News from Abroad: UK Court of Appeal Considers Sufficiency

by McDonnell Boehnen Hulbert & Berghoff LLP

GenentechThe Court of Appeal recently heard a case relating to Genentech's patent, which claimed the use of human vascular endothelial growth factor (hVEGF) antagonists for the treatment of non-cancerous diseases which are characterised by excessive blood vessel growth (neovascularisation or angiogenesis).  Regeneron and Bayer sought a declaration of non-infringement and revocation of the patent based on construction, novelty, inventive step, and sufficiency arguments, all of which were rejected at first instance.  Regeneron and Bayer then appealed.

RegeneronThe main issue discussed in the appeal proceedings was that of sufficiency.  The appellants argued that the patent's scope was too broad as it covered a wide range of antagonists and diseases.  It would therefore impose an undue burden on the skilled person to identify which diseases can be treated with which antagonists.  The judge held that if it is plausible or credible that the invention will work over substantially the entire scope of the claims, the claims can be defined in general terms.  This was found to be the case in the present proceedings due to the common thread of angiogenesis between the claimed disease states and so the scope of the claims was considered appropriate.  However, if only a few embodiments would work, these must be claimed specifically.  As for evidence to support the claims, it was held that there is no need to report results of clinical trials, but the evidence must show that the therapeutic effect is plausible.

BayerFurther, the fact that regulatory approval would be hard to obtain was deemed to be irrelevant, as it takes into account factors such as side effects, which are not considered by the patent.  The appellants also cited various diseases as not being treated by the invention.  However, it was highlighted that it was only the angiogenic component that needed to be treated.  There was no evidence that there was no effect on the angiogenic component of the cited diseases, despite other components not being affected.  When discussing the construction of the claim, the judge found that angiogenesis must contribute to the pathology of the diseases covered, but need not be the cause of it.  This construction also meant that the skilled person would be able to easily identify the diseases covered by the claims.

Finally, it was argued that the patent was insufficient if it extended to the allegedly infringing molecule (a chimeric molecule demonstrating high affinity and improved pharmacokinetics), as production of such molecules would require undue effort and is not described in the patent.  However, it was held that the skilled person would have regarded chimeric molecules as variants falling within the scope of the claim.  It was emphasised that a claim for a broad invention could cover embodiments that may be invented in the future and which may have further advantageous properties.  The allegedly infringing molecule was such an embodiment as it encompassed the technical contribution of the claimed invention by binding VEGF and inhibiting its biological activity, despite requiring in itself a good deal of ingenuity.

The appellants also raised novelty and inventiveness objections over a document that discussed in vivo assays using VEGF antibodies and disclosed that the VEGF antibodies "may have therapeutic potential."  However, the judge held that the document did not disclose a therapeutic effect of the antibodies, or clear and unmistakeable directions to perform the invention.  Further, while the prior art suggested that VEGF may have therapeutic applications, it was disclosed as one of many factors being investigated.  The document also disclosed the antibodies as a research tool and so gave no reasonable expectation of success of using such antibodies therapeutically.

The claims were therefore found to be novel and inventive.  The appeal was dismissed and the patent was found to be valid and infringed on all counts.

This report comes from European Patent Attorneys at WP Thompson & Co., 55 Drury Lane, London UK.  Further details and commentary can be obtained from Gill Smaggasgale, a partner at the firm.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© McDonnell Boehnen Hulbert & Berghoff LLP | Attorney Advertising

Written by:

McDonnell Boehnen Hulbert & Berghoff LLP

McDonnell Boehnen Hulbert & Berghoff LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at:

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.