Patents: Illumina Cambridge v MGI Tech
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Patents Court (Mr Justice Birss) Illumina Cambridge Ltd v Latvia MGI Tech SIA and others [2021] EWHC 57 (Pat) (20 Jan 2021)
This was an action for patent infringement and a counterclaim for revocation. The defendants, referred to collectively as "MGI", wish to sell DNA sequencing systems in the UK. The claimant, Illumina Cambridge Ltd ("Illumina") contended that 4 of those systems infringed its patents. MGI denied infringement and alleged that the patents were invalid for obviousness, insufficiency and added matter, The action and counterclaim came on for trial before Mr Justice Birss on 9 to 13, 16 to 20, 25, 26 Nov and 9 Dec 2020. Judgment was delivered on 20 Jan 2021 (see Illumina Cambridge Ltd v Latvia MGI Tech SIA and others [2021] EWHC 57 (Pat) (20 Jan 2021).
The Patents
The patents upon which Illumina relied are as follows:
- EP (UK) No. 1 530 578,
- EP (UK) No. 3 002 289
- EP (UK) No. 3 587 433
- EP (UK) 1 828 412, and
- EP (UK) 2 021 415
The Issues
These are set out conveniently in the annexe. The first list consists of issues relating to the modified nucleotide patents that were identified by Illumina. The second consists of issues relating to the same patents that were identified by MGI. The third consists of issues relating to 412 and 415 which were identified by MGI.
Whether claims 1, 12 and 24 of 578 (claim set A) were obvious in light of Zavgorodny 1991 or Zavgorodny 2000
"Zavgorodny 1991" was a paper entitled “1-Alkythioalkylation of Nucleoside Hydroxyl Functions and Its Synthetic Applications: A New Versatile Method in Nucleoside Chemistry”, Zavgorodny et al., Tetrahedron Letters (1991) Vol. 32, No. 51, pp 7593-7596. Zavgorodny 2000 was a paper entitled “S, X-acetals in nucleoside chemistry. III1. Synthesis of 2’- and 3’-O-azidomethyl derivatives of ribonucleosides”, Zavgordony et al., Nucleosides, Nucleotides and Nucleic Acids (2000) Vol. 19, Issue 10-12, pp 1977-1991. MGI originally contended that claims 1, 12 and 24 of 578 were obvious over International patent application WO 91/06678 ("Tsien") and International patent application WO 02/29003 ("Ju") as well as Zavgorodny 1991 or Zavgorodny 2000. By the end of the trial, most of the prior art had been abandoned so that MGI relied only on Zavgorodny 1991.
(b) Identify the relevant common general knowledge of that person;
(2) Identify the inventive concept of the claim in question or if that cannot readily be done, construe it;
(3) Identify what, if any, differences exist between the matter cited as forming part of the 'state of the art’ and the inventive concept of the claim or the claim as construed;
(4) Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?”
(Pozzoli SPA v BDMO SA [2007] EWCA Civ 588; [2007] FSR 37, para 23 per Jacob LJ). The fourth question is the statutory question and the first three questions or tasks, the second and third of which involve knowledge and consideration of the invention, are a means of disciplining the court’s approach to that fourth question: DSM NV’s Patent [2001] RPC 35, para 55 per Neuberger J; Actavis UK Ltd v Novartis AG [2010] EWCA Civ 82; [2010] FSR 18, para 21 per Jacob LJ."
"in a case in which it is necessary to define the skilled person for the purposes of obviousness in a different way from the skilled person to whom the patent is addressed, the approach to take, bringing Schlumberger and Medimmune together, is:
i) To start by asking what problem does the invention aim to solve?
ii) That leads one in turn to consider what the established field which existed was, in which the problem in fact can be located.
iii) It is the notional person or team in that established field which is the relevant team making up the person skilled in the art."
“It follows that the common general knowledge is all that knowledge which is generally regarded as a good basis for further action by the bulk of those who are engaged in a particular field. It is that knowledge which those working in that field will bring to bear when they are reading or learn of a piece of prior art. It is not necessary that those persons have that knowledge in their minds, however. The common general knowledge includes material that they know exists and which they would refer to as a matter of course if they cannot remember it and which they understand is generally regarded as sufficiently reliable to use as a foundation for further work”.
"a 'good basis for further action' does not mean only things which work can be common general knowledge. The common general knowledge of a skilled person will often be as much about knowing what does not work as it is about knowing what does. Both are examples of a “good basis for further action” in that they are ideas which are worth acting upon. In a similar vein, in Merck v Ono [2015] EWHC 2973 (Pat) at para 24, I held that the common general knowledge includes contradictions as long as the information was sufficiently well known to be common general knowledge. So the fact a given technique was something which had been proposed for some years, tried out by a number of groups, but not (yet) shown to work, would not in and of itself preclude information about that technique being held to be part of the common general knowledge. A technique like that which was sufficiently well known could be common general knowledge."
