Paris Court of Appeal overturns preliminary injunctions against Mylan and Sandoz/ MSD's ezetimibe/simvastatine SPCs

Many thanks to Denis Schertenleib, from Schertenleib Avocats (an old friend of the blog) for the following report on events before the Paris Court of Appeal, in relation to Merck's ezetimibe/simvastatine SPC, in which he was involved: 

On 14 February 2020, the Paris Court of Appeal overturned a series of preliminary injunctions against Mylan and Sandoz based on Merck's ezetimibe/simvastatine SPC. These decisions are of specific interest as they are the first to follow a series of injunctions and substantial awards of provisional damages granted against several generics by the High Court of Paris from 2018 to 2019.  Commentators following such injunctions and awards of provisional damages had argued that this constituted a landmark change of practice at the High Court in pharmaceutical cases. However, these decisions had not been subject to appellate review.  On appeal the court held that, in addition to the relevant SPC being invalid, the measures ordered were disproportionate. The Court of Appeal held that Merck’s SPC suffered from serious grounds of invalidity, thus overturning the previous High Court decision that found this SPC valid and infringed. The Court of Appeal further held that the various product recalls and provisional damages ordered were disproportionate and thus should not have been granted even if the SPC was valid. 

A translation of the Mylan decision is attached here and the Sandoz decision here.

No more launch at risk in France?

Recently, the Paris High Court decided for a preliminary injunction against the commercialization of Darunavir by Sandoz.  A copy of the decision is available here.  Matthieu Dhenne from Dhenne Avocat has kindly provided the below summary for the case. 

A recent decision of the Paris High Court (January 11, 2019) decided preliminary injunctions against the Darunavir commercialization by Sandoz (Prezista generic). The SPC was found to be presumably valid and thus infringed by Sandoz.  

The question was: how should we applied article 3(a) SPC Regulation (Regulation (EC) No. 469/2009)?  We must beforehand recall that the CJEU has never ruled on how article 3(a) should be applied with respect to a Markush claim. Thus, should darunavir be considered as being “specified in the wording of the claims” (Medeva)? Or should we hold that the claim “relates, implicitly but necessarily and specifically“ to darunavir (Eli Lilly)? But maybe those questions are irrelevant since the claim is not a functional one? 

Firstly, the Paris High Court analyzed the CJEU case law about SPC and concluded that the Eli Lilly test was not applicable to a Markush claim:

“It should be noticed that, in Eli Lilly, the case concerned a functional claim, so that the CJEU insisted on a double condition of necessity and specificity. In the present case, the claims of the basic patent are structural and better allow the skilled person to determine in view of the claims whether the active compound protected by the SPC was covered by the basic patent.” 

Secondly, following the examination of the formula of claim 1 of the patent and the various meanings of the variable groups in this claim and some of the dependent claims, the Judge concluded that: 

“Thus darunavir is identified by the skilled person as being implicitly but necessarily and specifically protected by the EP’209 patent in view of the substituents identified in the claims, in keeping with the requirements of article 3(a) of the EC Regulation and of the CJEU case law.” 

Therefore, the judge considered that the defendant did not prove that the SPC was manifestly invalid. Accordingly, a preliminary injunction was ordered, under a 50,000 euro-penalty per violation of the injunction. The judge also ordered a seizure of the infringing drugs, as well as a product recall. 

The recent French case law (and the reform of nullity actions limitation period with PACTE Law?) send a clear sign to the drug manufacturers: launch at risk should now be avoided in France.

Thank you Matthieu!

France - Court of Appeal of Paris refers questions to the CJEU

Thomas Bouvet and Laura Romestant (Jones Day) kindly report below on a recent decision (here, in French only) of the Court of Appeal of Paris to refer questions to the CJEU:

On 9 October 2018, the Court of Appeal of Paris issued a decision which refers two questions to the CJEU intended to clarify the terms “different application” and “falling within the scope of protection conferred by the basic patent” as addressed in the CJEU Neurim decision. 

Background
Santen is the holder of:

• European patent № 1 809 237, entitled “Ophthalmic oil-in-water type emulsion with stable positive zeta potential”, filed on 10 October 2005 and granted on 31 December 2008;
• a central marketing authorization № EU/1/15/990 valid in the entire European Union, granted on 19 March 2015 and notified on 23 March 2015, for the medicinal product with the proprietary name Ikervis, whose active ingredient is ciclosporin in the formulation, covered by EP 1 809 237, indicated for the treatment of severe keratitis in adult patients with dry eye disease, for which ciclosporin has not been approved before.

