Sandoz Ltd v Bristol-Myers Squibb Holdings Ireland Unlimited Company
| Jurisdiction | England & Wales |
| Judge | Lord Justice Arnold,Lord Justice Nugee,Lord Justice Warby |
| Judgment Date | 04 May 2023 |
| Neutral Citation | [2023] EWCA Civ 472 |
| Docket Number | Case Nos: CA-2022-001183, 001203 |
| Court | Court of Appeal (Civil Division) |
and
[2023] EWCA Civ 472
Lord Justice Arnold
Lord Justice Nugee
and
Lord Justice Warby
Case Nos: CA-2022-001183, 001203
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 (ChD),
PATENTS COURT
Mr Justice Meade
Royal Courts of Justice
Strand, London, WC2A 2LL
Daniel Alexander KC and Anna Edwards-Stuart (instructed by Hogan Lovells International LLP and Wilmer Cutler Pickering Hale and Dorr LLP) for the Appellant
Michael Tappin KC, Stuart Baran and Alice Hart (instructed by Bristows LLP) for Sandoz
Justin Turner KC and Thomas Lunt (instructed by Pinsent Masons LLP) for Teva
Hearing dates: 19–20 April 2023
Approved Judgment
Introduction
This appeal requires this Court once again to consider the concept of plausibility when determining the validity of a patent. This is a concept which is not mentioned in either the European Patent Convention or in the provisions of the Patents Act 1977 which give effect to the EPC, yet over a period of nearly 30 years it has come increasingly to the fore in discussions of validity, resulting very recently in a decision of the Enlarged Board of Appeal of the European Patent Office in Case G 2/21 (not yet reported, 23 March 2023). This is the first occasion on which the courts of this country have had to consider that decision. It is also a case in which the question as to the role of plausibility is posed very starkly, because it concerns a claim to a single chemical compound per se.
The Defendant (“BMS”) was the proprietor of European Patent (UK) No. 1 427 415 entitled “Lactam-containing compounds and derivatives thereof as factor Xa inhibitors” (“the Patent”), which expired on 16 September 2022, and is the proprietor of UK Supplementary Protection Certificate No. SPC/GB11/042 (“the SPC”) based on the Patent, which expires on 19 May 2026. The claims of the Patent relate to a compound called apixaban, marketed by BMS under the trade mark Eliquis pursuant to a marketing authorisation granted on 20 May 2011, which is used to treat thromboembolic disorders. The Claimants (“Sandoz” and “Teva”) contend that the Patent is invalid, and therefore the SPC is invalid. There is no challenge to the claimed priority date of 21 September 2001.
Apixaban's use in therapy depends on its activity as a factor Xa inhibitor. It is not in dispute that apixaban has subsequently proven to be a potent factor Xa inhibitor and a useful therapeutic for thromboembolic disorders, but the Claimants contend that the Patent is invalid because the specification did not make it plausible that apixaban would have any useful factor Xa inhibitory activity. It is common ground that, if and to the extent that plausibility is required, it should be tested by reference to the application for the Patent, published as WO 03/026652 (“the Application”), because if plausibility arose from something that was only in the Patent and not in the Application, the Patent would be invalid for added matter.
The Claimants contend that, due to lack of plausibility, the claimed invention made no technical contribution to the art and was therefore both lacking an inventive step and insufficiently disclosed. It is common ground that it makes no difference to the outcome whether the issue is viewed as one of inventive step or one of sufficiency.
The judge held that the Patent was invalid. BMS appeals with permission granted by Lewison LJ. The scope of the issues on the appeal is rather narrower than it was before the judge since the Claimants do not pursue a secondary ground of attack on the validity of the Patent and BMS does not pursue some of the strands of the case on plausibility it advanced before the judge.
The law
Article 52(1) EPC provides that European patents “shall be granted for any inventions” provided that (among other things) they “involve an inventive step”. Article 56 provides an invention “shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art”. Article 83 requires that an application for a European patent “shall disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art”. Article 100 provides the grant of a European patent may be opposed on grounds that include lack of patentability under Article 56 and failure to comply with Article 83. Article 138(1) provides that a European patent may be revoked with effect for a Contracting State by the courts of that State on grounds that again include lack of patentability under Article 56 and failure to comply with Article 83. Sections 1(1)(a), 3, 14(3) and 72(1) of the 1977 Act give effect in the United Kingdom to Articles 52(1), 56, 83 and 138(1) EPC. None of those provisions mentions the criterion of plausibility. It has been developed through the case law initially of the Boards of Appeal of the EPO and latterly of the courts of the Contracting States including the UK.
