Our regular Patent and Pharma update aims to keep you informed of recent developments in United Kingdom and European law relating to patents and the pharmaceutical industry.
1. SPC updates CJEU refuses UK High Court’s request for preliminary ruling on SPC applications based on third-party MAs
Eli Lilly v Genentech CJEU C-239/19, 5 September 2019
On 5 September 2019, the Ninth Chamber of the Court of Justice of the European Union ("CJEU") refused a request for a preliminary ruling concerning the SPC Regulation (Regulation 469/2009).
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 & Wales) in proceedings [2019] EWHC 388 (Pat) between Eli Lilly and Genentech (see our last update here). 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 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 pursued as a standalone ground in that case by the time it reached the CJEU, the CJEU observed in that case that if an SPC were granted to the patent holder, even though it 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).
Table of contents
1. SPC updates 1 2. Novelty – what needs to be enabled? A
closer look at Takeda v Roche 3 3. Updates from France 4 4. Green light for damages compensation in
case of lifted PI? Not always, says the CJEU 6
5. 'Jurisdictional imperialism' – the Court of Appeal pulls back 7
6. Procedural updates 8 7. The UK Patents Court judges 11 8. Brexit – updates to the Brexit legal guide 11 9. The Unified Patent Court 11 10. Table of patents decisions 13 11. Table of other relevant decisions 16
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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 was 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 remain 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, Partner, Martina Maffei, Associate and Priyanka Madan, Associate Milan and London
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AG's Opinion on the interpretation of Article 3(a) of the SPC Regulation
Joined Cases C‑650/17 (Royalty Pharma/Sitagliptin) and C‑114/18 (Sandoz v Searle), 11 September 2019
Advocate General Hogan has provided his opinion on the interpretation of Article 3(a) of the SPC Regulation. In doing so, he has clarified aspects of the test enunciated by the CJEU in Teva v Gilead (previously reported here), which AG Hogan considered to be the "definitive test".
In Teva v Gilead, the Grand Chamber of the CJEU set out the following two-limbed test for Article 3(a):
Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 6 May 2009, concerning the supplementary protection certificate for medicinal products, must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:
• the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and
• each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent. In his opinion on the current cases, AG Hogan stressed that it was not his intention to depart from the Teva v Gilead test for Article 3(a) or attempt to graft further conditions onto it.
With this in mind, AG Hogan gave his view of certain issues that had arisen in the joined cases before him. In his Opinion, the Teva v Gilead test:
• applies both to products consisting of a single active ingredient and products composed of several active ingredients (ie, combination products);
• does not involve the concept of "core inventive advance". AG Hogan gave his clear view that this concept does not apply and is of no relevance in the context of Article 3(a) of the SPC Regulation. On this point, AG Hogan agreed with AG Wathelet who had arrived at a similar conclusion in his Opinion in the Teva v Gilead case prior to the Grand Chamber's ruling;
• is technologically neutral in nature. This means that it applies to active ingredients which fall under the invention covered by the patent and which are specifically identifiable in the claims of a patent by means, inter alia, of a structural definition/formula, including a Markush formula (such as the claim in issue in Sandoz v Searle), and a functional definition/formula (such as the claim in issue in Royalty Pharma/Sitagliptin); and
• is to be applied from the point of view of the skilled person and on the basis of the prior art at the filing date or priority date of the basic patent. Sandoz had previously argued that instead of assessing the claim on the basis of the prior art, the assessment should be carried out on the basis of "the common general knowledge". Such an approach had been adopted by Mr Justice Arnold in the UK High Court in Teva v Gilead when applying the CJEU's guidance and another case regarding Article 3(a) (Lilly v Genentech [2019] EWHC 388 (Pat) – reported on here). In AG Hogan's view, use of the "common general knowledge" for the purposes of applying the Teva v Gilead test "should be rejected as it is in direct conflict with the unambiguous wording of the operative part of the ruling in [Teva v Gilead]".
Regarding the two specific limbs of the Teva v Gilead test, AG Hogan opined that:
• "The first part of the two-part test…is not satisfied and an SPC may not be granted in respect of a product if, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent, the claims in a patent in relation to that product are not required for the solution of the technical problem disclosed by a patent;
• The second part of the two-part test…requires that it be established that a person skilled in the art would have been able, in the light of all the information contained in a patent, on the basis of the prior art at the filing date or priority date of the patent in question, to derive the product in question. This is not the case where, in the light of all the information contained in a patent, a product or constituent element of the product remains unknown to a person skilled in the art on the basis of the prior art at the filing date or priority date of the patent in question."
Alex Freelove, Senior Associate London
2. Novelty – what needs to be enabled? A closer look at Takeda v Roche Takeda UK Limited v F Hoffmann-La Roche AG [2019] EWHC 1911, 17 July 2019
This case related to Roche's patent EP 2 007 809 ("EP'809") entitled "Glycosylated Antibodies". Takeda applied for revocation and Roche claimed that Takeda's product Entyvio, a formulation of a monoclonal antibody vedolizumab, infringed EP'809.
EP'809 was found invalid for lack of novelty, lack of inventive step and insufficiency.
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Background
In this case when considering the validity of EP'809, key aspects of common general knowledge concerned antibody dependent cellular cytotoxicity ("ADCC") which, in simplistic terms, is the antibody's propensity to kill target cells and the relationship between the level of fucosylation of the antibody and ADCC. A paper by Shields et al showed that low levels of fucosylation enhances ADCC which is useful, for example, in cancer therapies. Antibodies with a 98% fucosylation levels were mentioned in that paper where the ADCC for such antibody is reduced to background. Low ADCC is advantageous when treating other conditions, such as auto-immune diseases, like in the case of vedolizumab which was aimed at ulcerative colitis and Crohn's disease.
Claim 1 of EP'809 required an antibody to have a fucosylation level of 99% or more (the quantity could have been calculated using a number of different methods, all described as "crazy math" by Takeda's expert Prof Bertozzi).
Infringement
Vedolizumab was found by the judge to fall within Claim 1 as it was an "antibody" within the meaning of the claim with >99% fucosylation, using the preferred calculation method adopted by Birss J (known in the judgment as the "99%-TRM" method).
Novelty
Birss J reiterated the position from Synthon BV v SmithKline Beecham plc [2005] UKHL 59 whereby for a patent claim to lack novelty over the prior art there must be both disclosure and enablement. A product is enabled if a skilled person can reproduce it without undue burden. Takeda cited a number of prior art references that disclosed antibodies with >99% fucosylation which Roche argued were not enabling.
