Judge, Supreme Court, President of the District Court of Aosta
Supplementary protection certificates: the evolution of European case law on the terms of patent extension and the scope of protection
The supplementary protection certificate (SPC) is a right that extends the legal duration of a pharmaceutical patent for the period corresponding to that necessary to obtain marketing authorisation, requiring a long and complex administrative procedure to protect human health.
The SPC strikes a balance between the proprietor's interest in making use of rights of sufficient duration to cover the research investments and public interest in public control on pharmaceutical products.
General legislation was introduced with the revision of Article 63 of the European Patent Convention, [ 1 ] making it possible for any contracting state to extend the term of a patent (twenty years) when its use is subject to an administrative authorisation procedure, for a period equal to that spent obtaining the authorisation itself.
States have not made use of this option, instead equipping themselves with specific legislation in the pharmaceutical field which has resulted in a framework of inconsistencies which may hinder the free movement of medicinal products and alter the operation of the internal market.
To prevent heterogeneous development in the pharmaceutical field, the European legislator has therefore established a uniform set of rules by issuing protection regulations for medicinal products (Reg. 469/2009, the "codified version" of Reg. 1768/92), for medicinal products for paediatric use (Reg. 1901/2006) and for plant protection products[ 2 ] (Reg. 1610/96, which serves as a tool for the authoritative interpretation of Reg. 1768/92).
The provisions of the EU regulations supplement or replace the inconsistent national regulations[ 3 ] and have resulted in numerous problems of interpretation which have been repeatedly referred to the Court of Justice for a preliminary ruling (under Article 267 of the Treaty), especially by the High Court of Justice of England and Wales (Chancery Division).
The most debated issues have concerned:
1. the temporal extension of pharmaceutical patents (known as "patent term restoration")
2. the relationship between the SPC's scope of protection and the patent's scope of protection.
I will try to give an account of the principles progressively established by the Court of Justice on these issues by following a logical line comparing some relevant examples of national jurisprudence.
II. The temporal extension of pharmaceutical patents
The first states to extend the life of pharmaceutical patents for the period between the date of application filing and the marketing authorisation (for a maximum of five years) were the USA in 1985 and Japan in 1988.
With legislation similar to that adopted by France and other European countries, Italy introduced the supplementary protection certificate for medicinal products with Law No. 349 of 19 October 1991, extending the patent term up to 18 years after legal expiry.
This term was so far-reaching in delaying the time when pharmaceutical inventions fell into the public domain (with an exponential increase in pharmaceutical expenditure for the reimbursement of drugs by the national health service) that Law No. 112 of 15 June 2002 shortened the term to a maximum of five years, bringing it into line with the Community "standard" and - for certificates issued under the old law - providing for a process of progressive reduction of the extension equal to six months per calendar year with effect from 1 January 2004 until full alignment.
This curtailment of the exclusive rights enjoyed by the pharmaceutical industry caused massive disputes in those years before the PTO Board of Appeal (where the Office's "recalculation" measures were challenged), before the Constitutional Court (because of the uncompensated limitation of intellectual property rights and the violation of legitimate expectations as to the inviolability of the original term), before the administrative judge[ 4 ] and before specialised intellectual property courts. [ 5 ]
Italian courts in the end - disregarding any possible unconstitutionality of the new legislation, also in the light of the intervention of the Court of Cassation[ 6 ] - validated the legal curtailment system because it ensured gradual adaptation to EU legislation, alignment with the laws of the other member states, and greater liberalisation in the marketing of generic drugs in accordance with the principle of free competition.
According to Article 7 of Reg. 469/2009 (like Reg. 1768/92) the application for a certificate must be filed with the competent authority (in Italy the Patent and Trademark Office) [ 7 ] within a period of six months from the date on which the marketing authorisation was granted.
This is a mandatory term protecting third parties that may have made significant investments in view of the invention falling into the public domain, and its effective date has been the subject of differing interpretations and conflicts with the Ministry of Industry.
The Court of Cassation has ruled that the dies a quo should be identified not on the issue date of the ministerial authorisation measure but on the (later) date of its publication in the Official Journal, the person concerned only then being reasonably in a position to find out about it. [ 8 ]
According to Reg. 469/2009 (Article 13) the certificate has a duration equal to the period between the date on which the patent application was lodged and the date of the first marketing authorisation, reduced by five years.
Five years is the maximum term of effectiveness of the certificate, but a six-month extension is permitted for medicinal products for paediatric use (Reg. 1901/2006) when the application is supported by studies and research carried out in line with a paediatric investigation plan (known as a "paediatric extension").
