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.

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.

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.

Medeva: it isn't over till it's over ...

The 4 July 2012 issue of the UK Intellectual Property Office's Patents Journal (No.6424) contains the following entry:

"MEDEVA BV

EP1666057

Method of manufacture of an acellular vaccine comprising bordetella pertussis antigens

Notice of Appeal against the decision of the Court of Appeal dated 05 May 2012 [judgment delivered on 3 May, with comment on The SPC Blog on 4 May here] lodged with the Supreme Court on 31 May 2012 (UKSC 2012/0144)

Appeal - Lodged"

It is by no means certain that the Supreme Court will agree to hear the appeal.

Thanks, Daniel Wise (Carpmaels & Ransford), for letting us know.

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.

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)

******************************************** 

"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).

********************************************

“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).

********************************************

"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).

********************************************

"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).

********************************************

"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)

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.  

JIPLP note on Medeva, Georgetown Opinion available online

"Supplementary Protection Certificates for combination products" is the title of a Current Intelligence note by Tim Powell and Rebecca Lawrence (Powell Gilbert LLP) on the Advocate General's Opinion of 13 July 2011 in Joined Cases C322/10 Medeva and C422/10 Georgetown University.

The Fourth Chamber of the Court of Justice of the European Union will -- as regular readers of this weblog know -- be giving judgment on Thursday 24 November.  It may be a few weeks till the printed version of Tim and Rebecca's note is published in the Journal of Intellectual Property Law & Practice (JIPLP). Meanwhile, you can read it in full on the jiplp weblog here.

Medeva and the role of the Advocate General: a call for more communication

Regular reader and occasional commentator Paul Inman (Wragge & Co. LLP) has been giving some further thought to the role of the Advocate General in shaping and applying legal policy where issues have been referred to the Court of Justice of the European Union for a preliminary ruling. He writes:

"One (of many) of the causes of consternation arising from Advocate-General Trstenjak’s Opinion in the Medeva reference (discussed many times  in earlier posts on this weblog) was her contention (in para 102) that:

“according to the Court’s case-law, only one supplementary protection certificate may be granted for each basic patent”.

This has caused more than a few squawks of concern by commentators across the continent (and indeed beyond), not least on this blog.

A-G Trstenjak attributes this “case-law” to paragraph 28 of the ECJ Judgment in the Biogen case, from which she has taken a literal quote of the final words of that paragraph. As the world and his wife have since pointed out, however, this is not consistent with past and current practice around Europe (and many examples of multiple SPCs based on single patents have been brought forward).

Of course, the ECJ judgment in Biogen was founded on, and came to very much the same conclusion as that reached by Advocate-General Fennelly in that case. I was struck, therefore, while perusing A-G Fennelly’s opinion in Biogen (as one does on a Friday evening) with paragraph 53 of his opinion, which closes with the words:

“It is nowhere stated that a patent can be the subject of only one certificate, or of a certificate only in respect of one medicinal product, as the same patent may be used for widely differing medicinal products.”

Hurrumph! Don’t these Advocates-General talk to each other? Perhaps Angela Merkel is right – perhaps peace in Europe should not be taken for granted".

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".

More comments to the AG opinion in Medeva

Dorothea von Renesse and Norbert Schwenk (König, Syznka, Tilman, von Renesse, Düsseldorf) have kindly provided their input (here) to The SPC Blog's call for thoughts to Paul Inman's and Herwig von Morze's comments last week on Medeva and the interpretation of EU law.

Dorothea and Norbert's comments are strongly influenced by the German perspective about the meaning of the "subject matter of the patent" and will be published in the September issue of the Mitteilung der deutschen Patentanwälte.

Medeva and the interpretation of EU law: literal or teleological?

Earlier this week The SPC Blog posted "The holiday is over: a close reading of the Opinion in Medeva", in which Paul Inman expressed some bewilderment as to what precisely the Advocate General was advising the Court of Justice. It seems that Paul is not alone, since the blog has now received a further admission from a reader that this Opinion has caused confusion, this coming from International Patent Consultant Herwig von Morze. Writes Herwig:

"I share Paul Inman's confusion regarding paras 67-69 of the Advocate General's Opinion in Medeva, in particular since Art.1(c) uses the word "protects". May I add a confusion of my own? I am confused by the fact that the AG uses a literal interpretation for the purpose of rejecting the infringement test as the basis for the assessment of Art. 3(a). However, thereafter in the paras starting with 75, she rejects the literal interpretation essentially of the same articles as in conflict with the aims of the regulation. 

