Patented Medicines (Notice of Compliance) Regulations — 5
ry protection referred to in the allegation would be infringed, and (iv) if the second person is alleging that the patent or certificate of supplementary protection is invalid or void, an electronic copy of any document — along with an electronic copy of it in English or French if available — on which the person is relying in support of the allegation; (d) provide, without delay, to the first person any portion of a submission or supplement referred to in subparagraph (c)(iii) that is changed on or before the later of the 45th day after the day on which the notice of allegation is served and the day of the disposition of any action that has been brought under subsection 6 (1); and (e) provide to the Minister proof of service of the documents referred to in paragraphs (a) and (b), along with a copy of the notice of allegation. (3.1) A second person who makes an allegation that the patent or certificate of supplementary protection is invalid or void may, when the notice of allegation is served, request (a) the name of and contact information for any inventor who might have information relevant to the allegation, along with an indication as to whether that inventor is an employee of the first person or of the patent owner; and (b) any laboratory notebook, research report or other document that may be relevant to determine whether a particular property, advantage, or use asserted by the second person to be part of the invention was established as of the filing date of the application for the patent, if the second person identifies the specific allegation in the notice of allegation that is relevant to the request and the portion of the patent in which that property, advantage or use is set out. (3.2) A document referred to in paragraph (3.1)(b) must be provided in a searchable electronic format but, if it is not available in that format, in an electronic format. In addition, if the document provided is not already in English or French, it must also be provided, if available, in English or French and be in a searchable electronic format but, if it is not available in that format, in an electronic format. (3.3) Within five days after the day on which the first person is served with any notice or document under subsection (3), they shall forward a copy of it, along with any request made under subsection (3.1) when the notice was served and an indication of the date of the service, (a) to the owner of each patent in respect of which an allegation is made in that notice; and (b) to the owner of a patent that is set out in each certificate of supplementary protection in respect of which an allegation is made in that notice. (3.4) The first person shall, without delay, notify the second person that they forwarded the copy under subsection (3.3) and, if they are owner of any patent referred to in that subsection, that they are its owner. (3.5) The second person may impose on the first person referred to in paragraph (3)(a) and any owner of a patent to whom a document is forwarded under subsection (3.3) any reasonable rules for maintaining the confidentiality of any portion of a submission or supplement referred to in subparagraph (3)(c)(iii). (3.6) Those confidentiality rules are binding and enforceable by the Federal Court, which may award any remedy that it considers just if they are not respected. (3.7) On motion of the first person or of the owner of the patent — or on its own initiative after giving an opportunity to be heard to that first person, that owner and the second person — the Federal Court may set aside or vary any or all of those confidentiality rules in any manner that it considers just. (3.8) A second person who is, under subparagraph (3)(c)(iii) or paragraph (3)(d), required to serve or provide a document may — if there is reason to believe that the intended recipient of the document is not in Canada — refuse to do so unless that recipient attorns to the jurisdiction of the Federal Court with respect to the confidential