European Union: EPO Practice

A Strict View of Priority in the UK’s Court of Appeal

A recent decision in the United Kingdom suggests that the strict priority approach applied in the European Patent Office (EPO) Boards of Appeal will also be enforced in that jurisdiction against patentees relying on the filing dates of earlier applications.  The Court of Appeal in Hospira UK Generics Ltd. v. Novartis AG, [2013] EWCA Civ. 1663 (Dec. 19, 2013), held that a claim directed to use of a specific compound to treat osteoporosis at a certain dosage was not entitled to the earlier priority date of a U.S. patent application, notwithstanding that all the claim elements appear to be disclosed in the U.S. application, when read as a whole. 

UK Priority Law

Applicants may benefit from the filing date of a foreign application under the terms of the Paris Convention for the Protection of Industrial Property.  In the United Kingdom, Section 5 of the Patents Act 1977 (PA 1977) provides for reliance on an earlier priority date.  The corresponding provision of the European Patent Convention (EPC) is Article 87(1).  While Section 5 PA 1977 uses different language from Article 87 EPC, the Court of Appeal has held that the UK statute and the EPC article mean the same thing.1

Article 87(1) EPC governs priority in this context, stating that

[a]ny person who has duly filed, in or for . . . any State party to the Paris Convention . . . , an application for a patent . . . shall enjoy, for the purpose of filing a European patent application in respect of the same invention, a right of priority during a period of twelve months from the date of filing of  the first application (emphases added).

Thus, under Article 87(1) EPC, an applicant's claim will benefit from a right of priority of an earlier application if for the "same invention."  See id.  Importantly, this has been interpreted by the Enlarged Board in G02/98 to mean that priority is effective "only if the skilled person can derive the subject-matter of the claim directly and unambiguously, using common general knowledge, from the previous application as a whole."2  This standard requires, at minimum, that all elements from the claim be disclosed, explicitly or implicitly, in the earlier application.  See id

The UK courts have also recognized the significance of G02/98, finding its approach not inconsistent with leading UK decisional law on priority.3  On the one hand, in Pharmacia Corp. v. Merck & Co., [2002] R.P.C. 41, priority was lost by narrowing down from the disclosure of the priority document so that the invention could not be directly and unambiguously derived from it.  On the other hand, in Beloit Technologies Inc. v. Valmet Paper Machinery Inc., [1995] R.P.C. 7005, priority was lost by overgeneralizing from the disclosure of the priority document.4                

Background

The patent-at-issue in Hospira UK Generics was European Patent (UK) 1 296 689, belonging to Novartis.  [2013] EWCA Civ. 1663, ¶ 1.  The Novartis patent related to the use of a particular member of the bisphosphonate class of drugs.  Id.  Specifically, Novartis's claim 7 claimed the use of a zoledronate medicine for the treatment of osteoporosis and adapted for intravenous administration in a unit dosage form which comprises from about 2 to 10 mg of zoledronate, administered about once a year.  Id.  Claim 7 covered Novartis's commercial drug product ACLASTA, a successful, once-yearly infusion product.   Id. ¶ 3.  Claim 7 was argued to have the priority date of an earlier U.S. application filed June 20, 2000.  Id. ¶ 2.  The main issue with respect to this claim was whether the disclosure in the U.S. application contained the subject matter, because, if not, the parties agreed that an intervening publication would be invalidating.  Id. ¶ 3. 

The High Court held that, although the elements of claim 7 were disclosed in the U.S. application, "there was nothing to link the dosage sizes and intervals there claimed with the other features of the claims, such as treatment of osteoporosis and intravenous administration."  Id. ¶ 22.  Mr. Justice Arnold explained that

[t]he nearest one gets is the abstract, which links zoledronate, osteoporosis and six monthly administration, but does not mention intravenous administration . . . .  As for Example 5, this is limited to the intravenous administration of particular doses of zoledronate to post-menopausal osteoporosis patients six monthly and yearly . . . ."5

Since the court found that there was no linkage of the elements in the disclosure, Novartis was deemed to lack priority for claim 7 and the patent was invalidated in the first instance.6

Court of Appeal Decision

On appeal, Novartis argued that the High Court erred by reading the relevant passages in isolation.  Had the High Court properly read the disclosure as a whole, Novartis contended, it would have credited, inter alia, the "2-10 mg once a year" passage7 as containing a clear and unambiguous disclosure for the claim.  Id. ¶ 23.  Although the critical "2-10 mg once a year" passage does not expressly mention osteoporosis or a particular mode of administration, Novartis explained that treatment of osteoporosis was the very focus of the U.S. application.  Id.  Further, according to Novartis, intravenous administration appears throughout the disclosure as a principle route taught.  Id.          

For a unanimous court, however, Lord Justice Floyd succinctly stated "that the problem for Novartis in seeking to establish that claim 7 is entitled to priority from [the U.S. application] is that the disclosure . . . is either too general or too specific."  Id. ¶ 32.  When focused on the priority disclosure for zoledronate, the "'2-10 mg once a year' passage tells the skilled reader nothing about the dosage range for any particular method of administration . . . [and] does not tell the reader about dosage range for any particular condition, such as osteoporosis," meaning that it was too general to support priority.  Id.  When focused on the priority disclosure for mode of administration, "Example 5, on the other hand, is specific[,] . . . teach[ing] that 4 mg, once a year, administered intravenously to patients with post-menopausal osteoporosis is effective, but nothing about what other doses could be used at that dosage interval."  Id.         

