The Appeal - Sandoz v Bristol Myers Squibb
This was an appeal by Bristol Myers Squibb Ireland ("BMS") against Mr Justice Meade's judgment in Sandoz Ltd and another v Bristol-Myers Squibb Holdings Ireland (Unlimited) Company [2022] EWHC 822 (Pat) (7 April 2022) which I discussed in Patents - Sandoz Ltd v Bristol-Myers Squibb on 28 Aug 2022. In that judgment, his lordship held that European patent (UK) 1 427 415 B1 (“the patent”) was invalid for lack of plausibility and technical contribution. Permission to appeal against Mr Justice Meade's judgment was granted by Lord Justice Lewison. The appeal was heard by Lord Justices Arnold, Nugee and Warby on 19 and 20 April 2022. They handed down judgment on 4 May 202. Their lordships unanimously dismissed the appeal (see Sandoz Ltd v Bristol-Myers Squibb Holdings Ireland Unlimited Company [2023] EWCA Civ 472).
The Judgment
The lead judgment was delivered by Lord Justice Arbold. Lord Justice Nugee and Lord Justice Warby simply agreed with him.
Lord Justice Arnold's judgment divides as follows:
- Paras [1] to [5] contain an introduction
- Paras [6] to [53] an analysis of the law
- Para [54] the trial judge's finding on the skilled addressee
- Paras [55] to [58] the common general knowledge
- Paras [59] to [66] the closest prior art
- Paras [67] to [76] the application
- Paras [77] to [80] the claims
- Para [81] BMS;s case on plausibility
- Paras [82] to [87] Mr Justice Meade's judgment
- Paras [88] to [90] the grounds of appeal
- Paras [91] to [97] grounds (1) to (4)
- Paras [98] to [99] ground 5
- Paras [100] to [105] ground 6, and
- Para [106] his conclusion.
As I discussed most of the above issues and analysed Mr Justice Meade's judgment in some detail in my previous case note, there is no need for me to repeat them here.
Grounds of Appeal
"(1) The judge erred in law because, in the case of a claim to a single chemical compound, there is no requirement that the specification makes it plausible that the compound is useful. It is sufficient that the specification discloses the structure of the compound and a method of synthesis and contains an assertion of potential utility for the compound, provided that that assertion is not manifestly speculative or wrong.
(2) The judge erred in law because he applied the standard of plausibility laid down by the majority in Warner-Lambert when he should either have applied the standard advocated by the minority or applied the standard laid down by the majority less strictly.
(3) The judge erred in law because he wrongly held that it was not enough for the specification to encourage the skilled person to test the efficacy of the claimed compound and to identify simple tests which the skilled person could carry out for that purpose and which, if carried out, would confirm that the compound was likely to have the efficacy claimed for it.
(4) The judge erred in law or principle because he failed to stand back and consider whether the claimed invention fulfilled the "patent bargain".
(5) The judge erred in principle because he should have held that the Application contained an implicit disclosure that apixaban had a nanomolar Ki against factor Xa or (which comes to the same thing given the judge's finding as to common general knowledge) had a Ki which made it suitable for therapeutic use.
(6) The judge was wrong to hold that page 170 line 28-32 and Example 18 taken together did not make it plausible that apixaban was an effective factor Xa inhibitor."
Before considering those grounds, the lord justice noted that it was not BMS's case that the invention claimed in claim 1 of the Patent was merely a new chemical compound. It was that the compound was effective in treating thromboembolic disorders because it was subsequently found to be a factor Xa inhibitor.
Grounds (1) to (4)
Lord Justice Arnold took those grounds together because they were essentially alternative submissions
Earlier in his judgment, Lord Justice Arnold had reviewed the decision of the Enlarged Board of Appeal in Case G 0002/21 and the cases preceding that decision and the judgment of the Supreme Court in Warner-Lambert Company LLC v Generics (UK) Ltd (t/a Mylan) and another [2018] RPC 21, [2019] 3 All ER 95, [2019] Bus LR 360, (2019) 165 BMLR 14, [2018] UKSC 56 and the cases leading up to it. He said that it was common ground that the majority judgment in Warner-Lambert was binding on the Court at least in second medical use cases, and it had not been suggested that G 2/21 would justify the Court in departing from Warner-Lambert in a second medical use case.
