PATENT AND PHARMA UPDATE
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
The die is cast: the SPC waiver Regulation has been approved
JULY 2019 London
EU Regulation 2019/933, which amends Regulation (EC) 469/2009 on supplementary protection certificates ("SPCs") introducing a waiver to the patentee's right in favour of EU generics and biosimilars, was published on the Official Journal on 11 June 2019 and took effect from 1 July 2019.
Going further than the original proposal of the EU Commission in 2019, the final text - save for formal and linguistic revisions by the European Union's lawyer-linguists mirrors the provisional agreement that was reached in the inter-institutional tripartite negotiations between the Parliament, Council and Commission in February 2019 (see the April edition of the Patent & Pharma update here).
The Regulation allows EU-based manufacturers of generics and biosimilars not only to manufacture a product for export to non-EU markets where patent or SPC protection has expired or never existed, but also to stockpile the product to allow a "Day-1" launch, even in EU markets or countries where SPC protection exists.
Table of contents
1. SPC updates
2. Update on injunction decisions and guidance 3
3. Updates from France
4. Prior public disclosure in the UK, the doctrine of
equivalents and garden hoses
5. The Patents Court applies Actavis v ICOS
6. Latest Patents Court case on Arrow declarations 9
7. Can a party waive its FRAND/RAND rights? 10
8. Procedural updates from the Patents Court
9. Brexit and the Pharma Sector: further UK guidance
10. Table of patents decisions
11. Table of other relevant decisions
What is the impact for SPC holders?
The Regulation introduces a waiver reducing the effects of
SPCs so they no longer confer protection against certain acts which would otherwise require the consent of the SPC holder. In particular, under specific conditions, generic and biosimilar
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companies will be allowed to manufacture SPC-protected active ingredients and corresponding medicinal products, not only - as originally provided for in the Commission's proposal
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- for the purpose of export to third countries outside the EU,
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but also for entering the EU market immediately after SPC
expiry. Manufacturing for export is allowed throughout the
entire SPC lifetime, whereas, manufacturing and stockpiling for "Day-1" marketing in the EU is permitted only during the last six
months before SPC expiry.
The Regulation sets out a series of obligations for generics and biosimilars that seek to safeguard SPC holders' rights.
First of all, the generic or biosimilar companies must notify the competent Industrial Property Office (using AnnexIa of the Regulation) of their intention to commence manufacturing and must simultaneously inform the SPC holder, in both cases no later than three months before commencing manufacture or the first related activity. The competent National Patent Office will in turn be required to publish the notified information together with the date of notification as soon as possible.
The information to be notified to the competent National Patent Office includes, amongst other things, the name and address of the manufacturer, an indication of the purpose of the intended manufacture (for the purpose of export, storing, or both export and
PATENT AND PHARMA UPDATE
storing) and, in the case of export to third countries, the reference number of the marketing authorisation in each third country of export. Any subsequent changes to this information must also be notified.
However, there is still some concern as to the scope of this obligation and the impact it will have on markets.
For example, the duty of disclosure is quite general. It includes the indication of the "name and the address of the maker" but it is not clear if it also extends to the name and address of any person in a contractual relationship with the maker that performs waived acts for the maker. This information would be useful for the SPC holder to verify whether the proposed manufacturing complies with the Regulation and whether the generics or biosimilar companies are correctly applying the Regulation.
On a literal reading of the Regulation, generic and biosimilar manufacturers must also ensure that their entire supply chains, or any person in a contractual relationship with them, are fully aware that the medicinal products in question are for export only, and that placing on the market, importing or reimporting these products into the EU might infringe an SPC. However, the surveillance obligation placed on the generic and biosimilar companies appears to be ultimately limited to a formal "obligation to inform" through appropriate and documented means rather than - as perhaps would be more balanced in terms of SPC holder's rights by a more thorough and substantial obligation.
