Warner-Lambert v Novartis: Patent Amendment, Industrial Application & Novelty in Pharmaceutical Patent Dispute
Warner-Lambert Company LLC, the plaintiff, sued Novartis (Singapore) Pte Ltd, the defendant, in the High Court of Singapore, regarding a pharmaceutical patent for pregabalin. The plaintiff sought to amend the patent under s 83(1) of the Patents Act. The defendant opposed the amendment, arguing it would be futile, disclose additional matter, and extend patent protection. The court dismissed the plaintiff's application, finding that the proposed amendments would extend the protection conferred by the patent and that there had been an unreasonable delay in seeking the amendments.
1. Case Overview
1.1 Court
High Court of the Republic of Singapore1.2 Outcome
Application to amend the patent in suit is dismissed with costs to the defendant.
1.3 Case Type
Intellectual Property
1.4 Judgment Type
Judgment
1.5 Jurisdiction
Singapore
1.6 Description
Pharmaceutical patent dispute over pregabalin. Court dismissed Warner-Lambert's application to amend patent, citing extended protection and delay.
1.7 Decision Date
2. Parties and Outcomes
| Party Name | Role | Type | Outcome | Outcome Type | Counsels |
|---|---|---|---|---|---|
| Novartis (Singapore) Pte Ltd | Defendant | Corporation | Judgment for Defendant | Won | |
| WARNER-LAMBERT COMPANY LLC | Plaintiff | Corporation | Application Dismissed | Lost |
3. Judges
| Judge Name | Title | Delivered Judgment |
|---|---|---|
| George Wei | Judge | Yes |
4. Counsels
4. Facts
- The plaintiff owns a pharmaceutical patent for pregabalin, used in the drug Lyrica to treat pain.
- The defendant sought product licenses for pregabalin products, alleging non-infringement of the plaintiff's patent.
- The plaintiff sued the defendant for potential patent infringement.
- The plaintiff applied to amend the patent to a "Swiss-style" claim after the defendant challenged its validity.
- The defendant counterclaimed for revocation of the patent, arguing it claimed a monopoly over methods of treatment.
- The patent was filed on 16 July 1997 and was granted in Singapore on 23 May 2000.
5. Formal Citations
- Warner-Lambert Company LLC v Novartis (Singapore) Pte Ltd, Suit No 390 of 2015 (Summons No 4136 of 2015), [2016] SGHC 106
6. Timeline
| Date | Event |
|---|---|
| Patent filed | |
| Patent granted in Singapore | |
| Plaintiff received notice of defendant’s applications to the Health Sciences Authority for product licences | |
| Plaintiff commenced action against the defendant | |
| Plaintiff notified the defendant of its intention to apply to amend the patent | |
| Defendant filed its defence and counterclaim | |
| Plaintiff’s proposed amendments were advertised | |
| Defendant filed its notice of opposition to the application to amend | |
| Plaintiff filed this application to amend the claims in its patent | |
| Hearing date | |
| Judgment reserved |
7. Legal Issues
- Patent Amendment
- Outcome: The court dismissed the plaintiff's application to amend the patent.
- Category: Procedural
- Sub-Issues:
- Extension of protection
- Disclosure of additional matter
- Unreasonable delay
- Industrial Application
- Outcome: The court considered whether the proposed amendments would result in the specification disclosing any additional matter, namely the use of compounds of Formula I in the preparation of a medicament.
- Category: Substantive
- Sub-Issues:
- Method of treatment exclusion
- Novelty
- Outcome: The court considered the requirement of novelty in the context of new uses of known substances in the pharmaceutical industry.
