Millennium Pharmaceuticals v Zyfas Medical: Patent Infringement, Bortezomib Synthesis & Validity
In [2023] SGHC 360, the High Court of Singapore addressed a patent infringement suit between Millennium Pharmaceuticals, Inc and Johnson & Johnson Pte Ltd (Plaintiffs) and Zyfas Medical Co (Defendant) concerning two patents (SG 151322 and SG 10201600029P) related to bortezomib synthesis. The plaintiffs alleged the defendant infringed their patents by supplying bortezomib. The defendant denied infringement and counterclaimed for revocation of the patents, asserting invalidity due to lack of novelty, inventive step, and sufficiency of particulars. The court found SG 151322 valid but not infringed, and SG 10201600029P invalid for lacking an inventive step. The claim of patent infringement was therefore dismissed.
1. Case Overview
1.1 Court
General Division of the High Court1.2 Outcome
One patent valid but not infringed, and the other patent invalid for lack of inventive step.
1.3 Case Type
Intellectual Property
1.4 Judgment Type
Judgment
1.5 Jurisdiction
Singapore
1.6 Description
Singapore court rules on patent infringement suit regarding bortezomib synthesis, finding one patent valid but not infringed, and another invalid.
1.7 Decision Date
2. Parties and Outcomes
| Party Name | Role | Type | Outcome | Outcome Type | Counsels |
|---|---|---|---|---|---|
| Millennium Pharmaceuticals, Inc | Plaintiff | Corporation | Claim Dismissed | Lost | Suhaimi Bin Lazim, S Siddharth Sriram, Shahera Safrin |
| Johnson & Johnson Pte Ltd | Plaintiff | Corporation | Claim Dismissed | Lost | Suhaimi Bin Lazim, S Siddharth Sriram, Shahera Safrin |
| Zyfas Medical Co (sued as a firm) | Defendant | Partnership | Judgment for Defendant | Won | Wong Siew Hong, Poonaam Bai |
3. Judges
| Judge Name | Title | Delivered Judgment |
|---|---|---|
| Dedar Singh Gill | Judge | Yes |
4. Counsels
| Counsel Name | Organization |
|---|---|
| Suhaimi Bin Lazim | Mirandah Law LLP |
| S Siddharth Sriram | Mirandah Law LLP |
| Shahera Safrin | Mirandah Law LLP |
| Wong Siew Hong | Eldan Law LLP |
| Poonaam Bai | Eldan Law LLP |
4. Facts
- The suit involves two patents (SG 322 and SG 29P) claiming processes for manufacturing bortezomib.
- The plaintiffs allege the defendant infringed their patents by supplying bortezomib to hospitals in Singapore.
- The defendant denies infringement and contends the patents are invalid for lack of novelty, inventive step, and sufficiency.
- SG 322 teaches the use of an ether solvent with low miscibility in water during bortezomib synthesis.
- SG 29P teaches the use of convergent synthesis for large-scale bortezomib manufacture.
- The defendant distributes pharmaceutical products made by Dr Reddy’s Laboratories Limited (DRL).
- In 2018, the defendant applied for approval to import and distribute a generic version of bortezomib manufactured by DRL.
5. Formal Citations
- Millennium Pharmaceuticals, Inc and another v Zyfas Medical Co (sued as a firm), Suit No 817 of 2019, [2023] SGHC 360
- Millennium Pharmaceuticals, Inc v Zyfas Medical Co (sued as a firm), , [2020] SGHC 28
- Zyfas Medical Co (sued as a firm) v Millennium Pharmaceuticals, Inc, , [2020] 2 SLR 1044
6. Timeline
| Date | Event |
|---|---|
| Zyfas Medical Co applied to the Health Sciences Authority for approval to import, market and distribute a generic version of bortezomib. | |
| The Health Sciences Authority approved Zyfas Medical Co's registration of bortezomib. | |
| Millennium Pharmaceuticals issued a letter of demand to Zyfas Medical Co. | |
| Millennium Pharmaceuticals commenced the present suit. | |
| Millennium Pharmaceuticals commenced originating summons HC/OS 1034/2019. | |
| Johnson & Johnson Pte Ltd was joined as party to the suit. | |
| The court ordered that Zyfas Medical Co be restrained from performing any of the acts for which registration of the Alleged Infringing Product had been obtained. | |
| The Court of Appeal upheld the decision in HC/OS 1034/2019 and dismissed Zyfas Medical Co’s appeal. | |
| The plaintiffs filed HC/OS 264/2021 for leave to be granted to them to apply for a quashing order. | |
| The Health Sciences Authority cancelled the registration of the Alleged Infringing Product. | |
| Parties consented to discharge the interim injunction which was granted in SUM 430 on 2 April 2020. | |
| Parties provided further submissions on the issue of sufficiency. |
7. Legal Issues
- Patent Infringement
- Outcome: The court found that the plaintiffs failed to prove that the defendant infringed the asserted claims of SG 322.
