(1) An application under section 42 of the Act for a declaration that a specification does not comply with section 40 of the Act unless the deposit requirements are satisfied in relation to a micro-organism, must:
(a) be made in the approved form to a prescribed court or the Commissioner; and
(b) be lodged at the court or filed.
(2) A person who applies for a declaration under section 42 of the Act must give a copy of the application:
(a) to the applicant or patentee; and
(b) to such other person as the court or Commissioner directs.
(3) If the Commissioner on his or her own motion proposes to declare under section 42 of the Act that the specification in respect of a patent application or patent does not comply with the requirements of section 40 of the Act unless the deposit requirements are satisfied in relation to a micro-organism, he or she must give to the applicant or patentee a statement of the facts relied upon to justify the making of that declaration.
(4) A person to whom:
(a) a copy of an application under subregulation (2); or
(b) a statement under subregulation (3);
has been given:
(c) may, within 3 months, give to the court to which the application is made or to the Commissioner a reply to that application or statement; and
(d) must give a copy of the reply to the applicant or patentee and to such other persons as the court or the Commissioner directs.
(5) As soon as practicable after:
(a) a copy of a declaration by a court under subsection 42(1) of the Act is given to the Commissioner under subsection 42(6) of the Act; or
(b) the making of a decision of the Commissioner under subsection 42(1) of the Act;
notice of the making of the declaration or decision must be published in the Official Journal .
(6) The terms of a declaration or decision referred to in subregulation (5) need not be published, but the declaration or decision must be open to public inspection.