- Category: Substantive
- Sub-Issues:
- New use of known substance
8. Remedies Sought
- Declaration of Patent Infringement
- Amendment of Patent
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 |
|---|---|---|---|---|---|
| Trek Technology (Singapore) Pte Ltd v FE Global Electronics Pte Ltd and other and other suits | High Court | Yes | [2005] 3 SLR(R) 389 | Singapore | Cited for the base-line criteria that the claims are to be clear and concise. |
| Smith Kline & French Laboratories v Evans Medical Limited | N/A | Yes | [1989] FSR 561 | N/A | Cited for the factors guiding the court's discretion to allow or disallow proposed amendments. |
| Ship’s Equipment Centre Bremen GmbH v Fuji Trading (Singapore) Pte Ltd and others and another suit | High Court | Yes | [2015] 4 SLR 781 | Singapore | Cited regarding the timing of considering the validity of the amended patent. |
| Texas Instruments Ltd v Hyundai Electronics UK Ltd | Chancery Division (Patents Court) | Yes | (1999) 22(12) IPD 22116 (Ch D (Patents Ct)) | United Kingdom | Cited by the defendant for the proposition that the court may visit issues of validity in deciding whether to allow amendments to the patent. |
| Richardson-Vicks Inc’s Patent | N/A | Yes | [1995] RPC 568 | N/A | Cited by the defendant for the proposition that the court may visit issues of validity in deciding whether to allow amendments to the patent. |
| Chiron Corp v Organon Teknika Ltd (No 11) | N/A | Yes | [1995] FSR 589 | N/A | Cited for the principle that it is not permissible when amending a patent by deleting claims to allege that the remaining unamended claims should never have been granted. |
| Actavis UK Ltd v Merck & Co Inc | N/A | Yes | [2009] 1 WLR 1186 | N/A | Cited regarding novelty claims for old substances with new uses. |
| Mobil Oil III/Friction reducing additive (G 2/88) | European Patent Office | Yes | [1990] EPOR 73 | Europe | Cited for the view that the use of X as a friction reducing additive in a lubricant composition for engines was new even though use of X in such a composition for the purpose of rust inhibition was known and part of the prior art. |
| Eisai/Second medical indication (G 5/83) | European Patent Office | Yes | [1979–1985] EPOR B241 | Europe | Cited for the principle that a claim to the use of a compound for therapeutic treatment is confined to the step of treatment and so was unpatentable. |
| ABBOTT RESPIRATORY/Dosage regime (G 2/08) | European Patent Office | Yes | [2010] EPOR 26 | Europe | Cited for the effect of Art 54(5) of the EPC 2000. |
| Genelabs Diagnostics Pte Ltd v Institut Pasteur and another | N/A | Yes | [2000] 3 SLR(R) 530 | Singapore | Cited to note that Singapore has modelled much of its current patent legislation on equivalent provisions of the UK Patents Act 1977. |
| Ng Kok Cheng v Chua Say Tiong | N/A | Yes | [2001] 2 SLR(R) 326 | Singapore | Cited to note that Singapore has modelled much of its current patent legislation on equivalent provisions of the UK Patents Act 1977. |
| Bonzel and another v Intervention Ltd and another (No 3) | N/A | Yes | [1991] RPC 553 | N/A | Cited for the test to determine whether there was an extension of disclosure. |
| FE Global Electronics Pte Ltd and others v Trek Technology (Singapore) Pte Ltd and another appeal | Court of Appeal | Yes | [2006] 1 SLR(R) 874 | Singapore | Cited for endorsing and applying the Bonzel formulation. |
| Novartis AG and another v Ranbaxy (Malaysia) Sdn Bhd | High Court | Yes | [2013] 2 SLR 117 | Singapore | Cited for applying the Bonzel formulation. |
| Warner-Lambert Company LLC v Actavis Group PTC EHF | N/A | Yes | [2015] RPC 25 | N/A | Cited for the skilled person's understanding that it is necessary for the (Swiss-style) claim to include a manufacturing step to ensure that the claim does not touch the doctor, and fall afoul of the method of treatment exclusion. |
| Vifor Medical AG v Fresenius AG and another | Technical Board of Appeal of the European Patent Office | Yes | (T 134/95) (22 October 1996) | Europe | Cited for the principle that it would be permissible to re-formulate a product claim to a use claim if the result is to cut down the scope of what is protected. |
| Cytoplasmic male sterile plants/ENZA ZADEN | Technical Board of Appeal of the European Patent Office | Yes | (T 579/01) (30 June 2004) | Europe | Cited for the test that one must examine and compare the totality of the claims before and after the proposed amendments. |
| First Currency Choice Pte Ltd v Main-Line Corporate Holdings Ltd | N/A | Yes | [2008] 1 SLR(R) 335 | Singapore | Cited for the principle that where the words of the claim are clear and unambiguous, it is not permissible to put a gloss on or expand the claims by relying on the statement in the specification. |
| KU Leuven Research & Development v Sedaxnyl SpA and others | Technical Board of Appeal of the European Office | Yes | (T 495/10) (3 July 2012) | Europe | Cited for the principle that the amendment did not extend the protection conferred by the patent. |
| EI du Pont de Nemours and Company v Hoechst Aktiengesellschaft | Board of Appeal of the European Patent Office | Yes | (T 619/88) (1 March 1990) | Europe | Cited for allowing an amendment of claim from process to use of compound in process. |
