The new and noteworthy decision T 670/20 by Technical Board of Appeal 3.3.07 provides more legal certainty for patentees of formulation patents.
The proprietors of pharmaceutical formulation and pharmaceutical use patents do often not have it easy, if and when – as is often the case – they have conducted clinical trials before the priority date of their patent. Let me leave 2nd medical use patents for another post and focus on pharmaceutical formulation patents for the moment. The owners of such patents are nowadays quite regularly confronted with the argument that their patents lacks novelty, because the patented formulation had already been used in clinical trials before the priority date and thereby become publicly available. Opponents usually refer to T 7/07 to support their case. In this decision it was held that the sponsor of the clinical trial concerning an anti-baby pill had 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.
Conversely, in T 670/20 the Board clarified that T 7/07 was limited to its particular circumstances and that clinical trials that were set up so that the patients had to return unused medication do generally not render the formulation public, even if the patients were allowed to take the medication home. The patients in case T 670/20 were under the obligation to take the tablets according to a prescribed scheme and to prepare respective documentation. The TBA held that under these circumstances the patients did not represent the public and the tablets were not prior art.
The Board summarized its findings in the following catchword:
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. (see section 4.3)
The appellants 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 Board did not accept this argument, though. An obligation is an obligation, irrespectively of any sanction on non-compliance. The Board further held that “the possibility of non-compliance to the instructed use an return of the tablets by the participating patients does not affect the essence of this agreement.”
This new decision might provide some relief to patent proprietors in this field, at least to the extent that “standard” clinical trials are concerned. Nonetheless, it goes without saying that each case will be decided on its own merits. Thus, it is unlikely that this decision will settle this question once and for all times.
(Disclosure: Members of the author’s law firm represented the patentee in this case)
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For once I do not agree with Mr Bausch and consider the argumentation of the board not convincing.
There is a decision other than T 7/07 which seems as much, if not more, relevant than the latter.
It is T 239/16. This decision also deals with clinical tests and comes to the conclusion that the mere fact that when patients are encouraged to discuss their participation to a clinical test with family members and their family doctor they have to be considered as members of the public. This was also the case here.
In T 239/16, there was no obligation to return unused medicines. Therefore, I would at best consider this criteria determining if the patent holder would bring the proof that the unused medicament had indeed been returned.
If there is no sanction for not returning the unused médicaments, the mere theoretical possibility of this obligation in the EMEA test guidelines appears insufficient to exclude patients participating in a study from being members of the public.
On the balance of probabilities there is no reason to believe that patients will always return unused medicaments.
After all, it is not for nothing that Art 63(2,b) provides for the extension of the patent term by a SPC.
If an applicant/proprietor takes the risk to carry out clinical testing before the priority or filing date he is fully aware of what he is doing, and the EMEA Guidelines are not allowing participating patients not to be considered members of the public.
Coming on the market early represent a definite advantage, but T 239/16 and T 7/07 show that there is a non-negligible risk.
T 239/16 is not so old that the board in T 670/20 could not be aware of it.
Those diverging decisions in similar situations show that not only on procedural matters but also in substantial matters boards seem to consider themselves free of what other boards might have decided.
It is a pity that reliability and predictability suffer for this reason.
I can however agree with Mr Bausch that T 670/20 has not settled the matter!
“The proprietors of pharmaceutical formulation and pharmaceutical use patents do often not have it easy, if and when – as is often the case – they have conducted clinical trials before the priority date of their patent.”
Why would a proprietor not file a patent application on hist stable formulation before even designing a clinical trial, let alone starting it?
Likely because he knows that the formulation as such would be an obvious alternative, unless of course he tells the story that it is the selection of that specific formulation which allowed for the success in the therapeutic treatment, and by this trick makes the formulation so very unobvious…
I admit this case seems free of such intertwining, but your introductory statement made me recall the case of the fulvestrant formulation for use in treatment…
For readers‘ benefit, this case was decision T 1680/17, where the problem underlying T 860/20 did not come up, though.
One of many real-world problems in this field is that there are compounds that are notoriously difficult to formulate and you only know whether your formulation really works once you have tried it out in patients or at least healthy volunteers.
Prompted by comments in Le Blog from Laurent Teysseidre and in my own blog, I have had an even deeper look in the matter.
The Phase IIa clinical trials described in D19 (606 participants) were conducted in the USA between January 2005 and December 2005. The Phase IIb clinical trials described in D20 (903 participants) were conducted in the USA between May 2006 and June 2007.
The Phase IIa trials took place before the priority application was filed and the Phase IIb trials took place partly before the priority date. As the priority is not validly claimed, the Phase IIa and IIb trial reports did take place before the filing date. Document D29 (Protocol redacted from D19) is dated 18.10.2004 and D30 (Protocol redacted from D20) is dated 14.03.2007.
Document D21 which is the Assessment Report published by the European Medicines Agency regarding Lixiana (Edoxaban) EMA/321083/2015. (see page 15, line 8) indicates that the formulation of edoxaban studied during the clinical studies described in documents D19 and D20 was the same as the one used for marketing. The MA application dates from 07.01.2014 and is based on the phase Iia and IIb clinical trials.
It happens that the proprietor is a Japanese Company and the clinical tests have been carried out in the US. See D19 and D20.
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. 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.
With all due respect, a formulation that has been approved to be tested in humans has already been demonstrated to work with a sufficient probability to make it plausible under the EPC. Hence this argument doesn’t seem to take you very far.
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