UK - Truvada SPC does not comply with Article 3(a)

Last week, Mr Justice Arnold handed down his judgement in Teva UK Limited & Ors v Gilead Sciences Inc [2018] EWHC 2416 (Pat) (here), following the CJEU's  preliminary ruling in C-121/17 (here).

In brief, Teva UK Limited, Accord Healthcare Limited, Lupin Limited and Generics UK Limited challenged the validity of Gilead's SPC (SPC/GB05/041) for a "composition containing both Tenofovir disproxil, optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate, together with Emtricitabine".  They contended that the SPC does not comply with Article 3(a) of the SPC Regulation.  Gilead contended that the product described in the SPC was protected by the basic patent, EP (UK) 0 915 894.   In his first judgement (here), Mr Justice Arnold referred the following question to the CJEU: "what are the criteria for deciding whether 'the product is protected by a basic patent in force' in Article 3(a) of the SPC Regulation?".  The CJEU provided its judgement in C-121/17 in July 2018.  Mr Justice Arnold applied the two tests described in C-121/17 and found that the SPC does not comply with Article 3(a).  His reasoning is set out below:

1. The first test is that, from the point of view of a person skilled in the art and on the basis of the prior art at the priority date, the combination of active ingredients must necessarily, in the light of the description and drawings of the patent, fall under the invention covered by that patent. As explained above, this is not a simple extent of protection test. Rather, the combination must be one that the skilled person would understand, on the basis of the description and drawings and their common general knowledge, to embody the technical contribution made by the patent.

1. As the Court of Justice rightly says at [56], the Patent says nothing about the possibility that TD and emtricitabine may be combined to treat HIV. Indeed, it does not even mention emtricitabine. All it says at [0047] is that the claimed compounds may be administered as pharmaceutical formulations with optionally other therapeutic ingredients. Accordingly, as the Court rightly indicates, there is no basis for the skilled person to understand that the combination embodies the technical contribution of the patent. TD embodies the technical contribution of the Patent, but that is a different matter.

1. The second test is that, from the point of view of a person skilled in the art and on the basis of the prior art at the priority date, each of the active ingredients must be specifically identifiable, in the light of all the information disclosed by the patent. There is no dispute that TD is specifically identifiable. In my view it is clear that emtricitabine is not specifically identifiable. Once again, it is not mentioned in the Patent. It is not even a member of a specific class of compounds mentioned in the Patent, whether by reference to their structure or activity, as being suitable for combination with the compounds of the invention. Furthermore, although emtricitabine was known at the priority date, there is no evidence that it was known that emtricitabine was an effective agent for the treatment of HIV in humans, still less that this was common general knowledge to the person skilled in the art to whom the Patent is addressed.

1. As counsel for the Claimants submitted, this result is perfectly consistent with the objectives of the SPC Regulation. As noted in my first judgment at [24], Gilead obtained a marketing authorisation in respect of Viread, which contains TDF, on 5 February 2002, less than five years after the application for the Patent was filed. Thus Gilead did not suffer sufficient regulatory delay in exploiting the Patent to warrant the grant of an SPC in respect of Viread. Moreover, although Gilead applied for and was granted a patent for the combination in Truvada, that patent was revoked by the Opposition Division of the European Patent Office and Gilead's appeal against that decision was dismissed. Thus Gilead made no invention in devising the combination which warranted the grant of a patent, let alone an SPC.

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.

Tenofovir - the Swiss Bundespatentgericht goes for the infringement test

The SPC Blog is grateful to Siegfried Grimm at E. Blum & Co. for providing the following summary of a recent Tenofovir case in Switzerland:

The year is 2017 B.C. Europe is entirely governed by European Legislation. Well, not entirely... One small country of indomitable Swiss still holds out against the invaders. And life is not easy for the European judges who reside the fortified camps of Luxembourg ... 

In its decision of October 3, 2017 (here in German), the Swiss Federal Patent Court clarified what the criteria are for deciding “whether the product is protected by a basic patent in force”.  The Swiss court clearly refused to adopt the CJEU's “Medeva” line of decisions. As a consequence, Swiss SPCs will be assessed based on the infringement test.  No additional criteria, such as “specified in the wording of the claims” (Medeva), “the claims relate, implicitly but necessarily …” (Eli Lilly), “core inventive advance …” (Actavis) or the like are to be applied.  Accordingly, the Swiss court applied a more liberal approach compared to the CJEU, leaving room for Swiss SPCs where European SPCs are likely not available.  

