The Trade and Cooperation Agreement and its impact on IP, Pharma and Medical Devices

The final Brexit agreement, the Trade and Cooperation Agreement (the “TCA”) was agreed between the UK and the EU on 24 December 2020. Within this agreement are provisions that set out the standards expected to be recognised (mutually) between the EU and the UK in relation to intellectual property (including SPCs and trade secrets). There are some provisions concerning pharmaceutical regulation and product standards, but overall there is a lack of mutual recognition, with the consequence that, for both pharmaceuticals and medical devices, there are now effectively two separate regimes for the EU and the UK.

Intellectual Property

The provisions on IP match or exceed those for IP set out in the various treaties to which the UK and EU have acceded (such as WIPO, WTO and TRIPS agreements).  These IP standards are to be maintained as a minimum. The cited objectives and scope in relation to intellectual property (see Title V) indicate the aims behind these provisions which are to:

(a) facilitate the production, provision and commercialisation of innovative and creative products and services between [the UK and the EU] by reducing distortions and impediments to such trade, thereby contributing to a more sustainable and inclusive economy; and

(b) ensure an adequate and effective level of protection and enforcement of intellectual property rights.

The provisions are intended to “complement and further specify the rights and obligations of each [of the UK and the EU] under the TRIPS Agreement and other international treaties in the field of intellectual property to which they are parties” and do not “preclude either [the UK or the EU] from introducing more extensive protection and enforcement of intellectual property rights than required under [this section of the TCA] provided that such protection and enforcement does not contravene [those provisions]”. However, there are aspects of current UK and EU IP law, such as the dilution provisions in trade mark law, to which the agreement does not refer, instead referring to the Paris Convention provisions on the protection of well known marks. Whether this will be a point of future divergence remains to be seen.

Both the UK and the EU also have the ability to develop their own exhaustion regimes. The provisions on geographical indications (“GIs”) indicate that a mutual future scheme has not be agreed although a review clause on GIs has, which provides that the UK and EU may (if both parties agree it is in their interests) use reasonable endeavours to agree rules for the protection and domestic enforcement of their GIs.

The UK Government’s Summary document that accompanies the TCA (see here) states that the agreement “includes mechanisms for cooperation and exchange of information on IP issues of mutual interest” and “retains regulatory flexibility for each [of the UK and the EU], enabling the UK to develop an IP system in line with [its] domestic priorities“, thus enabling the UK to diverge where it so requires.

We have already commented on the changes to the UK IP regime in the firm’s guide to Brexit here (see the IP section).

The Regulation of Medical Devices and Medicinal Products

Medical devices: The TCA has a chapter (4) (under Trade – Title I) on eliminating unnecessary technical barriers to trade which deals with conformity of standards. However, this only provides for an approach under which each party can agree that its standards bodies (including those relating to medical devices) will conform with international standards and will work together to influence those and to “foster bilateral cooperation with the standardising bodies of the other Party“.

For medical devices, it had been hoped that there would be at least mutual recognition of conformity assessment under which each of the EU and the UK would recognise the other’s certification bodies. However, as things stand, although Great Britain will continue to accept CE marked medical devices until 30 June 2023 those devices certified by the UK and marked as UKCA (standing for UK Conformity Assessed, as discussed in more detail in our post here), will not mutually recognised by the EU.

Medicinal Products: For medicinal products there is a dedicated annex in the TCA, Annex TBT-2 – Medicinal Products (the “Medicinal Products Annex”), which applies to all medicinal products listed in its Annex C, namely:

  • marketed medicinal products for human or veterinary use, including marketed biological and immunological products for human and veterinary use,
  • advanced therapy medicinal products,
  • active pharmaceutical ingredients for human or veterinary use,
  • investigational medicinal products,

with this list being subject to amended by the UK-EU Partnership Council (the main governing body for the agreement and supplementing agreements).

The aim of the Medicinal Product Annex is to “facilitate availability of medicines, promote public health and protect high levels of consumer and environmental protection in respect of medicinal products”.  To help achieve this aim, the Annex provides for:

  • the mutual recognition of Good Manufacturing Practice (“GMP”) inspections and certificates, meaning that manufacturing facilities do not need to undergo separate UK and EU inspections;
  • the individual inspection, on notice, by the EU or UK of each other’s facilities); and
  • for the suspension of the mutual recognition arrangements.

