Regen Lab SA v Estar Medical Ltd & Ors

A patent claim is construed according to its language read in the context of the specification. A therapeutic-use limitation cannot be implied where the claim contains no such limitation. For inventive step, separate documents may be combined only where the cited document refers to the other, the other forms part of common general knowledge, or the skilled person would routinely consult it when addressing the patent’s problem. The same approach applies to pages of a website, including inconvenient details on pages the skilled person would notionally read. Under the doctrine of equivalents, numerical limitations are not exempt. Equivalence is assessed for the accused product or process as a whole, by applying the revised Improver questions to the inventive concept. A patent may be reopened after trial only exceptionally, having regard to the overriding objective, fresh-evidence principles and abuse of process.

Regen, proprietor of European Patent (UK) 2 073 862, alleged that the defendants supplied kits used to prepare platelet-rich plasma by the patented method, contrary to sections 60(1)(b) and 60(2) of the Patents Act 1977. The defendants counterclaimed for revocation for lack of novelty, lack of inventive step and insufficiency. Regen also applied conditionally to amend claim 1.

The court considered construction of the claims, prior disclosure and confidentiality, common general knowledge, inventive step, sufficiency, the proposed amendment, infringement by equivalents, and a post-trial application to reopen the trial based on newly discovered evidence.

1. Construction and validity. Claim 1 as granted contained no therapeutic-use limitation. The proposed amendment would not achieve that limitation because “for” meant “suitable for”, and a composition suitable for therapeutic use was not shown to be unsuitable for in-vitro diagnostic use.

2. Novelty. The defendants’ sales of AZ and A kits did not disclose the claimed method. The June 2005 demonstrations in Tokyo did disclose it: the method used one centrifugation, removed about half the plasma and resuspended the platelets in the remainder. The disclosures were not made under an obligation of confidence. Claim 1 therefore lacked novelty.

3. Inventive step. A skilled team in possession of the relevant kits would have found the claimed single-spin method and removal of about half the supernatant obvious. The website material did not establish obviousness because the skilled team had to consider all pages it would notionally read, including misleading or distracting details. The BD Vacutainer Instructions and Smith did not assist because the Cascade kit was not part of the relevant common general knowledge.

4. Common general knowledge. For a UK patent, the relevant common general knowledge was that of the skilled team in the UK, although knowledge originating abroad could become relevant after sufficient dissemination. There was no necessary inconsistency between that territorial approach and section 2(2) of the Patents Act 1977.

5. Insufficiency and amendment. The specification sufficiently disclosed enrichment of adhesion proteins through enrichment of platelets, including vitronectin. The amendment application was dismissed. Claims 1 to 5 were invalid for lack of novelty and inventive step.

6. Infringement. Had the patent been valid, the defendants’ process would have infringed by equivalence. The non-polyester gel and 0.136M citrate solution achieved substantially the same result in substantially the same way. Numerical claim limitations are subject to the doctrine of equivalents, and prosecution history did not restrict the scope of claim 1.

7. Reopening. The defendants’ application to reopen the trial was dismissed. The proposed new case could and should have been advanced before trial, and a further hearing would not have affected the overall result while causing disproportionate expense and delay.

First-instance judgment. No prior appellate decision is stated in the judgment.