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UK – Regen Lab v. Estar Medical et al.

06 Feb 2019

Regen Lab SA v (1) Estar Medical Limited, (2) Estar Technologies Limited, (3) Medira Limited, (4) Lavender Medical Limited, (5) Antoine Turzi, UK Patents Court, 18 January 2019, [2019] EWHC 63 (Pat)

The Patents Court held Regen’s European Patent (UK) 2 073 862 lacked novelty over a non-confidential prior use, and notably rejected the Defendants’ obviousness allegations. Despite this finding, HHJ Hacon went on, obiter, to adopt a broad approach to the interpretation of variants to claims comprising numerical ranges under the new law on equivalents. He also refused an application to re-open the trial and adduce fresh evidence, on the basis that there was no pleaded case to support it.

Regen’s patent claimed a centrifugation method for making platelet rich plasma (“PRP”) from blood. PRP is used by clinicians to promote the healing of wounds and also has non-clinical in vitro diagnostic (“IVD”) uses. The method claimed in the patent employed a thixotropic gel to aid with separation of centrifuged blood layers. Thixotropic gels when centrifuged change phase from solid to semi-liquid. The gel is selected to have a density such that during the spin it moves to position above the denser red blood cells and below the platelet-containing layer. After centrifugation, the gel re-solidifies and creates a barrier between the two layers.

HHJ Hacon first considered issues of construction, the skilled team and common general knowledge (“CGK”) before turning to validity and infringement. The claim was construed so as not to be limited to therapeutic uses, including IVD. The proposed amendment to include an express limitation “for” such a therapeutic use also failed, as the Court held that “for” would mean “suitable for” and did not exclude use in IVD.

Interestingly, following Schlumberger v Electromagnetic Geoservices [2010] EWCA Civ 819, HHJ Hacon accepted that the skilled team for inventive step and insufficiency would be different. The former would have knowledge of kits for therapeutic use (which did not include kits comprising thixotropic gels) and the latter would also have knowledge of the thixotropic gels (which were only found in IVD kits at the priority date).

Additionally, the court reaffirmed the earlier decision in Generics (UK) Ltd v Warner-Lambert Company LLC [2015] EWHC 2548 (Pat) that matter asserted to be CGK must be sufficiently disseminated so as to be CGK in the UK. HHJ Hacon went on to assess the CGK in the UK, although he also took the precaution of considering what would be CGK in other relevant territories.

The Defendants made various novelty allegations. Of particular interest was a demonstration in Japan by Regen’s CEO (Mr Turzi), which the Court held disclosed the claimed method in its entirety. Regen alleged that the disclosure at the demonstration was confidential. The demonstration took place in front of an audience of clinicians who, according to the witness evidence, would not have felt free to take a note of what they were shown or to prepare competing products.

However, this did not establish that the disclosure was confidential. First, the clinicians would not have needed to take a note of anything which was contained in the instructions which accompanied the Regen kit demonstrated. Second, the confidential aspect of the demonstration would have been perceived as the idea of using of the kits for cosmetic applications/wrinkles. Mr Turzi appeared to show no interest in maintaining confidentiality in the method he demonstrated. Accordingly, the disclosure was held to have been made free of any obligation of confidence and the patent therefore lacked novelty.

Also of note was one of the Defendants’ allegations of lack of inventive step, which relied on prior art published on Regen’s website. A website may not be invariably treated as one document and HHJ Hacon held that the approach to assessing obviousness in view of a combination of internet web pages was, in principle, the same as in relation to printed documents.

That is, there are three circumstances in which the skilled person may be permitted to ‘mosaic’ the documents: (i) the cited document refers to the other document; (ii) the other document forms part of the skilled person’s CGK; and (iii) the skilled person would, as a matter of routine, consult the other document and read it together with the cited document.

In relation to websites, if a single page is cited, the skilled person cannot be taken to have consulted the entire website; evidence may be required as to which pages the skilled person would look at before or after the cited page.
Also, an argument that the patent is obvious based on the combined teaching of multiple web pages cannot ignore the other pages a skilled person would read – there can be no inappropriate selection. In view of these principles, the Defendants had not provided sufficient evidence to establish that the patent was obvious.

