Genelabs v Institut Pasteur: HIV-2 Patent Validity & Infringement
In Genelabs Diagnostics Pte Ltd v Institut Pasteur, the Singapore Court of Appeal heard an appeal regarding the validity and infringement of Institut Pasteur's patent relating to the Human Immunodeficiency Virus-2 (HIV-2). The court upheld the High Court's decision, finding that Genelabs Diagnostics had infringed the patent by manufacturing and selling diagnostic kits for HIV-2. The court dismissed the appeal, affirming the validity of the patent and the infringement by Genelabs.
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
The Court of Appeal upheld the validity of Institut Pasteur's HIV-2 patent and found Genelabs Diagnostics infringed it by manufacturing and selling diagnostic kits.
1.7 Decision Date
2. Parties and Outcomes
| Party Name | Role | Type | Outcome | Outcome Type | Counsels |
|---|---|---|---|---|---|
| Another | Respondent | Other | Appeal dismissed | Won | |
| Genelabs Diagnostics Pte Ltd | Appellant | Corporation | Appeal dismissed | Lost | |
| Institut Pasteur | Respondent | Other | Appeal dismissed | Won |
3. Judges
| Judge Name | Title | Delivered Judgment |
|---|---|---|
| Chao Hick Tin | Justice of the Court of Appeal | Yes |
| L P Thean | Justice of the Court of Appeal | No |
| Yong Pung How | Chief Justice | No |
4. Counsels
4. Facts
- Institut Pasteur owns a European patent (No 0239425) covering HIV-2 and its antigens.
- The patent was re-registered in Singapore on 15 January 1993.
- Genelabs Diagnostics manufactured and sold HIV-2 diagnostic kits (Blot 1.2 and Blot 2.2).
- Institut Pasteur alleged that Genelabs' kits infringed claims of their patent.
- Genelabs argued the patent was invalid due to lack of novelty and inventive step.
- Genelabs also claimed insufficient disclosure and acquiescence by Institut Pasteur.
- The trial judge held the patent valid and found infringement by Genelabs.
5. Formal Citations
- Genelabs Diagnostics Pte Ltd v Institut Pasteur and Another, CA 14/2000, [2000] SGCA 60
6. Timeline
| Date | Event |
|---|---|
| Collaboration agreement entered into between Institut Pasteur and Another. | |
| French patent application filed by Institut Pasteur. | |
| European patent application filed by Institut Pasteur. | |
| European patent granted to Institut Pasteur. | |
| Collaboration agreement between Institut Pasteur and Another renewed. | |
| Patent re-registered in Singapore. | |
| Institut Pasteur sent a letter to Genelabs regarding HIV2 license agreement. | |
| Institut Pasteur became aware that HIV-2 test kits were manufactured and sold by Genelabs. | |
| Institut Pasteur carried out investigations on Genelabs' diagnostic kits. | |
| Trap purchases of Genelabs' Blot 1.2 and Blot 2.2 diagnostic kits. | |
| Action commenced against Genelabs. | |
| Collaboration agreement registered. | |
| Decision Date |
7. Legal Issues
- Patent Novelty
- Outcome: The court held that the patent was novel as the prior art documents did not clearly disclose the antigen having the amino sequence described in claim 19.
- Category: Substantive
- Sub-Issues:
- Prior art disclosure
- Anticipation by prior art
- Inventive Step
- Outcome: The court found that the invention involved an inventive step as it was not obvious to invent an antigen with the specified sequence to detect an unknown virus.
- Category: Substantive
- Sub-Issues:
- Obviousness to a person skilled in the art
- Sufficiency of Disclosure
- Outcome: The court held that there was sufficient disclosure in the patent, enabling a person skilled in the art to understand and carry out the invention.
- Category: Substantive
- Sub-Issues:
- Enablement of invention
- Understanding and carrying into effect by a person skilled in the art
- Patent Infringement
- Outcome: The court found that the appellants' diagnostic kits infringed the patent as they used a highly immuno-reactive portion of the amino acid sequence set out in claim 19.
- Category: Substantive
- Sub-Issues:
- Scope of patent claims
- Material difference in infringing product
- Acquiescence
- Outcome: The court held that the defence of acquiescence did not apply as the respondents did not induce the appellants to believe they consented to the infringing act.
- Category: Procedural
- Sub-Issues:
- Delay in pursuing relief
- Inducement to commit infringing act
- Registration of Exclusive Licence
- Outcome: The court held that s 75 of the Patents Act 1994 did not have retrospective operation and did not preclude the second respondent from recovering damages or seeking an account of profits.
