Novartis (Singapore) Pte Ltd v Bristol-Myers Squibb Pharma Co  SGHC 322
In the recent case of Novartis (Singapore) Pte Ltd v Bristol-Myers Squibb Pharma Co  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").
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.