UK: Case Note: Synthon BV v SmithKline Beecham plc, House of Lords

Last Updated: 8 November 2005
Article by Sally Field and Robert Fitt

Summary

The House of Lords has recently provided guidance on the law of novelty, in particular, what constitutes a disclosure and what is meant by enablement. The case in question was between Synthon BV and SmithKline Beecham plc and the dispute related to who was first to disclose, in a fully enabling fashion, paroxetine methanesulfonate. This is a form of the well-known compound paroxetine used to treat depression and related disorders which had been marketed in the form of its hydrochloride hemihydrate salt under the names Paxil or Seroxat. Paroxetine methanesulfonate has properties which make it more suitable for pharmaceutical use in that it is more stable, less hygroscopic and more soluble and can be prepared in high concentrations.

The facts

On 10 June 1997 Synthon filed a patent application which claimed a broad class of sulfonic acid salts including paroxetine methanesulfonate. Example 1 of the patent described how to make paroxetine methanesulfonate in crystalline form and drew attention to its characteristic absorbance spectrum when subjected to infra-red radiation (IR). On 6 October 1998 SmithKline Beecham filed its own patent application claiming paroxetine methanesulfonate and identified a particular crystalline form by reference to its IR spectrum. The IR peaks disclosed in the Synthon application were, however, different to those in the SmithKline Beecham application. This would lead a person skilled in the art reading both applications to believe that the two disclosures identified different crystalline forms or polymorphs of the same compound.

In March 2001 Synthon began proceedings to have the SmithKline Beecham patent revoked on the ground that the crystalline form described in its claim 1 was not new in the light of Synthon’s own patent application. In order to succeed, Synthon had to satisfy the trial judge that their application disclosed what was claimed in claim 1 of the SmithKline Beecham patent and that an ordinary skilled man would be able to perform a disclosed invention by following the instructions and information in the Synthon application, in the light of his common general knowledge.

The difficulty Synthon faced was that when eminent chemists from the University of Oxford tried to carry out the instructions of Example 1 in the Synthon application, and produce crystals of paroxetine methanesulfonate, they were unable to do so. Eventually, after a good deal of skilled manipulation not described in Synthon’s application, the Oxford chemists produced crystals which turned out not to have the IR spectrum disclosed in Synthon’s application but the spectrum described in SmithKline Beecham’s patent.

Synthon then produced evidence to show that the IR spectrum in their application was the result of a mistaken reading. There was only one form of paroxetine methanesulfonate, whose IR spectrum was as per the information set out in SmithKline Beecham’s patent. Secondly, on enablement, Synthon said that although the method described in their application did not produce seeding crystals, it did not mean that the ordinary skilled man would have difficulty in crystallising paroxetine methanesulfonate. By using a different solvent (as set out in the Synthon application) or by routine trial and error, the skilled man would be able to produce the compound in question. The trial judge agreed with this approach, and held as a matter of fact that a skilled man would be able to produce crystals as described in the SmithKline Beecham patent. This meant that not only did the Synthon application disclose paroxetine methanesulfonate, but also that the making of that product was enabled. Consequently, the Synthon application anticipated the SmithKline Beecham patent, which was therefore invalid for lack of novelty.

However, on appeal to the Court of Appeal, the trial judge’s decision was reversed on the basis that the Synthon application did not disclose the invention of claim of the SmithKline Beecham patent sufficiently clearly to enable the skilled man to produce crystals of paroxetine methanesulfonate. The Court of Appeal found support for this finding on the basis of the difficulty the Oxford chemists retained by Synthon had in attempting to prepare the crystals described in the Synthon application.

Analysis

In the leading judgment on the further appeal to the House of Lords, Lord Hoffmann sought to separate the concepts of disclosure and enablement. On disclosure he summarised the law as follows: namely, that the matter relied upon as prior art must disclose subject matter which, if performed, would necessarily result in an infringement of the patent. He defined enablement as meaning that the ordinary skilled person would have been able to perform the invention which satisfies the requirement of disclosure. Consequently, when applying this two tier analysis to the facts, Lord Hoffmann stated that on disclosure there was no doubt that the Synthon application disclosed the existence of paroxetine methanesulfonate crystals of 98% purity and claimed they could be made. Their existence and their advantages for pharmaceutical use were clearly disclosed and carrying out the invention would produce crystalline paroxetine methanesulfonate. Even if the skilled person reading the patent did not think he was going to infringe it because of the incorrect IR data, he would inevitably do so. On enablement, Lord Hoffmann referred to the finding by the trial judge that the skilled man would have tried some other form of solvent from the range mentioned in the Synthon application or forming part of his common general knowledge and would have been able to make paroxetine methanesulfonate crystals within a reasonable time. Consequently, Lord Hoffmann overturned the findings of the Court of Appeal.

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.