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!

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!

Germany - Gilead's SPC for Truvada nullified by the Federal Patent Court

Last week, the German Federal Patent Court nullified Gilead's German SPC for the combination of tenofovir disoproxil and emtricitabine.  Eva Geschke (Wildanger) and Derk Vos (Maiwald), who acted for Generics UK, have provided the following summary on the case:

"On May 15 the 4th Nullity Senate of the German Federal Patent Court (FPC) nullified Gilead’s German SPC DE 2005 000 0041.8, which had been granted for tenofovir disoproxil in combination with emtricitabine. 

This combination of active ingredient is present in various anti-HIV drugs marketed by Gilead and other companies such as TRUVADA® and ATRIPLA®. Four claimants (Teva GmbH, Hexal AG, Generics [U.K.] Ltd., and Hormosan Pharma GmbH) had challenged the validity of the SPC arguing that the product in question was not protected by claim 27 of the basic patent.  While tenofovir disoproxil was specified in the claim, the parties were in dispute on the issue whether the active ingredient emticitabine was specified in the wording of claim 27 of the basic patent by the term “other therapeutic ingredients” for the purpose of Art. 3 (a) SPC-Regulation according to the criteria set by the CJEU in Eli Lilly (C-493/12). 

The FPC in its preliminary opinion had outlined its interpretation on the criteria set by the Eli Lilly decision (C-493/12) in that a functional definition – as a broad generic term, under which various actives may fall – only relates implicitly, but necessarily and specifically, to the active in question as defined in the SPC, i.e. emtricitabine in the present case – if said active forms an active ingredient which is comprised by said generic term. The FPC demands at the same time that it is excluded that other active ingredients are representatives of said generic term, which, however, do not share the specific medicinal characteristics of the active ingredient in question. 

In defending their SPC, Gilead took the position that the CJEU’s case law, and in particular the Eli Lilly decision, does not require any further criteria than the assessment of Art. 69 EPC and the protocol of its interpretation for the determination whether a product is protected by the basic patent or not. 

It appears that the FPC did not follow the interpretation advanced by Gilead on the Eli Lilly decision but considered that further criteria are to be met in addition to the coverage of the product by Art. 69 EPC for an active ingredient to be implicitly, but necessarily and specifically referred to in a claim of the basic patent. 

The Claimants argued that the generic term “other therapeutic ingredients” was completely unspecific and covered various compound classes with different medicinal characteristics and thus the wording used in claim 27 was not suitable to specifically identify the active ingredient emtricitabine of the product in question. 

The FPC decided that the wording “other therapeutic ingredients” was insufficient to specify the active ingredient emtricitabine according to the criteria set by the Eli Lilly decision. Consequently, the requirements of Art. 3 (a) SPC-Regulation were not fulfilled for the product in dispute.

The decision taken by the FPC is in line with the decision taken by the Munich District Court in the preliminary injunction proceedings initiated by Gilead in August 2017, where the District Court rejected Gilead’s request on the grounds that Art. 3 (a) of the SPC-Regulation is not met. 

In addition, the position from the FPC is also in agreement with the opinion of the AG Wathelet, issued on April 25, 2018 in the CJEU referral C-121/17, which referral originates from the parallel invalidation proceedings in the UK. 

The reasons for the decision will be issued by the FPC in due time. "

Many thanks to Eva and Derk!

Denmark - Gilead successfully enforces its SPC for Truvada

Last year, the SPC Blog reported (here) the decision of the Danish Maritime and Commercial High Court not to grant a preliminary injunction against Accord Healthcare Limited on the basis of Gilead's SPC for the combination of tenofovir disoproxil (as fumarate) and emtricitabine.

On 7 March 2018, the Eastern High Court in Denmark overturned this decision and granted the preliminary injunction against Accord.

Mikkel Vittrup and Jeppe Brinck-Jensen at Plesner (who assisted Gilead in this case) have kindly provided the summary below of the Eastern High Court's decision.

The Eastern High Court (the court of appeal) in Denmark has granted a preliminary injunction against Accord Healthcare Limited on the basis of Gilead's Danish SPC for TRUVADA®, overturning the first instance decision of the Maritime and Commercial High Court. The Eastern High Court did not accept that Accord had proven that Gilead's SPC was invalid. Furthermore, it found that the SPC was infringed even though the title of the SPC mentioned a specific salt of the active ingredient tenofovir disoproxil, and Accord's product was not sold as such a salt.  

In relation to validity of the SPC, the question was whether the active ingredient emtricitabine was specified in the wording of claim 27 of the basic patent by the wording "other therapeutic ingredients", for the purposes of Article 3(a) of the SPC Regulation. Gilead's SPC is for the combination of active ingredients tenofovir disoproxil and emtricitabine, and it was not in dispute that tenofovir disoproxil is explicitly named in the claims of the basic patent. 

