Pregabalin patent – Supreme Court finds the patent bargain broken

The United Kingdom Supreme Court today (14 November 2018) handed down a significant patent decision[i] relating to the degree to which a patentee must demonstrate an invention at the time of making the application.  At the heart of the decision lies what, in the Judge’s view, is the fundamental rationale of the patent system – that the inventor obtains a monopoly in return for disclosing the invention and dedicating it to the public for use after the monopoly has expired.

 

The case related to Warner-Lambert’s patent[ii] for pregabalin.  Pregabalin is marketed under the brand name “Lyrica”. Lyrica is one of four first-line treatments recommended by NICE for neuropathic pain. It is one of the most successful drugs in the United Kingdom.

 

As pregabalin was already known, the patent contained claims directed to the medical use of pregabalin, including the treatment of pain (claim 1).  Claim 3 was more specific, being directed to the treatment of neuropathic pain (pain resulting from damage or injury to the nerves).  The Court agreed with the referring instances in agreeing that “neuropathic pain” was to be interpreted broadly, as covering all such types of pain.

 

The central question was whether the patent application as filed disclosed some reason to regard the use of pregabalin for the treatment of neuropathic pain as “plausible”.  Only if this question were answered in the positive could the patent fulfil the requirements of sufficiency[iii].

 

The Supreme Court acknowledge the practical difficulty of demonstrating therapeutic efficacy at the stage when the patent application must in practice be made.  Nevertheless, the specification must disclose some reason for supposing that the implied assertion of efficacy in the claim is true; in other words, to make it “plausible”.  The test is relatively undemanding, but cannot be deprived of all meaning or reduced to little more than a test of good faith.

 

The experimental data in the specification were predictive of efficacy for the treatment of inflammatory pain, but there were no data to make it plausible that pregabalin was effective for the treatment of any kind of neuropathic pain. Claim 3 would stand only if it would have suggested to the skilled person that there was some unifying principle which made it plausible that pregabalin would also work with neuropathic pain.

 

To determine this question, the Supreme Court determined the correct question to be not whether the invention was plausible, but whether the specification discloses something that would make it so in the eyes of the skilled person.  In the present case there was nothing to suggest, even as a hypothesis, that pregabalin works with peripheral neuropathic pain by blocking central sensitisation.

 

Although the patent was found insufficient, the Supreme Court unanimously held that if Claims 1 and 3 had been valid, they would not have been infringed.  The infringement issues will be the subject of a further bulletin in the near future.

 

CASEY’s comment

 

The decision strikes a balance between the interests of the patentee, who is required in practice to file at an early stage, often before the invention is understood, and third parties, who are entitled to be protected from wholly speculative “armchair” (in the words of the Court) patents.

 

Although the plausibility hurdle is low, patent applicants need to be mindful of it.  If data supporting a particularly important aspect is not available, a plausible hypothetical reason why this aspect works should always be included in the description.

 

 

 

[i] Warner-Lambert Company LLC (Respondent) v Generics (UK) Ltd t/a Mylan and another (Appellants) [2018] UKSC 56

[ii] EP(UK)0641330

[iii] UK Patents Act Section 14; European Patent Convention Article 83

Icescape v Ice-world: Cool for patentees, chilling for others?

The UK Court of Appeal recently applied the new(ish) ‘Actavis test’ for determining whether a patent has been infringed.

In the Actavis test the Court assesses whether the alleged infringement falls within the meaning of the claim wording. If it does not, the Court then asks whether the alleged infringement is an ‘equivalent’ which should nevertheless infringe the patent.

In this case the inventive features of the claim were found to be flexible joints which allowed a mobile ice rink to be folded. The alleged infringement had these flexible joints but lacked other claimed features which were deemed to be less technically important to the foldability. Although the alleged infringement lacked those claimed features, the features which it did posess were held to be equivalent. Infringement was therefore found. No infringement was found at first instance under the old law.

A secondary point of interest was that, as in L’Oréal, the prosecution history was held to be of no assistance in determining the scope of the claims.

This decision is confirmation that UK Courts have become more patentee friendly. It will be interesting to see how the ‘equivalents’ test is applied to features which themselves are found to give the core benefit of the invention.

