UK: UK Supreme Court Overturns Existing Case Law To Broaden The Scope Of Patent Protection

The UK Supreme Court has overturned existing case law to, for the first time, formally recognise a "doctrine of equivalents", resulting in a broader scope of patent protection under UK law. This new approach is more patentee-friendly and brings the UK into closer alignment with courts elsewhere in Europe and in the US.

Historically the English courts have held that the wording of the claim is decisive when determining whether a patent is infringed, resulting in a relatively narrow scope of protection. The Supreme Court held that this approach placed too much weight on the words of the claim and did not provide fair protection for patent holders. Fair protection requires a broader scope of protection, extending beyond the wording of the patent claims to also cover products which are technically equivalent. In the case at hand, the Supreme Court held that Eli Lilly's patent claims covering "pemetrexed disodium" would be infringed by Actavis' products containing various alternative forms of pemetrexed, which did not fall within the wording of the claims, properly interpreted, but were nonetheless technically equivalent.

Background

Pemetrexed is a cancer treatment which Lilly has sold under the brand name Alimta since 2004. Lilly has a patent which claims, effectively, the use of pemetrexed disodium in combination cancer therapy.

In order to avoid infringing this patent, Actavis intended to launch products containing a number of alternative forms of pemetrexed, for use in combination cancer therapy: pemetrexed diacid, pemetrexed ditromethamine, or pemetrexed dipotassium. Actavis accepted that these alternative forms are all therapeutically equivalent to pemetrexed disodium, and the judgment considers whether these alternative forms infringe, either directly or indirectly, a claim to use of pemetrexed disodium.

Direct infringement

Lilly argued that, although the words of the patent claim refer specifically to pemetrexed disodium, the claim should be interpreted broadly to cover the alternative but technically equivalent forms of pemetrexed that Actavis proposed to sell. This argument raises an issue with which the Supreme Court is very familiar: how to strike the right balance between giving effect to the specific words used in a legal document, and reaching a conclusion that makes practical sense.

As we discussed in a 2016 article1, this issue arises in relation to a wide range of legal documents - from negotiated contracts to unilateral documents like wills. In the context of patents, the approach to construction is shaped by two unique factors: an express requirement in European patent law to balance literalism and fair protection, and the possibility of using the patent prosecution history to shed light on the "negotiations" between the patentee and the patent office.

Balancing literalism and fair protection

European patent law2 requires a court construing a patent claim to conduct a balancing act between literalism and fair protection, and in particular to take due account of "any element which is equivalent to an element specified in the claims".

Many European jurisdictions apply a "doctrine of equivalents" under which a patent can be infringed by something which is technically equivalent to, but falls outside the wording of, the patent claim. This broader approach had historically been rejected by the English courts: the House of Lords (the predecessor to the Supreme Court as the UK's highest appellate court) held in Kirin Amgen [2005] RPC 9 that the "doctrine of equivalents" extends protection beyond the scope of the claims and is therefore impermissible. The English approach was to treat the wording of the claims as decisive, and to take the existence of equivalents into account merely as part of the background context in order to construe, purposively, the wording of those claims.

The Supreme Court in Actavis v Lilly held that this approach was wrong as a matter of principle, because it approached patent infringement on the basis that there is only one question: whether the alleged infringement falls within the words of the claim. It held that, in order to give fair protection to the patentee, the court must also consider whether something which does not fall within the wording of the claim "on any sensible reading" nevertheless infringes because it is an immaterial variant (or "equivalent").

To implement this new approach the Supreme Court set out a reformulated test for determining the scope of protection of a patent. The Supreme Court held that the court must first determine the "normal" interpretation of the claims, following the established principles of construction considered by the Supreme Court earlier this year (in the context of a contract) in Wood v Capita Insurance Services Ltd [2017] 2 WLR 1095. In the case of a variant which does not fall within the claims as interpreted, the court must then go on to consider whether the variant nevertheless infringes because it varies from the invention in a way which is immaterial.

The test for determination of this second issue is based on the "Improver" / "Protocol" questions developed in previous case law, but with some reformulations and a reduced emphasis on the wording of the claims. The reformulated questions are:

i) Notwithstanding that it is not within the literal meaning of the relevant claim(s) of the patent, does the variant achieve substantially the same result in substantially the same way as the invention, i.e. the inventive concept revealed by the patent?

ii) Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?

iii) Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?

