Supplementary protection certificate
Encyclopedia
In European Union
member countries, a supplementary protection certificate (SPC) is a sui generis
, extension of a patent
under a specific, different, set of right. This type of right is available for medicinal products, such as drugs
, and plant
protection products, such as insecticide
s, and herbicide
s. Supplementary protection certificates were introduced to compensate for the long time needed to obtain regulatory approval of these products (i.e. authorization to put these products on the market).
A supplementary protection certificate comes into force only after the corresponding general patent expires. It normally has a maximum lifetime of 5 years. The duration of the SPC can, however, be extended to 5.5 years when the SPC relates to a human medicinal product for which data from clinical trials conducted in accordance with an agreed Paediatric Investigation Plan (PIP) have been submitted (as set out in Article 36 of Regulation (EC) No 1901/2006).
The total combined duration of market exclusivity of a general patent and SPC cannot normally exceed 15 years. However, the reward of a 6-month SPC extension for the submission of data from an agreed PIP can extend this combined duration to at least 15.5 years (it is yet to be judicially clarified whether more than 15.5 years can be obtained in some circumstances).
SPCs extend the monopoly period for a "product" (active ingredient or a combination of active ingredients) that is protected by a patent. For many SPC applications, there is no controversy about the definition of the "product" or whether it is protected by the patent upon which the SPC application was based. However, there are other SPC applications (particularly for medicinal products containing multiple active ingredients) where there may not be clear answers to questions such as what is a permissible definition of a "product", and what test should be applied for determining whether a patent protects that "product".
Supplementary protection certificates in the European Union are based primarily upon two regulation
s. Although all countries in the EU are required to provide supplementary protection certificates, no unified cross-recognition exist. Applications must be filed and approved on a country-by-country basis.
(a) are protected by a patent;
(b) have been subject to an administrative authorisation procedure; and
(c) have not been placed on the market anywhere in the EEA
as a medicinal product prior to the date(s) of the Marketing Authorisation(s) (MA(s)) specified in the SPC application.
Those decisions focussed on point (c) above, and ruled out the possibility of SPC protection for all "products" previously included in medicinal products that were marketed prior to the dates stated in the transitional provisions of the SPC legislation (even if the earlier marketing was based upon an authorisation that was not compliant with the standards for testing of safety and efficacy that were introduced in the 1970s).
With respect to (a) above, the question of how to determine whether a "product" is protected by a patent is the subject of current controversy. However, this may soon be resolved by the ECJ, for example in connection with pending cases such as C-322/10 and C-422/10.
Further, although the SPC legislation mentions only Directives 2001/83/EC and 2001/82/EC as the "administrative authorisation procedure" for human or veterinary medicaments, SPCs are known to have been granted when MAs have not been obtained via those procedures (but instead via procedures that involve a similar level of safety and efficacy testing)http://thespcblog.blogspot.com/2010/03/spc-on-basis-of-ma-for-active.html.
and can be determined by the equation:
Term = ([date of 1st MA in the EEA] - [date of filing of corresponding patent]) - 5 years
Under normal circumstances, this means the following.
There have been very few cases where there was any controversy over the precise date of the 1st MA in the EEA. The Hässle AB case (ECJ case C-127/00) was one of that small number. In that case, the ECJ ruled that the decisive date for SPC purposes is the date of an authorisation from a regulatory body tasked with assessing safety and efficacy, and not the date of a subsequent authorisation that may be required under national pricing or reimbursement provisions.
So-called "centralised" (European Medicines Agency / European Commission) MAs were introduced by Regulation 2004/726 and became available from 20 November 2005 (i.e. some 13 years after the introduction of the original SPC legislation for medicinal products). The introduction of these authorisations added a new layer of complexity to the issue of determination of the date of a MA. This is because there are two dates associated with "centralised" authorisations, namely: (1) the date of the European Commission's decision to issue an authorisation; and (2) the date of notification of that decision to the MA applicant. Date (2) is usually a few days (e.g. 2 to 4 days) later than date (1). 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 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). Paramount amongst the reasons for preferring date (2) to date (1) is that a "centralised" authorisation does not become effective until it is notified to the MA applicant.