By Nick Bennett

New UK Trade Mark Regulations will come into force on 14 January 2019

A summary of the most important changes is set out below

Changes to a definition of a trade mark: 

When filing a UK trade mark application, it will not be necessary to provide a graphic or visual representation of the mark. You will be able to present the mark in a wider range of electronic formats, such as in an MP3 or MP4 format, via an online application. It still needs to be clear and precise to others, as to what it is, but this change envisages the registration of marks which incorporate, for example, movement or sounds. However if a UK application will form the basis of an International application, it will still have to be submitted in traditional graphic format.

Changes to extend “technical function” objections that can be raised to trade mark applications:

If the shape of a mark, as currently applied for, performs a purely technical function and adds value to the goods (or, the shape results from the nature of the goods), then it will not be registrable. This prohibition will extend beyond shapes to any characteristic which is intrinsic to the goods applied for

Changes to citation (and status) of expired trade marks:

Expired marks won’t be cited by the UK IPO any more. For the duration of the period a mark isn’t on the Register, it won’t be notified to the Applicant of a later similar mark. As the Applicant will be unaware of the earlier mark, the earlier owner will not be able to assert infringement for any usage by the Applicant of its later mark made during the period the expired mark wasn’t on the Register, even if subsequently restored.

Change to 5 year non-use period for purpose of opposition:

The relevant 5 year period to substantiate an earlier mark with evidence of use in opposition proceedings will be the 5 years immediately preceding the filing (or priority) date of the opposed mark (no longer its publication date).

Changes to who may own a Collective Mark:
“Legal persons governed by public law” will be able to own a Collective Mark, and, the type of Associations that will be able to own Collective Marks has been clarified.

Changes to Regulations for a Collective Mark:

These will have to include “conditions of use of the mark” and “sanctions that will be taken if the mark has been misused”. Also, if a Collective Mark contains a reference to a geographical area, the Regulations will have to allow any person whose goods or services originate in that region to become an authorised user of the Collective Mark (provided they meet all other conditions).

Changes to permissions of the owner of a Collective Mark:
The Association members of the Collective Mark holder will need permission of the Association Owner to initiate trade mark infringement proceedings (though they will be able to intervene directly in infringement proceedings to claim damages).

Widening of powers for trade mark owner against counterfeit goods in transit:

Counterfeit goods in transit will be detainable by UK Customs, if the person shipping the goods cannot prove that it is free to market the goods in the country of destination. In other words, the burden of proof now rests with the shipper of the goods in transit that they may be lawfully marketed at their destination rather than with the claimant trade mark proprietor. Civil claims may also now be brought by a trade mark owner against “preparations to infringe”.

New powers of trade mark owners against generic dictionary entries:

Where a publisher incorrectly identifies a trade mark as a generic term in a dictionary, the trade mark owner will be able to require the publisher to clarify that the dictionary entry is a registered trade mark, failing which a court order may be sought.

Proprietors of a trade mark will be able to remedy the unauthorised application or restoration of a trade mark by their agent/representative.

Invalidation of a registered trade mark will be considered by the Courts during the course of infringement proceedings based upon that registered trade mark:

It will no longer be necessary to file a separate invalidation or revocation action against a registered UK trade mark before or alongside infringement proceedings. As a defence in infringement proceedings, it will now be possible to request proof of use of the earlier mark (where applicable) to remove the need to file separate proceedings to contest its validity.

The ‘own name’ defence to trade mark infringement will only apply to personal names:

The “own name” defence no longer applies to trade names and company names. It is not clear what the position is for companies that would have previously been able to rely on this defence before the change in law i.e. whether they may still be able to rely on the defence by virtue of their prior use.

Widening of proof of use requirements for older marks in invalidation proceedings:

Where an earlier mark is relied on, in an invalidation attack on a later registration, and where that earlier mark has been registered for more than five years, it will now be possible for the owner of the contested registration to request proof of use of the earlier mark across two time periods i.e. for the five year period prior to the filing (or priority) date of the later contested registration and for the five year period running up to the filing of the invalidation action. (In other words, an earlier proprietor is obliged to show that its registration was valid both at the time the later mark was filed and at the time the attack is brought against the later mark.)

Changes to licensing provisions and recordable procedures:

A trade mark owner will be able to take legal action under the Trade Marks Act against a licensee, if they have failed to observe license terms including: how long it lasts, the way the mark is used, what goods or services are covered, the geographic area of use and quality of the goods or services.

