Patent and Pharma Update, February 2020

Key recent developments in the United Kingdom and Europe relating to patents and the pharmaceutical sector

In this issue we report on the Supreme Court decision of Shanks v Unilever on employee inventor compensation. We update on two CJEU decisions relation to public access to documents submitted to the EMA and a key competition decision on “pay-for-delay” agreements. We cover a string of patent-related UK Court of Appeal cases, including Ablynx v VHSquared on jurisdiction, Anan Kasei v Neo on insufficiency and joint tortfeasorship and L’Oreal v Liqwd on claim amendments and admission of late evidence. We provide brief updates from the EPO on the recent CRISPR priority decision, as well as its AI inventorship decision. We have bumper SPC and FRAND updates covering key Court of Appeal and CJEU decisions in respect of SPCs and a string of interesting interim decisions in the UK in the case of FRAND. We round off the issue with a link to our new IP podcast series and updates on Brexit and the UPC. Continue reading

ECJ rules for the first time on “pay-for-delay” agreements

On 30 January 2020 the European Court of Justice (“ECJ”) clarified for the first time the criteria governing whether so-called “pay-for-delay” agreements entered into between originator and generic pharmaceutical companies fall foul of EU competition law rules. Such agreements are a form of patent dispute settlement, whereby in return for a value transfer, a generic manufacturer acknowledges the patent of the originator pharmaceutical company, and agrees to refrain from marketing its generic version of the drug in question for a specified period of time. Pay-for-delay agreements have been in the spotlight of the European Commission (“EC”) and national competition authorities for over a decade.

In line with the non-binding Opinion delivered by Advocate-General Kokott on 22 January 2020, the ECJ held that such agreements may constitute “by object” infringements of the prohibition on anti-competitive agreements (such that a competition regulator is not required to prove effects on the market) or “by effect” infringements, and may also amount to an abuse of a dominant position.

The ECJ had been asked to provide guidance on this issue by the UK Competition Appeal Tribunal (“CAT”), by way of a reference for a preliminary ruling in the UK Paroxetine case. That case involves an appeal by GlaxoSmithKline (“GSK”) and five generics against a 2016 decision of the UK Competition and Markets Authority (“CMA”) imposing fines totalling £45 million on the basis that such pay-for-delay agreements infringed competition law.

Why is the ECJ’s judgment important?

The ECJ’s judgment is expected to have significant implications for both ongoing and future cases in the pharmaceutical sector:

  • The ECJ has sent a clear message to both originator and generic companies that once a generic has demonstrated a clear intention to market a rival version of an originator drug, it is likely to be considered a “potential competitor” of the originator (and thus any patent settlement between the originator and that generic involving a value transfer is likely to attract antitrust scrutiny).
  • The ECJ held that patent settlement agreements can be lawful. In particular, the existence of a value transfer (pecuniary or not) is not, by itself, sufficient to classify the agreement as a restriction of competition by object. This is because such value transfer may be justified taking into account the parties’ legitimate objectives (e.g. if it constitutes compensation for the generic’s litigation costs). However, the ECJ considered that where the value transfer by the originator to the generic cannot have any explanation other than the commercial interest of both parties not to compete on the merits, the agreement at issue will constitute a restriction of competition “by object” (i.e. it will be anticompetitive by its very nature). Therefore, although patent settlement agreements between originators and generics are not automatically anti-competitive, it appears that agreements with large value transfers from the originator to the generic(s) in exchange for a delay in market entry are highly likely to be deemed to be an “object” infringement in most cases. Pharmaceutical companies wishing to argue otherwise are likely to face an uphill struggle (although the ECJ has left the door open in very limited circumstances).
  • Further, the judgment indicates the approach the ECJ is likely to take in pending appeals against EC infringement decisions in two other pay-for-delay cases: Lundbeck (citalopram) and Servier (perindopril).
  • It also seems likely to encourage both the EC and national competition authorities to aggressively pursue more pay-for-delay cases in the future. Indeed, Commissioner Vestager commented to journalists that the judgment “looks very promising on first reading, and in that of course we feel very much encouraged because we find these cases important”. Similarly, the CMA has welcomed the judgment, noting that it “has clarified a number of important questions and will help competition authorities, including the CMA, in their work to tackle this harmful behaviour by pharmaceutical companies”.

