Novartis v Ranbaxy: Patent Amendment, Valsartan, Pharmaceutical Preparations, Singapore

In Novartis AG and another v Ranbaxy (Malaysia) Sdn Bhd, the Singapore High Court considered an application by Novartis AG and its exclusive licensee to amend claims in Patent No SG120119 concerning pharmaceutical preparations containing valsartan. Ranbaxy opposed the amendment, arguing it would add matter to the patent application and that Novartis had unduly delayed seeking the amendment. The High Court, presided over by Lee Seiu Kin J, granted Novartis's application, finding that the amendments did not add matter and that there was no undue delay on Novartis's part. The court ordered the parties to appear before the Registrar for directions regarding the amendment of pleadings.

1. Case Overview

1.1 Court

High Court

1.2 Outcome

Prayer 1 of the plaintiffs’ application is granted in terms.

1.3 Case Type

Intellectual Property

1.4 Judgment Type

Written Judgment

1.5 Jurisdiction

Singapore

1.6 Description

Singapore High Court allows Novartis to amend patent claims for valsartan pharmaceutical preparations, rejecting Ranbaxy's opposition based on added matter and undue delay.

1.7 Decision Date

27 December 2012

2. Parties and Outcomes

Party Name	Role	Type	Outcome	Outcome Type	Counsels
Novartis AG	Plaintiff	Corporation	Application Granted	Won	Tony Yeo of Drew and Napier LLC Dora Tay of Drew and Napier LLC D K Rozalynne PG Dato Asmali of Drew and Napier LLC
Ranbaxy (Malaysia) Sdn Bhd	Defendant	Corporation	Application Denied	Lost	Daniel Koh of Eldan Law LLP Andrew Quirk of Mirandah Law LLP

3. Judges

Judge Name	Title	Delivered Judgment
Lee Seiu Kin	Judge	Yes

4. Counsels

Counsel Name	Organization
Tony Yeo	Drew and Napier LLC
Dora Tay	Drew and Napier LLC
D K Rozalynne PG Dato Asmali	Drew and Napier LLC
Daniel Koh	Eldan Law LLP
Andrew Quirk	Mirandah Law LLP

4. Facts

Novartis AG is the registered proprietor of Patent No SG120119.
Ranbaxy sought to import Starval Tablets for marketing in Singapore, potentially infringing Novartis’s patent.
Novartis commenced a suit seeking declarations of infringement.
Ranbaxy counterclaimed that the patent was invalid due to prior art (DA1 and DA2).
Novartis applied to amend the patent claims to enhance clarity and distinguish them from prior art.
The proposed amendments related to the composition of a compressed tablet comprising valsartan.
The key issues were whether the amendments added matter and whether there was undue delay.

5. Formal Citations

Novartis AG and another v Ranbaxy (Malaysia) Sdn Bhd, Suit No 150 of 2011, [2012] SGHC 253

6. Timeline

Date	Event
2011-01-01	Defendant served notices on the plaintiffs in Singapore.
2011-04-01	Defendant filed its defence.
2011-08-05	Plaintiffs gave the defendant notice of its intention to take out the present application.
2012-07-25	Plaintiffs’ closing submissions filed.
2012-09-07	Defendant’s closing submissions filed.
2012-12-28	Judgment reserved.

7. Legal Issues

Amendment of Patent Claims
- Outcome: The court held that the proposed amendments did not add matter to the patent claims and that there was no undue delay on the part of the plaintiff in taking out the present application.
- Category: Substantive
- Sub-Issues:
  - Addition of matter to patent application
  - Undue delay in seeking amendments
  - Intermediate generalisation
Validity of Patent
- Outcome: The court did not make a final determination on the validity of the patent, but the defendant's claim of invalidity due to prior art was a factor in the court's consideration of the amendment application.
- Category: Substantive
- Sub-Issues:
  - Anticipation by prior art

