12.4 article

KUIPERS, DOUMA AND KOKKE : RECENT EUROPEAN DEVELOPMENTS REGARDING PATENT EXTENSIONS (SPCs AND PAEDIATRIC EXTENSIONS) : VOL 12 ISSUE 4 BSLR (‘the Court’). In November 2011 the court rendered judgments in two cases, and reasoned orders1 in three more, about the interpretation of Article 3(a) and (b) of the Regulation (EC) 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products (‘the SPC Regulation’). In December 2011, the court handed down an important decision that related to supplementary protection certificate (‘SPCs’) and paediatric extensions. And just recently, the court published its orders of 9 February 2012 regarding the scope of protection of SPCs. For easy reference, the court’s late 2011 and early 2012 case law regarding SPCs is summarised in Table 1. Even though the overall effect of the decisions for the innovative pharmaceutical industry is positive, not all issues regarding In this article we first discuss what SPCs are. Subsequently we highlight the main points of the decisions of November 2011. This SPC case law concerns the interpretation of Article 3(a) and (b) of the SPC Regulation, that is, two of GERTJAN KUIPERS, TJIBBE DOUMA AND MARGOT KOKKE the conditions for obtaining SPCs. The December 2011 Merck case2 concerns the duration of an SPC (Article13 SPC Regulation) and is dealt with next. The following section addresses the scope of protection of SPCs as decided in the Novartis cases. Although the rules for granting SPCs are now considerably clearer, several issues remain unresolved.
These issues as well as the practical implications of the Supplementary protection is key to the pharmaceutical late 2011 and early 2012 SPC case law are dealt with in the industry and has now in general been made available discussion. A short conclusion can be found at the end of more easily by the Court of Justice of the European Union Table 1: Late 2011 and early 2012 Court of Justice Case Law on SPCs for Medicinal Products3 Article 104(3) first subparagraph of the Rules of Procedure of the court, C–125/10, decision 8 December 2011, case 6 in Table 1.
provides that where a question referred for a preliminary ruling is identical to a All decisions can be found, by case number, on the court's website at question on which the court has already ruled, or where the answer to such a http://curia.europa.eu/en/content/juris/c2–juris.htm or through eur-lex.
question may be clearly deduced from existing case law, the court may, afterhearing the Advocate General, at any time give its decision by reasoned order.
BIO-SCIENCE LAW REVIEW PUBLISHED BY LAWTEXT PUBLISHING LIMITED VOL 12 ISSUE 4 BSLR : KUIPERS, DOUMA AND KOKKE : RECENT EUROPEAN DEVELOPMENTS REGARDING PATENT EXTENSIONS (SPCs AND PAEDIATRIC EXTENSIONS) Conditions for Obtaining an SPC: the Court’s SPCs are sui generis industrial property rights intended to compensate pharmaceutical companies for the loss of As set out in Article 3 SPC Regulation, an SPC shall be granted effective patent term caused by the delay in obtaining (by the IPO of the Member State in which the application is regulatory approval for medicinal products,4 that is for submitted) if, at the date of the application: (performing clinical studies and) obtaining a marketing authorisation (‘MA’) for the product, as laid down in Directive the product is protected by a basic patent in force; 2001/83/EC or Directive 2001/82/EC (for human or veterinary a valid MA to place the product on the market as a medical product has been granted in accordance There is a similar regulation in place for the extension of with Directive 2001/83/EC or Directive 2001/82/EC7 as patents for plant protection products that have been granted a marketing authorisation,5 to promote research and innovation for plant protection (‘the Plant SPC Regulation’).
the product has not already been the subject of an The Plant SPC Regulation will not be discussed separately here. However, as both regulations are similar in the sense the MA referred to in (b) is the first authorisation to that the conditions to obtain an SPC are virtually identical: most of what is discussed below6 is likely to be relevant to place the product on the market as a medicinal product.
SPCs for plant protection products as well.
These requirements all gave rise to different interpretations SPCs are highly valuable as they extend the period during and were (or still are) the subject of referrals to the court. The which a drug can be marketed exclusively to the benefit of the late 2011 cases concerning conditions (a) and (b) will be originator pharmaceutical company. An SPC can extend the term of exclusivity of a patent for up to five years. Such patent To illustrate the issues regarding the application of extensions are regulated by way of EC regulations with a view requirements 3(a) and (b), we will first look at the different to harmonising SPC law throughout the Community. However, interpretations given in pre-Medeva and Georgetown Europe.
as SPCs are applied for nationally with the competent We then discuss the new situation regarding combination national Industrial Property Office (‘the IPO’), the SPC products clarified by the court in the Medeva and Georgetown Regulation has been interpreted differently in various judgments and the Daiichi and Yeda orders. An additional countries, leading to disharmony, notably to granting or not teaching regarding product-by-process claims of the granting SPCs, different durations and different scopes of Queensland order is addressed and we will also discuss the exclusive rights attributed to SPCs throughout Europe. Both German and UK courts posed questions to the court regarding the interpretation of the SPC Regulation. Six of these referrals Pre-Medeva and Georgetown: disharmony in Europe resulted in final rulings in late 2011. Two resulted in rulings in Disharmony regarding the interpretation of the requirement early 2012. Rulings of the court are binding on all EC national ‘the product is protected by a basic patent in force’ of Article 3(a) SPC Regulation existed in Europe, especially with regard to combination products. The SPC Regulation defines a ‘product’ as the active ingredient or combination of active Obtaining an SPC: Conditions and Duration ingredients of a medicinal product (Article 1(b) SPC In the first part of this section, the conditions for obtaining Regulation). If the (combination) product is fully disclosed in an SPC is discussed and in the second part we address the claims of a patent, and if the MA is granted for the same a specific issue regarding the duration of SPCs, namely (combination) product, no issue arises. However, a mismatch whether a negative term SPC is possible and why this may occur between the ‘product’ that is patented and the ‘product’ for which an MA is granted. When an MA is granted Medicinal products are defined as any substance or combination of Regulation (EC) 1610/96 of the European Parliament and of the Council of substances presented for treating or preventing disease in human beings or 23 July 1996 concerning the creation of a supplementary protection certificate animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical Obviously with the exception of the considerations regarding negative diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals (Article 1(a) SPC Regulation).
