Warner-Lambert v Novartis: Patent Amendment, Industrial Application & Novelty
In Warner-Lambert Company LLC v Novartis (Singapore) Pte Ltd, the Singapore Court of Appeal heard an appeal regarding the dismissal of Warner-Lambert's application to amend a pharmaceutical patent for pregabalin, used in the drug Lyrica, to treat pain. Novartis sought product licenses for pregabalin products, claiming non-infringement. Warner-Lambert sought a declaration of infringement, and Novartis counterclaimed for revocation based on the patent's invalidity under Singapore's patent law, which excludes methods of treatment of the human body from industrial application. The Court of Appeal dismissed Warner-Lambert's appeal, agreeing with the High Court's decision that the proposed amendments would extend the patent's protection and that there was undue delay in seeking the amendments.
1. Case Overview
1.1 Court
Court of Appeal of the Republic of Singapore1.2 Outcome
Appeal dismissed
1.3 Case Type
Intellectual Property
1.4 Judgment Type
Grounds of Decision
1.5 Jurisdiction
Singapore
1.6 Description
Singapore Court of Appeal addresses patent amendment for pregabalin, industrial application, and novelty in pharmaceutical patents. Appeal dismissed.
1.7 Decision Date
2. Parties and Outcomes
| Party Name | Role | Type | Outcome | Outcome Type | Counsels |
|---|---|---|---|---|---|
| Novartis (Singapore) Pte Ltd | Respondent | Corporation | Appeal dismissed | Won | |
| WARNER-LAMBERT COMPANY LLC | Appellant | Corporation | Appeal dismissed | Lost |
3. Judges
| Judge Name | Title | Delivered Judgment |
|---|---|---|
| Sundaresh Menon | Chief Justice | No |
| Chao Hick Tin | Judge of Appeal | No |
| Andrew Phang Boon Leong | Judge of Appeal | No |
| Judith Prakash | Judge of Appeal | No |
| Tay Yong Kwang | Judge of Appeal | Yes |
4. Counsels
4. Facts
- Warner-Lambert owns a patent for the use of pregabalin to treat pain.
- Warner-Lambert manufactures and distributes the product “Lyrica” in Singapore under the Patent.
- Novartis applied for product licenses for pregabalin products, claiming the Patent would not be infringed.
- Warner-Lambert commenced Suit 390 seeking a declaration that the Patent would be infringed.
- Novartis counterclaimed for revocation of the Patent, arguing it claimed a monopoly over methods of treatment.
- Warner-Lambert applied to amend the Patent to Swiss-style claims.
- The High Court dismissed Warner-Lambert’s application to amend the Patent.
5. Formal Citations
- Warner-Lambert Company LLC v Novartis (Singapore) Pte Ltd, Civil Appeal No 121 of 2016, [2017] SGCA 45
6. Timeline
| Date | Event |
|---|---|
| Patent filed | |
| Patent granted in Singapore | |
| Warner-Lambert received notification of Novartis’ applications to the HSA for product licences | |
| Warner-Lambert commenced Suit 390 | |
| Warner-Lambert informed Novartis of its intention to amend the Patent | |
| Novartis filed its defence and counterclaim | |
| Warner-Lambert applied by Summons 4136 of 2015 for leave to amend the Patent | |
| The Judge dismissed Warner-Lambert’s application to amend the Patent | |
| Warner-Lambert was granted leave by the Judge to appeal against his decision to dismiss SUM 4136 | |
| Patents (Amendment) Act 2017 (No 18 of 2017) was passed by Parliament | |
| Judgment reserved | |
| Judgment delivered |
7. Legal Issues
- Patent Amendment
- Outcome: The court held that the proposed amendments would extend the scope of protection of the patent and that there was undue delay in bringing the amendments.
- Category: Substantive
- Sub-Issues:
- Extension of patent protection
- Undue delay in seeking amendments
- Industrial Application
- Outcome: The court considered the method of treatment exclusion under s 16(2) of the Patents Act, which deems methods of treatment to be incapable of industrial application.