After reviewing the law on the scope of patent claims, and in particular the law on equivalence as recently articulated by the Supreme Court in Actavis v Lilly [2017] UKSC 48 as summarised in Icescape Limited v Ice-World International BV [2018] EWCA Civ 2219, HHJ Hacon addressed three particular issues on infringement by equivalence: (i) how to address multiple differences between the alleged infringement and the claim, (ii) how to address numerical ranges, and (iii) whether the court’s dictum in Step v Emson [1993] RPC 513, concerning the relevance of features of a patent claim unrelated to the claim’s inventive concept, still applies to the third reformulated Improver question.

Applying the Improver questions in turn and addressing those particular issues as they arise:

The first Improver question, as revised in Actavis, concerns whether the inventive concept is exploited in substantially the same way to achieve the same result (and not whether the variant has a material effect on the way the invention as a whole works). It is therefore important to appreciate the distinction between the invention (as defined by s. 125 of the Patents Act 1977) and the inventive concept or “new technical insight” of the patent.

HHJ Hacon held that where there are multiple differences between the alleged infringement and the inventive concept on a normal, purposive construction, the differences should be considered as part of a single overall assessment of whether the accused product or process is a variant falling within the claims, taking all equivalents into account. In the case at hand, the differences between the inventive concept and the variant were that the gel was not polyester based, and that the sodium citrate was at 0.136M rather than 0.10M. Taking those differences together, the court considered that the inventive concept of claim 1 was exploited to achieve substantially the same result in substantially the same way as the invention.

Applying the second Improver question, the parties agreed that it would be obvious to the skilled person reading the Patent at the priority date in the knowledge that the variant achieves substantially the same result, that it does so in substantially the same way as the invention.

Applying the third Improver question, HHJ Hacon considered that the skilled person would not have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the claim was essential to the inventive concept. HHJ Hacon noted that the law on the approach to claims containing numerical limits, as set out in Smith & Nephew Plc v Convatec Technologies Inc [2015] RPC 32 and Jushi Group Co. Ltd v OCV Intellectual Capital LLC [2018] EWCA Civ 1416, is no different to other claims.

The Defendants contended that if the accused product or process falls outside the scope of a numerical claim on a normal construction, the skilled person would have understood that strict compliance was essential. HHJ Hacon disagreed. Such a finding would put numerical claims into a special class whereby the doctrine of equivalence would not apply to them.

Further, HHJ Hacon considered that the normal construction of a claim may now be narrower than under Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2005] RPC 9. If the Defendants were right, the effect of Actavis would be to narrow numerical claims and this would run contrary to the intention underlying the Supreme Court’s judgment.

HHJ Hacon suggested that, while it was relevant to the normal interpretation of the claim, the patentee’s choice of 0.10M in the claim language (rather than 0.1M), was not relevant to the question of equivalence. Further, in the context of deciding whether a concentration of 0.10M sodium citrate would cover a concentration of 0.136M, HHJ Hacon considered Step v Emson [1993] RPC 513.

Step is authority that purposive claim construction does not mean that an integer can be struck out if it does not appear to make any difference to the inventive concept of a claim. According to Hoffmann LJ in Step, it may have some other purpose buried in the prior art and even if this is not discernible, the patentee may have had some reason of his own for introducing it. The Defendants argued that this principle remained good law and its effect would be that 0.1 M could not be read to cover a concentration of 0.136 M sodium citrate. HHJ Hacon found that this did not rule out the possibility of concluding that the patentee did not require strict compliance with the claim language.

HHJ Hacon therefore held that the molarity of the sodium citrate was not essential to the inventive concept, as there was not a sufficiently clear indication in the specification or the CGK that the skilled person intended such strict compliance. Therefore, if valid, the claim would have been infringed notwithstanding the differing molarity of the sodium citrate and the fact that the gel employed was not a polyester as specified in the claim.

Finally, the Defendants sought to reopen the trial following the hearing but prior to judgment. They sought to adduce new evidence of instructions found with a PRP kit discovered in a witness’s home during the course of preparing for opposition proceedings before the EPO. The kit and instructions were said to establish a prior disclosure of the claimed method for producing PRP.

HHJ Hacon refused the application. Whilst the particulars of the discovered kit itself could not have pleaded, the proposed case on supply of the kit and its accompanying instructions for use could and should have been pleaded before trial. It was clear that the application should not be allowed: a further hearing could make no difference to the outcome of the trial as a whole and any risk that a further hearing would be required if the Defendants successfully appealed the judge’s decision was outweighed by the certainty that significant expense and delay would be incurred if the judge were to order a further hearing.

A copy of the judgment can be found here.

Headnote by Chloe Dickson, Bristows LLP