Patents - Regen Lab SA v Estar Medical Ltd

Human blood after centrifugation
Source Wikipedia

Jane Lambert

Patents Court (HH Judge Hacon) Regen Lab SA v Estar Medical Ltd and others [2019] EWHC 63 (Pat) (18 Jan  2019)

This was a claim by Regen Lab SA ("Regen") against the Israeli company, Estar Technologies Ltd., and the British companies, Medira Ltd, and Lavender Medical Ltd. for patent infringement.  The defendants counterclaimed for revocation of the patent alleged to have been infringed on grounds of anticipation, obviousness and insufficiency.

The Patent
The patent alleged to have been infringed was for a method for the preparation of platelet-rich plasma ("PRP") for unprocessed use and combination thereof with skin and bone cells. It was granted by the European Patent Ofice under publication number EP2073862. Judge Hacon described the invention at paragraph [13] of his judgment:

"The patented method involves taking blood from a patient and transferring it to a tube containing a thixotropic gel and an anticoagulant. The blood and gel are centrifuged at a slow rate (there is a specified maximum). The gel is selected to have a density such that during the spin it moves to position above the denser red cells and below the less dense buffy layer. The plasma moves to the top of the tube, above the buffy layer. When centrifugation is complete the gel re-solidifies, forming a barrier isolating the buffy layer and plasma from the red cells. About half the plasma is removed from the top and discarded. The remainder of the plasma and the buffy layer are harvested. The platelets and other contents of the buffy layer are then resuspended in the plasma to give the PRP."

PRP is used for treating wounds and diagnosis.   It is prepared from a patient's own blood by centrifugation.  Anticoagulants and thixotropic gels had been used in making PRP for diagnosis but not for wound treatment.  Regen claimed the preparation of PRP by the method set out in claim 1

"A process for the preparation of a cell composition, comprising the steps of:

(a) Centrifuging whole blood in a separator tube selected from:
  • a glass separator tube containing a polyester-based thixotropic gel and a buffered sodium citrate solution at 0.10M; and 
  • a polyethylene terephthalate separator tube containing a highly thixotropic gel formed by a polymer mixture and an anhydrous sodium citrate at 3.5mg/mL;
(b) Separating enriched platelet-rich plasma from full plasma by removing about half of the supernatant containing platelet poor plasma;

(c) Re-suspending the enriched plasma;

wherein the centrifugation step a) is performed at a force of about 1500g up to about 2000g in a sufficient length of time to form a barrier between plasma containing platelets, lymphocytes and monocytes and a pellet containing erythrocytes; the separation step b) is made by collecting the supernatant from atop of said barrier and wherein the enriched plasma is enriched in leucocytes, thrombocytes and adhesion proteins as compared to native whole blood."

The Alleged Infringement
Regen complained that the defendants had supplied kits in the UK subsequently used to prepare PRP according to the method claimed in the patent, thereby infringing the patent contrary to s.60 (1) (b) and (2) of the Patents Act 1977.

The Judgment
Following a 7 day hearing at the end of June 2018, the judge found at paragraph [257] that the patent was invalid for want of novelty and inventive step. However, he also found that had the patent been valid it would have been infringed.  He refused to permit the claimant to amend on the ground that the patent would still have been invalid even after amendment.  Finally, His Honour declined an application by new solicitors for the defendants to reopen the trial in order to consider new evidence.   

Want of Novelty
One of the conditions for the grant of a patent is that the invention is new (see s (1) (a) o the Patents Act 1977).  S.2 (1) provides that an invention is new if it does not form part of the state of the art.  S.2 (2) defines the "state of the art" as "all matter (whether a product, a process, information about either, or anything else) which has at any time before the priority date of that invention been made available to the public (whether in the United Kingdom or elsewhere) by written or oral description, by use or in any other way."

