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At a recent bar conference, Judge Paul Michel of the U.S. Court of Appeals for the Federal Circuit jokingly reminded lawyers that the judges’ memo traffic is not subject to open records laws. “We have a very intense debate,” Michel allowed, describing with Judge Arthur Gajarsa how each member of the Federal Circuit gets to review — and can hold up for changes or en banc consideration — decisions by three-judge panels. One can only imagine the memos concerning Eli Lilly & Co. v. Barr Laboratories Inc., et al., a ruling written by Gajarsa that last week invalidated Lilly’s lucrative patent for the popular antidepressant Prozac. The May 30 decision reaffirmed a ruling last August by a three-judge panel –Gajarsa, Chief Judge H. Robert Mayer, and Senior Judge Daniel Friedman. But the case went through some odd procedural twists to reach a similar result. The new decision came after the full Federal Circuit reviewed the matter and then — instead of issuing its own en banc ruling — reassigned it to the Gajarsa-Mayer-Friedman panel for a specific revision. The key issue: The panel’s conclusions regarding “double patenting,” the problem that prompted the court to invalidate the Prozac patent. Acknowledging that the panel was using a “different legal basis” than it had used the first time, Gajarsa concluded that Lilly’s method of using Prozac to treat anxiety in humans was inherent — and therefore legally indistinct — from an earlier method of using Prozac’s active ingredient to block a chemical change related to depression in animals. The revised decision prompted a passionate dissent from Judge Pauline Newman. “Later discoveries and scientific advances may well elucidate the earlier one,” she wrote, “but that does not retrospectively erase the patentability of the earlier work.” Newman added, “In this period of unprecedented development of patent-supported biological advance, the nation needs a stable and comprehensible patent law, lest this court falter in its leading role in implementing the law’s fundamental purposes.” In addition to revisiting the patent issue, the court refereed an odd dispute over whether to consider five amicus briefs supporting Eli Lilly & Co. Barr Laboratories Inc., Lilly’s lead opponent, had argued that the briefs by the Federal Circuit Bar Association, two intellectual property groups, one pharmaceutical company, and a law professor were too biased in favor of Lilly to help the court. In an unpublished order in February, the court disagreed — but just barely. “The present briefs barely assist this court in its analysis, if at all, and they are for the most part repetitive of the arguments made by the parties,” the unsigned order said. Last week’s ruling clears the way for Barr and other generic competitors to start marketing their own versions of Prozac later this year. Lilly has vowed to pursue appeals at the full Federal Circuit or the Supreme Court.

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