Darunavir in Swedish Preliminary Injunction Proceedings

Recently, the Paris High Court decided for a preliminary injunction against the commercialisation of Darunavir by Sandoz, the SPC Blog report can be found here. In parallel proceedings, the Swedish Patent and Market Appeal Court has come to the opposite conclusion, and found that that the contested SPC would most likely be found invalid and thus denied a request for a preliminary injunction. Hampus Rystedt from Zacco has kindly provided the following summary of the case.

The first instance Patent and Market Court, which is quite experienced in SPC appeals originating from the examination at the Swedish Patent Office, granted a preliminary injunction. The Patent and Market Appeal Court however reversed the decision. The PMAC specifically referenced the Teva case from the CJEU (C-121/17; EU:C:2018:585) and found that the criteria set out in Teva should be applied when assessing the plausibility that an SPC will be considered valid. The PMAC finds that darunavir is not specifically identified in the claims, and indeed appears to have been first synthesized only after the priority date. The PMAC therefore finds that it is likely that the SPC will be considered invalid in the main proceedings and that a preliminary injunction cannot be granted.

Of interest to note is that the decision in PMAC was split 3 to 2, with the chairwoman and the only chemical expert dissenting. The two dissenting judges found that the case law is not clear on how Art 3(a) of 469/2009 should be applied when the basic patent defines the invention by means of a Markush-formula. These judges were thus of the opinion that it had not been sufficiently shown that the SPC would likely be held invalid, and that the preliminary injunction granted by the lower court should be upheld.

The main proceedings will now continue in the first instance court.

Many thanks Hampus!

C-121/17 - Teva ruling out now

The CJEU gave its ruling today in C-121/17 (here), Teva UK Ltd and others v Gilead Sciences Inc.

In brief, the question referred by Justice Arnold, was:

What are the criteria for deciding whether "the product is protected by a basic patent in force" in Article 3(a) of Regulation No. 469/2009?

The Court has ruled as follows:

"Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 6 May 2009, concerning the supplementary protection certificate for medicinal products, must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent: 

–        the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and
–        each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent."

C-121/17 - The Advocate General advises the CJEU

The Opinion of Advocate General Wathelet in the UK reference for a preliminary ruling from the Court of Justice of the European Union in Case C-121/17 (Teva UK Ltd and others v Gilead Sciences Inc.) was posted on the Curia website (here) this morning.  At the time of this blogpost, the Opinion was only available in French.

As a recap, the referring court asked the following question:

What are the criteria for deciding whether "the product is protected by a basic patent in force" in Article 3(a) of Regulation No. 469/20091 ?

The Advocate General has advised the Court to rule as follows (thanks to Google translate):

"Article 3 (a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, precludes the issue of a certificate supplementary protection relating to active ingredients which do not appear in the wording of the claims of the basic patent. The fact that a substance or composition falls within the scope of the protection of the basic patent is a necessary, but not sufficient, condition for constituting a product protected by a patent within the meaning of Article 3 (a) of Regulation No 469/2009. 

A product is protected by a patent within the meaning of Article 3 (a) of that Regulation if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and specifically identifiable in the wording of the claims of the basic patent. In the case of a combination of active ingredients, each active ingredient in that combination must be specifically and precisely as well as individually identifiable in the wording of the claims of the basic patent."

An SPC Hat-trick: a THIRD referral under Article 3(a) heads to the CJEU

Many thanks to Nicholas Fischer and Andrew Hutchinson (Simmons & Simmons) for sharing their article (here) on the latest referral to the CJEU on SPCs from the UK Court, which will be published in Bio-Science Law Review.

In short summary, the UK Court of Appeal referred another question to the CJEU seeking clarity concerning the correct interpretation of Article 3(a) of the SPC Regulation. This makes it a hat-trick of referrals (England 2 – Germany 1) trying to understand what it means for a product to be ‘protected’ by a patent. This referral follows Sandoz’s appeal of Arnold J’s first instance decision, in which the outcome was held to be clear (in favour of SPC grant), even if the legal test was not. The UK Court of Appeal has overturned Arnold J’s decision, stayed the appeal and referred another question to the CJEU.