Further, the TCA also states that the EU and the UK should work together to implement agreed international guidelines and that any changes to either the UK or the EU’s regulation regime should be on 60 days’ notice and be subject to discussion by a Working Group on Medicinal Products, which will be established to enable mutual consultation. This Working Group on Medicinal Products will be under supervision of the Trade Specialised Committee on Technical Barriers to Trade, and will monitor and review implementation and ensure the proper functioning of the Medicinal Products Annex. It is noteworthy that the Medicinal Products Annex is specifically excluded from the TCA’s disputes mechanism, however, through its role in facilitating discussions and functioning as an appropriate forum for issues relating to Medicinal Products, it is hoped that it will be a sufficient mechanism to deal with any concerns.

When considering the confidentiality of information supporting applications for marketing authorisations (“MAs”), regulatory protection of pharmaceutical products, and Supplementary Protection Certificates (“SPC”) it is noteworthy that this is not included in the Medicinal Products Annex, but is included in the IP section (Title V) of the TCA.

  • In relation to regulatory data protection generally, the TCA requires that both the UK and the EU ensure that commercially confidential information submitted to obtain an MA is protected against disclosure to third parties, unless there is an overriding public interest or steps are taken to ensure the data is protected from unfair commercial use.
  • For the regulatory protections of data and market exclusivity, the TCA provides that, subject to any international agreement to which both the EU and the UK are party, and without prejudice to any additional periods of protection which either party may wish to provide for in its domestic law, these regulatory protections will be “for a limited period of time to be determined by domestic law”. This allows each of the UK and the EU to determine the length of such regulatory exclusivities under their own regulatory regimes.
  • For SPCs, the TCA records the agreement of both the UK and the EU to provide for further patent protection to compensate for the impact of regulatory administrative procedures but, again, the length of time is not stipulated.

The effect of these provisions is that they provide some comfort that these valuable forms of protection for medicinal products will be maintained by both the UK and the EU.

For detailed commentary on the new regulatory position for Pharma in the UK, and the impact on IP rights generally, see our series of posts on the HSF Intellectual Property Notes blog here.

Other provisions relevant to the pharmaceutical and medical device industry

The TCA also has provisions relating to the UK’s continued participation in EU programmes and on UK / EU cooperation on “serious cross-border threat[s] to health that are relevant for the pharmaceutical industry.

  • Subject to the UK making financial contributions, Part 5 of the TCA includes agreement on the UK’s continued participation in EU programmes, including the EU’s research and innovation funding programme, Horizon Europe.
  • UK / EU cooperation on serious cross-border threat[s] to health is covered by the TCA including agreement between the UK and the EU on emergency relief in relation to importation requirements, tax and road transport exemptions, and agreement to cooperate in relation to international health security systems.

Future developments

Although tariff free and quota-free trade has been agreed, there is little mutual recognition of regulatory provisions. This may not be the end of negotiations, with automatic reviews every 5 years written into the TCA and termination possible on 12 months’ notice.  See the HSF Brexit blog for further information, and the updated Intellectual Property section of our Beyond Brexit Legal Guide is now available, in which we look at the impact of the end of the Brexit transition period on:

  • EU trade mark rights
  • Community design rights
  • Patents & SPCs
  • Copyright
  • Designs
  • .eu Domain names
  • Plant variety rights
  • sui generis database rights
  • Exhaustion of IP rights
  • Licensing
  • Disputes

Key contacts and authors

Jonathan Turnbull

Jonathan Turnbull
Partner, London
+44 20 7466 2174

Rachel Montagnon

Rachel Montagnon
Professional Support Consultant, London
+44 20 7466 2217

George McCubbin

George McCubbin
Senior Associate, London
+44 20 7466 2764

Priyanka Madan

Priyanka Madan
Associate - London
+44 20 7466 2986

As the Bundestag passes the legislation to ratify the UPC Agreement, the UPC may finally open its doors in 2022

The Unified Patent Court (UPC) took another step closer to coming into being on November 26 with a Bundestag vote passing the legislation necessary for Germany to ratify the UPC Agreement and the Protocol on Provisional Application with (more than) the two thirds majority found to be required by the German Federal Constitutional Court in its decision rejecting the initial vote on these measures as unconstitutional for lack of sufficient majority (decision dated 13 February 2020, announced 20 March 2020).