By a decision dated 6 October 2017, the Director General of the INPI dismissed the application to grant an SPC for ciclosporin eye drop emulsion, filed by Santen on 3 June 2015. 

The Director of the INPI considered that the marketing authorization, on which the application is based, would not be the first authorization to place the product on the market as a medicinal product:

• it considered that the sole active ingredient of the specialty object of MA № EU/1/15/990 for “ciclosporin for use in the treatment of keratitis” is ciclosporin which should be considered as the product object of the requested SPC, within the meaning of Article 1(b);
• it considered that the previous MA for ciclosporin had been granted on 23 December 1983 for the medicinal product Sandimmun;
• it considered that CJEU Neurim decision C-130/11 would not apply in the circumstances of the case because:

- the application for which Ikervis is authorized is not a different application from that of Sandimmun as both relate to inflammatory diseases of the eye;
- the basic patent does not protect a new application of ciclosporin, but a new formulation containing no specific use limitation.

Santen lodged an appeal against this decision by declaration of 3 November 2017.
In its written submissions filed before the Court of Appeal of Paris, Santen requested:

• as a main request, that the Court of Appeal hold the decision of the Director General of the INPI null, as it is contrary to the case law of the CJEU as set out in the Neurim judgment of 19 July 2012 as well as to the case law of the Court of appeal itself as it is set out in the Merck & Co decision of 15 February 2013;
• as an auxiliary request, that the Court of Appeal refer a question for a preliminary ruling to the CJEU, in the terms set out in its written submissions before the Court.

The decision of the Court of Appeal of Paris of 9 October 2018
The decision of the Court of Appeal (here) refers two questions to the CJEU, which read in working translation as follows: 

“1 - Should the notion of different application within the meaning of the CJEU Neurim decision of 19 July 2012, C-130/11, be strictly understood, i.e.:

- be limited to the case of a human application following a veterinary application,
- or concern an indication in a new therapeutic field, in the sense of a new medical specialty, compared to the previous MA, or a drug in which the active principle exerts an action different from that which it exerts in the drug that was the subject of the first MA;
- or more generally, in the light of the objectives of Regulation (EC) No 469/2009 aiming at establishing a balanced system taking into account all the interests at stake, including those of public health, be assessed according to more stringent criteria than those used for the assessment of the patentability of the invention;

or, on the contrary, should it be understood in an extensive way, i.e. including not only different therapeutic indications and diseases, but also different formulations, dosages and/or modes of administration?

2 - Does the notion of application falling within the scope of protection conferred by the basic patent within the meaning of the CJEU Neurim decision of 19 July 2012, C-130/11, imply that the scope of the basic patent should be consistent with that of the MA invoked and, therefore, limit itself to the new medical use corresponding to the therapeutic indication of said MA?” 

The Court of Appeal found it necessary to ask two questions resulting from the Neurim decision:

- the first one is intended to clarify the meaning of the term “different application” within the meaning of the CJEU Neurim decision of 19 July 2012, C-130/11;
- the second one intended to clarify to what extent the basic patent should cover said different application, in particular whether it should be limited to the new medical use.

Thomas Bouvet and Laura Romestant  represented Santen.

France - Paris Court of First Instance nullifies Truvada SPC

Moving on to France on the tour of national court rulings on Gilead's SPC on the combination of tenofovir disoproxil and emitricitabine: Gerard Dossmann and Marianne Gabriel, who acted for Biogaran, report below the recent decision of the Paris Court of First Instance to nullify Gilead's SPC FR05C0032.  A copy of the judgement can be found here.

By judgment of May 25th, 2018, the Paris Court of First Instance canceled the SPC on the combination of "tenofovir disoproxil and its salts, hydrates, tautomers and solvates in combination with other therapeutic compounds such as emtricitabine". 

The basic patent mentioned, in its claim 27, a "pharmaceutical composition comprising a compound according to any of claims 1 to 25 [i.e., tenofovir disoproxil], together with a pharmaceutically acceptable carrier, and optionally, other therapeutic ingredients. " 

The Paris Court of First Instance held that "the patent on the basis of which the SPC 0032 was delivered does not mention, in the wording of its claims, emtricitabine, the active ingredient on which the SPC relates in combination with the tenofovir disoproxil, neither makes it necessarily and specifically identifiable, nor does it mention a functional formula implicitly but necessarily and specifically aiming at emtricitabine, so that the product is not protected by the basic patent and that the condition laid down in Article 3 (a) of Regulation (EC) No 469/2009 is not fulfilled ". 

