Warner-Lambert Company LLC v Novartis (Singapore) Pte Ltd

JudgeSundaresh Menon CJ
Judgment Date01 August 2017
Neutral Citation[2017] SGCA 45
Plaintiff CounselStanley Lai Tze Chang, SC, Gloria Goh En-Ci and Clara Tung Yi Lin (Allen & Gledhill LLP)
Date01 August 2017
Docket NumberCivil Appeal No 121 of 2016
Hearing Date02 May 2017
Subject MatterPatents and Inventions,Industrial application,Novelty
Defendant Counseland Professor David Llewelyn (School of Law, Singapore Management University) as amicus curiae.,Prithipal Singh s/o Seva Singh, Suhaimi Bin Lazim and Chow Jian Hong (Mirandah Law LLP)
CourtCourt of Appeal (Singapore)
Citation[2017] SGCA 45
Published date08 August 2017
Tay Yong Kwang JA (delivering the judgment of the court): Introduction

This appeal arises from an ongoing dispute in Suit 390 of 2015 (“Suit 390”) between two large pharmaceutical companies, Warner-Lambert Company LLC (“Warner-Lambert”) and Novartis (Singapore) Pte Ltd (“Novartis”). The subject matter of Suit 390 is a pharmaceutical patent owned by Warner-Lambert which claims a monopoly over the use of a substance known as pregabalin for the treatment of pain (“the Patent”). Under the Patent, Warner-Lambert manufactures and distributes the product “Lyrica” in Singapore. “Lyrica” is approved by the Health Sciences Authority (“the HSA”) for use in treating ailments which include neuropathic pain and chronic pain disorders, including fibromyalgia. The Patent was filed on 16 July 1997 and granted in Singapore on 23 May 2000. Its twenty-year statutory protection therefore expired on 16 July 2017.

On 23 March 2015, Warner-Lambert received notification of Novartis’ applications to the HSA for product licences for pregabalin products, pursuant to s 12A(3)(a) of the Medicines Act (Cap 176, 1985 Rev Ed). In the notification, Novartis claimed that the Patent would not be infringed by the acts for which the product licences were sought. On 21 April 2015, Warner-Lambert commenced Suit 390 seeking, among other relief, a declaration that the Patent would be infringed by Novartis if it did the acts for which the product licences were sought. On 5 May 2015, Warner-Lambert informed Novartis of its intention to amend the Patent.

On 2 June 2015, Novartis filed its defence and counterclaim seeking revocation of the Patent on the ground that the Patent was invalid as it claimed a monopoly over methods of treatment of the human or animal body, something impermissible under Singapore’s patent law. One of the requirements of a patent is that it is capable of industrial application. However, s 16(2) of the Patents Act (Cap 221, 2005 Rev Ed) provides: An invention of a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body shall not be taken to be capable of industrial application.

On 26 August 2015, Warner-Lambert applied by Summons 4136 of 2015 (“SUM 4136”) for leave to amend the Patent pursuant to s 83(1) of the Patents Act. The amendments aimed to cure the invalidity in the Patent’s granted claims (“the Granted Claims”) which clearly contradicted s 16(2) of the Patents Act.

The High Court judge (“the Judge”) dismissed Warner-Lambert’s application to amend the Patent. He was of the view that the amendments, if granted, would extend the scope of protection of the Patent. He also held that there had been undue delay by Warner-Lambert in seeking the amendments which warranted the exercise of the court’s discretion to disallow the amendments. The Judge’s decision is reported as Warner-Lambert Co LLC v Novartis (Singapore) Pte Ltd [2016] 4 SLR 252 (the “Judgment”). On 1 August 2016, Warner-Lambert was granted leave by the Judge to appeal against his decision to dismiss SUM 4136 “insofar as it relate[d] to [his] findings that the amendment would extend the protection conferred by the patent under Section 84(3)(b) of the Patents Act and that the court should exercise its discretion to disallow the amendments because they were sought after a lengthy and inexplicable delay”.

Having considered the parties’ written and oral submissions and those of Professor David Llewelyn from the School of Law, Singapore Management University as amicus curiae, we agree with the Judge’s decision and dismiss Warner-Lambert’s appeal. This appeal also raised certain issues in patent law which have not been considered by the Singapore courts. These issues relate to the protection of subsequent medical uses of known substances and the validity of “Swiss-style” claims under the Patents Act. Although the determination of these issues is not necessary for this appeal, we take the opportunity in this judgment to make our observations on these issues.