Case law of the Boards of Appeal prior to G 2/21
Since 1995 there have been many decisions of the Boards of Appeal in which the concept of plausibility (or credibility) has been invoked. It is neither feasible nor necessary to review all of them. It is sufficient for present purposes to mention five of the key cases. Before doing so it may help to explain that a recurrent issue in such cases is whether the patent applicant or proprietor can rely upon “post-published” evidence (i.e. evidence post-dating the filing of the application for the patent) as either demonstrating or supporting a technical effect asserted in the application.
In T 939/92 Agrevo/ Triazoles [1996] EPOR 171 the patent application claimed chemical compounds consisting of a class of triazole derivatives defined by reference to a Markush formula. The specification asserted that all these compounds had herbicidal activity, but it only contained test results for some of the compounds. The application was refused by the Examining Division, and the applicant appealed. The main issue on the appeal was whether the claims complied with the requirement for an inventive step in accordance with Article 56 EPC. In its decision the Board of Appeal began its consideration of this issue by observing:
“2.4.2 … it has for long been a generally accepted legal principle that the extent of the patent monopoly should correspond to and be justified by the technical contribution to the art …. Now, whereas in both the above decisions this general legal principle was applied in relation to the extent of the patent protection that was justified by reference to the requirements of Articles 83 and 84 EPC, the same legal principle also governs the decision that is required to be made under Article 56 EPC, for everything falling within a valid claim has to be inventive. If this is not the case, the claim must be amended so as to exclude the obvious subject-matter in order to justify the monopoly.”
Having referred to the problem-and-solution approach adopted by the Boards of Appeal to the assessment of inventive step, the Board said at [2.5]:
“… if the claimed compounds were to be assumed not to have any technically useful property, then it could be postulated that the technical problem which is solved by the claimed compounds (or, in other words, the technical result achieved by them, on the basis of which the question of inventive step has to be decided), would be the minimalist one in such a situation, namely the mere provision of further (or alternative) chemical compounds as such, regardless of their likely useful properties.”
Although the Board was not convinced that, in the absence of any technically useful properties, the claimed compounds could be regarded as being a technical invention at all, it nevertheless considered whether the person skilled in the art would have considered the claimed compounds to be a solution to that problem. The applicant argued that, even on the basis of known starting compounds and known synthetic methods, the skilled person would have faced an unlimited number of possibilities for solving this problem, and that a particular selection from that unlimited number was inventive, even if it was arbitrary, unless there was a direct pointer to the preparation of these particular compounds in the prior art. The Board rejected this argument for the following reasons:
“2.5.3 … The answer to the question as to what a person skilled in the art would have done depends on the result he wished to obtain, as explained in point 2.4.2 above. If this result is only to be seen in obtaining further chemical compounds, then all known chemical compounds are equally suitable as the starting point for structural modification, and no inventive skill needs to be exercised in selecting, for instance, the compound of formula XIV of [prior art citation] D3 for this purpose. Consequently, all structurally similar chemical compounds, irrespective of their number, that a skilled person would expect, in the light of the cited prior art, to be capable of being synthesised, are equally suitable candidates for solving such a hypothetical ‘technical problem’ to the skilled person, and would therefore all be equally ‘suggested’ to the skilled person. It follows from these considerations that a mere arbitrary choice from this host of possible solutions of such a ‘technical problem’ cannot involve an inventive step … In...
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Case Analysis: Sandoz And Teva v Bristol Myers Squibb ' Court Of Appeal
...read for pharmaceutical companies, and the timing of claiming to have invented a drug. Sandoz and Teva v Bristol-Myers Squibb [2023] EWCA Civ 472 Case BMS obtained a patent for lactam-containing compounds as a factor Xa inhibitor, which reduce the risk of blood clots and treat thromboemboli......