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
Email | Profile
+33 15 357 1360
Krishna Kakkaiyadi
Krishna Kakkaiyadi
Associate
Email
+44 20 7466 2979

 

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

Filed under EU, France, Patents and SPCs, Pharma

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:

Continue reading

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

Filed under Agribio, Consumer, Copyright (and related rights), Designs and Databases, EU, IP licensing and transactions, Media and Advertising, Patents and SPCs, Pharma, Trade marks, Passing off, Geographical indications, PDOs, UK, Uncategorized

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.

Contacts

Jonathan Turnbull
Jonathan Turnbull
Partner
Email | Profile
+44 20 7466 2174
Alex Freelove
Alex Freelove
Senior Associate
Email | Profile
+44 20 7466 7452

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

Filed under Patents and SPCs, Pharma, UK

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

Comments Off on THE COURT OF APPEAL MAKES FRIENDS WITH SEP HOLDERS

Filed under IP licensing and transactions, Patents and SPCs, UK

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.

Contact

Frédéric Chevallier
Frédéric Chevallier
Partner
Email | Profile
+33153571360

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

Filed under Confidential information and trade secrets, France, Patents and SPCs, Pharma

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.

Continue reading

Comments Off on Patent and Pharma Update – October 2018

Filed under EU, Patents and SPCs, Pharma, UK

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.

Continue reading

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

Filed under Consumer, EU, Innovation, AI, AR and VR, Patents and SPCs, Pharma

UK Government launches consultation on role of MHRA post-Brexit and confirms commitment to underwrite Horizon 2020 funding

The UK Government has today launched a consultation on the role of the Medicines and Healthcare products Regulatory Agency (MHRA) post-Brexitseeking views on how the MHRA legislation and regulatory processes would have to be modified in the event of the UK not securing a deal with the EU after the UK’s exit, with no Implementation Period“. As the consultation closes at 11.45 pm on 1 November 2018, time is short for making a response.

Also today, the Government has released an overview of the UK’s relationship with the EU’s Horizon 2020 science and innovation funding programme including a link to the portal where those with current funding can submit data which will be used to guarantee funding post-Brexit.

MHRA Consultation

  • This consultation was promised in the no-deal technical notice on medicines, clinical trials and medical devices, discussed in our blog post of 29 August 2018. It is expressed to be set in the context of “the UK not securing a deal with the EU after the UK’s exit, with no Implementation Period“, i.e. a “cliff edge” no-deal scenario, with no transitional period. However, if the EU Withdrawal Agreement (which sets out the terms on which the UK leaves the EU and is currently being negotiated between the UK and the Commission) is concluded on the terms that have so far been declared as agreed between the negotiators, then there would be a period until the end of 2020 when the UK would still effectively be part of the EU, despite technically having exited at 11pm on 29 March 2019.
  • A direct link to the consultation can be found here.  More detail on the consultation, including the specific areas being covered, can be found in the Consultation Introduction. As the introduction to states, “the overall approach in no-deal is for the MHRA to be a stand-alone medicines and medical devices regulator, taking any decisions and carrying out any functions which are currently taken or carried out at EU-level. This would include decisions on Marketing Authorisation (MA) applications which are currently authorised through the Centralised Procedure, paediatric investigation plans and orphan status, as well as pharmacovigilance responsibilities“. The consultation also asks for comments on clinical trials issues.
  • The introduction recommends that you read the Draft Statutory Instrument (SI) text, Impact Assessment and Consultation Annex before responding. The Draft SI text relates to statutory instruments that will be needed to update the Human Medicines Regulations 2012, the Medicines for Human Use (Clinical Trials) Regulations 2004, the Medicines (Products for Human Use) (Fees) Regulations 2016, and the Medical Devices Regulations 2002.
  • Response to the consultation is in the form of an on-line survey. Each section of the survey is optional, so you can limit your response to the sections you are interested in.

Horizon 2020 funding

  • Following on from the no-deal technical notice on Horizon 2020 funding which was issued with the other life sciences related notices in August (here), the UK Government has published an overview of the UK’s relationship with Horizon 2020, followed by a Q&A, which aims to clarify the UK’s eligibility to participate in Horizon 2020 – here. Current UK recipients of Horizon 2020 funding are invited to provide data about their projects on a portal managed by UK Research and Innovation (UKRI) (linked on the same page), so that the UKRI has the information it needs in order to underwrite the guaranteed payments if this becomes necessary.
  • As we previously stated in our blog post: If there is ‘no deal’, the Government says it has taken steps to provide continued support for research and innovation currently being funded through this EU project fund. The Government will guarantee funding in most cases, for the full duration of the project, where the funding relates to successful bids submitted by UK participants before the UK exits the EU. Funding will only be for UK participants however. Where UK participants are leading consortia of non-UK parties and would normally be distributing the Horizon 2020 funds, the Government will seek to discuss with the EU Commission how best to address this. In it’s no-deal notice, the Government said it was considering what other measures may be necessary to support UK research and innovation in the event that the EU’s funding is no longer available. Looking beyond 2020, the notice said that “the UK remains committed to ongoing collaboration in research and innovation and wants to work with the EU on a mutually beneficial outcome“.