The rights of licensees are changing. Previously, a non-exclusive licensee was entitled to bring proceedings for trade mark infringement (where it had called upon the proprietor to take action, without success, and where its licence permitted). This has now been changed so that a non-exclusive licensee may not now sue without the trade mark owner’s permission.

The status quo remains for exclusive licensees; they may bring proceedings in their own name albeit after they have asked the proprietor to sue, without success.

A licensee (of either type) will nevertheless be able to intervene directly in infringement proceedings brought by the proprietor to obtain damages for its losses suffered as a result of the infringement.

Licence provisions will now apply to both trade mark applications and registrations.

It will now be possible to divide trade mark registrations, as well as applications.

Extension of renewal reminder period:

The point at which the UK IPO will notify a trade mark owner or their representative that a mark has become due for renewal will now be about 6 months before the renewal fee is due to be paid and the registration expires. Reminders are currently issued about 4 months before the due date.

By Joanna Larkey

Strong rankings for Cleveland Scott York in Chambers & Partners 2019

Intellectual property law firm, Cleveland Scott York which has offices in London, Hertfordshire, the Thames Valley and Brussels, has been ranked in the 2019 edition of the Chambers & Partners guide to the legal sector.

The firm has been recognised for its work relating to both patents and trade marks, with a ranking in the Patent and Trade Mark Attorneys practice area.

Meanwhile, Partner Jonathan Clegg has been ranked in Band One of the Trade Mark Attorneys practice area.

Jonathan said: “We’re delighted with this recognition, especially because it’s substantially based on feedback from our clients.

“We remain as committed as ever to providing a strong personal service that protects and enhances our clients’ commercial interests.

“On a personal note, I am very happy to have been ranked in Band One again this year.”

Four new ‘Recommended Lawyers’ at ‘top-notch’ Cleveland Scott York, as Legal 500 rankings are published

Four Partners at intellectual property law firm, Cleveland Scott York, which has offices in London, Hertfordshire, the Thames Valley and Brussels’ have been named as ‘Recommended Lawyers’ for the first time by the prestigious Legal 500 guide to the legal sector.

Chartered Patent Attorneys Michael Williams and Jonathan Midgley and Chartered Trade Mark Attorneys Peter Houlihan and Cathy Ayers are all ranked. They join their colleagues, Chartered Patent Attorneys, Dr Adrian Bradley, Andrew Mackenzie and Tom Faulkner and Chartered Trade Mark Attorneys, Jonathan Clegg and Lorna Hobbs as ‘Recommended Lawyers’. Meanwhile, Sophie Maughan has the distinction of being a ‘Recommended Lawyer’ for both her Patent and Trade Mark work as a cross-qualified attorney.

Cleveland Scott York continues to be ranked in Tier 2 for Trade Marks and Tier 3 for Patents, consolidating its position in the second edition of the guide to be published since the firm was formed from the merger of Cleveland IP and Scott & York IP Law in April 2017.

The firm is described as ‘top-notch’ for its trade mark work, while its patent work is praised for its pragmatism.

Dr Adrian Bradley said: “We are delighted to have made further progress in our Legal 500 recommendations this year.

“This is a great endorsement of the work of our team and our efforts to provide the best possible levels of service to each of our clients.”

Court of Appeal rules backs rights holders in Standard Essential Patents (SEP) case

The Court of Appeal handed down judgment in the Unwired Planet v Huawei appeal yesterday (23 October 2018).  The decision has been eagerly anticipated, dealing as it does with important mechanisms for the way technology standards are agreed upon.

Standard Essential Patents (SEP) – those essential to the implementation of certain telecommunications standards, including 2G, 3G and 4G – pose a particular challenge when it comes to balancing the rights of patent holders and those implementing the standards. This is because being critical to the implementation of a standard means that the patent holder could exploit their position to engage in anti-competitive behaviour, such as demanding excessive fees from particular parties to be able to use the technology.

To ensure SEP holders can still generate sufficient revenue, without impeding the implementation of important standards, the Standard Setting Organisations (SSOs) require patent owners to licence their technology on terms which are fair, reasonable and non-discriminatory (FRAND).

However, this arrangement does not entirely negate the challenges that SEPs raise and this is illustrated by the long-running dispute between SEP owner Unwired Planet International and phone maker, Huawei over technology relating to 2G, 3G and 4G.