"In a way the difference between Zavgorodny 1991 and claim 1 of 578 is quite small. Claim 1 claims a nucleotide (i.e. with the 5' phosphates) with an azidomethyl group at the 3' oxygen whereas Zavgorodny 1991 discloses a nucleoside with such a group at the 3' oxygen. However in order to render claim 1 invalid the skilled person has to make the claimed molecule and for that to happen the skilled person has to have a reason to do so. As a result the inventive step(s) of all the relevant claims of the modified nucleotide patents stand or fall together. If performing sequencing by synthesis using a nucleotide with an azidomethyl blocked 3' oxygen as a reversible chain terminator is obvious over Zavgorodny 1991, then claim 1 also lacks inventive step because it would be obvious to make the relevant compound. If that exercise was not obvious then none of the claims, including claim 1 of 578, are obvious for the converse reason. Another way of approaching the same question would be to ask whether it was obvious to the skilled person given Zavgorodny 1991, with a reasonable prospect of success, to try out a sequencing by synthesis test using a nucleotide with an azidomethyl blocked 3' oxygen as a reversible chain terminator."
Priority
"6. Are each of claims 1, 12 and/or 24 of EP 578 (claim set A) entitled to claim priority from priority document P2?
7. If the answer to issue 6 is no, are each of claims 1, 12 and/or 24 (claim set A) obvious over Barnes?"
Illumina claimed that the modified nucleotide patents were based on the British patent application GB 0230037 which was filed on 23 Dec 2002 some months before the US patent application. That claim was challenged by MGI.
In Icescape Ltd v Ice-World International BV and others [2018] EWCA Civ 2219, the Court of Appeal had held that the test for priority was whether the priority document contained sufficient material to constitute an enabling disclosure of the claims in issue. In determining the question the court will consider the position through the eyes of the skilled person who reads the priority document with his or her common general knowledge.
The reason why MGI contended that claims 1, 12 and 24 of 578 were obvious is that s.72 (1) (a) of the Patents Act 1977 permits a patent to be revoked if the invention is not patentable. S.125 (1) defines an invention for the purposes of the Act as that specified in a claim of the specification of a patent. The conditions for the grant of a patent are set out in s.1 (1) of the Act. One of those conditions is that the invention involves an inventive step which is defined as follows by s.3.
"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)."
If an invention as represented by a claim in the specification would have been obvious to a person skilled in the art having regard to a scientific paper or previous invention it can be declared invalid. If the claim is invalid it cannot be infringed by the manufacture or sale of a product or the use of a process that falls within its wording.
In Actavis Group PTC EHF and others v ICOS Corporation and another, [2019] UKSC 15, [2019] Bus LR 1318, Lord Hodge said at para [60] of his judgment:
"In addressing the statutory question of obviousness in section 3 of the 1977 Act it is common for English courts to adopt the so-called Windsurfing/Pozzoli structure which asks these questions:
'(1) (a) Identify the notional ‘person skilled in the art’;(b) Identify the relevant common general knowledge of that person;
(2) Identify the inventive concept of the claim in question or if that cannot readily be done, construe it;
(3) Identify what, if any, differences exist between the matter cited as forming part of the 'state of the art’ and the inventive concept of the claim or the claim as construed;
(4) Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?”
(Pozzoli SPA v BDMO SA [2007] EWCA Civ 588; [2007] FSR 37, para 23 per Jacob LJ). The fourth question is the statutory question and the first three questions or tasks, the second and third of which involve knowledge and consideration of the invention, are a means of disciplining the court’s approach to that fourth question: DSM NV’s Patent [2001] RPC 35, para 55 per Neuberger J; Actavis UK Ltd v Novartis AG [2010] EWCA Civ 82; [2010] FSR 18, para 21 per Jacob LJ."
However, Lord Hodge recognized another approach to determining whether there had been an "inventive step" in his next paragraph:
"An alternative approach which the EPO often adopts is the so-called 'problem-and-solution approach#. The EPO has described the approach in these terms:
'the Boards of Appeal consistently decide the issue of obviousness on the basis of an objective assessment of the technical results achieved by the claimed subject-matter, compared with the results obtained according to the state of the art. It is then assumed that the inventor did in fact seek to achieve these results and, therefore, these results are taken to be the basis for defining the technical problem (or, in other words, the objective) of the claimed invention. … The next step is then to decide whether the state of the art suggested the claimed solution of this technical problem in the way proposed by the patent in suit …' (Agrevo/Triazoles (above) para 2.4.3)
The test is helpfully summarized in the EPO’s Guidelines for Examination in the EPO (November 2017) (Part G - Chapter VII) para 5:
'Problem-and-Solution Approach
In order to assess inventive step in an objective and predictable manner, the so-called ‘problem-and-solution approach’ should be applied. Thus deviation from this approach should be exceptional.
In the problem-and-solution approach there are three main stages:
(i) determining the ‘closest prior art’,
(ii) establishing the ‘objective technical problem’ to be solved, and
(iii) considering whether or not the claimed invention, starting from the closest prior art and the objective technical problem, would have been obvious to the skilled person.”
Lord Hodge did not seem to have a preference for either approach. He said ar [62]:
"While both approaches focus on the inventive concept put forward in the claims, neither approach should be applied in a mechanistic way. Both are glosses on the text of section 3 of the 1977 Act and article 56 of the EPC and neither require a literalist approach to the wording of the claim in identifying the inventive concept."
In this case, MGI relied upon both the Windsurfing/Pozzoli and the EPO's Problem and Solution approaches.
