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

• Jurisdiction: Singapore
• Judge: George Wei J
• Judgment Date: 26 May 2016
• Neutral Citation: [2016] SGHC 106
• Plaintiff Counsel: Stanley Lai Tze Chang, SC, Gloria Goh En-Ci and Clara Tung Yi Lin (Allen & Gledhill LLP)
• Docket Number: Suit No 390 of 2015 (Summons No 4136 of 2015)
• Date: 26 May 2016
• Hearing Date: 23 November 2015
• Subject Matter: Industrial application,Novelty,Patents and Inventions
• Published date: 15 August 2017
• Citation: [2016] SGHC 106
• Defendant Counsel: Suhaimi Bin Lazim and Chow Jian Hong (Mirandah Law LLP)
• Court: High Court (Singapore)
• Year: 2016

George Wei J: Introduction

This dispute revolves around a pharmaceutical patent (“the patent”) owned by the plaintiff, a well-established pharmaceutical company. The central issue before me is whether the plaintiff should be granted leave to amend the patent under s 83(1) of the Patents Act (Cap 221, 2005 Rev Ed) (“the Act”). For reasons that will be set out in this judgment, I dismiss the plaintiff’s application for leave to amend its patent.

Background The patent

The patent claims a monopoly over the use of pregabalin for the treatment of pain. Under the patent, the plaintiff manufactures and distributes the product known as “Lyrica” which has pregabalin as its active ingredient. Lyrica is approved by the Health Sciences Authority (“the HSA”) for use in treating, inter alia, neuropathic pain and chronic pain disorders including fibromyalgia.

The patent was filed on 16 July 1997 and was granted in Singapore on 23 May 2000. Since patents in Singapore are protected for a term of 20 years from the date of filing the application (s 36 of the Act), it follows that the patent is approaching the end of its term of protection. Apart from this patent, the plaintiff owns equivalent patents in other jurisdictions. In particular, it is relevant to note that the plaintiff’s patents in Australia, Europe and Singapore were derived from an international application filed on 16 July 1997.

The material events

On 23 March 2015, the plaintiff received notice of the defendant’s applications to the HSA for product licences in respect of pregabalin products. The notification was made pursuant to s 12A(3)(a) of the Medicines Act (Cap 176, 1985 Rev Ed). In the notice, the defendant alleged that the patent would not be infringed by the doing of the acts for which the product licences were sought.

On 21 April 2015, the plaintiff commenced an action against the defendant seeking inter alia a declaration that its patent would be infringed by the doing of the acts for which the product licences were sought. Thereafter, the plaintiff notified the defendant of its intention to apply to amend the patent on 5 May 2015.

On 2 June 2015, the defendant filed its defence and counterclaim in which it counterclaimed for a revocation of the patent on the basis that the patent is and always has been invalid for the reason that it claims a monopoly over methods of treatment of the human or animal body, which are not patentable in Singapore.¹

The plaintiff’s proposed amendments were subsequently advertised on 29 June 2015, as required under O 87A r 11(1) of the Rules of Court, and the defendant filed its notice of opposition to the application to amend on 24 July 2015. On 26 August 2015, the plaintiff filed this application to amend the claims in its patent. It is clear that the application is the plaintiff’s attempt to address the claim that the patent as granted is and always has been invalid for claiming a monopoly over methods of treatment.

The amendments

In essence, the amendments pertain to a change from a claim to a method of treatment to a “Swiss-style” claim in the following generalised form: “the use of compound X in the manufacture of a medicament for a specified (and new) therapeutic use Y”.

The proposed amendments are marked up against the claims of the patent as granted:

Analysis and Decision

The present application is governed by s 83 of the Act. For the avoidance of doubt, the Registrar’s general power to allow the specification of the patent to be amended under s 38 of the Act is inapplicable in cases like the present where there are pending proceedings before the court in which the validity of the patent has been put in issue. In such cases, the application to amend must be brought under s 83 of the Act. I note in passing that there are similar provisions set out in s 75 of the UK Patents Act 1977 which extends to proceedings where validity could have, but was not, put in issue: see CIPA Guide to the Patents Act (Paul G Cole gen ed) (Sweet & Maxwell, 7th Ed, 2011) (“CIPA Guide”) at para 75.03.