Lord Justice Arnold took those grounds together because they were essentially alternative submissions
Earlier in his judgment, Lord Justice Arnold had reviewed the decision of the Enlarged Board of Appeal in Case G 0002/21 and the cases preceding that decision and the judgment of the Supreme Court in Warner-Lambert Company LLC v Generics (UK) Ltd (t/a Mylan) and another [2018] RPC 21, [2019] 3 All ER 95, [2019] Bus LR 360, (2019) 165 BMLR 14, [2018] UKSC 56 and the cases leading up to it. He said that it was common ground that the majority judgment in Warner-Lambert was binding on the Court at least in second medical use cases, and it had not been suggested that G 2/21 would justify the Court in departing from Warner-Lambert in a second medical use case.
There was, however, a factual difference between Warner-Lambert and the present case in that claim 1 of the Patent claimed a single chemical compound. The question was whether that factual difference enabled Sandoz to be distinguished from Warner-Lambert. The lord justice thought it could not. While acknowledging that the plausibility doctrine had been applied in cases like Case T 939/92 Agrevo/Triazoles [1996] EPOR 171 where multiple compounds had been claimed, the doctrine has also been applied in cases like T 0488/16 BMS/Dasatinib where the claimed invention was a single compound. As his lordship said at para ]92]. "the underlying principles are applicable as much to claims to single chemical compounds as to claims to classes of compounds and second medical use claims."
He continued:
"The fundamental principle is that the scope of the patent monopoly must be justified by the patentee's technical contribution to the art. This remains so whether the scope of the claim is broad or narrow. Thus when considering inventive step it is necessary to consider what technical problem the claimed invention solves. If it is not plausible that the invention solves any technical problem then the patentee has made no technical contribution and the invention does not involve an inventive step. Equally, when considering insufficiency it is necessary to consider whether the specification sufficiently discloses the claimed invention. If it is not plausible that the invention solves any technical problem then the patentee has made no technical contribution and the specification does not disclose any invention. It follows that, in order for a claim to a single chemical compound to be patentable, the application must make it plausible, when read in the light of the skilled person's common general knowledge, that the compound has the utility asserted for it. Moreover, it makes no difference whether the claim incorporates the use of the compound as a technical feature or whether the claim is simply to the compound per se and the assertion of utility is only to be found in the specification. This is because, as explained above, there is no invention in merely identifying a new chemical compound; invention can only lie in identifying its utility."
"The fundamental principle is that the scope of the patent monopoly must be justified by the patentee's technical contribution to the art. This remains so whether the scope of the claim is broad or narrow. Thus when considering inventive step it is necessary to consider what technical problem the claimed invention solves. If it is not plausible that the invention solves any technical problem then the patentee has made no technical contribution and the invention does not involve an inventive step. Equally, when considering insufficiency it is necessary to consider whether the specification sufficiently discloses the claimed invention. If it is not plausible that the invention solves any technical problem then the patentee has made no technical contribution and the specification does not disclose any invention. It follows that, in order for a claim to a single chemical compound to be patentable, the application must make it plausible, when read in the light of the skilled person's common general knowledge, that the compound has the utility asserted for it. Moreover, it makes no difference whether the claim incorporates the use of the compound as a technical feature or whether the claim is simply to the compound per se and the assertion of utility is only to be found in the specification. This is because, as explained above, there is no invention in merely identifying a new chemical compound; invention can only lie in identifying its utility."
As Sandoz could not be distinguished from Warner-Lambert, it followed that the criterion of plausibility must be applied when determining whether the claimed invention involved an inventive step and was sufficiently disclosed. For that reason, his lordship rejected ground (1). Addressing the proviso "that that assertion is not manifestly speculative or wrong", he added that he did not understand how it was possible to determine whether a claimed invention was speculative other than by assessing whether it was plausible as they are "two sides of the same coin."
Turning to the second ground of appeal, Lord Justice Arnold said that as the Supreme Court's judgment in Warner-Lambert as a whole was binding on the Court of Appeal it followed that the standard adopted by the majority of justices in that decision would also be binding. Although the Enlarged Board of Appeal used different language in Case G 0002/21, its reasoning was much closer to that of the majority than the minority. Accordingly, ground (2) was rejected.
