For the sake of completeness, here's the Generics ruling

Also before the Court of Justice of the European Union today was Case C‑427/09, Generics (UK) Ltd v Synaptech Inc., a reference for a preliminary ruling from the Court of Appeal (England and Wales).  This time the contested substance was not memantine but galantamine -- which had been on sale as a medicinal product in various European countries for more than 40 years. In central Europe, it was used to treat neuromuscular conditions. In 1963 a marketing authorisation was issued in Austria, under that countty's 1947 medicines regulations, to use galantamine in the treatment of poliomyelitis under the trade mark Nivalin. In Germany, galantamine was already on the market in the 1960s under the same trade mark and, under the German Law of 1976, galantamine could remain on the German market as a product deemed to be authorised as a medicinal product under a ‘fictitious’ authorisation.

In January 1987 Synaptech filed an application for a basic galantamine patent in the European Patent Office, claiming the use of galantamine for the treatment of Alzheimer’s Disease. In 1997 Janssen-Cilag took over distribution of Nivalin in Austria and, in 1999, filed an application in Sweden for a marketing authorisation for the use of galantamine in a medicinal product to treat Alzheimer’s Disease under the brand name Reminyl. After an assessment carried out in accordance with Directive 65/65, Reminyl was authorised in March 2000. Six months later, the United Kingdom also issued a market authorisation for Reminyl.

All good fictions come to an end, and the fictitious authorisation of Nivalin was no exception: the German and Austrian authorisation were withdrawn in the second half of 2000 and in 2001 respectively.

In December 2000 Synaptech applied for a UK SPC for galantamine, listing the Swedish marketing authorisation as the first authorisation to place the product on the market as a medicinal product in the Community. Based on that marketing authorisation, Synaptech's application was granted with a maximum term of five years, expiring in January 2012, with the basic galantamine patent expiring on 16 January 2007.

Generics was not happy about this, taking the view that the SPC’s date of expiry had not been calculated correctly by the UK Patent Office when it chose to rely on the Swedish marketing authorisation. Generics therefore sought rectification under section 34 of the Patents Act 1977. That claim was rejected, so Generics appealed to the Court of Appeal. The company accepted that the German and Austrian marketing authorisations had never complied with the requirements of Directive 65/65 and that the first authorisation that did comply with it was the Swedish authorisation.  The Court of Appeal (England and Wales) (Civil Division) had doubts as to the interpretation which should be given to the concept of ‘first authorisation to place the product on the market in the Community’ in Article 13(1) of Regulation 1768/92, so it decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

‘(1) For the purposes of Article 13(1) of [Regulation No 1768/92], is the “first authorisation to place the product on the market in the Community” the first authorisation to place the product on the market in the Community which was issued in accordance with [Directive 65/65] (now replaced with Directive 2001/83/EC [of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67)]) or will any authorisation that enables the product to be placed on the market in the Community or [European Economic Area] suffice? 

(2) If, for the purposes of Article 13(1) of [Regulation No 1768/92], an “authorisation to place the product on the market in the Community” must have been issued in accordance with [Directive 65/65] (now replaced with Directive 2001/83/EC), is an authorisation that was granted in 1963 in Austria in accordance with the national legislation in force at that time (which did not comply with the requirements of [Directive 65/65]) and that was never amended to comply with [that directive] and was ultimately withdrawn in 2001, to be treated as an authorisation granted in accordance with [that directive] for that purpose?’

The Court today, in a very short ruling indeed, observed that the answer to these questions is relevant only if galantamine is within the scope of that regulation and can thus be the subject of an SPC. Citing this morning's other SPC in Case C‑195/09 Synthon [2011] (noted here), the Court said Article 2 of Regulation 1768/92 means that a product like galantamine, placed on the market in the Community as a medicinal product for human use before receiving a Directive 65/65 marketing authorisation and without undergoing safety and efficacy testing, was not within the scope of Regulation 1768/92 and could not therefore be the subject of an SPC. Since galantamine couldn't be the subject of an SPC, Articles 13 and 19 of Regulation 1768/92 don't apply. If they don't apply, the Court doesn't need to interpret them.

The ECJ therefore ruled as follows:

"A product, such as that at issue in the main proceedings, which was placed on the market in the European Community as a medicinal product for human use before obtaining a marketing authorisation in accordance with Council Directive 65/65 ... as amended ... may not be the subject of a supplementary protection certificate.".

