This type of right is available for various regulated, biologically active agents, namely human or veterinary medicaments and plant protection products (e.g. insecticides, and herbicides).
The European Court of Justice has decided, however, that the scope of an SPC is sometimes capable of encompassing more than just the single form of the active ingredient that is included in the medicinal product authorised for sale.
Thus, in case C-392/97,[3] the European Court of Justice held that: "where an active ingredient in the form of a salt is referred to in the marketing authorisation concerned and is protected by a basic patent in force, the certificate is capable of covering the active ingredient as such and also its various derived forms such as salts and esters, as medicinal products, in so far as they are covered by the protection of the basic patent".
Article 63 of the EPC was modified on 17 December 1991 to specify to, although European patents have a term of 20 years as from the date of filing of the application (Art.
The term of an SPC depends on the date of issuance of the first marketing authorization (MA) within the EEA and can be determined by the equation: Under normal circumstances, this means the following.
Although the standard practice of many national patent offices seems to be to calculate SPC term based upon date (1), an October 2011 article in Scrip Regulatory Affairs by Mike Snodin[12] argues that this standard practice is incorrect and that date (2) should be used instead (with the result that some products may be entitled to a slightly longer SPC term than previously thought).
The UK Intellectual Property Office has now accepted Snodin's arguments on this point and has changed its standard practice regarding the calculation of SPC term.
Thus, there are divergent practices across different territories within Europe with regard to the selection of a date for a "centralised" MA, with Belgium and the UK IPO being in the minority.
This was decided by the European Court of Justice (ECJ) in joined cases Novartis et al. v. Comptroller-General and Ministère de l'Economie v. Millennium Pharmaceuticals.
[14][15] The same point was also confirmed in case C-617/12 (AstraZeneca AB v Comptroller General of Patents, Designs and Trade Marks),[16] in a case where the data that persuaded Swissmedic to grant the (earlier) Swiss MA was held by the European Medicines Agency to not be complete or persuasive enough to justify the grant of a MA under EU legislation (Directive 2001/83/EC).
The extension is available only under certain conditions, the most notable being the requirement for the submission of a new MA application containing data from all trials conducted in accordance with an agreed Paediatric Investigation Plan (PIP).
As an unextended SPC only has a positive term if more than 5 years have elapsed between patent filing and MA issuance, this leads to the following two questions.
Model A assumes that SPC term can validly be either zero or negative if 5 years or less have elapsed from filing of the corresponding patent to issuance of the first MA in the EEA.
In this event, a positive (and non-zero) SPC term is obtained (after extension) if the time from patent filing to MA issuance is more than 4.5 years.
This has the consequence of providing a minimum of 6 months of SPC term, irrespective of how little time has elapsed from patent filing to MA issuance.
For example, from mid-August to mid-September 2007, Merck & Co. filed SPC applications in various countries, including the UK,[18] Ireland,[19] the Netherlands[20] and Italy.
The Teva decision (2018) slightly relaxed that requirement, by clarifying that, in respect of a product composed of several active ingredients, Art.