The dispute centred on whether the technology involved was subject to a SEP and whether the terms offered were FRAND.

The High Court found that the technology was subject to a valid SEP, which had been infringed by Huawei. It ordered that Huawei would be subject to an injunction if it did not enter into a global licence agreement with Unwired Planet International on terms determined by the court to be FRAND.

Huawei appealed this judgement that imposed worldwide terms set by a national court on the basis of a domestic infringement was unjust. It also argued that it should have been offered the same terms as Samsung for the rights to use the technology and that the injunction contravened Article 102 of the Treaty on the Functioning of the European Union.

The Court of Appeal yesterday dismissed all three grounds for appeal in Unwired Planet International Ltd & Anor v Huawei.

Cleveland Scott York comment:

SEPs pose some distinctive challenges when it comes to ensuring that the party that invested in the development of a technology is appropriately rewarded and incentivised to continue developing such technologies, while ensuring this does not impede the implementation of a standard.

The High Court and the Court of Appeal have both ruled in favour of the SEP holder in this case, which will be welcome news for firms investing millions of pounds into research and development.

The case also shows that while determining the validity of a SEP and whether terms are FRAND can be challenging, the courts are prepared to make detailed judgements in relation to the precise terms of a licence.

Intellectual property law specialists lend their backing to the UK’s best business women

A prominent firm of intellectual property law specialists has lent its backing to UK’s best business women.

Cleveland Scott York, which has offices in Hertfordshire, the City of London, the Thames Valley and Brussels has sponsored the Best Business Women Awards for the third consecutive year.

The awards are an opportunity to celebrate the contribution that business women make to the UK and its economic success.

The team at Cleveland Scott York was involved in judging the Best Customer Service Awards, which was presented by Cleveland Scott York Partner, Sophie Maughan, to Carolyn Lewis of eLearning Marketplace Ltd.

eLearning Marketplace is one of the UK’s largest suppliers of immediate access online training, with more than 2,000 courses covering a wide range of topics.

Sophie Maughan said: “It was a real pleasure to be able to present the award to Carolyn. The standard of entries was, as usual, very high, so this is a great achievement.

“Here at Cleveland Scott York, we place a strong emphasis on our own client service, so it is wonderful to be able to recognise Carolyn’s achievement.”

Also shortlisted for the award were Amy Hambleton of Red Law Recruitment, Jacqui Frost of The Office Genie Ltd, Jane and Kerri Lewis of The Skin to Love Clinic, Joanne Dixon of HBP Systems Ltd, Kathy Doran of More Staff Recruitment, Louise Hampton of Attend2Health, Lucia Melilo of Lucia Hair & Beauty and Sarah Marshall of Bicester Specsavers Ltd.

The glittering award ceremony took place on Thursday 11 October 2018 at Tewin Bury Farm.

Our ‘rising stars’ celebrated by prestigious directory

Two of our Senior Associates have been named as ‘rising stars’ by a prestigious directory to the sector.

Chartered Patent Attorney, Nick Bennett, and Chartered Trade Mark Attorney, Andrew Clemson were recognised by IP Stars 2018.

Each is described as a “rising star to watch” by the guide. This is the first year that IP Stars has celebrated the ‘rising stars’ of the intellectual property field.

Chartered Patent Attorney and Partner, Dr Adrian Bradley, is listed as a Patent Star, while Chartered Trade Mark Attorneys and Partners, Jonathan Clegg and Lorna Hobbs are named as Trade Mark Stars.

Nick Bennett said: “It is great to have received this recognition, which is especially satisfying because it is based on research with clients of the firm.”

Andrew Clemson said: “It is wonderful to be named in this way and great that our clients have such confidence in us.”

Dr Adrian Bradley added: “We are delighted that Nick and Andrew have been recognised as rising stars. We already knew that they were well-regarded by our clients, but it is great to see this highlighted by a prestigious directory.”

UK confirms it’s business as usual for patents after Brexit

The UK government recently issued guidance on the impact of a ‘no deal Brexit’ on patents and related intellectual property rights. The good news for rights holders and prospective rights holders is that it will essentially be business as usual for the foreseeable future.

