on November 1 were delayed following a last-minute court ruling. On October 31, U.S. District Court for the Eastern District of Virginia, ruling on a complaint filed by GlaxoSmithKline, issued a preliminary injunction delaying the new rules from taking effect.
USPTO employees will continue processing and examining patent applications under the rules and procedures in effect on October 31, 2007, until further notice, according to the USPTO Web site.
The Biotechnology Industry Organization (BIO), Pharmaceutical and Research Manufacturers of America, and the American Intellectual Property Law Association filed supporting complaints. Opponents to the rules identified key concerns:
- The proposed rules would reduce the number of times a patent applicant could contest or amend rejected or pending patent claims. Previously, applicants could file an unlimited number of amendments or challenges, known as continuations. Under the new rules, applicants could file two continuations; any additional challenges must include an explanation justifying the request.
- Continuations are considered an important tool for pharmaceutical patent applicants, because new information about an invention often comes to light after the initial patent application has been filed. Many companies use continuations to delay introduction of a product, monitor market developments, and then modify their patents to take advantage of emerging trends. This information can be added to the application via a continuation, allowing the applicant to retain the original filing date.
- The US Patent and Trademark Office (USPTO) wants to limit the number of continuations to help make the patent-application process more efficient and to reduce its massive application backlog. Continuation requests accounted for nearly 30% of all patent applications in 2006, up from 27% in 2005 and 25% in 2004, according to the office.
- Opponents of the new rules said the rules were unclear, stifled innovation, and would make it more expensive for small companies and individual inventors to patent their inventions.
USPTO employees will continue processing and examining patent applications under the rules and procedures in effect on October 31, 2007, until further notice, according to the USPTO Web site.
More information:
USPTO
Biotechnology Industry Organization
