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Pharmaceutical company GlaxoSmithKline PLC and inventor Triantafyllos Tafas have each petitioned the U.S. Court of Appeals for the Federal Circuit for an en banc rehearing of a March 20 decision that upheld the U.S. Patent and Trademark Office (PTO)’s authority to issue three of four controversial patent rules. The 2-1 majority opinion in Tafas v. Doll upheld rules that requires a more cumbersome process for requesting continuing patent applications and other rules that sharply restrict the number of patent claims on an application unless the applicant files so-called examination support documents, which are detailed and expensive to produce. Tafas v. Doll, No. 2008-1352 (Fed. Cir.). The patent bar’s sole victory in Tafas v. Doll was the decision’s invalidation of the PTO rule limiting the number of continuing patent applications, or additional applications for the same invention filed before the first application is patented or abandoned. The Federal Circuit deemed that rule “inconsistent” with patent law mandates. Patent lawyers believe the challenged rules would particularly drive up the cost of life sciences patents because they typically involve numerous claims to protect many compounds while scientists work on a final product. Tafas’ June 3 petition, filed by New York’s Kelley Drye & Warren, argued that the Federal Circuit misapplied the standard in the Chevron Supreme Court case, which explains when courts should give deference to government agency regulations. Chevron USA. Inc. v. Natural Resources Defense Council Inc., 467 US 837 (1984). The court also “misapplied significant binding [U.S.] Supreme Court and Federal Circuit precedent concerning the correct standing for classifying administrative rules as ‘substantive’ versus ‘non-substantive,” according to the brief. The Federal Circuit’s incorrect analysis “turns administrative law on its ear,” said Steven Moore, a partner in the Stamford, Conn., office of Kelley Drye, who filed the Tafas petition. “That needs to be cleared up because it has bigger ramifications than just this case,” Moore said. The Tafas petition also argues that the Federal Circuit failed to address whether the PTO has the statutory authority to enact the final rule and “to fully consider evidence that the Final Rules significantly and adversely affect individual rights.” GlaxoSmithKline’s chief argument in a June 3 petition primarily authored by four Sidley Austin lawyers is that the Federal Circuit panel decision conflicts with binding precedent by concluding that the approved final rules are within the PTO’s rulemaking authority. The brief states that the Federal Circuit broke from its own precedent when it “improperly and incorrectly dismissed” a test in a case involving Chrysler of whether government agency rules are procedural, and thus allowed, or substantive and reserved for Congress. Chrysler Corp. v. Brown, 441 U.S. 281, 289 (1979). GlaxoSmithKline’s brief also cited the “unprecedented number of amicus filings” explaining the rules’ detrimental impact on patent filing, innovation and investment. “Whether and how those rights should be altered is a task reserved to Congress and the political process, not one delegated to the PTO,” states GlaxoSmithKline’s brief. The PTO declined to comment.

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