The first 3 issues of Illumina's list of ssues were concerned with the Windsurfing/Pozzoli approach:
"1) The identity of the Skilled Team;
2) Whether sequencing using reversible chain terminators (RCTs) was common general knowledge at the priority date;
3) Whether claims 1, 12 & 24 of EP 578 (claim set A) are obvious in light of:
a) Zavgorodny 1991; or b) Zavgorodny 2000,"
The third of those issues was also the first of those identified by MGI:
The Identity of the Skilled Team
The first step of the Windsurfing/Pozzoli analysis is to identify the skilled addressee and common general knowledge.
At para [58] of his judgment, Mr Justice Birss asked: "Who is the person skilled in the art?" Referring to para [81] of Mr Justice Henry Carr's judgment in Garmin (Europe) Ltd v Koninklijke Philips N.V. [2019] EWHC 107 (Ch) (29 Jan 2019) the judge replied: "Stated generally the law is clear that patents are directed to those likely to have a real and practical interest in the subject matter of the invention." However, he also mentioned the Court of Appeal's decision in Schlumberger Holdings Ltd v Electromagnetic Geoservices AS [2010] RPC 33, [2010] EWCA Civ 819 in which it was noted that the concept of the person skilled in the art actually applies in two distinct circumstances. The judge concluded at [68] that:
i) To start by asking what problem does the invention aim to solve?
ii) That leads one in turn to consider what the established field which existed was, in which the problem in fact can be located.
iii) It is the notional person or team in that established field which is the relevant team making up the person skilled in the art."
Applying this methodology, his lordship found at [98] that "the team can be regarded as having two members. One member would have a background in molecular biology or genetics, with a focus on DNA sequencing, in particular, the other member would have a background in organic chemistry. They would both have a post-graduate degree, probably a PhD but perhaps a Masters, and some years research experience."
Common General Knowledge
The next task was to identify the "common general knowledge". Mr Justice Birss referred to para [72] of Lord Justice Kitchen's judgment in Idenix Pharmaceuticals Inc v Gilead Sciences Inc and others [2016] EWCA Civ 1089:
Mr Justice Birss added at [102] that
He set out his findings on common general knowledge between paragraphs [103] and [130] of his judgment.
Construing the Claims
The second step was to identify the inventive concept of the claim in question or if that could not readily be done, construe it. Mr Justice Birss chose to construe the claims rather than identify the inventive concept. Between paragraphs [131] and [152] of his judgment, he considered the body of the specification. He then turned to the claims at para [153]. As Illumina had applied to amend the claims of the modified nucleotide patents the judge considered the claims as proposed to be modified. These are set out in the annexes. Between para [155] and [166] the judge construed the claims of European patent number 1,530,578. Between [177] and [174] he construed those of European patent number 3, 002, 289. Between [175] and [178] he construed those of European patent number 3 587 433.
The Prior Art
Lord Hodge said in Actavis that the third step of the Windsurfing/Pozzoli analysis is:
"Identify what, if any, differences exist between the matter cited as forming part of the 'state of the art’ and the inventive concept of the claim or the claim as construed,"
Accordingly, Mr Justice Birss directed himself as follows at para [183]:
"In order to identify the differences the next task is to address the disclosure of the cited prior art."
"In order to identify the differences the next task is to address the disclosure of the cited prior art."
As I said above, the prior art upon which MGI relied at trial was the scientific paper previously referred to as "Zavgorodny 1991". The judge analysed that paper between paras [184] and [192] and considered the differences between the claims and the prior art in [193]:~
"In a way the difference between Zavgorodny 1991 and claim 1 of 578 is quite small. Claim 1 claims a nucleotide (i.e. with the 5' phosphates) with an azidomethyl group at the 3' oxygen whereas Zavgorodny 1991 discloses a nucleoside with such a group at the 3' oxygen. However in order to render claim 1 invalid the skilled person has to make the claimed molecule and for that to happen the skilled person has to have a reason to do so. As a result the inventive step(s) of all the relevant claims of the modified nucleotide patents stand or fall together. If performing sequencing by synthesis using a nucleotide with an azidomethyl blocked 3' oxygen as a reversible chain terminator is obvious over Zavgorodny 1991, then claim 1 also lacks inventive step because it would be obvious to make the relevant compound. If that exercise was not obvious then none of the claims, including claim 1 of 578, are obvious for the converse reason. Another way of approaching the same question would be to ask whether it was obvious to the skilled person given Zavgorodny 1991, with a reasonable prospect of success, to try out a sequencing by synthesis test using a nucleotide with an azidomethyl blocked 3' oxygen as a reversible chain terminator."
"Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?”
