A Supplementary Protection Certificate (SPC) extends the term of a patent for a medicinal or plant protection product by a period of not more than five years. The aim of SPCs is to compensate the patent owner for ‘lost’ patent protection which was caused by the time it took to obtain marketing authorisation for the product in question. An SPC is a national right, available in member states of the European Union (EU) by application to the national patent office of the state for which a certificate is desired. The SPC is based on a patent and is granted in respect of an active ingredient in a medicinal or plant protection product.
Adding to the long series of referrals concerning the interpretation of Art. 3(a) Reg. (EC) No. 469/2009 (“SPC Regulation”) (“the product is protected by a basic patent in force”) the UK Court of Appeal (Sandoz/Searle, Case No. A3 2017 1483) on 25 January 2018 referred further questions to the CJEU. This latest referral from the…
In our last blog (Will the Spanish Patent Office accept the modification of an SPC’s term after the Incyte judgment?), published on 8 January 2018, we raised the question as to whether the Spanish Patent and Trademark Office (“SPTO”) would accept the modification of the term of a supplementary protection certificate (“SPC”) after the judgment…
Co-author: Zsolt Lengyel, Danubia Patent and Law Office Just before Christmas, on 20 December 2017, the Court of Justice of the European Union (CJEU) announced its judgment in C-492/16, Incyte, in a preliminary ruling proceeding initiated by the Budapest High Court. The decision can be considered a sequel to the CJEU’s earlier judgment C-471/15, Seattle…
Readers will recall that, in its judgment of 6 October 2015 (Case C-471/14, Seattle Genetics), the CJEU concluded that the relevant date for calculating the term of a supplementary protection certificate (“SPC”) is not the date on which a marketing authorisation (“MA”) is granted, but the date when the addressee is notified of the decision…
I hope that all the readers of the Kluwer Patent Blog enjoyed a good start into a joyful, healthy and successful 2018. At the beginning of the new year it seems to be the right point in time to look back at the past year and recall the most remarkable developments and cases in Swiss…
When a company is not prepared to charge a socially acceptable price in the Netherlands for a medicine, the government should use other instruments such as compulsory licences, encouraging pharmacy preparation and allowing patients to order medicinal products abroad in order to ensure that the medicine is available for patients. The Dutch Council for Public…
Just as the case has been in other European jurisdictions, Gilead is currently attempting to enforce its (Danish) SPC for the combination of tenofovir disoproxil (as fumarate) and emtricitabine in Denmark. In the first decision regarding Gilead’s enforcement of this SPC in Denmark, the Danish specialty patents court, the Maritime and Commercial High Court, turned…
A positive view is spreading on post-filing experimental data in China since the recent official post of the proposed revisions to the Guidelines for Patent Examination (the “Guidelines”) by the State IP Office (the “SIPO”) of China. People tend to think that the window is about to open to post-filing experimental data, just like it…
by Steven Willis In a judgment handed down at the end of last week, Arnold J has indicated his intention to make a reference to the CJEU concerning the interpretation of Article 3(d) of the SPC Regulation i.e. the requirement for the marketing authorisation (“MA”) on which an SPC application is based to be the…
To ensure the continued development of medicinal products which are the result of enormous R&D costs the supplementary protection certificate (‘SPC’) was introduced into EU law in 1993 with the entry into force of the SPC Regulation (Council Regulation (EEC) No 1768/92). After the Ukraine’s declaration of independence, hard work on adopting new legislation began…