For the export of products outside the EU, an export logo must be attached to the medicinal products marked for exportation. This measure has been provided for to avoid any form of placing on the EU market, importation or re-importation of exported medicinal products. However, according to the provisions of the Regulation, the logo must be attached only to the outer packaging of the product and, only where feasible, to its immediate packaging. This may represent a potential weakness in the safeguards for SPC holders; a generic or biosimilar company could argue that affixing the logo on the immediate packaging is not possible, such that they could commence manufacture with an alleged intention of exporting well before the six months prior to the SPC expiry date and then convert the product manufactured for "Day-1" launch in the EU.
Interestingly, the waiver extends not only to "making" and "storing" of SPC-protected products but also to "any related act that is strictly necessary for the making", which is not further defined. For example, where the waiver is being used for a "Day-1" launch in the EU, does this permit a generic or biosimilar company to make public announcements that it has started storing the product for "Day-1" launch?
It is therefore necessary to assess whether the safeguards set out by the Regulation are sufficient, as stated in the Preamble of the Regulation, to "maintain the core rights" of SPC holders.
There is, however, a reasonable transition period to adapt to the changed legal context, which means that the impact of introducing these waivers on SPC holders is softened, at least in the short term. The Regulation provides for a transition period until 2 July 2022 (three years after the waiver actually comes into force), which also impacts the SPCs to which the Regulation will apply. In the transition period, the SPC waiver will only apply to SPCs that were applied for on or after the entry into force of the Regulation, ie, 1 July 2019 (regardless of the timing of their coming into force or their grant). Only after the end of the transitional period will the SPC waiver extend to SPCs filed on or before that date and then, only as from the end of the transitional period.
Laura Orlando, Partner and Martina Maffei, Associate Milan
A further reference to the CJEU on Article 3(c) of the SPC Regulation
Novartis AG (Case C-354/19), reference made on 2 May 2019
The Swedish Court of Appeal has referred a further question to the Court of Justice of the European Union ("CJEU") on Article 3(c) of the SPC Regulation (Regulation 469/2009).
The case concerns the rejection by the Swedish Patent Office (PRV) of an SPC application by Novartis for the active ingredient canakinumab. The Swedish Patent Office rejected this SPC application on the basis of Article 3(c), which provides that an SPC applicant cannot obtain an SPC if the product (ie, active ingredient) of a medicinal product has already been the subject of an SPC.
The application in question was based on Novartis's patent EP 1 940 465 B1 relating to "New use of anti-il-1 beta antibodies" which claims the use of human IL-1 beta-binding antibodies for the treatment of juvenile rheumatoid arthritis and the marketing authorisation for the medicinal product, Ilaris, for which canakinumab is approved for the treatment of, inter alia, systemic juvenile idiopathic arthritis.
The Swedish Patent Office rejected this SPC application in light of Novartis's earlier SPC for canakinumab, which was based on a different Novartis patent protecting canakinumab as such and on its earlier marketing authorisation for that active ingredient for the treatment of cryopyrine associated periodic syndrome.
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On the basis of the arguments put before it, the Swedish Court of Appeal was asked to consider whether adopting a strict approach to Article 3(c) preventing Novartis from obtaining a subsequent SPC was consistent with:
1) the objective of the SPC Regulation to stimulate pharmaceutical research in the European Union (as set out in Recital 11 of the SPC Regulation);
2) the CJEU's decision in Neurim (Case C-130/11); (The CJEU's decision in Neurim did not consider a case in which there was an earlier SPC, but held that an SPC can be obtained for a new use of a known (and previously approved) product where there is a patent that protects a new therapeutic use of that known product and for which a marketing authorisation has been obtained for that new use).
3) Article 3(2) of the Plant Protection Regulation (Regulation 1610/96), which applies mutatis mutandis to the SPC Regulation, under which an SPC may be issued for the same product to different parties for each of their patents, but each patentee may only obtain one SPC for that product irrespective of the number of patents it holds covering that product; and
4) striking the right balance between all relevant interests at stake, including those of public health and of the pharmaceutical industry.