For human use (2001/83/EC) or for a veterinary medicinal product BIO-SCIENCE LAW REVIEW PUBLISHED BY LAWTEXT PUBLISHING LIMITED KUIPERS, DOUMA AND KOKKE : RECENT EUROPEAN DEVELOPMENTS REGARDING PATENT EXTENSIONS (SPCs AND PAEDIATRIC EXTENSIONS) : VOL 12 ISSUE 4 BSLR for a combination of active ingredients, as is frequently the court cases, with contradictory results across Europe.
case with multi-disease vaccines where public health policy Novartis owned a European patent EP 0443983 (which requires such combined marketing, the combination of active expired on 12 February 2011) claiming the active ingredients is ‘the product placed on the market as a pharmaceutical ingredient valsartan, processes for the medicinal product’ of Article 3(b). However, in those cases the production of valsartan as well as first and second medical patent usually covers only one active ingredient (or a uses of valsartan. It also has an MA for valsartan and another combination of two) and does not ‘disclose’ the full MA for the combination product valsartan/HCTZ combination in the claims of the patent. It was generally (Hydrochlorothiazide) for the treatment of hypertension. In assumed that the concept ‘the product’ of Article 3(a) needed most European countries, Novartis applied for two SPCs (one to match ‘the MA product’ of Article 3(b). The question arose for the product valsartan and one for the combination whether in these circumstances the product of Article 3(b) product) and for a paediatric extension. The different SPCs that has been placed on the market is ‘protected by a basic granted can be seen in Table 2 below. In most countries patent in force’ as required by Article 3(a). Can an SPC be Novartis could only obtain an SPC for its product valsartan granted in case the basic patent relates to active ingredient A and not for its other product valsartan in combination with and the MA was granted for the combination of active HCTZ (except for Belgium and Italy).
The table below would imply that many countries already The focus in these types of cases was not on the interpreted the SPC Regulation as the court would later do in Medeva and Georgetown but this is not the case. In several interpretation of the term ‘product’ of Article 3(a) and 3(b) of countries, Novartis had two MAs and since one of them the SPC Regulation but rather on the interpretation of (valsartan) did not suffer from a mismatch between the the requirement ‘protected by a basic patent’ of Article 3(a).
‘patent’-product and the ‘MA’-product, Novartis could obtain The court previously held in Farmitalia8 that the question an SPC for valsartan, also in countries where the ‘disclosure whether a product is protected by a basic patent according to Article 3(a) of the SPC Regulation must be answered based on the national rules governing that patent, in the absence Table 2: Novartis’s SPCs in Different European Countries, of Community harmonisation of patent law. Different theories Based on the Same Basic European Patent for Valsartan developed across Europe regarding the interpretation of (‘A’). B is HCTZ (Hydrochlorothiazide). Novartis in Some ‘protected by a basic patent’, that can be divided into two main ‘tests’. The controversy was whether the wording of the basic patent (‘the disclosure test’9) or the patent's scope of protection (‘the infringement test’) should be decisive in determining whether the product (for which the MA was given) is ‘protected’ by a basic patent according to Article 3(a). This lack of clarity resulted in conflicting interpretations by national IPOs and courts throughout Europe. In the Netherlands, France, Germany and the United Kingdom the ‘disclosure doctrine’10 was applied, whereas authorities in, for instance, Switzerland, Belgium and Italy applied the infringement test. The latter was more advantageous for the originator pharmaceutical company The court has now addressed the issues regarding the interpretation of Article 3(a) and (b) for combination products Illustrative of the disharmony in Europe is Novartis’s in Medeva and Georgetown and in the three subsequent experience regarding the granting of SPCs for its product reasoned orders (Yeda, Queensland and Daiichi) as is valsartan: the uncertainty led to different SPCs and many 11) In so far as we can assess on the information publicly available to us.
Also referred to as the ‘subject-matter test’ or ‘literal test’.
12) In the United Kingdom, interpretations given to the ‘disclosure test’differed between cases (between judges).
10) The disclosure test in itself also contained many different interpretationsbetween countries and even within the United Kingdom.
