Medeva: the final chapter in the UK

First, thanks to all those kind readers who sent copies of the final judgment of Medeva to us yesterday; we now have the link, too: it's here and the citation is Medeva BV v Comptroller General of Patents [2012] EWCA Civ 523. In this ruling the Court of Appeal for England and Wales (the Chancellor -- Sir Andrew Morritt, Lords Justices Etherton and Elias) applied the now-familiar preliminary ruling of the Court of Justice of the European Union (CJEU) in Case C-322/10 Medeva and dismissed the appeal.

To recap for new readers of The SPC Blog, Medeva had filed five SPC applications. Three related to vaccines against five diseases (diphtheria, tetanus, meningitis, polio and whooping cough), while the other two omitted the vaccine against meningitis (Hib). The UK IPO's hearing officer rejected all five applications. In the case of four of them, the active ingredients included some which were not protected by Medeva's patent (ie the vaccines against diseases other than whooping cough); as to the fifth, while the active ingredients were limited to those protected by Medeva's patent, the market authorisation covered a combination vaccine which included vaccines against the other four diseases. Thus in all five there was a mismatch between the active ingredients protected by the patent and the active ingredients in the vaccine or medicinal product for which the relevant market authorisations had been given.

Medeva appealed unsuccessfully to the Patents Court and then again to the Court of Appeal, which stayed the proceedings and referred a number of questions concerning art.3(a) of the SPC Regulation to the CJEU for a preliminary ruling. In its ruling, the CJEU held that art.3(a) had to be interpreted as precluding the competent industrial property office of a Member State from granting an SPC relating to active ingredients which were not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.

Medeva put quite a positive spin on this ruling.  The way they saw it, the CJEU's explanation of the law still entitled them to the grant of SPCs on the first four of their applications --  or, if this was not so, that the EU's senior court had insufficiently answered the questions referred , so that another reference was needed.

The Court of Appeal dismissed Medeva's further arguments and, with it, the appeal. It held that, since both the Advocate General and the CJEU had rejected any test based on infringement or on the protective effect of the basic patent, all that was left for the national court to do was to determine which active ingredients were specified in the wording of the patent's claims. In this context, "specified" is an interesting word: it could mean anything between expressly naming, actually describing, effectively implying something, or this could be the result of a reasonable construction of the claims. Medeva's problem was that, wherever the dividing line was to be drawn, the active ingredients relating to vaccines against diphtheria, tetanus, meningitis and polio were excluded, while the CJEU's ruling required that the other elements or active ingredients be specified in the wording of the claims. Here was no such wording to indicate that the active ingredients of the vaccines against diphtheria, tetanus, meningitis and polio were included.

Post-Medeva analysis: the dialogue continues

A fortnight ago, Dorothea von Renesse and Norbert Schwenk (König, Syznka, Tilman, von Renesse, Düsseldorf) wrote a thoughtful article (here) in response to The SPC Blog's call for comments on Paul Inman's and Herwig von Morze's comments the previous week on Medeva and the interpretation of EU law. Dorothea's and Norbert's article is to be published in the September issue of the Mitteilung der deutschen Patentanwälte.

Herwig con Morze has now kindly produced a detailed response to Dorothea's and Norbert's article, which we reproduce here:

"While I agree with a number of statements in the article written by Dorothea von Renesse and Norbert Schwenk, some statements relating to the abuse of the SPC system must be challenged. In addition, the AG’s Opinion is rather problematic. 

Fundamentally, Article 1(b) of Regulation 469/2009 treats a combination of active ingredients of a medicinal product as a product different from a single active ingredient of a medicinal product (this is a clear difference to the law in the United States). To make it even clearer: the combination A + B is a product different from single active ingredient A or single active ingredient B. Therefore, their fates of supporting an SPC should not be tied to each other, unless special circumstances apply. The AG does not appear to grasp when special circumstances apply requiring tying of SPC eligibility of the active ingredient with that of a combination and when not. In other words, one has to distinguish two scenarios: 

1. The basic patent is limited to active ingredient A, but the first approved product is A + B. According to the AG in Medeva an SPC could issue for the product A. Later on, a second product obtains approval directed to the single active ingredient A. Because previously an SPC already issued for A on the basis of the marketing authorization for A + B, no further SPC can issue for A (Art. 3(c) of the Regulation), but the SPC already issued for A covers also A as single active ingredient (Art. 4 of Regulation 469/2009). Beyond the bar of Art. 3(c), the further extension of A’s exclusivity could result in an abuse of the SPC system, as the duration of its exclusivity could exceed the 15-year maximum term. 

2. The basic patent has two claims, one directed to A, the other one directed to A + B. Assume again, the first approved product is A + B. Here, the SPC does not require any adjustment like in Medeva. The subject of the marketing authorization is identical with the product A + B, the subject of a patent claim. Later on, a second product obtains approval directed to the single active ingredient A. Because A + B is a product different from single active ingredient A, an SPC directed to A can issue. In other words, in this situation the possibility of securing an SPC for A has not been consumed by the earlier marketing authorization for A + B or the earlier SPC directed to A + B. Articles 3(c) and 3(d) do not apply. Because of the clear distinction between a combination of active ingredients and a single active ingredient from this combination pursuant to Art. 1(b), SPCs with different duration may result. A legitimate extension beyond the 15-year exclusivity maximum may result not for a single active ingredient but for the totality of products containing this ingredient in accordance with current practice. This outcome does not amount to an abuse of the SPC system. 

3. This legitimate extension beyond the 15-year term cannot be limited to the situation where the combination of active ingredients is the subject matter of a separate patent in which the combination is specifically claimed, and this combination patent is the basic patent of the SPC request, as argued by Dorothea von Renesse and Norbert Schwenk (No. 17). Otherwise, the existence of an additional basic patent would create a legitimate use of the SPC system, which in the absence of this additional patent would be considered an abuse of the SPC system. Both situations could have the same effect of producing an extension beyond the 15-year exclusivity for the totality of products A and A + B. 

4. In summary, the prevention of abuse of the SPC system has to be tied to a scenario where the facts of Medeva prevail: the product authorized for marketing includes more active ingredients than what is the subject of the patent. The AG failed to recognize the distinction between a set of circumstances akin to Medeva and the more common circumstance where the active ingredients of the approved product coincide with the product claimed in the patent. On a fundamental level the AG did not understand the mandate of Art. 1(b) to distinguish between individual active ingredients and a combination of these individual active ingredients. In sum, you cannot have a second SPC for the same active ingredient (Article 3(c)) but you can have two SPCs for two different products even if the two products have an active ingredient in common but are different with respect to their other active ingredient(s). 

5. The AG’s Opinion would be acceptable to the extent it is directed to the Medeva scenario, albeit the infringement test would have been much cleaner and less tortuous and achieve the same result. However, as the AG ventures outside the boundary conditions of Medeva, her views are rather troublesome for the biochemical and pharmaceutical industry. She appears to sweep a number of previously accepted practices under the “abuse of the SPC system” carpet. Let’s hope that her carpet will not fly at the ECJ".