After citing the case-law of the General Court of Justice and the brief of the General Attorney Wathelet, the Court specified the conditions to which a claim must comply in order for a product to be considered protected by the basic patent and therefore meet the requirement of Article 3 (a) of Regulation (EC) No 469/2009. 

Thus, according to the Court, "the requirement for that product to be protected by a basic patent in force "presupposes":

• "that the product is mentioned in the wording of one of the claims or at least, if not mentioned by name, that it is necessarily and specifically identifiable as such by a person skilled in the art"
• “and that where – in the case of a combination of active ingredients – each active ingredient be also mentioned in the claims or, failing that, necessarily and specifically identifiable individually',
• “one must note that if it may considered that - to be considered protected by the basic patent – an  active ingredient is not mentioned in the claims of the basic patent by means of a structural definition but simply by means of a functional definition, it is also important to establish that these claims, interpreted inter alia in light of the invention’s description, as provided by Article 69 of the Convention of 5 October 1973 on the Grant of European Patents (EPC ) and its interpretative protocol, implicitly but necessarily aim in a specific manner at the active principle in question. " 

The Court of First Instance also ruled on the interpretation of Article 69 EPC and held that "the interpretation pursuant to which, for the person skilled in the art, in the context of European Patent No 894, the sentence 'and, where appropriate other therapeutic ingredients' would target an active ingredient with therapeutic properties which may be capable of being combined with tenofovir disoproxil, such as emtricitabine, clearly exceeds what is permitted by Article 69 EPC and its interpretative protocol in this respect, therefore leading to the admission that "the protection also extends to what, in the opinion of a person skilled in the art having examined the description and the drawings, the patent owner intended to protect", and may therefore disregard the reasonable degree of legal certainty that third parties are entitled to expect. " 

The Court noted, for the sake of completeness, that the purpose of Regulation (EC) No 496/2009 had been respected in the present case, since the owner had a 15-year monopoly between February 5th,  2002, date on which the marketing authorization was granted for the drug on the tenofovir disoproxil subject of the patent no. 894 and July 25th, 2017, the patent’s expiry date, so that it did not suffer from any lack of protection within the meaning of recital (9) of the Regulation.

This very recent judgment is not yet final.

Many thanks to Gerard and Marianne!

Telmisartan/HCTZ combination: a French appeal

Here, thanks to our good friend and European patent attorney Edouard Kling ("en collaboration avec august & debouzy avocats"), is an English translation of Boehringer Ingelheim v Actavis, a limitation decision (which you can read or download) issued a couple of months ago by the French Court of Appeal which, though French readers are already aware of it, is ripe for spreading to the rest of the SPC Blog community. Edouard explains:

The decision actually relates to some of the previous posts of the Blog:

* first, because it deals with the basic patent and SPC application for the Telmisartan/HCTZ combination product and 

* secondly because it further illustrates the trend among the French jurisdictions to focus on the technical content of the specification and examples when assessing the subject matter disclosed in pharmaceutical patents.

In line with the previous decision of the High Court of Paris which revoked, for insufficiency of disclosure, the basic claim directed to the Irbesartan/Diuretic combinations in the absence of any related example, the Court of Appeal ruled that Boehringer should not be entitled to limit the subject matter of claim 8 to a combination product comprising both Telmisartan and HCTZ. The underlying reason for this was that, even though the specification explicitly teaches that the benzimidazoles of the invention could be administered in combination with a list of additional active ingredients (among which was HCTZ), such combinations should not be part of invention as the patent fails to study and exemplify the effects of these combination therapies. The Court considered that the teaching of the patent was merely speculative.

The readers will probably remember that a different section of the Court of Appeal of Paris decided last year (on June 8, 2012) to confirm the rejection of the SPC application to the combination product regardless of the pending request for limitation of claim 8. Notably the Court had, at the time, already raised concerns about the “hypothetical” combinations envisaged in the specification. The case is currently pending before the Supreme Court, but will most certainly be impacted by this decision.

The original French version of the decision can be read or downloaded.

Irbesartan + HCTZ: news from France

From our friend Denis Schertenleib, Avocat, of Cabinet Schertenlieb, Paris, comes a timely update on the Coapprovel (irbesartan + HCTZ) litigation in France, following the revocation of the SPC in this dispute on the merits (said the court, claim 20 of the basic patent was invalid).