It is still too early to tell whether these arguments will prompt any of the above-mentioned national patent offices to change their standard practice. However, inspection of Belgian SPC certificates for products authorised via the "centralised" procedure reveals that at least the patent office in Belgium already appears to base calculations of SPC term upon date (2). For this reason, it seems that there are divergent practices across different territories within Europe with regard to the selection of a date for a "centralised" MA. If the issue were ever to be debated in a national court, this fact that there are divergent practices across different territories could provide basis for such a court to seek an authoratitive ruling from the ECJ in relation to which of dates (1) and (2) should be used for SPCs. This is because, as European Commission legislation, the Regulations governing SPCs should be interpreted consistently across all member states of the EU.
A MA in Switzerland
was also considered as being a first MA for the calculation of the SPC duration, even though Switzerland is not part of the European Economic Area
(EEA). This is because such a MA was automatically effective in Liechtenstein
, which is a member of the EEA (since May 1, 1995). 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.
However, as answer to the decision of the ECJ the contract between Switzerland and Liechtenstein was amended. Since July 1, 2005 the automatic effect of a Swiss MA in Liechtenstein is abolished. The recognition is now delayed by a time period, which is normally 12 months.
Undisputed consequences of the introduction of the 6-month SPC extension are that:
An extension of an SPC can only be awarded if there is an SPC to extend. 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.
(1) Is an SPC available if less than 5 years and 1 day have elapsed between filing of the corresponding patent and issuance of the first MA in the EEA?
(2) If the answer to (1) is yes, what term should be awarded to the (unextended) SPC?
According to a July 2007 paper by Snodin and Miles, there are only three possible answers to this combination of two questions.
If the answer to question (1) is no, then it is not relevant to consider question (2). This corresponds to "Model B" of the 2007 Snodin and Miles paper, and produces a curious situation where longer marketing exclusivity can be obtained if the issuance of the first MA in the EEA is delayed (to at least 5 years and 1 day from filing of the corresponding patent).
If the answer to question (1) is yes, then question (2) becomes relevant. This question can be answered in two ways, corresponding to either "Model A" or "Model C" of the 2007 Snodin and Miles paper.
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.
Model C assumes that all term calculations that provide a negative answer are 'rounded up' to zero. 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.
Subsequent to the publication of the Snodin and Miles article, Merck & Co. filed SPC applications for the product sitagliptin
. For example, from mid-August to mid-September 2007, Merck & Co. filed SPC applications in various countries, including the UK, Ireland, the Netherlands and Italy. These SPC applications provided an early opportunity for Models A to C to be tested in practice. Curiously, the patent offices of various EU member states did not reach any consensus on which model is correct. For example, the Netherlands and the UK favour Model A, Germany, Portugal and Slovenia favour Model B and Greece favours Model C.
In connection with an appeal against refusal of the SPC application in Germany, and in view of the different stances taken by different national patent offices, the German Federal Court of Justice (Bundesgerichtshof) has sought clarification of the law from the ECJ (in pending case C-125/10).
Advocate-General Yves Bot of the ECJ has provided an opinion in case C-125/10. Essentially, Mr Bot agrees with Model A of the 2007 Snodin and Miles paper. Mr Bot's opinion is non-binding, but it will be considered by the court in the preparation of their final ruling. The decision of the ECJ will follow in due course.
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, 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".
The above Regulations have now been codified under the following regulation:
Supplementary protection certificates may come into life at the expiry of a national or European patent. However, the European Patent Convention
(EPC) needed to be modified to allow such "extension" of the term of European patent. Article 63 of the EPC was modified on December 17, 1991 to specify to, although European patents have a term
of 20 years as from the date of filing of the application (Art. 63(1)),
This constituted the first revision of the European Patent Convention since its signature in 1973.
