Switzerland - Truvada and moving away from the "infringement test" for future SPCs for combination products

In a recent decision, the Swiss Federal Supreme Court confirmed the validity of Gilead’s Swiss TRUVADA® SPC and provided some guidance for combination products.  A copy of the decision is available here. 

Simon Holzer, Kilian Schärli and Marco Borer of Meyerlustenberger Lachenal AG, who acted for Gilead, have provided the summary and comments below along with an English translation of the decision (here).

"The Swiss Federal Supreme Court issued a landmark decision concerning the requirements for Supplementary Protection Certificates (SPCs) for combination products. Until recently, Switzerland stood solid as a rock and defended the so-called infringement test for SPCs for combination products. The Federal Supreme Court has now ruled that while the infringement test shall still apply to existing SPCs, new SPCs for combination products shall be examined in light of the Medeva ruling and other decisions of the CJEU concerning combination products. Whether the Swiss SPC in dispute meets the requirements of the EU case law is not relevant and, therefore, has not been decided by the Swiss Federal Supreme Court. 

The Swiss dispute in a nutshell
The Swiss litigation is about the validity of Gilead Sciences Inc.’s Swiss SPC C00915894/01 for the combination of tenofovir disoproxil fumarate plus emtricitabine. The SPC was granted by the Swiss Institute of Intellectual Property on 29 August 2008 based on the marketing authorization for TRUVADA®, a medication used to treat (and in some jurisdictions also to prevent) HIV/AIDS. It is a fixed-dose combination of the two antiretroviral medications tenofovir disoproxil fumarate and emtricitabine. 

On 3 January 2017 Mepha Pharma AG, a Swiss subsidiary of Teva, filed a revocation action against Gilead’s Swiss SPC. Mepha essentially argued that the ratio legis of the Swiss law on SPCs requires that the “infringement test”, which had been confirmed in a decision of the Swiss Federal Supreme Court in 1998 (BGE 124 III 375), be set aside, and that this change of practice shall be applicable with immediate effect even for existing SPCs. Mepha was of the opinion that Swiss courts should apply EU case law and if it did, Gilead’s SPC would be invalid in light of the practice of the CJEU for combination products because the two active ingredients were not specified in the claims of the basic patent and did not correspond to the basic patent’s core inventive advance. 

Gilead argued several lines of arguments. First, it was of the opinion that Switzerland should stick to the infringement test. Second, it argued that even if the EU practice for SPCs for combination products were to be introduced in Switzerland, this practice would only apply to new SPCs whose applications were filed after the change of practice. A change of practice could not have a retroactive effect according to Gilead. Third, Gilead took the position that even if the criteria established by the CJEU would apply to existing Swiss SPCs, those requirements – if correctly interpreted and applied – would be fulfilled by the SPC for TRUVADA®. 

In October 2017 the Swiss Federal Patent Court ruled that it was not appropriate to move away from the infringement test that had been applied in Switzerland since the Supreme Court’s decision BGE 124 III 375 (Fosinopril) in 1998. The Federal Patent Court examined several decisions of the CJEU dealing with SPCs for combination products (i.e. C-322/10 – Medeva, C-518/10 – Yeda, C-630/10 – University of Queensland, C-6/11 – Daiichi Sankyo, C-493/12 – Eli Lilly, and C-443/12 – Actavis/Sanofi) and came to the conclusion that the requirements of Article 3(a) of the EU SPC-Regulation No 469/2009, i.e. whether the product of an SPC is protected by the basic patent, are unclear and, therefore, there was no reason to move away from the infringement test. 

According to previous Swiss case law, it was not necessary that the product of the SPC be named and described in the basic patent. Rather, it was sufficient if the product was covered by the scope of the basic patent. The Federal Patent Court therefore dismissed the revocation action brought by Mepha against Gilead’s Swiss SPC. 

The decision of the Federal Supreme Court
Mepha filed an appeal against the verdict of the Federal Patent Court with the Swiss Federal Supreme Court. On 11 June 2018 the Federal Supreme Court dismissed Mepha’s appeal, but the dismissal is based on other grounds. 