8. Remedies Sought

Declarations of Infringement

9. Cause of Actions

Patent Infringement

10. Practice Areas

Patent Litigation
Intellectual Property Litigation

11. Industries

Pharmaceuticals

12. Cited Cases

Case Name	Court	Affirmed	Citation	Jurisdiction	Significance
Bonzel (T) and anr v Intervention Limited and anr (No 3)	N/A	Yes	[1991] RPC 553	N/A	Cited for the test to determine whether amendments to a patent’s specifications would disclose additional matter.
FE Global Electronics Pte Ltd and others v Trek Technology (Singapore) Pte Ltd and another appeal	N/A	Yes	[2006] 1 SLR(R) 874	Singapore	Endorsed the Bonzel test for determining whether amendments to a patent's specifications would disclose additional matter and factors to consider when exercising discretion to allow amendment.
Martek Biosciences Corp v Cargill International Trading Pte Ltd	N/A	Yes	[2011] 4 SLR 429	Singapore	Endorsed the Bonzel test for determining whether amendments to a patent's specifications would disclose additional matter. Used as an analogous case regarding amendments and disclosure in patent claims.
Main-Line Corporate Holdings Ltd v DBS Bank Ltd	N/A	Yes	[2012] 4 SLR 147	Singapore	Endorsed the Bonzel test for determining whether amendments to a patent's specifications would disclose additional matter. Accepted evidence of patent attorneys as experts and discussed the distinction between statutory frameworks in Europe and Singapore.
European Central Bank v Document Security Systems Incorporated	N/A	Yes	[2007] EWHC 600	N/A	Elaborated on the Bonzel test, emphasizing the court's role, the perspective of a skilled addressee, and the avoidance of hindsight.
Smith Kline & French Laboratories Limited v Evans Medical Limited	N/A	Yes	[1989] 1 FSR 561	N/A	Outlined factors to be taken into account when exercising the discretion to allow or disallow a proposed amendment of a patent.
Matbro Limited v Michigan (Great Britain) Limited and Another	N/A	Yes	[1973] RPC 823	N/A	Held that mere delay is not, of itself, necessarily sufficient to justify refusal of amendment. There must have been or be likely to be some detriment to the respondents or to the general public caused by such delay before it can be an effective bar to relief.
Trek Technology (Singapore) Pte Ltd v FE Global Electronics Pte Ltd and others and other suits	N/A	Yes	[2005] 3 SLR(R) 389	Singapore	A patentee ought to act expeditiously from the time he discovers the relevant prior art.
Ng Kok Cheng v Chua Say Tiong	N/A	Yes	[2001] 2 SLR(R) 326	Singapore	Defined a person skilled in the art.
British Thomson-Houston Company Ld v Stonebridge Electrical Company Ld	N/A	Yes	(1916) 33 RPC 166	N/A	Defined common general knowledge.
ASM Assembly Automation Ltd v Aurigin Technology Pte Ltd and others	N/A	Yes	[2010] 1 SLR 1	Singapore	Held that a patent lawyer could not be considered an expert on the views of a person skilled in the art.
Lubrizol Corp and another v Esso Petroleum Co Ltd and others	N/A	Yes	[1998] RPC 727	N/A	Explained that patent specifications are intended to be read by persons skilled in the relevant art, but their construction is for the Court.
V-Pile Technology (Luxembourg) SA and others v Peck Brothers Construction Pte Ltd	N/A	Yes	[1997] 3 SLR(R) 981	Singapore	Patent attorneys with specializations in relation to certain types of inventions are capable of assisting the court in relation to the disclosures made in patent specifications.
Merck & Co Inc’s Patents	N/A	No	[2004] FSR 16	N/A	While deletion of portions of the patent claims have the effect of narrowing the scope of invention claimed, such deletion can nevertheless add matter to a patent.
Palmaz’s European Patents (U.K.)	N/A	Yes	[1999] RPC 47	N/A	Discussed the distinction between acceptable narrowing of claims originally expressed as generalisations of various examples and narrowing of claims which would add matter.
LG Philips LCD v Tatung	N/A	Yes	[2007] RPC 21	N/A	The English Court of Appeal specifically rejected the argument that the principle of intermediate generalisation was an unhelpful and illegitimate concept.
Fosroc International Limited v W R Grace & Co-Conn	N/A	Yes	[2010] EWHC 1702	N/A	Case regarding intermediate generalisation.
Vector Corporation v Glatt Air Techniques Ltd	N/A	Yes	[2007] EWCA Civ 805	N/A	Case regarding intermediate generalisation.

13. Applicable Rules

Rule Name
O 87A r 11(6) of the Rules of Court (Cap 322, R 5, 2006 Rev Ed)

14. Applicable Statutes

Statute Name	Jurisdiction
Rules of Court (Cap 322, R 5, 2006 Rev Ed)	Singapore
Patents Act (Cap 221, 2005 Rev Ed)	Singapore
Medicines Act (Cap 176, 1985 Rev Ed)	Singapore
Evidence Act (Cap 97, 1997 Rev Ed)	Singapore

15. Key Terms and Keywords

15.1 Key Terms

Valsartan
Patent Amendment
Microcrystalline Cellulose
Crospovidone
Pharmaceutical Preparations
Prior Art
Added Matter
Undue Delay
Free Form
Active Agent
Tablet Formulation

15.2 Keywords

patent
amendment
valsartan
pharmaceutical
Singapore
intellectual property

17. Areas of Law

Area Name	Relevance Score
Patents	95
Pharmaceutical Law	85
Civil Procedure	40
Evidence Law	30
Affidavits	20
Contract Law	15
Contracts	10

16. Subjects

Intellectual Property
Patent Law
Pharmaceuticals