Patent Act — P-4 55.2
Exception 55.2 (1) It is not an infringement of a patent for any person to make, construct, use or sell the patented invention solely for uses reasonably related to the development and submission of information required under any law of Canada, a province or a country other than Canada that regulates the manufacture, construction, use or sale of any product. (2) and (3) [Repealed, 2001, c. 10, s. 2] Regulations (4) The Governor in Council may make regulations respecting the infringement of any patent that, directly or indirectly, could result or results from the making, construction, use or sale of a patented invention in accordance with subsection (1), including regulations (a) respecting the conditions that must be fulfilled before a document — including a notice, certificate or permit — concerning any product to which a patent may relate may be issued to any person under any Act of Parliament that regulates the manufacture, construction, use or sale of that product, in addition to any conditions provided for by or under that Act; (b) respecting the earliest day on which such a document may be issued to a person and the earliest day on which it may take effect, and respecting the manner in which each day is to be determined; (c) respecting the issuance, suspension or revocation of such a document in circumstances where, directly or indirectly, the document’s issuance could result or results in the infringement of a patent; (d) respecting the prevention and resolution of disputes with respect to the day on which such a document may be issued or take effect; (e) respecting the prevention and resolution of disputes with respect to the infringement of a patent that could result directly or indirectly from the manufacture, construction, use or sale of a product referred to in paragraph (a); (f) respecting the resolution of disputes with respect to the infringement of a patent that results directly or indirectly from the manufacture, construction, use or sale of such a product; (g) conferring rights of action with respect to disputes referred to in any of paragraphs (d) to (f); (h) restricting or excluding the application of other rights of action under this Act or another Act of Parliament to disputes referred to in any of paragraphs (d) to (f); (i) designating the court of competent jurisdiction in which a proceeding with respect to rights of action referred to in paragraph (g) is to be heard; (j) respecting such proceedings, including the procedure of the court in the matter, the defences that may be pleaded, the remedies that may be sought, the joinder of parties and of rights of action and the consolidation of other proceedings, the decisions and orders the court may make and any appeals from those decisions and orders; and (k) specifying who may be an interested person for the purposes of subsection 60(1) with respect to disputes referred to in paragraph (e). Inconsistency or conflict (5) In the event of any inconsistency or conflict between (a) this section or any regulations made under this section, and (b) any Act of Parliament or any regulations made thereunder, this section or the regulations made under this section shall prevail to the extent of the inconsistency or conflict. For greater certainty (6) For greater certainty, subsection (1) does not affect any exception to the exclusive property or privilege granted by a patent that exists at law in respect of acts done privately and on a non-commercial scale or for a non-commercial purpose. 1993, c. 2, s. 4; 2001, c. 10, s. 2; 2017, c. 6, s. 39; 2018, c. 27, s. 192