Jut one SPC per patent? What the Court of Justice really said

Following Martijn de Lange's recent post, "'Just one SPC per patent': time for some number-crunching" (here), our friend and colleague Herwig von Morze has written this defence of the view that a single basic patent can support more than one SPC. He first quotes para.41 of the Court of Justice (ECJ) ruling in Medeva which states:

“Second, where a patent protects a product, in accordance with Article 3(c) of Regulation No 469/2009, only one certificate may be granted for that basic patent (see Biogen, paragraph 28)" 

and then explains that this statement

"may create the impression that each basic patent can only give rise to one certificate, regardless of how many different products this patent covers. However, this impression of the statement is misguided as it ignores Medeva’s (Biogen’s) reference to Art. 3(c) of Reg. 469/2009.  Art. 3(c) does not limit the number of certificates per basic patent to one in general terms but limits this number to one for a specific product. Art. 3 as a whole does not, and cannot, address a situation concerning an assortment of products covered by a basic patent, but defines the granting requirements for a single product. It is noteworthy that Art. 3(a) to (d) uses the definite article “the” product and not “a” product. If a certificate for a product covered by a basic patent would rule out a certificate for another product, then the indefinite article would have been used in Art. 3(c). Therefore para. 28 of Biogen and similarly para. 41 of Medeva must be read and supplemented in conformity with Art. 3 (c) as follows:

“Under Article 3(c) of the Regulation, however, only one certificate may be granted for a product for each basic patent.”

The statement in Medeva para. 41 does not create new law: it just repeats Biogen para. 28 which has been in place since 1997. To my knowledge there are no court decisions denying a certificate for a product covered by a basic patent where that basic patent already gave rise to an earlier certificate covering another product based on Biogen para. 28. However, if other SPC readers have different information, will they please come forward.

Daiichi (Case C-6/11) may be of relevance for the interpretation of Biogen para. 28/Medeva para. 41. It deals with a situation where the claims of a basic patent are limited to a single active ingredient A and the subject of the marketing authorization is directed to A+B. According to the decision, no SPC is possible for the combination A+B, because this combination is not identified (specified) in the claims of the basic patent, as required by Art. 3(a). However, Daiichi raised no objection pursuant to Art. 3(c), although previously a SPC had issued for A supported by the same basic patent, a fact before the British court and the ECJ. The ECJ’s ruling would at least imply that a SPC would have been possible for A+B, had the patent claims identified (specified) this combination. This further supports the opinion expressed here that, contrary to one impression created by  Biogen para. 28/Medeva para. 41, a single basic patent would be capable of supporting more than one SPC (one for the product A and another one for the product A+B)".

The SPC Blog thanks Herwig for his close analysis of the ipsissima verba of the ECJ and hopes to hear from any readers who have information concerning court decisions denying a certificate for a product covered by a basic patent where that basic patent previously gave rise to an earlier certificate covering another product based on Biogen para. 28.

Going Dutch: taking a view post-Medeva in interim proceedings

The SPC Blog is again grateful to its friends Tjibbe Douma, Gertjan Kuipers and Margot Kokke (De Brauw Blackstone Westbroek N.V., Amsterdam) for sharing news of an interesting recent decision from the Netherlands.  This time it's an interim ruling of the District Court The Hague in Sanofi v  Teva c.s., 14 September 2012.  As Tjibbe his colleagues explain:

Further to the  recent posts (here and here) regarding the decision of the Patents Court for England and Wales in  Actavis v Sanofi [2012] EWHC 2545 , the Dutch decision in the somewhat similar Sanofi v Teva case  rendered on 14 September 2012 (cited by the Patents Court in its own decision) gives a rather different perspective on the interpretation of the SPC Regulation post-Medeva.

Where the Patents Court for England and Wales felt (again) that questions should be referred to the Court of Justice before establishing the validity of the SPC, the Dutch Court considered that it was in a position to decide (provisionally) on this issue and actually prohibited Teva from launching a generic version of Sanofi's product. To this end the interim relief judge held in the Dutch case that:

(i)                  The one-SPC-per-patent rule should be interpreted to read "one-SPC-per-product-per-patent"; and

(ii)                 The Medeva test "specified in the wording of the claims of the basic patent relied on" should in practice boil down to determining whether the combination product is part of the subject matter of the patent.

This different approach (and outcome) can in some respects be explained by the difference of the facts and nature of these cases.

Sanofi's patent, SPCs and MAs 

Sanofi has two SPCs, one for irbesartan (the mono SPC) and another for irbesartan in combination with HCTZ (the combination SPC). The SPCs were based on separate Marketing Authorisations (MA) for the mono product and the combination product respectively. Both SPCs were based on (different claims of) the same patent. The mono SPC expired in August 2012, but the combination SPC is valid until October 2012. The combination SPC is based on claim 7 of the patent which claims irbesartan in combination with a diureticum. HCTZ is not mentioned explicitly as an example of a diureticum, neither in the claim nor in the description.

Differences Dutch case and the England and Wales case 

The case in England and Wales was brought forward by Actavis on 26 June 2012. Actavis apparently wanted to clear to road before entering the market and Patents Court to declare the SPC invalid; Sanofi was the defendant in that case. The Patents Court felt that there were reasons to refer questions to the Court of Justice --- and that the nature of the case allowed for that.

In the Dutch case, however, there was no time for referrals. This case was a response by Sanofi to Teva's actions. Teva was preparing a launch at risk on 1 September 2012 (i.e. before the expiry of the SPC for the combination product). To this end, Teva's combination product was listed in the Dutch "G-standard" on 21 August 2012. In the Netherlands, a product needs to be announced on this list about two weeks before it can be marketed.

Sanofi - as could be assumed - did not appreciate this move (enlisting on the G-standard is considered 'offering' and thus an infringing action in the Netherlands) and filed an action with the District Court of The Hague requesting preliminary relief with a writ of summons dated 23 August 2012. On 3 September 2012 the Court already granted Sanofi's initial preliminary relief claim: Teva was ordered to refrain from offering the generic version for the duration of the actual preliminary relief proceedings.

Subsequently, the case was continued and resulted in the decision dated 14 September 2012. Teva argued as a defence that the SPC should be held invalid. Besides incompliance with Article 3(c), Teva also argued that Sanofi's combination SPC was invalid because of incompliance with Article 3(a) SPC Regulation because the product is not protected by the basic patent.

One SPC per patent? 

In the Dutch decision the interim relief judge provisionally ruled that the one-SPC-per-patent rule should be interpreted to read "one-SPC-per-product-per-patent" Teva's reference to a consideration in the Medeva ruling that "only one certificate may be granted for that basic patent" should not be read as meaning that only one SPC per patent could be granted. If the Court of Justice had meant to deviate from its earlier case-law which was widely interpreted to mean one-SPC-per-product-per patent, it would have done so explicitly, according to the judge. The preliminary relief judge also stated that, given Teva's announced launch at risk, there was no time for a referral and that the administrative court of the Hague had proposed to refer questions regarding thereto to the Court of Justice, so this question will already be dealt with by that court.

Specified in the wording of the claims? 

In the same judgment, the judge applied Medeva and Georgetown, interpreting "specified in the wording of the claims of the basic patent relied on" in a broader way than was done before. 

