Teva Pharmaceutical v Bayer and Others
| Jurisdiction | England & Wales |
| Judge | Sir Anthony Mann |
| Judgment Date | 08 December 2023 |
| Neutral Citation | [2023] EWHC 3276 (Pat) |
| Year | 2023 |
| Court | Chancery Division (Patents Court) |
| Docket Number | Case No: HP-2022-000029; HP-2022-000032; HP-2022-000034; HP-2023-000005; HP-2023-000006; HP-2023-000017 |
[2023] EWHC 3276 (Pat)
Sir Anthony Mann
Case No: HP-2022-000029; HP-2022-000032; HP-2022-000034; HP-2023-000005; HP-2023-000006; HP-2023-000017
IN THE HIGH COURTS OF JUSTICE
BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERLY LIST (CHD)
PATENTS COURT
The Rolls Building,
7 Rolls Buildings,
Fetter Lane,
London, EC4A 1NL
Ms Anna Edwards-Stuart AND Mr. Adam Gamsa (instructed by Bristows LLP for Teva; Pinsent Masons LLP for Sandoz & Accord; Taylor Wessing LLP for Viatris; Penningtons Manches Cooper LLP for Cipla; HGF Law LLP for Amarox; Pinsent Masons LLP for STADA; Bristows LLP) for the Claimant.
Ms. Alice Hart (instructed by Allen & Overy LLP) for the Defendants.
APPROVED JUDGMENT
This is an application by the one of the claimants in this managed litigation (Teva) against the defendant, Bayer, for the production of a document which it is inferred exists in the form of presentation slides, acetates and/or handouts said to have been used for the purposes of a presentation at an American conference of scientists, the ACS Conference, which took place from 22–26 August 2004. Bayer does not deny that the document exists, though it has not admitted either. It does not claim that it does not have it, or cannot easily get it, or that it is confidential, although one of Bayer's main points is that it is not probative of any issue in the case and therefore irrelevant. It would seem that the production of this document would easily be achieved, but rather than take the simple cost-effective course of producing it, Bayer has chosen to spend £39,000 by way of costs in resisting the application. Its evidence reveals that it seeks to stand on some point of principle. I return to this attitude below, but in the light of Bayer's resistance, I therefore have to decide the point.
The application is brought within this present action, which is one of several actions, managed together as I understand it, in which various generic drug manufacturers challenge a patent of Bayer with the number EP UK 1845961B. They are all claimants, and as I understand it Teva is the particular claimant put up to make this application which, if successful, will operate for the benefit of all of them. The patent relates to a drug, which is now known as rivaroxaban and claims a particular dosage regime. Its priority date is 31st January 2005. The actual chemical compound in the drug was disclosed publicly in an earlier patent in 2001, but that patent said nothing, or nothing relevant, about a dosage regime. The actual compound is identified below and at this stage I need say no more about it than to observe that the drug is an antithrombotic drug and seems to be accepted as being a blockbuster drug; hence the interest of the generics and the great importance of this action, or these actions, to the parties.
One of the grounds on which revocation of the patent is sought is obviousness, stemming from one piece of prior art, which is a poster publication known as Harder. This poster, published by individuals, some whom were Bayer employees, refers to a compound known to be a Bayer antithrombotic compound, but identified in that poster only by the code BAY 59-7939. The poster contains what can be described as the start of the journey by the skilled addressee, which requires the identification of the BAY 59-7939 compound by the nature of its chemical structure. The chemical structure was not apparent from the poster. However, at the presentation in question, a Bayer scientist, Dr. Roehrig, apparently identified the compound known as BAY 59-7939 by reference to and identifying its chemical structure. That much is admitted by Bayer.
That is not entirely sufficient for the entirety of the claimant's obviousness attack. The claimant does not stop at that identification. Its obviousness case, or part of it, depends on it being able to establish that if Bayer, or Dr. Roehrig, if asked herself, were asked before or even after the presentation what the chemical structure of BAY 59-7939 was, then Bayer (or Dr Roerhig) would have told it. This point, so far as a pleading about what Bayer would have done, is a pleaded point, and this has been met in the evidence. The point about asking Dr. Roehrig specifically is not pleaded.