The key consideration was what exactly needed to be enabled: the very thing disclosed by the prior art (Roche's stance) or something within the claim, even if not exactly the same as the prior art (Takeda's stance). Birss J considered this in the context of prior use. In that context he considered the following question: what if a product had other features which would make no difference to whether it fell within the claim or not, but the skilled person could not reproduce them? There are EPO authorities which suggested that if a skilled person is unable to reproduce all features of the prior art antibody, such as amino acid sequence, or the glycosylation pattern, from the prior use of that antibody that was enough to find the relevant patented claim novel (T 2045/09 and T1833/14).
Birss J disagreed. He said as that the leading EPO authority (G1/92 Availability to the Public) does not go that far. In relation to prior use, he considered that as long as the skilled person can obtain enough information to put it to practical use by making their own version of that product, that second version is state of the art and a patent claim which covers it would lack novelty (see paragraph [130] of the judgment). In his judgment, the absence of a feature that had nothing to do with the invention and does not prevent the skilled person from making their own version of the product is not relevant (see paragraph [126]).
On the facts of this case, the prior art disclosed the idea of an antibody with somewhere between 99%-100% fucose. This was an enabling disclosure, as the skilled person would be able to make such antibody without undue burden, although a great deal of work would have been required.
Other findings
Birss J also found that EP'809 was invalid on the grounds of obviousness and insufficiency. Applying the Agrevo/Triazoles line of case law, Birss J found that the patent did not make any technical contribution over and above what was already known to the person skilled in the art. Contrary to what Roche argued, the patent did not make plausible the idea that the higher concentrations of fucose would reduce ADCC to background, as that was not addressed in the patent.
EP'809 was also found to be insufficient because depending on the machine used by a skilled person, the results obtained would differ, such that an antibody could either fall inside or outside the claim.
Monika Klajn, Associate London
3. Updates from France Interim Injunction
Bayer Intellectual Property GmbH, Bayer Animal Health GmbH v. Ceva Sante Animale
In a French case concerning animal health products, the President of the Paris First Instance Court dismissed the patentee's second attempt to claim at first instance for an interim/preliminary injunction against the same defendant (Paris First Instance Court, 11 September 2019, Bayer Intellectual Property GmbH, Bayer Animal Health GmbH v. Ceva Sante Animale).
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Background
Bayer Intellectual Property GmbH ("Bayer IP") holds EP 2 164 496 with the title "Formulations containing triazinones and iron", covering formulations of a triazinone such as toltrazuril and of iron such as iron(III) dextran for the simultaneous treatment of coccidial infections and iron deficiencies. Opposition Proceedings before the European Patent Office ("EPO") were initiated by Ceva Sante Animale ("Ceva") on 11 January 2018, and the Opposition Division dismissed the opposition on 16 May 2019. Bayer Animal Health GmbH ("Bayer AH") was granted a licence over this patent on 18 June 2019. On 20 May 2019, this same entity was granted a centralized MA for its veterinary product BAYCOX IRON®, comprising the abovementioned active substances toltrazuril and iron(III) dextran. The product has been on the French market since 13 June 2019.
Ceva had in parallel developed an injectable formulation of the same active ingredients, and sent a letter on 10 November 2017 to Bayer IP arguing that it considered Bayer IP's patent to only cover oral formulations of such active ingredients, to the exclusion of a solution for injection, such that Ceva's product FORCERIS® would not infringe Bayer's patent. Bayer responded in December 2017 that it disagreed with Ceva's interpretation of Bayer IP's claims.
Bayer IP initiated preliminary injunction proceedings against Ceva on 26 December 2017, and on 5 April 2018 the President of the Paris First Instance Court dismissed Bayer IP's claims for a preliminary injunction, notably on the ground that "in the case of a second therapeutic application of a substance or a composition, the results mentioned in a patent serve to assess the technical contribution of the latter and therefore its validity, but also as a necessary prerequisite to determine its scope; that in the present case all the examples are devoted to the oral preparation of the combination of triazinones of formula (II) or (III) and of complex polynuclear iron (III) polysaccharideen compounds for administration to piglets, and that "the only problem to be solved in the patent is the preparation of this juxtaposition of two active ingredients already known for a treatment in oral form, so that the omitted feature [concerning the administration route] in claim 1 will be problematic with respect to the validity of EP 496".
In February 2019, the solution for injection of Ceva's FORCERIS® product was granted an MA. On 20 June 2019, Bayer IP and Bayer AH tried to resume the first instance preliminary injunction proceedings that led to the abovementioned negative decision of 5 April 2018, in an attempt to seek a preliminary injunction.
Discussion
On the admissibility of this second attempt, the President of the Court ruled that this second claim for a preliminary injunction was admissible as new elements were relied upon, ie, the actual launch of the allegedly infringing product and the Opposition Division decision upholding the validity of the patent-in-suit. In this respect, the President of the Court ruled that Bayer AH could not be a party to these proceedings, as it was not being a party to the first preliminary injunction proceedings that led to the 5 April 2018 decision.
Nevertheless, the President of the Court confirmed the previous first instance decision against which no appeal had been lodged, and dismissed this second attempt to claim for a preliminary injunction. In doing so, and although the Opposition Division decision had been issued, the President of the Court implemented the same test as in all preliminary injunction proceedings, ie, that "the judge must, in this context, assess the seriousness of the arguments put forward in defence, which may relate to the materiality of the infringement and the validity of the patent, and assess the balance between the challenge of the alleged infringement and the provisional measures sought in the light of the risks incurred by each of the parties".
On the alleged infringement, the President of the Court confirmed what had already been ruled by his predecessor in her 5 April 2018 decision, and ruled that: "It is this surprising effect obtained in the context of an oral administration, and not by injection whose alternative use on the 3rd day is known and clearly not advocated, which is alone highlighted and protected by the patent. […] It may be noted that this scope of protection has been claimed by Bayer as part of the procedure of the same right before the Canadian Patent Office […]. The Canadian version of the patent covers "an oral formulation" […]. It follows from all of the foregoing that the arguments developed by Ceva in support of its position that the scope of protection conferred by EP 496 does not extend to a combination administered by injection, appear sufficiently serious such that - with respect to the respective risks incurred by each of the parties – the preliminary injunction measures be dismissed notwithstanding the lack of precision as to the method of administration of the product in claim 1, as read in light of the description and in particular the definition of the technical problem raised and the solution proposed by the invention. The decision of 5 April 2018 dismissing the claim for preliminary injunction therefore does not need to be overturned or modified. "
Conclusion
This decision is a rare application of the possibility to resume first instance proceedings for preliminary measures on the ground of alleged new circumstances. However, as in the only previous case (to our knowledge) of Warner-Lambert v Mylan (pregabalin), the second attempt has had the same negative outcome for the claimant, arguably because the latter actually requests the President of the Paris First Instance Court to overturn its own previous decision (although different judges heard the case in both attempts). A factor that may have made it more likely for the claimant to fail in each case may have been the failure to lodge an appeal against the first instance decision, thereby inherently acknowledging the grounds of the previous decision. For the sake of completeness, Warner-Lambert was ordered to pay the defendants almost 1 million Euros in legal fees in those first instance proceedings, and Bayer in this case has been ordered to pay 200,000 Euros in legal fees.