The interim Judge considered that, on the basis of the Dutch Court of Appeal's decision in Lundbeck/generieken, it should be determined whether the combination product was part of the subject matter of the patent. To determine what the subject matter was, she interpreted the claims taking into account not only the description and the drawings, but the general knowledge of the man skilled in the art at the priority date. Sanofi submitted several publications proving that, at the time of the priority, the man skilled in the art would immediately think of HCTZ when reading "a diureticum". This reading was not contested by Teva. . The judge therefore provisionally considered the product specified/identified sufficiently in the wording of the claims of the patent, the requirement of 3(a) met and the SPC valid

Thus, even though one of the active ingredients of the combination product for which an MA was obtained was not mentioned in the patent at all, the preliminary relief judge held that the SPC for the combination product was valid. This is different from the Lundbeck case where the active ingredient of the combination product was in fact mentioned in the (description of the) patent.

Where the Patents Court referred to the Dutch Court of Appeal decision in Lundbeck/ generieken  to point out the difference with Sanofi , the Dutch preliminary relief judge actually used Lundbeck/ Generieken to support her interpretation of the Medeva test,

In  Lundbeck/generieken  (The Hague Court of Appeal 24 January 2012)  the product of the MA was not mentioned literally in the wording of the claim. Claimed were escitalopram and certain salts thereof. The specific salt covered by the MA, escitalopramoxalaat, was mentioned in the description only. The Court of Appeal considered that escitalopramoxalaat "was obviously part of the subject matter of the patent" and was sufficiently 'specified or identified in the wording of the claims" for the SPC to be valid.

The judge's 'new' interpretation of the Medeva test in Sanofi v Teva is interesting and it remains to be seen how this will proceed.

Medeva ruling now out

The Court of Justice of the European Union gave its ruling this morning in Case C‑322/10, Medeva BV v Comptroller General of Patents, Designs and Trade Marks, a reference for a preliminary ruling from the Court of Appeal (England and Wales).

 Bordetella pertussis

In brief, in April 1990 Medeva applied for a European patent for a method for the preparation of an acellular vaccine against Bordetella pertussis (whooping cough agent), also known as ‘Pa’. This preparation consisted of a combination of two antigens as active ingredients -- pertactin and filamentous haemagglutinin (‘filamentous haemagglutinin antigen’). Their ratio was such as to provide a synergistic effect in vaccine potency. The patent was granted by the EPO on 18 February 2009, expiring on 25 April 2010.

Medeva filed five SPC applications with the UK's IPO, seeking supplementary protection for DTPa-IPV/HIB vaccines covering diphtheria (D), tetanus (T), whooping cough (Pa), poliomyelitis (IPV) and/or meningitis (Haemophilus influenzae, also known as ‘HIB’). In support of those applications, Medeva submitted marketing authorisations (MAs) granted by the French, German and UK authorities for a range of medicinal products each of which contained, in addition to the combination of pertactin and filamentous haemagglutinin, between eight and 11 other active ingredients.

In November 2009 the IPO refused to grant the SPCs applied for. In the case of four of the applications, more active components or ingredients were specified in the applications for SPCs covering those components than were identified in the wording of the claims of the basic patent, and they were not therefore protected by the basic patent under Article 3(a) of Regulation 469/2009. As for the fifth application, while the active components or ingredients identified in the patent were the same as those specified in the SPC application (ie combination of pertactin and filamentous haemagglutinin), the MAs submitted in support of that application did not fulfil the conditions laid down in Article 3(b) since they related to medicinal products containing nine active ingredients, that is to say vaccines which did not contain only the active components or ingredients specified in the SPC application and in the patent claims.

Medeva appealed unsuccessfully to the High Court and then again to the Court of Appeal, which stayed the proceedings and referred the following questions for a preliminary ruling:

‘1 Regulation No 469/2009 … recognises, amongst the other purposes identified in the recitals, the need for the grant of an SPC by each of the Member States of the Community to holders of national or European patents to be under the same conditions, as indicated in recitals 7 and 8 [in the preamble to that regulation]. In the absence of Community harmonisation of patent law, what is meant in Article 3(a) of … Regulation [No 469/2009] by “the product is protected by a basic patent in force” and what are the criteria for deciding this? 

2 In a case like the present one involving a medicinal product comprising more than one active ingredient, are there further or different criteria for determining whether or not “the product is protected by a basic patent” according to Article 3(a) of … Regulation [No 469/2009] and, if so, what are those further or different criteria? 

3 In a case like the present one involving a multi-disease vaccine, are there further or different criteria for determining whether or not “the product is protected by a basic patent” according to Article 3(a) of … Regulation [No 469/2009] and, if so, what are those further or different criteria? 

4 For the purposes of Article 3(a) [of Regulation No 469/2009], is a multi-disease vaccine comprising multiple antigens “protected by a basic patent” if one antigen of the vaccine is “protected by the basic patent in force”? 

5 For the purposes of Article 3(a) [of Regulation No 469/2009], is a multi-disease vaccine comprising multiple antigens “protected by a basic patent” if all antigens directed against one disease are “protected by the basic patent in force”?
…
6 Does … Regulation [No 469/2009] and, in particular, Article 3(b), permit the grant of a [SPC] for a single active ingredient or combination of active ingredients where:
(a) a basic patent in force protects the single active ingredient or combination of active ingredients within the meaning of Article 3(a) of the SPC Regulation; and
(b) a medicinal product containing the single active ingredient or combination of active ingredients together with one or more other active ingredients is the subject of a valid authorisation granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC which is the first [MA] that places the single active ingredient or combination of active ingredients on the market?’

The Court has just ruled as follows:

"1. Article 3(a) of Regulation ... 469/2009 ... must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.

2. Article 3(b) of Regulation ... 469/2009 must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude the competent industrial property office of a Member State from granting a supplementary protection certificate for a combination of two active ingredients, corresponding to that specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the marketing authorisation is submitted in support of the application for a special protection certificate contains not only that combination of the two active ingredients but also other active ingredients".

Comments to follow, as well as a post on this morning's other ruling in Georgetown.

Short Summary of the Medeva/Georgetown CJEU Hearing

Many thanks to Hugh Goodfellow (Carpmaels & Ransford) and Brian Cordery (Bristows) for submitting the report below on the Medeva/Georgetown hearing before the CJEU on 12 May 2011.

"On 12 May 2011, the Court of Justice of the European Union (CJEU) heard the joined cases of Medeva (Case C-322/10) and Georgetown (Case C-422/10) - both references from the UK Courts on the interpretation of certain provisions of Article 3 of the SPC Regulation (EC Regulation 469/2009).

For those readers who are not intimately familiar with the issues referred (and thus may have inadvertently stumbled across this blog), Article 3 of the SPC Regulation sets out certain conditions for an SPC to be obtained. Article 3(a) requires that at the time the SPC application is made, the product which is the subject of that SPC must be “protected by a basic patent in force”. Article 3(b) requires that “a valid authorisation to place the product on the market as a medicinal product” has been granted at the time that the application for the SPC is made.

Representatives for Medeva, Georgetown, the UK and Portuguese Governments, and the Commission gave oral submissions to a panel of five judges: (Jean-Claude Bonichot (France), Lars Bay Larsen (Denmark), Camelia Toader (Romania), Alexandra Prechal (The Netherlands), and Egidijus Jarašiunas (Lithuania)).

