Novartis AG and another v Ranbaxy (Malaysia) Sdn Bhd

• Jurisdiction: Singapore
• Judge: Lee Seiu Kin J
• Judgment Date: 28 December 2012
• Neutral Citation: [2012] SGHC 253
• Plaintiff Counsel: Tony Yeo, D K Rozalynne PG Dato Asmali and Dora Tay (Drew and Napier LLC)
• Docket Number: Suit No 150 of 2011
• Date: 28 December 2012
• Hearing Date: 26 July 2012,25 July 2012,27 July 2012
• Subject Matter: Patents and inventions
• Year: 2012
• Citation: [2012] SGHC 253
• Defendant Counsel: Daniel Koh (Eldan Law LLP) (instructed) and Andrew Quirk (foreign counsel from Mirandah Law LLP)
• Court: High Court (Singapore)
• Published date: 31 December 2012

Lee Seiu Kin J :

This is an application brought by the plaintiffs for leave to amend the claims in Patent No SG120119 (“Patent”) pursuant to O 87A r 11(6) of the Rules of Court (Cap 322, R 5, 2006 Rev Ed) and s 83 of the Patents Act (Cap 221, 2005 Rev Ed)(“the Act”).

Background Facts

The first plaintiff, Novartis AG, is the registered proprietor of the Patent, and the second plaintiff is its exclusive licensee. The defendant, Ranbaxy (Malaysia) Sdn Bhd, opposes the application made by the plaintiff.

The defendant, a pharmaceutical company, seeks to import for marketing in Singapore products known as Starval Tablets, of various compositions, which relate to the plaintiffs’ Patent. The defendant was obliged under s 12A(3)(a) of the Medicines Act (Cap 176, 1985 Rev Ed) (“Medicines Act”) to serve its applications made to the Health Sciences Authority for product licences on the first plaintiff. The purpose of the notices was to inform the plaintiffs that the products which the defendant intended to import for marketing in Singapore could potentially infringe the plaintiffs’ Patent, and that the plaintiffs ought to commence the necessary action before the High Court within 45 days to assert its rights under the Patent and to obtain the necessary relief from the court, failing which the relevant product licences would be granted to the defendant. Shortly after the receipt of the requisite notice, the plaintiffs commenced this suit, asserting, inter alia, that if the licences sought were granted, and the defendant’s products were imported and marketed in Singapore, the Patent will be infringed. Thus, the plaintiffs seek declarations of infringement with respect to the Patent. The defendant asserts, inter alia, in its defence and counterclaim, that the Patent is invalid because the invention it discloses has been anticipated by the prior art. In particular, two pieces of prior art have been relied upon, and they shall be referred to as DA1 and DA2 respectively for the purposes of this judgment.

In response, the plaintiffs seek to amend the Patent claims to “enhance clarity, to highlight the inventive contributions of the Patent and to reduce the number of claims”¹, as well as to “further distinguish the claims in [the Patent] from the matter disclosed in the ... references ... cited by the Defendant in its Defence and Counterclaim and Particulars of Objections”.²

In the application as filed in Singapore, it is stated in the Patent specifications that the invention relates to:³

... pharmaceutical preparations, which comprise an AT1 receptor antagonist or an AT2 receptor modulator, respectively, or a pharmaceutically acceptable salt thereof, for the treatment of conditions or diseases associated with the increase of AT1 receptors in the sub-epithelial area or increase of AT2 receptors in the epithelia.

It is also claimed that the invention may be used for the treatment of:⁴

... obstructive airways diseases ... chronic obstructive pulmonary disease, such as bronchitis, e.g. chronic bronchitis and emphysema, likewise from asthma, cystic fibrosis, interstitial lung disease, invasive lung and invasive breast cancer, pulmonary vascular disease, and increased resistance to airflow during forced expiration, any such treatment may also be associated with the treatment of hypertension as well as both non-smokers and smokers; for the treatment of specific forms of lung conditions and diseases; for the treatment of adults respiratory distress syndrome (ARDS); for reducing the proliferative capacity of the epithelium invasive cancer, for the treatment of sepsis syndrome, lung injury forms, such as pneumonia, aspiration of gastric content, chest trauma, shock, burns, fat embolia, cardiopulmonary bypass, O2 toxicity, haemorrhagic pancreatic, interstitial and bronchoalveolar inflammation, proliferation of epithelial and interstitial cells, collagen accumulation, or fibrosis.

The proposed amendments are marked up against the claims of the application as filed, as follows⁵:

1. A compressed tablet comprising valsartan in free form as the only active agent; and more than 30% of microcrystalline cellulose and 2 to 10% of crospovidone, both by weight based on the total weight of the core components of said the compressed form tablet.