BIO-SCIENCE LAW REVIEW PUBLISHED BY LAWTEXT PUBLISHING LIMITED VOL 12 ISSUE 4 BSLR : KUIPERS, DOUMA AND KOKKE : RECENT EUROPEAN DEVELOPMENTS REGARDING PATENT EXTENSIONS (SPCs AND PAEDIATRIC EXTENSIONS) Medeva (C–322/10) and Georgetown (C–422/10): if the basic patent claims A and the MA is for A+B, an SPC can be combination of two active ingredients, corresponding to that specified in the wording of the claims of the Medeva owned a patent relating to two antigens of the basic patent relied on, where the medicinal product whooping cough. However, the vaccines marketed (and hence for which the marketing authorisation is submitted in the MAs) contained additional active ingredients, directed at support of the application for a special protection diphtheria, tetanus, meningitis and/or polio. Medeva applied certificate contains not only that combination of the for five SPCs with the UK IPO, four covering combination two active ingredients but also other active vaccines and one limited to the two patented components ingredients. (emphasis added) only. The IPO rejected all SPCs, the first four for not complying This can be interpreted as follows. If the basic patent with Article 3(a) of the SPC Regulation, because the product specifies/identifies active ingredient A only, and the MA was containing multiple active ingredients of the MA relied on was granted for a combination of active ingredients A + B, an SPC not considered to be protected by the basic patent. The SPC can be granted for A. This is also apparent from paragraphs 31 directed at only the two patented components was rejected and 38 of the Georgetown and Medeva decisions respectively, for non-compliance with Article 3(b), as there was no valid MA making reference to paragraphs 34 and 39 of the Explanatory in place because the MA contained more active ingredients Memorandum.14 Georgetown also concerned a multi-disease than the product claimed in the patent. The Court of Appeal vaccine but only Article 3(b) was at issue and the patent (England and Wales) referred the case to the court in June concerned only one active ingredient; the court’s ruling in that 2010 where it was registered as C–322/10. On 24 November case is identical to the second part of Medeva and will not be 2011, the court handed down its decision in this case. It ruled The interpretation endorsed by the court is a combination of a Article 3(a) of Regulation (EC) No 469/2009 … must be teleological interpretation of Article 3(b) combined with a interpreted as precluding the competent industrial rather strict interpretation of Article 3(a). We will refer to this property office of a Member State from granting a as ‘the Medeva test’. Regarding the interpretation of 3(a), it supplementary protection certificate relating to active seems closer to the ‘disclosure test’ than to the ‘infringement ingredients which are not specified in the wording of test’, but it should be noted that the ‘disclosure test’ in itself the claims of the basic patent relied on in support of was the subject of different interpretations throughout the application for such a certificate. (emphasis Europe and even within countries; such was the case in the United Kingdom where the referrals originated from. The In other words, an SPC can only be obtained for the active court seems to have applied a strict interpretation of the ingredients that are specified in the wording of the claims of ‘disclosure test’. Some challenges regarding the applicability the patent. It is noteworthy that in its three reasoned orders, of the Medeva test are addressed in the discussion.
Yeda, Queensland and Daiichi (to be discussed below), the Daiichi (C–6/11) and Yeda (C–518/10): further clarifications court replaced ‘specified’ by ‘identified’ (in the original English language orders, not in translated versions13) without On 25 November 2011, the day after the Medeva and giving any explanation for this change. The possible Georgetown rulings, the court handed down three reasoned significance of this is a subject of discussion.
orders in other SPC cases concerning combination products. The Secondly, with regard to Article 3(b) of the SPC Regulation, rulings are mostly repetitions of the aforementioned cases, but provide some additional insights which are highlighted below.
Article 3(b) of Regulation No 469/2009 must be Daiichi owns a patent regarding an active ingredient A. It interpreted as meaning that, provided the other obtained an SPC for this product based on an MA containing requirements laid down in Article 3 are also met, that A as the sole active ingredient. Daiichi invested considerable provision does not preclude the competent industrial time and resources in undertaking further clinical trials and property office of a Member State from granting a studies for a combination therapy of A+B. The clinical trials 13) We checked the Spanish, German, French and Dutch decisions; in these products of 11 April 1990, the predecessor of the present SPC Regulation, languages the same verb is used in both the judgments and orders.
can be found at : https://sites.google.com/site/spccases/explanatory-memoranda/thememo.pdf?attredirects=0&d=1. This memorandum is 14) The Explanatory Memorandum to the proposal for a council regulation considered relevant for the present SPC Regulation.
concerning the creation of a supplementary protection certificate for medicinal BIO-SCIENCE LAW REVIEW PUBLISHED BY LAWTEXT PUBLISHING LIMITED KUIPERS, DOUMA AND KOKKE : RECENT EUROPEAN DEVELOPMENTS REGARDING PATENT EXTENSIONS (SPCs AND PAEDIATRIC EXTENSIONS) : VOL 12 ISSUE 4 BSLR were successful and Daiichi then sought an SPC relying on the The two MAs relied on for the SPC applications contain MA it had obtained for the combination product and on the a combination of active ingredients both from the divisional same basic patent. The British IPO refused this second SPC patents and from the parent patent. The actual court ruling for the combination therapy on the grounds that the active regarding most questions referred is no surprise and is a ingredients of the MA are not protected (that is, disclosed) by literal copy of the rulings in Medeva. However, a new the basic patent within the meaning of Article 3(a). After question was whether, in a case involving a basic patent another UK referral, the court in confirming the IPO’s decision relating to a product-by-process claim, it is necessary for the in Daiichi used the exact wording of Medeva, making clear ‘product’ to be obtained directly by means of that process.
that the Medeva test is not limited to multi-disease vaccines The court ruled that it is irrelevant whether the product but applies to all combination products.15 is derived directly from the process, but that Article 3(a) Yeda involved another reasoned order. Yeda owns a European patent that discloses a therapeutic composition A+B. The precludes [an SPC] being granted for a product other patent also claims the administration of both components than that identified in the wording of the claims of separately, provided they are part of the same composition.
that patent as the product deriving from the process Yeda applied for two SPCs, one for the composition A+B and one for active ingredient A only. The supporting MA only In other words, if the (in)direct product is not specified/ covered product A, but indicated that it should be identified in the wording of the claims, an SPC will not be administered together with B. Certain national IPOs granted possible for that active ingredient.