In Synthon BV v. Smithkline Beecham plc [2006] 1 All ER 685, [2005] UKHL 59, [2006] RPC 10, Lord Hoffmann said at paragraph [22]: 

"the matter relied upon as prior art must disclose subject-matter which, if performed, would necessarily result in an infringement of the patent. That may be because the prior art discloses the same invention. In that case there will be no question that performance of the earlier invention would infringe and usually it will be apparent to someone who is aware of both the prior art and the patent that it will do so. But patent infringement does not require that one should be aware that one is infringing: "whether or not a person is working [an] ... invention is an objective fact independent of what he knows or thinks about what he is doing": Merrell Dow Pharmaceuticals Inc v H N Norton & Co Ltd [1996] RPC 76, 90. It follows that, whether or not it would be apparent to anyone at the time, whenever subject-matter described in the prior disclosure is capable of being performed and is such that, if performed, it must result in the patent being infringed, the disclosure condition is satisfied. The flag has been planted, even though the author or maker of the prior art was not aware that he was doing so."

The defendants alleged that the patent had been anticipated by sales by Regen of kits known as 'the Vacutainer Regen THT kit and publication of a document entitled 'BD Vacutainer CPT – Cell Preparation Tube with Sodium Citrate' (the 'BD Vacutainer Instructions').  The judge found that the sales did not disclose the patented invention but a presentation that the inventor gave in Tokyo in 2005 did disclose the invention to the public.

Want of an Inventive Step
Another condition for the grant of a patent is that the invention involves an inventive step (see s.1 (1) (b) of the Patents Act 1977)  S.3 adds:

"An invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which forms part of the state of the art by virtue only of section 2(2) above (and disregarding section 2(3) above)."

It was common ground that the "person skilled in the art" would be a team consisting of a clinician, a bioengineer and a blood scientist, each of them working in the field of kits for making PRP destined for therapeutic use.

The matter relied on by the defendants consisted of the following:
(1)   Sales of AZ and A kits with instructions for use;
(2)   Documents on Regen's website'
(3)   The BD Vacutainer instructions; and
(4)    US Patent No. 5,667,963.

Even though the judge had held that AZ and A kits did not anticipate the invention,  he noted at [173] that the use of a single spin and thereafter removal of half the supernatant was a technique used for making diagnostic kits. The idea was there to be picked up for use n making therapeutic kits,  He concluded that such a technique was obvious to a team working on such kits.

As for the matter in (2), (3) and (4), His Honour did not think that the skilled team would have pulled together from Regen's website the various elements of claim 1.  He was not persuaded that the Vacutainer instructions were part of the common general knowledge.  He did not address the argument on the US patent.

S.14 (2) (b) of the Act requires every patent application to include a specification containing a description of the invention, a claim or claims and any drawing referred to in the description or any claim.  S.14 (3) further stipulates that the specification must disclose the invention in a manner which is clear enough and complete enough for it to be performed by a person skilled in the art.  Should it fail to do so, s.72 (1) (c) permits the courts or the head of the Intellectual Property Office to revoke the patent on the ground that the specification does not disclose the invention clearly enough and completely enough for it to be performed by such a person.

The defendants objected to the words "…and wherein the enriched plasma is enriched in leucocytes, thrombocytes and adhesion proteins as compared to native whole blood" arguing that the specification did not disclose how to make plasma enriched in adhesion proteins and therefore did not sufficiently disclose the invention.  Both sides' experts agreed that that technique was known at the filing of the invention and that it would have been understood by skilled addressees.  The judge rejected the objection.

S.60 (1) of the Act provides:
"Subject to the provisions of this section, a person infringes a patent for an invention if, but only if, while the patent is in force, he does any of the following things in the United Kingdom in relation to the invention without the consent of the proprietor of the patent, that is to say;
(b) where the invention is a process, he uses the process or he offers it for use in the United Kingdom when he knows, or it is obvious to a reasonable person in the circumstances, that its use there without the consent of the proprietor would be an infringement of the patent;
(c) where the invention is a process, he disposes of, offers to dispose of, uses or imports any product obtained directly by means of that process or keeps any such product whether for disposal or otherwise"

S.60 (2) adds:
"Subject to the following provisions of this section, a person (other than the proprietor of the patent) also infringes a patent for an invention if, while the patent is in force and without the consent of the proprietor, he supplies or offers to supply in the United Kingdom a person other than a licensee or other person entitled to work the invention with any of the means, relating to an essential element of the invention, for putting the invention into effect when he knows, or it is obvious to a reasonable person in the circumstances, that those means are suitable for putting, and are intended to put, the invention into effect in the United Kingdom."

