ADVOCATE GENERAL PROVIDES OPINION ON THE INTERPRETATION OF ARTICLE 3(A) SPC REGULATION

Advocate General Wathelet (the “AG”) has provided his opinion to the Court of Justice of the European Union (the “CJEU”) on the interpretation of Article 3(a) SPC Regulation (Case C-121/17 Teva v Gilead). In doing so, the AG rejected the suggestion of the English referring court that the concept of the “core inventive advance” was a relevant consideration in determining whether a basic patent protects an active ingredient within the meaning of Article 3(a).

In his view, the means of determining whether a basic patent protects an active ingredient within the meaning of Article 3(a) is to be found only in the wording, or interpretation of the wording, of the claims of the granted patent, and nowhere else. A product is protected by a patent in accordance with Article 3(a) of the SPC Regulation if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the claims of the basic patent. In the case of a combination of active ingredients, each active ingredient in that combination must be specifically, precisely and individually identifiable in the wording of the claims of the basic patent.

1. Business Impact

  • This non-binding opinion is of interest to all stakeholders in the pharmaceutical industry. It is the latest in a line of pronouncements from the CJEU in which the interpretation of Article 3(a) of the SPC Regulation has been discussed.
  • This opinion is of interest in that it rejects the “core inventive advance” test that has previously been proposed by the English Courts.
  • Whilst the opinion is non-binding on the CJEU, if the CJEU were to follow the reasoning of the opinion in its decision, the validity of an SPC in subsequent national proceedings would depend on the facts before the national court as to whether it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the claims of the basic patent.
  • The CJEU’s decision is expected in the coming months and it will be interesting to see if that decision will be broad enough to dispose of two other pending references on the interpretation of Article 3(a) that have been referred by the English Court of Appeal and German Federal Patent Court.

2. Background

Gilead’s UK SPC covers pharmaceutical compositions comprising the combination of tenofovir disoproxil and emtricitabine, a preferred “backbone” of active ingredients for the treatment of HIV. Such products include Gilead’s blockbuster anti-HIV treatments TRUVADA® and ATRIPLA®.

In 2016, Teva, Generics UK (t/a Mylan), Accord and Lupin commenced proceedings against Gilead in the High Court of England and Wales. They sought to revoke the SPC on the basis that the product the subject of the SPC is not protected by the basic patent.

Mr Justice Arnold delivered his judgment in January 2017. He found he was unable to decide on validity of the SPC on the basis of the existing CJEU case law and he therefore referred a single question to the CJEU: “What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?” (Case C-121/17).

The case was heard before 15 judges of the Grand Chamber of the CJEU on 20 February 2018, reflecting the importance of the question.

3. The AG’s Opinion

Advocate General Wathelet delivered his opinion on 25 April 2018. The AG considered the line of CJEU cases dealing with Article 3(a) SPC Regulation since the key 2011 decision in Medeva.

As part of his considerations, the AG rejected the suggestion of the referring court that the concept of the “core inventive advance” was a relevant consideration in determining whether a basic patent protects an active ingredient within the meaning of Article 3(a).

In his view, determining whether a basic patent protects an active ingredient within the meaning of Article 3(a) is to be found only in the wording, or interpretation of the wording, of the claims of the granted patent, and nowhere else. A necessary starting point for determining this is whether a substance or combination of substances falls within the scope of protection of a patent, in particular under Article 69 of the EPC and the Protocol on its interpretation and the provisions of relevant national law.

The AG’s conclusion was that a product is protected by a patent in accordance with Article 3(a) of the SPC Regulation if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the claims of the basic patent.

The AG’s opinion is not binding on the CJEU and it is not certain that the CJEU will follow the same reasoning when it decides the case in the coming months. However, if the CJEU does adopt the AG’s opinion, it will be for the national courts to determine the validity of the SPC at issue, based on the facts before them as to whether it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the claims of the basic patent.

It will be interesting to see if the CJEU’s decision will be broad enough to dispose of the two other pending references on the interpretation of Article 3(a): one referred by the English Court of Appeal (Case C-650/17 Sandoz v Searle), and the other referred by the German Federal Patent Court (Case C-650/17 Royalty Pharma/Sitagliptin).

Author

Sebastian Moore
Sebastian Moore
Partner
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Alex Freelove
Alex Freelove
Senior Associate
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Julian Gauld
Julian Gauld
Senior Associate
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+44 20 7466 7453

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The UK ratifies the Unified Patent Court Agreement on World IP Day

The UK has ratified the UPC Agreement today, 26 April 2018, which also happens to be World IP Day.

The UK IP Minister announced the ratification at a World IP Day event at the House of Commons this afternoon. It seems that the UK Government has listened to the many representative groups in the Patent arena who suggested that being part of the new system prior to Brexit was preferable to trying to join it post-Brexit.  Now we need to wait to see if the German constitutional challenges can be resolved before the end of March next year.

