PATENT AND PHARMA UPDATE – November 2017

Key recent developments in the United Kingdom and Europe relating to the patents and pharmaceutical sector. One of the most significant developments in the patent law arena in recent years has been the decision of the Supreme Court in Actavis v Eli Lilly, which has changed the approach to patent infringement in the UK. The update starts by commenting on the new rules of infringement and looks at how subsequent decisions may apply this new test. The case will impact most pharmaceutical sector players, whether they are originators or generics, and may impact the strategy that patentees adopt when litigating in the UK. The update further reports on other significant developments in UK and European law, including a recent TBA decision which elevates the threshold for plausibility and recent references to the CJEU on the SPC Regulation.

1. A new UK approach to infringement: equivalents infringe a patent, but do not anticipate it?

The UK Supreme Court has redefined the UK approach to patent infringement, holding that the scope of protection of a patent extends to “equivalents” of the claimed invention. However, the Patents Court has since held that such equivalents, even if they pre-date the patent, do not anticipate it Read more


2. Plausibility before the EPO and reliance on post-published evidence

BMS has filed a petition for review to the Enlarged Board of Appeal regarding the TBA’s decision to revoke BMS’s patent for the anti-cancer drug dasatinib. The Board’s decision to revoke the patent suggests that the threshold for plausibility has been elevated, at least in the context of an inventive step Read more


3. Further References to the CJEU on Supplementary Protection Certificates (“SPCs”)

The German Federal Patent Court has referred two further issues to the CJEU regarding the interpretation of Article 2 and 3(a) of the SPC Regulation. In relation to Article 2 the Court has asked whether an SPC can be obtained for drug device combination products and, if so, in what circumstances. With regards to Article 3(a) the Court has added further detail to the questions asked by Arnold J in Teva v Gilead Read more


4. New Unjustified Threats Regime in force from 1 October 2017 – encompassing unitary patents and European patents under UPC jurisdiction

The new Unjustified Threats Regime has recently come into force. This Regime is an attempt to encourage more pre-action communication by providing greater clarity on what amounts to an actionable threat Read more


5. Further information ordered to be provided in an enquiry as to damages under a cross-undertaking

Birss J has provided guidance on pleadings for damages under a cross-undertaking. The High Court found the Points of Claim were fundamentally lacking critical information and Sandoz was ordered to provide further information on their substantial £100 million claim for damages, including profit margins on each type of product and profit flows between the relevant Sandoz group companies (under agreed confidentiality terms) Read more


6. UK court strikes out a claim for loss suffered as a result of the tort of unlawful deceit

The High Court has struck out the NHS’s claim for damages based on the tort of causing loss by unlawful means regarding misrepresentations on novelty/obviousness. Roth J’s interim decision represents the latest instalment in the fall-out from Servier’s actions concerning delayed entry of perindopril, and suggests that this tort should be confined within a narrow ambit Read more


7. Judicial consideration of a collaboration agreement in Astex Therapeutics Limited v AstraZeneca AB [2017] EWHC 1442 (Ch), (“Astex”)

Arnold J’s judgment in Astex provides insight into how the Courts will approach the interpretation of a research and collaboration agreement. Arnold J also commented on the amount of witness evidence that was put before him concerning events that had occurred between 10 to 15 years ago Read more


8. Developments in Europe

A brief overview of the developments in the European arena in the past months, including an EU Commission consultation on SPCs, the new approach adopted by EPO to patentability of products obtained by essentially biological processes and how HSF can help you to successfully navigate the new data protection laws Read more


9. UPC Update

This article provides an update on the progress of ratification of the UPCA in the UK and Germany Read more

 

See our previous Patent and Pharma Updates on our IP Blog here:

Patent and Pharma Update – June 2017

Patent and Pharma Update – January 2017

Patent and Pharma Update – May 2016

 

Authors

Sophie Rich
Sophie Rich
Partner
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Jonathan Turnbull
Jonathan Turnbull
Senior Associate
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Monika Klajn
Monika Klajn
Associate
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+44 20 7466 7604
Rachel Montagnon
Rachel Montagnon
Professional Support Consultant
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Filed under EU, Patents, Pharma, SPCs, The Unified Patent Court and the Unitary Patent, Threats, UK, Uncategorized

November UPC Update

In June we gave an update on the progress of the UPC, including the announcement by the UPC Preparatory Committee that the 1 December 2017 start date could not be maintained. We reported on the need for ratification of the UPC Agreement, as well as the UPC Protocol on Provisional Application (the Protocol), by a number of states including the UK and Germany, which are mandatory signatories along with France.

