Paul England, senior counsel in Taylor Wessing’s Patents Group, examines the burgeoning influence of the Unified Patent Court and unitary patents within the life sciences sector. How popular are unitary patents and do they have potential to reshape European life sciences patent litigation?
It has been more than three months since the Unified Patent Court (UPC) and the European patent with unitary effect (unitary patent) came into full force on 1 June 2023, adding a new layer of options to the existing European patent system of national courts and European patents.
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
Access the full report now to discover the techniques, tools and innovations that are transforming pharmaceutical formulation, and learn how to position your organisation for long-term success.
What you’ll discover:
Key trends shaping the pharmaceutical formulation sector
Innovations leading progress in pharmaceutical formulation and how senior professionals can harness their benefits
Considerations and best practices when utilising QbD during formulation of oral solid dosage forms
The unitary patent is a new, single pan-European right protecting an invention, which prohibits anyone but the owner or their licensee from using that invention in all participating EU Member States.
The UPC is a new court whose decisions are currently effective, simultaneously, in 17 European countries (including France, Germany, Italy and the Netherlands). These decision-making powers include the enforcement and revocation of unitary patents and European patents.
How popular are unitary patents?
By 1 September 2023, the three-month anniversary of the opening of the new system, over 7,400 unitary patents were recorded as converted to unitary patents on the European Patent Office (EPO) register.1 If sustained, this would represent a rate of approximately 25 percent of all European patents granted. These numbers therefore represent a surprisingly high degree of interest in the cost savings that can be gained using the unitary patent, for those marketing protected products in a number of European countries. Furthermore, those proprietors who convert their newly granted patents into unitary patents do so in the knowledge that they can only be enforced in the UPC, and so it is also a demonstration of confidence in the new court.
Of the unitary patents registered at the EPO, approximately 20 percent were for what are described broadly by the EPO as “health-” related subject matter, or life sciences.1 More specifically, patents relating to life sciences inventions are designated by International Patent Classifications (A) human necessities (which includes pharmaceuticals and medical devices, or (C) chemistry and metallurgy, which includes biochemistry, microbiology and genetic engineering, or a combination of both (A) and (C).2
How are these classes represented in the early actions lodged at the UPC?
Life sciences patent disputes lodged in the UPC
At the beginning of September 2023, of 41 cases lodged in the UPC, according to the Darts-IPTM database, approximately a quarter of infringement cases concerned patents in the IPC classifications A and/or C. Most of the revocation actions lodged concern life sciences patents.3 More specifically, the patented subject matter in dispute in these early cases ranges from glucose monitors, antigen binding proteins, and composition and methods for analyte detection, to a method of producing retinal pigment epithelial cells.
By 1 September 2023, over 7,400 unitary patents were recorded as converted to unitary patents on the European Patent Office (EPO) register.
It is important to remember that this information only represents those cases that have passed through formality checks and been collected by the darts-IP database. The real number of actions is likely to be far higher and, although it lacks transparency, consultation of the UPC case management system suggests this is the case.
An interesting feature of some of these cases, such as the disputes between Edwards Lifesciences and Meril4 concerning a patent for a system comprising a prosthetic valve and a delivery catheter, is that the UPC is being used as a new front in patent litigation between these companies that has taken place elsewhere in the world, including the UK and US. This illustrates how the UPC is now acknowledged as an additional forum, even in addition to European national courts, for patent disputes. This does not imply that UPC patent litigation will always follow the US either. Indeed, the market size of the UPC rivals that of the US (the population of the US is approximately 330 million; the population in the 17 countries of the UPC is around 300 million) and in future the UPC may become the leading forum in many patent disputes, rather than the follower, particularly if it proves to be quicker and more cost effective.
Of the unitary patents registered at the EPO, approximately 20 percent were for what are described broadly by the EPO as “health-” related subject matter, or life sciences
At a tactical level, the Edwards Lifesciences case also illustrates how the pan-European structure of the UPC, which allows for local differences in approach to proceedings between its various local divisions and regional division, can be used according to which local and regional division is preferred in a particular case, perhaps due to local differences and the particular circumstances. In Edwards Lifesciences, one patent is being enforced in the Nordic-Baltic regional division centred in Stockholm. Two other patents are being enforced in the Munich local division. The 10x Genomics cases illustrate5 another variation in which the same patent is being enforced against different defendants in different local divisions.