Medeva and the UK Government advocated applying a so-called “infringement test” when considering Article 3(a), such that a combination of A+B would be protected by a patent for A because the patent would be infringed by the combination. For the UK Government, this represents a complete shift in thinking from the position previously adopted by the UK IPO on this issue. From the oral submissions made to the Court at the hearing, it was unclear what approach the Commission would prefer.

On Article 3(b), Georgetown and the Commission both considered that this should be interpreted so that a marketing authorisation (MA) for A+B could be specified as a valid authorisation to obtain an SPC for A, if the MA for A+B represents the first approval for A. The UK Government was opposed to this idea.

At the hearing, reference was made to questions submitted by the Court to the parties and the other bodies represented at the hearing on Article 4 (Subject Matter of Protection) and the Biogen decision (C-181/95). Those questions and the answers submitted to the Court have not been made public. However the representative for the Commission stated that an analysis of Article 4 was not necessary in order to be able to interpret Article 3.

The opinion in these cases will be delivered on 13 July 2011 by Advocate-General Verica Trstenjak of Slovenia. The actual decision of the Court – which of course may follow the AG’s opinion or deviate from it - will follow several months later."

AIPPI UK Group holds rapid response seminar on Medeva, Georgetown

The SPC Blog is pleased to announce that the AIPPI UK Group has organised a rapid response seminar which will enable interested parties to get together and discuss the repercussions of last week's rulings in Medeva and Georgetown, briefly noted here and here on this weblog.

Details of the seminar are as follows:

Tuesday 29 November 2011, 5.30pm for 6pm

SPCs for combination products –

Rapid Response to

CJEU Medeva and Georgetown judgment

Hugh Goodfellow

Partner, Carpmaels & Ransford

Venue:

Carpmaels & Ransford

One Southampton Row, London WC1B 5HA

Drinks will be served afterwards

There are a number of combination product cases pending before the Court of Justice of the European Union that, when taken together, probe almost every aspect of the Regulation’s requirements for a valid SPC to be obtained. The CJEU’s judgment in the Medeva and Georgetown cases has been handed down on Thursday 24 November, the first in the series of cases referred to that court.  Following up the AIPPI event on the topic in September, Hugh Goodfellow. Partner at Carpmaels & Ransford, has agreed to host a Rapid Response, to provide the opportunity to discuss and debate the implications of this Judgment.

If you would like to attend this event, whether you are a member or not, please register at:

www.aippi.org.uk/medeva

This course is directed at all levels of practitioners with an interest in intellectual property and will provide them with an understanding of current issues and future potential developments in the law of supplementary protection certificates.  Attendance is free.

SRA and IPReg, and (pending approval) BSB, CPD: 1.5 hours.  AIPPI United Kingdom is accredited under the Solicitors Regulation Authority’s and the Bar Standards Board’s CPD schemes.  

Another week, another dose of irbesartan/HCTZ -- this time from France

Arc de Triomphe: who
will eventually triumph in
the Combination SPC War?

The SPC Blog's French friends Pierre Véron and Isabelle Romet (Véron et Associés, avocats, Paris) have kindly sent us copies of the original French text and English translation of a French judgment handed down earlier this month. The case --  Sanofi, Sanofi Pharma Bristol Myers Squibb and Sanofi Aventis France / Teva Santé, tribunal de grande instance de Paris, France, ordonnance de référé (preliminary injunction), No. 12/57056, 3 October 2012, -- fits within the framework of the European litigation concerning Sanofi’s combination SPC irbesartan/HCTZ. A further act of kindness is their provision of this helpful summary:

"On 3 October 2012 the presiding judge of the tribunal de grande instance de Paris issued a preliminary injunction against Teva Santé. This is a French development of the European litigation concerning Sanofi’s combination SPC irbesartan/HCTZ covering its flagship drug for the treatment of hypertension marketed under the brand CoAprovel which gave rise, inter alia, to the following decisions:

• UK - Actavis v Sanofi (ECJ referral)
• NL - Sanofi / Pharmachemie & Teva – Irbetasan & HCTZ (preliminary injunction against Pharmachemie and Teva)
• DE – Sanofi / Actavis Landgericht Düsseldorf 15 August 2012 (preliminary injunction against Actavis)

 The order handed down on 3 October 2012 by the presiding judge of the tribunal de grande instance de Paris enjoins Teva Santé from marketing in France a generic irbesartan/ hydrochlorothiazide (HCTZ). 

Sanofi’s French SPC No. 99 C0001 on the combination of the two active ingredients irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a diuretic, is based on claim 20 of European patent No. 0 454 511 protecting the combination of irbesartan and “a diuretic”. Teva challenged the standing to sue of the plaintiffs (Sanofi itself, but also Sanofi Pharma Bristol Myers Squibb and Sanofi Aventis France which market in France CoAprovel): the judge dismissed this challenge. Teva also disputed the validity of the basic patent, European patent No. 0 454 511, for insufficiency and obviousness: having noted that it was somewhat surprising that such a challenge occurs only after the expiration of a successful patent, the judge examined these criticisms in greater details but held that she did not see any serious attack on this ground. 

The main attack was based on article 3(a) of Regulation 469/2009 and the Medeva holding that an SPC can only be granted for active ingredients which are “specified in the wording of the claims of the basic patent”. Teva argued that Medeva required that “hydrochlorothiazide” be mentioned in the claim as such, the mere mention of a “diuretic” being insufficient. Teva further argued that Sanofi’s SPC was invalid on the basis of articles 3(c) and 3(d) of Regulation 469/2009. 

The judge considered that none of the arguments put forward by Teva cast a serious doubt on its validity. 

About article (a) she considered that Medeva was not applicable because HCTZ was sufficiently identified in the wording of claim 20 by the word “diuretic”:

“HCTZ, which indisputably belongs to a therapeutic class of active ingredients, namely the diuretics family, could easily be identified at the time of the priority date of the patent, as was seen concerning the dispute relating to insufficiency; it is not obvious that the SPC is not valid.  

It cannot be inferred from Medeva, as the defendant does, that for a combination of active ingredients to be protected by an SPC, the basic claim must refer to all the active ingredients of the product.”

The judge further considered that the referral to the ECJ in parallel UK proceedings, concerning Actavis’ invalidity action of the UK corresponding SPC, by Arnold J on 20 September 2012, about articles 3(a) and 3(c) of Regulation 469/2009 did not preclude the grant of the requested preliminary injunction in France. 

She adopted a different view from that of earlier French decisions of 10 August 2012 which dismissed Sanofi’s request for a preliminary injunction against Mylan, Sandoz and Arrow Génériques because the validity of the SPC was “questionable”; in those previous cases, another French judge had considered that, with regard to article 3(a) and Medeva, the word “diuretic” in claim 20 of Sanofi’s patent No. 0 454 511 on the combination of irbesartan and a diuretic was not precise enough to cover HCTZ; appeals against these decisions are pending. 

The French decision of 3 October 2012 is in line with the decisions of the Landgericht Düsseldorf of 15 and 17 August 2012 which granted Sanofi preliminary injunction respectively against Actavis and Hexal, and the decision of the district court of The Hague of 14 September 2012 which granted similar relief against Teva.

