A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Friday, 14 June 2019

Update on the SPC export and stockpiling waiver


Following its approval by the European Parliament in April, the final legislation amending SPC Regulation EC/469/2009 – Regulation (EU) 2019/933 of 20 May 2019 – was published in the Official Journal of the EU on 11 June 2019, and will now enter into force on 01 July 2019

Thank you to Andrew Hutchinson and Nicholas Fischer of Simmons & Simmons for passing this on and providing some commentary on the new legislation, which is available here.

Wednesday, 12 June 2019

New SPC reference to the CJEU on Article 3(c) – Novartis (C-354/19)

Carpmaels & Ransford and Awa have kindly prepared the following summary on a recent SPC reference to the CJEU:

"The Swedish Patent and Market Appeal Court has made a reference to the CJEU relating to the interpretation of Article 3(c) of the SPC Regulation for Medicinal Products, in light of Article 3(2) of the SPC Regulation for Plant Protection Products. In brief, the court is asking whether, in a case such as the present, an SPC to a new therapeutic indication is available where the applicant has an earlier SPC to the same active ingredient.

Article 3(c) of the Medicinal Products Regulation states that one of the requirements for SPC grant is that “the product has not already been the subject of a certificate” in the same member state and at the date of the SPC application. Article 3(2) of the Plant Protection Regulation provides that “[t]he holder of more than one patent for the same product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for this product may be issued to each of these holders”, while Recital 17 of the Plant Protection Regulation suggests that Article 3(2) is also valid for the interpretation of Article 3 of the Medicinal Products Regulation.

The Swedish SPC application underlying this reference is based on Novartis’s marketing authorisation for the medicinal product Ilaris®, which contains the anti-IL1beta antibody canakinumab. The marketing authorisation supporting the SPC application is a decision from 2013 which for the first time authorises canakinumab for the treatment of systemic juvenile idiopathic arthritis (SJIA), which is a serious condition responsible for high childhood mortality and severe morbidity. The corresponding basic patent is limited to the use of antibodies such as canakinumab in the treatment of juvenile rheumatoid arthritis.

Novartis has an earlier granted SPC based on a separate patent which protects the canakinumab antibody per se. The SPC is supported by a marketing authorisation for canakinumab in the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), which is a different indication from SJIA and which falls outside of the scope of the patent that supports the later SPC application.

In view of the existence of the earlier SPC, the Swedish court is asking whether Article 3(c) in light of Article 3(2) precludes the grant of the later SPC application, which relates to a new therapeutic indication protected specifically by its own basic patent. The Swedish court has therefore referred the following question to the CJEU (our translation):
Against the background of the basic objective that supplementary protection for medicinal products aims to accommodate and which consists of stimulating pharmaceutical research in the Union, does Article 3(c) of the Regulation concerning Supplementary Protection Certificates for medicinal products, considering Article 3(2) of the Regulation concerning the creation of a Supplementary Protection Certificate for plant protection products, constitute an obstacle against an applicant, that has previously been granted a Supplementary Protection Certificate concerning a product which is protected by a basic patent in force for the product as such, being granted a Supplementary Protection Certificate concerning a new use of the product in a case such as the present where the new use constitutes a new therapeutic indication which is protected specifically by a new basic patent?
Carpmaels & Ransford represents Novartis AG in respect of its Ilaris® product. AWA represented Novartis AG before the Swedish patent office and courts in relation to the Swedish SPC application."

Tuesday, 11 June 2019

Free SPC Seminar in London tomorrow!

Daniel Wise of Carpmaels & Ransford has written in to the Blog to say that there are a few last places available for Carpmaels’ annual “SPC Summer Review” event taking place tomorrow, Wednesday, 12th June 2019, from 17:30 (for a 18:00 start) at their offices in central London (One Southampton Row, WC1B 5HA).  The seminar will focus on this year’s CJEU referrals and national court decisions, including the ongoing debates on the meaning of Article 3(a) and the validity of SPCs filed on competitors’ products.  Dr Oliver Werner from the German Patent Office will also be on the panel to discuss the new SPC manufacturing waiver.  Drinks and canap├ęs will be served afterwards.  If you would like to join, please send an email to kirstie.mcclumpha@carpmaels.com, with the subject line “I would like to attend the SPC Summer Review 2019”.  Attendance is free of charge.