Drug Labels Can Provide 'Specific Intent' For Inducement

Law360, New York (October 3, 2014, 11:26 AM EDT) -- Induced infringement under Section 271(b) of the Patent Act is particularly relevant in pharmaceutical litigation where method-of-use claims are an important component of patent protection. Generic pharmaceutical companies may attempt to draft U.S. Food and Drug Administration labels that allow them to avoid claims of inducement. For example, where a proposed label does not direct any action on the part of a physician, but merely provides information a physician can draw upon when prescribing a drug, even if such information could lead to infringement, the label does not induce infringement. This particular situation is exemplified by the recent decision in United Therapeutics Corp. v. Sandoz Inc., Nos. 12-1617, 13-316, 2014 U.S. Dist. LEXIS 121573 (D.N.J. Aug. 29, 2014). However, in many instances, the label itself will establish the requisite intent to induce infringement....

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