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New French legislation on the reimbursement of certain medicinal products, generic products and biosimilars
On 1 August 2019, the French Prime Minister executed a decree (the "Decree") which aims to simplify the assessment procedure of medicinal products under a temporary recommendation of use ("RTU"), as well as of generic and biosimilar products by the Transparency Commission ("CT") of the High Health Authority ("HAS") in order to speed up approval of their reimbursable status. For example, previously the assessment of a biosimilar product by the CT to assess its medical benefit was a prerequisite to its reimbursement; according to the Decree, such an assessment for biosimilar products is no longer necessary if the reference biological product is already registered on the list of reimbursable products. Reimbursement of medicinal products under a RTU will still not be possible if they trigger neither an improvement of the medical service rendered nor savings in the medical treatment of patients (unless they are registered as generics or biosimilar products).
Frédéric Chevallier, Partner Paris
4. Green light for damages compensation in case of lifted PI? Not always, says the CJEU Case C-688/17, Bayer Pharma AG v Richter Gedeon V, 12 September 2019
Summary On 12 September 2019, the CJEU issued its decision in case C-688/17 (Bayer Pharma AG v Richter Gedeon V) on a referral request made by the Metropolitan Court of Budapest regarding the interpretation of Article 9(7) of Directive 2004/48/EC (the "Enforcement Directive").
Article 9(7) of the Enforcement Directive provides that: "Where the provisional measures are revoked […] or where it is subsequently found that there has been no infringement or threat of infringement of an intellectual property right, the judicial authorities shall have the authority to order the applicant, upon request of the defendant, to provide the defendant appropriate compensation for any injury caused by those measures."
The above provision of the Enforcement Directive has been implemented in EU Member States to varying degrees and in a different ways, with some Member States not implementing it at all (and in such cases, general civil provisions on liability and damages apply). In Hungary – one of the countries where this provision has not been implemented – the Metropolitan Court decided to refer two questions to the CJEU regarding (i) the scope of Article 9(7) of Directive 2004/48/EC, and also (ii) whether the national court is precluded from taking into account the behaviour of the defendant and their own contribution to any damage suffered, as provided for by the general national law.
Background
The case originated from the Metropolitan Court of Budapest, between Bayer (the claimant), and Richter Gedeon ("RG") and Exeltis (the defendants).
The Hungarian patent litigation system is a bifurcated system with respect to assessing validity and infringement. In Hungary, when the judge considers a preliminary injunction ("PI") he does not consider the validity of the patent-in-suit. Following the grant of the requested PI, main infringement proceedings are usually started. These proceedings are suspended if parallel revocation/validity proceedings are commenced.
This is what happened in the present case. In short, RG and Exeltis launched their generic versions of Bayer's contraceptive medicinal product at risk, ie, without clearing the way. Bayer filed a PI application on the basis of its patent application which had not been granted at the time, this PI application was initially rejected. After its patent had been granted, and after both defendants had filed proceedings for a declaration of non-infringement, Bayer filed further PI applications, this time successfully obtaining PIs against both defendants which prevented them from marketing their products. After approximately two months, the PIs were lifted on appeal, and some months after this, Bayer's patent was declared invalid and was revoked. RG and Exeltis therefore brought proceedings against Bayer for the loss suffered as a result of the wrongfully granted PIs.
Bayer challenged any obligation to pay damages on the basis that RG and Exeltis had launched their products at risk, and without starting invalidity actions against Bayer's patent first, (ie, without clearing the way). Bayer, in particular, relied on provisions of the Hungarian law that rule out damages compensation if the injured party fails to act “as would generally be expected in the circumstances in question", keeping in mind all the factual and objective circumstances of the case (including the parties' behaviour). Bayer argued that RG and Exeltis were responsible for the loss they suffered having launched at risk and without clearing the way.
The Metropolitan Court decided to make a referral to the CJEU seeking clarification on two points:
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1) Whether the expression "provide … appropriate compensation" in Article 9(7) of Enforcement Directive means that Member States must establish the substantive rules of law on the liability of parties, as well as the amount and method of compensation in cases where a PI is subsequently lifted; and
2) if the answer to the above question is "yes", does Article 9(7) preclude the application of local laws on civil liability and compensation according to which the court may not grant compensation in certain cases, for example, where the defendant has failed to act as would be reasonably expected in the circumstances, or has failed to behave so as to mitigate his or her loss.
Analysis
In short, the CJEU clarified that Article 9(7) must be interpreted such that it does not preclude the application of general national rules on liability, provided that there are rules allowing the judge to order the PI applicant to pay "appropriate compensation" in cases where the provisional measures have lapsed, or are revoked, or it is subsequently found that there has been no infringement or threat of infringement of an intellectual property right.
On the other hand, the CJEU recognised the need for balance – a patentee should be able to seek the preliminary measures referred to in Article 9 of the Enforcement Directive for the purposes of legitimately protecting their rights. However, said measures and procedures are not to be abused.
The Court also held that the notion of "appropriate compensation" is one of EU law. Therefore the content, conditions and the application of this concept should be the same in all Member States.
In order to interpret the notion of "appropriate compensation", reference was made to Recital 22 of the Enforcement Directive which provides that the need to compensate for costs and injury arises when there is "an unjustified request" for preliminary measures. Just because a preliminary measure has lapsed or subsequently been revoked does not mean that the request for the measures was "unjustified" in the first place.
Instead, a revoked PI would have been "unjustified" only where there was no "irreparable harm" likely to be caused to the holder of an intellectual property right in the event that the PI was not granted without delay.
The Court also examined whether a launch a risk by the defendant means that a PI request by the claimant would automatically be "justified". The CJEU concluded that although not sufficient to demonstrate that the PI was justified, a launch at risk by the defendant would in most cases mean that the application for provisional measures would not a priori be regarded as "unjustified" for the purposes of Article 9(7) of the Enforcement Directive, but it is not sufficient to demonstrate that the grant of the PI was ultimately justified.
According to the Court, even in the case of a launch at risk, the grant of a PI could be considered "unjustified", if the conduct of the patentee constituted "a misuse of his right to file for a PI", in other words where the PI applicant had abused its right and the PI application created "barriers to legitimate trade".
Ultimately, the CJEU determined that whether or not the grant of the PI was justified is a matter to be considered by the national courts, and their assessment should take into consideration the behaviour of the parties.
Commercial impact
In conclusion, the CJEU tried to find a balance between the interests of the PI applicant and PI defendant in cases where a granted PI is subsequently revoked. However, a lot of questions still remain unanswered in relation to Article 9(7) of the Enforcement Directive. In Member States where Article 9(7) is not directly implemented, it is not clear whether general tort law and liability for “unlawful acts†are the appropriate tools to deal with the loss caused by an unjustified PI, given that in most cases PIs are granted by the Courts after a thorough technical and judicial assessment of the PI requirements.
