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Keryx Biopharmaceuticals Inc. Message Board

  • hugochazev hugochazev Feb 9, 2013 6:21 PM Flag

    Method of Use Patents:...... For All Intents Are UnEnforceable .......... Off-Label Use

    "Our method of use patents only protect the product when used or sold for the claimed methods. However, these types of patents do not limit a competitor from making and marketing a product that is identical to our product that is labeled for an indication that is outside of our patented methods, or for which there is a substantial use in commerce outside of our patented methods.

    Obtaining proof of direct infringement by a competitor for a method of use patent can be difficult because the competitors making and marketing a product typically do not engage in the patented use.

    Moreover, physicians may prescribe a competitive identical product for indications other than the one for which the product has been approved, or off-label indications, that are covered by the applicable patents. Although such off-label prescriptions may directly infringe or contribute to or induce infringement of method of use patents, such infringement is difficult to prevent or prosecute."

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