The question asked by the Court of Appeal is:

“Where the sole active ingredient the subject of a supplementary protection certificate issued under [the SPC Regulation] a member of a class of compounds which fall within a Markush definition in a claim of the patent, all of which class members embody the core inventive technical advance of the patent, is it sufficient for the purposes of Article 3(a) of the SPC Regulation that the compound would, upon examination of its structure, immediately be recognised as one which falls within the class (and therefore would be protected by the patent as a matter of national patent law) or must the specific substituents necessary to form the active ingredient be amongst those which the skilled person could derive, based on their common general knowledge, from a reading of the patent claims?”

Following the CJEU hearing the Teva v Gilead referral on Article 3(a) on 20 February (sitting as a Grand Chamber of 15 Judges) it will be interesting to see whether they deliver an overarching decision on Article 3(a) or approach this step-wise via the subsequent referrals from Germany and now the UK. We have heard that there will be an AG opinion in that case on or around 25 April so watch this space.

Formulations and Article 3(a) - a decision from the German Federal Patent Court

The German Federal Patent Court (Bundespatentgericht) recently issued a decision in ex parte appeal proceedings relating to the interpretation of Art. 3(a) of the SPC Regulation in regard to a patent protecting a formulation of known actives (Decision 14 W (pat) 10/16 of 23 January 2018, English translation here).  Many thanks to Bianca-Lucia Vos and Klemens Stratmann of Hoffmann Eitle for pointing this case out to us and for providing a thorough commentary, below:

The decision addresses an important aspect for determining whether a given product is “protected” by a basic patent in the sense of Art. 3(a) of Regulation (EC) no. 469/2009, which to date has not been addressed by any higher court in the EU. 

In the case underlying the decision, the GPTO had rejected SPC application 12 2010 000 015.7 submitted by GlaxoSmithKline Biologicals S.A. (“GSK”) for a combination of six antigens with reference to Art. 3(a). The Patent Division of the GPTO asserted in the appealed decision that, in view of the CJEU decisions Actavis/Sanofi (C-443/12), Georgetown II (C-484/12) as well as Actavis/Boehringer (C-577/13), a product is only then protected pursuant to Art. 3 (a) of the Regulation if the respective active ingredient or the active ingredient composition is protected by the basic patent “as such”.  

According to the GPTO, for protection “as such” to be affirmed within these terms, the product in question has to constitute the “core inventive advance” of the basic patent. To support this view, the Patent Division relied for instance on par. 29 of C-443/12, where the CJEU stated that it is possible, on the basis of a patent which protects several different ‘products’, to obtain several SPCs in relation to each of those different products, provided, inter alia, that each of those products is ‘protected’ as such by that ‘basic patent’ within the meaning of Article 3(a) of Regulation No 469/2009, in conjunction with Article 1(b) and (c) of that regulation.  

Since GSK’s basic patent (EP 0 835 663) related to formulations of previously known antigens with special adjuvants to provide hexavalent combination vaccines, the Patent Division opined that the inventive advance of the basic patent lay in the use of specific adjuvants and not in the provision of a new (and inventive) combination of antigens. From this, the Patent Division concluded that the product defined in the SPC application, i.e. “Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b conjugate, combination vaccine”, did not embody the inventive advance of the patent, respectively was not protected as such, and rejected the SPC application. 

The Federal Patent Court set aside this decision and granted the SPC for the requested product definition. In its decision, the Federal Patent Court first clarified that Actavis/Sanofi, Georgetown II as well as Actavis/Boehringer pertain primarily to the conditions for granting more than one SPC for the same product pursuant to Art. 3 (c) of Regulation (EC) No. 469/2009 and do not contain any assessment criteria going beyond the principles established by the CJEU in Medeva (C-322/10) and Eli Lilly (C-493/12) regarding the application of Art. 3 (a) of Regulation (EC) No. 469/2009. The Federal Patent Court highlighted that the circumstances of Actavis/Sanofi, Georgetown II and Actavis/Boehringer required an assessment as to whether the combination of active ingredients A+B has to be regarded as the “same innovation” as compared to the individual active ingredient A (for which the patent proprietor had already obtained an SPC), and therefore no further SPC should have been granted for the combination of active ingredients A + B under Art. 3(c) of the Regulation.  

Only for the purpose of examining under Art. 3(c), whether the combination of A + B embodies the inventive advance of the patent, it is therefore of relevance whether the individual actives (A and/or B) are protected as such by the basic patent.  