Synthon ruling rejects pre-65/65 authorisations

This morning the Court of Justice of the European Union handed down its ruling in Case C‑195/09 Synthon BV v Merz Pharma GmbH & Co. KGaA, this being a reference for a preliminary ruling from the Patents Court, England and Wales.

To summarise, even before 1 September 1976 Merz was offering memantine for sale in Germany as a medicinal product for human use under the brand name Akatinol. That product, used in the treatment of Parkinson’s Disease and for other indications, was covered by an authorisation issued in accordance with German legislation from 1961 which did not requiere medicinal products to be tested for safety or efficacy. Under the German Law of 1976 memantine was granted a marketing authorisation in Germany without going through the procedures required under Directive 65/65, the first-ever European pharma Directive.

In June 1983 Merz applied to the competent Luxembourg authorities for a marketing authorisation for that medicinal product.  This was was issued in September 1983 under a Luxembourg Law of 1983. However, the Luxembourg authorities relied on the German marketing authorisation issued previously and did not test the safety and efficacy of memantine. In April 1989 Merz applied for a European patent for memantine hydrochloride which was granted even though memantine was already available commercially, on the ground that the patent was for a second medical use of memantine: for the preparation of a medicinal product to treat Alzheimer’s Disease. This patent expired on 13 April 2009.

Both the German and Luxembourg marketing authorisations were withdrawn when, in May 2002, a series of marketing authorisations valid within the European Community (‘the 2002 marketing authorisations’) were issued to Lundbeck as a licensee of Merz under Council Regulation 2309/93. This authorisation of 2002 was for the medicinal product Ebixa, the brand name adopted in order to market memantine's second medical use. Before this authorisation was issued, the safety and efficacy of Ebixa had been tested by the European Agency for the Evaluation of Medicinal Products, in accordance with Directive 65/65.

In November 2002 Merz applied to the United Kingdom Patent Office for an SPC for memantine. In its application, Merz referred to the basic patent valid in the UK and also to the 2002 marketing authorisation, but not to the prehistoric German or Luxembourg marketing authorisations. The SPC was granted in August 2003 for a term of five years.

Generics manufacturer Synthon then challenged the validity of Merz's SPC and maintained that, if valid, its term of protection should be fixed at zero. The Patents Court had some doubt both as to the scope of the SPC regulation, Regulation 1768/92, and the definition of ‘first authorisation to place … on the market in the Community’, within the meaning of Articles 13 and 19 of that regulation, it decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

‘(1) For the purposes of Articles 13 and 19 of [Regulation No 1768/92], is an authorisation a “first authorisation to place … on the market in the Community” if it is granted in pursuance of a national law which is compliant with [Directive 65/65], or is it necessary that it be established in addition that, in granting the authorisation in question, the national authority followed an assessment of data as required by the administrative procedure laid down in that directive? 

(2) For the purposes of Articles 13 and 19 of [Regulation No 1768/92], does the expression “first authorisation to place … on the market in the Community” include authorisations which had been permitted by national law to co-exist with an authorisation regime which complies with [Directive 65/65]? 

(3) Is a product which is authorised to be placed on the market for the first time in the EEC without going through the administrative procedure laid down in [Directive 65/65] within the scope of [Regulation No 1768/92] as defined by Article 2? 

(4) If not, is an SPC granted in respect of such a product invalid?’

Today's ruling runs as follows:

"1. Article 2 of Council Regulation ...1768/92 ... must be interpreted as meaning that a product, such as that at issue in the main proceedings, which was placed on the market in the European Community as a medicinal product for human use before obtaining a marketing authorisation in accordance with Council Directive 65/65 ... and, in particular, without undergoing safety and efficacy testing, is not within the scope of Regulation ...1768/92, as amended, and may not, therefore, be the subject of a supplementary protection certificate.

2. A supplementary protection certificate granted for a product outside the scope of Regulation No 1768/92, as amended, as that scope is defined in Article 2 of that regulation, is invalid".

The Court's ruling is, by ECJ standards, unusually short and to-the-point for an intellectual property ruling.  The SPC Blog's post on the Advocate General's Opinion, on which the Court's ruling was based, can be read here.