His lordship addressed the above question (the last step of the Windsurfing/Pozzoli analysis) between paras [195] and [222]. He considered the expert evidence but concluded at [199]:
"As a matter of principle, as with any item of prior art, the skilled person is deemed to read Zavgorodny with interest. They would see that it was a paper concerned with chemical intermediates (synthons). They would see that one such intermediate was a nucleoside in which the 3' OH had been blocked with azidomethyl. They would see the reference to removal using mild and specific conditions and that Zavgorodny regarded the azidomethyl group as of special interest. In my judgment the most likely thing such a skilled team would think having read Zavgorodny is that this paper on synthetic chemistry had nothing to do with their focus on sequencing by synthesis. To the skilled person the concept of protecting groups in synthetic chemistry is commonplace. At most Zavgorodny would be seen as something to add to the organic chemist team member’s general toolbox concerning chemical synthesis (see Prof Marx in cross-examination at T6/729). There is simply nothing, absent hindsight, to suggest that what is disclosed here has an application in relation to sequencing by synthesis using reversible chain terminators. They would read it with interest and having done so, put it down and move on."
He concluded as follows at [216]:
"[216] Standing back, for the reasons explained above claim 1 of 578 is not obvious over Zavgorodny 1991. I reject MGI’s case on lack of inventive step. As mentioned at the outset, if the claim is not obvious over Zavgorodny 1991 then it is not obvious over Zavgorodny 2000 either.
[217]. If claim 1 is not obvious then neither is claim 12 of claim set A (to a sequencing method) nor claim 24 of claim set A (an oligonucleotide comprising a modified nucleotide of claim 1)."
"[216] Standing back, for the reasons explained above claim 1 of 578 is not obvious over Zavgorodny 1991. I reject MGI’s case on lack of inventive step. As mentioned at the outset, if the claim is not obvious over Zavgorodny 1991 then it is not obvious over Zavgorodny 2000 either.
[217]. If claim 1 is not obvious then neither is claim 12 of claim set A (to a sequencing method) nor claim 24 of claim set A (an oligonucleotide comprising a modified nucleotide of claim 1)."
Priority
This was not quite the end of the argument on obviousness because US patent application number 2003/0104437 A1 which was published on 5 June 2003 disclosed matter that would have rendered the modified nucleotide inventions obvious if that application had pre-dated the applications for the first of those patents. These were the 6th and 7th of MGI's issues:
7. If the answer to issue 6 is no, are each of claims 1, 12 and/or 24 (claim set A) obvious over Barnes?"
Illumina claimed that the modified nucleotide patents were based on the British patent application GB 0230037 which was filed on 23 Dec 2002 some months before the US patent application. That claim was challenged by MGI.
In Icescape Ltd v Ice-World International BV and others [2018] EWCA Civ 2219, the Court of Appeal had held that the test for priority was whether the priority document contained sufficient material to constitute an enabling disclosure of the claims in issue. In determining the question the court will consider the position through the eyes of the skilled person who reads the priority document with his or her common general knowledge.
After considering its specification and the parties' arguments the judge decided that the British patent application did disclose the invention and that Illumina was entitled to priority from 23 Dec 2002.
Agrevo-Obviousness
Agrevo-Obviousness
The fifth of Illumina's issues was:
"Whether claim 7 of EP 578 (claim set A) and claim 6 of EP 433 (claim set C) are invalid for Agrevo-obviousness / insufficiency".
"Whether claim 7 of EP 578 (claim set A) and claim 6 of EP 433 (claim set C) are invalid for Agrevo-obviousness / insufficiency".
"Aggrevo/obviousness" was the "problem-and-solution approach" to obviousness which Lord Hodge discussed in Actavis.
MGI expressed the point slightly differently:
"If the answer to issue 1 is no, are each of claims 1, 12 and/or 24 of EP 578 (claim set A) insufficient due to lack of enablement/lack of technical contribution?
"If the answer to issue 1 is no, are each of claims 1, 12 and/or 24 of EP 578 (claim set A) insufficient due to lack of enablement/lack of technical contribution?
The judge noted that MGI had contended:
"The claims to a method of controlling incorporation, which are claim 7 (claim set A) of the 578 patent and claim 6 (as granted) of the 433 patent, are both defined in such a way that the method is defined as applicable in a synthesis or a sequencing reaction. MGI contended that insofar as the claims covered the method in “a synthesis reaction not being a sequencing by synthesis reaction”, then the claim had no technical benefit over the common general knowledge or prior art and so the claims are invalid for lack of inventive step on the Agrevo basis."
The claim as originally drafted served no useful purpose and would have been invalid on Aggrevo grounds but the judge allowed the proposed amendments and upheld the claims' validity.
The claim as originally drafted served no useful purpose and would have been invalid on Aggrevo grounds but the judge allowed the proposed amendments and upheld the claims' validity.
Insufficiency
MGI contended that if claims 7 and 12 of the 578 patent are not obvious over Zavgorodny then those claims are insufficient.
S.14 (3) of the Patents Act 1977 requires every patent specification to disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the art. If it fails to do that the patent may be revoked under s.72 (1) (c) on the ground that the specification does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art. Failure to comply with that requirement is known as "insufficiency".
S.14 (3) of the Patents Act 1977 requires every patent specification to disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the art. If it fails to do that the patent may be revoked under s.72 (1) (c) on the ground that the specification does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art. Failure to comply with that requirement is known as "insufficiency".
