Singapore: Rectification Of The Register – A Singapore Perspective

Last Updated: 8 May 2018
Article by Gladys Mirandah and Hilmi Bin Zaini

Novartis (Singapore) Pte Ltd v Bristol-Myers Squibb Pharma Co [2017] SGHC 322

I. Introduction

In the recent case of Novartis (Singapore) Pte Ltd v Bristol-Myers Squibb Pharma Co [2017] SGHC 322, the Singapore High Court addressed, for the first time, key procedural issues associated with corrections to patent forms and priority data, as well as corrections to the Singapore Patents Register (the "Register").

II. Background

The respondent, Bristol-Myers Squibb Pharma Co ("BMS"), is the proprietor of 5 patents ("BMS' patents") in respect of the active pharmaceutical ingredient Efavirenz, namely, Singapore Patent Nos. SG 77853, SG 134977, SG 111980, and SG 111981 (the "SG 77853 Patent Family", comprising the parent application SG 77853 and the divisional applications SG 134977, SG 111980, and SG 111981), and Singapore Patent No. SG 76157.

The applicant, Novartis (Singapore) Pte Ltd ("Novartis") applied for product licences to market generic Efavirenz products (the "Efavirenz products") in Singapore.

Pursuant to section 12A(3)(a) of the Medicines Act (Cap 176, 1985 Rev Ed), Novartis notified BMS of its product licence applications and declared that BMS' patents would not be infringed by the Efavirenz products. Subsequently, BMS commenced action against Novartis, seeking, inter alia, a declaration that the Efavirenz products would infringe BMS' patents.

In its defence, Novartis argued that BMS was not entitled to rely on its claimed priority date of 11 June 1998 in respect of the patents in the SG 77853 Patent Family, because the priority document cited in support of the claimed priority date related to a completely different invention which was not associated with the pharmaceutical inventions as disclosed in the SG 77853 Patent Family. Novartis also counter-claimed for a revocation of the patents in the SG 77853 Patent Family, on the grounds of invalidity, misrepresentation and non-disclosure of material information. With regard to the ground of invalidity, given Novartis' position that BMS was not entitled to rely on the claimed priority date, Novartis cited some prior art which were published after the claimed priority date (i.e. 11 June 1998), but before the filing date of the SG 77853 Patent Family (i.e. 10 June 1999).

Upon inspecting its prosecution history, BMS discovered that errors had been made during the patent application process in respect of the SG 77853 Patent Family. In particular, the wrong US priority document had been submitted (i.e. US 60/089,981 for "Paper Carton and Blank therefor", instead of US 60/088,981 for "Crystalline Efavirenz"), and the wrong priority application number had been declared (i.e. US 60/089,981 instead of US 60/088,981) in the relevant forms over 15 years ago.

Thereafter, BMS filed requests to the Registrar of Patents (the "Registrar") to correct the entries in the Register, so as to reflect the correct US patent application number (i.e. US 60/088,981) in support of the claimed priority date. The Registrar granted BMS' requests, filed pursuant to Rule 58 of the Patents Rules (Cap 221, R 1, 2007 Rev Ed) ("Patents Rules"), and made the corrections to the Register.

Novartis applied to the High Court (by way of originating summons) for the corrections to the Register to be reversed (the "reversal application"), pursuant to section 44 of the Patents Act (Cap 221, 2005 Rev Ed) ("Patents Act"). SG 76157 did not feature in the reversal application.

In the reversal application, Novartis submitted, inter alia, that BMS' requests should have been filed pursuant to Rule 91 of the Patents Rules, whereby Novartis would have had the opportunity to oppose the corrections if the Registrar had decided to exercise its discretion to advertise the proposed corrections (note: no opposition mechanism was available under Rule 58 of the Patents Rules).

The High Court allowed Novartis' reversal application in its decision dated 20 December 2017.

III. Decision of the High Court

In deciding the reversal application in Novartis' favour, the Court made the following findings:

A. BMS was not entitled to seek the corrections under Rule 58 of the Patents Rules ("Rule 58"), as the applicable legal provisions were Rule 91 of the Patents Rules ("Rule 91") and section 107 of the Patents Act; and

B. Even if a request had been made by BMS under Rule 91 and section 107 of the Patents Act, such a request would have been refused.

A. BMS was not entitled to seek corrections under Rule 58

The Court began its analysis by commenting that the errors which were made during the patent application process (in respect of the SG 77853 Patent Family) were errors in the US priority application number as set out in the relevant forms. There were no "errors" in the Register in the sense that the entries in the Register accurately reflected the application number of the earlier US patent application as declared in the relevant forms.

Although Rule 58 allowed for the correction of errors in the Register or in any document filed at the Registry "in connection with registration", the Court held that Rule 58 was not applicable here as the relevant forms in question (i.e. Patent Forms PF1) were filed in relation to an application for the grant of a patent, but not in connection with registration. The Court stated that in the present case, the correct procedure for correcting the errors in the relevant forms would fall under the ambit of Rule 91 and section 107 of the Patents Act.

When BMS applied to correct only the entries in the Register under Rule 58, it left the errors in the underlying forms untouched. The Court agreed with Novartis' submissions that such a limited correction would result in a confusing state of affairs, as a person inspecting the patent files of the SG 77853 Patent Family would find a different US priority application number stated in the relevant forms and a different US priority document, as opposed to the details stated in the Register.

For the above reasons, the Court held that BMS was not entitled to seek the corrections under Rule 58.

B. BMS was not entitled to seek corrections even under Rule 91

The Court reviewed various decisions issued by the European Patent Office ("EPO") and its Board of Appeals, and distilled 6 broad principles from these decisions:

i) The relevant provisions of the European Patent Convention ("EPC") allowed for the correction of an incorrect priority declaration without any time bar, even after the publication of the patent application;

ii) Grant of the correction request by the EPO was discretionary and the EPO was not bound to permit corrections of any kind and at any time;

iii) The overriding principle was to balance the interests of the applicant and the interests of the public in respect of legal security;

iv) The request should be made in time so that an appropriate warning could be provided in the publication of the patent application;

v) Where the request for correction was made after the publication of the patent application, such a request could only be granted if there were "very exceptional" reasons; and

vi) Whether exceptional reasons existed depended on the facts and circumstances, including whether the error and the correct position was obvious or readily apparent on the face of the published application or by reference to other documents in the patent file.

The Court noted that the decisions of the EPO and its Boards of Appeal, although not binding in Singapore, were of some persuasive value since the Patents Act was based on the UK Patents Act (which in turn implemented the UK's obligations under the EPC).

Applying the principles stated above, the Court found that in the present case, BMS' requests for corrections came far too late (as the errors went uncorrected for over 15 years), and were not supported by exceptional grounds. The Court also commented in obiter that Rule 91 did not extend to corrections of an error in the filing procedure or the replacement of an erroneous document with a new (correct) document.

Accordingly, the Court held that BMS' requests (even if made under Rule 91 and section 107 of the Patents Act) would have been refused.

IV. Concluding Remarks

The above decision provides useful guidance on the procedural aspects associated with the correction of errors in the Register and in the relevant forms.

Crucially, a patent proprietor should file any request for corrections (either to the Register or to the relevant forms) as expeditiously as possible. In addition, although requests for correction may be granted after a patent application has been published, it is worth noting that such requests should be accompanied by exceptional grounds.

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
 
Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Practice Guides
by Mondaq Advice Centres
Relevancy Powered by MondaqAI
United States
Related Topics
 
Related Articles
 
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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