What is certain is that, even in countries where Article 9(7) of the Enforcement Directive is not implemented, there is likely to be greater scrutiny of the parties' behaviour when considering whether a PI can be considered "justified" or not.
Martina Maffei, Associate and Priyanka Madan, Associate Milan and London/Milan
5. 'Jurisdictional imperialism' – the Court of Appeal pulls back TQ Delta LLC v ZyXEL Communications UK Limited [2019] EWCA Civ 1277, 18 July 2019
Background
We reported on an interim decision of Mr Justice Birss in our previous update here, in which he rejected ZyXEL's application to vacate a scheduled RAND trial following a purported waiver by ZyXEL of its RAND rights. In that decision Birss J concluded "it is properly arguable that despite the waiver, a real dispute exists involving these defendants and this territory".
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The Court of Appeal has now reversed that decision, rejecting each of the points which Birss J raised as the basis for a sufficiently arguable case to proceed with the RAND trial (see our previous update for details). It is worth noting that since Birss J's decision, ZyXEL had agreed to pay TQ Delta's claimed damages in full. This changed the circumstances under which Lewison and Floyd LJJ were considering the case, as any RAND trial would no longer be considering past damages concurrently.
Summary
In reaching its decision the starting point for the Court of Appeal, with Floyd LJ giving the leading judgment, was that the court has a broad jurisdiction to grant relief. In exercising its discretion the court should decline such relief where it would serve no useful purpose, thereafter it should consider whether the grant of relief would serve the aims of justice, and finally it should consider any special reasons for or against granting relief.
In balancing up these factors, the Court of Appeal does not appear to have had the same difficulties as Birss J in determining the effectiveness of ZyXEL's waiver. Instead, the judges were prepared to accept the waiver at face value, although it remains open whether this is in fact the correct interpretation.
The Court of Appeal also considered the value of TQ Delta's claim for a declaration that ZyXEL are not 'willing licensees'. TQ Delta argued that such a declaration would have effect as res judicata in other proceedings, making it easier for TQ Delta to obtain injunctions in other jurisdictions. However, the Court of Appeal had little sympathy for this argument on the basis that at the time of the Court of Appeal hearing there were no foreign proceedings on foot involving the same parties (although there were with other entities in the ZyXEL group). In any event, the Court of Appeal held it was far from clear whether a declaration from the Courts of England & Wales would have any effect in those proceedings, let alone be res judicata.
Perhaps of most importance though was the Court of Appeal's reliance on the overriding objective, and in particular the need to allot an 'appropriate share of the court's resources' (CPR 1.1(2)(e)) to particular cases. RAND trials are notoriously long and complex, the RAND trial in this case was listed for approximately 10 days with a further £4 million estimated to be incurred to reach the end of trial. It is clear that in balancing up the utility of the declaration that TQ Delta were seeking, the Court of Appeal had these costs in mind and therefore declined to allow the RAND trial to proceed.
Conclusion
Considering these factors in the round, it appears that the Court of Appeal had firmly in mind the potential effect of a declaration in other jurisdictions, stating: 'it would be an exercise in jurisdictional imperialism to foist this court's view as to whether ZyXEL were unwilling licensees, or holding-out on an unknown foreign jurisdiction'. This is in contrast to a number of recent cases in which the Courts of England & Wales have sought to exercise an expansive approach to their discretion when exercising jurisdiction and is in sharp contrast to the recent decisions in Unwired Planet and Conversant (see our reporting here and here). It will be interesting to see whether the Supreme Court follows this approach when it hears the appeals from these decisions this week.
David Webb, Associate London
6. Procedural updates High Court applies IPCom guidance on stays of infringement proceedings
Coloplast A/S v Salts Healthcare Limited [2019] EWHC 1979 (Pat), 31 July 2019
The High Court recently refused to stay UK patent infringement proceedings pending Opposition Proceedings at the EPO. Mr David Stone (sitting as a deputy judge of the High Court) applied the guidance from Glaxo v Genentech [2008] EWCA Civ 23, as reformulated in IPCom v HTC [2013] EWCA Civ 1496, in dismissing an application for a stay of UK patent infringement proceedings pending the outcome of EPO Opposition Proceedings.
The claimant, Coloplast A/S ("Coloplast"), is the proprietor of a European Patent relating to ostomy collecting bags or stomas, which is currently subject to opposition by Hollister Inc. Following expiry of the opposition period, Coloplast brought UK infringement proceedings against Salts Healthcare Limited ("Salts"). Having been served with proceedings, Salts intervened in the Hollister Opposition and an oral hearing in the Opposition Proceedings was scheduled for September 2019. Salts applied for a stay of the UK infringement proceedings pending the ultimate outcome of the EPO opposition proceedings.
Coloplast opposed the application for a stay and offered an undertaking that if the stay of the UK proceedings were not granted, it would repay any damages awarded should the EPO later revoke its patent.
The Court began by observing that "a stay of the proceedings is the default option", and that it was for the claimant to show why the stay should not be granted. It then turned to the IPCom guidance (set out in full at paragraph 68 of the IPCom judgment). This contains 13 Guidelines that need to be considered by the court.
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An important factor in the exercise of the court's discretion is set out in Guideline 10, which relates to “the length of time that it will take for the respective proceedings in the national court and in the EPO to reach a conclusion". The parties disagreed in their estimates as to how long it would take to reach a final decision at the EPO: following an appeal to the Technical Board of Appeal of the EPO (the "TBA") Salts suggested a final decision could be reached as soon as late 2021, whilst Coloplast suggested January 2022-2024 was more likely. Coloplast also submitted that a decision might not be delivered until as late as January 2028 if the TBA referred the matter back to the Opposition Division (the "ping-pong effect"). However, this was considered unlikely – possibly in view of the revised Rules of Procedure of the Board of Appeal, which will be introduced at the EPO from 1 January 2020 with the intention to reduce the delay caused by appeals.
In contrast, Salts estimated the UK infringement proceedings (including appellate proceedings) would conclude by mid-2022, whilst Coloplast's estimate was late 2021.
The judge observed there appeared to be a "tendency to stretch the estimates a little", and considered that the UK proceedings (including appellate proceedings) were likely to conclude in late 2021, and the EPO proceedings were likely to take until at least January 2022.
Guideline 10 further states that timing must be considered "in conjunction with the prejudice which any party will suffer from the delay". Salts alleged it would suffer irreparable harm if the stay was refused, and a final injunction was issued, if the EPO then later revoked the patent. The Judge rejected Salts' submissions on the basis that these were matters related to the ultimate remedy which would be awarded following any finding of infringement, and not to the stay: the court would in any event take into account any prejudice to Salts in considering whether to grant a final injunction.