The defendants put their case two ways which the judge discussed at paras [244] and
"[244] The first one relates to read length. The point is that claim 12 (for example) claims a method for determining the sequence of a target single stranded nucleotide wherein at least one incorporation (my emphasis) is of a nucleotide defined in previous claims such as claim 2, in other words an azidomethyl 3' blocked nucleotide in which the base is linked to a detectable label by a linker. MGI says that this claim is open ended in terms of the length of the nucleotide to be sequenced and submits that the data in the patent only present results for a limited number of cycles, as shown in figures 5 and 6. Therefore, it is said, the monopoly claimed exceeds the technical contribution and the specification does not enable the skilled person to perform a sequencing method across the breadth of the claim without undue burden. The same point is made about claim 7 of claim set A in its amended form (limited to a sequencing reaction). The issue can be decided by reference to claim 12. Claim 7 will stand or fall with it."
Before considering those contentions, Mr Justice Birss analysed the Supreme Court's judgment in Regeneron Pharmaceuticals Inc v Kymab Ltd [2020] UKSC 27, [2020] Bus LR 1394 which I discussed in Patents - The Supreme Court's Judgment in Regeneron Pharmaceuticals Inc v Kymab Ltd 3 July 2020 NIPC Law, and referred to Novartis v Johnson & Johnson [2010] EWCA 1039, Dipeptidyl-Peptidase-Inhibitoren (X ZB 8/12) and Trustees of Princeton/ OLED (T 0455/12). From those authorities, he derived the following principles at [279]:
"i) When examining any aspect of claim scope for the purposes of the enablement it is necessary to distinguish between ranges relevant in the Regeneron sense and other ranges.
ii) For ranges relevant in the Regeneron sense, to be sufficient, there must be enablement across the whole scope of the claim within that relevant range (subject to de minimis exceptions) at the relevant date. If a type or embodiment within such a range is not enabled at that date then the fact it could be made later, as a result of further developments not enabled by the patent, even though it never could have been made without the invention, will not save the claim from insufficiency.
iii) Not all claims will necessarily contain a range relevant in the Regeneron sense but if they do, then this principle applies to that range.
iv) An example of an other range, not relevant in the Regeneron sense, will be a descriptive feature in a claim (whether structural or functional) which can cover a variety of things, but for which that variety does not significantly affect the value or utility of the claimed product or process in achieving its relevant purpose. The relevant purpose is judged in all the circumstances, starting from the terms of the claim itself but also, where appropriate, by reference to the essence or core of the invention.
v) For a claim feature which amounts to a range in this other sense, the skilled person must still be able to make a suitable selection, without undue burden, in order for the claim to be sufficiently disclosed. However provided that is so at the relevant date, such a claim feature will not be insufficient simply because it is capable of also covering within its scope things which had not been invented at that relevant date.
vi) When examining enablement of any kind, the test is always about what the skilled person is able to do without undue burden. The patentee is entitled to expect that the skilled person, in seeking to make the invention work, will exercise that skill. If need be that exercise will involve testing and experiments, as long as it is not unduly burdensome."
He applied those principles to "the impractical linkers" contention in [247] first and concluded that there would be no undue burden on a skilled addressee on performing the invention. He then turned to "read length" and concluded at [300]:
"There is no evidence which would allow me to make a finding on the balance of probabilities that the limit of what the skilled person is enabled to do, without an undue burden, is anything less than what they would reasonably regard as what had been promised by the patent, or claimed if, contrary to my finding, claim 12 does represent a range of read lengths in the Regeneron sense."
"There is no evidence which would allow me to make a finding on the balance of probabilities that the limit of what the skilled person is enabled to do, without an undue burden, is anything less than what they would reasonably regard as what had been promised by the patent, or claimed if, contrary to my finding, claim 12 does represent a range of read lengths in the Regeneron sense."
He, therefore, rejected the argument on insufficiency.
Squeeze
Both Illumina and MGI listed an obviousness/insufficiency squeeze in their lists of issues. The concept of a squeeze is the argument that if a patent is not bad for one reason it must be bad for another. For example, a patent is bad for obviousness because the specification does not say anything abut the invention that a skilled addressee could not work out for him or herself. If that is wrong it must be because there is something about the invention that has not been properly disclosed in which case the patent is bad for insufficiency.
Mr Justice Birss gave the squeeze argument short shrift:
"[290] ....... Part of MGI’s case, based as it is on a squeeze on inventive step, is that the need to select suitable types presents an undue burden for the skilled person. I reject that. On the facts I have found the skilled person can select suitable types of the various components without difficulty. The exercise of skill and some routine testing may be needed but I am not satisfied any burden of undertaking that work is undue. I reject this limb of the insufficiency.
[291] Moreover there is no squeeze with inventive step. The position of the skilled person is entirely different from the position they were in based on the prior art. Taking polymerases as an example, the fact that Metzker 1994 showed inconsistent results with a variety of the polymerases and blocking groups tested in that paper is not evidence that, armed with the patent, the skilled person has an undue difficulty selecting suitable polymerases to make the invention work with 3'–O–azidomethyl blocked nucleotides. I reach the same conclusions for linkers, cleavage conditions and detectable labels."
Mr Justice Birss gave the squeeze argument short shrift:
"[290] ....... Part of MGI’s case, based as it is on a squeeze on inventive step, is that the need to select suitable types presents an undue burden for the skilled person. I reject that. On the facts I have found the skilled person can select suitable types of the various components without difficulty. The exercise of skill and some routine testing may be needed but I am not satisfied any burden of undertaking that work is undue. I reject this limb of the insufficiency.