UK

The UK has recently drawn closer to ratification as a result of the International Organisations (Immunities and Privileges) (Scotland) Amendment (No 2) Order 2017 being approved by the Scottish Parliament on 25 October 2017. This order will confer certain privileges and immunities on the UPC and its judges and other staff. As we have reported previously, the equivalent statutory instrument, the Unified Patents Court (Immunities and Privileges Order) 2017 was laid before the House of Commons on 26 June 2017 and is awaiting approval by both chambers of the Westminster parliament. Before this can occur, it must pass through three committees: the Joint Committee on Statutory Instruments (JCSI), the Secondary Legislation Scrutiny Committee and the Delegated Legislation Committee. The members of the JCSI were recently re-appointed (on 31 October 2017), following its dissolution prior to the general election in June this year. It is now up to the JCSI to report on any instance where legislative power has been exceeded or the drafting of the order is defective or requires further explanation.

Germany

There has been some delay to the German ratification of the UPCA, owing to a case pending before the German Federal Constitutional Court (FCC) regarding the law passed by German Parliament on its implementation. The German court has asked for observations on the case and had previously set a deadline for any comment by end of October 2017 – though it has been reported that this has now been extended to the end of the year. The FCC will then determine whether or not to dismiss the complaint, a process which is expected to take until at least April 2018. If the complaint is dismissed, Germany will be able to ratify the UPCA soon after. There has, however, been talk of the possibility of the case being referred to the Court of Justice of the EU (CJEU), which would cause substantial delay to the case being decided and ultimately to Germany’s ratification.

Overall, according to the latest update on the UPC website, published on 21 September 2017, while good progress has been made, “[i]t is now difficult to predict any timeline”.

 

For more information and analysis see our UPC and unitary patent hub here.

Author

Katie Pryor
Katie Pryor
Senior Associate
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Filed under EU, The Unified Patent Court and the Unitary Patent, UK

UK HIGH COURT RULES ON COPYRIGHT PROTECTION OF TV FORMATS FOR GAME SHOWS

Summary

The High Court of England and Wales decided on 19 October 2017 that a particular television format document did not qualify for copyright protection as a dramatic work as its contents were unclear and lacking in specifics. Copyright protection has been notoriously difficult to obtain in respect of TV formats and the case contains useful guidance on the way television formats should be recorded or expressed in order to stand a chance of being protected by copyright as dramatic works. The High Court also considered that the TV format document was too vague and insufficiently developed to be protected as confidential information (Banner Universal Motion Pictures Limited v Endemol Shine Group Limited & others).

Business Impact

  • The decision acts as a warning for TV format developers that generalised commonplace game concepts, even if they are supported by specific examples, will likely fall short of the requirements for copyright protection as dramatic works.
  • Television producers who acquire the rights to TV formats should ensure that TV format documentation is sufficiently detailed and is kept up-to-date as the resulting shows develop. It shows the importance of a format bible.
  • To qualify for copyright protection as a dramatic work, contents of TV formats should be clear, specific and contain elements forming a coherent recognisable framework capable of being reproduced into a distinctive show.
  • In order to increase chances of their formats being protected by copyright, developers/producers should think of including the following in their documentation:
    • where the action is to take place;
    • who the contestants should be and the selection process;
    • the length of the programme;
    • when the show should be aired;
    • the source of the prizes (if any); and
    • catchphrases, identified as such (it is not sufficient to simply list words or expressions).
  • One of the major difficulties in establishing the infringement of copyright in formats for game shows is showing that what has been copied is the expression of ideas, rather than pure ideas themselves.
  • While the High Court acknowledged the possibility for television formats (even if not fully developed) to be protected by the law of confidential information, information which is too vague, insufficiently developed and of a very general nature is unlikely to qualify for protection under the common law of confidential information.
  • Claimants who have been unsuccessful in proceedings in one country should beware of starting similar proceedings against identical defendants elsewhere, as they may be estopped from doing so and such proceedings may amount to an abuse of process.