At para [53] of his judgment in Warner-Lambert, Lord Sumption explained why "it is not sufficient for the application to encourage the skilled person to carry out simple tests identified in the specification to confirm the efficacy of the claimed product even if carrying out such tests would indeed show that the product is likely to be efficacious" as asserted in ground (3). Lord Sumption said at para [40] of his judgment in that appeal that subsequent data cannot be a substitute for sufficient disclosure in the specification. Even though the headnote to Case G 0002/21 states that "[e]vidence submitted by a patent applicant or proprietor to prove a technical effect relied upon for acknowledgement of inventive step of the claimed subject-matter may not be disregarded solely on the ground that such evidence, on which the effect rests, had not been public before the filing date of the patent in suit and was filed after that date", Lord Justice Arnold agreed with Mr Justice Meade that this did not support the appellant's argument. If anything "the Enlarged Board's insistence in G 2/21 on focussing on the technical teaching of the specification read with the common general knowledge confirmed Lord Sumption's view. His lordship, therefore, rejected ground (3).
Finally, there was nothing in Lord Sumption's judgment in Warner-Lambert to support BMS's contention that the trial judge should have stood back at the end of his evaluation and considered whether the claimed invention fulfilled the "patent bargain." Even if he had done so there was no reason to think that he would have come to a different conclusion. Fulfilling "the patent bargain" requires sufficient disclosure in the specification. Mr Justice Meade had made no error of law or principle in his approach to the assessment of plausibility. He applied Warner-Lambert and was right to do so. It followed that ground (4) also failed.
Finally, there was nothing in Lord Sumption's judgment in Warner-Lambert to support BMS's contention that the trial judge should have stood back at the end of his evaluation and considered whether the claimed invention fulfilled the "patent bargain." Even if he had done so there was no reason to think that he would have come to a different conclusion. Fulfilling "the patent bargain" requires sufficient disclosure in the specification. Mr Justice Meade had made no error of law or principle in his approach to the assessment of plausibility. He applied Warner-Lambert and was right to do so. It followed that ground (4) also failed.
Ground (5)
Lord Justice Arnold held that this was a new ground that has not been raised in the notice of appeal or even argued at trial and was unsupported by evidence. It would not have assisted BMS anyway because the trial judge had found that the application for the Patent did not impliedly disclose that the compound had been tested and had been found to have a particular medicinal quality. He rejected that ground.
Ground (6)
Ground (6) amounted to a bald assertion that the judge was wrong in his evaluation of plausibility. It was common ground that plausibility involves a multi-factorial evaluation that an appeal court is only justified in intervening if the judge has made an error of law or principle. BMS submitted that the judge had misinterpreted the evidence and that the Court could review his finding. Lord Justice Arnold accepted the submission and considered the trial judge's reasoning but could find no fault with it. He said at para [105]:
"It follows that the invention claimed in claim 1 of the Patent made no technical contribution to the art. It is irrelevant that BMS subsequently proved that the assertion was well founded and limited the claim to apixaban."
Ground (6) amounted to a bald assertion that the judge was wrong in his evaluation of plausibility. It was common ground that plausibility involves a multi-factorial evaluation that an appeal court is only justified in intervening if the judge has made an error of law or principle. BMS submitted that the judge had misinterpreted the evidence and that the Court could review his finding. Lord Justice Arnold accepted the submission and considered the trial judge's reasoning but could find no fault with it. He said at para [105]:
"It follows that the invention claimed in claim 1 of the Patent made no technical contribution to the art. It is irrelevant that BMS subsequently proved that the assertion was well founded and limited the claim to apixaban."
Accordingly, he rejected ground (6).
Comment
As Lord Justice Arnold said in para [1], this appeal was the first opportunity for a court in the UK to consider Case G 0002/21 which was decided only on 23 March 2023. At first blush, that decision seems to contradict Warner-Lambert at least in relation to evidence of a technical effect coming to light after the filing of a patent application. However, Lord Justice Arnold seems to have reconciled the two judgments.
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