Patent Docs International IPWhat are SPCs A Supplementary Protection Certificate SPC is an intellectual property right available for active ingredients of human and veterinary medicinal products requiring marketing authorisation. The highest tribunal hearing disputes involving SPCs for EU member states is the Court of Justice of the European Union CJEU. Historically there have been numerous referrals to the CJEU on points of law relating to SPCs and this is expected to continue. Some of the key decisions are discussed below. The SPC regime was introduced as a mechanism to compensate patent holders for loss in effective patent term resulting from the time taken to receive marketing authorisation for such products. However, regulatory delay is not of itself sufficient to justify the grant of SPCs. In particular, the relevant regulation provides that an SPC can be granted only for an active ingredient. This has been held to exclude substances that may enable or enhance the activity of a therapeutic ingredient, but which have no therapeutic effect of their own on the human or animal body. Despite the clinical testing and consequent regulatory delay involved in developing such auxiliary substances, the CJEU has on two occasions. SPC.   Similarly, it is not currently possible to obtain SPC protection for a medical device, irrespective of whether or not the marketing of such a device has been subject to regulatory delay. PIPLA Annual Judges Dinner November 15, 2017 WIPO seminar on international IP protection to be held November 12 October 2014 meeting recap. Where are SPCs available SPCs are national rights at present there is no such thing as a Europe wide SPC. Accordingly, individual applications must be made to national patent offices in countries where SPC protection is desired. SPC protection is available in all EU member states, namely Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden and the United Kingdom. SPCs in these countries are governed by EC Regulation 4. SPC Regulation excerpts of which are included as Annex 1. SPC protection is also available in the following non EU States Norway and Iceland these States are members of the European Economic Area EEA, but not of the EU, and the governing legislation is the EU SPC Regulation. Switzerland Swiss SPCs are governed by legal provisions which are based on the EU SPC Regulation. An SPC issued in Switzerland will also automatically take effect in Liechtenstein. Albania, Bosnia Herzegovina, Macedonia, and Serbia These are non EUEEA countries which may nonetheless be covered by a European patent application granted by the EPO. SPC protection is available in these countries under national legal provisions. Patent Pilot Program Judges 6' title='Patent Pilot Program Judges 6' />Similar provisions also exist in neighbouring jurisdictions including Russia and the Ukraine, and in other countries worldwide. Those interested in rights in these jurisdictions can contact J A Kemp for more information. What scope of protection is provided by the SPC The scope of an SPC is limited to the product of the relevant marketing authorisation. It protects that product to the same extent as the patent on which the SPC is based the basic patent. For example, if the basic patent covers the product per se, the SPC will also cover the product per se. If the basic patent only covers a method of manufacturing or using the product, then the SPC will be similarly restricted. The product of the marketing authorisation has long been established to encompass therapeutically equivalent salts and esters of small molecule drugs. D00_16-McKeown_2D00_Expedited_5F00_Patent_5F00_Appeal_5F00_Pilot_5F00_ending_5F00_20150909.jpg' alt='Patent Pilot Program Judges 6' title='Patent Pilot Program Judges 6' />The situation is less clear for active ingredients which are biological molecules. A decision of the Norwegian Court of Appeal. EFTA court. 8 recognised that it would be desirable for therapeutically equivalent variants of a biologic product to be covered by an SPC, but provided little guidance as to the extent of such coverage. It is to be expected that this question will be referred to the CJEU. Subject to the scope of the basic patent, an SPC for a given active ingredient will cover any use of that active ingredient in a drug which is authorised before the SPC expires. Subsequent marketing authorisations made after grant of an SPC will therefore extend the scope of the SPC, even when the later marketing authorisation is obtained by an entity unconnected with the owner of the SPC. Also, subject to the scope of the basic patent, an SPC will cover all subsequently authorised combinations of active ingredients containing the product at issue. Home Federal Circuit Decisions Federal Circuit Finds NuvaRing Patent Nonobvious Without Hindsight. Federal Circuit Finds NuvaRing Patent Nonobvious Without Hindsight. Adobe After Effects 7 Incl Keygen. The DHS Acronyms, Abbreviations, and Terms DAAT list contains homeland security related acronyms, abbreviations, and terms that can be found in DHS documents. Patent Pilot Program Judges 6' title='Patent Pilot Program Judges 6' />What additional term is provided by the SPC An SPC takes effect at the end of the normal expiry term of the basic patent on which it is based, provided that the patent is maintained up to that point. For EUEEA member states, the SPC will expire at whichever is the earlier of 1. Marketing Authorisation in the EUEEA1. The effective maximum term is therefore 5 years in addition to the term of the basic patent. For non EUEEA member states, the term is determined by reference to the local marketing authorisation. For example, the term of a Swiss SPC is determined by reference to the date of the Swiss marketing authorisation. Since this can issue later than the EUEEA authorisation, the Swiss SPC for a medicinal product may have a longer term than the corresponding SPCs in the EUEEA countries. It is possible to extend the term of an SPC by a further 6 months by providing clinical results obtained from an agreed paediatric investigation plan. The request for extension may be filed at any time up to 2 years before normal SPC expiry. Further information is provided in J A Kemps briefing note on the Paediatric Products Regulation, which is available upon request. Who should apply for the SPC The Applicant for the SPC must own the basic patent, but need not hold the relevant marketing authorisation. Thus, it is possible to secure an SPC based on a marketing authorisation held by a third party. When should the SPC application be filed An application for an SPC must be filed with the national Patent Office of the country concerned within the later of 6 months from the date on which the first authorisation to place the product on the market is granted in that country or 6 months from the date of grant of the basic patent. Crack Football Manager 2010 Reloaded Crack more. If the basic patent expires before marketing authorisation is achieved, it may not be possible to secure an SPC. Under such circumstances, it may be worthwhile filing an application for an SPC before expiry of the patent and following up with the marketing authorisation when it is available. However, the chances of persuading Patent Offices to grant an SPC under such circumstances would at best be uncertain. What are the substantive requirements for obtaining SPCs The requirements for grant of an SPC are set out in Article 3 of the SPC Regulation. Article 3a requires that the product be protected by a basic patent. Articles 3b and 3d require that the SPC be based on the first valid authorisation to place the product on the market as a medicinal product. Article 3c requires that the product has not already been the subject of an SPC. Although these requirements may appear relatively simple, each has been subject to multiple referrals to the CJEU. More detailed discussion is provided below.