- Category: Substantive
- Sub-Issues:
- Use of patented process
- Direct infringement
- Reversal of burden of proof
- Patent Validity
- Outcome: The court found SG 151322 valid but not infringed, and SG 10201600029P invalid for lacking an inventive step.
- Category: Substantive
- Sub-Issues:
- Novelty
- Inventive step
- Sufficiency of disclosure
- Standing to Commence Proceedings
- Outcome: The court found that the second plaintiff did not have standing in the present suit.
- Category: Procedural
- Sub-Issues:
- Exclusive licensee
- Exclusive distributor
8. Remedies Sought
- Declaration of Infringement
- Injunction to Restrain Infringement
- Delivery Up or Destruction of Infringing Articles
- Inquiry as to Damages or Account of Profits
9. Cause of Actions
- Patent Infringement
- Counterclaim for Revocation of Patents
10. Practice Areas
- Patent Litigation
- Commercial Litigation
11. Industries
- Pharmaceuticals
12. Cited Cases
| Case Name | Court | Affirmed | Citation | Jurisdiction | Significance |
|---|---|---|---|---|---|
| IIa Technologies Pte Ltd v Element Six Technologies Ltd | Court of Appeal | Yes | [2023] 1 SLR 987 | Singapore | Cited for principles on claim construction, determining the substance of a claim, and clarifying the scope of protection of the invention. |
| Sunseap Group Pte Ltd and others v Sun Electric Pte Ltd | Court of Appeal | Yes | [2019] 1 SLR 645 | Singapore | Cited for principles on claim construction and the relationship between independent and dependent claims in a patent. |
| First Currency Choice Pte Ltd v Main-Line Corporate Holdings Ltd and another appeal | Court of Appeal | Yes | [2008] 1 SLR(R) 335 | Singapore | Cited for principles on claim construction, the purposive construction approach, and the four-step test to determine inventive step. |
| Rosedale Associated Manufactures Ld v Carlton Tyre Saving Coy Ld | N/A | Yes | [1960] RPC 59 | N/A | Cited for the principle that claims and descriptions are to be read together and construed contextually. |
| Electric & Musical Industries v Lissen Ld | N/A | Yes | (1938) 56 RPC 23 | N/A | Cited for the principle that if claims have an ordinary and plain meaning, reliance ought not to be placed on the language used in the body of the specification so as to make them mean something different. |
| Lee Tat Cheng v Maka GPS Technologies Pte Ltd | Court of Appeal | Yes | [2018] 1 SLR 856 | Singapore | Cited for the purposive approach to claim construction and the test for determining whether an alleged invention involves an inventive step. |
| FE Global Electronics Pte Ltd v Trek Technology (Singapore) Pte Ltd | Court of Appeal | Yes | [2006] 1 SLR(R) 874 | Singapore | Cited for the purposive interpretation of claims to balance the rights of the patentee and third parties. |
| Pfizer Ltd’s Patent | N/A | Yes | [2001] FSR 16 | N/A | Cited for the characteristics of a person skilled in the art. |
| Zipher Ltd v Markem Systems Ltd and another | N/A | Yes | [2008] EWHC 1379 (Pat) | N/A | Cited for the characteristics of a person skilled in the art. |
| Ng Kok Cheng v Chua Say Tiong | N/A | Yes | [2001] 2 SLR(R) 326 | N/A | Cited for the characteristics of a person skilled in the art and the correction of errors in a patent specification. |
| Rohm and Haas Electronic Materials CMP Holdings, Inc (formerly known as Rodel Holdings, Inc) v NexPlanar Corp and another | N/A | Yes | [2018] 5 SLR 180 | N/A | Cited for principles governing the state of the art for assessing patentability, including worldwide scope and modalities of disclosure. |
| Main-Line Corporate Holdings Ltd v United Overseas Bank Ltd and another (First Currency Choice Pte Ltd, third party) | N/A | Yes | [2007] 1 SLR(R) 1021 | N/A | Cited for the requirement of clear and satisfactory evidence for prior disclosure and the rule against mosaicking prior art. |
| Lee Tat Cheng v Maka GPS Technologies Pte Ltd | N/A | Yes | [2018] 3 SLR 1334 | N/A | Cited for the requirement of enabling disclosure for anticipation and the formulation of the 'obvious to try' factor. |
| Merck & Co Inc v Pharmaforte Singapore Pte Ltd | N/A | Yes | [2000] 2 SLR(R) 708 | N/A | Cited for the requirement of 'enabling disclosure' for anticipation. |
| Research in Motion v Inpro | N/A | Yes | [2006] RPC 517 | N/A | Cited for the principle that disclosure in prior art may be explicit or implicit. |
| ASM Technology Singapore Pte Ltd v Towa Corp | N/A | Yes | [2018] 1 SLR 211 | N/A | Cited for the requirement that prior art must inevitably produce something that would infringe the patentee's claim. |