The UK, along with France and Germany, is one of three signatory states which must ratify before the Agreement can come into force. France ratified long ago (2014), so German ratification is all that is now needed. Ratification by Germany has been held up by challenges to the legislation which was passed to allow Germany to ratify in both the Bundestag and the German Constitutional Court. Neither has yet been resolved.

15 other countries have already ratified the UPC Agreement. Once Germany ratifies, the Agreement will come into force on the first day of the fourth month after the month of that last required ratification. Assuming the constitutional challenges fail, German ratification will likely be timed to coordinate with the new Unitary Patent Court being ready to operate. Once in effect, the UPC court will operate across all current EU states except Croatia, Poland and Spain which have not signed up to the Agreement. A European patent with unitary effect (otherwise known as a unitary patent) will be available, covering all the participating states, once the UPC is established. Unitary patents will be enforced through the UPC which will also have jurisdiction over European patents which have not been opted out of the new system.

For more on the UPC Agreement including the other states which have ratified already see the UPC Agreement section of our UPC hub (www.hsf.com/upc).

Authors

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

 

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CONSULTATION ON THE DRAFT TRADE SECRETS (ENFORCEMENT, ETC) REGULATIONS 2018

The Trade Secrets (Enforcement, etc.) Regulations 2018 (the “Regulations”) are intended to be in force by 9 June 2018 to transpose Directive (EU) 2016/943 (the “Directive”) into UK law. The UK IPO is in the process of consulting on the proposed Regulations.

Summary:

  • The UK already has well-developed legal protection for trade secrets (either in common law, statute or by means of court rules), therefore the Directive does not require substantial changes to be made to UK law.
  • Changes mainly concern limitation periods, procedural issues for the courts when hearing cases on breach of confidence in relation to trade secrets and certain remedies.
  • Although the EU has largely adopted UK law concepts the changes will be more radical in some other EU jurisdictions. The aim of the Directive is to create a level playing field for enforcement by harmonising this area of law.
  • Certain provisions of the language proposed for the Regulations differ from that used in the Directive.  In addition, it is proposed that some parts of the Directive will not be transposed and it is not clear why this is the case.  If this approach is adopted, it may lead to a lack of clarity in the UK law on trade secrets.

Business Impact:

  • Greater protection for a business trade secrets and a common approach to enforcement is to be welcomed across the EU.  Trade secrets are increasingly important in protecting valuable information and technology, especially where the other forms of IP protection like patents may not be available or appropriate.

Read more on the proposed regulations on trade secrets.

 

Authors

Joel Smith
Joel Smith
Head of IP - UK
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Clare Blendis
Clare Blendis
Senior Associate, London
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+44 20 7466 2165

 

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Targeting Online Risk

In our latest publication in our Future of Consumer series on issues facing the Consumer sector, we look at some of the online risks threatening businesses today.

We examine the options available to tackle IP infringements online, such as the sale of counterfeit goods, with a focus on the most powerful weapon for rights holders – blocking junctions from the courts. We also provide some practical tips to help tackle and combat online infringements.
Authors

Joel Smith
Joel Smith
Head of IP - UK
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+44 20 7466 2331
Sarah Burke
Sarah Burke
Senior Associate, London
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+44 20 7466 2476

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Filed under Advertising, AI, Augmented reality (AR), Consumer products, Copyright, Counterfeiting, Databases, Designs, EU, Format rights, Media, Passing Off, Technology, media & telecommunications, Trade marks & Passing-off, UK, Virtual reality (VR)

UK Government agrees elements of the European Commission’s proposals for post-Brexit protection of EU-wide IP rights in the UK in the latest draft of the Withdrawal Agreement

In the latest draft of the Withdrawal Agreement (19 March 2018) the UK Government and European Commission negotiators appear to have agreed text providing for the replacement of EU-wide IP rights having effect in the UK with equivalent UK rights at the end of the transition period post-Brexit (until 31 December 2020). Further, during the transition period, EU-wide rights will still apply to the UK due to the effect of Article 122 which provides that EU law will be applicable to the UK during the transition period and that it will produce the same legal effects in respect of and in the UK as those which is produces within the EU and its Member States and shall be interpreted and applied in accordance with the same methods and general principles, and that during the transition period, any reference to Member States in EU law shall be understood as including the UK.

Other IP related measures include provision for dealing with: exhaustion of rights, pending applications, international registrations designating the EU and the effect of invalidity proceedings that are “on foot” at the end of the transition period, (see Articles 50-57).  Certain provisions (highlighted in green) are now listed as agreed between negotiators, whilst others are still just proposals from the Commission (those un-highlighted) including those on GIs, SPCs and who pays the administration costs involved.