[291] Moreover there is no squeeze with inventive step. The position of the skilled person is entirely different from the position they were in based on the prior art. Taking polymerases as an example, the fact that Metzker 1994 showed inconsistent results with a variety of the polymerases and blocking groups tested in that paper is not evidence that, armed with the patent, the skilled person has an undue difficulty selecting suitable polymerases to make the invention work with 3'–O–azidomethyl blocked nucleotides. I reach the same conclusions for linkers, cleavage conditions and detectable labels."
Added Matter
At para [302] Mr Justice Birss stated the rule that:
"No amendment will be allowed if it has the result that the matter disclosed extends beyond that disclosed in the application for the patent as filed."
"No amendment will be allowed if it has the result that the matter disclosed extends beyond that disclosed in the application for the patent as filed."
This rule is derived from s.76 (2) of the Patents Act 1977 and was discussed extensively in Nokia OYJ (Nokia Corporation) v IPCom GmbH & Co Kg [2013] RPC 5, [2012] EWCA Civ 567. The test is “whether the amendment presents the skilled person with new information about the invention which is not directly and unambiguously apparent from the original disclosure. If it does then the amendment is not permissible”.
The judge explained the issue at [303]:
"The issue relates to claim 9 (claim set B) of 289 (claim 13 as granted). Claim 9 adds to the sequencing method claims of 289 (claim 6 of claim set B et al) a requirement to remove the blocking group using a water soluble phosphine. Illumina seek to amend that claim to add the words “under neutral, aqueous conditions”. MGI says this amendment adds matter. The reason why is a bit of a paper chase. It is true (as Illumina points out) that there is textual support for the amendment at p43 ln 10 of the application as filed (this happens to be the same text about removing the azidomethyl group which has been quoted above from the priority document P2). The same passage also seems to have become para [0103] as granted in 289. However MGI says that in the application as filed there was also a limiting definition of an aqueous solution. It was at p5 ln 26-34. The definition places a lower limit on the amount of water in the liquid of at least 20%. This definition has not been carried forward into the granted patent. Therefore, it is said by MGI, whereas in the application as filed “aqueous conditions” would be understood to be at least 20% water, as amended the claim will add matter because it uses the general phrase and could be understood to envisage aqueous conditions with less than 20% water."
"The issue relates to claim 9 (claim set B) of 289 (claim 13 as granted). Claim 9 adds to the sequencing method claims of 289 (claim 6 of claim set B et al) a requirement to remove the blocking group using a water soluble phosphine. Illumina seek to amend that claim to add the words “under neutral, aqueous conditions”. MGI says this amendment adds matter. The reason why is a bit of a paper chase. It is true (as Illumina points out) that there is textual support for the amendment at p43 ln 10 of the application as filed (this happens to be the same text about removing the azidomethyl group which has been quoted above from the priority document P2). The same passage also seems to have become para [0103] as granted in 289. However MGI says that in the application as filed there was also a limiting definition of an aqueous solution. It was at p5 ln 26-34. The definition places a lower limit on the amount of water in the liquid of at least 20%. This definition has not been carried forward into the granted patent. Therefore, it is said by MGI, whereas in the application as filed “aqueous conditions” would be understood to be at least 20% water, as amended the claim will add matter because it uses the general phrase and could be understood to envisage aqueous conditions with less than 20% water."
His lordship noted that neither party devoted much effort to this point and no evidence was drawn to his attention which was said to have a bearing on the issue. He rejected the objection at [3-5] for the following reasons:
"I am not satisfied this amendment amounts to added matter for three reasons. First, for the argument to succeed it would have to be established that the skilled person (with the common general knowledge) would actually think that “neutral, aqueous conditions” disclosed the idea of conditions in which the water content was less than 20%. That would require evidence. There is none. Second it must be remembered that coverage is not the same as disclosure of information. Even if the claim could be said to cover solutions with less than 20% water, I am not satisfied there is a disclosure of such a solution by the amendment. Third I do not accept that the skilled reader of the application as filed would necessarily think that the definition given in one context was necessarily relevant to the reference to neutral, aqueous conditions in another context."
He, therefore, allowed the amendments in annexe A.
Infringement
MGI admitted that several but not all of its systems fell within some of the claims of the modified nucleotide patents. The judge considered the allegations that were not admitted. As Illumina relied on the doctrine of equivalents as well as the normal rules of claim construction, his lordship reminded himself of the Supreme Court's decision in Eli Lilly v Actavis UK Ltd and others [2017] UKSC 48, [2017] Bus LR 1731, [2017] RPC 21 between paras 308 and 310:
"[308] ........Following the Supreme Court’s decision in Actavis v Eli Lilly [2017] UKSC 48, the correct approach to infringement by equivalents is to ask three questions (see [66] of Lord Neuberger’s judgment in Actavis):
(i) Notwithstanding that it is not within the literal 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, ie. the inventive concept revealed by the patent?
(ii) 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?
(iii) Would such a reader of the patent have concluded that the patentee none the less intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?
[309] To establish infringement the answers have to be yes, yes and no.
