Supplementary Protection Certificates

Posted on 09 January 2018

Supplementary Protection Certificates

Views sought from across industry on SPCs and patent research exemptions

In October 2017, the European Commission launched a wide-ranging consultation on a 'recalibration' of the EU regime for supplementary protection certificates and patent research exemptions. The consultation raised a number of questions, focusing in particular on three issues:

  • The creation of a European SPC title – this is in the context of the Unitary Patent as, at present, there is no scope for a Unitary SPC in the proposed Unitary Patent regime (national SPCs would be granted based on a Unitary Patent).
  • An update of the scope of EU patent research exemptions – the approach to patent research exemptions across the EU is inconsistent (with the potential for further inconsistency under the Unified Patent Court regime).
  • The introduction of an SPC manufacturing waiver – the EU generics/biosimilars industry has long called for an SPC manufacturing waiver to allow it to export products during the EU SPC term of the reference medicine to countries with no SPC protection.

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SPC uncertainty continues with two more references to the CJEU

On 13 January 2017, Arnold J made two references to the European Court of Justice in relation to the Supplementary Protection Certificate Regulation, one concerning SPCs for combination products, the other new formulations of old active ingredients. In both cases, underlying the referral was Arnold J's trenchant criticism of the CJEU's inconsistent and unclear reasoning in key cases interpreting the Regulation. 

The first reference was in Teva & others v Gilead, a challenge to the validity of Gilead's SPC for Truvada, a "Composition containing both Tenofovir disoproxil, optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate, together with Emtricitabine". The patent does not mention or refer to emtricitabine. Instead, claim 27 is for: "A pharmaceutical composition comprising a compound according to any one of claims 1-25 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients".  Arnold J determined that claim 27 did not reflect any further 'inventive advance' (or technical contribution) over that in claims 1-25, i.e., it was not independently valid.

He concluded that the test to determine whether a product is protected by a basic patent remains unclear and a further reference was necessary, expressing hope that the CJEU will provide further and better guidance than it has done to date. The question referred is identical to one he made in 2012 in Actavis v Sanofi.

"What are the criteria for deciding whether 'the product is protected by a basic patent in force' in Article 3(a) of the SPC Regulation?"
Question referred to CJEU in Teva v Gilead

On the same day, Arnold J made a reference in Abraxis v Comptroller concerning whether an SPC can be granted where a product is a new formulation of an active ingredient (as opposed to a new therapeutic use of an active ingredient). Does this comply with Article 3(d), which requires the authorisation relied upon to be the first to place the product on the market as a medicinal product? In Neurim, the CJEU had endorsed SPC protection for new applications for existing 'old' active ingredients. Applying a teleological approach to the Regulation and focusing on its objectives, the CJEU decided that the existence of an earlier MA for a medicinal product would not preclude the grant of an SPC for a different application of the same product. Arnold J has criticised Neurim in previous cases and he returned to this line of attack here.

"Is Article 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the marketing authorisation referred to in Article 3(b) is the first authorisation within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an active ingredient?"
Question referred to CJEU in Abraxis v Comptroller

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No reference to the CJEU for triple combination Atripla SPC

In a subsequent decision, Arnold J decided, in the light of the relevant claim in the basic patent, that the SPC for the triple combination product Atripla (marketed by Gilead and Bristol-Myers Squibb) is invalid. Atripla is an anti-viral medication used in the treatment of HIV, consisting of three active ingredients: (1) efavirenz, (2) tenofovir in the form of the disoproxil fumarate and (3) emtricitabine.

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SPCs and Markush claims

Arnold J was also called upon to interpret Article 3(a) of the SPC Regulation in Sandoz v G.D. Searle. The SPC relates to darunavir (sold under the mark Prezista) and concerns a Markush claim, i.e., where a class of compounds is represented by means of a structural formula, thereby allowing large classes of compounds to be defined without being listed out.

Arnold J decided that the product was specified or identified in the claims of the patent, and rejected the Claimants' request for a reference to the CJEU. The case was heard by the Court of Appeal in December 2017.  

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End of procedure notice not sufficient for SPC

Following a referral made by Arnold J in MSD v Comptroller, the CJEU decided in December 2017 that it was legitimate to reject an SPC application for failure to meet the requirements of Article 3(b) of the SPC regulation which requires that there be a valid authorisation to place the product (Atozet) on the market as a medicinal product. MSD sought to rely upon the grant by the German Medicinal Products Agency of an end of procedure notice, given that the effect of the notice was that all Member States concerned, including the UK, had agreed to grant marketing authorisations for Atozet. However, the CJEU agreed with the UKIPO Comptroller: whilst the end of procedure notice fulfilled some of the functions of a marketing authorisation, the grant of a marketing authorisation was more than a mere administrative formality and the end of procedure notice was an intermediate stage.

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