Patents supplementary certificate

The laws concerning the French and Italian Certificate of omplementary Protection were abrogated in January 1993. ince this date the Community Supplementary Protection ertificate has been in force. According to the Community ertificate, it is possible to obtain a maximum extension of 5 ars to holders of pharmaceutical patents. This certificate mcems all the EEC and EPC contracting states. 

Patent protection under general law usually lasts for up to around 20 years. This creates a difficulty in relation to medicinal products, as it can take some 12 years for the products to undergo research, development, the extensive clinical trials that are required in order to obtain a marketing authorisation and the authorisation process itself. These steps are also extremely expensive. The amount of time that remains during which the patent holder can exploit his patent and recoup his massive investment can be severely curtailed in relation to medicinal products. For this reason, the European Community has provided a form of additional patent-related protection for medicinal products authorised within the European Community, by means of a Supplementary Protection Certificate. A patent holder may apply for a certificate that takes effect at the end of the term of the basic patent, for a period equal to the period that elapsed between the date on which the application for the basic patent was lodged and the date of the first authorisation to place a product derived from the patent on the market in the Community, reduced by a period of 5 years. The maximum duration of the certificate is 5 years. The certificate applies to all medicinal products derived from the basic patent, but the additional time that can be obtained under the SPC is calculated in relation to the first product derived from the patent, authorised in the EU. 

SPC (Supplementary Protection of Certification) Allows for a patent extension of approximately 5 years or longer... 

Another regulatory provision aimed at eliminating a competitive disadvantage of European API producers refers to the European Supplementary Protection Certificate (EPC). Adopted in 1992, it prevented de facto Europe-based API producers from being qualified as bulk sources before the effective marketing exclusivity date in their home country. By extension of the Bolar Roche Provision in the Waxman-Hatch Patent Restoration Act to Europe, the situation will be remediated. 

Effective on January 1, 1993, Supplementary Protection Certificates (SPC), a system of providing extended protection for pharmaceutical products, was created by the European Community (EC). Such certificates do not actually extend the patent per se but confers protection for the product covered by the granted... 

Patent and intellectual property aspects—Patent protection in Switzerland lasts for 20 years, with the possibility of a 5-year extension with a supplementary protection certificate (SPC). Also of interest is that the initial applicant has 10-year exclusivity protection for new active substances, new routes of administration and/or new dosage forms. 

Supplementary patent certificate Patent protection under general law usually lasts for around 20 years. 

The point in the development program at which a patent application is filed will vary somewhat from company to company, but will normally he at an early stage in the process, when the substance has been made and been shown to be active in early screening. For a patent with a nominal term of 20 years from filing, the effective term during which the patentee has exclusive rights to a marketed product is only 8 to 12 years. This explains the importance attached by the pharmaceutical industry to provisions to extend the patent term, whether directly, as in United States and Japan, or indirectly by way of the supplementary protection certificate (SPC) in Europe, in order to compensate for this loss of effective patent term. It also explains the importance to the industry of the minimum 20-year term guaranteed by the... 

Marketing exclusivity in Europe is linked to patent protection. Extensions are possible through grants of supplementary protection certificates (SPCs), which are comparable to U.S. patent term restorations and have the same maximum length of five years beyond the original expiration date. However, there are several important differences in the European SPC system. SPC extensions apply to any and all approved forms of a product (e.g., salts and metabolites) protected by... 

Adams SR. Information Sources on Postgrant Actions to Pharmaceutical Patents. World Patent Inf. 2001 42 467-472. Where to find information about patent term adjustments, supplementary protection certificates, and other modifications to U.S., Emopean, and other pharmaceutical patents. 

The key document from which all other text is derived, is the summary of product characteristics (SPC), sometimes referred to as the summary of major product characteristics (SmPC) to differentiate it, as abbreviated, from the supplementary protection certificate which is concerned with patent protection. 

Another source is the electronic Medicines Compendium (eMC http //emc.vhn.net/), with electronic versions of data sheets and Summaries of Product Characteristics (SPCs, sometimes also called SmPCs to differentiate them from Supplementary Patent Certificates) for medicines. It provides the same information as that contained in the latest edition of the Compendium of Data Sheets and Summaries of Product Characteristics, which covers 2500 medicines licensed in the UK. As an ongoing process, the eMC is also... 

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