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T 670/20 – Patients participating to clinical trials are not members of the public, even if they are under no obligation of secrecy

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The patent relates to a pharmaceutical composition (edoxaban) useful as an anticoagulant, which comprises a component that is improved in dissolution property.

Brief outline of the case

The patent was maintained by the OD according to a MR.

Both opponents appealed the decision.

The board considered that claim 1 as maintained was novel and inventive, although the priority was not valid.

In order to come to a positive assessment of the N, the board considered that participants to clinical tests were not members of the public.

Claim 1 of the MR was also considered inventive and the appeals were dismissed, i.e. the patent maintained according to the MR. When assessing IS the clinical trials were not taken into account.

Novelty and the clinical tests

It was not in dispute that clinical trials had started before the priority date claimed for the patent and that the trials concerned edoxaban tablets which were covered by the definition of claim 1 of the MR.

Clinical trials were described in documents D19 and D20 relating respectively to phase IIa and phase IIb clinical trials.

Tablets were provided to the patients discharged from hospital before the end of the treatment. This was not contested by the proprietor.

Opponents’ point of view

The opponents did not contest that the investigators involved in the trials were bound to confidentiality and could therefore not be considered as part of the public that had access to information regarding the internal structure of the used tablets.

The opponents did further not contend that the participating patients had actually been directly informed of the internal structure of the tablets under investigation.

The opponents argued that the patients participating in the trials were not bound by any confidentiality agreement, which was evident from the statements in documents D19 and D20 that patients were encouraged to discuss their participation with their doctor, relatives and friends (see D19/D20, under “Eligibility Criteria”).

According to the opponents it would actually be unethical to bind a patient to a duty of confidence that prevented them from discussing the trial with their doctor, family members or friends.

The opponents further argued that the patients may have been requested to return unused tablets, but that in the absence of any legal sanction no parallel to a confidentiality agreement could be assumed on such basis, especially as full compliance by all patients would not be likely.

The opponents brought forward T 7/07 which also dealt with clinical trials which were carried out before the priority date.

The board’s considerations

The assessment of the ground of lack of N in view of the trials described in documents D19 and D20 crucially depended on whether the participating patients who received the tablets are to be considered as members of the public who were free to dispose over the provided tablets and thus theoretically in a position to investigate the internal structure of the tablets.

The board held that the clinical trials were carried out in accordance with the EMEA Guidelines for Good Clinical Practice. These guidelines explicitly require adherence to the prescribed protocol and assurance of drug accountability. This set-up of the trials implies that the patients who decided to participate in the trials agreed, following their informed consent, to use the provided medication according to instruction or to return the unused medication.

Accordingly, the participating patients who were provided with the tablets under investigation entered into a special relationship with the investigators of the trials and were with regard to the provided tablets not members of the public that could freely dispose over these tablets.

The board acknowledged that the statements in documents D19 and D20 encouraging patients to discuss their participation in the trials indicates that the patients were not under a duty of confidence with respect to their participation to the trials and the information regarding the trial provided to them in that context.

The board found no reason why the absence of the patients’ duty of confidence with respect to the information relevant to their participation in the trials should affect the obligations of the participating patients regarding the use and return of the tablets provided to them, which resulted from their decision to participate in the trials.

The board noted, however, that the patients’ agreement to use the provided medication according to instruction or to return the unused medication obliges the patients irrespectively of any sanction on non-compliance and therefore disqualifies the patients as members of the public with respect to the medication provided to them.

The present board dismissed the argument based on T 7/07 in that it was of the opinion that in T 7/07 on the basis of the available information that apparently the sponsor of the trial had effectively lost control over the drugs after these had been handed out to the participants of the trial as members of the public who were not bound to secrecy.

In view of the evidence submitted, inter alia redacted protocols of the clinical tests and confidentiality agreements, the board concluded like the OD that the clinical tests were not public, contrary to what the opponents asserted.

Comments

In T 7/07, the proprietor did not contest that clinical trials were carried out prior to the priority date and that the principal investigators but not the participants entered into confidentiality agreements.