I attach the decision in French and in English. By way of a disclaimer, Denis tells us that he represented Mylan in these proceedings and has advised us that this decision is naturally subject to an appeal.

Further news is that the Cour d'appel, ruling on the injunction that was issued against Teva, lifted it on the grounds that the basic patent could be challenged on validity and also confirmed the decision not to grant an injunction against Sandoz and Arrow -- also on the basis that the SPC could be challenged on validity.

Thanks so much, Denis, for this update.

Valsartan: France back in line with the rest of Europe

From our good friend Laëtitia Bénard (Partner, Allen & Overy LLP, Paris) comes some more fascinating and instructive material for our readers. Laëtitia (whose firm acted as counsel to Novartis in the Valsartan case, and to MSD and Du Pont in the Losartan case) writes:

Novartis v Actavis on the Valsartan SPC: the French Supreme Court has quashed the decision of the Paris Court of Appeals and has put France back in line with the CJEU and national courts in Europe by ruling that an SPC covering Valsartan confers the same rights as the basic patent and is infringed by a medicinal product comprising Valsartan in combination with another active ingredient

Further to a preliminary injunction rendered against Actavis on 28 January 2011, which ruled that Actavis' generic medicines containing a combination of Valsartan and HCTZ infringed the SPC of Novartis for Valsartan, the Paris Court of Appeals rendered a decision on 16 September 2011 inconsistent with the almost unanimous interpretation of the SPC Regulation across Europe on the subject matter and effects of an SPC, including France, reversing the preliminary injunction measures ordered in first instance.

On 15 January 2013, ruling on Novartis' appeal, the French Supreme Court quashed the decision of the Paris Court of Appeals, aligning at the highest level the French case law with the interpretation of the SPC Regulation by the CJEU in its Reasoned Orders of 9 February 2012 (C-442/11 and C-574/11), as previously did the Paris First Instance Court ruling on the merits on 8 June 2012 in the Losartan case (decision now final -- you can read the French decision of 8 June 2012 here and the English translation here).

The French Supreme Court ruled that an SPC covering Valsartan confers the same rights as the basic patent and is infringed by a medicinal product comprising Valsartan in combination with another active ingredient.

The main findings of the French Supreme Court are as follows:

"Whereas by order of 9 February 2012 (C-442/11), the Court of Justice of the European Union ruled and held to be law that Articles 4 and 5 of Regulation No. 469/2009 must be interpreted as meaning that, where a product consisting of an active ingredient was protected by a basic patent and the holder of that patent was able to rely on the protection conferred by that patent for that product in order to oppose the marketing of a medicinal product containing that active ingredient in combination with one or more other active ingredients, an SPC granted for that product enables its holder, after the basic patent has expired, to oppose the marketing by a third party of a medicinal product containing that product for a use of the product, as a medicinal product, which was authorised before that certificate expired;  

Whereas the decision considers, in order to dismiss Novartis' claims, that the litigious generic medicinal product, comprising Valsartan associated with HCTZ, does not constitute the same product as Valsartan, solely covered by SPC No. 97C0050, and consequently that it does not appear likely that any marketing of a medicinal product containing Valsartan as an active ingredient constitutes an infringement and violates the rights owned by Novartis over this active ingredient; 

Whereas, by deciding so, without considering whether the rights owned by Novartis on patent No. EP 0 443 983 would have allowed them to oppose the use of Valsartan, as a medicinal product, in the litigious generic medicinal products associating it with HCTZ, and whether, consequently, these generic products would infringe SPC No. 97C0050, covering, as the basic patent, Valsartan, and conferring to Novartis the same rights as the patent, the Court of Appeals rendered a decision without legal basis;".

This decision of the French Supreme Court is final.

You can read the French decision of the French Supreme Court here and the English translation here. 

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.

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.

Benoxacor and (S)-metolachlor: French ruling now available in English too

On Thursday 16 February The SPC Blog posted this item from France on the rejection by the Cour de Cassation -- the nation's highest court -- of an appeal against the refusal of an SPC for Benoxacor and (S)-metolachlor.  Edouard Kling and his colleague François Pochart (august & debouzy avocats) provided the original news and said they'd let us have an English translation. Well, here it is. It's five sides long which, though very short by the standards of many countries, actually seems quite lengthy for a Cour de Cassation ruling.

Thanks, Edouard and François, for your help and support.