The Court of Appeal acknowledged Novartis was correct that intravenous administration is one of the preferred methods of administrations in the disclosure and that osteoporosis is highlighted in the disclosure as one of the conditions targeted.  Id. ¶ 33.  But the Court of Appeal rejected the notion that the "2-10 mg once a year" passage must be read to teach that no matter how one administers zoledronate, and no matter what condition one administers it for, 2-10 mg is always suitable dosage range.  Id.  "To put it another way," if Novartis's theory were adopted, "it would be read as saying that this particular dosage range can be used independently of the condition being treated and independently of the method of administration."  Id. ¶ 35.  Instead, Lord Justice Floyd explained that a skilled person would read the "2-10 mg once a year" passage quite differently, "namely that, depending on the method of administration and the condition being treated, some doses within this range may be suitable."  Id. ¶¶ 35-36.  

Supporting this conclusion, the Court of Appeal cited the following: (1) the specification elsewhere expressly states that the dosage is dependent on method of administration and condition; (2) the skilled person knows from common general knowledge that dosage is critically dependent on method of administration and condition; (3) the fact that other dosage ranges are given in the patent could not be taken as saying that they were suitable for every condition and every means of administration; and (4) the expert testimony that a 2-10 mg would be "in play" for intravenous administration was "well short" of what is required, such that "nothing in the expert evidence . . . displace[d] the view that there is no disclosure in [the U.S. priority application] of using 2-10 mg zoledronate once a year by intravenous administration to treat osteoporosis."   Id. ¶¶ 36-40. 

Accordingly, claim 7 could not rely on the disclosure of the U.S. application and its earlier priority date.  The trial court's invalidity judgment was approved and the appeal was dismissed, with Lord Justice Patten and Lord Justice Tomlinson in accord.  Id. ¶¶ 42-44.

Conclusions

In fact, all elements of claim 7 were in some fashion disclosed in the U.S. priority application, as the Court of Appeal acknowledged.  See id. ¶ 33.  But these disparate elements were deemed insufficiently linked to the claimed invention to find it directly and unambiguously disclosed to a person of skill.  Novartis's main contention that "reading the document as a whole, one sees a disclosure of the whole package of claim 7," was scarcely addressed and did not persuade the court.  Id. (emphasis added).  The resulting strict approach to priority means that U.S. practitioners need to be aware in preparing priority filings that will be relied on later at the EPO or in EPO member states.  A clear linking statement for all claimed subject matter is now advisable to avoid losing priority.

Footnotes

1 See, e.g., Unilin Beheer BV v. Berry Floor NV, [2004] EWCA Civ. 1021, ¶ 39 ("The UK 1977 Patents Act, seeking to implement this, does so in the unhelpful mode of "re-write" rather than "copy out."  The provisions are to be found in s[ection] 5. . . . They are supposed to mean the same as Art. 87 . . . .").

2 Enlarged Board of Appeal in G02/98, [2002] EPOR 167 (deciding that the basic test to determine whether a claim is entitled to the date of a priority document is the same as the test of whether an amendment to an application satisfies the requirement of Art. 123(2) EPC).

3 Pharmacia Corp. v. Merck & Co., [2002] R.P.C. 41 (finding that the leading UK authority on priority, Biogen Inc. v. Medeva PLC, [1997] RPC 1, is consistent with G02/98, even though decided before).

4 See also Unilin Beheer, [2004] EWCA Civ. 1021.

5 Novartis AG v. Hospira UK Ltd., [2013] EWHC 516 (Pat.), ¶ 137.

6 Subsequent to the invalidity determination by the High Court, a preliminary injunction was granted by the Court of Appeal until the case could be reviewed.  See Novartis AG v. Hospira UK Ltd., [2013] EWCA Civ. 583.

7 U.S. Application No. 60/267,689 states that "a unit dose of from about 1 up to about 10 mg may be used.  For example . . . from about 1 to about 5 mg may be used for dosing once every 6 months; whereas a dose of from about 2 up to about 10 mg may be used for once a year dosing."

This article previously appeared in Full Disclosure Patent Prosecution Update, January 2014.

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
Events from this Firm
17 Oct 2018, Other, Washington, DC, United States

Finnegan is a Platinum sponsor of the ChIPs Women in Tech, Law, & Policy Global Summit. The program will take place at the Mandarin Oriental Hotel in Washington, DC.

23 Oct 2018, Webinar, Washington, DC, United States

How do trademark and advertising trends impact your company? Join a discussion on the latest trends in the food and beverage industry in the United States and Europe.

24 Oct 2018, Other, Washington, DC, United States

Join the usual suspects from Finnegan as they take you through a detailed discussion of patent prosecution strategies from drafting to grant.

 
In association with
Related Topics
 
Related Articles
 
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
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

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 or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq 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 of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions