EPO insight report on mRNA patents reveals a steep increase in patent filing, shedding light on the dynamic future, and past, of this life-saving technology

A recent report from the European Patent Office (EPO), here, revealed that patents for mRNA technologies, which played a pivotal role in mitigating the impact of COVID-19, have increased at an accelerated rate in recent years. The report further highlights that the “above average” number of international applications made through the Patent Cooperation Treaty reflects “multinational commercialisation strategies” and thus serves as a proxy for the “high economic expectation” for these life-saving technologies.

The report identified 2,300 inventions (defined by the number of unique patent families) related to mRNA vaccines, pointing out the rate of increase in recent decades. Although mRNA vaccines were globally approved for medical use only in recent years, mRNA-based drug development has been studied since the 1980’s. Since then, there has been a steady growth in the number of inventions; in 1990, approximately 25 patents were filed compared to around 350 in 2021. This trend is reflected in Figure 1 of the report, which shows that the patent filings for mRNA technologies has outstripped the baseline rate across all technological fields. The insight report observes that pressure to “innovate at speed” during the COVID-19 pandemic alongside decades of research which gradually improved the design and delivery of mRNA vaccines, facilitated the dramatic increase in inventions and patents in recent years.

Figure 1

Moreover, the report revealed that WIPO received the highest proportion of patent applications under the Patent Cooperation Treaty, out of all multi-jurisdictional patent filings. This indicates a desire for widespread geographical reach and the EPO suggests that inventions related to mRNA vaccines are perceived as holding a high economic potential. The increasing use of international patent authorities when seeking to file mRNA technologies patents demonstrates that “multinational commercialisation strategies” are being adopted by companies hoping to exploit patents globally.

The report also outlines the key jurisdictions and companies from where patent applications were originating, highlighting “the key role of applicants from the United States, Europe and China”. Their analysis of international databases revealed that the top 20 patentees were based in one of these jurisdictions, with 13 coming from the United States alone. It also highlighted that Moderna topped the list for most patent filings, filling 96 applications in 11 years, with CureVac coming in a close second at 95 applications. These findings are compatible with what is reflected in the patent litigation landscape, with both patentees recently engaging in global litigation to assert their various patents.

Indeed, the EPO report provides a valuable lens into the ‘patent wars’ which have emerged around mRNA vaccines in the last years. As indicated in the report, mRNA-related technology holds “high economic expectation” and therefore has become the subject of various intellectual property disputes. Moderna’s infringement proceedings against Pfizer and BioNTech was one of the first to catch the headlines, with CureVac’s claims against the same following soon after. The increasing value being attributed to mRNA vaccine inventions and its future potential in medical therapy provides a clear insight into why it is becoming such a contentious field of intellectual property. As demonstrated by the EPO report, the “field of mRNA-based vaccines is very dynamic and the momentum in this field is clearly above average”. Patent exploitation will be key to marking out the various players’ claim to the mRNA market.

 

Key Contacts

Julie Chiu
Julie Chiu
Senior Associate, London
+44 20 7466 2658

 

 

 

Live figures from the European Patent Office show healthy appetite for Unitary Patents

The European Patent Office has released a “Unitary Patent dashboard” offering “a timely snapshot of applicants’ eagerness to opt for the Unitary Patent”.

Live figures show that as of today, 1 August 2023, there have been 5665 requests for unitary effect, with the most popular technologies being Infrastructure & Mechanics (20.8%), Health (19.2%) and Materials & Production (19.2%). Therefore the new system seems to be an appealing one for applicants seeking to benefit from greater country coverage (17 participating states so far) and to enjoy the reduction in overhead costs and administration afforded by the new regime. As shown in the graph below, the rate of requests for unitary effect is accelerating – 2839 requests were made in July 2023 alone, compared to 1981 in June 2023.

 

The majority (70.6%) of applicable patents were published in English, which is in line with European Patents more generally. Revocation proceedings brought in the Unified Patent Court on these patents will be heard in English by default. Germany is the origin of the largest share of proprietors (1109), with the United States second (812).

For more information on the UPC and strategies and opportunities within this new patent jurisdiction, see our UPC and UP Hub.

Key Contacts

Emily Bottle
Emily Bottle
Senior Associate
+39 02 3602 1402

HSF shares insights on the Milan local division UPC judges for Managing IP

Following the Unified Patent Court (UPC) Administrative Committee’s appointment of 85 legal and technical judges last month, including the appointment of two legally qualified judges in the Milan local division, Herbert Smith Freehills’ Joint Global Head of Intellectual Property Laura Orlando shares her insights with Managing IP on what this may mean for the UPC.