Thanks, Pierre and Isabelle, both for providing all of the above and for letting us have the original German and English translation of the judgment handed down on 15 August 2012 by the Landgericht Düsseldorf which are referred to above.

MedImmune and Queensland: UK court wrestles with the meaning of Medeva and related referrals

The SPC Blog is delighted to have received this morning a three-headed note from Hugh Goodfellow, Daniel Wise and Edward Oates (Carpmaels & Ransford), who thought we might be interested in the local events which transpired in the Patents Court for England and Wales this morning, when that court had to grapple with some recent rulings from the Court of Justice of the European Union (CJEU). They write:

"The Patents Court had a busy morning applying the CJEU’s recent decisions in Medeva (C‑322/10) and the related Georgetown (C-422/10), Queensland (C-630/10), Yeda (C‑518/10) and Daiichi (C-6/11) referrals to real world SPC cases.  We now therefore have the UK judiciary’s first guidance as to how the CJEU’s rulings should be interpreted.

At 10 am, Mr Justice Arnold handed down a decision in the second leg of the MedImmune v Novartis Lucentis litigation [the ruling, in [2012] EWHC 181 (Pat), can be read in full here].  A key issue was whether MedImmune’s patent to a method for producing “a molecule with binding specificity for a particular target” included within its claims adequate “specification” of the active ingredient in Lucentis (the ranibizumab monoclonal antibody) to obtain an SPC for this product.  MedImmune had argued that the CJEU’s requirement, set out in the Medeva judgment, for the active ingredient to be “specified in the wording of the claims” was unclear and required a further reference to the CJEU to determine how much “specification” was required.  The Court had some sympathy for this argument:

53. In my view, counsel for MedImmune is also correct to say that the test laid down by the Court of Justice in Medeva and its progeny is unclear save in its rejection of the infringement test in combination cases. In particular, it is unclear precisely what is meant by “specified (or identified) in the wording of the claims”. Does this mean that it is sufficient for the product to fall within the scope of the claim on its true construction, or is something more required and if so what? For example, is it sufficient, say, for the claim to incorporate a Markush formula which covers a large number of compounds one of which is the product in respect of which an SPC is sought? Is it sufficient for the product to be defined in functional terms? Even in combination cases, it is not clear to me how the test enunciated by the Court should be applied in a case like Gilead. Regrettably, therefore, it is inevitable that there will have to be further references to the CJEU to obtain clarification of the test.

Despite this sympathy, the Court found that the patent did not contain an adequate level of “specification”.  Among other reasons, the Court said:

57. […] In the present case, claim 1 merely identifies the product of the method as “a molecule with binding specificity for a particular target”. This covers millions of different molecules of various kinds. It is not even limited to antibodies. Although ranibizumab falls within this extremely broad class of products, there is nothing at all in the wording of the claim, or even the lengthy specification of the Patent, to identify ranibizumab as the product of the process in question.

MedImmune had argued that Arnold J should refer the matter in suit to the CJEU for further consideration but he declined to do so.  The first leg of the litigation, in which MedImmune’s patent was found to be invalid and not infringed, is already due to be heard by the Court of Appeal for England and Wales later this year, so the High Court felt that the higher court was better placed to order a reference should that become necessary to settle the dispute.

Although no referral was ordered in this case, many commentators have questioned the meaning of “specified in the wording of the claims” and time will tell whether the Court of Appeal -- or indeed another EU national court (e.g. the German court which will be considering the same facts soon) -- decides that the CJEU needs to explain what it meant by its test.  The Court of Appeal in the Hague has already opined on the point in Lundbeck v Tiefenbacher (escitalopram), holding that although escitalopram oxalate was not explicitly recited in the claims, the reference in the claims to non-toxic acid addition salts was adequate “specification” of escitalopram oxalate to support an SPC for this product.

Of further concern to some will be the Court’s questioning of the practice of applying for SPCs based on unlicensed third party products.  Although this point was not taken up by the parties, it seems that SPCs based on third party marketing authorisations might now, in certain cases, be challenged by alleged infringers:

61.          As noted above, in the present case the SPC is based upon a product obtained by means of an allegedly infringing process and upon a marketing authorisation obtained by an alleged infringer of the Patent. It might be thought that it was not the purpose of the Regulation to enable a patent owner to obtain an SPC in such circumstances, since the owner has not been delayed in getting the product to market by the need to get a marketing authorisation, and therefore no extension to the term of the patent is needed to compensate him for that delay.

At 1030 am, the same judge heard Queensland v CSL and UK Intellectual Property Office, which he had himself referred to the CJEU in late 2010.  The CJEU issued its decision in this referral shortly after Medeva, and today marked the first time that any of the referred cases had been back before a British judge to apply the CJEU’s logic.  The parties agreed that the effect of the CJEU’s decisions was that Queensland/CSL’s four SPC applications for the individual active ingredients in the Gardasil combination vaccine were allowable based on Queensland/CSL’s three basic patents.  Granting an order for these applications to proceed to allowance, neither the Court nor the IPO raised the controversial “one SPC per patent” objection that some commentators have derived from the CJEU’s judgments.  It seems that in the UK, at least, the established practice that more than one SPC is allowable per patent provided that each SPC is directed towards a different active ingredient remains alive and well.  It will be interesting to see whether other countries take the same approach: initial comments from the Dutch Patent Office suggest that things may be seen differently elsewhere.  Moreover, counsel for the IPO suggested that this point will be raised by Medeva when its own referral gets back to the UK Court of Appeal later this year".

Disclosure of interest: Carpmaels & Ransford acts for Queensland/CSL in their SPC applications across the EU and is also leading the Neurim SPC referral at the CJEU, which raises further fundamental questions of SPC law.

After Medeva: what the commentators say ...

With regard to patent extension as in most other areas, we depend on the 
commentators to tell us what they see as happening from their vantage points

Following last week's ruling of the Court of Justice of the European Union in Case C-322/10 Medeva, The SPC Blog has received comments and opinions from so many people -- readers and others -- that it has been difficult to sift through them all.  The blog records below some of the first impressions of those who work in the field:

"The confirmation of the Attorney General’s opinion that a “mis-match” between an SPC and an MA is not fatal to that SPC application is welcome to the research-based pharmaceutical industry. However, every issue relating to the SPC protection of combination products has by no means been resolved. Also, many in the pharmaceutical industry will be disappointed that the CJEU has not adopted the infringement test argued for by Medeva and the UK Government" (Tim Powell: Powell Gilbert LLP)

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"This decision has far-reaching consequences. It means that innovative pharmaceutical companies can benefit from SPCs for their patents also if the relevant MA was granted for a combination product that is only partly disclosed by the patent relied on. For countries where the disclosure test was applied (such as the Netherlands) the possibility to obtain SPCs has been broadened. It also means that SPCs cannot be granted for active ingredients A + B, if the MA is in place for A + B and the wording of the claims of the patent only specify A. This means a limitation of the granting practice in countries where the infringement test was used (where SPCs for A + B were granted). 