A centrally granted unitary SPC
The EU has now published proposals for two recast supplementary protection certificate (SPC) Regulations, applicable to both medicinal and plant protection products. The first proposed Regulation focuses on the prosecution procedure for SPCs in the EU.6 Specifically, applications for SPCs (based on European patent and unitary patents, but not national patents) are to be dealt with under a new centralised procedure with the EU Intellectual Property Office (the EUIPO, in Alicante, Spain) as the central examination and prosecution authority. It is also proposed that SPCs must be based on a centralised marketing authorisation only.
In the second proposed Regulation the Commission has set out legislation for a unitary SPC.7 This must of course be based on a unitary patent only, which would ensure that its claims are identical for all Member States it covers, and would avoid the risk of the basic patent being revoked, or lapsing, for one or some of the UPC territories. In substance this is the same as a national SPC and its grant will also be handled by the EUIPO. Paediatric extensions will also to be applicable in respect of unitary SPCs for medicinal products.
Given the popularity of the unitary patent, unitary SPCs are also likely to be well-received by proprietors.
A further marker of success
The UPC is designed to be attractive to patent owners of all sizes, and the first cases suggest that this is indeed how it is being used. For life sciences cases, however, the real marker that the UPC is being taken seriously and is likely to be successful is the claimants who are using it. These are large and sophisticated companies, many with household names: Sanofi, Astellas, Meril, Amgen, Edwards, Nutricia and Dexcom. These companies are placing significant confidence in the UPC and it can be expected that many others will follow.
About the author
Paul England, DPhil
Paul is senior counsel – knowledge, in Taylor Wessing’s Patents Group. He is an English qualified lawyer of over 20 years who specialises in advising on case theory and European strategic work for contentious patent matters, including in the Unified Patent Court, usually at the beginning of a dispute or potential dispute. Paul has particular expertise in the life sciences sector, having begun his career as a scientist and taken a doctorate in biochemistry and molecular biology at the University of Oxford.
References
1. EPO unitary patent dashboard. [Internet]. 2023. [Cited 2023Sept]. Available from: https://www.epo.org/en/about-us/statistics/statistics-centre#/unitary-patent
2. Patent classification [Internet]. 2017. www.gov.uk [Cited 2023Sept]. Available from: https://www.gov.uk/government/publications/patent-classification/patent-classification
3. IPTM database. [Cited Sept2023]
4. Edwards Lifesciences Corp v Meril GmbH & Ors CFI_8/2023, CFI_15/2023 and CFI_249/2023.
5. Harvard College & 10x Genomics Inc. v NanoString Technologies Inc. & Ors (CFI_17/2023) and (CFI_326/2023).
6. Proposal for a Regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast) COM(2023) 231 final, 27 April 2023.
7. Proposal for a Regulation of the European Parliament and of the Council on the unitary supplementary certificate for medicinal products COM(2023) 222 final (27 April 2023).
This website uses cookies to enable, optimise and analyse site operations, as well as to provide personalised content and allow you to connect to social media. By clicking "I agree" you consent to the use of cookies for non-essential functions and the related processing of personal data. You can adjust your cookie and associated data processing preferences at any time via our "Cookie Settings". Please view our Cookie Policy to learn more about the use of cookies on our website.
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorised as ”Necessary” are stored on your browser as they are as essential for the working of basic functionalities of the website. For our other types of cookies “Advertising & Targeting”, “Analytics” and “Performance”, these help us analyse and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these different types of cookies. But opting out of some of these cookies may have an effect on your browsing experience. You can adjust the available sliders to ‘Enabled’ or ‘Disabled’, then click ‘Save and Accept’. View our Cookie Policy page.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Cookie
Description
cookielawinfo-checkbox-advertising-targeting
The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Advertising & Targeting".
cookielawinfo-checkbox-analytics
This cookie is set by GDPR Cookie Consent WordPress Plugin. The cookie is used to remember the user consent for the cookies under the category "Analytics".
cookielawinfo-checkbox-necessary
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-performance
This cookie is set by GDPR Cookie Consent WordPress Plugin. The cookie is used to remember the user consent for the cookies under the category "Performance".