Click here to read our full briefing.

This post was first published on our Competition Notes blog.

Contacts

Kyriakos Fountoukakos
Kyriakos Fountoukakos
Partner, Brussels
+32 2 518 1840
Dafni Katrana
Dafni Katrana
Senior Associate, Brussels
+32 2 518 1846
Ruth Allen
Ruth Allen
Professional Support Lawyer, London
+44 20 7466 2556

CJEU AG’s Opinion in Santen referral proposes to abandon Neurim

CJEU’s AG in Santen referral (C-673/18) invites the Court to make a clear choice between reversing Neurim (main proposal) or extending the interpretation of the concept of ‘product’ in order to achieve the result sought in Neurim (alternative proposal)

On 23 January 2020, AG Giovanni Pitruzzella provided his Opinion on the interpretation of Article 3(d) 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 (“SPC Regulation“).

In doing so, AG Pitruzzella makes two proposals to the CJEU.

His favoured proposal would significantly curtail the availability of SPCs for second medical uses of known and previously authorised compounds, as it strictly interprets the meaning of ‘product’ under Article 1(b) and precludes an interpretation of Neurim according to which a marketing authorisation (“MA”) for a “different and new application of an old active ingredient” could be considered as the first MA of a previously authorised active ingredient.

His alternative proposal permit SPCs in a wider set of circumstances by interpreting Neurim as allowing an SPC to be granted if the new MA “covers a new therapeutic indication of said active ingredient or relates to a use of it in which this active ingredient exerts a new pharmacological, immunological or metabolic action of its own”.

Business impact

Article 3(d) of the SPC Regulation provides that an SPC cannot be granted if there has been an earlier MA for the same ‘product’ (ie, the active ingredient or active ingredients of the medicinal product under Article 1(b) of the SPC Regulation). However, the CJEU in Neurim (Case C-130/11) held that Article 3(d) did not preclude an SPC from being granted for a different application for human use of a product that had been previously authorised for a veterinary use, provided that the SPC application is based on a patent for which that second medical use falls within the limits of its protection.

The CJEU’s decision in Neurim was seen as a departure from its earlier case law (Yissum (Case C-202/05) and Pharmacia Italia (Case C-31/03)), as it did not strictly interpret Article 3(d) and indicated that SPCs were available for second medical uses of known active ingredients. This interpretation in Neurim was subsequently resumed notably in paragraph 27 of the CJEU’s decision in Actavis v. Sanofi (C-443/12). This was an encouraging development for the pharmaceutical industry and was an incentive to invest significantly in researching and developing new indications for known products that improve the treatment of patients and save lives.

However, in March of last year, the CJEU held in Abraxis (Case C-443/17) that an SPC could not be obtained for new formulations of previously approved active ingredients, with this following the Opinion of AG Saugmandsgaard Øe that suggested that the “Neurim exception” was limited to the “particular, and probably exceptional, kind of situations at issue in Neurim“ (see our update here). As a consequence, there is uncertainty as to the circumstances in which an SPC can be obtained for a second medical use of a known active ingredient and guidance is needed from the CJEU.

If the Grand Chamber of the CJEU follows the AG Giovanni Pitruzzella preferred proposal then this will severely limit the application of the “Neurim exception” and the availability of SPCs for second medical uses of known and previously authorised products and be a disappointing result for R&D based pharmaceutical companies.