In T 7/07 the proprietor further argued that the drug had not become publicly available before the priority date as according to established board of appeal case law any persons involved in clinical trials are (implicitly) bound to confidentiality. The board denied that this case law existed in the generality asserted by the proprietor. .

In T 7/07, applying G 1/92 (OJ EPO 1993, 277), the board concluded that the composition of the product under trial was publicly available and therefore was not any longer novel.

Whilst it has been acknowledged in T 7/07 that not all of the unused study drugs were returned, nothing like this is known in the present case. On the balance of probabilities, it is difficult to consider that all the patients returned the unused tablets.   

In the present case the patients where encouraged to discuss their participation to the clinical trial with their doctor, relatives and friends.

It is therefore difficult to reconcile that on the one hand the present board considered the participants were not being bound by a secrecy agreement, even if it was about the participation to the trial, but on the other hand they were not members of the public because they were meant to have returned the unused tablets.

We have here again on the same basis two apparently totally different approaches to clinical trials carried out before the priority/filing date of the patent.

In this respect T 158/96, cf. the catchwords, in which phase I trials were mentioned in the prior art appears more convincing

I would not say that a referral to the EPA is due, but it appears that not only on procedural matters, but also in matters of substance, boards are quite diverging in their views. This not enhancing reliability and predictability.  

https://www.epo.org/law-practice/case-law-appeals/recent/t200670eu1.html

IMPORTANT UPDATE

While preparing the present post, I remembered seeing a decision which was related to the present situation. I could not find it at the time. I have now found it following the comments made.

In T 239/16, the situation was similar to the present one. There was a clinical study in which patients participated without any obligation of confidentiality.  

The essential question to be answered was therefore whether the recipients of D 55 = “Information for the patient concerning the study 42446 02 041” were to be considered members of the public within the meaning of Art 54(2). D55 was addressed to a number of patients suffering from osteoporosis who were asked to participate in said study.

D 57 was an affidavit signed by Prof. Verbruggen who was a clinical investigator for Novartis study 42446 02 041 and who followed a number of patients during the study.

It has not been argued by the proprietors that there was an explicit confidentiality agreement between the study sponsor and these patients or an obligation to maintain confidentiality (under national law).

For the board it remained to be seen whether there existed a special situation or some special relationship between the sponsor of the study and the patients having the consequence that the patients, as recipients of the information provided in D 55, could not be considered members of the public due to an implied obligation to maintain confidentiality.

From the information that can be gained from the affidavit it was clear that the patients participating in the study were actively encouraged to discuss the contents of D 55 with “anyone” including their family and family doctor.

For the board in T 239/16, it was established case law that if a single member of the public who is not under an obligation to maintain secrecy has the possibility to access particular information, this information is considered as being available to the public within the meaning of Art 54(2).

In view of the fact that D 55 was handed out to people who were encouraged to discuss its contents with anyone, the board came to the conclusion that the contents of D 55 have been made available to persons neither being bound by any confidentiality agreement nor being in a special relationship to the study sponsor who are thus to be classified as members of the public.

There was no apparent obligation to return unused medicaments. As soon as patients are allowed to discuss the study with anyone including their family members or their family doctor, they are members of the public.

Further comments

T 670/20 is thus in clear contradiction with T 239/16.

The fact that unused medicaments had to be returned does not allow to exclude patients participating to the study from being members of the public. This is the more so since no proof of this return has been given by the proprietor.

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Comments

11 replies on “T 670/20 – Patients participating to clinical trials are not members of the public, even if they are under no obligation of secrecy”

Anonymoussays:

Daniel, how would T158/96 be fairly applied to this situation in the decision discussed where the claim related to a product and was not purpose limited to effective treatment of a disease?

DXThomassays:

Dear Anonymous,

I personally think that G 2/88, OJ 1990, 093 (friction reduction additive) would be applicable. I refer to catchword 3:

A claim to the use of a known compound for a particular purpose, which is based on a technical effect which is described in the patent, should be interpreted as including that technical effect as a functional technical feature, and is accordingly not open to objection under Article 54(1) EPC provided that such technical feature has not previously been made available to the public.