| Mühlbauer AG v Manufacturing Integration Technology Ltd | N/A | Yes | [2010] 2 SLR 724 | N/A | Cited for the construction of prior art as at the date of its publication and the permissibility of mosaicking in the assessment of obviousness. |
| Dien Ghin Electronic (S) Pte Ltd v Khek Tai Ting (trading as Soon Heng Digitax) | N/A | Yes | [2011] 3 SLR 227 | N/A | Cited for the 'reverse infringement' test in relation to disclosure. |
| Martek Biosciences Corp v Cargill International Trading Pte Ltd | N/A | Yes | [2012] 2 SLR 482 | N/A | Cited for the burden on the party challenging the novelty of a granted patent. |
| Technograph Printed Circuits Ltd v Mills & Rockley (Electronics) Ltd | N/A | Yes | [1972] RPC 346 | N/A | Cited for the principle that mosaicking is permissible in the assessment of obviousness as long as the mosaic can be put together by an unimaginative man with no inventive capacity. |
| Windsurfing International Inc v Tabur Marine (Great Britain) Ltd | N/A | Yes | [1985] RPC 59 | N/A | Cited for the four-step test to determine whether an alleged invention involves an inventive step. |
| Conor Medsystems Inc v Angiotech Pharmaceuticals Inc | House of Lords | Yes | [2008] UKHL 49 | England and Wales | Cited for the holistic approach to the obviousness inquiry and the 'obvious to try' factor. |
| Actavis Group PTC EHF and others v ICOS Corporation and another | Supreme Court | Yes | [2019] UKSC 15 | United Kingdom | Cited for the non-exhaustive list of considerations in the obviousness inquiry and the 'obvious to try' consideration. |
| Johns Manville Corp’s Patent | N/A | Yes | [1967] RPC 479 | N/A | Cited for the formulation of the 'obvious to try' factor as requiring a fair expectation of success. |
| ASM Assembly Automation Ltd v Aurigin Technology Pte Ltd and others | N/A | Yes | [2010] 1 SLR 1 | N/A | Cited for the principle that a mere workshop improvement or variation of existing prior art is not an inventive step. |
| Union Carbide Corp v BP Chemicals | N/A | Yes | [1998] RPC 1 | N/A | Cited for the concept of technical prejudice in overcoming preconceptions of the skilled person. |
| Dyson Appliances Ltd v Hoover Ltd | N/A | Yes | [2001] RPC 26 | N/A | Cited for the prejudice in favor of bags within the vacuum cleaner industry. |
| Cipla Ltd v Glaxo Group | N/A | Yes | [2004] EWHC 477 (Pat) | N/A | Cited for the distinction between technical prejudice and commercial prejudice. |
| Synthon BV v Teva Pharmaceutical Industries Ltd | N/A | Yes | [2015] EWHC 1395 (Pat) | N/A | Cited for the principle that the patent need not explain why the prejudice is wrong or provide a scientific explanation of how the invention works to overcome it. |
| Merck & Co Inc v Pharmaforte Singapore Pte Ltd | N/A | Yes | [1999] 3 SLR(R) 1072 | N/A | Cited for the definition of 'new product' in the context of patent infringement. |
| Oxford Nanopore Technologies Ltd v. Pacific Biosciences of California Inc | N/A | Yes | [2017] EWHC 3190 (Pat) | N/A | Cited for relevant principles to aid in the determination of whether a licence is exclusive. |
| Dendron GmbH v University of California (No 3) | N/A | Yes | [2004] EWHC 1163 (Ch) | N/A | Cited for relevant principles to aid in the determination of whether a licence is exclusive. |
| Courtauld's Application | N/A | Yes | [1956] RPC 208 | N/A | Cited for relevant principles to aid in the determination of whether a licence is exclusive. |
| Illumina Inc and others v Premaitha Health PLC and another | N/A | Yes | [2017] EWHC 2930 (Pat) | N/A | Cited for relevant principles to aid in the determination of whether a licence is exclusive. |
| Genetic Institute Inc v Kirin-Amgen Inc (No 2) | N/A | Yes | (1997) 149 ALR 247 | N/A | Cited for the role of the court assessor in cases featuring intellectual property disputes. |
13. Applicable Rules
| Rule Name |
|---|
| Rules of Court 2014 |
14. Applicable Statutes
| Statute Name | Jurisdiction |
|---|---|
| Patents Act (Cap 221) | Singapore |
| Health Products Act (Cap 122D) | Singapore |
| Supreme Court Judicature Act (Cap 322) | Singapore |
15. Key Terms and Keywords
15.1 Key Terms
- Bortezomib
- Matteson Homologation
- Convergent Synthesis
- Epimerization
- Boronic Acid
- Lewis Acid
- Ether Solvent
- Miscibility
- Pharmaceutical Process Chemistry
- State of the Art
- Inventive Step
- Novelty
- Tetrahydrofuran
- Methyl tert-butyl ether
15.2 Keywords
- patent infringement
- bortezomib
- synthesis
- validity
- intellectual property
- pharmaceuticals
- Matteson homologation
- convergent synthesis
16. Subjects
- Patents
- Intellectual Property
- Pharmaceuticals
- Organic Chemistry
- Process Chemistry
17. Areas of Law
- Patent Law
- Intellectual Property
- Pharmaceutical Process Chemistry