An invention is "taken to be that specified in a claim of the specification of the application or patent, as the case may be, as interpreted by the description and any drawings contained in that specification, and the extent of the protection conferred by a patent or application for a patent shall be determined accordingly" (see s.125 (1)),  When interpreting a claim s.125 (3) provides:

"The Protocol on the Interpretation of Article 69 of the European Patent Convention (which Article contains a provision corresponding to subsection (1) above) shall, as for the time being in force, apply for the purposes of subsection (1) above as it applies for the purposes of that Article."

That Protocol, which was revised in 2000, consists of two articles:
"Article 1
General principles
Article 69 should not be interpreted as meaning that the extent of the protection conferred by a European patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings being employed only for the purpose of resolving an ambiguity found in the claims. Nor should it be taken to mean that the claims serve only as a guideline and that the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patent proprietor has contemplated. On the contrary, it is to be interpreted as defining a position between these extremes which combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties.
Article 2
For the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of any element which is equivalent to an element specified in the claims."

The effect of that Protocol has been considered by the Supreme Court in Eli Lilly v Actavis UK Ltd. and others [2017] UKSC 48, [2017] RPC 21, [2017] Bus LR 1731 which I discussed in The Supreme Court's Judgment in Eli Lilly v Actavis UK Ltd and Others: how to understand it and why it is important 13 July 2017 and by the Court of Appeal in  Icescape Ltd v Ice-World International BV and others  [2018] EWCA Civ 2219.  In Icescape Lord Justice Kitchin (as he then was) said at paragraph [66] of his judgment:

"[66] The whole approach to interpretation and scope of protection therefore involves the following steps, considered through the eyes of the notional addressee:

i) Does the variant infringe any of the claims as a matter of normal interpretation?
ii) If not, does the variant nevertheless infringe because it varies from the invention in a way or ways which is or are immaterial? This is to be determined by asking these three questions:

a) Notwithstanding that it is not within the literal (that is to say, I interpolate, normal) meaning of the relevant claim(s) of the patent, does the variant achieve substantially the same result in substantially the same way as the invention, i.e. the inventive concept revealed by the patent?
b) Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?
c) Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?

[67] Of course, in order to establish infringement in a case where there is no infringement as a matter of normal interpretation, a patentee would have to establish that the answer to questions (a) and (b) above is 'yes' and that the answer to question (c) is 'no'."

Lord Justice Floyd agreed at paragraph [96]:

"It is now clear from the Supreme Court's decision in Actavis that purposive construction forms but the first stage in the determination of the scope of protection conferred by the claims. In a sense, the first extreme referred to in Article 1 of the Protocol has been replaced by purposive construction, because it now represents the minimum protection afforded by the patent. There is a second, non-interpretative exercise which allows the patentee a degree of protection outside the normal, purposive meaning of the claims where the variant from the claim achieves substantially the same effect in substantially the same way."

Judge Hacon drew the following conclusions between paragraphs [202] and [208] of his judgment:

"[202] At [60] Kitchin LJ pointed out that the normal construction of the first step involves a purposive interpretation. He continued:

'But I would add this: the question of equivalence is now addressed in issue (ii), as I will now explain.'
[203] I understand this to imply that the purposive interpretation carried out in the first step is not the same as the single purposive construction formerly carried out according to the law as explained in Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2005] RPC 9.

[204] In Actavis Lord Neuberger referred (at [53]) to Lord Hoffmann's view that the principle of purposive construction, that is to say his single approach to the construction of a patent claim, embraced equivalents to the extent necessary. The single construction complied with the requirement in art.2 of the Protocol to art.69 EPC 2000 that due account shall be taken of any element which is equivalent to an element specified in the claims. The old Improver questions, although part and parcel of the single purposive construction, were intended to deal with that part of the scope of a claim which embraced equivalents, see Kirin-Amgen at [49]-[52].