France: Cour de Cassation upholds rejection of SPC for Benoxacor and (S)-metolachlor.

From Edouard Kling and his colleague François Pochart (of the Paris-based international practice of august & debouzy avocats) comes this fascinating news of a recent decision of the French Cour de Cassation -- its Supreme Court. Edouard writes:

"Here is a link to a ruling of the French Supreme Court for your blog which may have remained unnoticed among the various Medeva and Queensland discussions. This ruling is concerned with SPC Regulation 1610/96.

The Cour de Cassation confirmed the decision of the Cour d'Appel to reject SPC application No 02C0020 directed to a mixture of Benoxacor and (S)-metolachlor. It came to the conclusion that the product was already the subject matter of a previous SPC (No 97C0048 based on a different basic patent), though the former SPC did not specify the stereochemistry of the metolachlor component. Said the Cour de Cassation

“Whereas, first, the Cour d'Appel decision found that SPC no. 02C0020 was requested for a plant protection product whose active substance is the combination of benoxacor and S-Metolachlor and that SPC no. 97C0048 granted previously on the basis of patent no. 84810599 covers the combination of benoxacor and metolachlor without reference to one or more specific spatial forms of metolachlor; it further pointed out, on specific and adopted grounds, that the metolachlor molecule has two R and S enantiomers and four possible spatial forms, and that S-Metolachlor is only one enantiomer of the metolachlor substance; finally, it pointed out, on valid grounds, that it is not demonstrated that the transition of the active substance in question, from a racemic form to an enantiomer form, implies that the product has a different activity profile; from these findings and assessments, the Court of Appeal, which carried out the study referred to in the second part of the argument, was able to infer that the combination of benoxacor and S-Metolachlor constituted the same active substance as the combination of benoxacor and metolachlor since it was composed of the same sequence of atoms and, thus, one and the same product within the meaning of Articles 1. 3, 1. 8 and 3 of EC Regulation 1610/96”

This ruling may be related to the different European Escitalopram decisions dealing with the definition of a product under the scope of medicament SPCs, i.e. the Austrian and German decisions you have posted earlier. It however remains unclear about the burden, requirements and means left to the patentee to demonstrate an improved profile".

Edouard and François look forward to providing readers of this weblog with a complete translation as soon as possible.

Valsartan: now it's the turn of the Cour d'appel de Paris

From our French friends Tougane Loumeau and Grégoire Triet (Gide Loyrette Nouel A.A.R.P.I.) comes news of more developments concerning the much-litigated Valsartan. These relate to an order of the Cour d'appel de Paris dated 16 September 2011, kindly translated into English here for the benefit of this weblog's non-French-reading followers. The facts are these:

Novartis owns a patent on medicinal substance A which expired on 12 February 2011 and an SPC on product A which will expire in November. Novartis currently markets a blockbuster drug composed of A + B (another active ingredient). Actavis took steps to put on the market a generic version of product A + B after the expiration of the patent but before expiration of the SPC. Novartis sued Actavis to obtain an interim banning injunction based on its SPC on A.

On three occasions, French courts had ruled that an SPC confers exactly the same protection scope as a patent so that a product A+ B was considered as infringing an SPC on A.

Now for the first time, the Cour d'appel has had a chance to consider the issue. This is how it ruled:

A product, as defined by the EU Regulation, is not restricted to an active ingredient. An SPC, within the meaning of Article 4 of the Regulation, protects a product and not an active ingredient. In this case, the SPC only protects Valsartan as a product. 

It follows that, although the medicinal product Valsartan + HCTZ contains the active ingredient Valsartan, it is not the "product" Valsartan within the meaning of the Regulation but another "product" comprising a combination of active ingredients. 

Any other interpretation would be contrary to the rule of non-aggregation of sources of protection laid down in Article 3 of the Regulation according to which an SPC cannot protect another product and there can by only one SPC per product per patent holder. The active ingredient HCTZ cannot be considered a mere additional ingredient in the same way as we might view a vitamin. 

Accordingly, it does not appear likely that any marketing and sale of a medicinal product containing Valsartan as an active ingredient will constitute an infringement and thus violate the rights owned by Novartis in this active ingredient until 13 November 2011. 

Actavis' interpretation of the EU Regulation and its objections to the injunctive and other relief requested by Novartis are genuine and have merit and, contrary to what the lower court summary hearings judge held, remove all obviousness from the allegation of infringement.

Thanks so much, Tougane and Grégoire, we do appreciate your kindness.