The Federal Supreme Court concluded that SPCs for combination products granted under the infringement test (as confirmed by the Federal Supreme Court in 1998) were still to be assessed in light of the requirements of the infringement test. In an obiter dictum, however, the Federal Supreme Court ruled that new SPCs for combination products must comply with the requirements of the Medeva et al. case law of the CJEU in the future. 

Whether Gilead’s SPC for TRUVADA® meets these requirements was left open by the Federal Supreme Court, as this question is irrelevant since this SPC will continue to be judged according to the infringement test. 

Change of practice
The Federal Supreme Court held that a diverging practice between the CJEU and the Swiss courts in the field of SPCs could be a serious reason for a change in practice of the Swiss law. The Federal Supreme Court was of the opinion that Swiss lawmakers wanted to harmonize the Swiss law on SPCs with the laws in the EU. In this context, the Federal Supreme Court emphasized that the interpretation of the requirement “protected by a patent” according to Article 140b para. 1 lit. a of the Swiss Patent Act in the Fosinopril decision in 1998 (BGE 124 III 375) differed from the interpretation of “protected by a basic patent in force” according to Article 3(a) of the EU SPC-Regulation No 469/2009 by the CJEU according to the previous Swiss case law. 

Due to the fact that the Swiss legislature wanted to bring the protection of SPCs into harmony with that of the neighboring jurisdictions the Federal Supreme Court advocates an adaptation to the concept of the CJEU case law as expressed in the decisions of Medeva et al. However, the CJEU case law shall only apply to new SPCs according to the Federal Supreme Court. 

Existing SPCs are still subject to the infringement test
The Federal Supreme Court examined whether a change of practice could and should have an effect on SPCs that had already been granted, and, thus, whether Gilead’s SPC is valid even in the (not conclusively assessed and therefore hypothetical) case that the requirements for granting an SPC in light of the case law of the CJEU might not be fulfilled. 

The Federal Supreme Court emphasized that Gilead’s SPC had been legally granted in light of the infringement test in force at the time of the application and grant of Gilead’s SPC. The nullity grounds of the Swiss Patent Act refer to the question of whether the conditions for granting the SPC were fulfilled at the time of filing the SPC application. In the opinion of the Federal Supreme Court, this was clearly the case, since the infringement test was undisputedly the relevant test at the time Gilead’s SPC application was submitted to the Swiss Institute of Intellectual Property. 

The Federal Supreme Court then examined whether, as an exception, a validly granted SPC can be revoked only because of a later change of practice, or more generally speaking, whether a legally binding administrative decision like the grant of an SPC could be reconsidered or revised as a result of a legal change of practice. As a general rule, the grant of an SPC cannot be revoked due to a later change of practice if the interest of the holder of the SPC in protecting his exclusive rights precedes the interest in the uniform implementation of the new law. Although this rule does not apply in absolute terms, the Federal Supreme Court could not see any particularly significant interest that would clearly demand a revocation of Gilead’s lawfully granted SPC simply because a change of practice has taken place many years after the grant. In the opinion of the Federal Supreme Court, Gilead’s interest in protecting its exclusive rights is clearly higher than the interest that in Switzerland all SPCs for combination products must be subject to exactly the same rules in the future. 

Comments
The recent ruling of the Federal Supreme Court strikes an interesting balance between the confidence of the owners of existing SPCs in the current practice and the industry’s interest in creating an EU-compatible system for Swiss SPCs. The judgment tries to protect the interests of patent owners and marketing authorization holders of originator pharmaceutical products who have made time-consuming and costly efforts in the authorization and marketing of their products on the one hand and the interest of the industry in bringing Swiss case law in line with the European Union practice. 