This applies even if according to G 1/92, OJ 1993, 277 (availability to the public) the composition of a product can be analysed and reproduced by the skilled person, irrespective of whether or not particular reasons can be identified for analysing the composition.
I would argue that the composition does not necessarily gives away an effect, if this effect has not been publicly available according to G 2/88.

Apprenticesays:

Interesting decision!
Outside the context of clinical trials, any product which is sold is immediately available to the public and thus prior art under Art.54(2). T952/92.
Why would it be different in the context of clinical trials, particularly if the patients are not bound to confidentiality?
In simple terms, the patient carrying the drug in the pocket could find the drug composition using standard analytical techniques.
Of course, if the patient is found as a member of the public, this would make clinical trials set up much more complex or even impossible in some situations…

Avatar photoDaniel X. Thomassays:

Dear Apprentice,

Clinical trials are necessary for obtaining the authorisation to market a drug.
This is the reason why according to Art 63(2,b) the term of the patent can be extended by a Special Protection Certificate.

The protection mechanism via SPC is there not to oblige applicants to start clinical trials in the priority interval or even before the filing of the priority application. But a quick access to the market is a temptation difficult to resist.

What was critical in the present case is that clinical trials occurred in the priority interval.
This is a dangerous game, and it is possible to consider that the proprietor was conscious of the danger, but took a non-negligible risk.

I would go as far as to say that the board had a kind of “BGH (German Federal Court) attitude”, that means the patent has to be saved as much as possible.

The present board found in favour of the proprietor, but this case law is not cast in iron. Other boards could easily follow T 7/07.

Claiming that patients participating in the trial were not members of the public as they had to return the unused medicaments is not really convincing, at least in the absence of proof. The proof of returning the medicaments lies entirely in the hands of the proprietor and it is difficult to discharge him so easily from this burden of proof.

Apprenticesays:

I agree with you that it is not really convincing. Good to know about the German approach! 🙂
Thanks for the clarification, I always read and learn with your posts here.

francis hagelsays:

It is important to distinguish a availability to the public from possession (or potential possession by analysis or reverse engineering) of novelty-defeating information.

I think of another situation, very common in business relationships : information a company discloses to a third party without the coverage of a NDA but in the course of business relationship. Does the mere reception – and possession – of the information by the third party qualify as public disclosure ? My own view is that there is no public disclosure as long as there is no evidence that the third party has spread the information to the public in one way or another. But there may case law which states the contrary i.e. the “public” is any person not bound by confidentiality. Which I find too harsh on the applicant/patentee.

Concerning the context of the decision, the fact that patients have pledged to return the unused products could be an argument to conclude that a third party having received and reverse analysed the product would act in bad faith, in support of the decision.

Avatar photoDaniel X. Thomassays:

Dear Mr Hagel,

I agree with you that possession is to be distinguished from availability of the public.
Possessing an item does also not mean that you have acquired the property of the item.

Possessing an item without a NDA does however in my opinion render the object available to the public.
Only a NDA, which can be implicit, protects against the availability to the public.

If company A requests a quote to build a prototype from company B, I would consider that there is an implicit NDA.
Requesting from B a quote for manufacturing a large number of items, cannot be considered as implying a NDA.
There has been litigation on the property of an application/patent following such request for a quote without a direct or implicit NDA.

I would like to draw your attention to T 239/16 which takes the view that as soon as the patients were encouraged to discuss the clinical study with their family members and their family doctor, they have to be considered as members of the public.

https://www.epo.org/law-practice/case-law-appeals/recent/t160239eu1.html

I have added an update to my original post discussing T 239/16.
This decision as well as T 7/07 might harsh on the applicant/patentee, but they are logical and coherent.

The fact that unused medicaments had to be returned cannot lead to the participants of the clinical study to be excluded from the public.

A very interesting decision. I would actually rather agree with it. One reason is that in G1/92 already the headnote states it is public when the skilled person can analyse and reproduce the chemical compound. However, a trial participant alone is not able to analyse the composition of the drug. Also under his obligations he isn’t allowed to do so. So both analysing the drug or giving it to a third party would be in breach of his obligations. And if you say that it is unreasonable to believe that the participants would not retain the drug, it is also unreasonable that they would be able to anylse it, so arguing with a real life situation would mean you would have to accept both things. So I would rather agree with this decision.

