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	Supplementary protection certificate - Wikipedia, the free encyclopedia
		Supplementary protection certificates were introduced to compensate for the long time needed to obtain regulatory approval of these products (i.e.
		Supplementary protection certificates in the European Union are based on two regulations:
		Supplementary protection certificates may come into life at the expiry of a national or European patent.
	en.wikipedia.org /wiki/Supplementary_protection_certificate (736 words)

	Patents (Supplementary Protection Certificates), Act, 1996, No. 11 (Site not responding. Last check: 2007-10-31)
		Protection certificates which supplement patents valid in Austria shall be granted by the Austrian Patent Office subject to the regulations of the European Community governing the creation of supplementary protection certificates.
		(2) The decision to nullify a protection certificate because of expiry of the basic patent prior to the end of the maximum statutory period or because the basic patent has been fully nullified shall be taken by the nullification department upon application or ex officio by a legally qualified member without instituting a hearing.
		References concerning supplementary protection certificates made under the provisions of Council regulations of the European Community concerning the creation of supplementary protection certificates or under Section 7 in combination with the provisions of the 1970 Patents Act, Federal Gazette no. 259, as set forth in Section 7, shall be published in the Patent Gazette.
	www.wipo.int /clea/docs_new/en/at/at050en.html (678 words)

	Publications (Site not responding. Last check: 2007-10-31)
		In this case, the ECJ considered an appeal from the German appeal courts regarding an application for a Supplementary Protection Certificate (SPC) by Pharmacia Italia SPA (formerly Pharmacia and Upjohn SPA) (Case C-371/02 AGO (Jacobs), dated 29 April).
		1768/92, which provides for supplementary protection of patents for a term not exceeding 5 years from the expiry of the patent in question.
		An SPC only extends the protection of a patent to the extent that the patent protects the particular product or active ingredient that is the subject of a marketing authorisation in human or veterinary treatments.
	www.mwe.com /info/news/euroip0504-patent.htm (631 words)

	Supplementary protection certificate
		The supplementary Protection Certificate extends the life-span of a patent for compulsory approval pharmaceuticals or pesticides for up to 5 years, but the scope of protection of the Protection Certificate is usually more limited than that of a patent.
		The application for the Certificate must be made either six months after the granting of an approval for marketing (market approval) in Austria or six months after the granting of the patent (if the granting of the patent does not take place until after the market approval).
		The granting of the supplementary Protection Certificate is done without examining whether a supplementary Protection Certificate has already been granted for the product and whether the presented approval is actually the first approval for the marketing of the product in Austria.
	www.patentamt.at /Home/Erfindungsschutz/Schutzzertifikat/11676_1.html (653 words)

	Gazette Highlights News 2001 - Thomson Scientific
		Nisoldipine, Bayer's Sular, finally lost protection in the UK at the beginning of November, on the expiry of a five-year supplementary protection certificate,...
		The flood of SPC activity continues, with Pliva's azithromycin entering its period of extended protection, and the grant of Certificates to RPR (now Aventis) for quinupristin and to Pharmacia for...
		Ortho's COX2 inhibitor tepoxalin is the subject of an application for a supplementary protection certificate (SPC), based on the November 1993 grant of EP248594B and the drug's...
	www.scientific.thomson.com /gazettenews/2001 (6264 words)

	Statutory Instrument 1997 No. 64
		A certificate shall be in the form set out in Part 1 or Part 2 of Schedule 3 to these Rules.
		and the holder of the certificate shall, within the period specified under paragraph (c), notify the Patent Office on Form SP2 of the effective period of the certificate, which notification shall be accompanied by the appropriate fees payable in respect of that period.
		(b) the comptroller shall write to the applicant for the certificate in the terms prescribed by paragraph (6), subject to subparagraph (a) of this paragraph, on the date on which he notifies him of the grant thereof.
	www.opsi.gov.uk /si/si1997/19970064.htm (2227 words)