Background

A reference was made to the CJEU by the Paris Court of Appeal following its decision of 9 October 2018. That case related to Santen’s French SPC application (No. 15C0040), which is based on the European Patent, EP 1 809 237 (entitled ‘Ophthalmic oil-in-water type emulsion with stable positive zeta potential’) and a centralised MA for the medicinal product, IKERVIS®. IKERVIS® contains as its active ingredient 1 mg/ml cyclosporine in the form of an emulsion, which is administered as an eye drop for the treatment of severe keratitis in adult patients. Originally the SPC application was for ‘cyclosporine eye drops, emulsion’, but following observations from the French Patent Office this was amended to ‘cyclosporine for use in the treatment of keratitis’.

Prior to the grant of the centralised MA for IKERVIS®, an MA had been granted for the medicinal product SANDIMMUN®, which contained as its active ingredient 100 mg/ml of cyclosporine in the form of an oral solution for the prevention of rejection of solid organ and bone marrow grafts, and for the treatment of endogenous uveitis (an inflammation of some or all of the uvea, which is the middle layer of the eye).

In light of the earlier authorisation for SANDIMMUN®, the French Patent Office rejected Santen’s SPC Application in its decision of 6 October 2017 and held that the requirements in Neurim were not satisfied as: (i) EP 1 809 237 protected not only a new use of cyclosporine (claims 23 to 24) but also types of ophthalmic emulsions of cyclosporine (claims 1 to 21 and 25 to 26); and (ii) the medical use of IKERVIS® was not a new therapeutic use of cyclosporine within the meaning of Neurim, as the therapeutic use of SANDIMMUM® was also for the treatment of ophthalmic inflammations.

The French Patent Office argued that the grant of an SPC is designed to be an exceptional reward for innovative medicinal products, such that several conditions must be satisfied and that Neurim must be narrowly applied. Despite arguing for a narrow application of Neurim, the French Patent Office did not want to limit its application to its specific facts (ie, where a human use follows a veterinary use). The French Patent Office therefore held that an SPC can be obtained if it relates to medicinal product that has a new therapeutic scope. The new therapeutic scope arising from either a medicinal product containing a new active ingredient, or from a medicinal product containing a known active ingredient utilising a different mode of therapeutic action when compared to the earlier authorisation.

On appeal, the Paris Court of Appeal noted the disagreement between Santen and the French Patent Office on the correct interpretation of the CJEU’s decision in Neurim. It also noted that “both medicinal products [in suit] relate to the treatment of inflammation of parts of the eye in humans, using the same anti-inflammatory mechanism of cyclosporine” and that both IKERVIS® and SANDIMMUM® “differ in their therapeutic indications and in their formulation, dosage and posology“, and that “it is not disputed that the [indications of both medicinal products relate to] different diseases, affecting different parts of the eye“. Given the uncertainty over the application of Neurim and when an SPC is available for a different application of a known active ingredient, the Paris Court of Appeal referred the following questions to the CJEU:

Must the concept of a ‘different application’ within the meaning of the judgment of 19 July 2012, Neurim (C-130/11, EU:C:2012:489), be interpreted strictly, that is to say:

–    as limited only to the situation where an application for human use follows a veterinary application;

–    or as relating to an indication within a new therapeutic scope, in the sense of a new proprietary medical product, compared with the earlier marketing authorisation, or a medicinal product in which the active ingredient acts differently from how it acts in the medicinal product to which the first marketing authorisation related;

–    or more generally, in the light of the objectives of Regulation (EC) No 469/2009 of establishing a balanced system taking into account all the interests at stake, including those of public health, must the concept of a “new therapeutic use” be assessed according to stricter criteria than those for assessing the patentability of the invention;

–    or must it on the other hand be interpreted broadly, that is to say, as including not only different therapeutic indications and diseases, but also different formulations, posologies and/or means of administration?

Does the expression “[application] within the limits of the protection conferred by the basic patent” within the meaning of the judgment [of the Court of Justice] of 19 July 2012, Neurim (C-130/11, [EU:C:2012:489]), mean that the scope of the basic patent must be the same as that of the marketing authorisation relied upon and, therefore, be limited to the new medical use corresponding to the therapeutic indication of that marketing authorisation?” 