Authors

Joel Smith
Joel Smith
Head of IP - UK
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+44 20 7466 2331
Alexandra Morgan
Alexandra Morgan
Senior Associate, London
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Filed under Consumer products, Copyright, Format rights, Passing Off, Technology, media & telecommunications, UK

The High Court considers the doctrine of equivalents in the context of patent infringement and novelty

The High Court in Generics (U.K.) v Yeda Research has considered the correct approach to the interpretation of patent claims in light of the recent Supreme Court decision in Actavis v Eli Lilly.

This High Court decision provides early indication of some possible ramifications of the decision in Actavis in relation to the assessment of novelty, but considerable uncertainty remains.  What is clear is that Actavis represents a significant change in English patent law.

The judge also reinforced that common general knowledge will only comprise information which is proven to have been common general knowledge in the UK at the relevant date, and refused to grant an Arrow declaration on the facts of this case.

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Filed under Patents, Pharma, UK, Uncategorized

Herbert Smith Freehills launches Milan office with leading disputes hire

Herbert Smith Freehills has further strengthened its European offering with the opening of a new office in Milan and the hire of Simmons & Simmons Dispute Resolution and IP Head in Italy, Laura Orlando. Continue reading

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EU Trade Mark reforms come into force – motion, hologram and multimedia marks can now be registered

A number of EU trade mark reforms came into force on 1 October 2017.  The key changes are:

  • The graphical representation requirement has been abolished. In theory, it should now be easier to file non-traditional forms of marks at EU level. Sound marks may be represented by digital sound files. Motion, multimedia and hologram marks may also be accepted. The graphic representation requirement has been replaced with a requirement that signs be represented in any appropriate form of generally available technology, as long as the representation is clear, precise, self-contained, easily accessible, intelligible, durable and objective.  The change in the law will also apply for all national marks filed in EU Member States once this provision is implemented into national laws. Brand owners should consider whether new filings for EUTMs should be made. In some industry sectors, the potential to more easily register sound, motion, multimedia and hologram marks could offer significant opportunity to add further layers of protection to brand portfolios on an EU level.
  • EU Certification Marks have been introduced which are a new type of trade mark at EU level which will guarantee specific characteristics of certain goods/services. The introduction of this form of marks aims to harmonise the position across the EU as some Member States did not allow for certification systems under their national systems. EU certification marks will be owned by the appropriate organisation or certifying institution responsible for certifying and monitoring the qualities or characteristics of the products. These marks may not be owned by suppliers of the goods and services in question.  An applicant for an EU certification mark must submit regulations governing its use to the EUIPO within two months of the filing of the application.
  • A number of procedural changes have also been introduced, the full details of which are contained in the updated EUIPO guidelines.  These include a change on acquired distinctiveness as applicants may now pursue a subsidiary claim of acquired distinctiveness after they have exhausted the right of appeal on the inherent registrability of a trade mark. Translation requirements have also been simplified and assignment of an EU trade mark can be sought as an alternative remedy to invalidation. Priority claims must be filed at the same time as filing of an application and not afterwards.  Applicants may rely on online sources recognised by the EUIPO for substantiation of earlier rights in oppositions and cancellation actions.

These recent changes form part of a package of EU trade mark reforms, many of which came into force on 23 March 2016. For further detail on all changes under the EU trade mark reform package, please see our previous e-bulletin here.