Taking a cue from this indication, the Court of Justice (Merck Sharp case) [ 9 ] determined that SPCs may be issued even when less than five years has elapsed between the patent application filing date and the date of the first marketing authorisation.
In fact, no systematic indication opposes the grant of certificates with a duration equal to zero or negative while a refusal would prevent the paediatric "extension" (which is always linked to a certificate) undermining efforts to evaluate the paediatric effects of the medicine.
In such a case, the period of the paediatric extension starts to run from the date determined by deducting from the patent expiry date the difference between five years and the duration of the period which elapsed between the lodging of the patent application and the grant of the first marketing authorisation.
Regulation 469/2009 (Article 13) takes into account the issue date of the first marketing authorisation in the EU for the drug according to the rules governing medicinal products for human and veterinary use in EEC Directives 65/65 and 81/851.
Reasons of legal certainty exclude reference to any other legislation concerning the fixing of prices or reimbursement for medicinal products, which are entirely national matters not yet harmonised at Community level.
As explained by the Court of Justice, this ensures that patent protection ceases simultaneously in all relevant member states (Hässle case). [ 10 ]
Based on Recital 9 of Reg. 469/2009 the Court of Justice then specified that the proprietor of both a patent and a certificate can never benefit from over 15 years of exclusivity (Merck Canada case). [ 11 ]
On this issue it has stated (AstraZeneca case) [ 12 ] that the marketing authorisation for a medicinal product issued in a third country (Switzerland), where automatically recognised in Liechtenstein as a result of the regional union between the two countries, should be deemed to be the first authorisation to place the product on the market if obtained prior to the authorisations granted through the centralised procedures by the European Medicines Agency (EMA) or by the authorities of the member states and irrespective of subsequent refusals.
That first marketing authorisation is not intended to take the place of the authorisation granted by the member states, but serves a purely temporal purpose to avoid prolonging the period of exclusivity (which is 15 years from the first authorisation) when two kinds of marketing authorisation coexist.
III. Relationship between the patent's scope and the SPC
As I have mentioned, the most important issues in this area have concerned the relationship between the patent's scope and the SPC.
There are many aspects to the rules of interpretation that the Court of Justice has adopted for the resolution of national disputes.
First of all, it should be pointed out that, in accordance with Reg. 1768/92 and 469/2009, the basic patent is the one which protects the product (or process of manufacture or its use), considered as an "active ingredient" or "combination of active ingredients" of a medicinal product.
The concept of product covers chemical elements and their compounds, including any impurity inevitably resulting from the manufacturing process, so that two products that differ only in the proportion of impurities must be regarded as the same product (BASF case). [ 13 ]
The active ingredient, which is the basic component (molecule) on which the curative action for human and animal diseases depends, [ 14 ] should be distinguished from the excipient, which is an inert substance that acts as a vehicle for the active ingredient to facilitate or expedite administration of the drug.
The excipient is never an active ingredient, although it contributes to the effectiveness of the medicinal product; a substance with no therapeutic effect cannot be considered an active ingredient.
The "combination of active ingredients" (which - like the active ingredient - constitutes the "product" as such protected by the basic patent) is interpreted restrictively by the case law of the Court of Justice in order to prevent the introduction of uncertainty over the application of the above-mentioned regulations.
Thus, the concept does not include the combination of two substances of which only one has a therapeutic effect (Massachusetts Institute of Technology-MIT case), [ 15 ] nor does it include the adjuvant that has the sole purpose of "enhancing" the therapeutic effect (GlaxoSmithKline case). [ 16 ]
The (extended) protection achievable with the SPC depends on the type of the basic patent.
If the patent covers the product as such, the protection conferred by the SPC will relate to that product.
If the patent covers the manufacturing process, the SPC will relate only to the process and the product obtained directly from it (where required by applicable national law).
As the IP offices of the member states are precluded from granting SPCs for active ingredients which are not identified in the claims of the basic patent, granting a certificate for a product other than that obtained from the above process is prohibited, irrespective of the means of realisation (University of Queensland case). [ 17 ]
If the patent concerns a new therapeutic application (for human use) of an active substance already known and previously authorised for marketing as a medicinal product (for veterinary use), the SPC's scope of protection will extend to the new use of that product (not to the active ingredient as such) as long as it falls within the scope of the basic patent (Neurim case). [ 18 ]
According to one "restrictive" interpretation of the text (Article 4) of Reg. 1768/92, in the past it was deemed that the SPC does not have an extension equal to that of the basic patent protecting the active ingredient (or combination of active ingredients) but confers exclusivity solely on the "pharmaceutical speciality" identified in the marketing authorisation.
This interpretation was also endorsed by a decision of the Court of Cassation, [ 19 ] which limited protection to what was actually produced under the patent under the marketing authorisation, and it has been appropriated by the "generics" who, on the natural expiry of the patent, have claimed the freedom to produce and sell other pharmaceutical specialities using the same active ingredient or raw material.
Regarding identification of the subject-matter of protection, currently a broader interpretation prevails, pursued by the "originators" and confirmed by the text of the European regulations, which was confirmed in Reg. 1610/96 on SPCs for plant protection products (according to Recital 17, which gives an authentic interpretation of Reg. 1768/92).
The Regulation - while adopting wording similar to that of Reg. 1768/92 (and Reg. 469/2009) on the subject of the scope of protection (Article 4) - states in Recital 13 that the certificate confers the same rights as those conferred by the basic patent; so when this covers an active substance and its derivatives (salts and esters), the certificate confers the same protection.
Consequently, the certificate holder can continue, even in the extension period, to maintain control of different, but essentially derived, formulations of the same product, preventing their reproduction by third parties.
The so-called "salt problem" has therefore been resolved by the Court of Justice (Farmitalia case) [ 20 ] in the sense that when a product - in the form indicated in the marketing authorisation - is protected by a basic patent, the SPC covers the product, as a medicinal product, in all its forms within the scope of protection of the basic patent.
Even Italian case law (in particular the Court of Rome[ 21 ] and the PTO Board of Appeal, [ 22 ] which in Italy acts as a special jurisdiction competent for disputes on patentability and trade mark registration) is in line with this position, stating that the protection afforded by the SPC is not limited to the drug for which the marketing authorisation was requested and obtained, but extends to the active ingredient covered by the basic patent in all its embodiments.
The reason for this is to allow the patent holder to enjoy the period of exclusivity recognised by the law in its "substantial entirety".
It follows that, whatever the definitions and forms of implementation of the patented drug, they all benefit from the extended patent protection as long as they fall within the scope of protection of the basic patent.
It has also been stated (Georgetown University I case) [ 23 ] that the fact that the medicinal product for which marketing authorisation is requested is associated with other active ingredients with other therapeutic purposes (whether protected or not by another patent) does not preclude granting an SPC for an active ingredient featuring in the text of the claims of the basic patent.
The court explained that medicinal products placed on the market for complex diseases often consist of multi-therapeutic combinations of active ingredients administered with just one preparation, and a restrictive solution would undermine the objective of Reg. 469/2009 of ensuring sufficient protection to encourage research and contribute to the improvement of public health.
A different issue is identifying the rules for determining the scope of protection of the basic patent.
The Court of Justice – even in the Farmitalia case – stated that, in the absence of harmonised patent law, reference should be made to national legislation (i.e. the rules which govern the patent).
So, for patents granted by the EPO (which are the majority), Article 69 EPC (and the protocol on its interpretation), which assign a key role to the claims, will apply.
It should be noted that, according to EPO rules of interpretation, the extent of patent protection is determined solely by the claims (in the light of the description and drawings), so that protection cannot be granted for any matter disclosed in the specification but not claimed (claims system).
In any event, the creation of a European patent with unitary effect (valid for the countries participating in enhanced cooperation) [ 24 ] and the explicit reference to the SPC in the context of the judicial protection guaranteed by the Agreement on a Unified Patent Court (Article 3(b)) [ 25 ] will serve in future to adopt common interpretative solutions at EU level.
The vital role of the claims was noted in the Medeva[ 26 ] and Daiichi[ 27 ] cases, where the court clarified that SPCs relating to active ingredients (or derivatives) not mentioned in the text of the claims of the basic patent cannot be granted, arguing that the SPC confers the same rights as the latter and is subject to the same limitations and obligations; moreover, in Recital 14 of Reg. 1610/96 on plant protection products, it is explicitly mentioned that products which are the subject of patents must be "specifically" claimed.
Consequently, the court in the Yeda case[ 28 ] stated that an SPC cannot be granted relating to active ingredients which are not specified in the text of the claims of the basic patent.
Similarly, it is not possible to grant an SPC for an active ingredient considered in isolation when the basic patent claims a combination of two active ingredients without containing claims for each of them.