Analysis

In his Opinion for the Grand Chamber of the CJEU, AG Giovanni Pitruzzella highlights that the CJEU’s decision in Neurim was out of line with its earlier case-law on the meaning of ‘product’ in Article 1(b) of the SPC Regulation. He emphasises that the use in Neurim of the undefined expressions “new therapeutic application”, “new use”, “different application” or “other therapeutic indication” rises several possible interpretations of this decision.

In light of this, AG Giovanni Pitruzzella considers the implications of the conclusions of Neurim, its departure from the CJEU’s earlier case-law and the subsequent case-law of the CJEU.

Considering the earlier case law, AG Giovanni Pitruzzella highlights the CJEU’s decision in Yissum where the CJEU held that “the concept of ‘product’ cannot include the therapeutic use of an active ingredient protected by a basic patent”. In his view, the CJEU’s decision in Neurim “dissociated” the concept of a ‘first MA’ from the concept of a ‘product’ under Article 1(b) of the SPC Regulation in order for it to be linked to the concept of ‘basic patent’ under Article 1(c) of the SPC Regulation. The cases following Neurim, then reaffirmed a strict definition of ‘product’, whilst at the same time acknowledging that Neurim permitted SPCs for new therapeutic indications of an old active ingredient (see GSK (Case C-210/13) and Georgetown (Case C-484/12)). This was the position until the recent decision of the CJEU in Abraxis, which in AG Giovanni Pitruzzella’s view, upheld a “different and inconstant interpretation of Article 3(d)” compared to Neurim, whilst not reversing that earlier decision. To resolve this position, AG Giovanni Pitruzzella’s recommendation to the CJEU is that it should not limit Neurim to a narrow exception on its facts, but that it should make a clear and definitive choice between either reversing Neurim or departing from a strict definition of the meaning of ‘product’ under Article1(b) of the SPC Regulation.

AG Giovanni Pitruzzella’s preference is for the CJEU to maintain a strict definition of ‘product’ and for the CJEU to reverse its decision in Neurim, as electing any criterion other than a chronological one for determining the first MA would be contrary to the clear drafting of Article 3(d). In the alternative, to permit SPCs for second medical uses of previously authorised products under Article 3(d) would require that the CJEU adopt a broader, less strict interpretation of ’product’ under Article 1(b).

Over several pages of his Opinion, AG Giovanni Pitruzzella considers the need for the CJEU to define “which type of research is encouraged” by the SPC Regulation and the current ambiguity that exists on this topic. In his Opinion, the reward of an SPC was not created for any kind of research, but he recognises the inconsistencies of the CJEU’s statements in Neurim and Abraxis. In doing so, he quotes and appears to endorse the CJEU’s statement in Abraxis that “the legislature intended, in establishing the SPC regime, to protect not all pharmaceutical research giving rise to the grant of a patent and the marketing of a new medicinal product, but to protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product”. AG Giovanni Pitruzzella therefore concludes that the SPC system should be consistent, easy and transparent, such that it achieves the correct balance of interests between the various stakeholders, and that this was not achieved in Neurim which “altered this balance in favour of pharmaceutical companies”. This, in his view, supports his preferred recommendation to the CJEU to reverse the decision in Neurim and maintain a strict definition of ‘product’.

Should the CJEU not agree with this conclusion, in the alternative, AG Giovanni Pitruzzella proposes that the correct balance needs to be found between strictly limiting the availability of SPCs to situations where a human use would follow a veterinary use and permitting SPCs for any subsequently authorised products that included the same active ingredient, such as new formulations, posologies or modes of administration. In his view, the correct balance is found if the MA on which the SPC is based “covers a new therapeutic indication of said active ingredient or relates to a use of it in which this active ingredient exerts a new pharmacological, immunological or metabolic action of its own.

A translation of the conclusion of AG Giovanni Pitruzzella’s Opinion, which is not currently available in English, is:

In light of all of the foregoing considerations, I suggest that the Court, mainly, respond to the Paris Court of Appeal (France) as follows:

Article 3(d) […] read in conjunction with Article 1(b) […] must be interpreted as meaning that the marketing authorization referred to in Article 3(b) of that regulation, relied upon in a supplementary protection certificate application relating to a different and new application of an old active ingredient, cannot be considered to be the first marketing authorization for the product in suit as a medicinal product when this active ingredient has already been the subject of such an authorization per se.