- Category: Procedural
- Sub-Issues:
- Damages or account of profits
- Retrospective operation of statute
8. Remedies Sought
- Injunction
- Damages
- Account of Profits
9. Cause of Actions
- Patent Infringement
10. Practice Areas
- Patent Infringement
- Patent Validity
11. Industries
- Biopharmaceutical
- Healthcare
12. Cited Cases
| Case Name | Court | Affirmed | Citation | Jurisdiction | Significance |
|---|---|---|---|---|---|
| General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd & Ors | Court of Appeal | Yes | [1972] RPC 457 | England and Wales | Cited for the principle of prior disclosure and anticipation in patent law, requiring clear and unmistakable directions in prior art to invalidate a patent claim. |
| Merrell Dow Pharmaceuticals Inc v HN Norton & Co | House of Lords | Yes | [1996] RPC 76 | England and Wales | Cited for the principle that knowledge of a product's existence can be part of the state of the art even without awareness of its chemical composition, relevant to novelty in patent law. |
| Availability to the Public Decision G01/92 | Enlarged Board of Appeal | Yes | [1993] EPOR 241 | EPO | Cited for the principle that a product's composition becomes part of the state of the art if a skilled person can discover and reproduce it without undue burden. |
| Merck & Co Inc v Pharmaforte Singapore Pte Ltd | Court of Appeal | Yes | [2000] 3 SLR 717 | Singapore | Cited for the principle that a prior publication must enable a skilled person to make or obtain the invention for it to anticipate a patent. |
| Hills v Evans | N/A | Yes | [1862] 31 LJ Ch 457 | N/A | Cited for the test to determine whether a prior document's disclosure invalidates a subsequent invention, requiring a person with ordinary knowledge to apply the discovery without further experiments. |
| Von Heyden v Neustadt | N/A | Yes | [1880] 50 LJ Ch 126 | N/A | Cited for the general rule that prior art documents should be read individually, not collectively, to determine their information content. |
| Sharpe & Dohme Inc v Boots Pure Drug Co Ltd | N/A | Yes | [1927] 44 RPC 367 | N/A | Cited as an exception to the rule against reading prior art documents collectively, applicable when documents refer to each other. |
| Ore Concentration Co (1905) Ltd v Sulphide Corp Ltd | N/A | Yes | [1914] 31 RPC 206 | N/A | Cited for the principle that a document should be construed as of its publication date, excluding subsequently discovered information. |
| Molnlycke AB v Procter & Gamble Ltd (No 5) | N/A | Yes | [1994] RPC 49 | N/A | Cited for the objective criterion for deciding whether a claimed invention involves an inventive step, based on obviousness to a person skilled in the art. |
| Windsurfing International v Tabur Marine (Great Britain) | N/A | Yes | [1985] RPC 59 | N/A | Cited for the four-step approach to determine inventive step, including identifying the inventive concept and assessing obviousness to a skilled person. |
| Mentor Corp & Anor v Hollister Inc | Court of Appeal | Yes | [1993] RPC 7 | England and Wales | Cited for the principle that the sufficiency of a patent specification is a question of degree, depending on the invention's nature and circumstances. |
| Catnic Components Ltd v Hill & Smith Ltd | N/A | Yes | [1982] RPC 183 | N/A | Cited for the principle that a patent claim should be construed purposively to provide fair protection while ensuring reasonable certainty for third parties. |
| Improver Corp v Remington Consumer Products Ltd | N/A | Yes | [1990] FSR 181 | N/A | Cited for the three questions to determine if a variant in an alleged infringement falls within the language of a patent claim, focusing on material effect and obviousness. |
| Farmers Build v Carier Bulk Materials Handling Ltd | Court of Appeal | Yes | [1999] RPC 461 | England and Wales | Cited for the definition of acquiescence, requiring a person to stand by and induce another to believe they consent to an infringing act. |
13. Applicable Rules
| Rule Name |
|---|
| No applicable rules |
14. Applicable Statutes
| Statute Name | Jurisdiction |
|---|---|
| Patents Act (Cap 221) s 13(1) | Singapore |
| Patents Act (Cap 221) s 14(1) | Singapore |
| Patents Act (Cap 221) s 14(2) | Singapore |
| Patents Act (Cap 221) s 15 | Singapore |
| Patents Act (Cap 221) s 80(1)(c) | Singapore |
| Patents Act 1994 s 75 | Singapore |
| Registration of United Kingdom Patents Act s 5 | Singapore |
| Patents Act s 116(3) | Singapore |
15. Key Terms and Keywords
15.1 Key Terms
- HIV-2
- Antigen
- Antibodies
- Patent
- Infringement
- Novelty
- Inventive Step
- Sufficiency of Disclosure
- Acquiescence
- Simian Immunodeficiency Virus
- Amino Acid Sequence
- Diagnostic Kits
- Western Blot
- 18mer
15.2 Keywords
- Patent
- HIV-2
- Infringement
- Diagnostic Kits
- Novelty
- Inventive Step
- Singapore
- Genelabs
- Institut Pasteur
17. Areas of Law
| Area Name | Relevance Score |
|---|---|
| Patents | 90 |
| Patent Infringement | 85 |
| Novelty | 70 |
| Inventive step | 65 |
| Sufficiency of Disclosure | 50 |
| Estoppel | 40 |
| Acquiescence | 35 |
| Contract Law | 30 |
16. Subjects
- Patent Law
- Intellectual Property
- HIV-2
- Diagnostic Kits