Merck v Pharmaforte: Lovastatin Patent Infringement & Validity Dispute
Merck & Co, Inc, the registered proprietors of Singapore Patent No 9690405-7, appealed against the decision of the High Court dismissing their claim against Pharmaforte Singapore Pte Ltd for patent infringement. Merck alleged that Pharmaforte's importation of Apo-Lovastatin infringed their patent rights relating to a process for the lactonization of mevinic acids and analogs thereof, specifically claims 16-21 (product claims) and claim 11 (process claim). The Court of Appeal dismissed the appeal, finding that the product claims lacked an inventive step. Merck abandoned the point on the process claim.
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
Merck's patent infringement claim against Pharmaforte over Apo-Lovastatin was dismissed. The court found Merck's product claims lacked an inventive step.
1.7 Decision Date
2. Parties and Outcomes
| Party Name | Role | Type | Outcome | Outcome Type | Counsels |
|---|---|---|---|---|---|
| Merck & Co., Inc | Appellant | Corporation | Appeal dismissed | Lost | |
| Pharmaforte Singapore Pte Ltd | Respondent | Corporation | Appeal dismissed | Won |
3. Judges
| Judge Name | Title | Delivered Judgment |
|---|---|---|
| Chao Hick Tin | Justice of the Court of Appeal | No |
| L P Thean | Justice of the Court of Appeal | No |
| Yong Pung How | Chief Justice | Yes |
4. Counsels
4. Facts
- Merck is the registered proprietor of Singapore Patent No 9690405-7, which relates to a process for the lactonization of mevinic acids and analogs thereof.
- The patent comprises both process (lactonization) and product (Lovastatin with a dimeric impurity of less than 0.2%) claims.
- Pharmaforte Singapore Pte Ltd imported and distributed Apo-Lovastatin, manufactured in Canada by Apotex Inc.
- Merck claimed that Apo-Lovastatin possessed dimeric impurity levels of less than 0.2% and infringed their patent rights.
- The respondents argued that the product claims are invalid because they lack novelty and an inventive step.
- The trial judge upheld the contentions of the respondents, finding that the product was not novel and lacked an inventive step.
- The Court of Appeal found that the prior art taught purification techniques that would have made achieving the claimed purity obvious.
5. Formal Citations
- Merck & Co, Inc v Pharmaforte Singapore Pte Ltd, CA 9/2000, Merck & Co, Inc v Pharmaforte Singapore Pte Ltd[2000] SGCA 39
6. Timeline
| Date | Event |
|---|---|
| Merck filed patent applications in the United States and elsewhere on the compound Lovastatin. | |
| Canadian patent No 1,161,380 (CP 380) filed. | |
| Canadian patent No 1,161,380 (CP 380) issued. | |
| Canadian patent No 1,199,322 (CP 322) issued to Merck. | |
| US Patent application No 221475 filed. | |
| European Patent No 0351918B1 filed. | |
| European Patent No 0351918B1 granted. | |
| Singapore Patent No 9690405-7 registered. | |
| Decision Date |
7. Legal Issues
- Patent Infringement
- Outcome: The court held that the respondents had not infringed the product claims because the patent in suit lacked an inventive step.
- Category: Substantive
- Sub-Issues:
- Validity of patent claims
- Scope of patent protection
- Patent Validity
- Outcome: The court found that the patent in suit lacked an inventive step and was therefore invalid.
- Category: Substantive
- Sub-Issues:
- Novelty
- Inventive step
- Utility
- Inventive Step
- Outcome: The court found that achieving Lovastatin with less than 0.2% dimeric impurity was obvious to a person skilled in the art.
- Category: Substantive
- Novelty
- Outcome: The court found that Lovastatin with a dimer level of less than 0.2% had not been anticipated by the two Canadian patents or any other prior art.