The Bucknell Book

In "A new book -- and a competition", The SPC Blog reviewed the new Oxford University Press publication, Pharmaceutical, Biotechnology and Chemical Inventions: World Protection and Exploitation, a massive two-volume work covering no fewer than 12 jurisdictions which is edited by Duncan Bucknell (for details click here).

There was also a competition, for which The SPC Blog offered Bucknell as a prize. Competitors were asked to state which country should be included in the second edition as the 13th jurisdiction, explaining in not more than 30 words why it should be included. No fewer than 27 responses were received, with readers generally agreeing that Brazil was the next country to include.  Voters cast their choices as follows:

15 Brazil
3   Israel, Russia, Switzerland
1, Belgium, France, Malta

There were some imaginative entries.  From Mary Smillie (Bird & Bird) we received this:

"There once was an editor called Buck-nell
Who produced a book which was swell
It covered the world with great skill
But left out Brazil
The next edition should include it - then it would sell!"

Antony Gallafent (Gallafents) was quite coy, refusing to nominate a country at all. As he observed, "If I told you that, you would know where I am going to manufacture my generic products ..."

A cheeky nomination came from Johan Brants (brantsandpatents.com, Ghent), who explains: "The missing country is of course Belgium. We have the only “IPee-man” in the world (illustrated, right), with the most billable hours too".

The winner, however, is Vijaykumar Shivpuje (IPM, Glenmark Pharmaceuticals), who nominates Brazil because of the following factors:

• BARRIER OF LANGUAGE
• RECENT REFORMS IN IP
• ANVISA’S ROLE
• (Z)STEADY PHARMA/BIOTECH GROWTH
• IN SYNC WITH BRIC (EMERGING MARKETS)
• (3rd) LARGEST AMERICAN PHARMACUETICAL MARKET

Well done, Vijaykumar! Your prize will be posted to you shortly.

Some comments on the Medeva, Georgetown Opinion

The Advocate General delivered his Opinion last week in the Medeva and Georgetown references for a preliminary ruling to the Court of Justice of the European Union (see earlier SPC Blog post here, which has attracted a record-breaking number of comments).

Since then we have received this link to a comment by Niklas Mattsson (Partner, Awapatent AB, Sweden). He succinctly observes:

"The opinion contains a very detailed analysis of the EU law on the subject, and is interesting reading. To summarize the AG’s position in relation to the ultimate question, however, does not take more than a few words: the AG is of the opinion that the infringement test is definitely not the correct test, but that national law still has to be applied in order to determine whether a combination product forms the subject-matter of the basic patent".

We have also received a briefing from Tim Powell and Rebecca Lawrence (Powell Gilbert LLP, London) who comment as follows:

"The references concerned SPC applications for vaccines. For public health reasons, it is desirable to have vaccines against multiple diseases combined in a single shot. However, this poses an issue for a patentee that has a patent against a component or sub-set of components of a multi-disease vaccine. If the "product" that is authorised in Europe is the multi-disease vaccine containing components A+B+C+D can an SPC be granted for a patent that only claims components A+B? The approach of the UKIPO and the UK courts has been to deny SPC protection in such cases, on the basis that there is a mis-match between the totality of the active ingredients of the authorised combination product and the subject matter of the patent. 

The Advocate General recognised that applying a literal interpretation of the SPC Regulation would lead to a conclusion that such SPC's should be refused. However, she was concerned that taking such a literal approach would not be in accordance with the aims of the Regulation as it would lead to the denial of SPC protection for extremely valuable combination products. In some therapeutic areas manufacturers find themselves obliged to include multiple components for legal or practical reasons. The Advocate General therefore adopted a "teleological" interpretation of the Regulation, concluding that it was possible to select a sub-set of components of a multi-component medicinal product as forming the subject matter of the certificate. A certificate could issue on this sub-set and would extend to all medicinal products containing that sub-set of active ingredients authorised before the certificate expires. However the abuse of "evergreening" (which had been of concern to the UK courts) would be avoided because a patentee could not apply for further SPC's of longer duration under the same patent even if later product approvals issue to the sub-set which is the subject of the SPC in combination with different active ingredients. 

On balance, this Opinion seems favourable to the research based pharmaceutical industry in that the Regulation has been interpreted to avoid an unduly harsh refusal of SPC protection".

