Responding to a question referred to it by the EPO’s President, the Enlarged Board of Appeal of the European Patent Office has issued its opinion in relation to what was perhaps the most controversial referral of 2019. In a complete reversal of its opinion of just five years ago, the EPO has held that plants and animal products produced by essentially biological (natural) processes are not patentable. Continue reading
Key recent developments in the United Kingdom and Europe relating to patents and the pharmaceutical sector
In this issue we report on the Supreme Court decision of Shanks v Unilever on employee inventor compensation. We update on two CJEU decisions relation to public access to documents submitted to the EMA and a key competition decision on “pay-for-delay” agreements. We cover a string of patent-related UK Court of Appeal cases, including Ablynx v VHSquared on jurisdiction, Anan Kasei v Neo on insufficiency and joint tortfeasorship and L’Oreal v Liqwd on claim amendments and admission of late evidence. We provide brief updates from the EPO on the recent CRISPR priority decision, as well as its AI inventorship decision. We have bumper SPC and FRAND updates covering key Court of Appeal and CJEU decisions in respect of SPCs and a string of interesting interim decisions in the UK in the case of FRAND. We round off the issue with a link to our new IP podcast series and updates on Brexit and the UPC. Continue reading
Key recent developments in the United Kingdom and Europe relating to patents and the pharmaceutical sector
In this issue we provide updates from the CJEU on SPCs: in one case the CJEU has declined to consider a referral from the UK while in another the Advocate General has issued his opinion on the interpretation of Article 3(a) of the SPC Regulation. We take a look at the decision in Takeda v Roche and the requirements for an enabling disclosure. In France, we consider a second attempt to secure a preliminary injunction as well as an update to the law on reimbursement. In another decision, the CJEU has considered the requirements of the Enforcement Directive in the context of a wrongly awarded preliminary injunction. On the RAND side, a Court of Appeal decision has also pulled back on the court’s exercise of its jurisdiction. There are a number of important procedural updates relating to: parallel UK and EPO proceedings; the Disclosure Pilot Scheme; and transfers from the IPEC to the Patents Court. We round off this issue with updates on the Patents Court judges; Brexit guidance on IP and the Pharma Sector; and the Unified Patent Court.
1. SPC updates
We report on the recent decision of the CJEU not to consider a referral from the High Court on the interpretation of Article 3(b) of the SPC Regulation, which related to the ability of an applicant for an SPC to rely on a third-party MA. The CJEU ruled that the referral was manifestly inadmissible. We also report on the recent AG’s Opinion on the interpretation of Article 3(a) of the SPC regulation.
2. Novelty – what needs to be enabled? A closer look at Takeda v Roche
In a dispute relating to monoclonal antibodies, Mr Justice Birss finds the patent-in-suit invalid on the grounds of lack of novelty and inventive step and insufficiency. We consider Birss J’s analysis of the requirements for an enabling disclosure in the context of novelty.
3. Updates from France
In a decision concerning animal health products, Bayer was permitted to apply for a preliminary injunction for a second time given that the circumstances had changed since its first application, although it was ultimately unsuccessful. We also provide an update on new French legislation relating to reimbursement of medicinal products, generic products and biosimilars.
4. Green light for damages compensation in case of lifted PI? Not always, says the CJEU
In a referral from the Hungarian Courts, the CJEU provides guidance on the requirements of the Enforcement Directive to compensate a party where a preliminary injunction has been granted but the patent subsequently revoked.
5. ‘Jurisdictional imperialism’ – the Court of Appeal pulls back
In the latest instalment of TQ Delta v ZyXEL the Court of Appeal rules that a RAND trial should not proceed in circumstances where ZyXEL has purported to waive its RAND rights. This reverses the decision of Mr Justice Birss, which we reported in the last edition of this update.
6. Procedural updates
We consider the High Court’s application of the IPCom Guidance in ordering UK patent proceedings to go ahead while opposition proceedings run in parallel in the EPO; over the summer there have been two patent cases applying the rules of the new Disclosure Pilot Scheme; and His Honour Justice Hacon considers an application to transfer proceedings from the Intellectual Property Enterprise Court to the Patents Court.
7. The Patents Court judges
We provide a brief update on the judges in the Patents Court.
8. Brexit – updates to the Brexit legal guide
Following further Brexit guidance from the UK government on IP and the Pharma Sector we have updated the Herbert Smith Freehills Brexit Legal Guide.
9. The Unified Patent Court
We reflect on the progress of the Unified Patent Court and the steps that remain for it to come into effect.
10. Table of patents decisions
11. Table of other relevant decisions
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.
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 scheme “which 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:
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.
This week the Supreme Court is hearing an appeal in Warner-Lambert v Generics (UK) Ltd (Mylan) and others (UKSC 2016/0197) which will consider the following questions relating to the role of plausibility in UK patent law:
- “Whether (and what) role plausibility should play in the statutory test for sufficiency, and whether a patent should be held insufficient for lack of plausibility even though it is in fact enabled across the full scope of the claim.”
- “If a plausibility test is appropriate, provided there is basis to support the claim across part of its scope, whether later evidence can be used to fill the gap.”
“Plausibility” has been an increasingly hot topic in patent litigation in recent years, particularly in cases relating to pharmaceuticals, and its rise has not been without controversy amongst patent lawyers. It has most frequently been associated with inventive step and insufficiency, but it has also come up in relation to industrial applicability, priority and novelty and it is now a firmly established concept for any lawyer considering the validity of a patent.