In the alternative, in the event that the Court decides to proceed to the interpretation of the Neurim decision, I propose that the Court answer the questions referred by the Paris Court of Appeal as follows:

1) Article 3 […] must be interpreted as meaning that the grant of a supplementary protection certificate for a different application of an active ingredient for which a previous marketing authorization has been granted in the Member State concerned, within the meaning of the decision of 19 July 2012, Neurim Pharmaceuticals (1991), (C-130/11, EU: C2012: 489), requires that the marketing authorization relied upon to apply for a supplementary protection certificate covers a new therapeutic indication of said active ingredient or relates to a use of it in which this active ingredient exerts a new pharmacological, immunological or metabolic action of its own.

2) Article 4 […] must be interpreted as meaning that, in the case where the supplementary protection certificate relates to a different application of an old active ingredient, the concept of ‘product’, in the meaning of this provision, designates only said application and does not extend to the active ingredient as such or to other applications thereof.

Frederic Chevallier
Frederic Chevallier
Partner, Paris
+33 1 53 57 13 60

AG’s Opinion in SkyKick maintains the case’s chilling effect on enforcement of trade mark rights, pending clarity from the CJEU

The CJEU’s Advocate-General (‘AG’) has delivered his Opinion that a registered trade mark cannot be declared invalid solely due to the terms used in the mark’s specification lacking ‘sufficient’ clarity and precision. However, this statement came with the substantial caveat that a lack of clarity and precision in the specification could cause the application/registration to fall within the ‘contrary to public policy’ provision, which is a ground for refusal or invalidity of EU and national trade marks. The Opinion also considered ‘intention to use’ and concluded that applying for registration of a trade mark with no intention to use it in connection with specified goods or services, could constitute an element of bad faith (bad faith itself a ground for refusal of registration & invalidity).  The AG’s Opinion follows a reference to the CJEU in the case Sky v SkyKick from the High Court of Justice (England and Wales) (‘the Court’).

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Patent and Pharma Update, October 2019

Key recent developments in the United Kingdom and Europe relating to patents and the pharmaceutical sector

In this issue we provide updates from the CJEU on SPCs: in one case the CJEU has declined to consider a referral from the UK while in another the Advocate General has issued his opinion on the interpretation of Article 3(a) of the SPC Regulation. We take a look at the decision in Takeda v Roche and the requirements for an enabling disclosure. In France, we consider a second attempt to secure a preliminary injunction as well as an update to the law on reimbursement. In another decision, the CJEU has considered the requirements of the Enforcement Directive in the context of a wrongly awarded preliminary injunction. On the RAND side, a Court of Appeal decision has also pulled back on the court’s exercise of its jurisdiction. There are a number of important procedural updates relating to: parallel UK and EPO proceedings; the Disclosure Pilot Scheme; and transfers from the IPEC to the Patents Court. We round off this issue with updates on the Patents Court judges; Brexit guidance on IP and the Pharma Sector; and the Unified Patent Court.

 

1. SPC updates

We report on the recent decision of the CJEU not to consider a referral from the High Court on the interpretation of Article 3(b) of the SPC Regulation, which related to the ability of an applicant for an SPC to rely on a third-party MA. The CJEU ruled that the referral was manifestly inadmissible. We also report on the recent AG’s Opinion on the interpretation of Article 3(a) of the SPC regulation.

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2. Novelty – what needs to be enabled? A closer look at Takeda v Roche

In a dispute relating to monoclonal antibodies, Mr Justice Birss finds the patent-in-suit invalid on the grounds of lack of novelty and inventive step and insufficiency. We consider Birss J’s analysis of the requirements for an enabling disclosure in the context of novelty.