This train of inquiry point is a live point at the forthcoming trial, which is fixed for January of next year. It might be thought that if Bayer had given its product a code name in the Harder poster, it would be unwilling to disclose the chemical structure of BAY 59-7939 at the time, but that is a point for the trial. However, it is accepted by Bayer that at the ACS conference, Dr. Roehrig, in terms, identified the BAY 59-7939 chemical compound as being the Bayer compound previously disclosed in 2001, and now, but not then, known as rivaroxaban.
Despite that, Bayer pleads that it denies “that this factor is not otherwise treated as confidential.” In other words, it seems to be averring that the identification of the chemical structure of BAY 59-7939 at the conference was still confidential, notwithstanding the apparent publication of that identity by one of its own employees at the conference. Whether that is a justifiable stance is again a matter for the trial.
The confidentiality point goes to the question of whether Bayer would have disclosed to an enquirer what the identity of BAY 59-7939 was if asked, which, as I indicated, is one of the questions arising on the pathway (or one of the pathways) to obviousness. The likelihood of that is plainly a question which arises in the proceedings and which Bayer has addressed in a particular witness statement, as will appear shortly. It is to that likelihood that the disputed document is said to go, potentially.
Precisely what was disclosed in the presentation, and how, is not known from third party evidence. The reason that Teva seeks the presentation documents is because it says they are capable of going to just how confidentially Bayer was then treating the identity of BAY 59-7939. It is said, by way of example, that if the slides contain the pictorial description of the compound as a sort of logo or freeform backdrop then that will support the case that Bayer had by then dropped any notion of confidentiality, which in turn would go to the likelihood of Bayer telling an enquirer what the chemical structure of the compound was, if asked. In other words, the manner of the presentation, judged by the physical material shown or presented, will bear on the question of the likelihood of Bayer disclosing the identity again. It is also suggested that if, as is said to be at least possible if not likely, the presentation invited post presentation questions to be addressed to Dr. Roehrig by e-mail or paper mail, then that would go to the same question.
One of the things I have to decide is whether or not the document is relevant to any issue at all, or is likely to be probative, a test suggested by Ms. Hart, who appeared for Bayer. The chain of reasoning to which it is said to relate is clearly pleaded and is clearly an issue. There is a dispute as to whether the pleadings allow reliance on putative requests of Dr. Roehrig, as opposed to Bayer generally, but that is not an issue I have to decide. There is at least a pleaded issue to which the document might go so far as the Bayer question/answer is concerned. Then there is the question of whether this document, whose contents are obviously not known to Teva at the moment, is likely to be probative on that issue. I consider the likelihood to be thin, but not in the realms of pure speculation, or at least not so far into those realms that disclosure of the document should not be ordered on the grounds of lack of probative value if it would otherwise be ordered.
It will be convenient to deal at this point with another point made by Ms. Hart, which is that the existence of the document as a matter of inference is purely speculative and its existence is not supported by any evidence. This submission plainly fails. Many entirely proper applications for disclosure relate to documents which the seeking party does not actually know to exist for certain, but which it is reasonable to infer to exist. That is commonplace.
In the context of this particular document, there is no difficulty in an inference that the document is likely to exist. The presentation is known to have been entitled “Discovery of the novel antithrombotic agent BAY 59-7939, an orally active Direct Factor Xa inhibitor” and was apparently a serious presentation intended for serious chemists. It is highly likely that it would have been accompanied by some form of physical presentation, whether in the form of computer-presented slides, acetates or documentary handouts, or perhaps a combination of those. One would expect that at a serious conference, and as Ms. Edwards-Stuart (who appeared for Teva) pointed out, it is very hard to see how the identity of the compound can have been communicated without some form of physical presentation. The full name of the compound is:...
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