The paediatric extension is based primarily upon:
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
member countries, a supplementary protection certificate (SPC) is a sui generis
Sui generis
Sui generis is a Latin expression, literally meaning of its own kind/genus or unique in its characteristics. The expression is often used in analytic philosophy to indicate an idea, an entity, or a reality which cannot be included in a wider concept....
, extension of a patent
Patent
A patent is a form of intellectual property. It consists of a set of exclusive rights granted by a sovereign state to an inventor or their assignee for a limited period of time in exchange for the public disclosure of an invention....
under a specific, different, set of right. This type of right is available for medicinal products, such as drugs
Medication
A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...
, and plant
Plant
Plants are living organisms belonging to the kingdom Plantae. Precise definitions of the kingdom vary, but as the term is used here, plants include familiar organisms such as trees, flowers, herbs, bushes, grasses, vines, ferns, mosses, and green algae. The group is also called green plants or...
protection products, such as insecticide
Insecticide
An insecticide is a pesticide used against insects. They include ovicides and larvicides used against the eggs and larvae of insects respectively. Insecticides are used in agriculture, medicine, industry and the household. The use of insecticides is believed to be one of the major factors behind...
s, and herbicide
Herbicide
Herbicides, also commonly known as weedkillers, are pesticides used to kill unwanted plants. Selective herbicides kill specific targets while leaving the desired crop relatively unharmed. Some of these act by interfering with the growth of the weed and are often synthetic "imitations" of plant...
s. Supplementary protection certificates were introduced to compensate for the long time needed to obtain regulatory approval of these products (i.e. authorization to put these products on the market).
A supplementary protection certificate comes into force only after the corresponding general patent expires. It normally has a maximum lifetime of 5 years. The duration of the SPC can, however, be extended to 5.5 years when the SPC relates to a human medicinal product for which data from clinical trials conducted in accordance with an agreed Paediatric Investigation Plan (PIP) have been submitted (as set out in Article 36 of Regulation (EC) No 1901/2006).
The total combined duration of market exclusivity of a general patent and SPC cannot normally exceed 15 years. However, the reward of a 6-month SPC extension for the submission of data from an agreed PIP can extend this combined duration to at least 15.5 years (it is yet to be judicially clarified whether more than 15.5 years can be obtained in some circumstances).
SPCs extend the monopoly period for a "product" (active ingredient or a combination of active ingredients) that is protected by a patent. For many SPC applications, there is no controversy about the definition of the "product" or whether it is protected by the patent upon which the SPC application was based. However, there are other SPC applications (particularly for medicinal products containing multiple active ingredients) where there may not be clear answers to questions such as what is a permissible definition of a "product", and what test should be applied for determining whether a patent protects that "product".
Supplementary protection certificates in the European Union are based primarily upon two regulation
European Union regulation
A regulation is a legislative act of the European Union that becomes immediately enforceable as law in all member states simultaneously. Regulations can be distinguished from directives which, at least in principle, need to be transposed into national law...
s. Although all countries in the EU are required to provide supplementary protection certificates, no unified cross-recognition exist. Applications must be filed and approved on a country-by-country basis.
Scope of the law
Decisions by the ECJ in cases C-195/09 and C-427/09, have clarified that SPCs for medicaments (human or veterinary) are only available for those “products” that:(a) are protected by a patent;
(b) have been subject to an administrative authorisation procedure; and
(c) have not been placed on the market anywhere in the EEA
European Economic Area
The European Economic Area was established on 1 January 1994 following an agreement between the member states of the European Free Trade Association and the European Community, later the European Union . Specifically, it allows Iceland, Liechtenstein and Norway to participate in the EU's Internal...
as a medicinal product prior to the date(s) of the Marketing Authorisation(s) (MA(s)) specified in the SPC application.
Those decisions focussed on point (c) above, and ruled out the possibility of SPC protection for all "products" previously included in medicinal products that were marketed prior to the dates stated in the transitional provisions of the SPC legislation (even if the earlier marketing was based upon an authorisation that was not compliant with the standards for testing of safety and efficacy that were introduced in the 1970s).