One question seems to remain open even after the decision of the Federal Supreme Court: According to the language of the decision of the Federal Supreme Court, the infringement test seems to apply to already granted SPCs. However, what happens with pending applications for SPCs for combination products? Those applications have been filed in light of the previous practice (i.e. by relying on the infringement test) as well. The Swiss Federal Patent Act explicitly provides that an SPC shall be granted if the requirements for the grant of the SPC are met at the filing date of the application. The applications for SPCs for combination products that are still pending before the Swiss Institute of Intellectual Property were filed in light of the then valid infringement test. It remains to be seen whether the fact that those applications have not yet resulted in a formal grant will make a major difference in whether they are examined in light of the infringement test or the EU case law. 

For example, on 11 January 2007 the Grand Chamber of the European Court of Human Rights decided that a trademark application had to be protected as private property in the sense of Article 1 of the Protocol to the Convention for the Protection of Human Rights and Fundamental Freedoms (Anheuser-Busch, Inc. v. Portugal, Case No. 73049). Although Switzerland has not ratified this protocol the considerations of the Grand Chamber of the European Court of Human Rights nevertheless seem to be relevant when examining the legal nature of an SPC application."

Many thanks!

Gardasil: Israel draws closer to EU practice on combination products

Liad Whatstein (now practising as Liad Whatstein & Co) has just sent The SPC Blog the following report on an decision recently handed down by the Israeli Patent Office in connection with a patent term extension (PTE) for combination products. In essence the Israeli Patents Commissioner held that a patent claiming a single active ingredient was eligible for a PTE in connection with a combination product that comprised additional active ingredients. This decision, adds Liad, brings Israeli law in closer conformity with EU law in connection with SPCs for combination products. Writes Liad:

Gardasil is a quadrivalent vaccine comprising the proteins HPV18 L1, HPV16 L1, HPV11 L1 and HPV6 L1. Each of the four proteins in the vaccine protects against a separate strain of the Human Papilloma Virus (HPV). Merck's Israeli patent covers the HPV18 L1 protein and a composition comprising the protein. It does not specifically claim the other proteins included in Gardasil.

Under sections 64D(1) and 64A of the Israeli Patents Act, in order to be eligible for extension, the patent must claim the "material" ("the active ingredient in the medicinal product"). The Israeli PTO initially rejected Merck's PTE petition on the ground that the Israeli patent did not claim all the active ingredients in the product (i.e. there was no "match" between the scope of the patent and the "material").

The office's approach was in line with the approach taken in the past by several Patent Offices in Europe but was rejected by the Court of Justice of the European Union (CJEU) in Medeva and subsequently in Queensland & CSL which also related to Gardasil. It was also opposed to the traditional approach taken by the USPTO.

Merck appealed to Patents Commissioner. On 11 January 2015 the Commissioner overruled the decision and granted the PTE petition. In reaching his decision, the Commissioner noted that each protein in Gardasil was produced in separate fermentation and was a standalone API. Accordingly, the fact that HPV 18 L1 was combined with three other active ingredients in the product did not undermine the eligibility for patent term extension for the patent claiming a single protein.

Significantly, the Commissioner essentially adopted the patentee's approach solely based on analysis of the relevant statutory provisions and related Israeli case law, and completely disregarded the CJEU Medeva ruling. Nevertheless, the Commissioner's decision is an important precedent that brings Israeli law in closer conformity with EU law in connection with SPCs for combination products.

Generally, the Israeli Office is attentive to the legal situation and judicial developments in major jurisdictions. One exception is with respect to the peculiar and rather restrictive PTE system under Israeli law (for a short overview of these peculiarities see earlier SPC Blog post here). The Office has traditionally taken a restrictive approach in interpreting the PTE provisions, often resulting in denial of PTE eligibility. It is yet to be seen whether the recent decision may be a first step in the direction of more balanced decisions on patent term extensions.

Liad represented the patentee in the proceedings.

A Bulgarian milestone as Supreme Court rules on Atripla application

From our friend Dimitar Batakliev (IP Attorney, Bulgaria) comes the following news:

"I would like to report a recent case before the Supreme Administrative Court of Bulgaria regarding an SPC application for Atripla, a drug for treatment of HIV infection.