Escitalopram in France

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

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

Monaco, France and SPCs

A friend of the SPC Blog has posed the following question for our readers, based upon the fact that Monaco does not appear to have made any provision for SPCs in its law.

Does a French SPC have any effect in Monaco? More specifically, can a French SPC produce a direct or indirect effect in Monaco?

A direct effect may simply result from the French SPC having a legal effect in Monaco, while an indirect effect could be that the existence of a French SPC effectively renders the lack of an SPC in Monaco irrelevant by governing the sales and price of the product in Monaco.

Our friend suspects that there is no direct effect of a French SPC in Monaco, but they are less sure about whether or not there is an indirect effect.

As always, any comments on this tricky issue will be gratefully received.

Losartan and HCTZ: now it's the turn of the French Cour d'appel

The Cour d'appel de Paris

The SPC Blog is grateful to Laëtitia Bénard (Partner, Allen & Overy LLP, Paris) for sending The SPC Blog some information concerning recent litigation before the Cour d'appel de Paris on 15 March 2011 in which that court ruled on Mylan's appeal against the order of the Tribunal de Grande Instance de Paris of 12 February 2010.  That earlier order had previously prohibited Mylan from launching a generic product containing Losartan and HCTZ on the basis of EI Du Pont de Nemours' SPC for Losartan (the first instance decision has previously been noted on The SPC Blog). For full disclosure, Laëtitia reminds readers that her firm acted as counsel to E.I. Du Pont de Nemours and Merck in this case.

The case, in short, is summarised as follows:

Du Pont - Merck v Mylan: the Paris Court of Appeals confirms that combination products infringe mono-SPCs and sets a precedent on the requirements for obtaining a paediatric extension 

Mylan and Qualimed had lodged an appeal against the preliminary injunction rendered on 12 February 2010, enjoining them, on the basis of Du Pont's SPC granted for Losartan as extended by a paediatric extension, from marketing a generic drug comprising Losartan and HCTZ. The appeal essentially rested on two grounds: 

(i) the appellants alleged that the owner of an SPC must file, along with his initial application for a paediatric extension, all "paediatric" (varied) marketing authorisations for each of the 27 Member States of the European Union, without a possibility to supplement the file at a later stage and
(ii) the appellants argued that a combination product does not infringe the SPC granted for one of the active ingredients of the combination. 

The Court of Appeals dismissed both arguments, and confirmed the first instance injunction. 

1. As far as the validity of the SPC is concerned, the Court first noted (in line with an earlier decision of the Dutch Patent Office of 2 June 2009) that it would place an undue burden on owners of SPCs to require them to provide all 27 "paediatric" marketing authorisations along with the application for paediatric extension: 

"This provision [Article 36 of the SPC Regulation], which only mentions the fact that the product must be authorised, does not specify that, at the date of the filing of the application, all the paediatric MAs must have been granted. Indeed, requiring the filing of the 27 paediatric MAs on the day of the filing of the application is in practice not possible in the absence of a centralised registration procedure and due to the variable speediness of the different agencies in charge of granting these authorisations." 

The Court went on to decide, in conformity with the practice of the French patent office, that the applicant for a paediatric extension must only prove that the product has been authorised in all 27 Member States, i.e. provide the initial ("non-paediatric") marketing authorisations: 

"The provision can only refer to the requirement to provide the initial MAs, while the paediatric MAs can be provided during the course of the granting procedure of the extension. It should be mentioned in this respect that this position has eventually been adopted by the INPI, as confirmed by the circular letter of the pharmaceutical industry trade union dated 7 January 2011. 

Du Pont filed its application for an extension on 27 February 2009 and the copies of the MAs for all other Member States were enclosed. Consequently, the procedure is lawful and the extension granted further to this application is not to be nullified."

2. The Court further confirmed, as also recently ruled by the President of the Paris First Instance Court in Novartis v Actavis (Valsartan), that an SPC covering a compound (Losartan in the present case) obviously prohibits the marketing of pharmaceutical products containing Losartan alone or in combination with another active ingredient. 

In this respect, the Court first referred to the basic principles of patent law: 

"It should be remembered that, under French law, infringement is assessed according to resemblances and not differences only, such that the inclusion of additional features to those claimed in a patent does not put an end to the infringement." 

It also analysed the purpose of SPCs: 

"An SPC, which aims at supporting innovation in the field of health, grants a protection to a product as a medicament under all the forms that fall within the protection of the basic patent." 

