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Legal Affairs : May 1, 2008 ( )
Court Blocks PTO-Initiated Patent Reform
If Congress Gets Involved, the Outcome Won’t Necessarily Be Any Better for Biotech Firms!--h2>
Patent reform has been a hot topic for several years now. Applicants complain about the U.S. Patent & Trademark Office (PTO) backlog, the PTO complains about low-quality patent applications, and industries complain about patents that some believe should not have been granted.
The PTO, Congress, and even the courts have taken steps to reform the U.S. patent system, but as of today, the prospect of meaningful patent reform remains uncertain. A U.S. district court recently blocked the PTO’s major attempt at reform, and all eyes are now on Congress, which continues to debate the Patent Reform Act of 2007.
Biotech applicants should be aware that Congress may devise a patent reform solution that causes even more problems than the PTO’s proposed rule changes with provisions that could significantly increase the already high costs of patent prosecution for biotechnology inventions.
In January 2006, the PTO proposed significant rule changes to address the backlog of unexamined patent applications. After an extended notice and comment period and several town meetings across the country, the PTO published the final Claims and Continuations rules in August 2007, with a stated effective date of November 1, 2007.
The rules would have made significant changes to patent prosecution by (1) limiting the number of continuation applications that can be filed without justification to two applications and one Request for Continued Examination (RCE) per application family, (2) limiting the number of claims that can be presented without having to provide a detailed patentability analysis (an Examination Support Document, or ESD) to 25 claims, and (3) requiring identification of, and in some cases justification of, certain commonly owned, copending applications.
While the PTO promoted the new rules as a solution to the backlog and patent quality issues, applicants railed against the substantive loss of rights that the continuation and claim limits might cause, the high costs and inequitable conduct risks associated with ESDs, and the burden of complying with the copending application disclosure rules.
Challenge to PTO’s Requirements
Just after the final rules were published, a sole inventor Triantafyllos Tafas challenged their validity in the U.S. District Court for the Eastern District of Virginia where the PTO is located. Soon thereafter, Smithkline Beecham (GlaxoSmithKline) brought a similar suit, and the two cases were joined.
The court’s decision is important on several fronts. First, it once again blocked the Claims and Continuation rules from taking effect, a decision that is welcomed by most applicants, particularly those in biotechnology arts where continuations and RCEs are often needed to obtain a full scope of patent protection.
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