- Category: Substantive
- Sub-Issues:
- Method of treatment exclusion
- Novelty
- Outcome: The court made observations on the patentability of second and subsequent medical uses of known substances under s 14(7) of the Patents Act.
- Category: Substantive
- Sub-Issues:
- Second medical use of known substances
8. Remedies Sought
- Declaration of Patent Infringement
- Revocation of Patent
9. Cause of Actions
- Patent Infringement
- Patent Revocation
10. Practice Areas
- Patent Litigation
- Intellectual Property
- Pharmaceuticals
11. Industries
- Pharmaceuticals
12. Cited Cases
| Case Name | Court | Affirmed | Citation | Jurisdiction | Significance |
|---|---|---|---|---|---|
| Warner-Lambert Co LLC v Novartis (Singapore) Pte Ltd | High Court | Yes | [2016] 4 SLR 252 | Singapore | The Judge’s decision was appealed against and the Court of Appeal agreed with the Judge’s decision and dismissed Warner-Lambert’s appeal. |
| CYGNUS/Diagnostic method | Enlarged Board of Appeal of the European Patent Office | Yes | [2006] EPOR 15 | Europe | Identified the exception to method of treatment exclusion as being based on socio-ethical and public health considerations. |
| Trek Technology (Singapore) Pte Ltd v FE Global Electronics Pte Ltd and other and other suits | Court of Appeal | Yes | [2005] 3 SLR(R) 389 | Singapore | Cited for the 'base-line criteria' provided in s 25(5) of the Patents Act. |
| 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 for the discretionary power to allow an amendment of patent specifications. |
| Kimberly-Clark Worldwide Inc v Proctor & Gamble Limited | Court of Appeal | Yes | [2000] FSR 235 | England and Wales | Cited for the underlying rationale of the discretion to refuse an application to amend, which is the ‘desire to protect the public against abuse of monopoly’. |
| Smith Kline & French Laboratories Limited v Evans Medical Limited | Court of Appeal | Yes | [1989] FSR 561 | England and Wales | Cited for the factors to be considered in the exercise of discretion when amending a patent. |
| FE Global Electronics Pte Ltd v Trek Technology (Singapore) Pte Ltd and another appeal | Court of Appeal | Yes | [2006] 1 SLR(R) 874 | Singapore | Endorsed the factors to be considered in the exercise of discretion when amending a patent. |
| Novartis AG and another v Ranbaxy (Malaysia) Sdn Bhd | High Court | Yes | [2013] 2 SLR 117 | Singapore | Applied the factors to be considered in the exercise of discretion when amending a patent. |
| TDA v TCZ and others | Court of Appeal | Yes | [2016] 3 SLR 329 | Singapore | Cited for the standard for overturning a judge’s exercise of discretion. |
| Ceramiche Caesar SpA v Caesarstone Sdot-Yam Ltd | Court of Appeal | Yes | [2017] SGCA 30 | Singapore | Cited for the standard for overturning a judge’s exercise of discretion. |
| Lian Soon Construction Pte Ltd v Guan Qian Realty Pte Ltd | Court of Appeal | Yes | [1999] 1 SLR(R) 1053 | Singapore | Cited for the circumstances for overturning a judge’s discretion. |
| Tjong Very Sumito and others v Chan Sing En and others | Court of Appeal | Yes | [2011] 4 SLR 580 | Singapore | Cited for the standard of review prescribed for overturning a judge's discretion. |
| Westacre Investments Inc v The State-Owned Company Yugoimport SDPR | Court of Appeal | Yes | [2009] 2 SLR(R) 166 | Singapore | Cited for the standard of review prescribed for overturning a judge's discretion. |
| Instance v CCL Label Inc | High Court | Yes | [2002] FSR 27 | England and Wales | Cited as an example where the court found that a delay of one year amounted to an undue delay. |
| CSL Limited v Novo Nordisk Pharmaceuticals Pty Ltd (No 2) | Federal Court of Australia | Yes | [2010] FCA 1251 | Australia | Cited for the approach 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. |