German ratification – next steps and any further challenges?

Germany is the last required ratifier of the UPC Agreement (UPCA).  Ratification by at least 13 contracting states is required for the UPCA to enter into force, additionally this must include the “three States in which the highest number of European patents was in force in the year preceding the year in which the signature of the Agreement takes place”. With UK having withdrawn, those three countries are France, Germany and Italy. So far 15 contracting Member States have ratified, including France and Italy (see the ratification table here) so Germany’s ratification is the last piece of the jigsaw for the UPCA to come into force.

The legislation will now be submitted to the German upper house (Bundesrat) where approval is expected to take place on December 18. The next steps after that are a countersignature by the Federal Government (a formality) and the signature of the Federal President (so-called “Ausfertigung” or legalization). This is followed by the publication in the Federal Law Gazette, by which the law enters into force, allowing the Federal Government to deposit the ratification of the UPCA and sign the Protocol.

In the first German ratification attempt the Federal President did not sign because a constitutional challenge had been filed after the Bundesrat vote and the Constitutional Court asked the Federal President to delay his signature to await the outcome of the challenge, which in the end was successful based on the majority vote issue.

A “Foundation for a Free Information Infrastructure” (FFII) has following the Bundestag vote started a crowd-funding campaign for a new constitutional challenge. However, unless the FFII or others started preparation a while ago it seems highly unlikely that such a challenge could be filed before the law enters into force. Further, it seems unlikely that the Constitutional Court will once again ask the Federal President to delay his signature.

In addition, even though the Constitutional Court referred in its decision to a number of issues as relevant but either not substantiated enough in the constitutional challenge or not necessary to decide due to the successful majority challenge, it appears unlikely that any further challenge would succeed.

Once the German ratification is deposited, the UPC will commence on the 1st day of the fourth month after the month of the deposit of instrument of ratification. Germany is expected to delay the deposit of its ratification of the UPCA until the UPC has become fully operational during a period of provisional application as explained further below.

The UPC “Provisional Application” phase

The Protocol on Provisional Application (PPA) provides for a provisional application of the UPCA before the UPCA actually enters into force. As well as ratifying the UPCA, participating states need to sign the PPA, so that the provisional application stage can start.

By signing the PPA, the signatory states agree to apply the institutional, organisational and financial sections of the UPCA provisionally. Once the Protocol enters into force, the UPC organisation (as such) will be created and acquire legal personality. The Administrative Committee, the Budget Committee and the Advisory Committee will be established at the start of provisional application stage and will then take over the responsibility of the preparations from the UPC Preparatory Committee.

The provisional application stage allows the final preparations to be made for the commencement of the UPC in the certain knowledge that it will actually commence. This allows the employment of judges for example, and the finalisation of court preparations. The UPC rules of procedure also need to be finalised during this period.

There is no prescribed time-frame for the provisional application period, however, it is currently expected that it may take approximately 12 months.

In order for the PPA to enter into force, in addition to Germany, two other UPCA contracting Member States still need to sign the Protocol. It is currently envisaged that this could happen by February 2021.

Thus, assuming that the provisional application starts in February 2021 and that Germany deposits the ratification of the UPCA by February 2022, thereby triggering the prescribed period running up to the commencement of the UPC, the UPC could then open its doors on June 1, 2022.

Support for the UPC from the Commission and the EPO

The day before the Budnestag vote, the Commission released its EU IP action plan: Making the most of the EU’s innovative potential – An intellectual property action plan to support the EU’s recovery and resilience (25 November 2020) – see our blog post here. The Commission considers the unitary patent (UP) and the UPC as key to ensure that innovators have access to “fast, effective and affordable protection tools“. The Commission states that once the ratification process is completed, the Commission will work with the EPO and Member States to make the UPC/unitary patent system operational across the contracting EU Member States and will encourage the Member States that have not done so to join the system (Spain, Poland and Croatia).