The Federal Patent Court acknowledges with this decision that formulation patents are eligible for an SPC extension to the same extent as other patent types such as use or process patents. This decision is of fundamental importance since the approach taken by the GPTO in the contested decision would have rendered it impossible to extend the vast majority of formulation patents. The reason being that, as a rule, formulation patents do not protect the product, i.e. the active ingredient or the combination of active ingredients in the sense of Article 1(b) of the Regulation, “as such”. It is rather the formulation of known actives by means of specific auxiliary substances, such as adjuvants (as in the case of vaccines) or excipients, that renders the claimed subject matter patentable and embodies the inventive advance of the patent.  

The decision of the Federal Patent Court appears to put into question as to whether the interpretation of Art. 3(a) of the Regulation proposed by J. Arnold would also be applicable in the event that the basic patent is not a product patent but rather a formulation, process or use patent. J. Arnold repeatedly suggested to the CJEU in proceedings before the UK High Court of Justice that Article 3(a) should be interpreted as meaning that the product is "protected" by the basic patent if (i) the product falls within the scope of the claim when interpreted in accordance with the Extent of Protection Rules and (ii) the product does so because it contains an active ingredient, or a combination of active ingredients, which embodies the inventive advance (or technical contribution) of the patent (cf. par. 97 of Teva UK Ltd & Ors v Gilead Sciences Inc [2017] EWHC 13 (Pat) (13 January 2017) and par. 11 of Sandoz Ltd & Anor v G.D. Searle LLC & Anor [2017] EWHC 987 (Pat) (3 May 2017). It would appear that this test is not suitable for determining if a given formulation, use or process patent protects the product in the sense of Article 3(a). By contrast, the test developed by J. Warren seems to have a broader applicability and would, in our view, also lead to the correct result in the case of formulation, use or process patents (cf. par. 65 to 71 of Eli Lilly v Human Genome Sciences [2014] EWHC 2404 (Pat) (18 July 2014)). J. Warren suggested that a given product will be protected within Article 3(a), if it falls within the claims, subject to one proviso relating to circumstances where the claims contain some general word or words extending their extent beyond the principal scope of the claims, typically by the use of a word such as "comprises". 

Meanwhile, three referral proceedings are pending before the CJEU all of which concern the interpretation of Article 3(a) of the Regulation and the criteria for determining whether a given product is protected by the basic patent or not (Reference for a preliminary ruling from the High Court of Justice (Chancery Division) (United Kingdom) made on 8 March 2017 – Teva UK Ltd, Accord Healthcare Ltd, Lupin Ltd, Lupin (Europe) Ltd, Generics (UK) trading as "Mylan" v Gilead Sciences Inc. (Case C-121/17); Request for a preliminary ruling from the Bundespatentgericht (Germany) lodged on 21 November 2017 (Case C-650/17); and Sandoz et al. v. G.D. Searle et. al [2018] EWCA Civ 49, UK Court of Appeal, Judgment of 25 January 2018). It would be desirable if the CJEU does not limit the forthcoming judgements to the concrete facts of the respective referral decision but rather develops a generally applicable test which allows to ascertain whether a given product is protected in the sense of Article 3(a) in all possible circumstances including those addressed by the Federal Patent Court in the recently issued decision.

Atripla - a combination of issues

Mr Justice Arnold gave his ruling earlier this week in Teva UK Limited & Ors v Merck Sharp & Dohme Corporation [2017] EWHC 539 (Pat).

In brief, Merck Sharp & Dohme (MSD) was granted an SPC for a combination product of  efavirenz, emtricitabine and tenofovir disoproxil fumarate based on EP (UK) 0 582 455 (the product is marketed as Atripla by Bristol-Myers Squibb Co. and Gilead Sciences Inc).  At trial, MSD relied on claim 16 as protecting the product.  Claim 16 reads:

“A combination of the compound of claim 12 or a pharmaceutically acceptable salt thereof with a nucleoside analog having biological activity against HIV reverse transcriptase.”

MSD also previously obtained an SPC for efavirenz based on the same patent.  Teva, Accord and Mylan challenged the validity of the SPC.

Mr Justice Arnold found that the SPC was invalid because it did not comply with either Article 3(a) or Article 3(c) of the SPC Regulation.  More specifically, he found that the scope of protection of claim 16 extended to a combination of efavirenz and tenofovir or a combination of efavirenz and emtricitabine, but not to a combination of all three actives.  He also found that the SPC does not comply with Article 3(c) because claim 16 does not represent a distinct invention from the invention protected by the claims for efavirenz.