Patents - Takeda UK Ltd v F Hoffmann-La Roche AG
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| Jane Lambert |
Patents Court (Mr Justice Birss) Takeda UK Ltd v F Hoffmann-La Roche AG (Rev 1) [2019] EWHC 1911 (Pat) (17 July 2019)
This was a claim by Takeda UK Ltd. ("Takeda") for revocation of European patent (UK) No EP2007809 on grounds of lack of novelty, want of an inventive step and insufficiency and a counterclaim by F. Hoffmann-La Roche AG ("Roche"), the owner of the patent, for infringement. This litigation appears to have arisen because Takeda has a product called Entyvio which is a formulation of a monoclonal antibody called vedolizumab. Roche believes that vedolizumab infringes its patent. The action and counterclaim came on for trial before Mr Justice Birss between the 12 and 27 June 2019. He delivered judgment on 17 July 2019.
The Patent
The title of the patent was glycosylated antibodies. Mr Justice Birsss discussed the patent between paragraphs [51] and [101] of his judgment. The claims alleged to have been infringed were 1, 2, 3, 4, 6 and 7. The judge set out claim 1 separated into integers at paragraph [3] of his judgment. He explained at paragraph [7] that if vedolizumab fell within claim 1 then the other claims listed above would have been infringed.
Structure of the Judgment
His lordship held at paragraph [29] that the skilled addressee would be a team. He construed claim 1 between paragraphs [84] and [101] and then turned to the question of infringement between paragraphs [102] and [116]. He found that vedolizumab fell within all the relevant claims of the patent. Had the patent been valid it would have been infringed. He considered novelty between paragraph [117] and paragraph [195], obviousness between paragraph [196] and paragraph [225] and insufficiency at paragra[h [226]. His conclusion at [257] was that the claims were invalid for want of novelty, a technical contribution and insufficiency and that the patent had to be revoked.
Novelty
The judge's starting point was art 54 (1) and (2) of the European Patent Convention:
"(1) An invention shall be considered to be new if it does not form part of the state of the art.
(2) The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application."
After considering the House of Lords' decision in Synthon BV v. Smithkline Beecham plc [2006] 1 All ER 685, [2005] UKHL 59, [2006] RPC 10 that for a patent claim to lack novelty over the prior art there must have been disclosure and enablement, the judge said at [118]:
"The issue of law between Roche and Takeda concerned what exactly it was which had to be disclosed and enabled. The issue is really about enablement. Roche contended that for anticipation what had to be enabled was the very thing disclosed in the prior art. It argued that this was supported by decisions of the Boards of Appeal of the EPO and the summary in the EPO's Case Law textbook (2016 edition). Although the cases in which the point had been decided were about prior use, Roche submitted the same principle applied to documentary prior art. Roche also argued that if all the skilled person could produce was something different from the prior art then that was a matter to be addressed under the lack of inventive step, it was not concerned with novelty. Takeda did not agree with the basic submission and argued that as long as the prior art enabled the skilled person to produce something within the claim, the claim would be anticipated. Takeda argued that Synthon was authority for its case and to the extent they were inconsistent, the EPO decisions were wrong."
"The issue of law between Roche and Takeda concerned what exactly it was which had to be disclosed and enabled. The issue is really about enablement. Roche contended that for anticipation what had to be enabled was the very thing disclosed in the prior art. It argued that this was supported by decisions of the Boards of Appeal of the EPO and the summary in the EPO's Case Law textbook (2016 edition). Although the cases in which the point had been decided were about prior use, Roche submitted the same principle applied to documentary prior art. Roche also argued that if all the skilled person could produce was something different from the prior art then that was a matter to be addressed under the lack of inventive step, it was not concerned with novelty. Takeda did not agree with the basic submission and argued that as long as the prior art enabled the skilled person to produce something within the claim, the claim would be anticipated. Takeda argued that Synthon was authority for its case and to the extent they were inconsistent, the EPO decisions were wrong."
