113 STAT. 1501A-556 PUBLIC LAW 106-113—APPENDIX I "(A) may be asserted as a defense under this section only for continued use by and in the laboratory or nonprofit entity; and "(B) may not be asserted as a defense with respect to any subsequent commercialization or use outside such laboratory or nonprofit entity; "(3) the term 'method' means a method of doing or conducting business; and "(4) the 'effective filing date' of a patent is the earlier of the actual filing date of the application for the patent or the filing date of any earlier United States, foreign, or international application to which the subject matter at issue is entitled under section 119, 120, or 365 of this title. " (b) DEFENSE TO INFRINGEMENT. — "(1) IN GENERAL.—It shall be a defense to an action for infringement under section 271 of this title with respect to any subject matter that would otherwise infringe one or more claims for a method in the patent being asserted against a person, if such person had, acting in good faith, actually reduced the subject matter to practice at least 1 year before the effective filing date of such patent, and commercially used the subject matter before the effective filing date of such patent. "(2) EXHAUSTION OF RIGHT. —The sale or other disposition of a useful end product produced by a patented method, by a person entitled to assert a defense under this section with respect to that useful end result shall exhaust the patent owner's rights under the patent to the extent such rights would have been exhausted had such sale or other disposition been made by the patent owner. " (3) LIMITATIONS AND QUALIFICATIONS OF DEFENSE. —The defense to infringement under this section is subject to the following: "(A) PATENT.— ^A person may not assert the defense under this section unless the invention for which the defense is asserted is for a method. "(B) DERIVATION. —A person may not assert the defense under this section if the subject matter on which the defense is based was derived from the patentee or persons in privity with the patentee. "(C) NOT A GENERAL LICENSE. —The defense asserted by a person under this section is not a general license under all claims of the patent at issue, but extends only to the specific subject matter claimed in the patent with respect to which the person can assert a defense under this chapter, except that the defense shall also extend to variations in the quantity or volume of use of the claimed subject matter, and to improvements in the claimed subject matter that do not infringe additional specifically claimed subject matter of the patent. "(4) BURDEN OF PROOF.— ^A person asserting the defense under this section shall have the burden of establishing the defense by clear and convincing evidence. "(5) ABANDONMENT OF USE.—^A person who has abandoned commercial use of subject matter may not rely on activities performed before the date of such abandonment in establishing a defense under this section with respect to actions taken after the date of such abandonment.
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