Another thing that comes to my mind: What about Art. 55(1)a) EPC? As the analysis of the drug is in breach of his obligations, would it be reasonable to argue that it is an evident abuse if he would either analyse it or give it to someone to analyse it? I must admit I haven’t read the decision yet and don’t know if this was discussed (mea culpa!)

DXThomassays:

I can follow your argumentation but I remain of the opinion that if an applicant/proprietor decides to carry out clinical tests before the priority or filing date, he is fully aware of the risk he is taking and cannot prevail himself from legal niceties like non opposable disclosures.

Coming on the market before competitors is very valuable but not absolutely necessary in view of the possibility of obtaining a SPC.

Furthermore G 1/92 is applicable when the patient is allowed to discuss its participation to clinical tests. G 1/92 simply states that the possibility of analysis exists, not that it has been actually carried out.

T 670/20 is indeed an interesting decision, but we should not forget T 7/07 and the more recent T 239/16.

Max Dreisays:

I’m not seeing in this thread any discussion about the meaning and “reach” of an NDA. In particular, must it be i) in writing and ii) signed by the info receiver? Receivers (eg a senior employee in a big company) are often disinclined to sign an NDA even when they accept an obligation not to divulge the info further.

There is case law in the English courts under the EPC, for example. Judge Robin Jacob (I think it was) heard a case where a product developer showed a prototype to a retail chain buyer. The “objective” test whether that made the prototype available to ” the public” was the “fly on the wall” enquiry. Would that fly, following the progress of the meeting in the room, the discussion, the oral understanding reached, conclude that the receiver of the information was being given the info under a mutual understanding that it was not to be diviulged further? The subjective test is to ask the receiver whether she felt obligated not to divulge the info further.

Of course, there is then the issue who bears the burden of proof that the info was made “available” to a member of the public. Daniel do you continue with your strict line, i wonder, or might you be a bit more forgiving if the fact matrix favoured the inventor?

Anonymoussays:

Dear Max Drei,

T 670/20 has also been commented on Le Blog des Droits des Brevets

https://europeanpatentcaselaw.blogspot.com/2023/01/t67020-les-personnes-participant-aux.html

I have sent a last comment in French, which I will try to summarise.

It is an acquired fact that clinical tests of phase IIa (606 participants) and IIb (903 participants) have been carried out before the filing date as the priority was not valid.

It happens that the proprietor is a Japanese Company and the clinical tests have been carried out in the US. See D19 and D20.

It happens further that Japan and the USA have a grace period which is unknown in Europe.

I see here an explanation as to why the proprietor felt secure to carry out not confidential tests as usual but went into clinical tests of phase IIa and IIb of its medicament before the priority or the filing date.

The patients have never signed a NDA. That a NDA can be implicit is not at stake here.

In the situation of clinical tests requiring patients to sign a NDA is not acceptable from an ethical point of view. If this would be the case, the reservoir of patients willing to participate to clinical homologation tests would dry out very quickly.
Furthermore in the absence of a NDA, even implicit, G 1/92 applies fully as explained in T 7/07.

With 1500 participants, simply discharging the proprietor from the proof that all medicines were consumed or returned is not really acceptable. For me, it is the fact that there is an absence of sanctions for not returning the unused medicine which is determining.

That a proprietor might not be allowed to exploit its patent freely due to specific regulations does not mean a contrario that abiding by some administrative rules without any proof of it, renders the proprietor immune of its own actions carried out before the priority or filing date.
In some countries it might be the case, in Europe no.

In the present case, I am thus more inclined to follow T 7/07 and T 236/19 than T 670/20.

In general, I could agree with you that the situation has to be looked at it carefully and if there was not a written and signed NDA, a NDA could nevertheless be implicit.

On the other hand, G 3/98 and G 2/99 have made clear that even in case of an evident abuse in relation to the applicant or his legal predecessor, the time limit is 6 months from the filing date. Here there is certainly no abuse.

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