SPCs to Yeda but the British IPO refused both SPCs. Yeda appealed only the refusal of the SPC for A stating that since A would indirectly infringe on the patent for A+B, the patent A consideration, though not part of the actual rulings, in would protect A and thus an SPC for A should have been Medeva,16 Georgetown17 and Queensland18 that sparked granted now that the MA was for A as well. Following a referral by the Court of Appeal, the court clarified that an SPC cannot where a product is protected by a number of basic patents in force, each of those patents may be … where the active ingredient specified in the designated for the purpose of the procedure for the (marketing) application, even though identified in the grant of a certificate but only one certificate may be wording of the claims of the basic patent as an active granted for that basic patent … .19 ingredient forming part of a combination in A similar consideration was given in Biogen/SKB20 in 1997. It conjunction with another active ingredient, is not the seems to imply that one MA concerning a combination of subject of any claim relating to that active ingredient active ingredients can be relied on for several SPC applications, provided the constitutive active ingredients are specified in the wordings of the claims of different basic Thus an SPC cannot be granted for A if the patent claims A + B patents and provided the other requirements of Article 3 are in combination only and the MA relied on for the application also met. However, the wording of the consideration was also understood to limit the number of SPCs granted for a basic Queensland (C–630/10): product-by-process claims and SPCs patent to one. If this understanding is correct, this would be The third reasoned order rendered on 25 November 2011 contrary to current practice, where several SPCs can be and concerned Queensland, the owner of a parent patent and are granted by national IPOs based on different active two divisional patents. The parent patent claims several ingredients specified in one basic patent. Biogen/SKB was active ingredients (by product-through-process claims) and widely interpreted to mean ‘one SPC per product per patent’.
the divisional patents claim additional active ingredients. This is also in line with Article 3(2) Plant SPC Regulation.21 We 15) In the UK referral, possible non-compliance with Articles 3(c) and (d) was 20) C–181/95 of 23 January 1997, paragraph 28.
not an issue. In the parallel French proceedings, the SPC application was 21) Article 3(2): ‘2. The holder of more than one patent for the same product dismissed because the product had already been the subject of a certificate.
shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from twoor more holders of different patents are pending, one certificate for this product may be issued to each of these holders.’ This illustrates exactly what is meant to be excluded from protection by a certificate, It does not exclude thesituation where one patent claims two different products in separate claims.
19) Queensland paragraph 35 (emphasis added).
BIO-SCIENCE LAW REVIEW PUBLISHED BY LAWTEXT PUBLISHING LIMITED VOL 12 ISSUE 4 BSLR : KUIPERS, DOUMA AND KOKKE : RECENT EUROPEAN DEVELOPMENTS REGARDING PATENT EXTENSIONS (SPCs AND PAEDIATRIC EXTENSIONS) therefore expect that the recent decisions will not affect the As the granting of a ‘paediatric extension’ is possible existing practice; it should remain possible to obtain more only if an SPC is in place, a six-month extension of a than one SPC relying on the same basic patent if the negative term SPC, provided the negative term is less than patent claims several active ingredients independently (that six months, can result in considerable benefits for the is, not as part of a combination). Indeed, Arnold J, in proprietor. Drugs are usually at their most profitable stage at Queensland22 allowed two SPCs based on the same basic the end of the patent term and every day of extended patent, for different active ingredients, with reference to the exclusivity can give considerable profits. However, not all national IPOs agreed on how to handle cases in which the MA was granted within five years of the application date for The Merck Case: SPC with Negative Term? – Disharmony in Europe: different term or no SPC(s) granted In Merck (C–125/10) the court was asked to clarify Article 13 Merck Sharp & Dohme Corp. (‘Merck’) applied for an SPC SPC Regulation. More specifically, it was asked to rule throughout Europe for its product sitagliptin, a DPP inhibitor whether an SPC can have a negative term. We first explain used in the treatment of type 2 diabetes. The MA on which what a negative term SPC is and why a company would be Merck based its application was obtained less than five years interested in obtaining one; we subsequently point out how after the application date of the basic patent. The resulting this gave rise to different interpretations in Europe; and we SPC term would be minus three months and 14 days. Merck’s round off this section with the decision of the court regarding application resulted in various decisions, including: the grant of a negative term SPC by the IPOs in the Article 13(1) and (2) SPC Regulation stipulate that an SPC takes effect at the end of the lawful term of the basic patent the grant of a zero term SPC in Greece (because it and that its duration may not exceed five years from the date was believed a negative term was not possible and should be on which it takes effect. The calculation of the duration of the no SPC in Germany as the IPO argued that a negative Merck appealed the German decision before the Y = application date of basic patent.
Bundespatentgericht, which referred the question of a negative For instance, if the patent was applied for on 1 July 1999 and term SPC to the court, in light of the possibility of obtaining a the first MA in the EU was granted seven years later on 1 July paediatric extension which would result in a positive term 2006, the SPC duration will be two years. In cases where the extended protection. This resulted in Case C–125/10.
MA is granted within five years of the application date of the Judgment of the court in Merck (C–125/10) (sitagliptin) patent, this would result in an SPC with a negative term. When On 8 December 2011, the court ruled on those questions that the predecessor of the present SPC Regulation was it is possible to obtain a negative term SPC in view of the introduced in 1992,23 a negative term SPC was not beneficial Paediatric Regulation. It also ruled that a paediatric extension for the rights holder and consequently not applied for. This should commence on the date determined in accordance with changed in 2006 with the introduction of the ‘Paediatric the (negative) term calculated according to Article 13(1) of the Regulation’,24 which provided for a six-month extension for an SPC Regulation (in other words, in this case prior to patent SPC already in place for a medicinal product, in order to expiry). The court also explained that a negative term SPC promote research regarding the effects of the medical product at issue on the paediatric population. After the introduction of the Paediatric Regulation, the maximum term … it is only in the case where the period between of patent-related exclusivity for a medicinal product is lodging the basic patent application and the date of 15.5 years (patent + SPC + paediatric extension).
the first MA in the EU for the medicinal product in 22) After referral, HC 14 February 2012.
24) Regulation (EC) 1901/2006 of the European Parliament and of the Councilof 12 December 2006 on medicinal products for paediatric use.
BIO-SCIENCE LAW REVIEW PUBLISHED BY LAWTEXT PUBLISHING LIMITED KUIPERS, DOUMA AND KOKKE : RECENT EUROPEAN DEVELOPMENTS REGARDING PATENT EXTENSIONS (SPCs AND PAEDIATRIC EXTENSIONS) : VOL 12 ISSUE 4 BSLR question is exactly five years that an SPC can have a Article 4 limits the protection to the product covered by the duration equal to zero and that the starting point of MA, whereas Article 5 confers on the SPC the same rights as the paediatric extension of six months is concurrent the basic patent. The question has arisen whether, for with the expiry date of the basic patent.25 instance, an SPC for A can be enforced against a medicinal product that contains not only active ingredient A but also In this case the SPC had a protection period of minus three active ingredient B. If the original product on the market months and 14 days, hence with a six-month paediatric contained only A, it would seem that according to Article 4 the extension, Merck could benefit from additional exclusivity protection cannot extend beyond a product containing only during the two months and 16 days following the expiry of The background of these two Articles is rather different, and Subject-matter of Protection and Effects of originates from the fact that the SPC is a sui generis right that lies at the interface between the system governing MAs for medical products on the one hand and patent law on the other Now that we have discussed cases concerning the obtaining hand. SPCs are meant to provide supplementary protection to of an SPC it is worth considering what it is that one actually a patented product. Article 5 aligns with the rights conferred obtains. SPCs are sui generis intellectual property rights that by the basic patent. However, the rationale of the SPC can extend the period of ‘protection’ of a pharmaceutical Regulation is to compensate for lost time in (performing product for five years (at the end of the patent term, which is clinical studies and) applying for an MA for a specific product.
generally the most beneficial period for pharmaceuticals). The In that respect, Article 4 could be understood to align the question is what the protection of an SPC actually consists of, scope of protection of an SPC to the actual product authorised and once again attempts at an answer caused disharmony in (for which the actual delay has occurred).
Europe. Recently this question was dealt with by the court in referrals from the United Kingdom and Germany in cases between Novartis and Actavis concerning valsartan (the UK As an example of the disharmony regarding the interpretation C–442/11 and German C–574/11 cases).
of Articles 4 and 5, we will again look at the valsartan situation in several European countries. As already mentioned, Novartis owned a European patent claiming the The subject-matter and effects of protection of SPCs is dealt active ingredient valsartan (‘A’), which expired on 12 February with by Articles 4 and 5 SPC Regulation. These Articles may be 2011. In several countries Novartis has two MAs for products seen as contradicting each other and they gave rise to that contain valsartan as an active ingredient: (i) an MA for a different interpretations, resulting in a difference in the scope product containing valsartan (‘A’) only, and (ii) an MA for a of protection afforded to SPCs in different European product containing valsartan in combination with HCTZ countries. Articles 4 and 5 of the SPC Regulation read: (‘A+B’). Novartis – in the pre-Medeva era – obtained SPCs in various European countries for A and/or A+B (see Table 2). In Article 4 Subject matter of protection most countries, however, Novartis had an SPC for A only.
Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate In late 2010, several generic companies indicated their shall extend only to the product covered by the intention to market a generic medicinal product containing authorisation to place the corresponding medicinal A+B after expiry of the patent. In several proceedings that product on the market and for any use of the product followed, the issue arose as to whether an SPC for A would as a medicinal product that has been authorised confer protection against a pharmaceutical product before the expiry of the certificate. containing A and B. The answer varied by country, by court and in some cases even by judicial chamber.
Article 5 Effects of the certificate Subject to the provisions of Article 4, the certificate In Norway, the court held on 10 February 2011 that Actavis’s shall confer the same rights as conferred by the basic generic A+B infringed Novartis’s SPC for A. In Belgium, the patent and shall be subject to the same limitations situation was different, as Novartis had SPCs for both A and and the same obligations. (emphasis added) A+B. In a declaratory action started by Teva, Teva sought to 25) Paragraphs 42 and 43 of the decision in C–125/10.