With respect to (a) above, the question of how to determine whether a "product" is protected by a patent is the subject of current controversy. However, this may soon be resolved by the ECJ, for example in connection with pending cases such as C-322/10 and C-422/10.
Further, although the SPC legislation mentions only Directives 2001/83/EC and 2001/82/EC as the "administrative authorisation procedure" for human or veterinary medicaments, SPCs are known to have been granted when MAs have not been obtained via those procedures (but instead via procedures that involve a similar level of safety and efficacy testing)http://thespcblog.blogspot.com/2010/03/spc-on-basis-of-ma-for-active.html.
Determination of term
The term of an SPC depends on the date of issuance of the first MA within the EEAEuropean Economic Area
The European Economic Area was established on 1 January 1994 following an agreement between the member states of the European Free Trade Association and the European Community, later the European Union . Specifically, it allows Iceland, Liechtenstein and Norway to participate in the EU's Internal...
and can be determined by the equation:
Term = ([date of 1st MA in the EEA] - [date of filing of corresponding patent]) - 5 years
Under normal circumstances, this means the following.
- No SPC term is available if less than 5 years have elapsed between the date of filing of the corresponding patent and the date of issuance of the first MA in the EEA.
- If the first MA is issued more than five years but less than ten years after the filing date of the corresponding patent, an SPC is granted for a term corresponding to the period elapsed between the five-year point and the MA issuance date.
- If the first MA is issued more than ten years after the filing date of the corresponding patent, an SPC is granted for a five-year term.
There have been very few cases where there was any controversy over the precise date of the 1st MA in the EEA. The Hässle AB case (ECJ case C-127/00) was one of that small number. In that case, the ECJ ruled that the decisive date for SPC purposes is the date of an authorisation from a regulatory body tasked with assessing safety and efficacy, and not the date of a subsequent authorisation that may be required under national pricing or reimbursement provisions.
So-called "centralised" (European Medicines Agency / European Commission) MAs were introduced by Regulation 2004/726 and became available from 20 November 2005 (i.e. some 13 years after the introduction of the original SPC legislation for medicinal products). The introduction of these authorisations added a new layer of complexity to the issue of determination of the date of a MA. This is because there are two dates associated with "centralised" authorisations, namely: (1) the date of the European Commission's decision to issue an authorisation; and (2) the date of notification of that decision to the MA applicant. Date (2) is usually a few days (e.g. 2 to 4 days) later than date (1). 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 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). Paramount amongst the reasons for preferring date (2) to date (1) is that a "centralised" authorisation does not become effective until it is notified to the MA applicant.
It is still too early to tell whether these arguments will prompt any of the above-mentioned national patent offices to change their standard practice. However, inspection of Belgian SPC certificates for products authorised via the "centralised" procedure reveals that at least the patent office in Belgium already appears to base calculations of SPC term upon date (2). For this reason, it seems that there are divergent practices across different territories within Europe with regard to the selection of a date for a "centralised" MA. If the issue were ever to be debated in a national court, this fact that there are divergent practices across different territories could provide basis for such a court to seek an authoratitive ruling from the ECJ in relation to which of dates (1) and (2) should be used for SPCs. This is because, as European Commission legislation, the Regulations governing SPCs should be interpreted consistently across all member states of the EU.
A MA in Switzerland
Switzerland
Switzerland name of one of the Swiss cantons. ; ; ; or ), in its full name the Swiss Confederation , is a federal republic consisting of 26 cantons, with Bern as the seat of the federal authorities. The country is situated in Western Europe,Or Central Europe depending on the definition....
was also considered as being a first MA for the calculation of the SPC duration, even though Switzerland is not part of the European Economic Area
European Economic Area
The European Economic Area was established on 1 January 1994 following an agreement between the member states of the European Free Trade Association and the European Community, later the European Union . Specifically, it allows Iceland, Liechtenstein and Norway to participate in the EU's Internal...