[205] Lord Neuberger left no doubt that the assessment of what might be called the equivalents part of the scope of a claim should now be conducted separately from the assessment of scope according to the normal construction of the claim. The single, conflated, interpretation of the scope of a patent claim in Kirin-Amgen was wrong in principle, see Actavis at [55].

[206] Therefore, although one way of approaching the single purposive construction of a claim used to be to go through the three Improver questions, this would not be a correct way of approaching the first step in Actavis, the normal construction of a claim. The three Improver questions, in revised form, have been relocated to the second step exclusively.

[207] It would follow that the normal construction of the claim is confined to interpreting the words of the claim in the context of the specification as a whole. This is to be done in a manner akin to, although of course it could never be identical to, the interpretation of a contract according to the principles explained by Lord Hodge in Wood v Capita Insurance Services Ltd [2017] 2 WLR 1095, at [8] to [15], see Actavis at [58]. Lord Hodge said:

'[10] The court's task is to ascertain the objective meaning of the language which the parties have chosen to express their agreement. It has long been accepted that this is not a literalist exercise focussed solely on a parsing of the wording of the particular clause but that the court must consider the contract as a whole and…give more or less weight to elements of the wider context in reaching its view as to that objective meaning.'

[208] In the case of a patent, the objective meaning is ascertained through the eyes of the skilled person who will bring the wider context by reason of his or her common general knowledge."

The essential difference between the defendants' process and the claimant's was that the thixotropic gel of their product was not polyester-based.  The question then arose as to whether art 2 of the Protocol applied.  The judge answered by applying the questions in (a), (b) and (c) of subparagraph (ii) of paragraph [66] of Lord Justice Kitchin's judgment in Icescape.  Upon considering the evidence, he answered the first and second questions in the affirmative and the third in the negative.  It followed that the defendants'' process would have infringed claim 1 of the patent had it been valid even though their gel was not polyester based.

Request to Reopen the Trial
After the hearing but before judgment was delivered, the defendants changed solicitors.  The new solicitors produced witness statements from their previous solicitors stating that one of them had found in her son's bedroom a Regen PRP kit that allegedly predated the priority date of the patent.  Those solicitors asked Judge Hacon to reopen the trial to consider that evidence.  His Honour refused their request because it would require a two-day hearing which "would not be in accordance with the need to deal with the case as expeditiously as is possible and at proportionate cost. It would also not allot to these proceedings an appropriate share of the court's resources" (paragraph [286] of his judgment). 

In reaching that conclusion the learned judge directed himself as follows at paragraph [274]:

"(1) The court has a discretion after the conclusion of the trial to order a further hearing at which the decision can be revisited, or alternatively further argument can be heard in advance of the decision being given, and where appropriate to permit the filing of further evidence, provided the order has not been sealed.
(2) Each case will depend on its circumstances. The court must be primarily guided by the requirement of the overriding objective that cases are dealt with justly and at proportionate cost. The assessment will involve taking into account the matters set out in CPR 1.1(2).
(3) A relevant factor is whether any party has acted upon the decision following the trial to his detriment, especially in a case where it is expected that they may do so before the order is formally drawn up.
(4) The three Ladd v Marshall factors on the filing of fresh evidence are also likely to be relevant but will not be determinative.
(5) Where a party seeks after the trial to advance a new case which it could have pleaded and advanced before the trial and there is no justification for failing to have done so, the application to amend will amount to an abuse of process pursuant to the rule in Henderson v Henderson."

Having found for the defendants on the evidence that was already before him, the new evidence would have made no difference to the outcome. The judge observed that it might be raised on appeal and the issue might be referred back to him for a further hearing which would be less than ideal.  However, that possibility had to be weighed against the certainty of extra expense and delay.  

The importance of this case lies in Judge Hacon's analysis of the judgments in Actavis and Icescape and his application of those principles to the facts of this case. However, as he had found claim 1 of the patent to be invalid, that part of his judgment was entirely obiter.  There was precious little discussion on novelty, obviousness or insufficiency as the law on those subjects was largely agreed.  The other useful part of the judgment is the judge's formulation of the principles for the exercise his discretion on reopening a hearing.

Should amplification or clarification of any part of this article be required, I can be contacted on 020 7404 5252 during office hours or through my contact page.


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