No direction on the issue of direct infringement for Swiss-form claims

Beyond the matter of sufficiency in the Warner-Lambert pregabalin case, the UK Supreme Court unanimously decided that there would have been no infringement had the claims in question been valid (had they not been found to suffer from a lack of sufficiency). The judges, however, had differing views on the grounds for the finding, leaving the test for infringement unclear with regard to Swiss-form claims (claims relating to use of a compound in the manufacture of a product for an indicated medical purpose).

The question of infringement arose when Warner-Lambert, the proprietor of patent EP0934061, brought proceedings against Actavis for marketing a generic version of the patented product pregabalin.  Although the generic pregabalin is marketed for the treatment of epilepsy and generalised anxiety disorder, Warner-Lambert held the view that it would be foreseeable for a manufacturer of the generic pregabalin that, in due course, product would also be used for the treatment of neuropathic pain, as covered in the patent.

Prior to the Supreme Court hearing, the lower courts construed that Swiss-form claims are purpose-limited process claims and hence involve a mental element test when considering the issue of infringement. The question which arises from this construction is whether the test of the manufacturer’s intention is subjective or objective.  Subjective intention may extend liability to a person such as a pharmacist/physician, who could be found to infringe a purpose-limited patent by virtue not of his/her own intentions but due to those of someone else (such as a generic manufacturer). On the other hand, considering objective intention could effectively give a patentee a de facto term extension for an expired patent for an original use, i.e. until the expiry of a patent for a new use.

Two of the five Supreme Court judges found both the subjective and the objective tests irrelevant for the purpose of considering infringement, however, and instead advocated the “outward presentation” test. According to the outward presentation test the only important factor is the physical nature of the product as it emerges from the manufacturing process (including its formulation and dosage, packaging and labelling, and the patient information leaflet which will identify the use of the product).

In contrast, another two of the judges found the “subjective intent” test fair and more reliable. They found that the purpose limitation of a Swiss-form claim would necessarily relate to a mental element on the part of the manufacturer and, in order to strike a fair balance between competing policy objectives, a person’s intention should be tested. Such intention could be shown objectively as well as by considering downstream marketing.

The last of the judges remained doubtful regarding the tests discussed above and held that the objective appearance and characteristics of the end-product, in terms of its preparation, presentation, and marketing, should not be viewed in isolation in certain situations (for example when considering the intent of the end-user).

Although it was ruled that there was no infringement in the pregabalin case, the Supreme Court judges acknowledge that the various tests are far from perfect.

By Khushbu Solanki

Draft EU Withdrawal Agreement – IP Provisions

On 14 November 2018, after months of negotiations, UK and EU officials agreed the draft text of an agreement on the UK’s withdrawal from the European Union. This includes provisions relating specifically to Intellectual Property, and the highlights are follows:

Existing registered EU trade marks and registered Community designs will be “cloned” onto the UK Registers

  • Whilst registered EU trade marks and registered Community designs will cease to be valid in the UK after the expiry of a transitional period (due to run until the end of December 2020), the UK will grant equivalent national rights in the UK, without any re-examination.
  • The Withdrawal Agreement confirms that the “cloning” of EU registered rights onto the UK Register will be carried out without the need for the owners of these rights to file any applications or take any other administrative steps.
  • The transposition of the EU rights onto the UK Register will not incur official fees.
  • The filing/priority dates of (and any seniority claims relating to) the EU rights will be maintained in the corresponding UK right. The first renewal date of the equivalent UK trade mark and design will correspond to the renewal date of the EU right from which the UK right arose.
  • The “cloned” UK trade mark created before the end of the transition period will not be subject to revocation on the ground that the corresponding EU trade mark had not been put to genuine use in the UK before the end of the transition period.
  • The owner of the equivalent UK trade mark will be able to rely upon the reputation acquired in the mark in the EU up until the end of the transitional period. Thereafter, any rights on the basis of reputation in the mark will need to be exercised on the basis of reputation acquired in the UK.

Option to “transpose” pending EU trade mark applications and Community design applications onto UK Registers on application

As envisaged in the case of a “no-deal Brexit”, EU trade mark applications and Community design applications pending at the end of the transitional period will not be automatically cloned onto the UK Registers, but the owners of these rights will have 9 months from the end of the transition period to apply to register an identical UK trade mark or design maintaining the filing/priority dates of the equivalent EU right.

International trade mark and design registrations

The Withdrawal Agreement also includes a commitment on the part of the UK to take measures to ensure continued protection in the UK of International trade mark and design registrations designating the EU in relation to which protection is obtained before the end of the transitional period. The Agreement does not include any provisions in relation to pending EU designations.

Unregistered Community designs

All unregistered Community designs which arise before the end of the transition period will also continue to be protected and enforceable in the UK for the remaining period of protection of the corresponding unregistered Community design. Since the UK law currently does not envisage the same level of protection for UK unregistered design as the EU regime, the UK will need to legislate in this respect.

Geographical Indications

The draft Withdrawal Agreement confirms that EU geographical indications, designations of origin or transitional speciality guaranteed, and traditional terms for wine, will remain protected in the UK “until the future economic relationship comes into effect and supersedes those arrangements”. Existing UK GIs will continue to be protected by the current EU regime.

Exhaustion of rights

The draft Withdrawal Agreement briefly states that IP rights which were exhausted both in the EU and in the UK before the end of transition period will remain exhausted both in the EU and in the UK. Goods will, accordingly, continue to move freely between the EU and UK during the transition.

Analysis of effect in UK

The provisions of the draft Withdrawal Agreement for the most part replicate the UK Government pledges in relation to IP rights in the case of a no-deal Brexit, but it is reassuring to see confirmation of the following:

  • That the status quo will remain until the end of transition period and that after the end of the transition period:
  • EU registered IP rights will be cloned onto the UK Registers;
  • Such cloned rights will retain the filing/priority/seniority dates of their EU equivalents;
  • The cloning process will incur no official fees for the IP rights owners.

The Withdrawal Agreement requires Parliamentary approval (and the matter is due to come before the House of Commons on Tuesday 11 December 2018). In the event that Parliament does not approve the agreement (and the EU/UK do not agree other arrangements), the UK will leave the EU on 29 March 2019 without an agreement. Our summary of the UK Government’s guidance notes on intellectual property in the event of a “no-deal” Brexit can be found here.

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

By Magda Ostrowska

Cleveland Scott York contributes to St Albans City of Expertise report

The ‘Barriers to Growth’ report found that the biggest challenge for businesses of all sizes in the St Albans area is recruitment and retention.

A total of 35 businesses including our firm contributed to the report, which was published last week.

Read the report here.

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.