The IPI is changing its practice for granting SPCs retroactively from 11 June 2018. This is based on the Federal Supreme Court “Tenofovir” decision 4 A_576/2017 of the same date.
In this judgment, the Federal Supreme Court (FSC) decided that the product to be protected must in future be detailed in the patent claims in a form recognisable for a person skilled in the art. This new practice is based on the European Court of Justice’s (ECJ) more recent practice. The ECJ takes into account whether the product in the SPC application is stipulated in the claims of the basic patent (“Medeva”, C-322/10) or whether the patent claims implicitly yet necessarily and specifically relate to the active ingredient or active ingredient combination (“Eli Lilly”, C-493/12). With “Tenefovir”, the Federal Supreme Court departed from the old “Fosinopril” practice (BGE 124 III 375), which examined whether the product fell under the scope of protection of the basic patent (known as the infringement test).
Since 2014, the IPI has been working with the patent attorney associations (VESPA, VSP and VIPS), AIPPI Switzerland, the industry associations in question (Interpharma, scienceindustries, vips and Intergenerika) and an external expert on an adaptation of the practice on the basis of the new European case law. At the beginning of 2017, the research and generic pharmaceutical industry urged for quick implementation of the drafted adaptation (in German). However, because an SPC had in the meantime been challenged in court proceedings which then led to the FSC “Tenofovir” decision, the old practice was retained for the time being.
The new practice applies retroactively from the date of the Federal Supreme Court decision, i.e. from 11 June 2018. It applies for all applications which were pending at this time, which has been separately communicated to the stakeholders involved. The change of practice is implemented in Chapter 13.2.1 of the Guidelines for the Substantive Examination of National Patent Applications (in German). It corresponds – without change – to the jointly developed examination principles, which were communicated to all parties on 22 March 2017. To gain a better understanding of the new practice, the IPI and the involved stakeholders have developed hypothetical examples (in German).
Entry into force: 11 June 2018
Published: 10 October 2018
If paediatric studies have been carried out for a medicinal product, since 1 January 2019, you can apply for a 'paediatric extension' of a supplementary protection certificate (SPC) or, if no SPC exists, what is known as a paediatric SPC.
- Can a paediatric extension of an SPC or a paediatric SPC be requested if the paediatric studies have been deferred at the request of Swissmedic?
No. This is because as long as paediatric studies - or part of them - are deferred, Swissmedic cannot issue a confirmation that the information on the medicinal product reflects the results of all studies conducted in accordance with the paediatric investigation plan (PIP) (Art. 140n para. 1 let. a, Art. 140t para. 1 let. a PatA). This confirmation is necessary for the grant of extensions of SPCs or paediatric SPCs.
- Can holders of an SPC with a negative term of protection replace it with a paediatric SPC?
With the introduction of the paediatric SPC, the IPI has discontinued the practice of granting SPCs with a negative term of protection. This is because a paediatric SPC allows pharmaceutical manufacturers to extend the protection of an authorised product by a full six months if paediatric studies have been conducted.
As the holder of an SPC with a negative term of protection, you can withdraw it and then submit an application for a paediatric SPC. For this purpose, all requirements for a paediatric SPC must be met, and in particular, you must submit the application on time.
- Which marketing authorisations for medicinal products does the IPI recognise for the granting of paediatric extensions?
The following authorisations granted by Swissmedic are considered as marketing authorisations for medicinal products, both for applications for an SPC and for paediatric extensions of SPCs and paediatric SPCs:
a. Ordinary authorisation under Article 11 of the Therapeutic Products Act (TPA)
b. Simplified authorisation under Article 14 TPA
c. Temporary authorisation under Article 9a TPA
For the conventional SPC, these authorisations are considered as the ‘first authorisation’ on the basis of which the SPC is granted. It determines, for example, the deadline for filing the application and the term of protection.
A temporary authorisation to place a medicinal product on the market for a limited time in accordance with Article 9b TPA is not considered an authorisation.
Entry into force: 1 January 2019
Published: 17 April 2019
The IPI begins the examination of SPC applications at the earliest one year after the grant of the patent. If the maximum term of protection of the basic patent is due to expire soon, the examination will take place earlier. SPC applications are generally examined in the order in which they are received.
The IPI automatically suspends SPC applications if opposition or appeal proceedings are pending at the European Patent Office (EPO) in respect of the associated basic patent. SPC applications for which the maximum term of protection of the basic patent is about expire will not be suspended. SPC applications with the same product, which are based on a basic patent other than the one challenged at the EPO, will not be suspended due to the constitutional acceleration requirement (see Federal Administrative Court Decision of 20 October 2010, B-1019/2010).
The suspension practice applies for all applications pending with the IPI as well as all future applications.
Entry into force: 1 July 2019
Published: 11 July 2019
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