Following the CJ decision, this has already led to the Court of Rome ruling (on 25 November) that Novartis cannot invoke its (Italian) SPC granted for a combination product that was not fully disclosed by its patent [noted by The SPC Blog here]. Several issues regarding both the application for SPCs and the protection granted by a valid SPC remain unresolved and are the subject of several other referrals to the CJ regarding the interpretation of the SPC Regulation. Medeva does provide possibilities for the pharmaceutical industry and companies should currently apply for SPCs as long as one of the active ingredients of the relevant MA is specified in the wording of the claims of the patent" (Gertjan Kuipers and Tjibbe Douma: De Brauw Blackstone Westbroek).

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“The CJEU rulings are welcome and have confirmed a relatively broad scope of SPC protection covering all combinations of a particular active ingredient with others, providing that the active ingredient is supported by the underlying patent. 

This is, perhaps, not as narrow a view of SPC protection as it was feared the Court of Justice might support. They have also expressed the legal position succinctly - the circumstances where you cannot obtain an SPC are now clearer. 

In essence, the CJEU has confirmed that it should not be possible to obtain SPC protection claiming active ingredients that owe nothing to the disclosure in the underlying patent. They have also avoided imposing the harsh result predicted by UK judges in previous cases such as Gilead” (Will James: Marks & Clerk Solicitors).

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"Although these decisions bring some much needed clarity to the application of the SPC regulations to combination drugs, we foresee several issues that remain unclear, particularly the meaning of “specified in the wording of the claims” in relation to Article 3(a). A brief review of the French, German and Spanish versions of the current decisions does not seem to remove the ambiguity, although they possibly lean towards a more restrictive approach than that implied by the English-language decisions" (Hugh Goodfellow and Daniel Wise, Carpmaels & Ransford).

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"The Medeva decision makes it clear that SPCs on combination products do not need to mirror the exact combination that is the subject of the marketing authorisation. Instead a patentee must match its SPC product to the active ingredients ‘specified’ in its patent. That SPC can then be enforced, it would seem, against any medicinal product containing (rather than matching) the active(s) the subject of the SPC. 

However, as ever, further questions are raised. What is meant by “specified”: do claims for classes of products and Markush formulae “specify” the individual actives they cover? Where does this leave biologic patents that claim, for example, antibodies to a particular antigen without disclosing the antibody? Is it really the intention that a patent can only ever have one SPC or is the CJEU’s decision limited to the single active A/combination A+B scenario? Has the CJEU stated that a single active SPC can be enforced against a combination? The wording of the CJEU decision is not clear. 

This is sadly another decision that raises as many important questions as it answers" (Marjan Noor and Andrew Hutchinson, Simmons & Simmons LLP).

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"In the quest for minimizing an alleged extension of protection for combination products, the CJEU has now come up with an answer which is primarily economically beneficial to the authorities charging applicants official fees for long specifications, and in reality confers a broader protection than would have been possible if using the infringement test to define the product, which may not be in the public interest.

On a constructive approach to the new legal situation, the best advice looking forward is for patent drafters to develop standard lists of all known active ingredients (approved or in the pipeline) in order to keep all options open for including combinations in the patent claims either in divisional applications, when time allows for that, or by limiting the patent using the central limitation procedure at the EPO" (Sidsel Hauge: Awapatent)

Court of Justice rulings and combination products: an article

Volume 12, Issue 2 of Lawtext Publishing's Bio-Science Law Review contains an article from Mike Snodin, John Miles and Michael Pears (all of Potter Clarkson’s SPC & Regulatory Group) entitled “Supplementary protection certificates: The CJEU issues its decision in two seminal cases”. This article discusses the Medeva (C-322/10) and Georgetown et al. (C-422/10) decisions, as well as the three further cases decided by reasoned order (Yeda, Daiichi and Queensland). In the article, Mike, John and Michael conclude that likely consequences of the Medeva and Georgetown et al. decisions in the short to medium term will include:

“• National courts will invalidate SPCs to combination products that have been granted on the basis of the ‘infringement test’ but where the active ingredient(s) are not specified in the wording of the claims of the basic patent. 

• More SPC applications will be filed in which the product is defined as one or more (but not all) of the active ingredients present in the authorised medicinal product. 

• Subject to confirmation in Case C-442/11 of the Court of Justice’s comments on point (C) above, national courts will enforce SPCs to single active ingredients against the manufacturers of generic versions of combination products containing a protected active. 

• Generic manufacturers will delay launch of combination products until SPCs to the individual actives have expired (or have been invalidated). 

Further, although it is a point of view that may not be shared by all practitioners, the authors believe that the decisions may not lead to any changes in established practices with regard to the numbers of SPCs granted for basic patents that protect more than one product.”

In relation to the latter issue, the article points to the similarity in wording between the Biogen decision and the Medeva and Georgetown et al. decisions in respect of comments on the number of SPCs that may be granted for each basic patent, and questions whether any change to the status quo was really intended by the Court of Justice on this issue.

The article also discusses possible longer term implications of the decisions, and suggests that further judicial interpretation will be required in order to clarify what is meant by “specified (or identified) in the wording of the claims” - particularly in connection with patent applications that can be argued to “specify” both a novel active ingredient (A) and the combination of that active with another, specific active ingredient (i.e. A+B).

Mike, John and Michael conclude the article by saying:

“Putting aside the issues where there is a need for further clarification, the Medeva and Georgetown et al. decisions should be welcomed by the pharmaceutical and agrochemical industries as representing a carefully balanced approach that rewards genuine innovation with an appropriate degree of protection.”

The points mentioned above are all explained in more detail in the article.

Post-Medeva CJEU references on the horizon, this time from the Netherlands

From The SPC Blog's friend Margot Kokke (De Brauw Blackstone Westbroek N.V., Amsterdam) comes news that a Dutch District Court is proposing to refer some questions to the Court of Justice of the European Union in Dutch Georgetown and Queensland cases regarding the continuing saga of "one SPC per patent" (it seems that not all national intellectual property offices are continuing the practice of granting "one SPC per product per patent" as they used to do in the days before before Medeva.

The Dutch court in question here is the District Court of The Hague, which wants to obtain preliminary rulings that clarify the "one SPC per patent" rule mentioned in paragraphs 41 of Medeva (C-322/10) and 34 of Georgetown (C-422/10) in two parallel decisions: (Dutch) Georgetown and (Dutch) Queensland.

Initially the Dutch IPO refused the requested SPCs, basing its decision on Article 3(b) of the SPC Regulation but, once it was clarified in Medeva that an SPC for a single product can be granted based on a marketing authorisation containing that product together with other active ingredients, this was no longer an issue. The IPO subsequently refused to grant the SPCs based on Article 3(c) of the Regulation: in both cases another SPC (Queensland) or SPCs (Georgetown) was/were granted based on the same patent. The Court doubts whether the fact that Queensland renounced its right to the other SPC makes a difference as it is not sure whether the renunciation of an SPC has retroactive effect. The most important questions are:

* Does Article 3(c), in the situation where (the claims of) a basic patent claims several products, preclude the grant to the owner of the patent of an SPC for every product that is claimed?

* If the answer to this questions if affirmative, where an SPC is granted for one product but was renounced, does this preclude the grant of an SPC for another product claimed by the same basic patent?

* If it should be relevant that the renunciation has retroactive effect, is this governed by Article 14 of the SPC Regulation or by national law? In the latter case, does renunciation of an SPC have retroactive effect?

The parties have six weeks to give their opinion on the proposed questions, before the Court will formulate its final referral.

