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Whether therapeutic product subject to patent

Health Products (Therapeutic Products) Regulations 2016

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—(1) In dealing with an application for the registration of a therapeutic product, the Authority must consider the following:(a)whether any of the following patents under the Patents Act 1994 is in force in respect of the therapeutic product as described in the application for registration:(i)a patent containing a claim for an active ingredient of that therapeutic product;(ii)a patent containing a claim for a formulation or composition of that therapeutic product;(iii)a patent containing a claim for the use of an active ingredient in the manufacture of that therapeutic product for a specific therapeutic, preventive, palliative or diagnostic use;(b)if one or more patents mentioned in sub-paragraph (a) are in force in respect of the therapeutic product as described in the application for registration —(i)whether the applicant for the registration of the therapeutic product is the proprietor of the patent or those patents; and(ii)if the applicant is not the proprietor of the patent or any of the patents —(A)whether the proprietor has consented to or has acquiesced in the grant of the registration of the therapeutic product to the applicant; or(B)whether the patent or any of the patents is invalid or will not be infringed by the doing of the act for which the registration of the therapeutic product is sought.(2) Unless the Authority otherwise determines, the applicant must, at the time of the application and at such other time before the determination of the application as the Authority may require, make and furnish to the Authority a declaration in the form specified on the Authority’s website, stating —(a)whether one or more patents under the Patents Act 1994 mentioned in paragraph (1)(a) are in force in respect of the therapeutic product; and(b)whether the applicant is the proprietor of the patent or those patents.(3) If the applicant is not the proprietor of the patent in respect of the therapeutic product and there is such a patent in force, the applicant must further state in the declaration mentioned in paragraph (2) —(a)the name and address of the proprietor of the patent;(b)whether —(i)the proprietor has consented to or has acquiesced in the grant of the registration of the therapeutic product by the applicant; or(ii)in the opinion of the applicant and to the best of the applicant’s belief, the patent is invalid or will not be infringed by the doing of the act for which the registration of the therapeutic product is sought; and(c)such other information as the Authority may require in any particular case.(4) For the purposes of paragraph (1), the Authority may rely upon, and need not be concerned to inquire into the truth of, any statement made in the declaration furnished under paragraph (2).(5) Where the applicant is not the proprietor of a patent under the Patents Act 1994 mentioned in paragraph (1)(a) that is in force in respect of the therapeutic product, the Authority may require the applicant to serve, in accordance with section 67 of the Act, on the proprietor of the patent, a notice in the form specified on the Authority’s website, and within such time as the Authority may determine, if —(a)the applicant has declared that, in the applicant’s opinion and to the best of the applicant’s belief, the patent is invalid or will not be infringed by the doing of the act for which the registration is sought; or(b)the Authority considers it appropriate in any particular case for the applicant to do so.(6) The applicant must furnish to the Authority such evidence of the service of the notice mentioned in paragraph (5) as the Authority may require.(7) The Authority need not determine the application until the applicant has complied with paragraph (2) and, where applicable, paragraphs (5) and (6), to the reasonable satisfaction of the Authority.(8) If the Authority is satisfied that the notice mentioned in paragraph (5) has been served on the proprietor of the patent, the Authority may register the therapeutic product if the proprietor does not, before the 45th day after the date that notice is served on the proprietor —(a)apply to a court for —(i)an order restraining the act for which the registration of the therapeutic product is sought; or(ii)a declaration that the patent is valid and will be infringed by the doing of the act for which the registration of the therapeutic product is sought; and(b)furnish the following to the Authority:(i)a written notice stating that an application under sub-paragraph (a) has been made;(ii)evidence of the application made under sub-paragraph (a);(iii)a declaration by the proprietor in the form specified on the Authority’s website that the application made under sub-paragraph (a) relates to a patent mentioned in paragraph (1)(a) that is in force in respect of the therapeutic product that is the subject of an application for registration.(9) The Authority may register the therapeutic product without further notice to the proprietor of the patent, if no order or declaration mentioned in paragraph (8)(a) has been made at the end of 30 months after the date of the application for the order or declaration.(10) If, before the end of the period mentioned in paragraph (9), the proprietor of the patent submits to the Authority a copy of the order or declaration mentioned in paragraph (8)(a), the Authority may refuse to register the therapeutic product.(11) To avoid doubt, this regulation does not apply to the following patents:(a)a process patent, other than a process patent that contains a claim for the use of an active ingredient in the manufacture of a therapeutic product for a specific therapeutic, preventive, palliative or diagnostic use;(b)a patent that contains only claims relating to packaging;(c)a patent that contains only claims relating to metabolites;(d)a patent that contains only claims relating to intermediates.

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