(EEA). This is because such a MA was automatically effective in Liechtenstein
Liechtenstein
The Principality of Liechtenstein is a doubly landlocked alpine country in Central Europe, bordered by Switzerland to the west and south and by Austria to the east. Its area is just over , and it has an estimated population of 35,000. Its capital is Vaduz. The biggest town is Schaan...
, which is a member of the EEA (since May 1, 1995). This was decided by the European Court of Justice
European Court of Justice
The Court can sit in plenary session, as a Grand Chamber of 13 judges, or in chambers of three or five judges. Plenary sitting are now very rare, and the court mostly sits in chambers of three or five judges...
(ECJ) in joined cases Novartis et al. v. Comptroller-General and Ministère de l'Economie v. Millennium Pharmaceuticals.
However, as answer to the decision of the ECJ the contract between Switzerland and Liechtenstein was amended. Since July 1, 2005 the automatic effect of a Swiss MA in Liechtenstein is abolished. The recognition is now delayed by a time period, which is normally 12 months.
Paediatric extension
Article 36 of Regulation 1901/2006 provides for a 6-month extension to SPC term. 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).Undisputed consequences of the introduction of the 6-month SPC extension are that:
- the maximum term of an SPC can now be up to 5.5 years; and
- the maximum duration of market exclusivity (patent + SPC) can now be up to at least 15.5 years.
An extension of an SPC can only be awarded if there is an SPC to extend. 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.
(1) Is an SPC available if less than 5 years and 1 day have elapsed between filing of the corresponding patent and issuance of the first MA in the EEA?
(2) If the answer to (1) is yes, what term should be awarded to the (unextended) SPC?
According to a July 2007 paper by Snodin and Miles, there are only three possible answers to this combination of two questions.
If the answer to question (1) is no, then it is not relevant to consider question (2). This corresponds to "Model B" of the 2007 Snodin and Miles paper, and produces a curious situation where longer marketing exclusivity can be obtained if the issuance of the first MA in the EEA is delayed (to at least 5 years and 1 day from filing of the corresponding patent).
If the answer to question (1) is yes, then question (2) becomes relevant. This question can be answered in two ways, corresponding to either "Model A" or "Model C" of the 2007 Snodin and Miles paper.
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.
Model C assumes that all term calculations that provide a negative answer are 'rounded up' to zero. 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.
Subsequent to the publication of the Snodin and Miles article, Merck & Co. filed SPC applications for the product sitagliptin
Sitagliptin
Sitagliptin is an oral antihyperglycemic of the dipeptidyl peptidase-4 inhibitor class. It was developed, and is marketed, by Merck & Co...
. For example, from mid-August to mid-September 2007, Merck & Co. filed SPC applications in various countries, including the UK, Ireland, the Netherlands and Italy. These SPC applications provided an early opportunity for Models A to C to be tested in practice. Curiously, the patent offices of various EU member states did not reach any consensus on which model is correct. For example, the Netherlands and the UK favour Model A, Germany, Portugal and Slovenia favour Model B and Greece favours Model C.
In connection with an appeal against refusal of the SPC application in Germany, and in view of the different stances taken by different national patent offices, the German Federal Court of Justice (Bundesgerichtshof) has sought clarification of the law from the ECJ (in pending case C-125/10).
Advocate-General Yves Bot of the ECJ has provided an opinion in case C-125/10. Essentially, Mr Bot agrees with Model A of the 2007 Snodin and Miles paper. Mr Bot's opinion is non-binding, but it will be considered by the court in the preparation of their final ruling. The decision of the ECJ will follow in due course.
Scope
According to Article 4 of Council Regulation (EEC) No 1768/92, the scope of an SPC extends "only to the product covered by the authorization to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorized before the expiry of the certificate".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, 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".