At paragraph [119] he observed that there is a clear line of authority in the EPO, starting from the Enlarged Board of Appeal's decision G1/92 Availability to the Public, that for a product which was on public sale to form part of the state of the art it must be possible for the skilled person to reproduce it without undue burden. The judge concluded at [130]:
"In my judgment the correct approach to prior use is as follows. The requirement of enablement is that whatever has been disclosed must be something the skilled person can use to produce a practical result (see Synthon paragraph 31 referring to Lord Reid in Van der Lely v Bamfords [1963] RPC 61 and also Synthon paragraphs 20 and 31 referring to Lord Westbury in Hill v Evans(1862) 31 L.J. Ch (NS) 457). In other words, in the case of a prior use, as long as the information the skilled person can obtain by analysing the old product is enough to enable the skilled person to put it to practical use by making their own version of that product, that second version is part of the state of the art and a patent claim which covers it would lack novelty."
He added at [134]:
"The same approach applies to documents. If a document published an amino acid sequence of an antibody and if the skilled person could make an antibody with that amino acid sequence, then a claim to that amino acid sequence lacks novelty. The fact that the document states that the amino acid sequence is of an antibody called "Antibody A" makes no difference. Nor does it matter that "Antibody A" will have had a particular glycosylation pattern which is unstated in the document and which a skilled person might never be able to reproduce because they can never know what it was. This makes no difference to the disclosure of the amino acid sequence as long as that disclosure is enabling,"
"In my judgment the correct approach to prior use is as follows. The requirement of enablement is that whatever has been disclosed must be something the skilled person can use to produce a practical result (see Synthon paragraph 31 referring to Lord Reid in Van der Lely v Bamfords [1963] RPC 61 and also Synthon paragraphs 20 and 31 referring to Lord Westbury in Hill v Evans(1862) 31 L.J. Ch (NS) 457). In other words, in the case of a prior use, as long as the information the skilled person can obtain by analysing the old product is enough to enable the skilled person to put it to practical use by making their own version of that product, that second version is part of the state of the art and a patent claim which covers it would lack novelty."
He added at [134]:
"The same approach applies to documents. If a document published an amino acid sequence of an antibody and if the skilled person could make an antibody with that amino acid sequence, then a claim to that amino acid sequence lacks novelty. The fact that the document states that the amino acid sequence is of an antibody called "Antibody A" makes no difference. Nor does it matter that "Antibody A" will have had a particular glycosylation pattern which is unstated in the document and which a skilled person might never be able to reproduce because they can never know what it was. This makes no difference to the disclosure of the amino acid sequence as long as that disclosure is enabling,"
Applying those principles, Mr Justice Birss considered each of the following:
a\) International Patent Application WO 2005/040221 A1 published 6th May 2005 ("Bihoreau");
b) The article by Shinkawa et al entitled "The Absence of Fucose but Not the Presence of Galactose or Bisecting N-Acetylglucosamine of Human lgGl Complex-type Oligosaccharides Shows the Critical Role of Enhancing Antibody-dependent Cellular Cytotoxicity" (2003) in the Journal of Biological Chemistry, Vol.278, No.5, Issue of January 31, pp 3466-3473, 2003;
c) The article by Ferrara et al entitled "The Carbohydrate at Fc?RIIIa Asn-162 An Element Required for High Affinity Binding to Non-Fucosylated IgG Glycoforms" published in The Journal of Biological Chemistry Vol.281, No.8 pp.5032-5036
d) A prior use by the company Novartis of chimeric monoclonal antibody known as basiliximab (trade name Simulect). This was advanced in the EPO opposition and supported by declarations given the numbers D57, D58 and D59.
a\) International Patent Application WO 2005/040221 A1 published 6th May 2005 ("Bihoreau");
b) The article by Shinkawa et al entitled "The Absence of Fucose but Not the Presence of Galactose or Bisecting N-Acetylglucosamine of Human lgGl Complex-type Oligosaccharides Shows the Critical Role of Enhancing Antibody-dependent Cellular Cytotoxicity" (2003) in the Journal of Biological Chemistry, Vol.278, No.5, Issue of January 31, pp 3466-3473, 2003;
c) The article by Ferrara et al entitled "The Carbohydrate at Fc?RIIIa Asn-162 An Element Required for High Affinity Binding to Non-Fucosylated IgG Glycoforms" published in The Journal of Biological Chemistry Vol.281, No.8 pp.5032-5036
d) A prior use by the company Novartis of chimeric monoclonal antibody known as basiliximab (trade name Simulect). This was advanced in the EPO opposition and supported by declarations given the numbers D57, D58 and D59.