	The UK Patent Office - Patents - SP1, application for grant of SPC (Site not responding. Last check: 2007-10-31)
		Supplementary Protection Certificates are available in Member States of the EU under EC Regulations 1768/92 and 1610/96 for medicinal and plant protection products respectively.
		A certificate extends the protection conferred by the patent beyond its 20-year term for a period of up to five years, but only in respect of a product which has received an authorization to market it in the particular Member State.
		A free booklet entitled "Supplementary Protection Certificates for Medicinal Products and Plant Protection Products: A Guide for Applicants" (PDF 121KB) is available from this web site, or by writing to Miss M Screen, The Patent Office, Room 2.R88, Cardiff Road, Newport, South Wales, NP10 8QQ, or telephone +44 (0)1633 814617.
	www.patent.gov.uk /patent/indetail/sp1.htm (349 words)

	Supplementary Protection Certificates at the EPO
		On February 8,1997 a new Regulation[1] came into effect providing for supplementary protection certificates for plant protection products such as insecticides, fungicides and herbicides that are also subject to regulatory approval before they can be marketed.
		The extension of protection effected by the supplementary certificate is restricted to products that have been granted marketing approval and do not provide for extension of protection for any other subject matter that might fall within the scope of the patent claims.
		Furthermore a supplementary protection certificate can be granted only in respect of the "basic" patent covering the product in question.
	ladas.com /Patents/Biotechnology/EPOBiotechInventions/SuppProtCert.html (222 words)

	PRV - PRV InterPat - Pharmaceutical/supplementary protection
		The term may, however, be extended for pharmaceutical patents by a maximum of five years; the extension of the term of protection is called an SPC (Supplementary Protection Certificate).
		The term of protection is calculated based on the date of the first approval for sale of the medicinal product within the EEA and the filing date of the patent application.
		Supplementary Protection Certificates may also be obtained for plant protection products in the same way as for medicinal products.
	www.prv.se /english/interpat/pharmaceutical_patents.html (304 words)

	Supplementary Protection Certificates unavailable for new formulations of known drugs - Withers and Rogers (Site not responding. Last check: 2007-10-31)
		In this decision, it was decided that a novel formulation, comprising the combination of a known active ingredient with an inactive excipient, was not entitled to SPC protection.
		In the European Union, a SPC extends the period of protection of a patent relating to a new drug by up to five years.
		This ruling means that products comprising the combination of a known active ingredient with an excipient to form a novel formulation are not entitled to SPC protection, however different the novel formulation may be in terms of characteristics in use.
	www.withersrogers.co.uk /content/view/82/45 (644 words)

	Barzanò & Zanardo - Supplementary Protection Certificates (Site not responding. Last check: 2007-10-31)
		A supplementary protection certificate is, in general, a title extending the duration of patents in specific fields beyond their original 20 years term.
		Obviously, each SPC application for medical products filed after January 2, 2003 is considered with the Italian patent and trademark office according to the community regulation.
		In both cases, a SPC application may be filed in connection with a basic patent covering the concerned product (or a process for its production, or a use of the same, etc.) within six months from the grant of the first marketing approval in the Community.
	www.barzano-zanardo.com /inglese/f-i-supplementary.html (296 words)

	EU - Supplementary Protection Certificates for Pharmaceuticals
		In the European Union (EU), extension of a period of protection given by a patent to compensate for delays in placing a pharmaceutical (and now also a plant protection product) on the market because of the need to obtain governmental marketing approval is effected by a Supplementary Protection Certificate.
		The application for a supplementary protection certificate must be made within six months of the date on which marketing approval for the product in question is granted anywhere within the EU.
		Furthermore the relevant directive implies that a supplementary protection certificate can be granted only in respect of the "basic" patent covering the product in question.
	www.ladas.com /BULLETINS/1997/0797Bulletin/EU_SupProtCertforPharm.html (303 words)

