DSM IP Assets B.v v. Algal Omega 3 Ltd
| Jurisdiction | England & Wales |
| Court | Chancery Division (Patents Court) |
| Judge | Mr Justice Mellor |
| Judgment Date | 20 March 2025 |
| Neutral Citation | [2025] EWHC 675 (Pat) |
| Docket Number | Case No: HP-2023-000001 |
THE HON Mr Justice Mellor
Case No: HP-2023-000001
IN THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERTY LIST (ChD)
PATENTS COURT
Royal Courts of Justice, Rolls Building
Fetter Lane, London, EC4A 1NL
James Abrahams KC and Kyra Nezami (instructed by Powell Gilbert LLP) for the Claimants
Adrian Speck KC and James Whyte (instructed by Bristows LLP) for the Defendants
Hearing dates: 1 st–3 rd, 7 th–9 th, 15 th–17 th October 2024
Approved Judgment
This judgment was handed down remotely at 10.30am on 20 March 2025 by circulation to the parties or their representatives by e-mail and by release to the National Archives.
THE HON Mr Justice Mellor
This Judgment is organised as follows:
| INTRODUCTION | 5 |
| THE WITNESSES | 7 |
| THE SKILLED TEAM | 10 |
| THE COMMON GENERAL KNOWLEDGE | 13 |
| Sources of CGK | 13 |
| The Statement of Agreed CGK | 14 |
| Definitions | 15 |
| Statement of Agreed EP 155 CGK | 16 |
| Lipids | 16 |
| Structure of fatty acids | 16 |
| Phospholipids | 17 |
| Triacylglycerides | 18 |
| Nomenclature | 19 |
| FAME analysis (Fatty Acid Methyl Ester Analysis) | 19 |
| Synthesis of lipids | 19 |
| Fatty acid research and health | 20 |
| Fish oils as a source of essential fatty acids | 21 |
| Increasing PUFA content in fish oils | 21 |
| Microorganisms as a source of essential fatty acids | 22 |
| Microbial oils at the EP 155 Priority Date | 23 |
| Crypthecodinium cohnii oils | 26 |
| Thraustochytrid oils | 26 |
| Culture Collections | 27 |
| Overview of microbial oil production process | 27 |
| The FRIOLEX Process | 31 |
| Purification to a refined oil | 32 |
| Oil quality and oxidation | 34 |
| Schizochytrium | 34 |
| CGK Disputes regarding 3 May 2002 | 35 |
| The composition of Schizochytrium cell walls (EP 155 Priority Date – 3 May 2002) 35 Lysis/disruption (EP 155 Priority Date – 3 May 2002) | 37 |
| DSM's mindset arguments | 41 |
| EP155 | 42 |
| The issue | 42 |
| Prior art to EP155 – Bijl | 42 |
| What does Bijl disclose to the Skilled Team? | 42 |
| EP155 — Disclosure | 48 |
| The Examples | 51 |
| Claim 1 of EP155 | 52 |
| The role of Sufficiency | 53 |
| Obviousness of EP155 over Bijl | 54 |
| What would the Skilled Team do, having read and considered Bijl? | 57 |
| My conclusions on Bijl | 58 |
| EP740 | 66 |
| Summary of DSM's overall position | 66 |
| Summary of the issues raised by Mara's case | 67 |
| Introduction to the issues | 68 |
| Agreed additional CGK for EP 740 | 69 |
| CGK disputes relating to EP740 | 70 |
| Properties of various oils (EP 740 Priority Date – 19 March 2009) | 70 |
| Refinement / enrichment (EP 740 Priority Date – 19 March 2009) | 70 |
| Fabritius — Disclosure | 70 |
| Disclosure of EP740 | 73 |
| The proposed Amended Claims | 78 |
| Applicable legal principles | 79 |
| Attempt 1 | 83 |
| Attempt 2 | 85 |
| Attempt 3 | 87 |
| Inventive Step/Obviousness of claim 1B over Fabritius | 89 |
| Mara's argument | 89 |
| DSM's argument | 90 |
| Legal context: technical effect | 90 |
| What technical effect does the invention have over Fabritius? | 91 |
| Analysis | 94 |
| AMENDMENT | 95 |
| Not clear and concise | 95 |
| Law | 95 |
| Application to this case | 97 |
| ‘from at least 55% to 65%’ | 98 |
| Thraustochytrids | 98 |
| INSUFFICIENCY | 102 |
| Introduction | 102 |
| Law | 102 |
| Mara's contentions | 102 |
| DSM's contentions | 104 |
| Application to the facts | 106 |
| Mara's explanation of their case on insufficiency in opening | 106 |
| DSM's contentions | 107 |
| The evidence | 108 |
| Every cell in Thraustochytrid Order | 109 |
| Level of DHA | 111 |
| Conclusions | 111 |
| ADDED MATTER | 113 |
| Introduction | 113 |
| Legal Principles | 113 |
| The pleadings | 116 |
| Mara's response | 119 |
| EP801 | 122 |
| Statement of Agreed EP 801 CGK | 122 |
| CGK disputes | 122 |
| Conclusion | 124 |
| Claims of EP801 | 125 |
| Summary of the issues | 126 |
| Applicable principles concerning construction | 129 |
| Numerical limits | 129 |
| Disclosure of EP801 | 132 |
| The teaching regarding the pH. . | 134 |
| The Examples | 138 |
| The Claims | 140 |
| Construction issues | 141 |
| Claim 1A: “a lysed cell composition” | 141 |
| Claim 1A: “to demulsify the cell composition” | 142 |
| Claim 1A: “wherein the lipid contains less than 5% by weight of an organic solvent” | 143 |
| Claim 1A: “raising the pH of the lysed cell composition to 8 or above to demulsify the cell composition” | 146 |
| Arguments on the ‘order of steps’ | 148 |
| Claim 1A: functional and structural features of the claim | 148 |
| Claim 1A: the order of steps | 149 |
| Validity of EP801 | 151 |
| Kobzeff – disclosure | 152 |
| Alleged anticipation by Kobzeff | 154 |
| Mara's contentions | 154 |
| DSM's contentions and Mara's responses | 155 |
| Conclusions | 156 |
| Alleged Obviousness over Kobzeff | 157 |
| Mara's contentions | 157 |
| DSM's contentions | 159 |
| Hendrik | 161 |
| Hendrik – disclosure | 161 |
| Alleged obviousness over Hendrik | 162 |
| Conclusion on Hendrik | 163 |
| Gillette / Formstein | 163 |
| Overall Disposal | 164 |
INTRODUCTION
This is my judgment from the trial of this action concerned with three patents relating to microbial oils and their production. These oils can contain a high level of polyunsaturated fatty acids (“ PUFAs”), such as an omega-3 PUFA called docosa hexaenoic acid (“ DHA”) which traditionally has been sourced from fish oil, and which is an important component of infant formula.