| Composition for contraception/Bayer Schering Pharma AG | Board of Appeal of the European Patent Office | Yes | (T 1635/09) (27 October 2010) | Europe | Cited for the application involving the conversion of a use claim to a Swiss-style claim and the issue of whether the reformulation extended the protection of the patent. |
| Warner-Lambert Company LLC v Actavis Group PTC EHF | Court of Appeal | Yes | [2015] EWCA Civ 556 | England and Wales | Cited for the question of construction of a patent in Swiss form. |
| Warner-Lambert Company LLC v Actavis Group PTC EHF | N/A | Yes | [2015] EWHC 2548 | England and Wales | Cited for the question as to whether there was infringement. |
| Kimberly-Clark Worldwide Inc v Procter & Gamble Limited | N/A | Yes | [2000] FSR 235 | N/A | Cited for the rationale of the discretion to refuse an application to amend. |
| Van der Lely NV v Bamfords Ltd | English Court of Appeal | Yes | [1964] RPC 54 | England and Wales | Cited for the reason for the difference in attitude between amendments designed to assist in the enforcement of a valid claim as opposed to those designed to validate an invalid one. |
| Chiron Corp v Organon Teknika Ltd (No 7) | N/A | Yes | [1994] FSR 458 | N/A | Cited for the reason for the difference in attitude between amendments designed to assist in the enforcement of a valid claim as opposed to those designed to validate an invalid one. |
| Kimberley Clark Worldwide Inc v Procter & Gamble Ltd (No 1) | N/A | Yes | [2000] RPC 422 | N/A | Cited for the principle that in cases where a patentee delays for an unreasonable period before seeking amendment, it will not be allowed unless the patentee shows reasonable grounds for his delay. |
| Instance v CCL Label Inc | N/A | Yes | [2002] FSR 27 | N/A | Cited for the principle that the period of the delay need not be long provided that there is no plausible explanation for the delay. |
| CSL Limited v Novo Nordisk Pharmaceuticals Pty Ltd (No 2) | N/A | Yes | [2010] FCA 1251 | Australia | Cited for the principle that an applicant’s actual or constructive knowledge of the need to amend should, in appropriate circumstances, suffice to disentitle the applicant to the favourable exercise of the court’s discretion. |
| Raleigh Cycle Co Ltd v Miller (H) & Co | N/A | Yes | [1951] AC 278 | N/A | Cited for the need to take into account the public interest which is injured when invalid claims are persisted in so that inventors are legitimately warned off the area of the art ostensibly monopolised by the claims. |
| Autoliv Development AB’s Patent | N/A | Yes | [1988] RPC 425 | N/A | Cited for the principle that a patentee who seeks to obtain an unfair advantage from a patent which he knows, or should have known, needed to be amended will not be allowed to amend. |
| CYGNUS/Diagnostic method (G 1/04) | Enlarged Board of Appeal of the European Patent Office | Yes | [2006] EPOR 15 | Europe | Identified the exception as being based on socio-ethical and public health considerations: the practice of medicine by various professionals needs to be carried on without them having to consider whether a patent licence is necessary for any method of treatment. |
| John Wyeth and Brothers Ltd's Application and Schering AG’s Applications | N/A | Yes | [1985] RPC 545 | N/A | The new therapeutic use is regarded as conferring novelty on the process of manufacture. |
| Sempra Metals Ltd (formerly Metallgesellschaft Ltd) v Inland Revenue Commissioners | N/A | Yes | [2008] 1 AC 561 | N/A | Legal rules which are not soundly based resemble proverbial bad pennies: they turn up again and again. |
13. Applicable Rules
| Rule Name |
|---|
| O 87A r 11(1) of the Rules of Court |
14. Applicable Statutes
| Statute Name | Jurisdiction |
|---|---|
| Patents Act (Cap 221, 2005 Rev Ed) | Singapore |
| Medicines Act (Cap 176, 1985 Rev Ed) | Singapore |
| s 83(1) of the Patents Act (Cap 221, 2005 Rev Ed) | Singapore |
| s 36 of the Patents Act (Cap 221, 2005 Rev Ed) | Singapore |
| s 12A(3)(a) of the Medicines Act (Cap 176, 1985 Rev Ed) | Singapore |
| s 84(3) of the Patents Act | Singapore |
| s 25(5) of the Patents Act | Singapore |
| s 16(2) of the Patents Act | Singapore |
| s 16(3) of the Patents Act | Singapore |
| s 14(7) of the Patents Act | Singapore |
| s 113 of the Patents Act | Singapore |
| s 66(1)(b) of the Patents Act | Singapore |
| s 66(1)(c) of the Patents Act | Singapore |
15. Key Terms and Keywords
15.1 Key Terms
- Pregabalin
- Lyrica
- Pharmaceutical patent
- Swiss-style claim
- Method of treatment exclusion
- Industrial application
- Novelty
- Patent amendment
- Medicament
- Therapeutic use
15.2 Keywords
- Patent
- Amendment
- Pharmaceutical
- Pregabalin
- Industrial application
- Novelty
- Swiss-style claim
17. Areas of Law
| Area Name | Relevance Score |
|---|---|
| Patents | 90 |
| Pharmaceutical Law | 85 |
| Inventions | 70 |
| Food, Drug and Cosmetics | 60 |
| Patent Amendment | 60 |
| Patent Litigation | 50 |
16. Subjects
- Patent Law
- Intellectual Property
- Pharmaceuticals
- Patent Amendment