Mr David Stone also considered Guideline 11, which states that "the public interest in dispelling the uncertainty surrounding the validity of monopoly rights conferred by the grant of a patent is also a factor to be considered". He preferred Coloplast's evidence on the matter of uncertainty: in his view, and given the nature of the patent, there was a public interest in removing any uncertainty on infringement as soon as possible "so as to minimise the number of patients impacted if the patent is in due course found to be valid and infringed".
Finally, the Judge considered Guideline 1, which states that "the discretion, which is very wide indeed, should be exercised to achieve the balance of justice between the parties having regard to all the relevant circumstances of the particular case".
In view of this "overarching" guideline, the judge considered that the "default position of a stay [had been] displaced", on the basis that:
• refusal to grant a stay would not irrevocably deprive Salts of a benefit of the concurrent jurisdiction of the EPO and the UK courts (in view of Coloplast's damages undertaking);
• early resolution of the UK proceedings would be in the interests of commercial certainty;
• resolution of the UK proceedings may promote settlement;
• given the relative timings for UK and EPO proceedings, granting the stay would cause prejudicial delay to Coloplast, whereas Salts would not suffer irrevocable harm if the stay were refused;
• there was public interest in dispelling the uncertainty; and
• the risk of wasted costs of not granting a stay would be outweighed by commercial factors associated with early resolution.
This decision appears to have been based largely on the relative timings of the EPO opposition proceedings as compared to the UK infringement proceedings. However, given the relatively slow speed of EPO proceedings it is not uncommon for there to be parallel national and EPO proceedings. It remains to be seen in what circumstances the court will apply the "default position" to grant a stay.
Laura Adde, Associate London
The Disclosure Pilot Scheme in action: updates from the summer
Merck Sharp & Dohme Limited v Wyeth LLC [2019] EWHC 1692 (Pat), 28 June 2019 Akebia Therapeutics Inc. v FibroGen, Inc. [2019] EWHC 1943 (Pat), 26 July 2019
As many readers will be aware, 1 January 2019 marked the start of the two year mandatory Disclosure Pilot Scheme in the Business and Property Courts of England & Wales. This Pilot was introduced via Practice Direction 51U in the Civil Procedure Rules, and is designed to address the "excessive costs, scale and complexity of disclosure" (Disclosure Working Group Press Release, July 2018). Notably, the Disclosure Pilot Scheme also applies to the Patents Court.
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We have previously reported on the Disclosure Pilot Scheme, including the recent case of UTB LLC v Sheffield United Ltd & Others (in our July Patent & Pharma Update here and our blog post here). Since our last update, two further cases have been handed down, this time from the Patents Court, which we report on below.
To understand some of the terms referred to in the case summaries below, it may be helpful to note that a key feature of the Scheme is a two-stage disclosure process comprising Initial and Extended Disclosure. Initial Disclosure, provided at the same time as the statements of case, involves disclosure of (1) the key documents relied upon by the parties in their statements of case, and (2) the key documents necessary to enable the other parties to understand the claim or defence they have to meet. Extended Disclosure arises where a party seeks disclosure of documents in addition to, or as an alternative to, Initial Disclosure. The Court will only make an order for Extended Disclosure where it is persuaded that it is appropriate to do so in order to fairly resolve one or more of the Issues for Disclosure (ie, the key issues which require the Court to refer to contemporaneous documents to be fairly determined).
Merck Sharp & Dohme Limited ("MSD") v Wyeth LLC
This case concerns a Wyeth patent for an injection device. In its Grounds of Invalidity, MSD relied upon a presentation given by the inventors of Wyeth's patent to show that the "siliconised container means" formulation in the patent did not have the claimed effect, and sought Extended Disclosure of the documents underlying the presentation in order to evidence this.
In his judgment of June this year, Mr Justice Arnold (as he then was) granted MSD's request for Extended Disclosure, on the basis that the order would likely result in documents being disclosed which would be probative of one party's case or the other. The "more difficult" question facing Arnold J was the scope of disclosure which ought to be ordered, as a "wide-ranging search would be costly and disproportionate". Arnold J considered disclosure of laboratory notebooks, internal reports, e-mails, meeting minutes or presentations created, modified or received by the inventors which go to the conclusion of the presentation to be proportionate in this case.
Akebia Therapeutics v FibroGen
This case concerns FibroGen's patents protecting products for the treatment of anaemia, with the patents being exclusively licensed to Astellas. Akebia and Otsuka (together "Akebia") and GSK are currently developing rival products, which has resulted in four actions, relating to infringement and validity between the four parties.
The scope of disclosure was agreed in the proceedings between GSK and FibroGen (the "Agreed Disclosure"), however, in the proceedings between Akebia and FibroGen, Akebia sought disclosure beyond this Agreed Disclosure. FibroGen disputed Akebia's request in relation to the disclosure of (1) documents relating to non-specific or "off-target effects" and (2) documents which collate, analyse or report on the results of experiments. Mr Nicholas Caddick QC (sitting as Deputy High Court Judge) refused Akebia's application for Extended Disclosure of both of these groups of documents. The application for the first group was refused on the basis that it was not "properly and substantively relevant to an issue in the actions". The application to disclose the second group of documents was refused on the basis that the primary evidence for insufficiency would be expert evidence. The experts would have access to the raw data from the assays and experiments and, as such, any limited benefit that the documents might provide would not justify the cost and effort involved in making the search for the documents.
Natasha Daniell, Associate London
Court issues guidance on applications to transfer proceedings from the IPEC to the Patents Court
Kwikbolt Ltd v Airbus Operations Ltd [2019] 7 WLUK 565, 31 July 2019
In a recent judgment, His Honour Justice Hacon has provided guidance on relevant considerations when determining applications to transfer a case out of the Intellectual Property Enterprise Court ("IPEC") to the Patents Court, and reaffirmed the IPEC's general jurisdiction to hear relatively complex claims.
The application in issue related to proceedings brought by a small component manufacturer (Kwikbolt) against Airbus, a large aircraft manufacturer with group revenue of £55.4 billion. Kwikbolt alleged that Airbus had infringed its patent for a temporary fixing used in aircraft manufacture.
Airbus applied to have the proceedings transferred up to the Patents Court. It relied upon two main grounds: that Kwikbolt had not established on the evidence that it could not afford to litigate in the Patents Court; and that the value of the claim made the case unsuitable for IPEC. Airbus alleged that, when the losses it would suffer if a final injunction was issued were considered (in addition to any damages awarded), its overall loss would exceed £100 million.
Having recited previous case law on the issue, and the provisions of paragraph 9 of Practice Direction 30 (which governs the transfer of proceedings from and to the IPEC), Hacon HHJ went on to make four general observations:
1) If a trial can be heard in 2 or at most 3 days, it will usually be of a complexity which makes it suitable for the IPEC.
