Consultation on Patent Extension of Term Regulations
Several options available for implementing TPP compliant extension of term provisions...
A consultation document on draft regulations for the (re-)introduction of extension of term provisions in the Patents Act has been released, with feedback being required by 8th August 2016.
In order to be TPP compliant the Patents Act will be amended to include extension of term provisions where there has been:
- unreasonable delays in patent grant; and
- unreasonable curtailment of the effective term of a patent covering a pharmaceutical substance or a biologic as a result of the Medsafe’s marketing approval process.
Requests for extension of patent term will need to be made during the patent term and the Commissioner will not be able to extend the patent term if the patent is subject to any proceedings in which the validity of the patent or any claim therein is in dispute.
Where the request is made for unreasonable delays in grant it is proposed that the patent owner will not be required to provide additional material as the register will contain the relevant information.
However, in the case of extension of term requests under the unreasonable curtailment provision will require the following additional material:
A statement specifying:
- the pharmaceutical substance per se or biologic in respect of which the extension of term is requested; and
- the claims of the patent that include within their scope the pharmaceutical substance per se or biologic.
A statement that the marketing approval to which the certificate from Medsafe relates is the first marketing approval of a product containing the pharmaceutical substance or biologic in respect of which the term extension is requested. The statement could be provided either:
- by the applicant for extension; or
- in the certificate provided under proposed s111D(2)(c).
Regarding when an extension of term request should be made in respect of unreasonable delays in grant, it is considered that there are 3 broad options:
- Option 1: the request for extension may be made any time up to the normal expiry date of the patent.
- Option 2: the request for extension may be made any time up to a period of years prior to the expiry date of the patent.
- Option 3: The request for extension must be made shortly after patent grant.
Option 2 is stated as the preferred option since it both gives the patent owner ample time to decide whether to apply for such an extension of term and also gives third parties advance notice of the maximum term of the patent. It is proposed that no extension of time would be allowed for making any such extension of term application. It is also proposed that the regulations should specify a non-exhaustive list of time periods that are to be disregarded in the calculation of any such extension of term.
For extension of term requests under the unreasonable curtailment provision, which are only available where marketing approval is obtained after grant, it is considered that there are 3 broad options:
- Option 1: the request for extension may be made at any time up to the normal expiry date of the patent;
- Option 2: the request for extension of term must be made at any time up to several years prior to patent expiry.
- Option 3: the request for extension of term must be made at any time up to a short period after grant of the first marketing approval.
Option 3 is stated as the preferred option, largely due to pharmaceutical patents being more likely than non-pharmaceutical patents to run their full term. Consequently, option 3 gives third parties advance notice of the maximum term of the patent without burdening too many patent owners with requesting an extension of term for a patent that may not run its full term. It is proposed that extensions of time for making any such extension of term application would only be allowed in exceptional cases, such as where the patent owner has disputed the content of the certificate that Medsafe proposes to provide. No regulations are proposed for specifying time periods that are to be disregarded for any such extension of term request. Rather, it would be left for Medsafe to develop practice guidelines over time.
It is noted without preference that the regulations for oppositions to extension of term applications could be modelled either on:
- the (more detailed) procedures set out for oppositions under sections 87 and 92 of the Patents Act 2013; or
- the (less detailed) procedures set out for oppositions under sections 120 and 127 of the Patents Act 2013.
Feedback is sought on which of the options is preferred and what the time period should be after publication of the grant of an extension of term within which an opposition must be filed and whether any extension of time should be allowed for such.