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, Consumer products, Counterfeiting, EU, Trade marks & Passing-off, UK

New Unjustified Threats Regime in force from 1 October 2017

Threatening proceedings for intellectual property right infringement can sometimes backfire. In relation to patents, trade marks and designs, there is a right for any person aggrieved by the threat to bring an action against the threatener. The “aggrieved” person may not necessarily be the person directly threatened with proceedings, it could be anyone whose commercial interests are damaged by the threat – such as a manufacturer whose suppliers or distributors are threatened. Not only does the threats action expose the IP rights-holder to the risk of damages, it also turns the potential claimant into a defendant, with the resulting reversal of burden of proof, requiring it to prove the validity of the rights which it originally asserted and their infringement.  This in turn creates a tension with the requirements of the Civil Procedure Rules to communicate a litigant’s case early before issuing proceedings, with rights holders more likely to sue first than to threaten first.

The new Intellectual Property (Unjustified Threats) Act 2017, which comes into force on 1 October, attempts to encourage more pre-action communication by detailing what an actionable threat is, whilst providing for “permitted communications” or communications for “permitted purposes” which cannot amount to an actionable threat. It harmonises the position across patent, trade mark and design rights (including providing for unitary patents and European patents under the proposed Unified Patent Court jurisdiction) and allows pursuit of information on primary infringers from secondary parties where reasonable efforts have been made to find the primary infringer already.

Summary and Business Impact

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Filed under 3D printing, Advertising, Agribio, Agribusiness, Consumer products, Copyright, Counterfeiting, Databases, Designs, Energy, Media, Passing Off, Patents, Pharma, Technology, media & telecommunications, The Unified Patent Court and the Unitary Patent, Trade marks & Passing-off, Trade secrets, UK

“PORT CHARLOTTE” Whisky does not infringe the EU protected designation of origin (PDO) “PORTO” or “PORT” – Consideration needed urgently for protection of PDOs and GIs, UK and EU-wide, post-Brexit

The CJEU has confirmed that “Port Charlotte”, registered as an EU trade mark for whisky, does not evoke (infringe) the protected designation of origin (PDO) for “porto” or “port”. The decision will be significant for consumer products businesses as it confirms that EU (not national) law applies to enforcement of Protected Designations of Origin (PDO) and highlights the importance of ensuring continued protection of UK PDOs post-Brexit.

Interestingly, the CJEU did not find that the use of “Port Charlotte” as a brand for whisky would have a detrimental impact upon the PDO for port (and the port producers protected by this designation). Yet we await the outcome in a not dissimiliar dispute before the CJEU between the Champagne wine producers and Aldi over the sale of champagne flavoured sorbet (see our report of the Aldi case here ).

Business Impact

·         The CJEU’s ruling that Regulation1234/2007 (which sets out the rules on PDOs for wine) (the “Regulation”) exclusively and exhaustively lays down the legal rules in the EU applicable to the protection of PDOs, to the exclusion of any national laws which seek to provide additional protection, confirms that the system for PDO protection is entirely as set out in the relevant EU law, and cannot be supplemented at a national level.

·         Assessing consumer perception of the meaning of a mark, throughout the EU, will be relevant to the assessment of whether that mark “evokes” in the mind of the consumer the PDO in question.  The impact of this point will be fact specific, in each case.  The likelihood that a PDO is evoked may also be affected by the similarity, or otherwise, of the features of the products in question.

·         In a post-Brexit world, the UK will need to give thought to the interaction of PDOs granted under the EU system and what level of protection would be offered going forwards to existing PDOs in the UK and whether the UK continues with its own system of protected designations and geographical indications for distinctive UK foods (such as cheeses and pork pies) and beers/wines (such as ales and bitters).

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Filed under Brexit, Consumer products, EU, GIs, PDOs, Trade marks & Passing-off, UK

Exhaustion, economic links and “unitary control” – the AG’s opinion in the Schweppes trade mark reference

Trade mark rights may still be exhausted even if goods are imported bearing identical trade marks (having been applied in another EU Member State (MS) by a separate entity) where, given the economic links between the trade mark holder and the entity applying the trade mark in the exporting MS, it is clear that the marks are under “unitary control” and that the proprietor of the mark in the importing MS has the possibility of determining directly or indirectly the goods to which the trade mark in the exporting State may be affixed and of controlling their quality.