[310] On equivalents, the only issue is the application of the third question. It is common ground that in both cases the first two questions are to be answered in the affirmative."
Applying these principles, his lordship considered whether:
"[308] ........Following the Supreme Court’s decision in Actavis v Eli Lilly [2017] UKSC 48, the correct approach to infringement by equivalents is to ask three questions (see [66] of Lord Neuberger’s judgment in Actavis):
(i) Notwithstanding that it is not within the literal 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, ie. the inventive concept revealed by the patent?
(ii) 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?
(iii) Would such a reader of the patent have concluded that the patentee none the less intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?
[309] To establish infringement the answers have to be yes, yes and no.
[310] On equivalents, the only issue is the application of the third question. It is common ground that in both cases the first two questions are to be answered in the affirmative."
Applying these principles, his lordship considered whether:
- MGI's Cool MPS fell within claim 12 of 578 (Claim set A) [MGI MNP Issue 10 between paragraphs [311] and [341] [MGI MNP Issue 10]; and
- either of the 2 colour variant of Standard MPS or the DNBSEQ E method fell within the kit claims, claim 20 of 578 (claim set A) or claim 4 of 289 (claim set B) between paragraphs [342] and [346] [MGI MNP Issue 9].
The judge decided at [333] that Cool MPS infringed on both a normal construction and under Actavis. His findings on the modified nucleotide patents at paras [515] to [517] were as follows:
"[515]. EP (UK) 1 530 578 with claims as amended in the form of claim set A is valid. All four of the MGI systems known as Standard MPS, Cool MPS, the two colour variant and DNBSEQ E infringe each of claims 1, 7, 12, 20, and 24 (claim set A) of that patent.
[516]. EP (UK) 3 002 289 with claims as amended in the form of claim set B is valid. All four of Standard MPS, Cool MPS, the two colour variant and DNBSEQ E infringe each of claims 1, 5 and 6 of that patent. In relation to claim 4, it is infringed by Standard MPS and Cool MPS but not by the two colour variant or DNBSEQ E. The amendment to claim 9 is allowable but Illumina needs to explain what the amendment is for.
[517]. EP (UK) 3 587 433 with claims as amended in the form of claim set C is valid. All four of Standard MPS, Cool MPS, the two colour variant and DNBSEQ E infringe each of claims 1 and 6 of that patent."
European Patent No 1 828 412
"[515]. EP (UK) 1 530 578 with claims as amended in the form of claim set A is valid. All four of the MGI systems known as Standard MPS, Cool MPS, the two colour variant and DNBSEQ E infringe each of claims 1, 7, 12, 20, and 24 (claim set A) of that patent.
[516]. EP (UK) 3 002 289 with claims as amended in the form of claim set B is valid. All four of Standard MPS, Cool MPS, the two colour variant and DNBSEQ E infringe each of claims 1, 5 and 6 of that patent. In relation to claim 4, it is infringed by Standard MPS and Cool MPS but not by the two colour variant or DNBSEQ E. The amendment to claim 9 is allowable but Illumina needs to explain what the amendment is for.
[517]. EP (UK) 3 587 433 with claims as amended in the form of claim set C is valid. All four of Standard MPS, Cool MPS, the two colour variant and DNBSEQ E infringe each of claims 1 and 6 of that patent."
European Patent No 1 828 412
The learned judge then turned to European Patent No 1 828 412.
The Issues in respect of 412
The Issues in respect of 412
MGI admitted that its Standard MPS and two coloured versions infringe claims 1 and 15, Informa alleged that CoolMPS infringes claim 1 of the patent both on a normal construction and by the doctrine of equivalents. MGI denied infringement and challenged the patent's validity on grounds of obviousness and added matter. The issues are summarized in the annexe.
Buechler
MGI alleged the invention was obvious over US patent No 6,544,797 Buechler. Illumina replied that Buechler added little or nothing to the prior art and that the attack on 412 amounted to an attack based on common general knowledge alone. The judge considered the evidence upon which Illumina relied but concluded that it did not assist the claimant.
Applying the Windsurfer/Pozzoli analysis Mr Justice Birss said at [347] that the skilled addressee for the 412 patent would be the same as before, namely, a team consisting of a molecular biologist and organic chemist as before with the addition of a fluorescence chemist. Between [350] and [359] he identified such team's common general knowledge. He discussed the specification between [377] and [380], construed the claims and identified the inventive concept at para [384] as "the use of ascorbate during the imaging step to reduce damage to the nucleic acid". Between [400] and [406] the judge considered the differences between the invention and Buechler. Finally, he addressed whether those differences constituted steps which would have been obvious to the person skilled in the art or whether they required a degree of invention. At [412] he concluded that the invention would have been obvious in the light of Buechler.
MGI's Alternative Case
MGI's Alternative Case
MGI contended at [414]:
"that even if the skilled person did not think of adding ascorbate at the start, when they ran their experiments they would encounter a fading of the signal in successive cycles (just as reported in the patent at paragraph [0005]). It would be obvious that the cause was photobleaching of the DNA and obvious to apply Buechler at that point and thereby add an antioxidant such as ascorbate."