2. A The compressed tablet according to claim 1 comprising up to 65% of microcrystalline cellulose.

3. A compressed tablet according to claim 1 or 2 comprising less than 13% of crospovidone.

4. A compressed tablet comprising valsartan in free form and microcrystalline cellulose wherein the weight ratio of valsartan to microcrystalline cellulose is from 2.5 : 1 to 0.3 : 1.

5 3. A The compressed tablet according to any one of claims 1 to 4 2 comprising 20 to 65% of valsartan.

6 4. A The compressed tablet according to any one of claims 1 to 5 3 comprising 20 to 360 mg of valsartan.

7 5. A compressed tablet, comprising 20 to 65% of valsartan in free form as the only active agent, by weight based on the total weight of the core components of the compressed tablet, 31 to 65% of microcrystalline cellulose by weight based on the total weight of the core components of the compressed tablet, 2 to 1013% of crospovidone by weight based on the total weight of the core components of the compressed tablet.

8. Use of the solid oral dosage form according to any one of claims 1 to 8 in the manufacture of a medicament for the treatment of conditions or diseases associated with the increase of AT1 receptors in the sub-epithelial area.

At the hearing, counsel for the parties agreed that the dispute really relates to whether amendments to claims 1 and 5 are permissible, because the amendments to the other claims as seen above are consequential to those amendments. The following matters are also not disputed: valsartan is an active agent for which a separate patent subsists; microcrystalline cellulose is an exigent which, when used in a certain dosage, improves the performance of valsartan as the active agent; crospovidone is a drug distegrant which will break up the drug inside the human digestive system; and the Patent relates to how valsartan, a known active agent, is delivered to and absorbed by the human body, and not the compound of valsartan. The law on amendment of patent claims Amendment shall not add matter to the patent application as filed

Before turning to the issues arising out of the present application, it is necessary to first set out the legal principles which govern the amendment of patent specifications. The plaintiff’s application is brought pursuant to s 83(1) of the Act, which provides that:

Amendment of patent in infringement or revocation proceedings 83. —(1) In any proceedings before the court or the Registrar in which the validity of a patent is put in issue, the court or, as the case may be, the Registrar may, subject to section 84, allow the proprietor of the patent to amend the specification of the patent in such manner, and subject to such terms as to the publication and advertisement of the proposed amendment and as to costs, expenses or otherwise, as the court or Registrar thinks fit.

Thus, the court has discretion to grant leave to amend the specifications of a patent. However, such discretion is subject to s 84(3) of the Act, which provides that: (3) No amendment of the specification of a patent shall be allowed under section 38(1), 81 or 83 if it — (a) results in the specification disclosing any additional matter; or (b) extends the protection conferred by the patent. For the purposes of the present application, only s 84(3)(a) is germane.

In determining whether the amendments to a patent’s specifications would disclose additional matter, the applicable test is that which has been laid down in the oft-cited case of Bonzel (T) and anr v Intervention Limited and anr (No 3) [1991] RPC 553 (“Bonzel”) at p 574, as follows:

… The task of the Court is threefold:

(1) To ascertain through the eyes of the skilled addressee what is disclosed, both explicitly and implicitly in the application. (2) To do the same in respect of the patent as granted. (3) To compare the two disclosures and decide whether any subject matter relevant to the invention has been added whether by deletion or addition. The comparison is strict in the sense that subject matter will be added unless such matter is clearly and unambiguously disclosed in the application either explicitly or implicitly.

[emphasis added]

The test laid down in Bonzel has been endorsed in three local cases, namely, FE Global Electronics Pte Ltd and others v Trek Technology (Singapore) Pte Ltd and another appeal [2006] 1 SLR(R) 874 at [24] (“FE Global”), Martek Biosciences Corp v Cargill International Trading Pte Ltd [2011] 4 SLR 429 (“Martek”) at [81] and Main-Line Corporate Holdings Ltd v DBS Bank Ltd [2012] 4 SLR 147 at [73] (“Main-Line”). The Bonzel test has been further elaborated upon in a subsequent English case, European Central Bank v Document Security Systems Incorporated [2007] EWHC 600 at [97]–[102]:

97. A number of points emerge from [the Bonzel] formulation which have a particular bearing on the present case and merit a little elaboration. First, it requires the court to construe both the original application and specification to determine what they disclose. For this purpose the claims form part of the disclosure ... though clearly not everything which falls within the scope of the claims is necessarily disclosed.

98. Second, it is the court which must carry out the exercise and it must do so through the eyes of the skilled addressee. Such a person will approach the documents with the benefit of the common general knowledge.

99. Third, the two disclosures must be compared to see whether any subject matter relevant to the invention has been added. This comparison is a strict one....