A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Showing posts with label combination SPC. Show all posts
Showing posts with label combination SPC. Show all posts

Monday, 15 October 2012

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:
 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.

Saturday, 6 October 2012

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.

Sunday, 23 September 2012

Combination SPCs: more hypertension for the Court of Justice?

Last week Mr Justice Arnold gave judgment in the Patents Court, England and Wales, in Actavis Group PTC EHF & another v Sanofi Pharma Bristol-Myers Squibb SNC [2012] EWHC 2545 (Pat). In this action Sanofi was granted a second SPC in respect of European Patent (UK) No 0 454 511, "N-substituted heterocycle derivatives, their preparation, compositions containing them" (this being antihypertensive drug known by its international non-proprietary name of irbesartan).  The first SPC, for the single product irbesartan, expired on 14 August of this year.  The second SPC, granted in December 1999 and with an expiry date of 14 October 2013, is for a combination of irbesartan and hydrochlorothiazide sold under the trade mark CoAprovel.  Actavis challenged this grant and the judge has decided to refer two questions to the Court of Justice of the European Union (CJEU) for a preliminary ruling

The first question for reference relates to Article 3(a) of the SPC Regulation, which states that an SPC shall be granted in respect of a patent when, on the date of the application for it, "the product is protected by a basic patent in force". Arnold J's first question to the CJEU, at [74], is this:
"What are the criteria for deciding whether 'the product is protected by a basic patent in force' in Article 3(a) of the Regulation?"
The second question is found at [92], where Arnold J states:
"It appears ... that the Dutch Patent Office has adopted the opposite interpretation of [the CJEU's ruling in Case C-322] Medeva to that adopted by the UK Intellectual Property Office, namely that it prohibits the grant of more than one SPC per patent regardless of the number of products claimed in the basic patent. In Case AWB 10/4769 Georgetown University v Octrooicentrum Nederland (11 July 2012), which is a parallel case to the Georgetown case in this country, the Rechtbank 'S-Gravenhage (Judge van Walderveen) held that the correct interpretation of Article 3(c) was unclear and decided to refer a question to the CJEU provisionally worded as follows:
    "Does [the Regulation], more specifically Article 3(c), in the situation in which multiple products are protected by (the claims) of a basic patent, preclude the proprietor of the basic patent being issued a certificate for each of the products protected?" ...
Arnold J has provisionally decided to ask this question too.

Sunday, 8 July 2012

Telmisartan + hctz: combination SPC in Spain -- now in English

Pamplona: city of great
excitement -- even for SPCs
Last month, in "Telmisartan + hctz: combination SPC revoked in Spain" (here), Javier Huarte and his colleague Sara Pelaz (Grau & Angulo, Barcelona) kindly sent us information concerning a judgment of the Commercial Court No. 1 of Pamplona, which upheld a revocation action by Cinfa and Actavis against the Spanish SPC for telmisartan + hctz.

Javier and Sara have now sent us an English translation of this decision, which you can read here.  Thanks so much, Javier and Sara, for your thoughtfulness.

Tuesday, 26 June 2012

Telmisartan + hctz: combination SPC revoked in Spain

Javier Huarte and his colleague Sara Pelaz (Grau & Angulo, Barcelona) have kindly sent The SPC Blog the following information to share with our readers:
"By means of a judgment dated 20 June 2012 (here), the Commercial Court No. 1 of Pamplona has upheld a revocation action by Cinfa and Actavis against the Spanish SPC for telmisartan + hctz, on the grounds of article 15.1(a), in relation to article 3(a), of the SPC Regulation.

The active ingredient ‘hctz’ was not specified in the wording of the claims of the basic (mono) patent. Accordingly, since it couldn’t do otherwise, the court has relied on the ECJ Medeva decision to conclude that the SPC must be deemed invalid and revoked. As far as we are aware, this is the first post-Medeva decision in Spain to decide on an SPC for combination products.
The SPC holder (Boehringer) can appeal the judgment.
Javier and Sara hope to be able to forward an English translation of the decision within a few days. On behalf of all our readers, we thank you both very much!