DSM IP Assets BV & Anor v Algal Omega 3 Limited & Anor

In patent validity proceedings, the skilled team must be modelled realistically, including relevant laboratory and development experience. Obviousness is assessed by identifying the differences from the prior art and asking whether the claimed combination would have been obvious without hindsight.

Product-by-process features generally cannot confer novelty or inventive step unless they impart an identifiable product characteristic. Claims covering a broad range must be enabled across any range that materially affects the product’s value or utility. Numerical limits are construed in the context of the specification and common general knowledge; a stated target of “8 or above” meant 8 or above, not 7.5 or above.

The claimants, DSM, alleged infringement of three patents concerning microbial oils and their production. The defendants, Mara, counterclaimed for invalidity.

EP155 concerned enzymatic liberation of lipids from Schizochytrium biomass. EP740 concerned microbial oils with high DHA content in the triglyceride fraction and included proposed product-by-process limitations. EP801 concerned demulsification of lysed microbial cell compositions by raising pH and using further treatments.

The court determined infringement and validity issues, including obviousness over Bijl, Fabritius, Kobzeff and Hendrik, clarity, added matter, insufficiency, construction of numerical limits and product-by-process claims.

1. EP155. The skilled team would regard enzymatic lysis as common general knowledge, but the question was whether Bijl would motivate the team to apply enzymatic lysis with a suitable protease to Schizochytrium. The proposed route involved several steps, including choosing the organism, selecting enzymatic lysis, selecting an enzyme, investigating cell-wall composition or performing laboratory tests, and obtaining the oil. The evidence did not establish that this combination would have been obvious without hindsight. EP155 was therefore valid, and infringement was understood to be admitted.
2. EP740. The process limitations in claim 1B concerned the history of the oil and did not define an identifiable product characteristic. Applying [2014] EWHC 3857 (Pat) and [2004] UKHL 46, the claim had to be treated as “obtainable by” the stated process for validity purposes. The proposed amendments were unclear under section 14(5), and added matter was also established. Even if allowed, claim 1B would have been obvious over Fabritius. The breadth of the claim was additionally insufficient because EP740 disclosed only one relevant thraustochytrid strain and did not enable the entire claimed order.
3. EP801. The limitation that the lipid contained less than 5% organic solvent applied to the lipid produced by the claimed process. It did not prohibit the use and subsequent removal of solvent during the process. The pH expression “8 or above” meant a strict lower limit of 8. The process steps were not required to occur in the rigid sequence proposed by DSM; lysis and demulsification could overlap, subject to logical constraints.
4. Kobzeff disclosed the relevant enzymatic lysis, pH range, demulsification treatments and separation steps, although it did not anticipate the strict pH limitation. The use of pH 8 or above with Alcalase, together with salt, heat or agitation, was nevertheless obvious. Claims 1A, 6A and 7A of EP801 were invalid for obviousness over Kobzeff. The obviousness case over Hendrik failed because Hendrik did not sufficiently motivate investigation of enzymatic lysis and did not establish that enzymatic lysis would produce an easier-to-break emulsion.
5. EP155 was valid. EP740 and EP801 were invalid on the grounds stated above. A form of order hearing was directed, with time for any appeal or permission application extended until 21 days after judgment at that hearing.