Commenting on the appointment of Pierluigi Perrotti and Alima Zana from the District Court of Milan, Laura says “there has been a high turnover recently in the domestic courts and that a number of new judges have joined the IP division. Conversely, Zana and Perrotti have been at the division for several years. Certainly, they are the judges with the most experience of patent cases.”

Discussing their respective styles, Laura says that “both Zana and Perrotti tend to carefully consider the established case law and approach previously taken in similar cases at the Italian and foreign courts, as well as the European Patent Office’s (EPO) approach to patent validity. This also stems from the standard Italian practice of using European patent attorneys as court experts in patent cases”.

Laura adds “Perrotti, in addition to his work as a judge, has always been very active in non-judicial activities, such as panel discussions at universities.”

The original article “Experience will benefit Italy’s UPC judges” was published by Max Walters at Managing IP on 17 November 2022. The full article is available to subscribers-only.

More information about the UPC and unitary patent can be found on our dedicated UPC & UP Hub.

For any questions relating to the UPC, please contact Laura Orlando or another member of our European patents team.

Laura Orlando
Laura Orlando
Partner, Milan
+39 02 3602 1371

EPO issues guidance on achieving unitary patent status from day 1 of the UPC/UP system for European patent applications coming up to grant

With the Unified Patent Court (UPC) and unitary patent (UP) system now likely to commence towards the second half of 2022, the European Patent Office (EPO) has issued transitional measures aimed at ensuring that patents coming to grant close to the start of the new system are able to get unitary protection (ie UP status) from “day 1”, including via a delayed grant mechanism.

The EPO, which is entrusted with the administration of the UP, has issued new guidance on transitional measures applicable to European patent applications. These measures apply to applications that have reached the final stages of grant procedure. The measures will come into effect on the date of deposit of Germany’s instrument of ratification of the UPCA, i.e. 3-4 months before the actual start of the UPC/UP system.

The transitional measures will apply only once Germany has deposited its instrument of ratification and only in respect of applications that have received an intention to grant (IGRA) communication from the EPO under Rule 71(3) EPC. On receipt of the IGRA communication, applicants have a non-extendable 4 month period in which to pay the fee for grant and publishing and to file a translation of the claims in the two official languages of the EPO other than the language of the proceedings. If the applicant pays the fee and files the translations within this period, he will be deemed to have approved the text intended for grant.

The purpose of the new measures is to allow those applying for patents which will grant on the start date of the UPC/UP system (Day 1) or shortly after, to select unitary status in advance, rather than waiting for the commencement of the new system to do so. Since Germany’s deposit of its ratification of the UPCA itself creates a non-extendable timetable to commencement of the new patent system, this means that the EPO will be accepting unitary status requests during that fixed run-up period when the existence and start date of the new system is guaranteed.

Further, since some patents might just miss the opportunity to apply for unitary status in advance of Day 1 even with these arrangements because they would normally be coming to grant shortly before the new system commences, the transitional measures will also allow applicants for patents (which are already in receipt of an IGRA) to apply to the EPO to delay the grant decision, so that they come to grant only once the new system has started and so can get unitary status from Day 1. Unitary effect would otherwise not have been available if they have come to grant before that date.

In summary:

  • The first measure – the early request for unitary effect – will enable applicants who have already received an IGRA, the 4 month response period of which would end on the start date of the UPC/UP system or later, to file early requests for unitary effect as soon as Germany deposits its ratification of the UPCA, and before the start of the UPC. This will allow the EPO to register unitary effect immediately at the start of the new patent system, provided all corresponding requirements are met.
  • The second measure – the request for a delay in issuing the decision to grant a European patent – will provide the possibility, as soon as the Germany ratification deposit has occurred, for the applicant who has already received an IGRA communication from the EPO in relation to which the 4 month time period would run out before Day1, to request a delay in the EPO issuing the decision to grant a European patent. This will allow a European patent that would otherwise have been granted before the start of the new system and thus miss the opportunity for unitary effect, to have its grant delayed so that it will then become eligible for request for unitary effect at the start of the new system.

Without such measures, patentees would only be able to request unitary status for their newly granted patents within the first month of grant.  Those whose patents would have come to grant after Day 1, are being given the chance to request unitary status from Day 1 using these new procedures. Others whose patents were granted more than a month before Day 1 and would therefore miss out on this opportunity will now be able to do the same through the grant delay mechanism.

The full guidance issued by the EPO is available here with helpful examples of how these new transitional measures are intended to work including illustrative timelines.

These transitional measures should ease some of the timing difficulties that would otherwise have been present and may encourage uptake of the unitary effect option amongst those applying for European patents. In the words of EPO President António Campinos:

“With the start of the provisional application, the Unitary Patent will now become a reality. A cost-attractive patent, uniformly covering the territory of all participating EU member states will be available a few months from now. Thus, the patent system will more effectively support growth and innovation, help more efficiently to tackle challenges like the COVID-pandemic, and foster economic growth to overcome the current crisis.”

For more on this development and the UPC and unitary patent in general, see our UPC & UP Hub.

Our fully integrated, market leading European patent litigation team is ready to advise on all aspects of the practical and strategic issues you should be considering in preparation for the UPC. Please contact us for further information.

Authors

Rachel Montagnon
Rachel Montagnon
Professional Support Consultant
+44 20 7466 2217

Priyanka Madan
Priyanka Madan
Associate
+39 02 3602 1389

Approach to assessing entitlement to priority unchanged – TBA in the CRISPR case confirms

On 6 November 2020, the Technical Board of Appeal (TBA) issued a written decision in case T 844/18, which concerned whether or not the Broad Institute’s patent (EP 2 771 468) relating to CRISPR gene editing technology could validly claim priority from several US provisional applications. In summary, the TBA confirmed that the applicable rules governing the entitlement to priority remain unchanged. As a result, the priority had not been validly claimed and the patent in question was revoked for lack of novelty due to intervening prior art. The outcome does not come as a surprise, since the TBA made known its decision following the oral hearing which took place in January 2020 (see our summary in the Patent & Pharma update from February 2020).

Under Article 87(1) EPC, any person who has duly filed an application for a patent or their successor in title shall enjoy a right of priority during a period of twelve months from the date of filing of the first application (emphasis added). Article 87(1) EPC corresponds to Article 4A of the Paris Convention for the Protection of Industrial Property.

The disputed issue, as summarised by the TBA, was as follows: “A and B are applicants for the priority application. A alone is the applicant of the subsequent application. Is this priority claim valid even without any assignment of priority right from B to A? The appellants say that the answer is ‘yes’ and the respondents that the answer is ‘no’.” The TBA sided with the respondents and in doing so decided the following points:

  • EPO are empowered and obliged to assess the validity of a priority right claim;
  • “Any person” under Article 87(1) EPC refers to all persons listed as applicants for the priority application, such that all persons listed as applicants for the priority application, or their successors in title, must be listed as applicants for the subsequent application (reaffirming the so-called “all applicants” approach); and
  • It is the Paris Convention and not national law which determines who “any person” is.

The TBA reiterated that Article 87(1) EPC has been consistently interpreted by the EPO since the inception of the European patent system and the practice is based on a reasonable interpretation of the legal provisions in question. The TBA also emphasised that the bar for overturning a long-established case law and practice should be a high one because of the disruptive effects a change may have.

A policy reason put forward in support of the appellant’s position was that a mistake in the formality of correctly naming the applicants should not lead to the revocation of the patent (echoing the remarks of Birss J in Accord Healthcare v Research Corporation Technologies [2017] EWHC 2711 (Ch)). The TBA responded that the present case is an example of a deliberate choice of the appellants rather than a mistaken omission and, also, that a formal requirement cannot be merely disregarded or ignored even if the consequence of its non-compliance can be a revocation of a patent. The TBA also noted the different context in which the remarks were made in the English High Court case (which dealt with a distinction between legal and equitable title).

The consequences of non-compliance with rules pertaining to claiming priority are significant and may result in invalidating an otherwise valid patent. With that in mind, considerable thought should be given to naming applicants on the priority application and the effect of any subsequent assignments of priority rights during the priority year to minimise future challenges to priority entitlement.

Monika Klajn
Monika Klajn
Senior Associate, London
+44 20 7466 7604
Alex Freelove
Alex Freelove
Senior Associate, London
+44 20 7466 7452
Jonathan Turnbull
Jonathan Turnbull
Partner, London
+44 20 7466 2174

Pepper trumps Broccoli: EPO finds products produced by essentially biological processes are not patentable

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

Patent and Pharma Update, February 2020

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

Patent and Pharma Update, October 2019

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.

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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.

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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.

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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.

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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.

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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.

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7. The Patents Court judges

We provide a brief update on the judges in the Patents Court.

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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.

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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.

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10. Table of patents decisions

 

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11. Table of other relevant decisions

 

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Key contacts

Jonathan Turnbull
Jonathan Turnbull
Partner
+44 20 7466 2174
David Webb
David Webb
Associate
+44 20 7466 2629
Rachel Montagnon
Rachel Montagnon
Professional Support Lawyer
+44 20 7466 2217

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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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.

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