Background Facts The method of treatment exclusion

As mentioned above, method of treatment claims are excluded from patentability by s 16(2) of the Patents Act which deems such claims incapable of industrial application, a requirement for patentability under s 13(1) of the Patents Act. The rationale behind the method of treatment exclusion has been set out clearly by the Judge at [31] to [33] of the Judgment as follows:

The method of treatment exclusion

It is not uncommon for patent systems to exclude methods of treatment from its domain. It has been rightly observed that the limitation rests on a legal fiction that methods of treatment and diagnosis are not capable of industrial application. Thus, it is commented in William Cornish, Intellectual Property: Omnipresent, Distracting, Irrelevant? (Clarendon Law Lectures 2002) (Oxford University Press, 2004) at p 11 that the fear of adverse impact on the health system lies at the heart of the exclusion of methods of medical treatment. The real reason is that it is not in the interest of the public to have methods of treatment and diagnosis controlled by a few: Ng-Loy Wee Loon, Law of Intellectual Property of Singapore (Sweet & Maxwell, 2nd Ed, 2014) (“Ng-Loy Wee Loon”) at para 30.1.69. In the same vein, in CYGNUS/Diagnostic method (G 1/04) [2006] EPOR 15, the Enlarged Board of Appeal of the European Patent Office (“EPA”) identified the exception as being based on socio-ethical and public health considerations: the practice of medicine by various professionals needs to be carried on without them having to consider whether a patent licence is necessary for any method of treatment (at [4]). In Singapore, the method of treatment exclusion is statutorily embodied in s 16(2) of the Act which deems methods of treatment to be incapable of industrial application…

The purpose of s 16(2) is to exclude from the patent system inventions that comprise a method of treatment of the human or animal body. The provision is carefully and precisely crafted. The method of treatment (be it surgery, therapy or diagnosis) must be practised on the human or animal body. However, s 16(3) clarifies that any product that was invented for use in the method of treatment is not caught by the exclusion. The intention is clear — the medicinal product that was invented for use in the method of treatment may be patented provided that it fulfils all the other requirements of the patent system (such as enabling disclosure, novelty, inventive step and industrial application). For instance, a drug invented to be used in a treatment plan for Parkinson’s disease is not caught by s 16. Therefore, the practical effect of the method of treatment exclusion is to “compel” would-be patentees in the area of medical research to focus their claims on the product that is invented for use in the treatment. I note in passing that s 16 of our Act is in pari materia with s 4A of the UK Patents Act 1977 (as amended in 2004).

As helpfully pointed out by the amicus curiae, “a 2014 study by the International Association for the Protection of Intellectual Property, known as AIPPI (Association Internationale pour la Protection de la Propriété Intellectuelle), reported that “method of human treatment” claims are permitted only in the USA, Australia and Russia”.1

The Patent

Before delving into the details of the Patent, it is useful to look at the registration system in place at the time the Patent was filed and granted in Singapore. At the time of Warner-Lambert’s application in 1997, Singapore’s patent system was a self-assessment system under the Patents Act (Cap 221, 1995 Rev Ed). In this self-assessment system, the Intellectual Property Office of Singapore (IPOS) did not conduct an independent search and examination to determine if the invention was patentable, ie, that it fulfilled the three requirements of novelty, inventive step and industrial application. Instead, the burden was on the applicant to self-certify the patent’s compliance with the patentability requirements under the Patents Act. A summary of the self-assessment system is provided at para 29.4.8 of Ng-Loy Wee Loon, Law of Intellectual Property of Singapore (Sweet & Maxwell, 2nd Ed, 2014) (“Ng-Loy Wee Loon”):

… Under this system, it was not the Registrar of Patents who decided whether the patent applicant was eligible to proceed to grant. Instead, it was the patent applicant who decided whether to make a request for the grant of patent. When the patent applicant decided to request for grant and this request was received by the Registrar of Patents, the patent would be granted if a few matters had been complied with. These matters did not include the fulfilment of the patentability criteria of novelty, inventive step and industrial application. The premise underlying this self-assessment system was that patent applicants would exercise good judgment and proceed to request for grant of patent only if the examination report was a positive one, that is, a report that indicated that the subject-matter of the application satisfied all the patentability criteria… [emphasis added]

The reason for having a self-assessment system was explained by then Minister for Law, Professor S Jayakumar, during the Second Reading of the Patents Bill (see Singapore Parliamentary Debates, Official Report (21 March 1994) vol 62 col 1446):

In order to ascertain patentability, an invention has to undergo a search and examination process. We have decided to avoid the substantial investment in building up full-fledged search and examination capabilities in Singapore, and therefore search and examination reports furnished by designated Foreign Patent Offices and International Search and Preliminary Examinations Authorities under a treaty known as the Patent Cooperation Treaty will be accepted.

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2 cases
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