6 December, 2018

Cadbury’s colour purple trade mark can’t be split

Clarity and precision in a trade mark description are the winners in the Court of Appeal

Cadbury’s attempt to argue its trade mark registration for the colour purple was actually a series mark which could be split and partially maintained was rejected yesterday by the Court of Appeal. Although another blow in Cadbury’s multi-decade, hard-fought attempt to trade mark the colour purple for chocolate bars in the UK, the decision helps to maintain clarity and certainty on the trade marks register.

Key take away: If you are applying for a trade mark, then it is important that the monopoly you are claiming is clear and precise – especially if your mark is ‘unusual’, such as a colour or shape mark. To be successful, the trade mark application should not be able to be interpreted in multiple different ways.

Cadbury v Comptroller of Patents [2018] EWCA Civ 2715 (5 December 2018)

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30 November, 2018

Italy moves the unitary patent a step closer

The Italian Government approved a draft Bill on 21 November 2018 aimed at adapting the Italian IP Code to the Unitary Patent Regulation (EU 1257/2012) and the Unified Patent Court (UPC) Agreement. The next step before the Bill is passed will be for the Italian Parliament to give its favourable opinion.

The draft Bill will essentially amend the Industrial Property Code in Italy to incorporate unitary patent protection and the jurisdiction of the UPC.

What’s new?

  • Safety net

Under the current system a European patent acquires effect in Italy once an Italian translation of the patent has been filed with the Italian Patent Office within three months of the publication of the patent grant. Once the UPC is in place, holders of European patents will be entitled to apply for their European patents to have unitary effect in all 26 Member States that have participated in the enhanced cooperation to create the unitary patent, within one month of the patent grant being published on the European Patent Bulletin.

There is a degree of uncertainty as to whether the process for applying for unitary effect will take longer than the 3 months, in which case the patentee will have lost out on the chance to validate their patent in Italy.

The draft Bill has therefore introduced a safety net mechanism whereby if an application for unitary effect is rejected or withdrawn, the 3 month term for the validation in Italy will take effect from the date when they receive the rejection or of the withdrawal. This will allow patentees to validate a patent in Italy even if their unitary application is not granted.

  • Experimental use exception

Another important amendment concerns the experimental use exemption. Under the draft Bill, the rights conferred by a patent shall not extend to acts carried out for experimental purposes relating to the subject matter of the patented invention or to the use of biological material for the purpose of breeding, or discovering and developing other plant varieties.

The previous wording of the Italian Industrial Property Code did not include a specification regarding the type of experimental use. In essence, this limitation of the experimental purposes to “the subject matter of the patented invention” could lead to a more restrictive interpretation of the scope of permitted “experimental use” (e.g. limited to experiment “on the patented invention” and not “with the patented invention” in line with Italian case law).

  • Infringement exemption for vessels/aircraft/vehicles

The draft Bill would introduce an exemption for the use of patented inventions on board vessels or in the construction or operation of aircraft or land vehicles or other means of transport of countries of the International Union for the Protection of Industrial Property (Paris Union) or members of the World Trade Organisation, when such vessels or vehicles temporarily or accidentally enter the Italian territory.

  • Transition period

The draft Bill guarantees the application of Italian law to proceedings concerning European patents until the UPC Agreement comes into force and for the duration of its transition period.

The final touches

The remainder of the draft Bill is aimed at removing any inconsistencies with existing provisions governing patents in force in Italy and their application to unitary patents where necessary. If significant changes are not required to it, the draft Bill could be approved in the near future.

The draft Bill rounds off Italy’s preparations for the unitary patent and UPC system, which had been put into motion with the amendment of the Italian Industrial Property Code to incorporate provisions on indirect infringement as required by the UPC Agreement.

 

Contacts

Sebastian Moore
Sebastian Moore
Partner
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Sara Balice
Sara Balice
Senior Associate
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Martina Maffei
Martina Maffei
Associate
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+39 0200681353

 

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23 November, 2018

CJEU rules on whether the NHS reimbursing off-label medicinal products for cost-cutting purposes conflicts with Directive 2001/83/EC

Novartis Farma S.p.A. v Italian Medicines Agency and Roche Italia S.p.A.

On 21 November 2018, the CJEU issued an important decision in Novartis Farma v Italian Medicines Agency and Roche Italia et al. (C-29/17). The case was referred to the CJEU by the Italian Council of State and regarded an Italian law that allows the national healthcare insurance system (NHS) to reimburse a medicinal product for a use not covered by its marketing authorisation (off-label use) in order to reduce expenditure, notwithstanding the existence and market availability of a valid therapeutic alternative.

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19 November, 2018

French court upholds validity of MSD’s SPC protecting ezetimibe and simvastatin in combination

A French Court has upheld the validity of a Supplementary Protection Certificate (“SPC“) protecting the ezetimibe+simvastatin combination under Article 3(a) of the SPC Regulation.

Merck Sharp & Dohme (“MSD“) is the owner of a basic patent covering the compound ezetimibe. The basic patent also covers ezetimibe’s combinations with statin compounds, such as simvastatin, in its dependent claim, and simvastatin was already known as at the priority date. On the basis of this basic patent, MSD was granted an SPC for ezetimibe that expired on 17 April 2018, and an SPC for the combination ezetimibe+simvastatin expiring on 2 April 2019. Facing generic entry for the combination product when the ezetimibe SPC expired, MSD initiated preliminary injunction proceedings against a generic company, and a main revocation action was initiated by another generic company against the combination SPC.

In the PI case, the President of the Paris First Instance Court and the Paris Court of Appeal refused to grant the injunction on 5 April 2018 and 26 June 2018 respectively, relying primarily on the CJEU referrals in Georgetown and Sanofi to rule that since ezetimibe is the only “core of the invention” in the basic patent, the combination SPC could not be granted for ezetimibe+simvastatin.

Nevertheless, on the merits, the Paris First Instance Court upheld the validity of the combination SPC in a decision issued on 25 October 2018. The Court ruled on the basis of Georgetown and Sanofi as well as the decision in Gilead on 25 July 2018, that for the purposes of Article 3(a) of the SPC Regulation, “if the product, which is a combination of active ingredients according to Article 1 of EC Regulation No. 469/2009, necessarily belongs to the invention covered by the patent and if each active ingredient is specially identifiable, the grant of an SPC for the combination of active ingredients is possible“, as in the present case. Although the SmPC of the ezetimibe product mentioned the possibility of combining ezetimibe with statin compounds even before the combination was authorised as a medicinal product, the Court disagreed with the generic and also ruled that the marketing authorisation for the ezetimibe product could not be considered the first marketing authorisation in respect of the combination product for the purposes of Article 3(d) of the SPC Regulation.

In addition to the SPC argument, the decision rules on other issues, such as the statute of limitation of a revocation action (not time barred in the present case), and the sufficiency of disclosure of the combination ezetimibe+simvastatin in the basic patent (upheld on the basis of the test set in the finasteride decision of the French Supreme Court).

Please see here for the court’s decision in French.

Contacts

Frederic Chevallier
Frederic Chevallier
Partner
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Krishna Kakkaiyadi
Krishna Kakkaiyadi
Associate
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+44 20 7466 2979

 

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15 November, 2018

Draft Withdrawal Agreement Approved by UK Cabinet – IP and Marketing Authorisation Provisions Summarised

As was widely reported yesterday evening, the Draft Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (the Draft Withdrawal Agreement (14 November 2018)), detailing the arrangements for the UK to leave the EU has now been agreed by the UK Cabinet. The draft is as agreed between the UK and the EU’s negotiators. As stated in HSF’s Brexit Withdrawal Agreement webinar invitation here, a special European Council, anticipated to be held on 25 November 2018, will be asked to approve the Draft Withdrawal Agreement and the full text of the political declaration. The deal will also have to pass through the European Parliament. However, the main challenge to a deal being ratified is the requirement for approval by the UK Parliament. The first vote by the UK Parliament is expected within two weeks of the European Council.

We set out below a summary of the Draft Withdrawal Agreement’s provisions on intellectual property. The situation is not much changed from the previous draft issued in March 2018 although the provision for geographical indications has now been agreed: EU-wide rights will be replaced or recognised in the UK and provision has been made for pending applications, including for supplementary protection certificates (SPCs). The sharing of information for assessment of marketing authorisations between the MHRA and the EMA and vice versa is also provided for.

The Draft Withdrawal Agreement provides for an implementation/transition period from the date the UK leaves the EU (29 March 2019) to end of 31 December 2020. If the Draft Withdrawal Agreement is agreed, this transition period will mean that effectively the UK will continue to be treated as part of the EU from a legislative point of view. As the Commission’s press release puts it,”During this period, the entire Union acquis will continue to apply to and in the UK as if it were a Member State”. IP registrations and enforcement will carry on as normal during this period. Until the end of the transition period you will still be able to acquire/register and maintain EU-wide IP rights that will have effect in the UK. See the detail in our summary section below.  However, “as of the withdrawal date (i.e. including during the transition period), the UK, having left the EU, will no longer be part of EU decision-making. It will no longer be represented in the EU institutions, agencies and bodies, and persons appointed, nominated, or representing the UK, and persons elected in the UK, will no longer take part in the EU institutions, agencies, and bodies“.

The accompanying political agreement document “Outline of the political declaration setting out the framework for the future relationship between the European Union and the United Kingdom” (currently a summary version, with a fuller version to follow) looks to the future relationship between the UK and the EU post-transition. There is mention of IP in the section on Economic Partnership, but all that is said is: “Protection and enforcement of intellectual property rights beyond multilateral treaties to stimulate innovation, creativity and economic activity”.  Under ‘Basis for cooperation’, the political agreement states that “Terms for the United Kingdom’s participation in Union programmes, subject to the conditions set out in the corresponding Union instruments, such as in science and innovation, culture and education, development, defence capabilities, civil protection and space”. There is also mention of “Cooperation in matters of health security”.  For more on the impact of no deal on the pharma industry see our post on the UK Government’s “no deal technical notices” published on 23 August 2018.

Summary of the Draft Withdrawal Agreement’s provision for IP and marketing authorisations:

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15 November, 2018

UK SUPREME COURT RAISES SUFFICIENCY STANDARD FOR SWISS-FORM CLAIMS AND LIMITS THE ABILITY TO ASSERT THEM AGAINST “SKINNY LABEL” PRODUCTS

Commercial impact

Yesterday’s Supreme Court decision in Warner-Lambert v Mylan is disappointing news for patentees who may have made significant investment in R&D to develop new uses for known medicines. The full judgment and press release can be found here.

The Supreme Court recognised the value of such second (and further) medical uses and the importance of their patent protection so as to reward and incentivise the patentee. In spite of this, the Supreme Court:

  1. raised the standard of sufficiency of disclosure, with the result that existing Swiss-form claims may be more vulnerable to attack and future medical use claims may be more difficult to obtain; and
  2. limited the protective effect of Swiss-form claims.

Whilst its decision concerns Swiss-form claims, the Supreme Court recognised that although EPC 2000 claims (which have superseded Swiss-form claims) may be drafted differently, they give rise to similar difficulties as those discussed in the decision. As a consequence, yesterday’s decision will have long-felt ramifications for patentees both in terms of litigation and prosecution strategy, as well as being influential in the courts of other jurisdictions.

Comment

The Supreme Court has adopted a higher standard for the assessment of the plausibility of Swiss-form claims than previously used. In doing so, the Supreme Court appears to increase the amount of information required to be disclosed in a patent’s description as well as the specificity required in claims where there are sub-categories of related indications. This may narrow the window that innovative companies have to file patent applications in advance of clinical trials and may necessitate the need for additional dependent claims covering the separate, related indications rather than relying on a category claim. The decision was by a majority view (Lord Sumption, Lord Reed and Lord Briggs).

Although obiter, the Supreme Court prefers an approach to the infringement of Swiss-form claims (which are purpose-limited process claims) in which:

  1. the ability to assert indirect infringement ends at the manufacturer’s gate; and
  2. an objective approach is taken to direct infringement by the sale of the product of the infringing process (under section 60(1)(c) of the Patents Act 1977). Under this objective approach, “skinny labels” carving out the patented indication will often be effective in avoiding infringement.

This approach to direct infringement appears to have taken its lead from the approach in Germany. However, as highlighted by Lord Briggs, the Supreme Court was not provided with any information about the particular features of the German system for prescribing and dispensing medicines or about the market conditions within which a fair balance has to be struck, all of which could have a significant impact on this balance. This would particularly be the case if, for instance, it was not possible to obtain reimbursement in Germany for the off-label prescription, but reimbursement was possible in the UK.

On the facts of the case before it, the Supreme Court held that the claims of Warner-Lambert’s patent relating to neuropathic pain were invalid for insufficiency in their entirety, and that there would have been no infringement by Actavis had the claims been held to be valid.

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Jonathan Turnbull
Jonathan Turnbull
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Alex Freelove
Alex Freelove
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25 October, 2018

THE COURT OF APPEAL MAKES FRIENDS WITH SEP HOLDERS

Unwired Planet International Limited v Huawei Technologies Co. Limited [2018] EWCA Civ 2344

The Court of Appeal has endorsed the approach taken by Birss J at the first instance in relation to determining fair, reasonable, and non-discriminatory (FRAND) royalties and the rights and obligations of parties negotiating licences for standard essential patents (SEPs), dismissing Huawei’s appeal in its entirety.   Continue reading →

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24 October, 2018

France adopts a confidentiality regime for the trade secrets relied upon in (patent) litigation

As part of the French Law on the Protection of Trade Secrets dated 31 July 2018, French lawmakers have finally adopted a long-awaited array of confidentiality rules covering the trade secrets that are being relied upon in cases that come before civil and commercial courts. Such provision was a requirement of the EU Trade Secrets Directive of 8 June 2016. These confidentiality rules have already been applied in patent litigation in a decision of the Paris Court of Appeal of 9 October 2018.