The modalities for specifying the product in the wording of the claims of the basic patent have been clarified by the Court of Justice in the Eli Lilly case[ 29 ] (a case relating to the structural formula and functional formula of the active ingredient mentioned in the claim).
The court - invoking its case law on the fundamental importance of the claims in determining whether the product is protected by a basic patent - established that the active ingredient does not need to be mentioned in the claims in a "structural" formula; it is sufficient for it to be covered by a "functional" formula provided that - according to the usual rules of interpretation (i.e. on the basis of the claims interpreted in the light of the description) - it is possible to deduce that the claims relate implicitly, but necessarily and specifically, to the active ingredient.
I would like to emphasise that Italian case law (in particular the Milan IP Court) [ 30 ] with substantial decisions and provisional measures issued between 2012 and 2013 has to some extent anticipated this interpretation of the Court of Justice.
The Italian court established that, for the granting and the validity of an SPC, it is sufficient that the active ingredient or combination of active ingredients is protected by the basic patent, but it is not necessary for the product to be specifically described by name and identified in the text of the patent, since this is not a condition prescribed by Reg. 469/2009 (Article 3(a)).
It has been argued that the patent protects the idea of solving a technical problem that can be implemented in practice in a variety of actual creations belonging to the same inventive concept.
That is why the so-called "general formula" patents in the chemical and pharmaceutical fields, whose scope of protection also includes compounds that are not individually identified but can be derived from the formula, are perfectly valid.
The active ingredients may therefore be indicated in general terms in the text of the claim by specifying the category to which they are attributable.
On this point, it was specified that the requirement for adequate description must be deemed to be met when a medical specialist in the field is able to implement the invention based on his professional experience, without having to resort to more complex investigations and experiments, but referring to simple laboratory tests to supplement the information provided by the patent and choosing the most suitable and effective active ingredient from the category to implement the claim.
IV. Further questions on the extension of protection
Finally, let me conclude my reflections on multiple protection.
In this regard I would like to report how the IP Court of Milan has followed and developed the principles established by the Court of Justice in its Actavis[ 31 ] and Georgetown II[ 32 ] judgments (see below), considered binding on the national judge and aimed at avoiding a mere "sequence" of SPCs likely to postpone, indefinitely in time, the end of protection through combinations of an "innovative" active ingredient with other components only generically described in the basic patent (and not protected "as such" by that patent).
According to European case law, it is possible, in principle, on the basis of a patent which protects several "different" products, to obtain several SPCs in relation to each of those products, provided that each of those products is protected "as such" by that "basic" patent.
It should be pointed out that in the Biogen[ 33 ] and Ahp Manufacturing[ 34 ] cases the court went on to state that if a product is protected by multiple basic patents belonging to two or more holders (whether a product as such or a manufacturing process or use of the product), each of them has the right to obtain an SPC in order to balance the interests at stake and avoid different pharmaceutical product protection between member states.
On the other hand, more than one certificate cannot be obtained for the same product.
It should be noted on this point that, although the Biogen judgment formally made a connection with the prohibition on granting several certificates for the same patent, the limit is found in the "product", as quoted in Article 3(c) of Reg. 469/2009 (and Reg. 1768/92).
The Italian decisions previously mentioned[ 35 ] took this line, stating that a "basic patent" can give rise to as many SPCs as there are "products" protected therein.
In those decisions (of Italian case law) it was held that the term "product" contained in Article 3(c) of Reg. 469/2009 refers to the product as a medicinal product and not the entire patent (which may legitimately protect several products); the rule that the patent cannot concern more than one invention is never relevant, given that its violation would have purely administrative consequences, with the obligation to file a divisional application without any resultant invalidity.
It is therefore permitted to grant "multiple" SPCs in relation to a basic patent protecting several "different" products; the holder who has obtained the certificate for a combination of active ingredients can thus obtain another certificate for one of them that - considered individually - is protected "as such" by the patent in question (Georgetown II case). [ 36 ]
Consequently it has been argued (Actavis case) [ 37 ] that the holder of a patent protecting the active ingredient for which a corresponding SPC has been granted cannot, based on the marketing authorisation for medicinal products containing the active ingredient in combination with another active ingredient not protected by the patent, obtain a second SPC relating to the combination of these active ingredients.
Moreover, according to these precedents, the Italian court[ 38 ] stated that the product (active ingredient) protected "as such" by the basic patent has to be understood and identified as being the one containing the central inventive core, so that it is not sufficient to include a mere designation in the claims regarding the active ingredient, possibly in combination, if the "innovative" character is missing.