Marjan Noor and Andrew Hutchinson (Simmons & Simmons LLP, London) comment thus:

"The AG notes the risk that a manufacturer could seek to obtain successive SPCs on the same patent based on differing combinations containing the same patented active (or combination of active), for example a first covering the patented active ingredient and a second SPC covering the patented active in combination with another active. To avoid 'such an undermining of the system', the AG states that the manufacturer must designate the patented active or patented combination of actives as its product and then only one SPC can be granted with respect to that product, consistent with Article 3(c) which requires that the product must not already be the subject of an SPC. 

The knock on effect is also seen in Articles 4 and 5 which concern the scope of an SPC. Articles 4 and 5 were also not the subject of the referral but the AG states that the SPC for a single active or combination of actives gives protection against unauthorised production and distribution of all subsequent medicinal products that contain that active or combination of actives. This issue has been the subject of pan-European litigation relating to Losartan, which have resulted in inconsistent decisions from the French and Belgian courts.

The Opinion creates confusion with respect to whether or not the number of SPCs linked to the basic patent is restricted to one. This would be a departure from current practice where there are examples of more than one SPC per patent. In the context of combinations, if a patent 'protects' both active A and combination A+B, currently the patentee can obtain SPCs on A and A+B on the basis that each would be interpreted as a different 'product'. However, the Opinion (at para 103) suggests that a patentee would need to pick either A or A+B, even if they are both protected by the basic patent. In light of the preceding paragraphs of the Opinion, it may be the case that the AG is considering the situation of combinations consisting of the patented product alongside other non-patented actives. In other words where a patent covers A+B and the patentee has an authorisation for A+B+C and one for A+B+D, an SPC would not be available for both as they would be with respect to the same product (ie A+B) - again consistent with Article 3(c). The AG may also have made these comments under an assumption that a patent does not cover A and A+B.

Though clearly influenced by the importance of vaccines in the medical field which appears to have led the AG to adopt her teleological approach, the AG states that there is no special case for multi-disease vaccines under Article 3.

If the ECJ follows the AG Opinion, SPCs on combination products will no longer need to mirror the exact combination the subject of the marketing authorisation. Instead a patentee would match its SPC product to the product the subject of its patent. A knock on effect is that the scope of the SPC would then be more commensurate with the scope of the patent, ie the SPC could be enforced against any unauthorised use of a product containing the product the subject of the SPC rather than be limited to the product the subject of the SPC. 

Interesting follow-on issues include:
1. How will the subject matter test be applied in practice? The Daiichi case referral may provide useful guidance in the absence of any harmonised European legal test for determining the subject matter of a patent.

2. Despite the AG's opinion in the context of combinations and the commentary on one SPC per patent, (a) where a basic patent protects A and A+B, would obtaining an SPC on A prevent a subsequent SPC on A+B on the same patent and (b) where a basic patent protects A and separately B (eg as part of a markusch formula - no combination intended), can the patentee have an SPC on each of A and B based on the same patent? 

3. Whether a combination product A+B the subject of its own separate patent is entitled to an SPC where the same patentee has already obtained an SPC on A based on an earlier patent and which would have been enforceable against A+B, given the AG's comments on Article 4?
As is customary with SPC law, no doubt many further questions will arise".

Escitalopram in France

On Friday Chris Hayes (Lundbeck) furnished The SPC Blog with an English-language translation of the Austrian Supreme Court’s ruling concerning an SPC for Escitalopram (17 Ob 5/11a).  Today we have further reason to thank Chris: he has also let us have this translation of another decision involving Escitalopram -- this time from the Tribunal de Grande Instance (first instance court) de Paris, dated 30 September 2010.

The decision relates both to the patent and the SPC and, Chris explains, the SPC part of the judgment raises some interesting points about the interplay of the SPC Regulations and other pharma regs.

Escitalopram in Austria -- Supreme Court ruling now in English too

The recent posts concerning the recent Austrian Supreme Court’s ruling concerning an SPC for Escitalopram (17 Ob 5/11a) continue to generate interest. Following Rainer Schultes's kind provision of the original German-language text of the Austrian Supreme Court's decision (here), The SPC Blog has now received via Chris Hayes (Lundbeck) an English translation of that decision (here).  Many thanks!