BIO-SCIENCE LAW REVIEW PUBLISHED BY LAWTEXT PUBLISHING LIMITED VOL 12 ISSUE 4 BSLR : KUIPERS, DOUMA AND KOKKE : RECENT EUROPEAN DEVELOPMENTS REGARDING PATENT EXTENSIONS (SPCs AND PAEDIATRIC EXTENSIONS) (i) invalidate Novartis’s SPC for A+B, and (ii) obtain a SPC, but had refused to prohibit the importation, detention or declaration of non-infringement of Novartis’s SPC for A by Teva’s generic A+B. On 13 May 2011 the Antwerp Court held It is not appropriate to grant the respondents’ claim that Teva’s generic A+B did not infringe Novartis’s SPC for A for prohibition of the manufacture, holding, use or because the scope was limited, but at the same time held that importation of these products before this date it did infringe Novartis’s valid SPC for A+B. The Antwerp Court because the products at stake are generic products made reference to the Explanatory Memorandum:26 that have been granted the necessary authorisations 20. The proposed system takes the legal form of a new from the public authorities, and which must be protection certificate, sui generis, which is national in marketable as soon as the protection granted by the character and lies at the interface between two patent and SPC held by the respondents lapses. Only systems, that of prior authorizations for the placing on the marketing before the end of the protection period the market of medicinal products and that of their protection by patent, and which confers on the system Secondly, Novartis v Sanofi contradicts a judgment regarding its specific characteristics and special nature. These valsartan of the Paris Court of Appeal of 16 September 2011 can be seen first of all in the scope of the certificate where the combination product valsartan and HCTZ was held not and the conditions for obtaining it … They can also be to infringe Novartis’s SPC for valsartan.29 The Court of Appeal: seen in the subject of protection. [This last sentence is Considering that the product as defined by the regulation is not restricted to an active ingredient and 38. [The SPC is] a protection certificate sui generis that the SPC pursuant to Article 4 does not protect the inasmuch as it is linked to both an authorization to active ingredient but rather the product so that the place the product on the market … and to a previous SPC protects the valsartan product only. Questions from the United Kingdom and Germany regarding The Antwerp Court also made reference to preamble 10 to the the interpretation of Articles 4 and 5 SPC Regulation were … the protection granted should be strictly confined to the product which obtained authorisation to be placed on the market as a medicinal product. It furthermore considered it relevant that Novartis had in fact accepted the limited protection of its SPC for A by applying for Articles 4 and 5 of (the SPC) Regulation … must be interpreted as meaning that, where a ‘product’ In France, conflicting decisions have been handed down in consisting of an active ingredient was protected by a cases concerning the scope of protection of an SPC. In basic patent and the holder of that patent was able to Novartis v Sanofi, the Paris Court of First Instance held27 that rely on the protection conferred by that patent for that Sanofi’s combination generic A+B infringes Novartis’s SPC for ‘product’ in order to oppose the marketing of a A. An injunction was granted prohibiting the manufacture, medicinal product containing that active ingredient in importation, offer for sale, holding, storing and marketing of combination with one or more other active ingredients, the generics as well as ordering the recall of the products a supplementary protection certificate granted for that from every distribution channel. This contradicts earlier ‘product’ enables its holder, after the basic patent has French case law in two ways. Firstly, in the Losartan cases, the expired, to oppose the marketing by a third party of a injunction granted was more limited, as both the President of medicinal product containing that product for a use of the Paris Court of First Instance and the Court of Appeal had the ‘product’, as a medicinal product, which was only prohibited the sale of generics until the expiration of the authorised before that certificate expired.30 26) Note 14 above, Considerations 20 and 38.
29) Paris Court of Appeal, 16 September 2011, Actavis v Novartis.
27) On 27 and 31 October 2011 in proceedings ex parte and inter partes 30) At the time of writing the order in C–574/11 was only available in German and French and the order in C–442/11 had been made available in English andFrench.
28) Paris Court of Appeal, 15 March 2011, Mylan and Qualimed v Dupont andMerck.
BIO-SCIENCE LAW REVIEW PUBLISHED BY LAWTEXT PUBLISHING LIMITED KUIPERS, DOUMA AND KOKKE : RECENT EUROPEAN DEVELOPMENTS REGARDING PATENT EXTENSIONS (SPCs AND PAEDIATRIC EXTENSIONS) : VOL 12 ISSUE 4 BSLR In other words, if Novartis was able to invoke its patent for A define a product in functional terms? For example, is an against an authorised medicinal product containing A and antibody sufficiently specified/identified by claiming that it is other active ingredients, it could also invoke its SPC for A specific to a certain antigen without disclosing the exact against such product. Whether this is the case is, of course, structure of the antibody itself? What if the patent claims a left to national courts to decide on the basis of national law.
whole list of products defined by the same functional terms? The court did note in the order on the UK referral: The drafting practice for patents will presumably be reconsidered as a consequence of the Medeva test.
In the case before the national court, it is common ground that the marketing of a medicinal Since the court’s decisions, several cases were decided by product containing valsartan in combination with national courts in which this issue came up. In Lundbeck v hydrochlorothiazide for use in the treatment of high Tiefenbacher and Centrafarm33 the Court of Appeal of blood pressure would infringe the rights conferred by The Hague found that the salt escilatopramoxalate, although not named in the wording of the process claim, was sufficiently specified/identified. The court first nullified all product claims of the patent. The remaining process claim concerned a method for the preparation of escitalopram In this section we first address several issues that still remain (an S-enantiomere of citalopram) and non-toxic acid-addition insufficiently clear after the late 2011 and early 2012 salts thereof. With reference to Queensland and the Medeva decisions, with reference to some examples of the court’s test, the court then determined whether the SPC granted for recent case law applied by national courts. Subsequently we ‘Escilatopram, if so desired as a pharmaceutically acceptable look at the possible consequences of the decisions for SPCs acid-addition-salt thereof, especially escitalopramoxalate’34 that in retrospect should not have been granted. Lastly we (based on an MA for the same active ingredient) was valid.