Therefore, it is necessary to exclude from such a definition those combinations between active ingredient and other known principles (for example, proposed independent claims benefiting from the requirements of inventiveness of the main one on which they depend) that result in mere forms of administration of drugs usually prescribed jointly.
Thus the pro-competition approach to the system is confirmed.
In fact, supplementary protection as a tool for extending exclusive patent rights constitutes an exception to the general principle of falling into the public domain, so that such protection should be deemed achievable solely and exclusively for the matter which constitutes the actual invention covered by the patent. On expiry of the certificate, the pharmaceutical invention must therefore be made available to the public in order to foster the price dynamics that normally follow the end of the monopoly) – which is a favourable outcome for consumers.
[ 1 ] The text adopted on 17 December 1991 at the Diplomatic Conference entered into force on 4 July 1997. The Final Act of the Conference was ratified by Italy with Law No. 125 of 12 April 1995.
[ 2 ] Plant protection products and pesticides are substances used to fight diseases and pests in plants.
[ 3 ] Paragraph 61 of the Italian Industrial Property Code (Legislative Decree No. 30 of 10 February 2005 as amended by "corrective" Decree No. 131 of 13 August 2010) refers - in terms of release and effects - to the provisions of the aforementioned Regulations, providing in Article 81 for transitional rules for SPCs granted in accordance with Law No. 349 of 19 October 1991.
[ 4 ] Administrative Court of Lazio, 12 June 2003, No. 7 858, in Industrial Law 2003, 512.
[ 5 ] Court of Rome, 21 October 2007, in Review of case law of the specialised IP sections. vol. 2007, No. 387.
[ 6 ] Court of Cassation 25 September 2008, No. 24 083.
[ 7 ] The Constitutional Court judgment of 4 July 1996 dismissed the claim that not allowing the application to be filed at UPICA (Provincial Office of Industry, Trade and Crafts) was unconstitutional for prejudice to the principle of freedom of economic initiative.
[ 8 ] 2 June 1999, No. 5378.
[ 9 ] Court of Justice, 8 December 2011, C-125/10.
[ 10 ] Court of Justice, 11 December 2003, C-127/00.
[ 11 ] Court of Justice, 13 February 2014, C-555/13.
[ 12 ] Court of Justice, 14 November 2003, C-617/12.
[ 13 ] Court of Justice, 10 May 2001, C-258/99.
[ 14 ] Reg. 847/2000 of 27 April 2000 on the classification of medicines known as "orphans" (drugs for diseases so rare that their production would not be possible without incentives to the pharmaceutical industry to recover the research costs) defines an active substance as a "substance with physiological or pharmacological activity."
[ 15 ] Court of Justice, 4 May 2006, C-431/04. In contrast, the conclusions of the Advocate General are that those combinations where the substance or excipients are essential to ensure the therapeutic efficacy of the active ingredient should also be included in the concept of combination of active ingredients.
[ 16 ] Court of Justice, 14 November 2003, C-210/13.
[ 17 ] Court of Justice, 25 November 2011, C-630/10.
[ 18 ] Court of Justice, 19 July 2012, C-130/11.
[ 19 ] Cass. 5378/99 as above.
[ 20 ] Court of Justice, 16 September 1999, C-392/97.
[ 22 ] Board of Appeal, Italian Patent and Trademark Office, judgment 11/11 of 27 January/28 April 2010.
[ 23 ] Court of Justice, 24 November 2011, C-422/10.
[ 24 ] Reg. 1257/2012 of 17 December 2012.
[ 25 ] 11 January 2013, 16351/12.
[ 26 ] Court of Justice, 24 November 2011, C-322/2010.
[ 27 ] Court of Justice, 25 November 2011, C-6/11.
[ 28 ] Court of Justice, 25 November 2011, C-518/10.
[ 29 ] Court of Justice, 12 December 2013, C-493/12.
[ 30 ] Court of Milan, 22 and 29 December 2012, 6 March 2013, 20 April 2013, in Journal of Industrial Law, 2013, II, pp. 169 et seq.
[ 31 ] Court of Justice, 12 December 2013, C-443/12.
[ 32 ] Court of Justice, 12 December 2013, C-484/12.
[ 33 ] Court of Justice, 27 January 1997, C-181/95.
[ 34 ] Court of Justice, 3 September 2009, C-482/07.
[ 35 ] See footnote 30.
[ 36 ] Court of Justice, 12 December 2013, C-484/12.
[ 37 ] Court of Justice, 12 December 2013, C-443/12.
[ 38 ] IP Court of Milan, 10 July 2014.