The Supreme Court has lowered the hurdle for the patentee to establish infringement in two respects. First, when considering the second question, the skilled person is told that the variant does actually achieve the same result as the invention - previously, the patentee was required to prove that this would have been obvious to the skilled person at the priority date of the patent. Second, the Supreme Court held that when answering the third question, the court should avoid placing too much weight on the words of the claim: "the fact that the language of the claim does not on any sensible reading cover the variant is certainly not enough to justify holding that the patentee does not satisfy the third question".To place too much weight on the words of the claim would result in the second issue —whether an "equivalent" infringes—being effectively decided by the court's determination of the "normal" interpretation of the claim.

Use of the patent prosecution history

The role of the prosecution history —the "negotiation" between the patentee and the patent office during the examination of the patent application—in interpreting patent claims varies in different jurisdictions. The US has a doctrine of "file wrapper estoppel" which requires reference to the prosecution history. By contrast, many European jurisdictions permit reference to the prosecution history only in limited circumstances.

In Actavis v Lilly the Supreme Court confirmed, in line with existing English case law, that the prosecution history is admissible in principle when considering the interpretation of a patent claim, but that it should be treated with scepticism. In this particular case, reviewing the prosecution history did not alter the Supreme Court's initial view that the "equivalents" test was satisfied in relation to Actavis' products.

Direct infringement in France, Italy and Spain

In addition to its UK action, Actavis sought declarations of non-infringement in France, Italy and Spain. The English court's jurisdiction to make those extra-territorial declarations was confirmed by the Court of Appeal in an earlier decision in the same case ([2013] EWCA Civ 517).

At first instance, Arnold J held that the patents were not directly infringed under French, Spanish or Italian law. The Court of Appeal declined to rule formally, but recorded its agreement with Arnold J. In line with its broader approach under English law the Supreme Court disagreed, finding that Lilly's patent was directly infringed in all three foreign jurisdictions.

Indirect infringement

Section 60(2) of the English Patents Act 1977 provides that a patent will be indirectly infringed if

"a person ... supplies or offers to supply ... any of the means, relating to an essential element of the invention, for putting the invention into effect when he knows, or it is obvious to a reasonable person in the circumstances, that those means are suitable for putting, and are intended to put, the invention into effect"

Actavis' proposed products were to be reconstituted or diluted with a saline solution, and the resulting solution would contain sodium ions and pemetrexed ions in a ratio of at least 2:1. The relevant claim of Lilly's patent was to the use of pemetrexed disodium in the manufacture of a medicament for combination cancer therapy.

The High Court and Court of Appeal had been divided on this issue. Arnold J held that there was no indirect infringement: the claim required the use of pemetrexed disodium in the manufacture of a medicament, and at no stage was pemetrexed disodium used. The Court of Appeal disagreed, holding that Arnold J's conclusion was based on the incorrect conclusion that "pemetrexed disodium" meant "solid pemetrexed disodium". In the view of the Court of Appeal the claim, properly interpreted, also covered a solution including both pemetrexed and sodium ions, the invention was put into effect when a pharmacist or doctor prepared such a solution, and the Actavis products were therefore means relating to an essential element of that invention.

Perhaps unsurprisingly, the Supreme Court agreed with the Court of Appeal's broader interpretation, finding that Actavis' products would also indirectly infringe if Actavis knew, or it was obvious in the circumstances, that ultimate users would dilute those products with saline.

Conclusion

The Supreme Court's decision represents a significant departure from the established English case law in this area. It marks both a more patentee-friendly approach, and an increased desire to ensure harmonisation with the approach taken elsewhere in Europe.

The Supreme Court's decision to depart from the literal meaning of the words used in a patent claim could be viewed as a contrast to the approach it has taken in recent cases relating to contractual interpretation, where the Supreme Court has (in Wood v Capita and Arnold v Britton [2015] AC 1619) rejected attempts to depart far from the plain wording of a contract. In the view of the Supreme Court this results from the distinction between (1) the meaning of the words in a patent claim, which is to be determined following the principles of construction common to all legal documents, and (2) the scope of protection of the patent, which is subject to an express requirement to ensure fair protection for the patentee which is unique to the law of patents.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

Disclaimer

Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

Registration

Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

Cookies

A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

Links

This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

Mail-A-Friend

If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

Security

This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.