Fibrogen Inc. v Akebia Therapeutics Inc.
| Jurisdiction | England & Wales |
| Judge | Lord Justice Birss,Sir Christopher Floyd,Lord Justice Phillips |
| Judgment Date | 24 August 2021 |
| Neutral Citation | [2021] EWCA Civ 1279 |
| Docket Number | Case No: A3/2020/0895 and A3/2020/0893 |
| Court | Court of Appeal (Civil Division) |
[2021] EWCA Civ 1279
Lord Justice Phillips
Lord Justice Birss
and
Sir Christopher Floyd
Case No: A3/2020/0895 and A3/2020/0893
IN THE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERTY LIST
PATENTS COURT
Lord Justice Arnold
HP-2018-000036 and IL 2019-000031
Royal Courts of Justice
Strand, London, WC2A 2LL
Tom Mitcheson QC and Joe Delaney (instructed by Carpmaels & Ransford LLP) for FibroGen
Justin Turner QC, Kathryn Pickard and Michael Conway (instructed by Potter Clarkson LLP) for Astellas
Iain Purvis QC, Piers Acland QC and Anna Edwards-Stuart (instructed by Hogan Lovells) for Akebia and Otsuka
Hearing dates: 8th, 9th and 10th June 2021
By Teams
Approved Judgment
This appeal relates to six patents belonging to FibroGen and exclusively licensed to Astellas. The patents relate to the use of medicines known as HIF-PH inhibitors for the treatment of anaemia. Astellas obtained the first marketing authorisation for a HIF-PH inhibitor for this disease in Japan in 2019. The authorisation was based on FibroGen's and Astellas' roxadustat product, which it hopes will turn out to be a blockbuster ($1 billion sales) by 2023.
Akebia and Otsuka together have a rival HIF-PH inhibitor which is in clinical trials for anaemia. It is called vadadustat. The proceedings in this jurisdiction began with a claim for revocation of the patents brought by Akebia and Otsuka together against FibroGen as patentee. Astellas as exclusive licensee then brought a claim for quia timet infringement against Akebia and Otsuka, contending that the launch of vadadustat would infringe. As patentee, FibroGen was joined as a defendant to that claim. Before this court FibroGen and Astellas make common cause and the patentee's/licensee's side of the case can simply be referred to as FibroGen. Also Akebia and Otsuka make common cause and so it is convenient to refer to the side contending for invalidity and non-infringement as Akebia.
The patents form two families. Family A, based on application WO 03/053997 (“WO 997”), consists of EP (UK) 1,463,823, EP (UK) 2,289,531 and EP (UK) 2,298,301. Family B, based on application WO 2004/108121 (“WO 121”), consists of EP 1,633,333, EP (UK) 2,322,153 and EP (UK) 2,322,155. The earliest claimed priority date for Family A is 6 December 2001. WO 997 was published on 3 July 2003. It is common ground that the validity of the Family B patents should be assessed as at its second claimed priority date of 29 April 2004. Thus WO 997 is full prior art with respect to the Family B patents.
There are two kinds of anaemia – CKD anaemia and ACD. CKD anaemia is a chronic condition associated with kidney disease, the abbreviation standing for Chronic Kidney Disease. ACD is different and the abbreviation stands for Anaemia of Chronic Disease. Broadly speaking the claims of the Family A patents all relate to a class of compounds defined in structural and functional terms for use in the treatment of CKD, while the claims of the Family B patents relate to the same compounds, but for the treatment of ACD. Nevertheless, although the claims of Family A relate to CKD, the content of the Family A application WO 997 includes some material relating to ACD as well, which gives rise to difficulties for the later Family B patents. Moreover, to be precise not all claims in the Family A include a limitation to chronic kidney disease, e.g. claim 17A of EP 531 does not do so, but nothing turns on that for present purposes.
In addition to the claims based on classes of compounds, there are two claims which relate to single compounds. In Family A it is claim 17A of EP 531, which relates to a compound called Compound C. In Family B it is claim 36A of EP 333 which relates to the same compound.