I haven't read any ECJ decision or AG Opinion which vacillates between literal interpretation for arriving at one conclusion and teleological interpretation to support the aims of a regulation. Such a selective approach seems arbitrary to me. Perhaps somebody with more ECJ experience can help and set me straight?"

My personal recollection is that the ECJ seems to favour starting from the teleological approach in intellectual property references even when its application contradicts the clear and unambiguous literal meaning of plainly expressed words (see eg Case C-292/00 Davidoff v Gofkid).  However, as a common lawyer I have no problem with inconsistency between the two approaches since I was brought up to believe that they were complementary rather than in conflict: one started with the literal interpretation and applied it -- unless (i) there was an ambiguity as to how it should be applied or (ii) its application produced a result that was clearly nonsensical, in which case one moved straight away to a teleological approach. The ECJ's approach is fortified by the availability of considerable material that is prepared for the purpose of aiding interpretation of Directives and Regulations, particularly in the form of the recitals in the preamble, whereas domestic statutory interpretation in the United Kingdom does not have such useful guidance, especially in the case of older statutes. However, the Court of Appeal for England and Wales in Neurim must have been wearing teleological spectacles when it viewed the law on SPCs and questuined whether it was "fit for purpose"

Readers' thoughts on Herwig's and Paul's comments are very welcome.

The holiday is over: a close reading of the Opinion in Medeva

Will our correspondent be applying
for a Supplementary Holiday
Certificate ...?

Paul Inman (Partner, Wragge & Co LLP) has been taking a close look at the recently-delivered Opinion of the Advocate General 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 (noted here by The SPC Blog, with further comments here). He writes (and the comments in square brackets are his asides, not our additions):

"Dear SPC Blog

Sorry for harking back to the Medeva AG opinion (but its holiday season and some of us have been away!)

As regards the first question in this reference - what is meant by "the product is protected by a basic patent in force", it seems to me (unless I have missed something) that the AG has -- in rather an off-hand manner -- answered this in passing somewhere around the late 60s (paras).

• In para 67 she makes reference to the "subject matter" of a patent when she states that the subject matter of each of the three categories of patent referred to in Art 1(c) (i.e. product, process and use) is always the "active" [not sure if this is correct -- but anyway]. 

• In para 68, she then appears simply to proclaim that "the subject matter" of a patent equates to the "extent of protection" of that patent. [So there we have her answer: "protected by a basic patent" = "the subject matter of a basic patent"]. Somewhat bizarrely, she then differentiates this concept of "extent of protection" from "the protective effect" of the basic patent (despite the obvious link in the word "protect" in both phrases). Whilst there may indeed be a distinction between these two concepts, there appears to me to be no reasoning behind her proclamation that "extent of protection" equates to "the subject matter". [and anyway -- what does that mean?] 

• In para 69 she fortifies her position by stating "The decisive consideration in that context is the fact that the definition of the basic patent in Art 1(c) of [the Regulation] takes as its basis the subject matter of the patent, and not its protective effect." (emphasis in original). Again, there seems to be no basis for this statement, despite the fact that Art. 1(c) uses the word "protects" and not "subject matter". Nevertheless, the entire remainder of the Opinion is built on this "rock" of principle - that "protects" in Article 1(c) actually means "is the subject matter of", and "protected by" in Art. 3(a) actually means "the subject matter of".

Looking at this from a wider perspective of the legislation - what does Art. 4 now mean?

• That article is entitled "Subject matter of protection". Should this be construed (in the context of this Regulation) as "Subject matter of subject matter"? 

• The substance of Art. 4 states: "Within the limits of protection conferred by the basic patent …". Does this therefore mean "Within the subject matter of the basic patent"? 

• Art. 4 goes on: "the protection conferred by a certificate shall extend only to the product …". Does this mean "the subject matter of the certificate shall extend only to the product …"? If that is the case, how does her inference that SPCs for active(s) forming only part of multi-active medicinal products will protect those multi-active medicinal products stack up?

Finally, does this mean we now have to refer to this Regulation as the 'Supplementary Subject Matter Certificate Regulation'?

Back from Holiday and Confused".

As ever, readers' thoughts and comments are invited.

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".

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."