The Claimants (collectively “ DSM”) and the Defendants (collectively “ Mara”) are competing producers of such oils (it being unnecessary for present purposes to distinguish as between the two Claimants and as between the two Defendants).
DSM asserts infringement of three patents (from three different families). In order of priority date, the patents are as follows (there is no challenge to priority).
i) EP 2 921 155 (“ EP155”) entitled “Methods for producing high-quality lipids by enzymatic liberation from biomass” (priority date 3 May 2002). It relates to the use of a protease enzyme in the process to extract microbial oil from Schizochytrium microorganisms. It expired on 4 May 2023;
ii) EP 3 530 740 (“ EP740”) entitled “Thraustochytrids, fatty acid compositions, and methods of making and uses thereof” (filing date 19 March 2009 and no earlier priority date). It provides a new microbial oil, which is a crude oil product derived from a Thraustochytrid microorganism, which has a high triglyceride fraction and a high percentage of DHA in that triglyceride fraction.
iii) EP 2 576 801 (“ EP801”) entitled “Extraction of lipid from cells and products therefrom” (earliest priority date 01 June 2010). It relates to a microbial oil extraction process which solves the emulsion problem without the use of organic solvents.
DSM were keen to emphasise that all three patents have been considered by the EPO Opposition Division (“ OD”):
i) EP155 was maintained as granted by the OD. Opposition proceedings were commenced in 2020 by a strawman entity, and following oral proceedings on 28 September 2022 the opposition was rejected. That decision was not appealed.
ii) EP740 was upheld in amended form by the OD. Opposition proceedings were commenced in 2022 by a strawman entity (another opponent unrelated to the parties to these proceedings initially also opposed EP 740 but withdrew its opposition at an early stage). The First and Second Defendants in these proceedings each filed interventions in March and April 2023 respectively, on the basis of the present proceedings. Following oral proceedings held on 23 November 2023 the OD found claim 1 as granted invalid for added matter, but upheld EP 740 amended in a form corresponding to claim 2 as granted. An appeal to the Technical Boards of Appeal is outstanding, with the appeal hearing date yet to be set.
iii) EP801 was upheld in amended form by the OD. Opposition proceedings were commenced in 2020 by a strawman entity. The First and Second Defendants in these proceedings each filed interventions in March and April 2023 respectively, on the basis of the present proceedings. Following the oral proceedings of 10 and 11 September 2024 the OD found claim 1 as granted invalid for added matter, but upheld EP 801 on the basis of Auxiliary Request 2 (being claim 1, with step c1 (salt addition) and one or more of steps c2 to c4 being required). At the trial the written reasons of the OD were yet to be provided.
Mara counterclaims for invalidity on a variety of grounds. Much
The claims said to be independently valid and infringed are:
i) EP155: claims 1 and 5.
ii) EP740: claims 1B and 2B (these being claims from the claim set at Annex B of a second amendment application, which is the only claim set now relied on).
iii) EP801: claims 1A, 6A & 7A (these being claims from the claim set at Annex A of the amendment application). I note in passing that shortly before trial, DSM confirmed that it no longer seeks to introduce claim 2A.
Mara has carried out (and proposes to carry out) a variety of processes to produce two oils: a lower-DHA oil called Mara DHA, and a higher-DHA oil called Mara DHA Plus. These use different microbial strains and different process conditions.
Mara DHA is Mara's standard DHA microbial oil...
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DSM IP Assets B.v v. Algal Omega 3 Ltd
...because the costs involved are substantial. 2 The backdrop is my judgment from the trial on liability in this action on 20 March 2025: [2025] EWHC 675 Pat (my ‘Main Judgment’). DSM sued for infringement of 3 patents and Mara counterclaimed alleging invalidity. I summarised the overall outco......