| Martek Biosciences Corp v Cargill International Trading Pte Ltd | Court of Appeal | Yes | [2011] 1 SLR 1287 | Singapore | Cited for the public interest in “preventing unworthy inventions and products from monopolising the market”. |
| Raleigh Cycle Co Ltd v Miller (H) & Co | House of Lords | Yes | [1951] AC 278 | United Kingdom | Cited for 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. |
| Schering AG‘s Application | Court of Appeal | Yes | [1971] RPC 337 | England and Wales | Cited for the view that a person who is able to produce a substance which would cure or prevent cancer should be offered a limited monopoly as a reward. |
| John Wyeth and Brothers Ltd’s Application and Schering AG’s Applications | High Court | Yes | [1985] RPC 545 | England and Wales | Interpreted the equivalent provision, s 2(6) of the UK Patents Act 1977, as protecting only the first medical use of known substances. |
| Eisai/Second medical indication | European Patent Office Enlarged Board of Appeal | Yes | G 5/83 | Europe | First recognised Swiss-style claims in Europe. |
| Composition for contraception/Bayer Schering Pharma AG | Technical Board of Appeal of the European Office | Yes | T 1635/09 | Europe | Supports the interpretation of the scope of the Granted and Amended Claims. |
| Warner-Lambert Company LLC v Actavis Group PTC EHF | Court of Appeal | Yes | [2015] EWCA Civ 556 | England and Wales | Offers some guidance as to the scope of protection of Swiss-style claims. |
| Warner-Lambert Company LLC v Generics (UK) Ltd (trading as Mylan) and others | Court of Appeal | Yes | [2016] EWCA Civ 1006 | England and Wales | Observed that the law is struggling to give the patentee a proper reward for his contribution to the art by elucidating the new use for the drug, whilst at the same time not excluding the competing manufacturer from making and marketing the drug for its known purpose. |
| Vifor Medical AG v Fresenius AG and another | Technical Board of Appeal of the European Office | Yes | T 134/95 | Europe | An example of where such a change was allowed is the case of Vifor Medical AG v Fresenius AG and another (T 134/95) (22 October 1996). There, a patentee had been granted a product claim in respect of a “container for medical use”. The patentee applied for the product claim to be amended into a use claim, which covered only the use of the container. The Technical Board of Appeal of the European Office (“the Board”) allowed the amendment on the basis that the change in category resulted in reduction of the scope of protection rather than in extension. |
13. Applicable Rules
| Rule Name |
|---|
| Rules of Court (Cap 322, R 5, 2014 Rev Ed), O 87A r 11(1) |
14. Applicable Statutes
| Statute Name | Jurisdiction |
|---|---|
| Medicines Act (Cap 176, 1985 Rev Ed) | Singapore |
| Patents Act (Cap 221, 2005 Rev Ed) | Singapore |
| Patents Act, s 83(1) | Singapore |
| Patents Act, s 84(3) | Singapore |
| Patents Act, s 25(5) | Singapore |
| Patents Act, s 14(7) | Singapore |
| Patents Act, s 16(3) | Singapore |
| Patents Act, s 66 | Singapore |
15. Key Terms and Keywords
15.1 Key Terms
- Pregabalin
- Patent
- Swiss-style claims
- Method of treatment exclusion
- Industrial application
- Novelty
- Second medical use
- Amendment
- Undue delay
- Scope of protection
15.2 Keywords
- Patent
- Amendment
- Industrial Application
- Novelty
- Pregabalin
- Pharmaceutical
- Singapore
17. Areas of Law
| Area Name | Relevance Score |
|---|---|
| Patents | 95 |
| Pharmaceutical Law | 80 |
| Patent Infringement | 60 |
| Industrial application | 40 |
| Novelty | 40 |
| Contract Law | 20 |
16. Subjects
- Patent Law
- Pharmaceuticals
- Intellectual Property
- Civil Procedure