In light of the above, the Swedish Court of Appeal referred a question to the CJEU on Article 3(c), a rough translation of which is:
"In view of the basic purpose that SPCs for medicinal products are intended to satisfy, which consists of stimulating pharmaceutical research in the European Union, does Article 3 (c) of [the SPC Regulation] when considered with Article 3 (2) of [the Plant Protection Regulation] preclude an SPC applicant who was previously granted an SPC for the same product protected by a basic patent for that product as such from being granted an SPC for a new use of that product where the new use is a new therapeutic indication specifically protected by a new basic patent?"
This reference is the latest in a series of references to the CJEU which, at their heart, are seeking to determine the availability of SPCs where a pharmaceutical company has conducted expensive and time consuming research into bringing to market new formulations or new indications of previously known active ingredients. In Abraxis (Case C-334/17), the CJEU held that SPCs cannot be obtained for new formulations of previously approved active ingredients (see our previous update here). In that decision, the CJEU described its decision in Neurim as "the exception" to the narrow interpretation of Article 3(d), but did not elaborate further on when that exception can be relied upon beyond the facts of the Neurim case itself. As a consequence, it is hoped that the CJEU in this pending reference, along with that from the Paris Court of Appeal in Santen (Case C-673/18), provides further clarity on when the "Neurim exception" applies and when SPCs are available to pharmaceutical companies to compensate them for their further research into known active ingredients.
Jonathan Turnbull, Partner London
2. Update on injunction decisions and guidance
Change to the Patents Court Guide concerning interim injunctions
A revised version of the Patents Court Guide was published in April 2019 and can be found here. One of the key changes is the addition of section 10, which should be considered whenever a party is seeking an interim injunction to restrict sale of a medicinal product or medical device which is used by the NHS. Section 10 reads as follows:
"Attention is drawn to PD25A para. 5.2, which requires the Court, when making an order for an interim injunction, to consider whether to require the applicant to give an undertaking to pay any damages sustained by a person other than the respondent who suffers loss as a result of the order. Where a party seeks an interim injunction which would affect dealings in a pharmaceutical product or medical device purchased by the National Health Service ("NHS"), the Court will consider whether the applicant should give such an undertaking in favour of the NHS. The applicant must notify the Department of Health by email to [email protected] of (i) the application when it is made and (ii) any order made following the application as soon as practicable. Notification to this email address will amount to notice to all four NHS agencies in England, Scotland, Wales and Northern Ireland."
This addition to the Patents Court Guide comes following Mr Justice Birss' decision in Novartis v Dr Reddy's Laboratories  EWHC 92 (Pat) to write to the NHS himself to make it aware of an interim injunction and inform the NHS that it had permission to apply for an undertaking in its favour from Novartis. The amendment to the Patents Court Guide formalises the process of notifying the NHS in appropriate cases and now places an obligation on the applicant, rather than the court, to notify the NHS.
PATENT AND PHARMA UPDATE
Fortification of cross-undertakings once the injunction in question has ended
Napp Pharmaceutical Holdings Ltd v Dr Reddy's Laboratories (UK) Ltd  EWHC 1009 (Pat), 15 April 2019
Mr Justice Carr refused an application by Sandoz Limited ("Sandoz") to fortify a cross-undertaking in damages which was given by Napp Pharmaceutical Holdings Limited ("Napp").
At an early stage in proceedings, Sandoz had given undertakings to the Patents Court to refrain from launching a transdermal buprenorphine patch under the brand name Reletrans. The undertakings were later replaced by an interim injunction. In return, Napp had provided a cross-undertaking in damages to compensate Sandoz in the event that Sandoz's transdermal patches were found not to infringe Napp's patents.
In the main proceedings, the High Court found that Sandoz did not infringe Napp's patent and the Court of Appeal affirmed this decision. The interim injunction was accordingly discharged and Sandoz subsequently commenced its inquiry in damages for the six month period for which the cross-undertaking had been in force following the grant of the interim injunction.