PHPSESSID
This cookie is native to PHP applications. The cookie is used to store and identify a users' unique session ID for the purpose of managing user session on the website. The cookie is a session cookies and is deleted when all the browser windows are closed.
viewed_cookie_policy
The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
zmember_logged
This session cookie is served by our membership/subscription system and controls whether you are able to see content which is only available to logged in users.
Performance cookies are includes cookies that deliver enhanced functionalities of the website, such as caching. These cookies do not store any personal information.
Cookie
Description
cf_ob_info
This cookie is set by Cloudflare content delivery network and, in conjunction with the cookie 'cf_use_ob', is used to determine whether it should continue serving “Always Online” until the cookie expires.
cf_use_ob
This cookie is set by Cloudflare content delivery network and is used to determine whether it should continue serving “Always Online” until the cookie expires.
free_subscription_only
This session cookie is served by our membership/subscription system and controls which types of content you are able to access.
ls_smartpush
This cookie is set by Litespeed Server and allows the server to store settings to help improve performance of the site.
one_signal_sdk_db
This cookie is set by OneSignal push notifications and is used for storing user preferences in connection with their notification permission status.
YSC
This cookie is set by Youtube and is used to track the views of embedded videos.
Analytics cookies collect information about your use of the content, and in combination with previously collected information, are used to measure, understand, and report on your usage of this website.
Cookie
Description
bcookie
This cookie is set by LinkedIn. The purpose of the cookie is to enable LinkedIn functionalities on the page.
GPS
This cookie is set by YouTube and registers a unique ID for tracking users based on their geographical location
lang
This cookie is set by LinkedIn and is used to store the language preferences of a user to serve up content in that stored language the next time user visit the website.
lidc
This cookie is set by LinkedIn and used for routing.
lissc
This cookie is set by LinkedIn share Buttons and ad tags.
vuid
We embed videos from our official Vimeo channel. When you press play, Vimeo will drop third party cookies to enable the video to play and to see how long a viewer has watched the video. This cookie does not track individuals.
wow.anonymousId
This cookie is set by Spotler and tracks an anonymous visitor ID.
wow.schedule
This cookie is set by Spotler and enables it to track the Load Balance Session Queue.
wow.session
This cookie is set by Spotler to track the Internet Information Services (IIS) session state.
wow.utmvalues
This cookie is set by Spotler and stores the UTM values for the session. UTM values are specific text strings that are appended to URLs that allow Communigator to track the URLs and the UTM values when they get clicked on.
_ga
This cookie is set by Google Analytics and is used to calculate visitor, session, campaign data and keep track of site usage for the site's analytics report. It stores information anonymously and assign a randomly generated number to identify unique visitors.
_gat
This cookies is set by Google Universal Analytics to throttle the request rate to limit the collection of data on high traffic sites.
_gid
This cookie is set by Google Analytics and is used to store information of how visitors use a website and helps in creating an analytics report of how the website is doing. The data collected including the number visitors, the source where they have come from, and the pages visited in an anonymous form.
Advertising and targeting cookies help us provide our visitors with relevant ads and marketing campaigns.
Cookie
Description
advanced_ads_browser_width
This cookie is set by Advanced Ads and measures the browser width.
advanced_ads_page_impressions
This cookie is set by Advanced Ads and measures the number of previous page impressions.
advanced_ads_pro_server_info
This cookie is set by Advanced Ads and sets geo-location, user role and user capabilities. It is used by cache busting in Advanced Ads Pro when the appropriate visitor conditions are used.
advanced_ads_pro_visitor_referrer
This cookie is set by Advanced Ads and sets the referrer URL.
bscookie
This cookie is a browser ID cookie set by LinkedIn share Buttons and ad tags.
IDE
This cookie is set by Google DoubleClick and stores information about how the user uses the website and any other advertisement before visiting the website. This is used to present users with ads that are relevant to them according to the user profile.
li_sugr
This cookie is set by LinkedIn and is used for tracking.
UserMatchHistory
This cookie is set by Linkedin and is used to track visitors on multiple websites, in order to present relevant advertisement based on the visitor's preferences.
VISITOR_INFO1_LIVE
This cookie is set by YouTube. Used to track the information of the embedded YouTube videos on a website.