The EPO President António Campinos responded to the Bundestag vote saying that, the so-called “the Unitary Patent package” (ie the UPC/unitary patent system) “will make Europe even more attractive for innovation and investors – and help with economic recovery in light of the COVID-19 crisis.” He declared that the EPO stands ready to register the first UPs, once the UPCA comes into force. The UPC is the only court in which UPs can be litigated. Campinos expects the UPC to start its work in 2022.

For more on the UPC and unitary patent system see our dedicated hub here.

Authors 

Sophie Rich

Sophie Rich
Partner, Global Head of IP, London
+44 20 7466 2294

Ina vom Feld

Ina vom Feld
Partner, IP, Dusseldorf
+49 211 975 59091

Sebastian Moore

Sebastian Moore
Partner, IP, Milan and London
+39 02 3602 1398

Rachel Montagnon

Rachel Montagnon
Professional Support Consultant, IP, London
+44 20 7466 2217

Jurisdictional tussling: the UK is open for business on FRAND

The recent Supreme Court decision in Unwired Planet v Huawei (see our reporting here and PLC Magazine article here) answered many important questions about the UK court’s approach to FRAND disputes. However, it also left areas of uncertainty, particularly on the issue of jurisdiction. The High Court decision in Philips v TCL ([2020] EWHC 2553 (Ch)), handed down around a month after the Supreme Court’s judgment, confirms that the UK will take an expansive approach to its jurisdiction to determine FRAND licence terms. Indeed, it is unclear under what circumstances (if any) the UK courts will cede jurisdiction to another national court.

Background

Philips commenced proceedings in the UK against TCL on 30 October 2018 for patents it claimed were (and are now accepted to be) essential to the 3G and 4G standards. Its particulars of claim confirmed that it was willing to license those patents on fair, reasonable and non-discriminatory (FRAND) terms.

On 19 February 2019 TCL commenced proceedings in France for the determination of FRAND licence terms under Philips’ undertaking to the European Telecommunications Standards Institute (ETSI). The ETSI undertaking is governed by French law.

On 5 July 2019 Philips served a FRAND statement of case in the UK, setting out what it considered to be FRAND terms. On 19 July 2019 it submitted a written challenge to the jurisdiction of the French court under, inter alia, Articles 29 and 30 of the Brussels I Regulation (EU) 1215/2012 (the “Brussels Regulation”) essentially on the basis that the French and English proceedings had the same cause of action between the same parties and the English court was first seised.

The French court delivered its judgment on 6 February 2020. It rejected Philips’ jurisdictional challenge, confirming that the French courts had jurisdiction to hear the dispute. Philips filed an appeal to that judgment which is due to be heard on 15 February 2021. Judgment in the main French proceedings (assuming the appeal fails) is expected in late 2022 or early 2023, which is after one of the patents in suit in the English proceedings expires.

The decision

On 9 April 2020 TCL issued an application for a stay of “all aspects of [the UK proceedings] concerning [Philips’] FRAND licensing obligations”. The judgment of Mr Justice Mann was issued in relation to that application. In its application TCL asked that the UK proceedings be stayed under Articles 29 and 30 of the Brussels Regulation.

Article 29

Article 29 states that “where proceedings involving the same cause of action and between the same parties are brought in the courts of different Member States, any court other than the court first seised shall of its own motion stay its proceedings until such time as the jurisdiction of the court first seised is established”.

TCL argued that although the English proceedings had been commenced first, the issue of appropriate FRAND licence terms had not arisen until Philips served its FRAND pleadings, which it did after the French proceedings had been commenced. Accordingly, TCL argued that the French courts were first seised with the FRAND licensing issues. A key basis for TCL’s argument was that the French courts had already ruled in favour of French jurisdiction on the basis that the French courts were first seised and so the English court must give effect to that judgment.

Philips, on the other hand, argued that the French court had not decided that it was first seised but rather that the issues in dispute in the two proceedings were different and therefore Article 29 was not engaged. The basis for this interpretation being that the English proceedings concerned infringement of UK patent rights (and the FRAND determination merely arose as a consequence of TCL raising a FRAND defence), while the French proceedings were contractual in nature.

Mr Justice Mann preferred Philips’ interpretation of the French judgment. In particular, he noted that this was consistent with the UK Supreme Court’s characterisation of FRAND proceedings that the key issue in dispute is one of UK patent rights (the FRAND aspects of the proceedings apparently being ignored for the purposes of considering jurisdiction). Accordingly the Article 29 challenge failed at that stage.

Mann J nevertheless went on to consider when the issue of a FRAND licence determination first arose in the English proceedings. His view was that Philips’ original statements of case clearly brought the issue of a FRAND licence determination into play in the UK proceedings. The fact that it later served a specific FRAND statement of case was to further particularise its position on appropriate FRAND licence terms, but it did not raise a new issue in the proceedings. He therefore held that the English court would have been first seised with the FRAND issues if those issues had been the same as those in France.

Article 30

Article 30 states that “Where related actions are pending in the courts of different Member States, any court other than the court first seised may stay its proceedings” where there is a “risk of irreconcilable judgments”.

Given that Mann J had already found that the English court was first seised the Article 30 challenge failed immediately as there was therefore no jurisdiction for it to stay proceedings under Article 30 (because article 30 only applies to courts “other than the court first seised”). Mann J nevertheless went on to consider the position if he were wrong about the English court being first seised.

Following UK Court of Appeal authority, he found that even if the proceedings only became “related” within the meaning of Article 30 at the point when Philips served its FRAND statement of case, the fact that the UK proceedings were commenced first still meant that the English court was first seised and so there was still no discretion to order a stay.

Although not determinative given Mann J’s previous findings, he also considered evidence from Philips’ French law expert that there was serious doubt about whether the French court would in fact determine FRAND terms. Along with that point, he also considered relevant the fact that the English court would be in a position to decide on the issue imminently, while any French judgment would take another two years and, importantly, would be given after expiry of one of the patents in dispute.

Mann J therefore decided that, even if he did have discretion to order a stay under Article 30, he would exercise that discretion against ordering a stay. The only point he considered weighed in favour of the French court determining FRAND terms was the fact that the ETSI undertaking was governed by French law. However, Mann J noted that “English courts are well used to construing foreign contracts, with the aid of evidence from foreign lawyers, and this contract is no exception”.

Analysis

Given this judgment, it is hard to envisage a situation where the English courts would cede jurisdiction to another national court to determine FRAND licence terms where English infringement proceedings are afoot.

Although in this case Mann J found that the UK courts were first seised, he made clear that even if that were not the case then (1) the Article 29 challenge would fail because the issues in dispute in the English and French proceedings were different and (2) he would have exercised his discretion under Article 30 against a stay. Therefore, even where English proceedings are commenced after those in another national courts, it seems possible that the courts will still refuse to stay the English proceedings.

This decision is another example of the English court’s expansive approach to jurisdiction in FRAND cases. It remains to be seen whether there will be any circumstances in which the court will cede jurisdiction. Ultimately, it may then become a question of which national court can give judgment on appropriate FRAND licence terms first and the risk of conflicting judgments is clear.

 

Andrew Moir

Andrew Moir
Partner, Intellectual Property and Global Head of Cyber & Data Security
+44 20 7466 2773

David Webb

David Webb
Associate, London
+44 20 7466 2629

FRAND patent licensing: Supreme Court stays the course

Andrew Moir and David Webb have today published an article about the recent Supreme Court FRAND decision in Unwired Planet in PLC Magazine.

This article first appeared in the October 2020 issue of PLC Magazine.

The article analyses the Supreme Court’s judgment, which provides welcome guidance on the UK’s approach to FRAND licensing, much of which will be welcomed by standard essential patent owners. You can also find an in depth summary of the case in our separate blog post.

Please do not hesitate to contact the authors if you would like to discuss this decision and its implications in more detail.