This was the Opinion of Advocate General Mengozzi (delivered on 12 September 2017), in Case C291/16 Schweppes SA v Red Paralela SL, referred to the CJEU by the Commercial Court of Barcelona.  Schweppes SA, the Spanish subsidiary of the Orangina Schweppes Group, opposed the importation into and/or marketing in Spain (where it owns the trade mark SCHWEPPES) of Schweppes branded tonic water which had come from the United Kingdom, where that mark had been applied by and is owned by Coca-Cola.

Exhaustion of rights is an area mentioned as requiring immediate consideration in the recent Commission paper on the future of IPRs in Europe post-Brexit (see our blog posting on this here).  Once outside the EU the EU-wide exhaustion rules would not apply to marks applied in the UK, but it is possible that the UK courts might consider applying international exhaustion principles in their place, barring any other provision on exhaustion enacted by the UK Government in advance of the UK’s withdrawal from the EU.

Author

Rachel Montagnon
Rachel Montagnon
Professional Support Consultant, London
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Filed under Brexit, Consumer products, EU, Trade marks & Passing-off, UK

Commission paper on IPR post-Brexit highlights the importance of resolving key issues prior to withdrawal

The European Commission has published a “Position paper transmitted to EU27 on Intellectual property rights (including geographical indications)” (7 September 2017) which proposes that the (Brexit) Withdrawal Agreement should ensure that:

  • The protection enjoyed in the United Kingdom on the basis of Union law by both UK and EU27 (the remaining EU states) holders of intellectual property rights having unitary character within the Union before the withdrawal date is not undermined by the withdrawal of the United Kingdom from the European Union. The paper suggests there should be automatic recognition of an IP right in the UK on the basis of the existing, unitary character IP right i.e. that, for example, any EU trade mark rights applying in the UK prior to Brexit should be automatically replaced by UK rights post-Brexit. Further, the fact that use may not be in the UK should not be able to form a basis for revocation of the rights. The implementation should be not result in any financial cost for the IPR holders and any administrative burden should be kept to a minimum.  The paper also requires that the UK Government put in place a system to continue the protection of Geographical Indications (GIs) and protected designations of origin (PDOs) which are currently legislated for under EU law and for which there is no current domestic legislation in the UK. However there is no suggestion of a reciprocal recognition of UK-based PDOs or GIs post-Brexit.
  • Procedure-related rights (e.g. right of priority) in relation to an application for an intellectual property right having unitary character within the Union still pending on the withdrawal date are not lost when applying for an equivalent intellectual property right in the United Kingdom ie. that where an application is in progress at the point of the UK’s withdrawal from the EU, the applicant should be entitled to keep the benefit of any priority date when applying after the withdrawal date for an equivalent IPR in the UK.
  • Applications for supplementary protection certificates or for the extension of their duration in the United Kingdom on-going before the withdrawal date are completed in accordance with the conditions set out in Union law (and any certificate so granted or extended should provide for protection equivalent to that provided for by Union law.
  • Databases protected in the EU27 and the UK before the withdrawal date continue to enjoy protection after that date. This involves waiving the requirements of Article 11(1) and (2) in the EU27 Member States in respect of UK nationals and UK companies and firms; and the UK should not exclude EU27 nationals and EU27 companies and firms from legal protection of databases in the UK on nationality or establishment grounds. No provision for any continuing mutual recognition of database rights is referred to however.
  • Exhaustion before the withdrawal date within the Union of the rights conferred by intellectual property rights is not affected by the withdrawal of the United Kingdom from the European Union. The conditions for exhaustion of each IPR should be those defined by Union law.

These points highlight the key areas that have concerned IP stakeholders since the Brexit referendum and serve as a timely reminder to the UK Government that these issues need to be dealt with prior to Brexit, in one way or another.

Joel Smith, Head of IP at Herbert Smith Freehills, commented,Whilst it is reassuring that the Commission recognises that there are important issues for continuity of IP protection to be addressed upon Brexit, this paper only begins to scratch the surface for the number of issues that need examining by UK Government”.

Author

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

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Filed under Brexit, Consumer products, Databases, Designs, EU, Pharma, Technology, media & telecommunications, Trade marks & Passing-off, UK