The law on the amendment of patent specifications under s 83 of the Act is clear and well-established. The court’s power to amend a patent is circumscribed by s 84(3) which precludes amendments resulting in the specification disclosing any additional matter or extending the protection conferred by the patent. Further, any amendments must satisfy the “base-line criteria” set out in s 25(5) of the Act which provides, inter alia, that the claims are to be clear and concise: Trek Technology (Singapore) Pte Ltd v FE Global Electronics Pte Ltd and other and other suits [2005] 3 SLR(R) 389 (“FE Global (HC)”) at [52]. At the end of the day, the court has a general discretion to allow or disallow the proposed amendments and the exercise of this discretion is guided by the factors outlined in Smith Kline & French Laboratories v Evans Medical Limited [1989] FSR 561 (“Smith, Kline and French Laboratories Ltd”) at 569.

I turn now to the defendant’s main grounds of opposition which I will examine in the following order. The proposed amendments, if adopted, would be futile as the amended patent would nonetheless fail to satisfy the requirements for patentability, namely, novelty, inventive step and industrial application. The proposed amendments fall afoul of s 84(3) of the Act because they result in: (i) the disclosure of additional matter; and (ii) the extension of the protection conferred by the patent. The court should exercise its discretion to reject the proposed amendments because: there has been an unreasonable delay in seeking the proposed amendments; the plaintiff is seeking to obtain an unfair advantage from the patent which it knew is and always has been invalid; and the plaintiff has failed to make full disclosure of all relevant matters in relation to the proposed amendments.

For completeness, I note that the defendant has reserved its rights to file submissions on two issues after the parties have filed their respective expert evidence for the trial of the main action.² The issues pertain to: (a) whether the amended claims lack novelty and inventiveness; and (b) whether the amended claims are unclear and imprecise. However, for reasons that will become apparent, it will not be necessary to visit these issues.

Whether the amendments would be futile

The defendant resists the proposed amendments on the basis that the amended patent would nonetheless fail to fulfil the requirements for patentability, namely, the requirements of novelty, inventive step and industrial application. It is essential, however, to first resolve a logically anterior issue: whether the validity of the amended patent should be considered alongside the pre-requisites before the court grants leave to amend the patent.

This issue was recently considered in the case of Ship’s Equipment Centre Bremen GmbH v Fuji Trading (Singapore) Pte Ltd and others and another suit [2015] 4 SLR 781 (“Ship’s Equipment”). In that case, the defendants opposed, inter alia, the plaintiff’s proposed amendment to the first claim of its Singapore Patent SG110370 on the basis that the amended patent would still be invalid. Lee Seiu Kin J rejected this ground of opposition, holding that the defendant’s approach puts the proverbial cart before the horse and should not be accepted where the issue of validity was scheduled to be heard after the applications to amend the patents (at [19]).

The parties have also referred me to the following comments made by the learned authors of Terrell on the Law of Patents (Richard Miller, Guy Burkill, Colin Birss & Douglas Campbell, Terrell on the Law of Patents (Sweet & Maxwell, 17th Ed, 2010) at para 15-44):

It is not the normal procedure to attack the validity of a patent as it is proposed to be amended (other than in the course of other proceedings in which validity is in issue), and it has been held that it is not permissible when deleting claims to allege that the remaining unamended claims should never have been granted.

However the court or Comptroller will not allow an amendment which is sought to strengthen the validity of the patent if the amendment still clearly leaves the patent invalid or if what remains is so small as not to warrant the grant of a patent.

Where validity is in issue in the same proceedings, and the proposed amended claims are held to be still invalid, the court may either formally allow the amendment but then find the amended patent invalid and order its revocation, or it may refuse leave to amend on the basis that the amendment is pointless and simply revoke the patent in its existing form. Given that the court has a wide discretion as to costs in either event, the difference appears to be one of form only.

[emphasis added in bold italics]

A few key points emerge from the passage above. First and foremost, it is not the normal procedure to attack the validity of a patent as it is proposed to be amended. The court may, however, decide issues of validity where validity is put in issue in the same proceedings. Second, the court will refuse an amendment if it clearly leaves the patent invalid or if what remains is so small as not to warrant the grant of a patent. These comments largely cohere with the approach taken by the court in Ship’s Equipment but appear to go one step further by suggesting that the court disallow the proposed amendment in cases where it is clear that the amendment is pointless.

I agree with the view espoused in Ship’s Equipment that it is inappropriate for issues of validity to be heard together with the hearing to amend the patent. Even if, as opined by the learned authors of Terrell on the Law of Patents, the court may refuse an amendment where the amended patent would still be clearly invalid, this is not the case here. Quite the contrary, it is far from clear, on the material before me, whether the amended patent...