There are still unresolved issues for those who hold IP rights in the EU and those who license (in or out) EU-wide IP rights or have agreements linked to the “EU” as territory, which we discuss below.

Despite the areas of current agreement, there remains the possibility of a “no deal” scenario in relation to the whole agreement, in which case none of the areas agreed would stand (although the UK Government could make separate arrangements to create equivalent rights at the moment of Brexit). Anything agreed between the Commission and the UK under the Withdrawal Agreement needs European Council approval and then European Parliament approval. Thus, although a good start has been made on agreeing the post-Brexit fate of EU-wide IP rights currently having effect in the UK, the final arrangements are still far from certain. Indeed, if the Withdrawal Agreement is not accepted then there will be no transition period at all and a “hard” Brexit will come into effect on 30 March 2019, with all that implies for IP rights (see our comments from January 2017 here).

In summary, the proposals in the revised Withdrawal Agreement, and problems associated with them, are:

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Filed under Agribio, Agribusiness, Brexit, Consumer products, Copyright, Counterfeiting, Databases, Designs, EU, GIs, Licensing, Patents, PDOs, Pharma, SPCs, The Unified Patent Court and the Unitary Patent, Trade marks & Passing-off, Transactions, UK

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
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+44 20 7466 2331
Rachel Montagnon
Rachel Montagnon
Professional Support Consultant, London
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+44 20 7466 2217

 

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Filed under 3D printing, Advertising, Agribio, Agribusiness, AI, Augmented reality (AR), Consumer products, Copyright, Counterfeiting, Databases, Designs, Energy, EU, Format rights, GIs, Licensing, Media, Passing Off, Patents, PDOs, Pharma, SPCs, Technology, media & telecommunications, Threats, Trade marks & Passing-off, Trade secrets, Transactions, UK, Uncategorized, Virtual reality (VR)

Advocate-General opinion sets the bar high for establishing infringement of the registered geographical indication ‘Scotch Whisky’ by the use of ‘Glen’

Certain geographical indications (“GIs“) are protected by EU Regulation 110/2008/EC, which aims to ensure that use of such indications is to identify a spirit drink as originating within a certain territory where a given characteristic is attributable to its geographical origin. In the case of The Scotch Whisky Association, The Registered Office v Michael Klotz, the Advocate General has provided guidance, for the first time, on the extent to which a protected geographical indication (being ‘Scotch Whisky’) with no similarity, either phonetic or visual, with a designation (being the term ‘Glen’), may nevertheless be infringed by that indication.

The Advocate General’s opinion states that the use of ‘Glen Buchenbach’ on the label of a whisky produced by a distillery located in Germany is: (1) not unlawfully ‘indirectly using’ ‘Scotch Whisky’ unless ‘Glen Buchenbach’ is identically or phonetically and/ or visually similar to ‘Scotch Whisky’; and (2) not unlawfully evoking ‘Scotch Whisky’ unless, when the average European consumer is confronted with the term ‘Glen’, the image triggered in his mind is that of ‘Scotch Whisky’.

The Scotch Whisky Association had taken issue with Mr Michael Koltz’s use of the term ‘Glen’ alongside the word ‘Buchenach’ (a valley) on the labels of the German-produced whisky. The whisky labels included the address in Germany where the whisky was produced. However, such additional information is not necessarily to be taken into account when looking to establish the existence of a prohibited ‘evocation’, nor a ‘false or misleading indication’, the Advocate- General opined.

The Court of Justice will deliver its judgment later in the year hopefully, but the Advocate General has set the bar high for infringement of a GI.

A link to the decision can be found here.

Author

Jessica Welborn
Jessica Welborn
Associate
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Dyson argues against unfair and misleading labelling comparison by competitor

Compulsory energy labels on vacuum cleaners must strictly comply with an EU Labelling Regulation. In the case of Dyson Ltd, Dyson BV v BSH Home Appliances NV (C-632/16), the Advocate General of the EU Court of Justice held that there is no leeway within energy label regulations regarding the format or content of energy labels. This means that energy labels must contain only the classification of a vacuum cleaner’s energy consumption as required by the Regulation, and cannot specify the conditions under which the energy tests were performed. In addition, supplementary labels clarifying the information further are not acceptable.

Dyson brought this action against BSH, arguing that BSH’s energy labels were misleading consumers in breach of the Unfair Commercial Practices Directive 2005/29/EC, because they did not explain BSH’s tests were carried out with an empty dust bag. Dyson’s own products do not have a dust bag, and so there is no loss of energy efficiency during normal conditions of use. However, BSH’s vacuums do have a dust bag—and therefore Dyson argued become more energy inefficient the more the dust bag is filled. Dyson sought to force BSH to specify its testing conditions on its energy labels, or for its current energy labels to be declared misleading.

