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THE FIRST FORMAL CLINICAL TRIALSCONDUCTED ON AN “OLD” ACTIVEINGREDIENT DO NOT GIVE RISE TO THERIGHT TO AN SPC
On 28 July 2011, the Court of Justice of the European Union(CJEU) provided rulings in two cases relating to SupplementaryProtection Certificates (SPCs). The rulings clarify the law and arebinding upon all national patent offices and courts.
The CJEU has effectively closed a loophole in the law relating to SPCs by confirming that SPCs willnot be available for any “product” (active ingredient or combination of active ingredients) that waspresent in a previously authorised medicinal product, even if the prior authorisation was notcompliant with the safety and efficacy standards that were introduced in the 1970s. The rulings alsoaffect the validity of existing SPCs granted in such circumstances.
SPCs provide additional protection, beyond patent expiry, for products (medicinal or plantprotection) that require a marketing authorisation. The purpose of SPCs is to compensate patentholders for at least part of the delay in commercialising a patented active ingredient (orcombination of active ingredients) caused by the need to conduct trials on safety and efficacy (andthereafter to obtain regulatory approval).
The principles underlying the SPC legislation were considered in relation to medicinal productscontaining the “old” active ingredients memantine and galantamine.
Memantine was the active ingredient in a product (Akatinol®) that had been sold in Europe formany years as a treatment for Parkinson’s disease. Similarly, galantamine was the activeingredient of the product Nivalin®, which was first authorised for sale in Austria in 1963, for thetreatment of poliomyelitis.
After the first marketing of Akatinol® and Nivalin®, legislation was introduced in Europe(Directives 65/65/EEC and 75/319/EEC) that set standards for the testing of safety and efficacy ofhuman medicaments prior to their authorisation for sale. Nonetheless, both Akatinol® andNivalin® remained on the market for some time after the introduction of that legislation.
In the late 1980s, a new medical use (the treatment of Alzheimer’s disease) was discovered foreach of memantine and galantamine, and separate patents were filed, by Merz and Synaptech, toprotect the new use of those products. Applications for new marketing authorisations (MAs) werethen filed. The MAs that subsequently issued for Ebixa® and Reminyl® were the first everEuropean authorisations for medicinal products containing, respectively, memantine andgalantamine that were compliant with the safety and efficacy standards set by Directive65/65/EEC.
Merz and Synaptech then filed SPC applications for, respectively, memantine and galantamine,citing the second medical use patents and the MAs for Ebixa® and Reminyl®. The validity of someresulting SPCs were then challenged by the generic manufacturers Synthon BV and Generics (UK)Ltd. Those challenges led the English Patents Court (in the case of Synthon v Merz) and the EnglishCourt of Appeal (in the case of Generics (UK) v Synaptech) to ask the CJEU to clarify whether theSPCs were valid and, if so, whether they were granted with the correct term.
The cases of Synthon v Merz (C-195/09) and Generics (UK) v Synaptech (C-427/09) were handledseparately by the CJEU. However, they were both decided on the same day.
The decision in C-195/09 contains the key reasoning of the CJEU. In essence, the CJEU decided that
Article 2 of the SPC Regulation 1768/92 (now 469/2009) should be interpreted to mean that theSPC legislation only applies to those “products” that:
(i) are protected by a patent; (ii) have been subject to an administrative authorisation procedure; and (iii) have not been placed on the market anywhere in the European Economic Area as a medicinal product prior to the date(s) of the MA(s) specified in the SPC application.
Contravention of Article 2 is not one of the formal grounds of invalidity of an SPC (as defined inArticle 15 of the regulation). Nevertheless, the CJEU found there to be a direct connection betweenArticles 2 and 3 of the regulation, in so far as there exists a common concept of the “product” thatcan be the subject of an SPC. Contravention of Article 3 is a ground of invalidity of an SPC, so theCJEU decided that the SPCs for memantine and galantamine were invalid, as they each related to a“product” that falls outside of the scope of the regulation.
Please contact us for advice if you have questions regarding the validity of an SPC for a “product”that may have been marketed in Europe prior to the date of the marketing authorisation(s)specified in the SPC application. Our SPC experts are ideally placed to answer any such questions.
If you would like more information please contact: John Miles, Mike Snodin, Michael Pears
The information in this Newsletter was correct at the date of release. More up to date information is available bycontacting Potter Clarkson LLP. All comments contained here are of a general nature and full professional advice shouldbe sought on any specific problem. Please note that all our Newsletters can be found on ourwebsite:www.potterclarkson.com.
Potter Clarkson LLP 2011N:15729 July 2011
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