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STAFF REPORTER It wasn’t readily apparent, buried in an exhaustive 67-page decision amid references to land mines, chocolate bars and the conversion rate of the Canadian penny, but the Canadian drug maker Apotex has scored a major victory in its fight to market a generic form of Paxil. Paxil is the world’s best-selling anti-depressant and anti-anxiety medication. U.S. sales of the drug, which is made by SmithKline Beecham Corp., reportedly topped $2.2 billion last year. On March 3, U.S. Circuit Judge Richard A. Posner, in a rare trial court appearance, ruled after a three-week trial that Apotex had not infringed on SmithKline’s patented product. “The decision moves Apotex one step closer to getting a generic version of Paxil to the market,” said winning attorney Paul J. Molino, a partner at Chicago’s Lord, Bissell & Brook. With partner Scott B. Feder, Molino led a six-lawyer team into trial only three weeks after Posner sent both parties an e-mail announcing the trial date. In addition to short preparation time, each side was given just 20 hours to present its case. Several witnesses offered direct examination by affidavit, taking the stand only for cross, Molino said. SmithKline experts According to the judge, SmithKline spent $1 million on expert witnesses. But Posner said in his ruling that his confidence in the independence and accuracy of those experts was shaken by revelations that one expert’s procedures were manipulated by SmithKline’s lawyers, and that another expert received testing instructions from a SmithKline employee. SmithKline’s lead counsel, Richard O’Brien of Chicago’s Sidley Austin Brown & Wood, filed an appeal one day after the decision was rendered. He declined to talk about the trial, referring inquiries to his client’s corporate communications department. Spokeswoman Mary Anne Rhyne said, however, that because an appeal was pending the company would have no comment beyond a press release announcing the verdict and the appeal. Posner actually decided two separate issues. First, he concluded that SmithKline’s patent for paroxetine hydrochloride, the active ingredient in Paxil, was valid. He then ruled that SmithKline had failed to prove that Apotex’s formula for making a molecularly different version of paroxetine hydrochloride infringed on SmithKline’s patent, even if Apotex incidentally manufactured almost undetectable amounts of SmithKline’s paroxetine in making its own product. Underlying the conflict is the atomic similarity between the two products. SmithKline’s paroxetine is “hemihydrous,” meaning its basic crystalline structure incorporates a water molecule. Apotex based its paroxetine on an expired third-party patent for creation of an “anhydrous” form, one that does not contain the water molecule. Historically, the anhydrate has proven unstable, tending to attract water that converts it to SmithKline’s patented form. Apotex maintained at trial that it has learned to make an essentially stable anhydrous crystal that will not readily convert to the infringing hemihydrate. It conceded that some conversion is unavoidable due to ambient humidity and the processes needed to form paroxetine into pills. But how much conversion, if any, is tolerable under SmithKline’s patent? Arguing for a literal reading, SmithKline asserted that the presence of even a single hemihydrous crystal in Apotex’s pills would constitute infringement. Posner rejected that assertion, ruling that the limits of present-day technology would not allow Apotex or anybody else to discover that it was selling such small amounts of SmithKline’s molecule. But reliably establishing the presence of any amount of the hemihydrate in Apotex’s pills became problematic for SmithKline’s experts. Relying in part on the testimony of University of Leeds physicist Dr. David Batchelder, SmithKline tried to prove that laser microscope research revealed detectable amounts of the hemihydrate in many of the samples Apotex furnished during discovery. On cross-examination, Mazzochi confronted Batchelder with the contents of a lab notebook maintained by one of his assistants. The book revealed that the assistant had repeatedly used the same brush to clean a knife used to cut the pills and to dust the pills before cutting, meaning that stray hemihydrate molecules may have been transferred from sample to sample. Batchelder was also shown to have been tutored in his analysis by a SmithKline in-house scientist. Analytical error Another SmithKline expert, University of New Mexico chemist Dr. Thomas Niemczyk, was called to testify about the results of his spectral analysis of the chemical composition of Apotex’s product. But on cross by Mazzochi and Feder, it was revealed that Niemczyk had used an incorrect standard-deviation figure in interpreting his results. Feder said that because of this error, Niemczyk was “unable to delineate the difference between a [hemihydrate] sample that was close to detectable and zero.” Mazzochi said the experts’ arguments were hurt by their failure to conduct their research under the same strict conditions that SmithKline’s lawyers said Apotex should have adopted. “SmithKline took none of these precautions when evaluating our product,” she added. The appeal will be heard by the U.S. Court of Appeals for the Federal Circuit and not by Posner’s 7th Circuit colleagues. Feder said, “The issue is: What is the scope of the patent claim? And that is a purely legal matter, one that can only be resolved by the Federal Circuit.” Harris’ e-mail address is

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