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3. Updates from France

In a decision concerning animal health products, Bayer was permitted to apply for a preliminary injunction for a second time given that the circumstances had changed since its first application, although it was ultimately unsuccessful. We also provide an update on new French legislation relating to reimbursement of medicinal products, generic products and biosimilars.

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4. Green light for damages compensation in case of lifted PI? Not always, says the CJEU

In a referral from the Hungarian Courts, the CJEU provides guidance on the requirements of the Enforcement Directive to compensate a party where a preliminary injunction has been granted but the patent subsequently revoked.

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5. ‘Jurisdictional imperialism’ – the Court of Appeal pulls back

In the latest instalment of TQ Delta v ZyXEL the Court of Appeal rules that a RAND trial should not proceed in circumstances where ZyXEL has purported to waive its RAND rights. This reverses the decision of Mr Justice Birss, which we reported in the last edition of this update.

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6. Procedural updates

We consider the High Court’s application of the IPCom Guidance in ordering UK patent proceedings to go ahead while opposition proceedings run in parallel in the EPO; over the summer there have been two patent cases applying the rules of the new Disclosure Pilot Scheme; and His Honour Justice Hacon considers an application to transfer proceedings from the Intellectual Property Enterprise Court to the Patents Court.

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7. The Patents Court judges

We provide a brief update on the judges in the Patents Court.

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8. Brexit – updates to the Brexit legal guide

Following further Brexit guidance from the UK government on IP and the Pharma Sector we have updated the Herbert Smith Freehills Brexit Legal Guide.

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9. The Unified Patent Court

We reflect on the progress of the Unified Patent Court and the steps that remain for it to come into effect.

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10. Table of patents decisions

 

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11. Table of other relevant decisions

 

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Key contacts

Jonathan Turnbull
Jonathan Turnbull
Partner
+44 20 7466 2174
David Webb
David Webb
Associate
+44 20 7466 2629
Rachel Montagnon
Rachel Montagnon
Professional Support Lawyer
+44 20 7466 2217

CJEU refuses UK High Court’s request for preliminary ruling on SPC applications based on third-party MAs, on account of referred question being “hypothetical” (C-239/19 Eli Lilly v Genentech)

On 5 September 2019, the Ninth Chamber of the CJEU refused a request for referral in relation to the interpretation of Article 3(b) 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 (‘SPC Regulation‘).

Business impact

In its order, the CJEU held that this request for a preliminary ruling was manifestly inadmissible a under Article 52(3) of the Rules of Procedure of the Court of Justice, as the question referred was hypothetical for the purposes of the dispute in the main proceedings.

The referral request was made by High Court of Justice (England and Wales) in proceedings [2019] EWHC 388 (Pat) between Eli Lilly and Genentech. The referral was concerned with whether the SPC regulation should preclude SPC applications based on third-party marketing authorisations (‘MAs‘), which is where a patent holder seeks to obtain an SPC for a product without the consent of the unrelated third party that has developed that product and obtained the necessary a MA for it.

This issue is not a new one, and was previously referred to in Eli Lilly v HGS (C-493/12). Although it was not being pursued as a standalone ground, the CJEU decision observed in this case that if an SPC were granted to the patent holder, even though he was not the holder of the MA granted for the medicinal product developed from the specifications of the patent, and had therefore not made any investment in research relating to that aspect of his original invention, that would undermine the objective of the SPC Regulation. In a similar vein, in Gilead v Teva (C-121/17; a case that did not concern grant of SPCs based on third-party MAs) the CJEU held in paragraph 50 of its decision that when applying Article 3(a) of the SPC Regulation no account should be taken of research which took place after the filing date or priority date of the basic patent, as this would enable the SPC holder to unduly to enjoy protection for those unknown results.

The refusal of the reference means that disappointingly, the rather important question of SPC applications based on third-party MAs remains unanswered. Nevertheless, it is likely that there will be a further reference on this issue in the future, perhaps from one of the other national courts where the dispute between Eli Lilly and Genentech remains live, or from the Court of Appeal in the UK (should this happen before Brexit).

