SINGAPORE: WARNER-LAMBERT TAKES ON NOVARTIS (SINGAPORE)

September 12th, 2017

 

The appeal arises from the dispute of two pharmaceutical giants, Warner-Lambert Company LLC (hereinafter referred to as “Warner-Lambert”) and Novartis (Singapore) Pte Ltd (hereinafter referred to as “Novartis”). The subject matter refers to a pharmaceutical patent owned by Warner-Lambert which monopolises the use of a substance known as “pregabalin” (the Patent discussed) used in the treatment of pain. “Lyrica”, is the product manufactured and distributed by Warner-Lambert with pregabalin as the main ingredient and is approved by the Health Sciences Authority (HSA). “Lyrica” is used in the treatment of chronic pain disorders such as fibromyalgia. The patent for the named substance was filed in Singapore on 16 July 2017 and granted on 23 May 2000. Therefore, the 20 year protection expired on 16 July 2017.

On 23 March 2015, Warner-Lambert was notified of Novartis’ applications to the HSA for the product licences for pregabalin related products. Novartis claimed that the Patent would not be infringed in the manner of which the licences are applied for. However, approximately a month later, Warner-Lambert commenced a suit, stating that the Patent would indeed be infringed by Novartis in the manner of which the licences were sought for. Following 5 May 2015, Warner-Lambert then informed Novartis of its intension to amend the Patent.

Novartis then counterclaimed the suit by seeking the revocation of Warner-Lambert’s patent based on the ground that the patent was invalid as it has a monopoly over methods of treatment of the human and/or animal body which is not permissible under the Singaporean Patent Law. Warner-Lambert proceeded to amend the claims of the granted patent from method of
treatment style claims into “Swiss-style” claims. However, the High Court dismissed Warner-Lambert’s application to amend the claims in the view that such amendments, if granted, would broaden the scope of the protection of the patent. The court also disallowed the amendments as they were only sought for after an undue delay.

Prior to 2014, the patent system of Singapore operated on a “self-assessment” basis. Under this system, the Intellectual Property Office of Singapore (IPOS) may conduct a search and examination on a particular patent, depending on the prosecution procedure selected. However, it is the burden of the applicant to certify the patent’s compliance with the patentability requirements before proceeding to the grant of the patent. The issuance of a negative search and examination report by IPOS does not hinder a patent from being granted. In the present case discussed, the Court of Appeal suggests that a patent is obviously invalid when it fails to meet the criteria for patentability, such as when all claims are method of treatment claims. Thus, the granted patent confers no protection to the applicant, and the amending an application to validate what was not valid from the beginning would be fatal for any application. Furthermore, the Court of Appeal also justified that patents granted under the “self-assessment” system provided patentee to obtain an invalid patent and allows the patentee to obtain a monopoly over the subject matter once the patent entered the registrar. Thus, the Court decided that the patentee should have ensured that the patent applied for is in compliance with the requirements of the Patents Act under the “self-assessment” system.

In conclusion, Warner-Lambert’s appeal was dismissed based on the grounds brought by the undue delay by Warner-Lambert to amend their application. Furthermore, the amending the claims would extend the scope of protection covered by the prior granted claims.