SPCs and Escitalopram in Austria: a correction

From our friend Rainer Schultes (ENWC Rechtsanwälte, Vienna) comes some helpfully corrective information regarding the SPC Blog's earlier post on June 28. This post referred to an item published by International Law Office (ILO) about the recent Austrian Supreme Court’s ruling on an SPC for Escitalopram (17 Ob 5/11a). Rainer explains that the facts were incorrectly represented:

"The law suit did not arise between the holder of an earlier SPC and the holder of a later SPC (and not between licensor and licensee) but between the holder of both, the earlier SPC for the racemate Citalopram and the later SPC for Escitalopram on the one side and a generic Escitalopram on the other side.

With reference to ECJ Case C-431/04 – MIT the Supreme Court confirmed that substances which do not have an effect of their own on the organism, cannot be considered “active ingredients” in the sense of EC Regulation 469/2009.

The decision was rendered in summary proceedings. On a prima facie basis, the defendant could not demonstrate that the R-enantiomer contained in the racemate Citalopram did not have an effect of its own on the human. Thus it remains to be verified in the main action whether the R-enantiomer has a clinical effect or not".

Rainer (who meanwhile points out that the illustration on the 28 June post was the Austrian Constitutional Court, not the Supreme Court -- this being an error induced by a Google Image search) has also kindly supplied this weblog with the anonymised full text of the decision in German. Rainer, thanks so much!

Medeva and Georgetown: AG's Opinion published today

The Curia website has just posted a 124-paragraph Advocate General's Opinion in Joined Cases C‑322/10 Medeva BV v Comptroller-General of Patents, Designs and Trade Marks and C‑422/10 Georgetown University, University of Rochester and Loyola University of Chicago v Comptroller-General of Patents, Designs and Trade Marks, both of which are references from England and Wales. You can read the Opinion in full here.

The SPC Blog plans to post some comments on the Opinion. In the meantime, the Advocate General recommends the Court of Justice to rule as follows:

"A – Questions 1 to 5 of the Court of Appeal (England and Wales) (Civil Division) (Case C-322/10)

(1) The condition for the classification of an active ingredient or combination of active ingredients of a medicinal product as a product within the meaning of Article 3(a) of Regulation ... 469/2009 ...  concerning the supplementary protection certificate for medicinal products is that that active ingredient or combination of active ingredients forms the subject‑matter of a basic patent within the meaning of Article 1(c) of that regulation. Whether an active ingredient or combination of active ingredients of a medicinal product forms the subject‑matter of a basic patent within the meaning of Article 1(c) and whether that active ingredient or combination of active ingredients is protected by a basic patent in force in accordance with the requirement of Article 3(a) are determined, in principle, according to the rules governing the basic patent. However, the definition of the basic patent laid down in Article 1(c) of the regulation precludes use of the protective effect of the basic patent from being invoked as a criterion for the purpose of answering the question whether an active ingredient or combination of active ingredients of a medicinal product forms the subject‑matter of a basic patent.

(2) In the context of the assessment of a supplementary protection certificate application relating to a medicinal product with multiple active ingredients or to a multi‑disease vaccine, there are no further or different criteria for determining whether a product within the meaning of Article 3(a) of Regulation No 469/2009 exists and whether that product is protected by a basic patent in force.

(3) The questions whether a multi‑disease vaccine can be classified as a product within the meaning of Article 3(a) of Regulation No 469/2009 and whether that product is protected by a basic patent in force where only one of its active ingredients or each of its active ingredients against one of the diseases is protected by a basic patent in force must, in principle, be answered according to the rules governing the basic patent. However, the protective effect of the basic patent must not be used as a criterion for the purpose of answering the question whether a product within the meaning of Article 3(a) of the regulation exists.

B – Sixth question of the Court of Appeal (England and Wales) (Civil Division) (Case C-322/10) and sole question of the High Court of Justice of England and Wales Chancery Division (Patents Court) (Case C-422/10)

(4) A valid authorisation to place the product on the market as a medicinal product within the meaning of Article 3(b) of Regulation No 469/2009 exists for a single active ingredient or combination of active ingredients where that active ingredient or combination of active ingredients is contained together with one or more other active ingredients in a medicinal product which was the subject of a valid marketing authorisation granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC".

Grape-flavoured Lipitor gets the go-ahead for children

The Financial Times reported yesterday that pharma giant Pfizer could earn an estimated US$800m following the grant of a six-month paediatric extension to its top-selling drug Lipitor. The children's version is described as "a chewable grape-flavoured low-dose version" which will be launched when its patents expire in November.