Contacts

Jonathan Turnbull
Jonathan Turnbull
Partner
Email | Profile
+44 20 7466 2174
Rachel Montagnon
Rachel Montagnon
Professional Support Consultant, London
Email | Profile
+44 20 7466 2217

Comments Off on UK Government launches consultation on role of MHRA post-Brexit and confirms commitment to underwrite Horizon 2020 funding

Filed under EU, Innovation, AI, AR and VR, Patents and SPCs, Pharma, UK

Brexit “no deal” technical notices published on Patents, Trade marks, Designs, Copyright, GIs, and Exhaustion of rights

The latest tranche of “no deal” technical notices was released yesterday afternoon by the UK Government. Amongst them are several notices that highlight the Brexit issues faced by intellectual property right owners and, in some cases, confirm the Government’s approach to resolving them. The Government also released this news story today which comments on the guidance given in the technical notices and comments on the Government’s longer term aims for IP protection.

Key announcements, in the context of no deal, are:

  • Provision of a new right to replace unregistered Community design rights, to be known as “the supplementary unregistered design right“.
  • Existing EUTMs and Community registered designs will be replaced with new, equivalent rights in the UK at the end of the implementation/transition period, “with minimal administrative burden“.
  • The SPC, compulsory licensing, pharmaceutical product testing exception and patenting of biotechnological inventions regimes will remain unchanged at least initially.
  • If the UPC comes into force the UK will replace unitary patent rights with equivalent rights if the UK needs to withdraw from the new system, although the UK “will explore whether it is possible to remain within it“. The Government’s news story states that “The UK intends to stay in the Unified Patent Court and unitary patent system after we leave the EU.”
  • UK originating sui generis database rights will no longer be enforceable in the EEA; “UK owners may want to consider relying on other forms of protection (e.g. restrictive licensing agreements or copyright where applicable) for their databases
  • The UK will set up its own GI schemewhich will be WTO TRIPS compliant“. The new rights “will broadly mirror the EU regime and be no more burdensome to producers“.  Since the UK would no longer be required to recognise EU GI status, EU producers would be able to apply for UK GI status. Those wishing to protect UK GIs in the EU will need to submit applications on a third country basis.
  • The UK will continue to accept the exhaustion of IP rights in products put on the market in the EEA by, or with the consent of, the rights holder. However, the EU will likely not consider that goods placed on the UK market are exhausted in the EEA, and thus permission may need to be sought from the rights holder to transfer goods to the EEA that have legitimately been put on the market in the UK. The Government news story says that “The UK looks forward to exploring arrangements on IP cooperation that will provide mutual benefits to UK and EU rights holders and we are ready to discuss issues the EU wishes to raise in the negotiations on our future relationship, including exhaustion of IP rights”.

Links to the notices:

  1. Patents
  2. Trade marks and designs
  3. Copyright
  4. Geographical Indications
  5. Exhaustion of IP rights

More detail on each of these is provided below. For those with an interest in Life Sciences please also see our blog post on the notices related to that sector that were released last month.

Continue reading

Comments Off on Brexit “no deal” technical notices published on Patents, Trade marks, Designs, Copyright, GIs, and Exhaustion of rights

Filed under Agribio, Consumer, Copyright (and related rights), Designs and Databases, EU, France, Italy, Media and Advertising, Patents and SPCs, Pharma, Trade marks, Passing off, Geographical indications, PDOs, UK

TRADE SECRETS – SHORT VIDEO ON THE IMPACT OF THE NEW UK REGULATIONS IN IP AND EMPLOYMENT CONTEXTS

Here’s a short video made for Practical Law, in which Herbert Smith Freehills IP and Employment Professional Support Consultants, Rachel Montagnon and Anna Henderson, discuss the impact of the UK’s recent Trade Secrets (Enforcement etc) Regulations 2018 and practical approaches to protecting confidential information and trade secrets.

Key issues discussed are:

  • The new, common definition of a trade secret
  • What constitutes lawful and unlawful acquisition, use and disclosure of a trade secret
  • Practical steps businesses can take to protect confidential information
  • Considerations in relation to whistleblowing
  • Guidance around reverse engineering
  • Bringing a claim under the regulations
  • Remedies and provision for damages.
These new UK trade secrets regulations have implemented the Trade Secrets Directive ((EU) 2016/943) and came into force on 9 June 2018.  Also on our IP Notes blog, see our Milan office’s post on the Italian implementation of this Directive and our previous posting on implementation of the Directive in the UK.

Comments Off on TRADE SECRETS – SHORT VIDEO ON THE IMPACT OF THE NEW UK REGULATIONS IN IP AND EMPLOYMENT CONTEXTS

Filed under Confidential information and trade secrets