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2) Where a trial will clearly take significantly longer due to the number of issues, the case will not be suitable for the IPEC and even concerns such as access to justice will not assist a party seeking to have it heard in the IPEC. However, most applications to transfer into or out of the IPEC do not concern such cases. Rather, most applications involve one party insisting that a case would involve a 4-6 day trial, with the other insisting it can be completed in 2 days. In assessing for itself the likely timescale, the Court must take into account the extent to which case management can be used to reduce/focus the issues. If a case could be heard fairly in 2 - 3 days when case management is applied, then the most important factor is to ensure that parties with limited financial means are afforded access to justice. Where one party is an SME of limited means, this will usually mitigate in favour of hearing the case in the IPEC.
3) The value of an injunction should not be confused with the cap on damages in the IPEC (of £500,000); the fact that an injunction may cause harm to a defendant company (significantly) above this cap is not a factor in and of itself in determining that the IPEC is an unsuitable forum. That said, a substantial financial impact from an injunction may be a relevant, in that a defendant facing a costly injunction is entitled to a greater extent to ensure that all reasonable arguments in their defence are taken.
4) The approach to litigation adopted by the party seeking to have a case heard in the IPEC is relevant. A claimant that pleads and approaches a case in a manner fit for the High Court is liable to have it transferred out of the IPEC list.
In applying the above, Hacon HHJ was satisfied that the case in hand could be heard in the IPEC and that a two day trial was ample time to hear the case fairly. The pleaded matters included non-infringement, invalidity, insufficiency and a reliance by the claimant on the doctrine of equivalents. He found that such arguments were familiar and that significantly more complex claims had been heard in 2 day trials at the IPEC.
Hacon HHJ then went on to consider Airbus's two points; that Kwikbolt had not established on the evidence that it could not afford to litigate in the Patents Court, and the potential harm that Airbus would suffer if an injunction was granted.
1) Affordability of litigation in the Patents Court: Considering the evidence, Hacon HHJ noted that Airbus' ability to fund
a patent action was limited only by what it wanted to spend. Kwikbolt, on the other hand, was a "micro-entity" with just 5 employees and total net assets of £34,890. Whilst the Court could not assume that Kwikbolt could not obtain additional funding to run a claim in the Patents Court, it was entitled to infer that it would put serious financial strain on Kwikbolt's business, possibly to the point that it was unable to continue. Hacon HHJ noted that costs in the Patents Court tend to exceed some hundreds of thousands of pounds, and even though Airbus had offered to undertake to accept the IPEC recovery of costs caps if the case was transferred, it was still the case that Kwikbolt would face an increase in costs in running its own case that it might not be able to bear.
2) Value of an injunction: Hacon HHJ noted that the potential loss caused to Airbus by an injunction would be the same whether the case was heard in the Patents Court or the IPEC; the effect of an injunction was only a relevant factor in this application if there was a realistic risk that Airbus' ability to argue its defence would be significantly limited in the IPEC. Since Hacon HHJ had held that there was no such risk, this point was not relevant.
Peter Dalton, Senior Associate London
7. The UK Patents Court judges It is with great regret that we report the death of Mr Justice Henry Carr in July of this year, the official announcement can be found here. In other news, Lord Justice Arnold (formerly Mr Justice Arnold) has been appointed to the Court of Appeal and the announcement can be found here. He was sworn in on 17 October of this year. For the time being this leaves Mr Justice Birss as the only full time Patents Court judge qualified to hear category 4 and 5 trials (the most complex patent cases).
8. Brexit – updates to the Brexit legal guide In light of further guidance issued by the government the IP and pharma section of the Herbert Smith Freehills Brexit Legal Guide has been updated. Links to other sections of the guide can be found here.
9. The Unified Patent Court As those with an interest in patents will be aware, the Unified Patent Court is still not a reality. The final ratification of the Unified Patent Court Agreement ("UPCA") required for the agreement to come into effect, is that of Germany. (Over 13 states having ratified including the UK and France, which, along with Germany, were the three states which were required to have ratified along with at least ten more, before the UPCA could come into force – see here for ratification details.) Without the UPC established to enforce them, unitary patents cannot be granted. Germany's ratification has yet to be received.
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The outcome is still awaited of the constitutional case objecting to a ratification of the UPCA by Germany, which was listed for this year (2019) but which has yet to be heard. It is generally thought that the German court is likely to reject the objector's case, but only once this is determined can the German government make a decision on whether to ratify the UPCA. Indications are that all administrative preparations to ratify have been made in readiness, however, the issue of Brexit is also key. In a response to a recent Brief Enquiry, the German government stated that the consequences of Brexit were as yet unknown (and by implication were delaying ratification), but also reasserted the current government's commitment to the unitary patent and UPC project.
For more information on the UPC and the unitary patent visit our dedicated hub here.
Rachel Montagnon, Professional Support Consultant London
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10. Table of patents decisions
Patentee /
Patent no.
Other party/ies Subject matter / product (active ingredient)
Court Judge/s Legal issue Outcome
England & Wales High Court (Patents Court)
F. Hoffmann-La Roche AG
(Patentee / Defendant)
EP (UK) 2 007 809
Takeda UK Limited
(Claimant / Marketing Authorisation Holder)
ENTYVIO ®
A monoclonal antibody with vedolizumab as approved for ulcerative colitis and Crohn's disease
High Court (Patents Court)
Birss J Whether Takeda's product Entyvio infringed Roche's patent; whether the patent was invalid for lack of novelty, lack of inventive step and insufficiency.
The Court found that vedolizumab as authorised fell within all the relevant claims of the patent, as it was an antibody and had 99% levels of fucose. The Court found that EP'809 was anticipated by prior art which disclosed the idea of an antibody with between 99%-100% level of fucose and person skilled in the art would be able to make such antibody without an undue burden.
The patent as a whole was also found to be obvious for lack technical contribution over and above the prior art. Additionally, the patent was found to be insufficient because an antibody could either fall inside or outside the claim depending on the machine used for measurements.
[2019] EWHC 1911 (Pat) (17 July 2019)
England & Wales High Court (Intellectual Property Enterprise Court ("IPEC"))
Linpac Packaging Limited
R Færch Plast A/S
(Patentees / Defendants)
GB 2 478 028 (owned by Linpac)
Quinn Packaging Limited
(Claimant)
Plastic containers of the type used in supermarkets for food
High Court (IPEC)
Hacon HHJ Whether the patents lacked inventive step over a piece of prior art.
Whether the Linpac patent could be amended.
The Court found that both of the patents lacked inventive step over the cited prior art, an Australian patent. Linpac's application to amend its patent refused on the basis that the amended patent would still lack inventive step.
