Warner-Lambert Company LLC v Novartis (Singapore) Pte Ltd
Jurisdiction | Singapore |
Judge | Sundaresh Menon CJ |
Judgment Date | 01 August 2017 |
Neutral Citation | [2017] SGCA 45 |
Plaintiff Counsel | Stanley Lai Tze Chang, SC, Gloria Goh En-Ci and Clara Tung Yi Lin (Allen & Gledhill LLP) |
Date | 01 August 2017 |
Docket Number | Civil Appeal No 121 of 2016 |
Hearing Date | 02 May 2017 |
Subject Matter | Patents and Inventions,Industrial application,Novelty |
Year | 2017 |
Defendant Counsel | and 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) |
Court | Court of Appeal (Singapore) |
Citation | [2017] SGCA 45 |
Published date | 08 August 2017 |
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)(
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:
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
Having considered the parties’ written and oral submissions and those of Professor David Llewelyn from the School of Law, Singapore Management University as
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
…
As helpfully pointed out by the
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,
… 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
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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