Sandoz returned to the High Court following the discharge of the interim injunction to request that the cross-undertaking be fortified on the basis that they had concerns about the financial position of Napp. This was based on evidence provided by Sandoz about difficulties faced by Purdue Pharma (a company said by Sandoz to be in the same network of companies as Napp, all connected to the Sackler family) in relation to the opoid product OxyContin.
After considering the law in this area, Carr J concluded that the court has no power to order a party to give a cross-undertaking in damages; rather, a cross-undertaking is the price that an applicant can choose to pay if it wishes to proceed to obtain an injunction. In a situation where the injunction had already been discharged, the applicant is not asking for anything further from the court and therefore the quid pro quo of offering an undertaking does not arise. As a result, the Judge held that the court only has jurisdiction to order the fortification of a cross-undertaking while the injunction in respect of which it is given is continuing.
In case he was wrong on that, Carr J went on to consider whether it would be appropriate to exercise his discretion to grant Sandoz the relief it had requested on the facts of the case. After reviewing the evidence of both sides, Carr J concluded that there was no material risk that Napp's assets would drop below 19m, which was the amount he believed that Sandoz had a good arguable case to claim under the cross-undertaking. As a result, Carr J held that even if he had jurisdiction to fortify the crossundertaking, he would refuse to exercise his discretion to do so.
As a consequence, a PI applicant who has concerns that a defendant may not be able to pay (or may dissipate assets in an effort to avoid paying) sums due under a cross-undertaking should ensure that it seeks fortification of that cross-undertaking prior to the discharge of the corresponding interim injunction.
Interim injunction refused for "test run" mitral valve treatment device
Evalve Inc. and others v Edwards Lifesciences Limited  EWHC 1158 (Pat), 3 May 2019
Mr Justice Carr refused to grant an interim injunction to Evalve Inc. and Abbott (together, "Evalve") against Edwards Lifesciences Limited ("Edwards") in relation to alleged patent infringement by a mitral valve repair device. The application was refused on the basis that Evalve did not show that damages would be an inadequate remedy in the event the Court declined to grant an injunction and Edwards' device was ultimately found to be infringing.
Evalve alleged infringement of two patents by Edwards' product, PASCAL, a device for treating mitral regurgitation which is implanted during transcatheter mitral valve repair ("TMVr"). Mitral regurgitation is a serious, life-threatening condition, in which the mitral valve of the heart does not close properly, resulting in backflow of blood into the heart.
Pending an expedited trial on the issue of infringement and Edwards' counterclaim for invalidity that is due to be heard in December 2019, Evalve sought an interim injunction to prevent Edwards from marketing the PASCAL device. The market for TMVr in the UK is very small, and is not currently reimbursed by NHS England, though it is expected that the NHS will soon make a positive decision to do so. Evalve markets its own device, MitraClip, for TMVr, which has been used in the UK and Europe since around 2008.
Edwards stated it intended to roll out PASCAL from October 2019 in a small number of hospitals for the purposes of obtaining feedback from clinicians so that it could be competitive when NHS reimbursement of TMVr comes into effect. Evalve claimed that it would suffer irreparable or unquantifiable loss if Edwards were not restrained from doing so, and therefore brought an application for an interim injunction pending hearing of the main action.
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In deciding whether to grant an interim injunction, Carr J looked at the well-established principles set out in American Cyanamid v Ethicom Ltd  AC 396. In his judgment, Carr J re-emphasised that the applicant first needs to establish that it would suffer irreparable harm or unquantifiable damage if the interim injunction were not granted. If damages would be sufficient to compensate the applicant, then there is no justification for the grant of an interim injunction. If not, then, and only then, should the court go on to consider irreparable harm to the alleged infringer and the balance of convenience.
During the hearing, Edwards was prepared to provide an undertaking that, pending final judgment of the main action, the PASCAL devices would only be implanted into 10 patients across two UK hospitals by way of a "test run". Edwards was also willing to accept that each of the 10 patients in which PASCAL was implanted would count as one lost sale for Evalve for the purposes of calculating Evalve's losses. Carr J found that such a limited launch would not cause irreparable harm to Evalve: a limited launch would have no impact on the price of the MitraClip and would be unlikely to disrupt Evalve's existing relationships with clinicians. Carr J also rejected Evalve's allegations that there would be cross-selling of products by Edwards, that Evalve would suffer reputational or brand damage, or that it would be difficult to re-train or re-familiarise clinicians with the MitraClip device if PASCAL were introduced and then ultimately removed from the market.
Carr J further found that, if he were wrong that damages would be an adequate remedy for Evalve, then the irreparable harm suffered by Edwards would outweigh any harm to Evalve, such that an interim injunction should still not be granted. He did so on the basis of there being an unquantifiable advantage to Edwards in being able to undertake its scheduled, gradual and controlled roll-out of PASCAL, such that Edwards would be able to compete at the outset of any market expansion caused by reimbursement of TMVr by NHS England.
In his analysis, Carr J highlighted that, if the assessment of harm to the parties were evenly balanced, then, and only then, would factors relating to the balance of convenience, including the public interest, and whether the defendant had failed to clear the way, become relevant.
A key factor in influencing Carr J's decision to reject the application for an interim injunction appears to have stemmed from the nature of the proposed limited "test run" launch by Edwards. The matter may have been decided differently in the event that Edwards were proposing a full commercial launch, in which case Carr J acknowledged the damage to Evalve may be considerably greater.
Finally, Carr J also sends a warning to parties to think very carefully when applying for interim injunctions. In particular, parties should be mindful of the costs associated with preparing evidence which may go to balance of convenience factors. In this case, evidence on the technical differences between PASCAL and MitraClip was filed on the issue of whether PASCAL is clinically superior, which would be relevant to the public interest in having access to it. The merits of this argument were not ultimately considered given Carr J's conclusions on irreparable harm and on the balance of convenience factors. In light of this, when considering costs of the application, Carr J allowed a significant deduction to the costs owed to Edwards to account for this evidence, which was estimated to be in the order of six figures.
Final injunction granted against an unwilling licensee with three months to patent expiry
TQ Delta LLC v ZyXEL Communications Ltd  EWHC 745 (Pat)
Following a technical trial in which one of TQ Delta's patents was found to be valid and infringed, but prior to the RAND trial (RAND refers to 'Reasonable And Non-Discriminatory', effectively equivalent to FRAND), Mr Justice Carr considered whether an injunction should be granted against ZyXEL.
Although it had been found to infringe a valid patent, ZyXEL argued that the grant of an injunction was not proportionate on the basis that only three months remained until expiry of that patent. In the alternative, it sought carve-outs to fulfil certain outstanding orders.
Carr J considered whether the grant of an injunction would be disproportionate but felt that to deprive the patentee of injunctive relief would be unjust. In reaching this decision he considered ZyXEL's 'hold-out' behaviour, whereby it had stretched out licensing negotiations with TQ Delta in order to avoid being forced to take a licence for TQ Delta's patent portfolio. He also considered that ZyXEL's refusal to undertake to submit to the Court's determination of an appropriate RAND royalty rate was a further example of unreasonable behaviour on its part.
In considering whether a carve-out should be granted to fulfil certain customer orders, Carr J held that there was no real evidence before him of prejudice, or even inconvenience, to those customers. In the absence of such evidence, Carr J held that there was no real basis for ZyXEL's proposed carve-out.
In refusing permission to appeal his judgment, Carr J also noted that: to refuse an injunction in these circumstances would amount to a compulsory licence of the patentee's exclusive rights in circumstances where ZyXEL had elected not to enforce TQ Delta's RAND undertaking, depriving it of meaningful protection; and "whether to grant an injunction in these circumstances is an
PATENT AND PHARMA UPDATE
exercise of discretion, from which it is difficult to appeal". This is a further warning to any infringer that resisting a final injunction once granted may be an uphill struggle.
Andrew Wells, Senior Associate, Julie Chiu, Associate (Australia) and David Webb, Associate London
3. Updates from France French law update on statutes of limitation
The French legislature initially planned in 2018 to have the following provisions enter into force on the same date as the Unitary Patent Court ("UPC"). However, French Law provision No. 2019-486 has now entered into force on 24 May 2019 prior to commencement of the UPC.
According to these provisions, firstly, no statute of limitation applies to a nullity action initiated against a patent in force as of 23 May 2019. In other words, the debate as to whether a nullity action can be time-barred in France for being initiated belatedly comes to an end, unless the action was already time-barred when these new provisions came into force on 24 May 2019.
Secondly, the statutory limitation period for initiating an infringement action remains 5 years, but the starting point for this period has been amended. Until 23 May 2019, "the infringement action [was] time-barred 5 years after the facts in suit"; in other words, acts of infringement committed more than 5 years before the initiation of the infringement action were time-barred. From 24 May 2019, and unless the acts of infringement were already time-barred on 23 May 2019, "the infringement action is time-barred 5 years as from the date the right holder is aware or should have been aware of the last fact allowing him to initiate such action"; in other words, and although there is obviously very limited guidance at this stage on how it will be applied by French courts, the obvious intention of the French legislature seems to be to avoid situations where acts of infringement become time-barred because the patentee was unaware of the existence of an infringement. Finally, for acts of infringement which were not timebarred on 23 May 2019, the new mechanism applies but the calculation of the 5 year limitation period will take into account the time period that has already elapsed.
In a French case concerning a biosimilar of HUMIRA, the President of the Paris First Instance Court dismissed the patentee's claim for an interim injunction based on the exception of prior personal possession of the invention (Paris First Instance Court, 14 February 2019, Fresenius Kabi Deutschland GmbH v. Amgen SAS).
Fresenius Kabi Deutschland GmbH ("Fresenius") holds EP 3 145 487 with a priority date of 23 May 2014, relating to a formulation of an adalimumab-based pharmaceutical composition. Fresenius enforced this patent in interim injunction proceedings against Amgen SAS (the French affiliate of Amgen, Inc.), which markets the biosimilar in suit, produced by Amgen Europe BV.
Amgen SAS raised the exception of prior personal possession of the invention, which requires that four conditions be met: (i) the alleged infringer must have possessed the technology before the patent application or priority date; (ii) said technology must be identical to the patented invention; (iii) the possession must take place in France although there is no requirement that the invention had been exploited; and (iv) the alleged infringer must have acted in good faith.
In the present case, the President of the Court ruled that Amgen, Inc. had filed an application for authorisation to carry out clinical trials on its biosimilar of HUMIRA "ABP501" before the French Health Agency on 13 August 2013. This filing included a protocol and a dossier specifying the formulation of Amgen's experimental product ABP501 which corresponds to the "essential features of the patented invention in the enforced claims 1 to 15 and notably 13 [of Fresenius' patent]."
In this respect, the French Judge ruled that "given the specific functioning of the Amgen group, it seems reasonable to consider, moreover in summary proceedings, that Amgen SAS, like the other European subsidiaries of the group, had direct access to the clinical trials document and therefore to the formulation of biosimilar product ABP501 by means of the group's "EPIC" platform, and so as from March 2013, some of the tests having in addition been carried out in France. It must therefore be considered that the possession of the formulation identical to that patented, although originating in the United States, has actually taken place in France".
Considering that this possession took place before the priority date and that no bad faith argument was raised by Fresenius, the interim injunction was dismissed on the ground of a serious challenge to the likely infringement of Fresenius's patent.
For the sake of completeness, the French Judge added as a supplementary argument that Fresenius's patent seemed to lack novelty based on a US patent published on 27 March 2014, such that the interim injunction was also dismissed on the ground of a serious challenge to the validity of the patent.