Akebia alleged the Family A patents were invalid for lack of inventive step and insufficiency. The inventive step challenge was that the use of Compound C was obvious over prior art called Epstein. If that case succeeded then, subject to a conditional application to amend the broad claims, all the claims in the unconditionally amended form before the court would be invalid. There was also an Agrevoobviousness case which corresponded to the insufficiency arguments but there was no wider obviousness case based on prior art advanced by Akebia against Family A. On the other hand the insufficiency objection was advanced across the board, contending that all the claims (save for the claim based on Compound C alone) were invalid on the grounds of excessive claim breadth on the basis of a lack of plausibility and of undue burden. There was also a specific point based on uncertainty taken against claims which included the requirement that a compound had to be a “structural mimetic of 2-oxoglutarate”.
On infringement of Family A there were two questions: whether vadadustat was a compound within the wider claims on a normal construction, and whether for the claim limited to Compound C (claim 17A of EP 531) vadadustat infringed that claim by equivalence. (The same equivalence was alleged relating to claim 36A of EP 333 in Family B.)
In relation to Family B the inventive step challenge was based on WO 997 and advanced against all claims. The insufficiency case was the same as the one against Family A, in other words it applied to all claims save the one which was limited to the single compound alone (claim 36A of EP 333).
FibroGen brought a quia timet infringement case related to Family B. The point was that the current clinical trials for vadadustat are aimed at CKD and the current draft marketing authorisation, if granted, would authorise the use of vadadustat for the treatment of CKD. It would not authorise use for treating ACD. However FibroGen contended that for various reasons it was possible to conclude that Akebia were today threatening and intending to market vadadustat in the future in a manner which would infringe the ACD based Family B patents under s60(2) of the Patents Act 1977.
At the trial there was extensive expert evidence relating to nephrology, medicinal chemistry and clinical practice. The judgment below had to grapple with all the issues identified above, putting them into context with the technical background and the common general knowledge. As one would expect from a judge of Arnold LJ's experience, the judgment is well structured and closely reasoned. The conclusions on the matters in issue are summarised at the end (paragraph 640). The conclusions are that the Family A patents are not obvious over Epstein but all the relevant claims of Family A both lack plausibility and cannot be performed across their scope without undue burden, and therefore are invalid for insufficiency (and would be Agrevo obvious for the same reason). The uncertainty insufficiency attack also succeeds. On infringement vadadustat is found to be within the relevant chemical definition (Formula I) and so the wide Family A claims would be infringed by vadadustat on a normal construction if they were valid. The equivalence infringement case based on claim 17A of EP 531 is rejected. On Family B, the obviousness attack based on WO 997 succeeds. In addition the relevant claims of Family B are insufficient for the same reasons as Family A. Finally on quia timet infringement, there was no current threat to infringe the Family B patents even if they were valid.
On appeal FibroGen challenges the conclusions on insufficiency (and Agrevo obviousness). This aspect of the appeal applies to both patent families (save for the claims in EP 531 and EP 333 which relate only to a single compound). FibroGen also appeals the conclusion that Family B is obvious over WO 997, arguing that the conclusion is inconsistent with the findings made in the course of rejecting the quia timet infringement case. By a Respondent's Notice Akebia challenges the conclusion that vadadustat is within Formula I. All these appeals are with the permission of the court below.
Thus before this court the conclusion that the Family A patents are not obvious over Epstein is unchallenged, as is the rejection of the equivalence case based on claims 17A or 36A and the finding of no threat to infringe the Family B patents. There is also no challenge to any of the conclusions on the skilled team, the extensive findings on common general knowledge at either priority date or the summary of the disclosure of the patents. It will be necessary to return to some of those issues below but for present purposes the best place to start is with the claims of Family A.
The claims of Family A
Although a variety of different claims were before the court, it is only necessary at this stage to set out two claims from Family A. I will start with what can be called claim 8A of EP 823, as dependent on claim 1 as unconditionally amended (judgment paragraph 155) and then move to claim 19A of EP 823 as dependent on claim 8A and unconditionally amended claim 2 (judgment paragraph 157). I will refer to these claims by shorthand as claim 8A and claim 19A even though a proper definition ought to retain the references to the claims on which they depend.
Claim 8A is set out below. I have added labels to the various parts for ease of...
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