	Droit et Nouvelles Technologies: Actualités (Site not responding. Last check: 2007-10-31)
		In Belgium, an SPC is be granted according to the Act of 29 July 1994 concerning the medicines protection certificate.
		This Regulation indeed introduces a SPC in completion to a previously granted national or European patent and at the request of the holder of this patent.
		For these reasons, the A.G. does not see why a medicinal combination, (i) protected by a patent and (ii) for which a marketing authorization has been granted, would be excluded from enjoying supplementary protection under Regulation No 1768/92, if that combination is also among the therapeutic innovations covered by this Regulation.
	www.droit-technologie.org /1_2.asp?actu_id=1143 (1635 words)

	PATPRESS.COM: Term Of Patent - Supplementary Protection Certificate
		This type of right is available for medicinal products, such as drugs, and plant protection products, such as insecticides, pesticides and herbicides.
		It is a patent application with a specification and drawing of an invention, but does...
		The Community Patent, also known as the European Community Patent or EC patent, is a patent law measure being debated within the European Union, which would allow individuals and companies to obtain a unitary patent...
	www.patpress.com /term/spc.html (746 words)

	Sample Contracts - License Agreement - BTG International Ltd. and TolerRx Inc. - Competitive Intelligence for Investors
		Both parties shall abide by the auditor's certificate and shall rectify any overpayment or underpayment (as the case may be).
		No provision of this clause 7 shall reduce the amount of the payment required to be made by the Licensee to BTG under clause 2.1.3.
		SUPPLEMENTARY PROTECTION CERTIFICATES 14.1 IN the event that BTG wishes to make any application for a Supplementary Protection Certificate or Certificates in respect of Products the Licensee shall promptly take all necessary steps to facilitate such application.
	contracts.onecle.com /tolerrx/btg.lic.2001.09.28.shtml (3448 words)

	Supplementary Protection Certificates
		The polifeprosan was necessary to enable the active ingredient to be administered in an effective way, however, polifeprosan did not itself have a therapeutic effect.
		MIT sought an SPC under EU Reg 1768/92 on the basis that its patent was for a 'combination of active ingredients of a medicinal product": reg.
		As polifeprosan did not have a therapeutic effect, it was not an active ingredient for the purposes of the EU regulation and so no SPC was available.
	homepage.mac.com /wrothnie/iblog/C149316833/E20060510172147 (246 words)

	Publications
		The application for an SPC for the combination product was rejected on the ground that polifeprosan could not be considered an “active ingredient” within the meaning of Article 1(b) and Article 3 of the said Regulation.
		Moreover, in his opinion, within the objectives of Regulation 1768/92/EEC, it is advisable to encourage the research and the development of existing ingredients by developing auxiliary substances enabling their use or their properties for a therapeutic indication and by trying to seek new ways to ensure greater safety of use by reducing undesirable effects.
		The case at issue, in his view, concerns a combination that is the result of costly and long research and therefore deserves the protection conferred by the Regulation at stake.
	www.mwe.com /info/news/euroip0106-patent.htm (1360 words)

	Supplementary protection certificate (Site not responding. Last check: 2007-10-31)
		Supplementary protection certificate can be granted after the expiry of a patent for the invention, provided that the subject-matter of the patent is a product, a process to obtain the product or an application of the product, for which an official authorisation is needed prior to commercial exploitation.
		For the purpose of implementing those Regulations, the Government of the Republic of Slovenia issued a Decree implementing Council Regulations concerning the creation of a supplementary protection certificate for medicinal products and for plant protection products.
		However, the duration of the certificate may not exceed five years from the date on which it takes effect.
	www.uil-sipo.si /SPC_en.htm (137 words)

	SPCs worth millions to Pharma Companies in Europe
		According to IMS Health's Patents International LifeCycle service, which monitors SPC filings and approvals, Lilly has SPCs in nine EU countries, affording marketing exclusivity of five years in each market.
		Sales of Prozac in the SPC period represent 60% of total 10-year sales, and the CCP has a further two years to run, with sales in France only now beginning to plateau.
		In contrast, the patent for fluoxetine expired in Germany in March 1993, and sales of Prozac began to decline from 1995 in the absence of SPC protection.
	www.ims-global.com /insight/news_story/news_story_000417a.htm (291 words)