Until now, parties to patent litigation in France might have been reluctant and even precluded from providing confidential data, such as (i) their own financial data in the interests of calculating damages, or (ii) confidential contractual documents, as confidentiality could not be adequately preserved once these were relied upon as evidence in open court. This vulnerability has historically had a deterrent effect on efficient patent litigation in France compared to what was possible in other jurisdictions.

The following provisions went into force on 1 August 2018, marking a great improvement and quickly proving their worth in French patent litigation.

Article L. 153-1 of the French Commercial Code now provides that “Where, in the course of civil or commercial proceedings aimed at obtaining a pre-trial order of investigative measures before any proceedings on the merits, or in the course of proceedings on the merits, and the exhibit has been deemed to infringe or alleged by a party to the proceedings or a third party to be capable of infringing a trade secret, the court may take any of the following steps sua sponte or at the request of a participating or third party if the trade secret cannot be otherwise protected, without prejudice to the rights of defence: 1° Have the court alone review the exhibit, and if deemed necessary, order an expert opinion and request an opinion from each of the parties via a person authorized to assist or represent the party so as to decide whether to apply the protective measures set out in this Article; 2° Decide to limit the disclosure or production of the exhibit to certain parts thereof, order disclosure or production of a summary of the exhibit only, or restrict all parties’ access to a single individual person and a person authorized to assist or represent that party; 3° Decide that hearings will be held and the decision issued in chambers; 4° Adapt the grounds of the decision and the mode of publication thereof to the need to protect the trade secret.”

In addition, Article L. 153-2 of the French Commercial Code provides that “Any person with access to an exhibit (or content thereof) that the court has deemed to be covered or likely to be covered by trade secret is bound by a duty of confidentiality and prohibited from any use or disclosure of the information in the exhibit. For a legal entity, this obligation […] applies to its representatives by law or pursuant to the articles of association and to any persons acting for the entity in court. Persons with access to the exhibit or its content are not bound by this duty either in their interactions with one another or with the aforementioned representatives of the entity that is party to the proceedings. Persons authorized to assist or represent the parties are not bound by this duty of confidentiality vis-à-vis said parties, except as provided in Article L. 153-1(1°). The duty of confidentiality does not expire at the end of the proceedings. It does expire, however, if a court issues a non-appealable decision that trade secrecy does not apply or where the information in question has since ceased to qualify as a trade secret or has become easily available.”

The ability to rely on confidential data could be a game changer in future patent litigation in France, and the Paris Court of Appeal has already enforced these provisions to allow confidential license agreements to be disclosed while ensuring their confidentiality. The decision, dated 9 October 2018, was issued in a SEP/FRAND case, but its solution could apply across an extremely broad range of patent litigation cases in France. The operative part of the decision reads as follows:

“Rule that the communication of these non-redacted documents, along with their possible schedules, will first be made between attorney’s only, that the attorneys will then revert to us – by 7 December 2018 at the latest – with their written observations on the excerpts or elements of those documents likely, on their opinion, to infringe or not a trade secret, such that we can decide, if relevant, to order one or several measures provided in paragraphs 2°, 3°, or 4° of Article L. 153-1 of the French Commercial Code.”

Our London and Milan offices have also commented on the implementation of the Trade Secrets Directive in their respective jurisdictions on the Herbert Smith Freehills Intellectual Property Notes blog: see here for the UK and here for Italy.

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Frédéric Chevallier
Frédéric Chevallier
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12 October, 2018

Patent and Pharma Update – October 2018

Key recent developments in the United Kingdom and Europe relating to patents and the pharmaceutical sector

The CJEU has provided its preliminary ruling in Teva v Gilead on the meaning of Article 3(a) in the context of a medicinal product composed of several active ingredients. It has also clarified principles of IP rights exhaustion applicable to parallel importation of medicinal products from “new” Member States that acceded to the EU after 2003. Closer to home, English courts have handed down some interesting decisions around claim construction, confidentiality clubs and delays in raising new arguments. Finally, as the UK moves closer to the March 2019 Brexit deadline, questions remain as to whether the Unified Patent Court will be set up in time for the UK to participate in the Unitary Patent system. The UK Government has made some progress in setting out its approach to various IP issues in the event of a “no-deal” Brexit by recently publishing several technical notes.

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10 October, 2018

EPO publishes 2018 revision of Guidelines for Examination directed to computer-implemented inventions

The EPO has recently published the 2018 revision to its Guidelines for Examination, which are generally updated annually to take into account developments in patent law and practice. For a complete list of sections that have been amended this year, please see the EPO’s website here. These new Guidelines will come into effect on 1 November 2018.

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