This bill prohibits, with certain exceptions, a governmental entity or a government-funded entity that operates, administers or contracts with a mental health facility or place of confinement from using a product that is or has ever been protected by a patent granted by the United States Patent and Trademark Office or is subject to review by certain federal agencies in a manner: (1) that is contrary to the terms of use of that product established by the current or most recent holder of the patent for the product or the manufacturer or distributor of the product; (2) that is inconsistent with any written instructions, limitations or directed uses included with the product; or (3) that exceeds the scope of the approved usage of the product, if a federal agency has approved the product for specific uses. This bill also prohibits such a governmental entity or government-funded entity from providing or dispensing such a product for use in such a manner.
However, this bill authorizes a covered entity to use, provide or dispense a product in such a manner if the covered entity transmits a written notice of the intended use to the patent holder and the manufacturer or distributor of the product, if different from the patent holder, that: (1) identifies the specific product at issue; and (2) describes the specific manner in which the entity plans to use, provide or dispense the product. This bill authorizes the patent holder or the manufacturer or distributor of a product to object to the use, provision or dispensing of the product in such a manner by transmitting a written notice of the objection to the covered entity. Once the covered entity receives a notice of objection from the patent holder, manufacturer or distributor, this bill requires the covered entity to cease and desist from using, providing or dispensing the product in the manner to which the patent holder, manufacturer or distributor objects. This bill further authorizes a covered entity to provide or dispense a patented or reviewed product to a resident of a mental health facility or place of confinement to be used in a non-conforming manner without providing notice to the patent holder, manufacturer and distributor of the product if the resident to whom the product is provided or dispensed provides informed consent with respect to the use and receipt of the product.