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Expert Analysis

Reasons To Limit Inventor Testimony In Hatch-Waxman Cases

By Michael Hogan ( February 14, 2019, 2:59 PM EST) -- Inventor testimony inevitably forms a part of every generic drug company's case in a Paragraph IV obviousness challenge under the Hatch-Waxman Act.[1] This is odd because the generic defendant in its validity challenge cannot use anything that the inventors did in support of its obviousness case; but, ironically, the patentee/innovator company can.[2] Given the success rate of Paragraph IV obviousness challenges and the legal framework for the obviousness analysis, one can only wonder why this costly practice continues....

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