Andrew Moir

Andrew Moir
Partner, Intellectual Property and Global Head of Cyber & Data Security
+44 20 7466 2773

David Webb

David Webb
Associate, London
+44 20 7466 2629

UK Supreme Court stays the course in Unwired Planet and Conversant – confirming the approach to FRAND adopted by the lower courts

On 26 August 2020 the UK Supreme Court handed down judgment in Unwired Planet v Huawei [2018] EWCA Civ 2344 (the “Unwired Planet Appeal”) and Conversant v Huawei and ZTE [2019] EWCA Civ 38 (the “Conversant Appeal”). The Unwired Planet Appeal concerned the courts’ jurisdiction to determine global FRAND (Fair, Reasonable And Non-Discriminatory) licence terms, the meaning of the ‘non-discrimination’ element of FRAND and an SEP (Standard Essential Patent) owner’s right to an injunction. The issue in the Conversant Appeal was whether England was the appropriate forum to hear such a FRAND case in the circumstances of that case (further explained below). Continue reading

Innovation Disruption and Technology – the legal and commercial issues for your business

Drawing on our practitioners’ experience and understanding of the intellectual property and technology issues facing our clients in the fast changing world in which we all now do business, we made innovation and disruptive technology the key themes at our 2018 IP Update Conference.

Described by one attendee as “The perfect mixture of commercial and legal content”, the event was held in our London offices in February 2018. We were joined by over 140 clients from the Technology, Banking, Consumer, Energy, Manufacturing, Media, Pharmaceutical & Healthcare, and Telecommunications sectors.

Click here for a briefing summarising the legal and commercial issues raised by the Herbert Smith Freehills presenters and our keynote speaker Kevin Mathers, Country Director at Google UK.

Our keynote speaker, Kevin Mathers, set the scene by discussing the current technological landscape for innovation and how Google looks at the future. Taking examples of how artificial intelligence, augmented reality and virtual reality are already being used by Google and looking at the major trends which will dictate our digital future. Kevin’s presentation was a great success, with attendees describing it as “really insightful and inspirational”; “engaging and interesting” and “stimulating and thought-provoking”.

The conference continued with sessions on

  • tackling the impact of AI on your business,
  • on-line risk,
  • open innovation,
  • interoperability and product standards, and
  • targeted advertising and the GDPR.

There was also a panel session at the end of the conference to discuss the issues facing businesses in relation to disruptive technology with contributions from partners and of counsel across the IP and IT practice areas and from several of our European offices.

Clients were impressed by the range of issues presented by the speakers and the practical approaches offered.

 

Joel Smith

Joel Smith
Head of IP - UK
+44 20 7466 2331

Rachel Montagnon

Rachel Montagnon
Professional Support Consultant, London
+44 20 7466 2217

 

First High Court judgment on FRAND royalties

UK Court takes tough stance on party unwilling to take Worldwide licence on FRAND terms.

The UK High Court has handed down its first decision determining FRAND royalties, and has provided clear guidance as to the rights and obligations of parties to licensing negotiations and litigation relating to standard essential patents (SEPs).

In the context of a dispute between patent owner, Unwired Planet, and prospective licensee, Huawei, relating to patents declared essential for various telecommunication standards, the Court has emphasised that FRAND characterises both the terms of a licence and a process by which a licence is negotiated. The Court will be prepared to grant an injunction against a party, such as Huawei, who fails to satisfy the Court of its willingness to take a license on FRAND terms.

The Court also answered many longstanding questions relating to the principles by which FRAND royalty rates are to be calculated. Among other things, the Court has favoured benchmarking using the proportional value of the patentee's portfolio, taking the view that royalty rates should not vary depending on the size of the licensee. It has also rejected the argument that the non-discriminatory requirement of the FRAND undertaking forced the licensor to offer the same or a similar royalty rate or terms as that agreed in any earlier licence with a similar licensee (so-called “hard-edged non-discrimination”).

Some aspects of the decision will no doubt lead to further questions but, overall, the decision demonstrates a willingness of the Court to grapple with, and take a clear position on, complex questions relating to SEPs and FRAND licensing.

The full judgment can be found here

Continue reading