Accord argued that claim 27 did not relate implicitly, but necessarily and specifically, to the combination of tenofovir disoproxil and emtricitabine, and therefore that the SPC did not meet the requirements of Article 3(a) as interpreted by the CJEU in Eli Lilly (Case C-493/12). At first instance, the Maritime and Commercial High Court agreed with Accord.  

The Eastern High Court did not agree.  

It stated, referring to the Protocol on the Interpretation of Article 69 EPC and the Eli Lilly decision, that the claims of the basic patent - including in relation to the question of which active ingredients are covered by the claims - should be interpreted in the light of the common general knowledge of the skilled person. 

The Eastern High Court referred to a declaration and oral testimony of Gilead's expert (a Danish HIV clinician) and found that the skilled person at the priority date of the basic patent (July 1996) would have understood "other therapeutic ingredients" as compounds contributing to antiviral activity, including in particular for the treatment of HIV, and therefore that the skilled person would think of a combination of tenofovir disoproxil with another NRTI, a NNRTI or a protease inhibitor. The Eastern High Court concluded that the term "other therapeutic ingredients" in claim 27 only concerned a limited number of compounds.  

Consequently, the Eastern High Court found that it could not be rejected with the sufficient degree of certainty that claim 27 implicitly, but necessarily and specifically also related to emtricitabine. 

The Eastern High Court also gave weight to the existing doubt as to the interpretation of Article 3(a), in particular in view of the pending referral to the CJEU (Case C-121/17).
The Eastern High Court's decision - overturning the first instance decision from the Maritime and Commercial High Court - also confirms the well-established Danish case law according to which a preliminary injunction will rarely be rejected on the basis of alleged invalidity of the asserted IP rights.  

In relation to infringement, the High Court concluded that Gilead had rendered it probable that the fumaric acid salt and the free base of tenofovir disoproxil should be considered the same active ingredient within the meaning of the SPC Regulation. Consequently, Gilead's SPC was infringed by a combination product containing the free base of tenofovir disoproxil, even though the title of the SPC mentioned tenofovir disoproxil as a fumaric acid salt. 

Tenofovir in Denmark - Accord Healthcare fends off Gilead's motion for a preliminary injunction

Nicolaj Lindgreen and Nicolaj Bording at Kromann Reumert report the following news on Gilead's SPC for the combination of tenofovir and emtricitabine in Denmark:

On 26 October 2017, the Danish Maritime and Commercial High Court issued a ground-breaking decision rejecting Gilead's motion for preliminary injunction against Accord Healthcare Limited based on Gilead's Danish SPC for the combination of tenofovir disoproxil (as fumarate) and emtricitabine. 

Accord had defended the motion for preliminary injunction by arguing non-infringement and invalidity of the asserted SPC.  

The Court supported Accord's argument that the SPC's combination of tenofovir disoproxil (as fumarate) and emtricitabine was not protected by the basic patent, and, accordingly, the SPC had been granted in contrary to Article 3(a) of the SPC Regulation.
The only claim in the basic patent that concerns the potential combination of tenofovir with another compound is claim 27, which claims an optional combination of tenofovir with "other therapeutic ingredients".  

Gilead had argued that the skilled person would understand the words "other therapeutic ingredients" in claim 27 as referring to emtricitabine. Hence, according to Gilead, the combination of tenofovir disoproxil (as fumarate) and emtricitabine was covered by the basic patent.  

Accord had argued, in particular, that case law from the CJEU dating from after the grant of the SPC makes it clear that a "product" according to the SPC Regulation has to be specified in the claims, either by reference to the compound's name, its chemical structure or by a functional definition, provided that the functional definition necessarily and specifically relates to the compound in question. Clearly, Accord argued, the words "other therapeutic ingredients" in claim 27 did not specify emtricitabine, neither by name/chemical structure nor by a functional definition, as the words "other therapeutic ingredients" say nothing about the specific function or nature of such "other therapeutic ingredients".  

As indicated, the Court agreed with Accord's invalidity arguments stating that Accord, on this basis, had "proved that the certificate-in-suit is invalid". Hence, the motion was rejected. 

The decision is ground-breaking as this is only the second time in 40 years that a motion for preliminary injunction in the patent area is rejected with reference to invalidity of the asserted right. Normally, it is considered close to impossible to fend off a motion for a preliminary injunction in a patent-related case, if invalidity arguments are the only defence. 

In terms of infringement, the Court found that, had the SPC been valid, Accord's combination product was covered by the SPC. Accord had argued non-infringement referring to the fact that the SPC was granted for tenofovir disoproxil in its fumarate salt form in combination with emtricitabine, whereas Accord's product contained tenofovir disoproxil in its free base form. The Court concluded that Gilead's marketing authorisation on which the SPC had been granted, which did not specify the fumarate salt form of tenofovir, covered tenofovir in all its forms, and, accordingly, so did the SPC. 

Nicolaj Lindgreen and Nicolaj Bording acted for Accord Healthcare Limited.