discuss some issues with respect to the protection and effect The Court of Appeal determined that the remaining claim of the patent specifically claims non-toxic acid-addition salts of escilatopram. The salt covered by the SPC and the MA (escilatopram oxalate) is not mentioned literally in the claim, but is mentioned as a specific example-product of the Challenges regarding the application of the Medeva test process in the description. The Court of Appeal was then left As pointed out above, the Medeva test seems closer to the with the question whether this would be considered to be ‘disclosure test’32 than to the ‘infringement test’. However, sufficiently specified/identified in the wording of the claims.
how practical are the guidelines provided by the court? The Court of Appeal referred to the latest decisions and It remains unclear what exact ‘identification’ or ‘specification’ orders by the court in this respect (Medeva and so on) and in the wording of the claims of the patent is required by considered the following on whether identified would be the Medeva test. The choice of a different verb (‘specified’ in Medeva and Georgetown and ‘identified’ in Yeda, and Daiichi), although not present in It seems plausible that the terms ‘identified’ and translations, might be relevant. Is one more precise or ‘specified’ have the same meaning in the absence of narrower than the other? It is to be expected that the question of whether an active ingredient is specified or identified in the The Court of Appeal then concluded that the SPC was indeed wording of the claims of the basic patent will lead to valid as the product was sufficiently identified in the wording discussion and possibly more referrals to the court. Is it always possible to identify the product of a process claim sufficiently for this test? When are complicated biologics The UK High Court also decided on this issue post-Medeva in specified or identified sufficiently? Is it sufficiently specific to 31) Consideration 21. In the German case in a similar consideration (19), the court mentions that the referring court established that Actavis's combination 34) The text of the SPC as granted in Dutch is: ‘Escitalopram, desgewenst in product infringed Novartis's valsartan patent.
de vorm van een farmaceutisch aanvaardbaar zuuradditiezout, in het bijzonder 32) As stated above, it should be noted that the ‘disclosure test’ in itself was the subject of different interpretations throughout Europe and even within countries; such was the case in the United Kingdom where the referralsoriginated. The court seems to have applied a strict interpretation of the BIO-SCIENCE LAW REVIEW PUBLISHED BY LAWTEXT PUBLISHING LIMITED VOL 12 ISSUE 4 BSLR : KUIPERS, DOUMA AND KOKKE : RECENT EUROPEAN DEVELOPMENTS REGARDING PATENT EXTENSIONS (SPCs AND PAEDIATRIC EXTENSIONS) It is noteworthy that in Arnold J’s first judgment in this product, which points away from an infringement-type case38, he held that (i) the patent was invalid, and (ii) claim 1 test. In the present case, claim 1 merely identifies the did not cover the process by which ranibizumab is produced product of the method as ‘a molecule with binding (and could thus not be infringed by a product containing specificity for a particular target’. This covers millions ranibizumab). As a result, the SPC for ranibizumab would be invalid. But, because Arnold J gave permission to appeal, of different molecules of various kinds. It is not even under UK law he needed to address all issues in these limited to antibodies. Although ranibizumab falls proceedings on the hypothesis that the patent would be held within this extremely broad class of products, there is valid and infringed in appeal, which resulted in his second nothing at all in the wording of the claim, or even the lengthy specification of the Patent, to identify The relevant claim of the basic patent was also a process claim ranibizumab as the product of the process in identifying the product of the method functionally as ‘a molecule with binding specificity for a particular target’. The The High Court of Justice also decided in Queensland v SPC and MA concerned the product ranibizumab, which was Comptroller General40 after referral. In this case the indeed a possible product of the process claimed. But there interpretation of the court’s instructions was straightforward.
was debate on whether ranibizumab would be actually Queensland’s appeal concerned two groups of SPC specified/identified in the wording of the claims as the product applications. The first group defined the product as the deriving from the process in question. Novartis argued that combination of antigens (that is, active ingredients) as claim 1 did not identify ranibizumab because this would not covered by the relevant MA; the second group of applications have been developed until several years after the patent was defined the product as a single antigen mentioned in the applied for. Arnold J held that ranibizumab was not basic patent and selected from the combination covered by specified/identified in the wording of the claims (and it was the MA. On 14 February 2012, Arnold J dismissed the appeal held not to be identified in the description either) as the relating to the first group of SPC applications as the product deriving from the process in question and on that appellants (Queensland), after the court’s ruling, accepted basis invalidated the SPC. In so doing, Arnold J made reference that they did not comply with Article 3(a) SPC Regulation to the recent decisions of the court, including the Medeva test.
since the combinations claimed included active ingredients Arnold J held that he found the test provided by the court was which were not identified in the wording of the claims of the not sufficiently clear, apart from its rejection of the basic patents. Arnold J allowed the appeal for the second infringement test. He expected that at some stage this would group of SPCs in view of the court’s interpretation of lead to more referrals. In this case no questions were referred Article 3(b), as accepted by the Comptroller General.
and Arnold J put forward some interesting considerations: Consequences for SPCs granted prior to these decisions that Secondly, the Court’s rulings do not merely require the product to be specified in the claims (compare section The court’s decisions regarding negative SPCs and Article 3(a) 125(1) of the 1977 Act), but specified or identified in the and 3(b) may have consequences for SPCs that in hindsight wording of the claims. It appears to me that this points should not have been granted. This is, for instance, the to a test which is more demanding than merely requiring case in countries where the infringement test was used that the product be within the scope of the claim, for the interpretation of Article 3(a), namely where SPCs for although it is not clear how much more demanding. A + B were granted even if the basic patent protected only A.