	Professional online searches for German Supplementary Protection Certificates (SPCs)
		In certain cases, patent protection for drugs or plant protection products can be prolonged by up to five years.
		The new file, PATDPASPC (German Supplementary Protection Certificates for Drugs and Plant Protection Agents), is made available worldwide through STN International, the premier online service for sci-tech information.
		New SPCs will be searchable in the database shortly after they have been filed with the German Patent and Trademark Office.
	www.pressbox.co.uk /Detailed/27282.html (590 words)

	Why were Supplementary Protection Certificates introduced?
		Parallel Importing was increasing in Germany, the Netherlands and the UK (started in Denmark in the early 1990s) and actively encouraged as a way of controlling government drug bill costs in some countries.
		SPCs worth millions to Pharma Companies in Europe
		Are SPC filings on the decline - now R&D development times are shortening?
	www.ims-global.com /insight/news_story/news_story_000417c.htm (262 words)

	Supplementary Protection Certificate - Takeda Chemical Industries - Controller General of the Patent Office - LegalDay
		Supplementary Protection Certificate - Takeda Chemical Industries - Controller General of the Patent Office - LegalDay
		Supplementary Protection Certificate - combination drug therapy -Takeda Chemical Industries - Controller General of the Patent Office
		of a SPC is to compensate the patent owner for the
	www.legalday.co.uk /lexnex/cmck/cmck260403.htm (190 words)

	Nomination Procedure & Schedule (Site not responding. Last check: 2007-10-31)
		What are the differences in SPCs between different EU member states?
		Does the existence or non-existence of SPCs indicate any advantages or disadvantages to participants in EU pharmaceutical markets?
		Further marketing experience followed in advertising before joining Lederle Laboratories in a senior market research capacity and also utilising his statistical skills in production forecasting.
	www.ipi-confex.com /Paltnoi.htm (235 words)

	Bookworkz:: Protecting Inventions in Chemistry: Commentary on Chemical Case Law under the European Patent Convention ...
		This book covers the protection of chemical inventions by means of Patents and Utility Models, as well as Supplementary Protection Certificates (SPCs) for medicaments and agrochemicals.
		The jurisdiction of both the European Patent Office and the relevant German Courts which has been developed in recent decades is presented and explained in a comparative manner.
		The authors of the commentary are Dr. Bernd Hansen, a Munich-based Patent Attorney and Dr. Fritjoff Hirsch, a former Judge of the German Federal Patent Court.
	www.bookworkz.com /business/law/3527288082.html (309 words)

	HPO - Legal Sources - Supplementary Protection Certficates - Legal Sources
		The legal institution of supplementary protection is introduced by Article 22/A of Act XXXIII of 1995 amended by Act XXXIX of 2002 (Patent Act)*.
		This provision of the Patent Act lays down that in matters concerning supplementary protection certificates the provisions of the Patent Act shall apply mutatis mutandis.
		26.) contains detailed rules concerning the implementation of Community Regulations relating to the supplementary protection of certain products.
	www.hpo.hu /English/jogforras/jogforras_spc (159 words)

	Legal status codes for a country
		Lapsed due to expiration of the term of protection
		SC Communications of assignments concerning granted supplementary protection certificates
		TC Communications of modifications of names of proprietors of granted supplementary protection certificates
	www.delphion.com /help/legalcodes?cn2=NL&name=Netherlands (941 words)

	Studio Legale Sutti - Italy - IP And The Pharmaceutical Industry In Italy (Patents And Supplementary Protection) ...
		Italy: IP And The Pharmaceutical Industry In Italy (Patents And Supplementary Protection)
		Until recently the pharmaceutical Industry had been complaining of the inadequacy of the Intellectual Property protection available in Italy, and, as far as national industry was concerned, of the negative effect that this was having on its competitiveness with foreign manufacturers, which were granted with a broader protection in their...
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	www.mondaq.com /article.asp?articleid=6296&product_id=4&company_id=509 (250 words)

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