Legal basis
Supplementary protection certificates in the European Union were based primarily upon two regulations:- Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products which entered into force on January 2, 1993. This has been cancelled by the below specified recodified regulation no. 469/2009 with effect from May 2009
- Regulation (EC) No 1610/96 of the European ParliamentEuropean ParliamentThe European Parliament is the directly elected parliamentary institution of the European Union . Together with the Council of the European Union and the Commission, it exercises the legislative function of the EU and it has been described as one of the most powerful legislatures in the world...
and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products which entered into force on February 8, 1997
The above Regulations have now been codified under the following regulation:
- Regulation (EC) No 469/2009 of the European ParliamentEuropean ParliamentThe European Parliament is the directly elected parliamentary institution of the European Union . Together with the Council of the European Union and the Commission, it exercises the legislative function of the EU and it has been described as one of the most powerful legislatures in the world...
and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (Codified version)
Supplementary protection certificates may come into life at the expiry of a national or European patent. However, the European Patent Convention
European Patent Convention
The Convention on the Grant of European Patents of 5 October 1973, commonly known as the European Patent Convention , is a multilateral treaty instituting the European Patent Organisation and providing an autonomous legal system according to which European patents are granted...
(EPC) needed to be modified to allow such "extension" of the term of European patent. Article 63 of the EPC was modified on December 17, 1991 to specify to, although European patents have a term
Term of patent
The term of a patent is the maximum period during which it can be maintained into force. It is usually expressed in number of years either starting from the filing date of the patent application or from the date of grant of the patent. In most patent laws, renewal annuities or maintenance fees have...
of 20 years as from the date of filing of the application (Art. 63(1)),
- " nothing (...) shall limit the right of a Contracting State to extend the term of a European patent, or to grant corresponding protection which follows immediately on expiry of the term of the patent, under the same conditions as those applying to national patents: (...) if the subject-matter of the European patent is a product or a process of manufacturing a product or a use of a product which has to undergo an administrative authorisation procedure required by law before it can be put on the market in that State. "
This constituted the first revision of the European Patent Convention since its signature in 1973.
The paediatric extension is based primarily upon:
- Regulation 1901/2006 of 12 December 2006 on medicinal products for paediatric use and amending Regulation 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004
- Regulation 1902/2006 of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use
Statistics
According to research, more than 8,000 SPCs for medicinal and plant protection products have been filed in Europe between 1991 and 2003.See also
- European Medicines AgencyEuropean Medicines AgencyThe European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
(EMA) - Orphan drugOrphan drugAn orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease...
- European Federation of Pharmaceutical Industries and AssociationsEuropean Federation of Pharmaceutical Industries and AssociationsEuropean Federation of Pharmaceutical Industries and Associations is a Brussels-based trade union founded in 1978 representing the research-based pharmaceutical industry operating in Europe....
(EFPIA)
External links
- Supplementary Protection Certificates for Medicinal Products and Plant Protection Products - A Guide for Applicants (PDF file 120Kb), by the UK Patent OfficeUnited Kingdom Patent OfficeThe Intellectual Property Office of the United Kingdom is, since 2 April 2007, the operating name of The Patent Office. It is the official government body responsible for intellectual property rights in the UK and is an executive agency of the Department for Business, Innovation and Skills...
- The SPC Blog, blog relating to supplementary protection certificates (SPCs) (contributors include Professor Jeremy PhillipsJeremy PhillipsProf. Jeremy John Phillips is a British academic, author and commentator in intellectual property law. He is reported to be "a respected IP academic" and "a well-known figure among IP lawyers."...
) - Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd & Anor [2008] EWHC 2413 (Pat) (15 October 2008), an example a SPC-related dispute in the UK, relating to the "(-) enantiomer of a racemic compound called ofloxacinOfloxacinOfloxacin is a synthetic chemotherapeutic antibiotic of the fluoroquinolone drug class considered to be a second-generation fluoroquinolone. The original brand, Floxin, has been discontinued by the manufacturer in the United States on 18 June 2009, though generic equivalents continue to be...
"
Search
- Supplementary Protection Certificate Search at the UK Intellectual Property Office