Thirdly, even if Medeva can be interpreted as leaving Article 15 SPC Regulation stipulates that the certificate will open the possibility that it is sufficient for the product be invalid if it was granted contrary to the provisions of to be within the scope of the claim where the claim is Article 3. Indeed, following the court’s decision in Medeva, a product claim, it seems to me that Queensland lays this has already led to the Court of Rome ruling on down a narrower rule in the case of process claims. 25 November 2011 that Novartis cannot invoke its (Italian) The Court of Justice requires the product to be SPC granted for the combination product valsartan and HCTZ, identified in the wording of the claim as the product as only valsartan is specified in the wording of the basic deriving from the process in question. Furthermore, it patent (Table 2), clearing the way for Mylan and others to says that it is irrelevant whether or not it was possible market their generic combination product in Italy (there was to obtain the product directly by means of that 39) See the judgment paragraphs 56 to 57.
BIO-SCIENCE LAW REVIEW PUBLISHED BY LAWTEXT PUBLISHING LIMITED KUIPERS, DOUMA AND KOKKE : RECENT EUROPEAN DEVELOPMENTS REGARDING PATENT EXTENSIONS (SPCs AND PAEDIATRIC EXTENSIONS) : VOL 12 ISSUE 4 BSLR In cases where the term of SPCs (and paediatric extensions) is the interface between the patent system and the rules incorrect after the Merck decision, for example in countries where negative SPCs were rounded up to zero, the SPCs can They [that is, the interface] can also be seen in the also be challenged. However, the SPC Regulation is less clear subject of the protection, which is limited both by the about the consequences for violation of Article 13. It is to be authorisation itself since the protection extends only to expected that the SPC will not be revoked but that its duration the authorised product and only for the therapeutic uses of it which were the subject of an authorisation, and in the claims for the basic patent. (emphasis added) It therefore remains to be seen whether the outcome would be Post-Medeva an SPC can now be obtained for A if the different if an SPC was obtained for A, the MA is for A+B and the patent protects A and the MA has been obtained for A+B. In patent for A (applying Medeva). What if (the majority of ) the Novartis, questions on the scope of protection and effects delay (in obtaining an MA) was caused by performing clinical were dealt with; an SPC for A confers the same rights trials on A+B or B and/or meeting the requirements of the as a patent for A (and thus the SPC for A could be enforced regulatory authorities directed at A+B (and thus not on A as against a product containing A+B). It has been suggested such)? Could such an SPC for A be enforced against a product (and in fact the decision itself seems to suggest) that containing A+C or even against a product containing only A this means that SPCs confer the same rights and have (let alone for which therapeutic uses)? If not, would this then the same scope of protection as the basic patent. However, prove to be of relevance to the SPCs granted post-Medeva? Novartis’s SPC for A in the United Kingdom was granted on the basis of an MA for A (pre-Medeva). Thus this case did not relate to an SPC granted post-Medeva applying In the past year issues regarding Articles 3, 4, 5 and 13 SPC the Medeva test. Because the MA was for A and the SPC as Regulation have been resolved. The court’s interpretation of well, the crucial part of Article 4 was no drawback to the Article 3(a) and (b) has clarified the granting of SPCs in particular for combination products, to a certain extent.
… the protection conferred by a certificate shall extend For easy reference we include a table summarising the only to the product covered by the authorisation to situation for granting SPCs for combination products after the place the corresponding medicinal product on the 2011 court decisions regarding Article 3(a) and (b) SPC Regulation (Table 3), obviously on the condition that A, B and This part of Article 4 has even more relevance in view of so on are (sufficiently) specified/identified in the wording of consideration 20 of the Explanatory Memorandum regarding Table 3: Summary of the Present Situation* * This reflects the case law regarding Article 3(a) and (b); obviously also the requirements of Article 3(c) and (d) need to be met.
BIO-SCIENCE LAW REVIEW PUBLISHED BY LAWTEXT PUBLISHING LIMITED VOL 12 ISSUE 4 BSLR : KUIPERS, DOUMA AND KOKKE : RECENT EUROPEAN DEVELOPMENTS REGARDING PATENT EXTENSIONS (SPCs AND PAEDIATRIC EXTENSIONS) However, issues remain. Regarding Article 3(a) the court ruled Furthermore, the rulings are likely to have consequences for that an SPC cannot be granted for ‘active ingredients which are not specified/identified in the wording of the claims of the The court has also clarified Article 13 SPC Regulation, ruling that negative SPCs are possible in view of the Paediatric It is unfortunate that this guideline provided by the court is rather unclear, leaving room for different interpretations and Lastly, the court clarified that a medicinal product for a is likely to lead to more referrals to the court. Arnold J combination of active ingredients A + B infringes an SPC for an mentioned in MedImmune v Novartis that he found the test active ingredient A. In other words, the court clarified that the provided by the court not sufficiently clear, apart from its scope of protection of an SPC for A extends to any product rejection of the infringement test, adding: ‘Regrettably, containing A as long as the patent also confers that right (and therefore, it is inevitable that there will have to be further as long as the MA is for A?). Yet in this respect also several references to the (Court) to obtain clarification of the test.’ BIO-SCIENCE LAW REVIEW PUBLISHED BY LAWTEXT PUBLISHING LIMITED

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