Background

The referral request was made by the UK High Court in proceedings which related to Genentech’s patent EP (UK) 1 641 822, entitled ‘IL 17A/F heterologous peptides and therapeutic uses thereof’ (the ‘Basic Patent’) and Eli Lilly’s MA for their product ‘ixekizumab’ marketed under the brand name ‘Taltz’.

Genentech contended that the formulation for ixekizumab fell within the scope of the Basic Patent, and applied for an SPC on the basis of the Basic Patent and Eli Lilly’s MA for ixekizumab.

Eli Lilly in turn contended that two grounds precluded the grant of the SPC: 1) the SPC application at issue did not comply with Article 3(a) of the SPC regulation, since the formulation for ixekizumab was not protected by the Basic Patent; and 2) the application did not comply with either Article 2 or Article 3(b) and (d) of the SPC Regulation, because the MA for ixekizumab is not a relevant MA, since it is owned by a third party and was relied upon without that party’s consent.

By the time the referring decision as handed down, the Basic Patent had already been held to be invalid in parallel proceedings. Nevertheless, Mr Justice Arnold considered it necessary to make a referral to the CJEU on whether the SPC Regulation should preclude SPC applications based on third-party MAs. Various factors played a role in making the referral:

  1. Even though the Basic Patent had been held to be invalid in parallel proceedings, it may be maintained on appeal;
  2. Because of Brexit, it is highly probable that the Court of Appeal will cease to have jurisdiction to refer a question for a preliminary ruling to the Court of Justice, so it was considered necessary that the High Court refer such a question now;
  3. As of the date of the reference decision, Eli Lilly and Genentech were in dispute on this issue not only in the United Kingdom but also in other Member States;
  4. This issue had arisen in other previous cases.

Keeping the above in mind, Mr Justice Arnold referred the following question to the CJEU:

Does [the SPC Regulation] preclude the grant of an SPC to the proprietor of a basic patent in respect of a product which is the subject of a marketing authorisation held by a third party without that party’s consent? 

Analysis

The CJEU’s order clarifies that the role of the CJEU is to aid with interpretation of such EU law as is necessary for national courts to give judgment in cases upon which they are called to adjudicate. A reference for a preliminary ruling made by a national court is to be rejected where it is obvious that the interpretation of EU law that is sought is unrelated to the actual facts of the main action or its object, or where the problem is hypothetical.

In considering whether the clarification or interpretation of EU law sought in the referral is necessary, the CJEU held that it is not sufficient to say that there may be an appeal down the line which may render the hypothetical scenario true. Neither is it of relevance that the same issue exists in proceedings in other jurisdictions, or may have been raised in previous proceedings – the existence of disputes in other Member States of the European Union or of previous disputes does not support the conclusion that the interpretation of EU law that is sought is necessary for the resolution of the dispute which the referring court is called upon to resolve.

The CJEU also clarified that the referring court could not pre-emptively request a reference pending Brexit, on the basis that the appeal court might subsequently lose its jurisdiction to refer the same question because of withdrawal from the European Union pursuant to Article 50 of the TFEU, and while EU law continues in full force in the UK.

Conclusion

Although the refusal of the CJEU to decide on the referral is disappointing, it is hoped that the question of SPC applications based on third-party MAs will not remained unanswered much longer, and that there will be a decision that clarifies this issue in the foreseeable future. Meanwhile, the CJEU’s order sheds light on some important issues like the CJEU’s approach to references in light of Brexit, which will no doubt inform litigation strategy in the coming months.