Telmisartan combination: the Cour d'appel de Paris rules

SPC Blog reader Edouard Kling and his colleague François Pochart (august & debouzy avocats , Paris) have let us have sight of another "sartan" ruling, this one being particularly significant in that it is the first post-Medeva decision in France to decide on SPC for combination products. They write:

"In its ruling dated Friday 8 June, the Court of Appeal of Paris confirmed the rejection of the SPC application 02C0028 directed to the combination product Telmisartan + HCTZ. The basic European patent EP 502 314 did not claim the combination product but the specification disclosed a list of additional compounds to be used in combination with Telmisartan.

Of note, Boehringer had applied for a limitation of the French part of the basic patent to enter HCTZ into the claims and comply with Medeva. However, the limitation was rejected only a few days before the hearings. As a matter of procedural law, the court disregarded the request for the stay of the proceedings, pending the appeal proceedings against the limitation and ruled:

“It is common ground, as the Director of the INPI (French National Intellectual Property Institute) points out, that the Court, ruling on the appeal, is required to evaluate the facts on the date the decision is handed down, so that proceedings that are brought subsequently to the issuance of the disputed decision have no impact on the dispute for which the court was seized.

Moreover, the outcome of the late patent limitation request will not influence the resolution of the dispute, in so far as Boehringer requests, as the Director of the INPI points out, that the Court “attributes to claim 9 (as granted) the appropriate scope, namely that in light of the description of the basic patent, the term medicament indeed protects a combination of active ingredients Telmisartan – Hydrochlorothiazide” (paragraphs 56 et seq. of its submissions); 

No ground derived from the proper administration of justice requires, consequently, that the examination of this appeal be postponed further;”

This issue of limitation may be related to a previous decision dated 7 September 2011 where the court considered that a combination product was concerned with a different subject matter than the mono product and could not be construed as a mere limitation. The decision is attached.

Therefore, the Court turned to the claims as granted and logically rejected the SPC. Nevertheless, the judge did provide some elements that may be used in view of Medeva and remaining issues of clarity.

“Whereas, however, it is in vain that the claimant supports that the terms of claim 9 of the basic patent prevail;

Indeed, said patent is concerned with Benzomidazoles, being the subject matter of claims 1 to 7 referred to in claim 9: that, contrary to Hydrochlorothiazide, only Telmisartan is protected by the patent claims, the Director of the INPI specifying, without being challenged, that Benzomidazoles works on the contraction of blood vessels whereas Hydrochlorothiazide has diuretic effects; even if claim 9 mentions the use of a compound for the preparation of a medicament, it does not refer in any way to a combination with an active ingredient such as Hydrochlorothiazide;

Moreover, the interpretation that it contemplates for the condition laid out in paragraph a) for it to be ruled that the scope of the basic patent must be determined by taking into account not only the actual claims but also the description of the patent could not be based on Article 69 paragraph 1 of the European Patent Convention which only attributes to the description of the patent the function of interpreting the claims; …

If the description of the patent considers, in hypothetical terms, a combination with active ingredients such as Hydrochlorothiazide, the protection of the combination of those two ingredients which is not the subject matter of a claim, would not allow the reasonable degree of legal certainty to be provided to third parties, within the meaning of this text;

Lastly, despite the positions that were adopted by the authors or despite previous decisions, the Court of Justice of the European Union, which intends to harmonize Member States’ rights and refers to different European texts that corroborate this approach (point 27), ruled, in a decision issued on 24 November 2011 (Medeva BV v Controller General of Patents, Designs and Trade Marks):

-that “it should be recalled that Article 5 of Regulation No 469/2009 provides that any SPC confers the same rights as conferred by the basic patent and is subject to the same limitations and the same obligations. It follows that Article 3(a) of the regulation precludes the grant of a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent” (point 25),

-and, in response to the preliminary ruling that were put forward to the Court, “Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the SPC for medicinal products must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate”. 

Whereas, regarding the difference in treatment also mentioned by Boehringer, the content of the preliminary ruling put to the CJEU in the previously mentioned decision by the High Court of Justice (England & Wales), Chancery Division (Patent Court) (point 17) as well as the grounds for this decision (point 20 et seq.), all noting that there are dissenting positions in the States and a will towards harmonization, contradict the claimant assertions according to which the INPI would have rendered a decision which is contrary to the unanimity of the European Offices and that INPI could not rely upon different conditions of Examination according to the Offices; 

It follows that none of the arguments invoked by Boehringer to support the appeal are valid and that therefore such claim should be dismissed”.

The text of the judgment has been kindly provided and can be read here. Edouard and François hope to be able to provide us with a full translation in due course.

No pre-emptive CJEU reference -- but Neutrokine α might still get to CJEU

Lilly & Company v Human Genome Sciences Inc [2012] EWHC 2290 (Pat) is a decision of Mr Justice Warren, Patents Court for England and Wales, of 3 August 2012 which touches on some interesting tactical issues relating to patent litigation in Europe as well as to SPCs in the wake of Medeva.

Eli Lilly

In short, Eli Lilly wanted to obtain a declaration that any SPC for which HGS might apply in respect of European Patent (UK) No 0 939 804 (Neutrokine alpha)--- which was expected to expire in 2016 -- would be invalid. Unusually, it applied for the Patents Court to make an immediate reference to the Court of Justice of the European  Union for a preliminary ruling regarding this claim for a declaration. This patent is one with which the British judiciary have become increasingly familiar: it has already been litigated all the way up to the Supreme Court on the question of industrial applicability (see posts here and here); the Supreme Court remitted the case to the Court of Appeal in November 2011 and the further decision of that court is keenly awaited.

Eli Lilly's application for a reference to the Court of Justice was made on two bases: (i) that it was impermissible for any party to apply for an SPC which was based upon an MA obtained by another party (such as, in this instance, Eli Lilly) when the two parties had no connection with each other (this was referred to  as the "third party SPC issue"); (ii) since HGS's patent did not specify or identify Eli Lilly's antibody in its claims, no valid SPC could be obtained even where the patent itself had been upheld as valid (this was referred to as the "specification issue"). HGS both opposed the application for an immediate reference for a preliminary ruling and sought to strike out the action on the basis that it was premature and incapable of resolution, given the current factual uncertainties.

Warren J ruled that Eli Lilly's application for declaratory relief should not to be struck out but should be allowed to proceed. However, the application would be stayed, pending the decision of the Court of Appeal. As to the application for an immediate reference to the Court of Justice for a preliminary ruling, his response was along the lines of "not yet, but maybe later". In the judge's view:

* The holder of a basic patent could apply for an SPC in reliance on an MA granted to a third party which had no connection of any sort with that holder; this issue was sufficiently devoid of doubt that there was no point in referring it for a preliminary reference;

* The 'specification issue' concerned the express words that a patent must contain in order to enable the grant of an SPC which related to an active ingredient within the scope of the patent. On this, the judge said at para.64:

" ... the law remains unclear in many aspects. Whilst sharing Arnold J's puzzlement with the reasoning in Case C-322/10 Medeva BV v Comptroller General of Patents, Designs and Trade Marks 24 November 2011, [2011] ECR I-0000 ("Medeva") and Case C-630/10 University of Queensland v Comptroller General of Patents, Designs and Trade Marks [2011] ECR I-0000 ("Queensland") (see at [37] and [49] of his judgment), it is not possible to disagree with what he says at [53] to the effect that the test laid down in Medeva and its progeny is unclear save in its rejection of the infringement test in combination cases or with his statement in [62] that it is inevitable that there will have to be further references to the ECJ.