[2019] EWHC 2119 (IPEC) (31 July 2019)
Court of Justice of the European Union / EPO Courts
C-650/17
Royalty Pharma Collection Trust (Patentee)
C-650/17
Deutsches Patent- und Markenamt
C-650/17
Method for lowering blood glucose levels in mammals
Court of Justice of the European
Advocate General Hogan
The interpretation of Article 3(a) of the SPC Regulation.
The AG gave further guidance on the interpretation of Article 3(a), as reported above.
Joined Cases C-650/17 and C-114/18 (11 September 2019)
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Patentee /
Patent no.
Other party/ies Subject matter / product (active ingredient)
Court Judge/s Legal issue Outcome
EP 1 084 705
C-114/18
G.D. Searle LLC (Patentee)
Janssen Sciences Ireland
EP 0 810 209
C-114/18
Sandoz Ltd
Hexal AG
SPC for Sitagliptin authorised for use in diabetics to lower blood glucose levels
C-114/18
Alpha - and beta-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors
Union
Bayer Pharma AG Richter Gedeon Vegyeszeti Gyar Nyrt.,
Exeltis Magyarország Gyógyszerkereskedel mi Kft.,
Court of Justice of the European Union
A Prechal (President of Chamber), F. Biltgen, J Malenovský (Rapporteur), C G Fernlund and L. S. Rossi (Judges)
Whether the concept of "appropriate compensation" referred to in Article 9(7) of the Enforcement Directive can be interpreted to mean that a generic drug manufacturer is entitled to damages to compensate for losses caused by a preliminary injunction granted in respect of a patent, where the patent was subsequently held to be invalid and the injunction lifted.
The CJEU found that "appropriate compensation" under the Enforcement Directive was an independent notion of EU law. Where provisional measures are revoked or lapse (eg, a preliminary injunction is lifted), that does not automatically mean that the provisional measure granted was unfounded and that the patentee would be obliged to pay compensation for damages suffered. The contrary position would deter the patentees from seeking protective measures and would run contrary to the aims of the Enforcement Directive.
Case C-688/17 (12 September 2019)
Eli Lilly and Company Genentech Inc. IL 17A/F heterologous Court of K Jürimäe Whether the SPC The CJEU found that the referral made by the
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Patentee /
Patent no.
Other party/ies Subject matter / product (active ingredient)
Court Judge/s Legal issue Outcome
EP 1 641 822 peptides and therapeutic uses thereof’
Justice of the European Union
(Rapporteur), D Šváby (President of the Chamber) and S Rodin
Regulation precludes 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.
High Court of England & Wales was manifestly inadmissible by refuting all three reasons cited by Arnold J. First, it was found that the need for an answer to this request was based on a hypothetical premise that Genentech would appeal the invalidity findings of the first instance court, that the Court of Appeal would overturn the invalidity finding and would find it necessary to refer the question to the CJEU. Second, it was found that the intention of the UK to withdraw from the EU is not relevant since the EU law continues in full force in the UK until its actual withdrawal. Third, the CJEU held that the existence of parallel proceedings between the parties or previous cases where the same issue was raised does not necessitate the interpretation of EU law by the CJEU for the resolution of the dispute before the High Court.
Case C-239/19 (5 September 2019)
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11. Table of other relevant decisions
Claimant / Appellant Defendant / Respondent
Subject matter /
product
Court Judge/s Legal issue Outcome
TQ Delta, LLC
(Claimant)
EP (UK) 1 453 268
EP (UK) 1 792 430
ZyXEL Communications UK Limited
ZyXEL Communications A/S
(Defendants)
Digital subscriber line (DSL) related technology – a multicarrier communication with variable overhead rate and cyclic redundancy checksums (CRC) counter normalisation
Court of Appeal (Civil Division)
Floyd and Lewison LJJ
Whether Birss, J had been right to order the scheduled RAND trial to proceed following a purported waiver of ZyXEL's rights.
The Court of Appeal held that ZyXEL's waiver of its RAND rights meant that there was no longer sufficient reason to proceed with the RAND trial, taking into account the court's resources in accordance with the overriding objective.
[2019] EWCA Civ 1277 (Civ) (18 July 2019)
Philip Price
Supawell Limited
Supahome by Maple Limited
(Patentee / Claimant)
GB 2 415 714 (owned by Philip Price)
GB 2 436 989 (owned by Philip Price)
Flitcraft Limited
Flitcraft Timber Frame Limited
Garry Flitcroft
Thomas Flitcroft
(Defendants)
Insulated timber framed building structure and components thereof
High Court (Patents Court)
Mr Recorder Douglas Campbell QC (sitting as the High Court Judge)
Whether Mr Flitcroft continued to infringe Claim 1 of the patent despite an injunction
The Court found that, to the criminal standard of proof, the defendants continued to infringe the patent in contempt of a Court ordered injunction. Prior to sentencing Mr Flitcroft in these commital proceedings, which could potentially result in a jail sentence for contempt of court, the Judge invited him to 'purge' his contempt.
[2019] EWHC 2476 (Pat) (12 September 2019)
Coloplast A/S (a company formed under the laws of Denmark)
(Patentee / Claimant)
EP (UK) 2 854 723
Salts Healthcare Limited
(Defendant)
Use of a textile layer consisting of fibre filaments attached to collecting bag material, which are ostomy products for human waste
High Court (Patents Court)
Mr David Stone (Sitting as Deputy High Court Judge)
Whether proceedings should be stayed pending Opposition Proceedings at the EPO.
The Court found that a stay should be refused, relying on the guidance set out by the Court of Appeal in IPCom v HTC Europe. In particular, it found that the default option of staying the action pending EPO Opposition Proceedings was displaced to achieve the balance of justice. As a result, the Court ordered the claimant to give an undertaking to repay any damages ordered by the Court if the EPO subsequently revokes its patent.
[2019] EWHC 1979 (Pat) (31 July 2019)
Emtelle UK Limited
(Claimant)
Hexatronix UK Limited
Hexatronics Cables &
Coating and construction of fibre-optic cables to facilitate those cables
High Court (Patents
Mann J What level of detail is required in patent pleadings.
The Court found that while an order requiring further particularisation of the statement of case may be made if an appropriate case is made for
PATENT AND PHARMA UPDATE
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Claimant / Appellant Defendant / Respondent
Subject matter /
product
Court Judge/s Legal issue Outcome
GB 2 409 908
GB 2 409 909
Interconnect Systems AB
Hexatronics Group AB
(Defendants)
being blown down ducts Court) it, the claimant in this case had not made a particularly compelling case about the need for further particularisation.
[2019] EWHC 2230 (Pat) (1 August 2019)
Merck Sharp & Dohme Limited
(Claimant / Applicant)
EP (UK) 2 676 679
Wyeth LLC
(Defendant / Respondent)
Formulation for a siliconised container which inhibits aggregation of a polysaccharide-protein conjugate
High Court (Patents Court)
Arnold J Whether, under the Disclosure Pilot Scheme, the patentee had to disclose documents underlying a presentation referenced in the Grounds of Invalidity.