Sebastian Moore
Sebastian Moore
Partner
+44 20 7466 2801
Martina Maffei
Martina Maffei
Associate
+39 02 0068 1353
Priyanka Madan
Priyanka Madan
Associate
+44 20 7466 2986

 

Misleading brand name ‘Glen Buchenbach’ infringes the registered geographical indication ‘Scotch Whisky’

In a decision that extends the law of geographical indications into the territory of the UK tort of passing off, the District Court of Hamburg (the ‘Court’) has prohibited the use of ‘Glen’ in the name of a whisky that did not originate from Scotland on the basis of the geographical indication protection associated with ‘Scotch Whisky’ . Continue reading

Patent and Pharma Update – December 2018

Key recent developments in the United Kingdom and Europe relating to patents and the pharmaceutical sector

This issue reports on several ground-breaking decisions from the UK courts on second medical use patents and skinny labels, infringement by equivalents and the possibility of global FRAND licences for standard essential patents (SEPs).  We also look at some significant decisions from the CJEU on SPCs and reimbursements in relation to medicinal products and a few developments at the European Patent Office. Finally, we provide our usual round-up of the latest UPC developments (this time from Italy) and Brexit-related developments relevant to the pharma sector. Continue reading

CJEU rules on whether the NHS reimbursing off-label medicinal products for cost-cutting purposes conflicts with Directive 2001/83/EC

Novartis Farma S.p.A. v Italian Medicines Agency and Roche Italia S.p.A.

On 21 November 2018, the CJEU issued an important decision in Novartis Farma v Italian Medicines Agency and Roche Italia et al. (C-29/17). The case was referred to the CJEU by the Italian Council of State and regarded an Italian law that allows the national healthcare insurance system (NHS) to reimburse a medicinal product for a use not covered by its marketing authorisation (off-label use) in order to reduce expenditure, notwithstanding the existence and market availability of a valid therapeutic alternative.

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Brexit “no deal” technical notices published on Patents, Trade marks, Designs, Copyright, GIs, and Exhaustion of rights

The latest tranche of “no deal” technical notices was released yesterday afternoon by the UK Government. Amongst them are several notices that highlight the Brexit issues faced by intellectual property right owners and, in some cases, confirm the Government’s approach to resolving them. The Government also released this news story today which comments on the guidance given in the technical notices and comments on the Government’s longer term aims for IP protection.

Key announcements, in the context of no deal, are:

  • Provision of a new right to replace unregistered Community design rights, to be known as “the supplementary unregistered design right“.
  • Existing EUTMs and Community registered designs will be replaced with new, equivalent rights in the UK at the end of the implementation/transition period, “with minimal administrative burden“.
  • The SPC, compulsory licensing, pharmaceutical product testing exception and patenting of biotechnological inventions regimes will remain unchanged at least initially.
  • If the UPC comes into force the UK will replace unitary patent rights with equivalent rights if the UK needs to withdraw from the new system, although the UK “will explore whether it is possible to remain within it“. The Government’s news story states that “The UK intends to stay in the Unified Patent Court and unitary patent system after we leave the EU.”
  • UK originating sui generis database rights will no longer be enforceable in the EEA; “UK owners may want to consider relying on other forms of protection (e.g. restrictive licensing agreements or copyright where applicable) for their databases
  • The UK will set up its own GI schemewhich will be WTO TRIPS compliant“. The new rights “will broadly mirror the EU regime and be no more burdensome to producers“.  Since the UK would no longer be required to recognise EU GI status, EU producers would be able to apply for UK GI status. Those wishing to protect UK GIs in the EU will need to submit applications on a third country basis.
  • The UK will continue to accept the exhaustion of IP rights in products put on the market in the EEA by, or with the consent of, the rights holder. However, the EU will likely not consider that goods placed on the UK market are exhausted in the EEA, and thus permission may need to be sought from the rights holder to transfer goods to the EEA that have legitimately been put on the market in the UK. The Government news story says that “The UK looks forward to exploring arrangements on IP cooperation that will provide mutual benefits to UK and EU rights holders and we are ready to discuss issues the EU wishes to raise in the negotiations on our future relationship, including exhaustion of IP rights”.

Links to the notices:

  1. Patents
  2. Trade marks and designs
  3. Copyright
  4. Geographical Indications
  5. Exhaustion of IP rights

More detail on each of these is provided below. For those with an interest in Life Sciences please also see our blog post on the notices related to that sector that were released last month.

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