Since this was a matter of European law to which the answer was unclear in the light of the guidance so far given by the Court of Justice, a further reference would be needed before the Patents Court was able to give an answer to the specification issue;

* The Patents Court had the power under the Civil Procedure Rules, CPR r.40.20, to make binding declarations regardless of whether any other remedy was claimed -- and where there was a commercial imperative that a clearly defined dispute should be adjudicated on, there was no reason why the Patents Court should not have jurisdiction to resolve that dispute by granting declaratory relief;

* The action for a declaration should not be struck out since there were powerful commercial reasons why Eli Lilly should be allowed to proceed, not least because the company was unable to invoke the procedures for challenging the grant of an SPC because no MA had yet been obtained and no application for an SPC could yet be made.

* While it was right for the court to assist in providing the certainty which Eli Lilly reasonably required, the action should not be allowed to proceed until the Court of Appeal had given its decision on the validity issue and any subsequent application for permission to appeal had finally been dealt with. If it turned out that the patent was invalid and no appeal to the Supreme Court was made, that would be an end of the matter and there would be no need for the declaration. If however the patent was held valid, the claim for a declaration should be allowed to proceed.

* There was no point in making any reference to the Court of Justice for a preliminary ruling for as long as the stay was in place. In this instance, no reference should be made unless the facts relevant to each of the third party SPC issue and the specification issue were established.

A new CJEU referral on claims with functional features

Last week, the 14th Senate of the German Federal Patent Court referred new questions to the CJEU on the criteria for Article 3(a) of Regulation (EC) No. 469/2009 (decision 14 W (pat) 12/17) in an attempt to clarify when a functional definition in a claim refers implicitly, but necessarily and specifically to the product in question, as stipulated by the CJEU in Eli Lilly (C-493/12).

Dirk Bühler (Maiwald), who acted for the patentee Royalty Pharma, has kindly provided a copy of the decision (here), an English translation of the decision (here) and a summary of the case (see below the questions).  For those who just want to read the questions, they are reproduced directly below:

1. Is a product protected by a basic patent in force according to Article 3 (a) of Regulation (EC) No 469/2009 only if it belongs to the protected subject-matter as defined by the claims and is thus provided to the person skilled in the art as a specific embodiment? 

2. Is it therefore not sufficient for the requirements of Article 3 (a) of Regulation (EC) No 469/2009 that the product in question meets the general functional definition of an active substance class as mentioned in the claims, but apart from that is not individualized as a specific embodiment of the teaching protected by the basic patent?

3. Is a product not protected according by Article 3 (a) of Regulation (EC) No 469/2009 by a basic patent in force if it is covered by the functional definition contained in the claims, but was developed only after the filing date of the basic patent based on independent inventive activity?

Summary 

Background 

It seems fair to say that Medeva (C-322/10) and its progenies have rather complicated than clarified as to when a product is protected by a basic patent in accordance with Article 3 (a) of the Regulation (see e.g. latest referral of Judge Arnold ([2017] EWHC 13 (pat)).

Even though it is clear in view of the numerous decisions by the CJEU since Medeva that Article 3(a) precludes SPCs for products which would infringe the patent despite not being referred to in the claims at all, e.g. for the presence of the term “comprising, there has been a debate as to how specifically the product must be disclosed in individualized form in the claims. 

For claims with functional definitions this debate has focused on whether the requirement set by Eli Lilly that such claims must refer implicitly, but necessarily and specifically to the product allows for SPCs in situations where the product is not disclosed as an individualized embodiment. Whilst this position has been endorsed by the UK courts for generic antibody claims ([2014] EWHC 2404 (Pat)) and claims with Markush formulas ([2017] EWHC 987 (Pat)), patent offices in other jurisdictions have taken a more restrictive standpoint and interpret Eli Lilly to require an individualized disclosure of the specific compound at least in the specification or to refer to antibodies only.

The referred case
The claims of the basic patent EP 1 084 705 B1 are concerned with the treatment of Diabetes mellitus by administration of DPIV-inhibitors and are based on the inventors’ recognition that inhibition of the enzyme DPIV generally allows for lowering of blood glucose levels by preserving the endogenous incretin hormones. The patent discloses individual DPIV inhibitors and points out that other DPIV inhibitors may be used as well. The general nature of the invention has been recognized by the German Federal Court of Justice in its decision on the German patent DE 196 16 486  based on the priority filing which belongs to the leading case on enablement in Germany (BGH X ZB 8/12 – Dipeptidyl-Peptidase-Inhibitoren).

DPIV-inhibitors marketed for treatment of Diabetes mellitus include sitagliptin which is not disclosed individually in the basic patent and has been developed by a licensee of the patent. Sitagliptin is also protected by a later filed composition of matter patent. The situation is thus comparable with Eli Lilly where the claims were directed to the genus of Neutrokine-alpha antibodies, but the product in question, tabalumab which is a Neutrokine-alpha antibody, was not individually disclosed in the claims or the specification and had been developed after the filing date of the basic patents.
An SPC application for sitagliptin was rejected by the German Patent and Trademark Office because sitagliptin would not be disclosed individually in the patent. The rejection was appealed.

In its referring decision the Senate acknowledges that sitagliptin is a DPIV-inhibitor as demonstrated by the assessment report of the EMA and would thus be within the extent of protection conferred by Article 69 EPC. However, according to the Senate’s interpretation of Medeva and Eli Lilly it would not be sufficient for the purpose of Article 3 (a) that the product in question, namely sitagliptin, falls within the extent of protection (Schutzbereich )conferred by the claims. It would rather be required that the product is disclosed specifically enough to form the subject matter (Schutzgegenstand) of the claims which in the absence of an individualized disclosure of sitagliptin in the basic patent would not be the case. 

The Senate however acknowledges that a different position has been taken by e.g. UK courts on highly comparable case scenarios (see [2017] EWHC 987 (Pat) in view of Medeva and Eli Lilly. This divergent interpretation of the CJEU’s case law by the national courts and patent offices would not be acceptable to applicants and run counter to the overall objective of the Regulation, namely to provide a uniform solution for the common market. 

The Senate has therefore decided to stay the appeal proceedings and to refer the following questions:

1. Is a product protected by a basic patent in force according to Article 3 (a) of Regulation (EC) No 469/2009 only if it belongs to the protected subject-matter as defined by the claims and is thus provided to the person skilled in the art as a specific embodiment?

2. Is it therefore not sufficient for the requirements of Article 3 (a) of Regulation (EC) No 469/2009 that the product in question meets the general functional definition of an active substance class as mentioned in the claims, but apart from that is not individualized as a specific embodiment of the teaching protected by the basic patent?

3. Is a product not protected according by Article 3 (a) of Regulation (EC) No 469/2009 by a basic patent in force if it is covered by the functional definition contained in the claims, but was developed only after the filing date of the basic patent based on independent inventive activity?

Thanks Dirk!