The Court found that disclosure of the documents underlying the presentation would be helpful in resolving the case, but restricted the scope of the order sought on the grounds of proportionality.
[2019] EWHC 1692 (Pat) (28 June 2019)
Optis Cellular Technology LLC
Optis Wireless Technology LLC
Unwired Planet International Limited
(Claimants)
Apple Retail UK Limited
Apple Distribution International
Apple Inc.
(Defendants)
SEPs in the telecoms sector.
High Court (Patents Court)
Morgan J Application for case management directions in a FRAND case & jurisdictional challenges.
The Court in considering a request for case management directions held that it was capable of giving directions for the first two defendants, which were not challenging the jurisdiction of the court per se. Their challenge, in reality, was one of whether the Court should nonetheless not proceed with the matter and stay the matter on forum grounds. The Court rejected the submission that the Court should not consider any case management directions until the applications for a stay has been determined (with this being heard at a two day hearing in December), particularly as these applications were not traditional applications for a stay as they raised issues that would normally be raised in a Defence. The Court therefore made directions for the first and second defendants to provide draft Defences setting out their case as to validity, infringement and whether the patents are essential. Although the judge indicated that the Civil Procedure Rules did not preclude him in making orders for Defences to be served, rather than drafts (which do not have the same
PATENT AND PHARMA UPDATE
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Claimant / Appellant Defendant / Respondent
Subject matter /
product
Court Judge/s Legal issue Outcome
procedural status), he ordered that drafts be served as this was what he had been asked to consider. Given the pending appeals to the Supreme Court in Unwired Planet and Conversant, the judge held that it would not be useful for the first and second defendants to set out their case on FRAND issues in the draft Defence. In addition due to the pending Supreme Court appeals, the judge refused to fix a trial date and ordered that a further case management conference take place in January 2020.
[2019] EWHC 1742 (Pat) (3 July 2019)
The Secretary of State for Health
NHS Business Services Authority
(Claimant)
Servier Laboratories Limited
Servier Research and Development Limited
Les Laboratoires Servier SAS
Servier SAS
(Defendants)
EP 0 308 341
EP 1 296 947
COVERSYL®
Prescription-only angiotensin-converting enzyme inhibitor used in the treatment of hypertension and cardiac insufficiency – perindopril
Court of Appeal (Civil Division)
Sir Terence Etherton MR, Longmore LJ and McCombe LJ
Whether the claimants' claim against the defendants for the tort of causing loss by unlawful means ("unlawful means tort") was correctly struck out at first instance.
The Court found that the claim was correctly struck out given the absence of interference with the NHS' liberty to deal with the offending party. The NHS was relying on an allegation of the defendant's deceit in obtaining a patent at the EPO and defending it in the English courts as the basis for its claim.
[2019] EWCA Civ 1160 (Civ) (12 July 2019)
Kwikbolt Ltd
(Claimant)
GB 2 455 635
Airbus Operations Ltd
(Defendant)
Temporary fixing used in aircraft assembly
High Court (IPEC)
Hacon HHJ Whether proceedings brought by a small manufacturing company against the defendant company, with annual revenues of £55.4 billion, should be transferred from IPEC to the Patents
The Court found that since proceedings in the Patents Court tended to be more expensive, it would place undue financial strain on the claimant. It stated that IPEC was well-placed to hear complex trials, and that if the trial judge were to find that the defendant would be prejudiced due to potential financial consequences of an injunction, they would be in a better position to decide on the appropriate relief.
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Claimant / Appellant Defendant / Respondent
Subject matter /
product
Court Judge/s Legal issue Outcome
Court.
[2019] 7 WLUK 565 (31 July 2019)
Akebia Therapeutics Inc.
Ostuka Pharmaceutical Company Limited
(Rival product developers / Applicants)
Fibrogen Inc.
(Patentee / Respondent)
EP (UK) 1 463 823
EP (UK) 2 289 531
EP (UK) 2 298 301
EP (UK) 1 633 333
EP (UK) 2 322 153
EP (UK) 2 322 155
Inhibitors of hypoxia inducible factor prolyl hydroxylase, an enzyme that regulates HIF activity and stimulates the production of red blood cells, treating various types of anaemia.
Roxadustat (patentee's product)
Vadadustat (Akebia and Ostuka's product)
Daprodustat (GSK's product)
High Court (Patents Court)
Mr Nicholas Caddick QC (Sitting as Deputy High Court Judge)
Whether an order could be sought for disclosure under the Disclosure Pilot Scheme (PD 51U) for (i) experiments relating to any off- target effect of the treatment and (ii) management documents reporting results referred to in assays and experiments for which disclosure had already been ordered.
The Court refused to order the requested disclosure.
In relation to the experiments relating to off-target effects, the disclosure sought did not go to the pleaded issue, as off-target effects were not cited as grounds for invalidity.
In relation to the documents reporting results, the Court found that it would be unreasonable and disproportionate to order such disclosure.
[2019] EWHC 1943 (Pat) (26 July 2019)
Glaxosmithkline UK Limited
Glaxosmithkline Intellectual Property (No. 2) Limited
(Rival product developers / Applicants)
Fibrogen Inc.
(Patentee / Respondent)
EP (UK) 2 322 153
EP (UK) 2 322 155
Astellas Pharma Inc.
(Collaborator / Applicant)
Akebia Therapeutics Inc.
Otsuke Pharmaceutical Company Limited
(Rival product developers)
Fibrogen Inc.
(Patentee)
PATENT AND PHARMA UPDATE
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Claimant / Appellant Defendant / Respondent
Subject matter /
product
Court Judge/s Legal issue Outcome
EP (UK) 1 463 823
EP (UK) 2 289 531
EP (UK) 2 298 301
EP (UK) 1 633 333
EP (UK) 2 322 153
EP (UK) 2 322 155
Astellas Pharma Inc.
(Collaborator / Applicant)
Glaxosmithkline UK Limited
Glaxosmithkline Intellectual Property (No. 2) Limited
(Rival product developers)
Fibrogen Inc.
(Patentee)
EP (UK) 2 322 153
EP (UK) 2 322 155
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Contacts
Jonathan Turnbull, Partner T +44 20 7466 2174 [email protected]
Rachel Montagnon, Professional Support Consultant T +44 20 7466 2217 [email protected]
David Webb, Associate T +44 20 7466 2629 [email protected]
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© Herbert Smith Freehills LLP 2019
The contents of this publication, current at the date of publication set out above, are for reference purposes only. They do not constitute legal advice and should not be relied upon as such. Specific legal advice about your specific circumstances should always be sought separately before taking any action based on the information provided herein.