At [158] he found that claims 1, 2 and 3 lacked novelty over Bihoreau, at [177] that claims 6 and 7 were novel over Shinkawa, at [184] that claims 1, 2 and 3 but not claims 6 and 7 were anticipated by Ferrara and at [194] that Simulect did not anticipate claim 2.
Obviousness
Art 56 of the EPC provides:
I have already mentioned above that the judge held that the skilled addressee would be a team at [29]. He said at [31] that the relevant common general knowledge would include:
"i) The use of monoclonal antibodies as therapeutic agents;
ii) How to make antibodies for therapy and for research relating to therapy;
iii) The biochemistry of antibodies - particularly glycosylation, its nature and importance, the various monosaccharides and oligosaccharide structures encountered;
iv) Immunology and in particular antibody effector functions; and
v) Techniques for analysing glycosylation."
He amplified his findings between paragraphs [32] and [50]. The prior art relied upon included Simulect and Bihoreau neither of which impressed the judge (see paragraphs [199] and [201]). At [202] his lordship said:
"Takeda's real case, supported by Prof Bertozzi, is based on an allegation of lack of technical contribution over Bihoreau and I will consider it in that context."
He added at [203]:
"The law is clear enough that a ground of invalidity exists which can be called different things including: lack of technical contribution, Agrevo obviousness, and failure to solve the technical problem. Depending on the facts one of these descriptions may be more apt in a given case than another but they are all getting at the same thing. I can do no better than refer to the decisions of the Technical Board of Appeal of the EPO in EXXON/Fuel Oils T 409/91 and Agrevo/Triazoles T 939/92. The general principle there identified is that the extent of the patent monopoly, as defined by the claims should correspond to the technical contribution to the art. This theme – that the patent monopoly should be justified by the actual technical contribution to the art – has often been referred to with approval in the UK, most recently in the two recent Supreme Court decisions: Warner-Lambert v. Generics (UK) Ltd t/a Mylan [2018] UKSC 65 and Actavis v ICOS Corp [2019] UKSC 15."
"The law is clear enough that a ground of invalidity exists which can be called different things including: lack of technical contribution, Agrevo obviousness, and failure to solve the technical problem. Depending on the facts one of these descriptions may be more apt in a given case than another but they are all getting at the same thing. I can do no better than refer to the decisions of the Technical Board of Appeal of the EPO in EXXON/Fuel Oils T 409/91 and Agrevo/Triazoles T 939/92. The general principle there identified is that the extent of the patent monopoly, as defined by the claims should correspond to the technical contribution to the art. This theme – that the patent monopoly should be justified by the actual technical contribution to the art – has often been referred to with approval in the UK, most recently in the two recent Supreme Court decisions: Warner-Lambert v. Generics (UK) Ltd t/a Mylan [2018] UKSC 65 and Actavis v ICOS Corp [2019] UKSC 15."
The judge considered the disclosures of the patent and compared them to what was already known and concluded at [225] that the case of invalidity based on lack of technical advance was made out.
Insufficiency
Art 78 of the EPC provides:
The judge set out the issues relating to insufficiency at [226]:
"i) A free standing issue, added during trial, relating to the rival approaches to calculating the amount of fucose;
ii) A kind of classic "it can't be done" kind of argument which is really a squeeze;
iii) A claim breadth argument which is a counterpart of the technical contribution case;
iv) An ambiguity type insufficiency concerned with how the skilled person works out whether a product is within the claim or not."
The judge rejected Takeda's arguments relating to the first three arguments but accepted the fourth. In his view, the claim was truly ambiguous and invalid (see paragraph [254]).
Comment
Comment
This case is likely to be read and cited in skeleton arguments for the judge's approach to novelty - particularly enablement - and lack of technical contribution. Anyone wishing to discuss this case or patents generally should call me on 020 7494 5252 or send me a message through my contact form.
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