The SPC in question relates to tenovofir disoproxil fumarate + emtricitabine.  Claim 1 of the basic patent covers tenovofir disoproxil fumarate and claim 27 mentions “optionally other active ingredients”, without mentioning of emtricitabine.  The Swiss court came to the conclusion that this SPC is protected by a basic patent in force and thus perfectly complies with Swiss practice.  The court also came to the conclusion, that the above CJEU decisions will not help deciding the case, as Eli Lilly might be in favor of such decision while Actavis would rule against it.  

The decision is open to appeal within 30 days. 

Interestingly, the same case is litigated before the High Court, [2017] EWHC 13 (Pat), now pending before the CJEU.

Tenofovir - High Court Decision in France

Those following the tenofovir SPC litigation in Europe will be pleased to hear that the High Court of Paris has recently handed down a decision in relation to Gilead's SPC based on EP0915894.  Denis Schertenleib, who acted for Mylan in these proceedings, has kindly provided a short summary of the case, along with a copy of the decision and an English translation.

"Recently, the High Court of Paris had to opine on the validity of the Gilead SPC on Truvada covering tenofovir and emtricitabine. The SPC was based on the basic patent for tenofovir.  One of its claims covered a combination of tenofovir with another optional therapeutic ingredient.  

In the context of preliminary injunction proceedings, the Presiding judge of the Paris High Court had to decide whether this SPC was likely to be held invalid on the merits. The Court held in a ruling dated 5 September 2017, that the SPC was likely to be invalid.

The reasoning of the Court was based on the finding that the reference to another “therapeutic ingredient” could not be deemed to constitute a functional definition of any compound under the Eli Lilly v HGS doctrine of CJEU case C-493/12. In addition, the Court held that nothing in the description or the prior art could be held to point to Emtricitabine as being this optional therapeutic ingredient. Finally, the Court noted that the combination of tenofovir and emtricitabine could not constitute the core invention of the basic patent under the Actavis v Sanofi doctrine of CJEU case C-443/12. The Court thus held that the SPC was likely to be invalid and that no preliminary injunction could be granted.

The Judgment in French and translated in English can be downloaded here.

The ruling can be appealed and a case on the merits is ongoing.”

Many thanks to Denis for this!

British court allows Gilead tenofovir appeal

Mr Justice Kitchen (Patents Court, England and Wales) gave his judgment yesterday in Gilead Sciences, Inc's appeal against the Comptroller's refusal of its tenofovir SPC application. The product in question was a combination therapy for HIV and the patent's claims were directed to a class of novel compounds, within which one of the compounds fell. That compound was also specifically disclosed and claimed. As well as compound claims, the patent had a claim directed to a pharmaceutical composition comprising the novel compound "together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients".

The Comptroller's refusal of the SPC application relied heavily on Takeda Chemical Industries Ltd's SPC Applications (No.3) [2004] RPC 1, [2003] EWHC 649 (Pat), where the Patents Court upheld a refusal of SPC applications on lansoprazole in combination with other named antibiotics. The judge held in Takeda that the patent did not protect the combination, but only the lansoprazole element of the combination.

The Comptroller in Gilead indicated that the specification of the patent should at least provide a clear pointer to the specific combination product. Kitchen J rejected this test, holding at para.33 that a clear test applicable to a product comprising a combination of active ingredients

"is to identify the active ingredients of the product which are relevant to a consideration of whether the product falls within the scope of a claim of the basic patent. It is those ingredients, and only those ingredients, which can be said to be protected within the meaning of the Regulation. So, in the case of a product consisting of a combination of ingredients A and B and a basic patent which claims A, it is only A which brings the combination within the scope of the monopoly. Hence it is A which is protected and not the combination of A and B. ... The product comprises two active ingredients... It falls within the scope of claims 1 and 25 only because of the presence of (one of those compounds). Hence, on the Takeda test, claims 1 and 25 do not protect the product within the meaning of the Regulation. However, claim 27 is directed to a composition comprising (the first compound) together with a carrier and optionally other active ingredients. The product falls within this claim too and it does so, in so far as the claim is directed to a combination, as result of the presence of both (compounds)."

The Comptroller has been granted leave to appeal.

Thanks to Helen Jones (Gill, Jennings & Every -- who acted the for appellant, instructing Charlotte May, 8 New Square) for supplying this information.