The Financial Times article goes on to discuss its assessment of the market value of Lipitor, which currently accounts for one-fifth of Pfizer's sales.

Source: "Pfizer gets $800m boost for Lipitor", Andrew Jack, 10 July 2011

Now we have a new logo

A while back, The SPC Blog announced that it was looking for a new logo since the phoenix which it had used since its launch was just a rather tired piece of free clip-art.  Readers were called upon to offer their own creative responses. Well, for the only time in this author's career as a blogger, his post calling for readers to demonstrate their talents received a zero response.  Nothing daunted, he commissioned a friend of his to rise to the challenge -- and this is what she has come up with.  Many thanks, Chana Simons, for your efforts!

A new book -- and a competition

Pharmaceutical, Biotechnology and Chemical Inventions: World Protection and Exploitation is the title of a blockbuster of a book, edited by Duncan Bucknell.  Divided into two volumes, this work covers a lot of ground that is of clear and immediate interest to readers of this weblog who hail from pharma companies, as well as the lawyers and patent attorneys who represent them.  According to the publisher, Oxford University Press, the work is "written by a handpicked team of expert practitioners" from each of the 12 jurisdictions which it spans. "Handpicked" makes it sound rather as though they grew on trees, which conjures up some delightful imagery.  You can check the identities of the authors here.  Anyway, as OUP says:

"This book highlights the special issues arising in obtaining, commercialising, enforcing or attacking intellectual property rights (including protection of regulatory data) in the pharmaceutical, biotechnology and chemical industries across the world's key jurisdictions. It is unique in presenting topic matter horizontally by subject to facilitate comparison between country practices. 

The first two chapters give a general introduction to the differences between the jurisdictions and an overview of some of the key concepts in patent law. The remainder of the book is dedicated to a detailed analysis of the major legal issues arising in these areas of technology. 

Each component chapter has a comparative introduction, looking at the variances in the laws of different domains, followed by side-by-side analysis of the relevant regimes, including tables and flow-charts which summarise and explain the key legal concepts. The jurisdictions covered are the United States, Europe (UK, Germany, Netherlands, France and Italy), Japan, Canada, Australia, India and China".

As is to be expected, supplementary protection certificate and patent terms extension issues are covered.

The publishers offer a sample chapter, this being the one on Infringing Acts and 'Literal Infringement', which you can peruse here at your leisure.

The SPC Blog is pleased to announce that it is sitting on a spare copy of this magnum opus, which it is offering as a prize.  As mentioned, the book covers 12 major jurisdictions. Your task is to state which country should be included in the second edition as the 13th jurisdiction, explaining in not more than 30 words why it should be included. Please email your answer to The SPC Blog here, with the subject line "Bucknell Book". Entries should be received by not later than midnight (BST) on Sunday 24 July.

Bibliographical data.  Hardback, 2 volumes, 2,536 pages. ISBN 978-0-19-928901-1. Price £295.00. Book's web page here.

That Merck Opinion: a handy note

The official English text of Advocate General Bot's Opinion in Case C-125/10 (briefly noted here by The SPC Blog) only become available this week, as our readers will know, and the Dutch duo of Tjibbe Douma and Gertjan Kuipers (De Brauw Blackstone Westbroek N.V.) were swift to pounce on it. Their explanation, entitled "AG's opinion in Merck C-125/10: zero/negative term: SPC may be granted in light of possibility to obtain a paediatric extension", goes like this:

"Advocate General Bot has delivered his opinion on a matter that has caused disharmony in Europe: zero/negative term SPCs. The Advocate General concluded in his opinion that a negative term SPC should indeed be granted. He further addressed an equally interesting point on the commencement date of the paediatric extension.

Why do pharmaceutical companies request a negative term SPC? 

Supplementary Protection Certificates ("SPCs") are intended to compensate pharmaceutical companies for the loss of effective patent term caused by the delay in getting regulatory approval. SPCs have a negative term if this delay is less than five years. At the time the first SPC Regulation (1768/92) came in effect, a negative term SPC was fruitless and thus not applied for.