"that even if the skilled person did not think of adding ascorbate at the start, when they ran their experiments they would encounter a fading of the signal in successive cycles (just as reported in the patent at paragraph [0005]). It would be obvious that the cause was photobleaching of the DNA and obvious to apply Buechler at that point and thereby add an antioxidant such as ascorbate."
The learned judge agreed:
"I find that even if it was not obvious to decide to add ascorbate to the buffers before carrying out any sequencing by synthesis tests in the first place, the skilled person who took that approach would, acting without any inventive step, encounter a problem of fading and would, without invention, find that it was caused by photodamage by adding ascorbate. The claims are obvious based on MGI’s alternative case too."
"I find that even if it was not obvious to decide to add ascorbate to the buffers before carrying out any sequencing by synthesis tests in the first place, the skilled person who took that approach would, acting without any inventive step, encounter a problem of fading and would, without invention, find that it was caused by photodamage by adding ascorbate. The claims are obvious based on MGI’s alternative case too."
Added Matter in Respect of 412
The case on added matter was as follows:"The added matter argument here is an intermediate generalisation point directed to something missing from claim 1 as granted (and dependent kit claim 15). Claim 1 is set out above. What is absent from it is essentially any reference to the character of the illumination needed to cause the label to fluoresce (such as being intense). The allegation is that the application as filed (published as WO 2006/064199) only discloses the method of claim 1 together with the requirement that the detection step includes repeated or prolonged exposure to intense illumination. MGI refer to p3 ln3-8 and ln12-18 of the specification in the application and also to claim 1 as filed (at p50 ln3-8). As a matter of the words in the document, MGI is correct. The argument then goes that the difference between the disclosure in the application and the claim as granted is not trivial because although in sequencing by synthesis one generally would use intense illumination, Prof Johnsson explained that that is not necessarily the case. The precise intensity required will depend on the equipment used and the time of illumination and, he said, “I do not think that intense light would strictly be necessary”. Thus argues MGI the application discloses the invention as applicable to a sub-set of sequencing by synthesis processes, namely those which include exposure to intense illumination, whereas the teaching of the granted patent is that the ascorbate containing buffer can be applied to all sequencing by synthesis processes. "
The judge rejected that contention at [420] on the grounds that no new information was provided in the granted patent as compared to what was disclosed to the skilled person imbued with the common general knowledge by the application as filed.
Whether 412 would have been infringed
Having construed the claims in order to identify the inventive concept, the judge considered whether the patent would have been infringed had the patent been valid. He found that Standard MPS and the two colour variant would have infringed but not Cool MPS.
Conclusions on 412
Conclusions on 412
The judge set out his findings at para [518]:
European Patent No 2 021 415
I introduced this patent at the beginning of this article. It relates to a conjugate molecule consisting of a nucleotide, a particular cleavable linker and a particular fluorescent dye compound.
Issues on 415
MGI admitted that StandardMPS infringed claim 1 but contended that the patent was bad for obviousness. It alleged that the patent was obvious over US Patent No. 4,900,686 (Arnost) and PCT Application No. WO 2004/018493 (Milton). Alternatively, they contended that the invention had been no technical contribution.
Whether 415 was obvious
The judge held at para [424] that the skilled addressee would be a team consisting of a molecular biologist, an organic chemist and a fluorescence chemist. He set out their common general knowledge between paras [425] and [435]. He construed the relevant claim between [436] and [450]. He compared the invention to both Arnost and Milton and found that there had been an inventive step.
Mere Collocation
Relying on Sabaf SpA v MFI Furniture Centres Ltd and others [2004] UKHL 45, MGI contended that the invention was a mere collocation and did not involve an inventive step. Milton disclosed the idea of using labelled nucleotides with cleavable detectable fluorescent labels in a sequencing by synthesis process. Milton teaches that this is a useful product in sequencing by synthesis. MGI argued that in the light of this prior art claim 1 is a mere collocation as in Sabaf v MFI. In the claimed molecule the nucleotide, the linker and the dye each act independently of one another. They each perform the function for which they were already known or was obvious. The whole is not greater than the sum of the parts. Therefore there is no synergy in the combination and thus no inventive step.
The judge rejected that contention. He said at [513]:
[514] Putting it another way, the molecule of claim 1 is a single invention. Its beneficial properties derive from the functional relationship, which includes non-interference, between the constituent parts. I find that claim 1 of the 415 patent is valid.
Lack of Technical Contribution
MGI contended that hat the specific rhodamine dye claimed in the 415 patent within the molecule of claim 1 does not provide any technical advance over Milton to use rhodamines in general. The dye in the claim has no beneficial properties over rhodamines in general and is thus an arbitrary dye. The judge rejected that contention. He held at [497] that the 415 patent discloses that the molecule of the claim is a useful compound with beneficial properties. He said later in [497]:Conclusion on 415
Mr Justice Birss said at [519] that the patent was valid and infringed.
Comment
Aa the validity of 5 very different patents was challenged on grounds of obviousness, insufficiency and added matter, this case is likely to be an important authority on all those areas of law. It is not an easy one to follow because of the complexity of the facts and the structure of the judgment. Anyone wishing to discuss this article or the case may call me on 020 7404 5252 during normal business hours or send me a message through my contact form.
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