In a decision of 8 June 2014 the Court held that the claimed product, consisting of efavirenz, emtricitabine and tenofovir disoproxil fumarate, was not protected by the basic patent BG 62612 and therefore did not meet the requirements of Article 3 of the SPC Regulation. According to the court, this combination was outside the scope of claim 8 which protected 

“a combination of a compound of Formula I or Formula II according to claim 2 with a nucleoside analog having biological activity against HIV reverse transcriptase”. 

Although efavirenz was found to be a compound of Formula I and emtizitabine -- a nucleoside analogue -- the court held that the claim envisaged only combinations of two active ingredients, while the applied product consisted of three. Further, the court confirmed that the third ingredient, tenofovir disoproxil fumarate, was also outside the scope of the claim as it was a nucleotide rather than a nucleoside analogue. Although after its intake it was transformed in the human body into a nucleoside, at the time of composing the claimed product it lacked such characteristics. As a result the Supreme Court reversed the decision of the court of first instance and instead upheld the decision of the Patent Office to reject the application of Merck Sharp & Dohme Inc.

In its detailed analysis the Supreme Court touched on a number of important topics of the SPC domain. It provided guidance on the methods of interpretation of patent claims, on the applicability of the infringement test and the significance of the Medeva and Eli Lilly decisions. It also commented on decisions of other jurisdictions which had been put forward by the parties in support of their arguments. Therefore, in my opinion the Atripla case resulted in a milestone decision of the Bulgarian case law with respect to the application of the SPC Regulation.

If you can cope with the original Bulgarian text of the judgment, Dimitar has kindly provided a link to it here.

Denmark's new post-Medeva guidelines on "specified"

From our friend Sidsel Hauge (Partner and European Patent Attorney, Awapatent A/S, Copenhagen) comes news of the Danish Patent Office's new guidelines on the interpretation of "identified/specified" after Medeva.  The following is Sidsel's unofficial translation:

Protection by a basic patent, particularly for combination products (Last update: 17‐12‐2012)

___________________________________________________ 

Before a product which consists of a composition of two or more active ingredients, known as a combination product, can be considered to be protected by a basic patent according to the Regulation, the combination of the active ingredients must be specified by the wording of the claims of the basic patent in accordance with the judgment of 24 November 2011 in Case C‐322/10 (Medeva) of Court of Justice of the European Union. 

For example, a combination product consisting of the two active ingredients A and B is considered to be protected by a basic patent, if the combination A and B appear in the wording of the claims. 

The product is considered to be specified in the wording of the claims when the product is described by a chemical name or a structural formula, i.e. specifically mentioned or being comprised by a Markush formula. 

A product may in some cases be considered to be specified in the wording of the claims of the basic patent, if the product is specified by functional terms. The actual protection will always be decided from case to case on a case by case basis. 

If the basic patent in an administrative re‐examination could be limited so that the combination of the active ingredients remains in wording of the claims of the basic patent, we also consider the combination product to be protected by the basic patent and thus Article 3, point a, to be fulfilled. 

You can read more about the effects of the foregoing for applications for a certificate for combination products under Combination products.

Combination products: one lump or two?

Following on from last Sunday's post on Actavis Group PTC EHF & another v Sanofi Pharma Bristol-Myers Squibb SNC, "Combination SPCs: more hypertension for the Court of Justice?" (here) our distinguished reader Herwig von Morze provides the following comment:

I believe a distinction must be made between the treatment of novel and inventive products (for example two distinct antibodies or active ingredients) and a combination product where the invention solely resides in one active ingredient, e.g., irbesartan, which is combined with HCT or a diuretic in general. In the first case. In the first case it should be possible to secure SPCs for each active ingredient. It is a pity that the question before the CJEU lumps the two types of "products" together. In case of a non-inventive combination, it could be said that you are only dealing with one product (for example, irbesartan), whether it is irbesartan alone or in combination with a diuretic.

Do readers agree with this sentiment? It presumably isn't too late to amend the questions which are being referred to the Court of Justice for a preliminary ruling but which, so far as one can tell from the Curia website, have not yet been received by the Court.

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.