The Court concluded from this that: 

"Consequently, in the case at hand, the certificate which has been extended grants the same rights as those of the basic patent covering losartan, and the protection granted by this certificate concerns the product covered by the MA for any use of this product as a medicament that has been authorised prior to the expiry of the certificate. Consequently, the protection encompasses any use of losartan as a medicament." 

The Court also specifically addressed the appellants' argument based on the fact that the claimants had also been the owners of a (then-expired) SPC specifically covering the combination product (Losartan and HCTZ°). In this regard, the Court followed a classical intellectual property reasoning, and held that

"The existence of another SPC whose protection is expired is irrelevant in the case at hand." 

A further appeal to the Supreme Court is still possible".

The authentic French version of the decision can be read here.  The English translation can be read here.

Infringement of SPCs by combination products

Philippe de Jong from Altius in Brussels has directed us to a couple of articles written for the EPLAW patent blog (http://www.eplawpatentblog.com/) relating to SPCs and combination products.

The articles are entitled:

SPCs and combination products - Infringement Issues, by Philippe de Jong

SPCs and combination products - Validity Issues, by András Kupecz (Simmons & Simmons)

Philippe also provides three recent decisions concerning losartan and SPCs, two of which are Belgian decisions (and for which he has provided English translations), and the third from the French courts. We'll put them onto the SPC resources page too.

English summaries of the 3 decisions are as follows:

Brussels court of appeal, 23 February 2010, Du Pont et al. / Mylan, losartan SPC, decision in summary proceedings (appeal) (English translation here)

According to the Brussels court of appeal, the scope of protection of the SPC for the active ingredient losartan does not, at first sight ("prima facie"), extend to a generic version of the medicinal product Cozaar Plus® (containing the active ingredients losartan and HCTZ) under Article 4 of the SPC-Regulation. The main reason raised by the court is that, since the combination of losartan and HCTZ was itself protected by an SPC, a medicinal product containing that combination could not infringe the SPC for losartan alone. According to the court, this would appear to run counter with Articles 3(c) and (d) of the SPC-Regulation.


Pres. Brussels commercial court, 12 February 2010, Du Pont et al. / Mylan, losartan SPC, decision in summary proceedings (first instance) (English translation here)

According to the President of the Brussels commercial court, the scope of protection of the SPC for the active ingredient losartan, whose duration had been extended pursuant to Article 36 of the Paediatric Regulation 1901/2006, does not at first sight ("prima facie") extend to a generic version of the medicinal product Cozaar Plus® (containing the active ingredients losartan and HCTZ). The main reason raised by the court is that, since the paediatric extension was applied for and granted only for the losartan-SPC and not for the separately obtained "losartan + HCTZ"-SPC, the combination product Cozaar Plus® could not benefit from the paediatric extension of the losartan-SPC. Consequently, generic versions of Cozaar Plus® could not fall under the scope of protection of the losartan-SPC either.


Pres. Paris district court, 12 February 2010, Du Pont et al. / Mylan, losartan SPC, decision in summary proceedings (first instance)

According to the President of the Paris district court, the basic patent for losartan covers any product comprising losartan, including a product comprising losartan and another product such as a diuretic, like HCTZ. Since pursuant to Article 5 of the SPC-Regulation, an SPC confers the same rights as the basic patent and since pursuant to the Article 4 of the SPC-Regulation the SPC protects any subsequently authorised use of the product as a medicinal product, the combination product losartan+HCTZ falls under the scope of protection for the losartan-SPC. The fact that the paediatric extension was only granted for the losartan SPC and not for SPC for the combination product, was not held to be relevant. According to the court, the extended protection of the basic patent and the subsequent SPC, could only lead to the conclusion that any medicament containing losartan as an active ingredient amounted to an infringement.
As to the prima facie validity of the SPC-extension, the court held, inter alia, that the relevant provisions of the SPC-Regulation and Regulation 1901/2006 do not specify that the MAs need to have been obtained at the time of the filing of the application. The paediatric MAs must have been applied for on the day of the filing of the application, but can be communicated whilst the application is under examination.

French say "non" to olmesartan medoxomil and hydrochlorothiazide combination

Thank you, Alice de Pastors, for supplying The SPC Blog with a copy of the decision of the Cour d’appel de Paris, pôle 5, 2e ch., 6 novembre 2009 (here) in which that court dismissed the appeal of Daiichi Sankyo against the decision of the Director-General of the French Patent Office (INPI) on 13 February 2009 to reject French SPC 06C0019.