The Advocate General found that the specific, standardised information selected to be provided to consumers was a deliberate choice by the EU Legislature. The methodology for measuring energy efficiency of vacuum cleaners is not included in the information to be provided to consumers. Therefore, BSH cannot be required to include additional test procedures on its labels and it is not necessary to consider whether BSH’s current practice is misleading. He concludes that the Unfair Commercial Practices Directive does not apply in situations where a Regulation provides no lee way for the traders involved.

Dyson will have to wait to see if the Court of Justice leaves the competition in the dust.

A link to the decision can be found here.

Author

Emma Sherratt
Emma Sherratt
Associate (New Zealand)
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+44 20 7466 2385

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Filed under Consumer products, EU

“Two stripes are enough” – adidas succeeds in opposing competitor’s 2 stripe trade mark application on basis of its 3 stripe registration

The similarity between a two stripe design for shoes and adidas’ earlier trade mark for its renowned three stripe shoe, combined with adidas’ significant reputation in that mark, means that adidas can oppose the two stripe application for use on shoes, as there is a substantial risk that the use of the two stripe mark being applied for is taking unfair advantage of the reputation of adidas’ mark.

This decision by the EU General Court on 1 March 2018 (cases T-85/16 and T-629/16) is a reminder that the courts will take a strict view on trade mark applications that sail too close to famous marks.  In this case, the General Court was particularly scathing of a 2007 advertising campaign used once by a licensee of Shoe Branding Europe, which featured the slogan “Two stripes are enough”.  The General Court considered this as evidence of the risk of unfair advantage being taken of the repute of the adidas mark by Shoe Branding Europe.  Care must be taken by brand owners not to engage in, and to ensure that any licensees do not engage in, marketing campaigns that could be misconstrued as taking advantage of, or seeking to trade on, the repute of a similar earlier mark.

The decision also suggests that any use of the two stripes by Shoe Branding will likely be infringing, given the findings of the General Court in relation to registration and the similarity of the tests for trade mark infringement. Last year, adidas sued Puma in relation to the latter’s use of four stripes on sports footwear.

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Supreme Court considers the role of plausibility in UK patent law

This week the Supreme Court is hearing an appeal in Warner-Lambert v Generics (UK) Ltd (Mylan) and others (UKSC 2016/0197) which will consider the following questions relating to the role of plausibility in UK patent law:

  • “Whether (and what) role plausibility should play in the statutory test for sufficiency, and whether a patent should be held insufficient for lack of plausibility even though it is in fact enabled across the full scope of the claim.”
  • “If a plausibility test is appropriate, provided there is basis to support the claim across part of its scope, whether later evidence can be used to fill the gap.”

“Plausibility” has been an increasingly hot topic in patent litigation in recent years, particularly in cases relating to pharmaceuticals, and its rise has not been without controversy amongst patent lawyers.  It has most frequently been associated with inventive step and insufficiency, but it has also come up in relation to industrial applicability, priority and novelty and it is now a firmly established concept for any lawyer considering the validity of a patent.

What is required for something to be “made plausible” has been considered by the Supreme Court before (HGS v Lilly (2011), in which it was found to be a low, threshold test) but that was in the context of industrial applicability.  This appeal to the Supreme Court asks the fundamental question of whether (and what) role plausibility should play in the statutory test for sufficiency.  The Court of Appeal has accepted that plausibility plays a role in sufficiency (and inventive step), based on EPO Technical Board of Appeal case law relating to both inventive step and insufficiency, combining it with English law relating to principles of general application.  It will be particularly interesting to see how the Supreme Court approaches this question, given the firmly established case law in the EPO on this issue.

Fundamentally, this is a question about what is required of a patentee at the time they file a patent application – is it enough for them to speculate in the specification on a possible use for the claimed compounds, in the hope that that speculation will later turn out in fact to be true (if it is not, the claim will be insufficient anyway), or should public policy require that the patentee at least provides some real reason for believing that the proposed use is true at the time of filing, to prevent patentees from excluding others from large areas of research in the hope that active compounds turn up one day?  The answer to that question has potentially significant ramifications for patentees, both in terms of what they need to be including in future patent applications by way of reasoning and/or data (which may affect the stage of the R&D process at which they are able to file them) and in considering the validity of their existing patents.  It is interesting that the UK BioIndustry Association has intervened in the case – more details on their position can be found here.

It’s worth noting that as well as the plausibility questions being considered, the Supreme Court will also hear argument on questions regarding expert evidence on claim construction and abuse of process in relation to late claim amendments, the answers to which may have effects on routine practice in the Patents Court.

Authors

Andrew Wells
Andrew Wells
Senior Associate
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+44 20 7466 2929

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