- Category: Substantive
8. Remedies Sought
- Injunction
- Damages
9. Cause of Actions
- Patent Infringement
10. Practice Areas
- Patent Infringement Litigation
11. Industries
- Pharmaceuticals
12. Cited Cases
| Case Name | Court | Affirmed | Citation | Jurisdiction | Significance |
|---|---|---|---|---|---|
| Genentech Inc`s Patent | N/A | Yes | [1989] RPC 147 | N/A | Cited for the principle that the 1977 Act provided a complete code for patents, displacing any residual common law element. |
| Unilever Ltd (Davis`s) Application | N/A | Yes | [1983] RPC 219 | N/A | Cited for the principle that the old law of patents was being swept away by the 1977 Act. |
| Badische Anilin Und Soda Fabrik v Levinstein | N/A | Yes | [1887] 4 RPC 449 | N/A | Cited for the principle that an invention must be useful, even if the word is not found in the statute. |
| Welsbach Incandescent Gas Light Co Ltd v New Incandescent (Sunlight Patent) Gas Lighting Co Ltd | N/A | Yes | [1900] 17 RPC 237 | N/A | Cited for the definition of utility in patent law. |
| Alsop`s Patent | N/A | Yes | [1907] 24 RPC 733 | N/A | Cited for the principle that the utility of an invention depends on whether the patentee can produce the professed result. |
| Lane Fox v Kensington & Knightsbridge Electric Lighting Co Ltd | N/A | Yes | [1892] 3 Ch 431 | N/A | Cited for the principle that utility is often a question of degree and always has reference to some object. |
| Lawrence v Perry & Co (Ltd) | N/A | Yes | [1884] 2 RPC 179 | N/A | Cited to show that an invention is not useful if it only differs from an earlier one by an ingredient which does neither harm nor good. |
| Merrell Dow Pharmaceuticals Inc & Ors v HN Norton & Co Ltd | House of Lords | Yes | [1996] RPC 76 | United Kingdom | Cited for the approach to determining anticipation by prior art and inventive step, particularly in the context of a metabolite formed in the body. |
| Farbenfabriken vormals Friedrich Bayer & Co v Chemische Fabrik Von Heydon | N/A | Yes | [1905] 22 RPC 501 | N/A | Cited for the principle that differences in degree of a compound are not patentable, only differences in the kind of the compound are. |
| Badische Anilin Und Soda Fabrik v Societe Chimique des Usines Du Rhone & Wilson | N/A | Yes | [1898] 14 RPC 875 | N/A | Cited for the principle that a purer form of a known product is patentable. |
| Joseph Lucas (Batteries) Ltd & Anor v Gaedor Ltd & Ors | N/A | Yes | [1978] RPC 297 | N/A | Cited for the principle that a dimensional limitation of a known product could be novel and patentable. |
| Application of Sune Bergstrom and Jan Sjovall | US Court of Customs and Patent Appeals | Yes | [1970] 427 F 2d 1394 | United States | Cited for the principle that pure materials necessarily differ from less pure or impure materials and are new with respect to them. |
| Toshiba/Thickness of Magnetic Layers | European Patent office | Yes | [1990] EPOR 267 | Europe | Cited for the principle that a dimensional limitation of a known product could be novel and patentable. |
| General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd & Ors | Court of Appeal | Yes | [1972] RPC 457 | N/A | Cited for the approach a court should take when considering the issue of prior disclosure by publication. |
| Flour Oxidizing Co Ltd v Carr & Co Ltd | N/A | Yes | (1908) 25 RPC 428 | N/A | Cited for the principle that to anticipate the patentee`s claim the prior publication must contain clear and unmistakeable directions to do what the patentee claims to have invented. |
| BTH Co Ltd v Metropolitan Vickers Electrical Co Ltd | N/A | Yes | [1928] 45 RPC 1 | N/A | Cited for the principle that to anticipate the patentee`s claim the prior publication must contain clear and unmistakeable directions to do what the patentee claims to have invented. |
| Windsurfing International v Tabur Marine | N/A | Yes | [1985] RPC 59 | N/A | Cited for the four steps one should take to assess whether an invention involved an inventive step. |
| Genentech | N/A | Yes | [1989] RPC 203 | N/A | Cited for the approach to determine whether there is an inventive step. |
13. Applicable Rules
| Rule Name |
|---|
| No applicable rules |
14. Applicable Statutes
| Statute Name | Jurisdiction |
|---|---|
| Patents Act 1994 | Singapore |
| Section 13(1) Patents Act 1994 | Singapore |
| Section 80(1) Patents Act 1994 | Singapore |
| Section 14(1) Patents Act | Singapore |
| Section 14(2) Patents Act | Singapore |
| Section 15 Patents Act | Singapore |
15. Key Terms and Keywords
15.1 Key Terms
- Lovastatin
- Dimeric impurity
- Patent infringement
- Inventive step
- Novelty
- Prior art
- Lactonization
- Statins
- Apo-Lovastatin
- Process claim
- Product claim
15.2 Keywords
- Patent
- Infringement
- Lovastatin
- Pharmaceutical
- Singapore
- Invention
- Validity
17. Areas of Law
| Area Name | Relevance Score |
|---|---|
| Patent Law | 90 |
| Intellectual Property Law | 70 |
| Pharmaceutical Patents | 50 |
16. Subjects
- Patent Law
- Intellectual Property
- Pharmaceuticals