What is required for something to be “made plausible” has been considered by the Supreme Court before (HGS v Lilly (2011), in which it was found to be a low, threshold test) but that was in the context of industrial applicability. This appeal to the Supreme Court asks the fundamental question of whether (and what) role plausibility should play in the statutory test for sufficiency. The Court of Appeal has accepted that plausibility plays a role in sufficiency (and inventive step), based on EPO Technical Board of Appeal case law relating to both inventive step and insufficiency, combining it with English law relating to principles of general application. It will be particularly interesting to see how the Supreme Court approaches this question, given the firmly established case law in the EPO on this issue.
Fundamentally, this is a question about what is required of a patentee at the time they file a patent application – is it enough for them to speculate in the specification on a possible use for the claimed compounds, in the hope that that speculation will later turn out in fact to be true (if it is not, the claim will be insufficient anyway), or should public policy require that the patentee at least provides some real reason for believing that the proposed use is true at the time of filing, to prevent patentees from excluding others from large areas of research in the hope that active compounds turn up one day? The answer to that question has potentially significant ramifications for patentees, both in terms of what they need to be including in future patent applications by way of reasoning and/or data (which may affect the stage of the R&D process at which they are able to file them) and in considering the validity of their existing patents. It is interesting that the UK BioIndustry Association has intervened in the case – more details on their position can be found here.
It’s worth noting that as well as the plausibility questions being considered, the Supreme Court will also hear argument on questions regarding expert evidence on claim construction and abuse of process in relation to late claim amendments, the answers to which may have effects on routine practice in the Patents Court.
Key recent developments in the United Kingdom and Europe relating to the patents and pharmaceutical sector. One of the most significant developments in the patent law arena in recent years has been the decision of the Supreme Court in Actavis v Eli Lilly, which has changed the approach to patent infringement in the UK. The update starts by commenting on the new rules of infringement and looks at how subsequent decisions may apply this new test. The case will impact most pharmaceutical sector players, whether they are originators or generics, and may impact the strategy that patentees adopt when litigating in the UK. The update further reports on other significant developments in UK and European law, including a recent TBA decision which elevates the threshold for plausibility and recent references to the CJEU on the SPC Regulation.
1. A new UK approach to infringement: equivalents infringe a patent, but do not anticipate it?
The UK Supreme Court has redefined the UK approach to patent infringement, holding that the scope of protection of a patent extends to “equivalents” of the claimed invention. However, the Patents Court has since held that such equivalents, even if they pre-date the patent, do not anticipate it Read more
2. Plausibility before the EPO and reliance on post-published evidence
BMS has filed a petition for review to the Enlarged Board of Appeal regarding the TBA’s decision to revoke BMS’s patent for the anti-cancer drug dasatinib. The Board’s decision to revoke the patent suggests that the threshold for plausibility has been elevated, at least in the context of an inventive step Read more
3. Further References to the CJEU on Supplementary Protection Certificates (“SPCs”)
The German Federal Patent Court has referred two further issues to the CJEU regarding the interpretation of Article 2 and 3(a) of the SPC Regulation. In relation to Article 2 the Court has asked whether an SPC can be obtained for drug device combination products and, if so, in what circumstances. With regards to Article 3(a) the Court has added further detail to the questions asked by Arnold J in Teva v Gilead Read more
4. New Unjustified Threats Regime in force from 1 October 2017 – encompassing unitary patents and European patents under UPC jurisdiction
The new Unjustified Threats Regime has recently come into force. This Regime is an attempt to encourage more pre-action communication by providing greater clarity on what amounts to an actionable threat Read more
5. Further information ordered to be provided in an enquiry as to damages under a cross-undertaking
Birss J has provided guidance on pleadings for damages under a cross-undertaking. The High Court found the Points of Claim were fundamentally lacking critical information and Sandoz was ordered to provide further information on their substantial £100 million claim for damages, including profit margins on each type of product and profit flows between the relevant Sandoz group companies (under agreed confidentiality terms) Read more
6. UK court strikes out a claim for loss suffered as a result of the tort of unlawful deceit
The High Court has struck out the NHS’s claim for damages based on the tort of causing loss by unlawful means regarding misrepresentations on novelty/obviousness. Roth J’s interim decision represents the latest instalment in the fall-out from Servier’s actions concerning delayed entry of perindopril, and suggests that this tort should be confined within a narrow ambit Read more
7. Judicial consideration of a collaboration agreement in Astex Therapeutics Limited v AstraZeneca AB  EWHC 1442 (Ch), (“Astex”)
Arnold J’s judgment in Astex provides insight into how the Courts will approach the interpretation of a research and collaboration agreement. Arnold J also commented on the amount of witness evidence that was put before him concerning events that had occurred between 10 to 15 years ago Read more
8. Developments in Europe
A brief overview of the developments in the European arena in the past months, including an EU Commission consultation on SPCs, the new approach adopted by EPO to patentability of products obtained by essentially biological processes and how HSF can help you to successfully navigate the new data protection laws Read more
9. UPC Update
This article provides an update on the progress of ratification of the UPCA in the UK and Germany Read more
See our previous Patent and Pharma Updates on our IP Blog here:
From 1 July 2017, the EPO will no longer grant patents for plants and animals exclusively obtained by means of an “essentially biological process”. This follows a European Commission Notice dated 8 November 2016 (please click here for the full text of the Commission Notice) clarifying that the EU legislator had intended to exclude such plants and animals (either in whole or in part) from patentability when adopting the EU Directive on biotechnological inventions (Directive 98/44/EC) (the “Directive“).