Daiichi Sankyo's 06C0019 SPC application was for an olmesartan medoxomil and hydrochlorothiazide combination, referring to EP0503785 patent and to the MA CIS 66838901 of 6 February 2006 relating to this combination and marketed as Colmetec®.
The Cour d'appel de Paris dismissed Daiichi Sankyo's appeal because it was not possible to get an SPC for the Olmesartan Medoxomil and Hydrochlorothiazide combination, as this combination was not protected by the patent.

The Cour d’appel de Paris added that the EP0503785 patent covered only Olmesartan Medoxomil and not the combination; SPC 03C0037 for Olmesartan Medoxomil was granted on 11 February 2005, referring to this patent and to MA NL No. 28,292, issued on 6 August 2003.

Enfin possible! Patent and SPC status searches on the INPI website

The Institut National de la Propriété Industrielle (INPI, aka the French Patent Office) recently launched its new patent and SPC information search site- accessible here. And it's free.

You can search by patent (or SPC) publication number for the current status or status history of the patent or SPC application or the granted patent or SPC in France. One nice thing is that if there is an SPC associated with your patent, then its status will be displayed along with that of the patent automatically.

En Anglais? Well, that would be asking too much so you'll have to brush up on your français.

Abelcet - a recent French SPC decision

Michèle Lavé of Cabinet Alice de Pastors in Paris has informed us of the following recently published decision by the French Patent Office:

"On 27 February 2009, the French Patent Office published the refusal of French SPC application FR97C0131.

SPC application FR97C0131, was lodged by The Liposome Company, Inc. on 8 December 1997 for a product comprising of a lipid complex of amphotericin B, a phosphatidyl choline and a phosphatidyl glycerol. The application is based on European patent EP0282405, on the British marketing authorisation 14188/0001 of 9 February 1995 and on the French marketing authorisation NL 21338 of 10 June 1997 for Abelcet®. The SPC application was transferred to Cephalon Limited.

On 26 September 2008, the French Patent Office rejected this SPC application on the following grounds:

• the French marketing authorisation NL 21338 relates to a drug containing amphotericin B as the sole active ingredient
• The 2 phospholipids which complex amphotericin B are mere excipients, which enable the reduction of the toxicity of amphotericin, but do not modify amphotericin therapeutic properties
• The therapeutic activity of Abelcet® is determined by amphotericin B
• The product subject of the SPC application can only be amphotericin B
• Amphotericin B was already covered by a previous French marketing authorisation, NL 5653 of 26 November 1973
• Therefore, as this SPC application does not refer to the first marketing authorisation for amphotericin B, it does not comply with conditions for obtaining an SPC set out in Regulation No. 1768/92.

This decision seems to be in line with the ECJ decision C-431/04 relating to carmustine/polifeprosan.

It is interesting to note that 12 SPC applications were filed in Europe by The Liposome Company, Inc. based on either EP0282405 or national corresponding patents. Ten applications were granted (AT, CH, DK, GB, IE, IT, LU, NO (2 SPCs), SE) and two were rejected (FR, NL). There is no published German SPC application referring to EP0282405 patent."

The French Patent Office cooks up controversy

The SPC Blog has obtained information from a source in France about several ongoing cases before the Cour d'Appel de Paris regarding appeals to decisions by the Institut National de la Propriété Intellectuelle (INPI - the French Intellectual Property Office) rejecting SPC applications based on "the same previously market authorised product":

The French PTO appears to have taken a very unhelpful and certainly
"technically unaware" stance, and are applying the ECJ decisions of Yissum,
etc, with gusto.

In essence the cases revolve around the distinction between what was marketed
as essentially a sort of "primordial soup", for example, a mix of enzymes or
cell extract where one enzyme is predominant although others present in the soup
influence its activity (this is not the subject-matter of the cases involved),
and the later and subsequently patented isolation of one particular active
substance over all the others which was found to have an enhanced desired
pharmaceutical effect and was stabler in the absence of all the junk that
hindered it previously. Unfortunately, the name of the "primordal soup" product
as previously authorised for marketing happens to be the same as the specific
name of the isolated substance, and so the INPI has refused the SPC applications
on the grounds that it is the "same product".

It should be interesting to see what the French courts make of it providing
the cases go all the way to trial, especially since there are political
ramifications involved, i.e. one or more state run/owned/shared entities have a
financial stake in the matter.