The Paediatric Regulation (1901/2006) introduced a six-month paediatric extension of the SPC. The rationale being - among others - to promote research in the paediatric population. To obtain a paediatric extension an SPC already granted is required. After the introduction of the Paediatric Regulation, requests for SPCs were filed by pharmaceutical companies in the understanding that a negative or zero term SPC might prove useful if a paediatric extension could be obtained. The reason for this is that every day of supplementary protection after the expiry of the patent can be highly beneficial for its proprietor.

Current disharmony in Europe 

In the Merck sitagliptin case, Merck applied for an SPC throughout Europe. This resulted in different decisions, including the grant of a negative term SPC in the UK and the Netherlands. In Greece Merck was granted a zero term SPC because it was believed a negative term was not possible and should be rounded up to zero. In Germany the SPC was refused as it would have a negative term. Merck appealed this decision to the Bundespatentgericht which then referred a question to the Court of Justice of the European Union ("CJEU").

Question referred to CJEU 

In the Merck Sharp & Dohme Corp. v. Deutsches Patent- und Markenamt C-125/10 case, the CJEU has to answer the question whether an SPC can be granted if it would not result in a positive term. This question was referred in light of the possibility to obtain a paediatric extension which would result in effective supplementary protection. Further, the Bundespatentgericht addressed the issue of the duration of such an SPC: should it be a negative term or rounded up to zero. However, this particular question was not referred to the CJEU.

Advocate General Bot rendered his opinion on 9 June 2011. Although not binding, such opinion is more often than not followed by the CJEU.

Why are negative or zero term SPCs allowed in the opinion of the AG 

The Advocate General concluded that it should be possible to obtain a negative or zero term SPC because – in short – (i) the SPC Regulation and the Paediatric Regulation do not require a positive term SPC, (ii) not allowing it could result in attempts to delay the marketing authorisation process which delay could harm public health, (iii) SPCs which, when extended, result in a positive term serve a useful purpose, and (iv) it would serve the objective of the Paediatric Regulation.

When should the paediatric extension commence? 

Further, the Advocate General took the view that it should also be specified when the six-month paediatric extension would commence, even though a question in this respect was not specifically referred to the CJEU. The issue was if the extension should start on (i) the date determined on the basis of the negative term of the SPC, or (ii) the date on which the patent expires (and thus rounding up the negative term of the SPC to zero).

The effect of a decision in this respect is as significant as the question actually referred to the CJEU. In the first case only an SPC with a negative term up to six months could benefit from a paediatric extension as the resulting term would be positive. In the second case, however, every proprietor of a patent with an SPC could benefit from a six-month paediatric extension, regardless of the time it took to obtain the marketing authorisation.

The Advocate General stated that on the basis of the SPC Regulation and the Paediatric Regulation, the maximum period of marketing exclusivity is 15 years and six months. Allowing a commencement date on the date of expiry of the patent could result in a total period of protection that would exceed that maximum. This would, according to the Advocate General, not be in conformity with the SCP Regulation. Therefore, he concluded that the negative term SPC should not be rounded up and thus a paediatric extension should commence on the date determined in accordance with the negative term SPC (i.e. prior to patent expiry). Specific to the Merck case: the SPC would have a protection period of minus three months and 14 days, adding the paediatric extension would result in a protection period of two months and 16 days following the expiry of the patent protection.

Practical significance 

This opinion could have far-reaching consequences if it were to be followed by the CJEU. Innovative pharmaceutical companies can benefit from paediatric extensions of their SPCs even when the SPC itself is not beneficial.

Further, it is currently unclear if the CJEU will limit its decision to the question referred by the Bundespatentgericht, or render a decision on the issue of the commencement date of the paediatric extension. If the CJEU does not decide on the issue, we will probably see a disharmonious European legal landscape or a new question referred to the CJEU.

If the CJEU does decide on the issue, it could go even further than the AG's opinion by concluding that the paediatric extension should commence on the date of expiry of the patent protection. An argument in favour of that position would be that this would best serve the objective of the Paediatric Regulation. The SPC is granted to compensate for delay in obtaining a marketing authorisation. A paediatric extension is, however, among others granted to serve as an incentive to do research on the paediatric population. Because of the different rationale and to meet the objective of the Paediatric Regulation, it could be argued that the commencement date of the paediatric extension is separate from the term of the SPC.

Overall it can be said that the AG's opinion is positive for both the innovative pharmaceutical industry and the paediatric population. Pharmaceutical companies should file for SPCs and apply for paediatric extensions as long as the combination could result in supplementary protection".