For patents there are only a few aspects of law that could be affected since relatively little relevant legislation is derived from the EU. The areas in question are supplementary protection certificates and specific provisions on compulsory licences as well as certain exemptions from patentability and infringement.

In the event of a no deal Brexit the government has stated that the relevant EU legislation and/or its UK implementing legislation will be retained. Existing systems will therefore remain in place and will subsequently operate independently from the EU regimes. This means that existing rights and licences, including supplementary protection certificates, will remain in force automatically and there will be no significant change to legal requirements or application processes.

For the possible unitary patent and Unified Patent Court systems, assuming these systems do subsequently come into effect the UK will explore the possibility of remaining a member. If the UK were to withdraw, however, any existing unitary patents would give rise to equivalent UK rights and continued protection would be ensured. Further, enforcement of UK patents would be through UK courts, as it is now.

As a non-EU agreement there will be no change to the European patent application system or UK rights of representation.

The last question addressed is the issue of service addresses and legal professional privilege. On these points the guidance states that there will be no change.

Patent proprietors therefore do not need to take any action for the foreseeable future.

UK Government issues guidance notes on intellectual property for “no-deal” Brexit

On 29 March 2019, the UK is scheduled to leave the EU. Negotiations are ongoing between the UK government and EU regarding their post-Brexit relationship.

If these negotiations are not concluded by the exit date, the UK will leave without a deal (i.e. a ‘no deal Brexit’). In order to allow businesses and citizens to plan for this possibility, the UK Government issued technical notices on the 24 September 2018 setting out the position regarding IP rights in a no deal scenario. The main points to note are:

Trade marks

  • All existing registered EU trade marks will continue to be protected and enforceable in the UK by virtue of an equivalent UK trade mark (which will be created by the UK Intellectual Property Office).
  • Owners will be notified that a new UK right has been granted. Any owner that may not want to receive a new comparable UK registered trade mark will be able to opt out.
  • Owners of pending EU applications will have 9 months from the date of exit to apply in the UK for the same protection, retaining the date of the EU application for priority purposes.
  • The new UK right will be provided with minimum administrative burden.
  • The UK trade mark will then be treated as if it had been applied for and registered under UK law.
  • The Government will work with the WIPO to provide continued protection in the UK after 29 March 2019 for trade marks filed through the Madrid/International system and which designate the EU , including seeking practical solutions for pending applications.
  • Provision will be made regarding the status of legal disputes which are ongoing before the UK courts. More information on that will issue closer to exit.

Designs

  • The scheme described above to maintain protection in the UK for existing and pending EU registered trade marks will apply also to registered Community designs;
  • All existing unregistered Community designs will also continue to be protected and enforceable in the UK for the normal period of protection;
  • A new supplementary unregistered design right will be established in the UK for new designs that are disclosed after Brexit – this will ensure that the UK provides unregistered design protection exactly mirroring the scope of the unregistered Community design right.

Geographical indications

  • A new UK Geographical Indication (“GI”) scheme will be created for the UK.
  • UK producers who currently have EU GIs will be automatically transferred into the UK scheme and will obtain UK GI protection.
  • Unlike the position with EU trade marks and designs, the UK does not plan to automatically opt in EU producers who own EU GIs.
  • It is not certain that the EU will maintain the existing EU GI protection for UK producers.
  • Owners of GIs are advised to review whether seeking additional protection under, for instance, collective marks may be advisable

Exhaustion of rights

  • For the moment, the UK will continue to recognise European Economic Area-wide exhaustion of relevant IP rights. That will mean that, as now, goods placed on the market anywhere in the EEA will continue to be freely imported into the UK.
  • Conversely, the EU’s position looks likely to be that it will not continue to apply EEA-wide exhaustion. Businesses that export goods from the UK to the EU, after Brexit, may need to consider the IP implications and, where necessary, seek permissions from relevant IP owners.
  • The UK is currently conducting policy work to establish what its long term position will be on this issue.

Broadly, the UK Government’s policy on all IP rights simply reflects what has long been anticipated in the IP community and aims to give comfort to proprietors of EU IP rights that their rights in the UK will not be substantively affected by Brexit. These plans are also similar to what the UK aims to do even where agreement with the EU is reached. There are nevertheless still some details of the planned schemes to be worked out and we will continue to monitor progress of the necessary legislation.

Please contact your usual CSY adviser if you have any questions about any of these issues.