Tuesday, 22 November 2011

T 7/07 – Fatal Yasmin

The opponent filed an appeal after the Opposition Division had rejected the opposition.

There were several third party observations (A 115) pointing out that the claimed subject-matter had been made publicly available through clinical trials of the oral contraceptive Yasmin® carried out between 1996 and 1998.

There also was an intervention (A 105) following the institution of infringement proceedings in Lithuania. Unsurprisingly, this intervention was found not to be admissible.

In what follows, the Board discusses the question of whether the clinical trials are novelty-destroying for the claims under consideration:

[3.1] In April 2008 a third party, Stragen Pharma, submitted a copy of a judgement by the United States District Court for the District of New Jersey dated 3 March 2008 […]. The judgement concerns the validity of US Patent No. 6 787 531, that corresponds to the patent in suit in the present appeal. The third party claims inter alia that claims 1-5 and 16-19 lack novelty over a prior use reflected in the US decision, namely the conduct of clinical trials with contraceptives containing the composition claimed in the patent in suit in the present appeal. These trials took place in the US between December 1996 and July 1998, i.e. before the priority date of the contested patent (31 August 1999). The participants were informed of the ingredients but had not signed a confidentiality agreement, and not all unused drugs had been returned. The third party claimed that as a result the drugs had become publicly available.

[3.2] During the oral proceedings the [opponent] argued for the first time that the trials mentioned in the US decision establish a novelty-destroying public prior use. Although these arguments were brought forward at a very late stage, they are nevertheless admitted by the board as the allegation of a novelty-destroying prior use does not amount to a new ground for opposition, was as a result of the third-party observations known since April 2008, and has prompted the [patent proprietor] to present counter-arguments in its written submissions.

[3.3] The [patent 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. The participants were informed about the active agents of the contraceptive, but were not told that the drospirenone was present in micronised form. Nor did the [patent proprietor] contest that the oral contraceptive used for the study comprised all the features of the subject-matter according to claim 1.

It is established board of appeal case law that if a single member of the public, who is not under an obligation to maintain secrecy, has the theoretical possibility to access particular information, this information is considered as being available to the public within the meaning of A 54(2).

The [patent proprietor] 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 does not agree with the [patent proprietor’s] interpretation of the case law. Both decisions cited by the [patent proprietor] (T 152/03 and T 906/01) concern prototype devices that were to be implanted in a small number of patients. Therefore, even if the patients did not sign a confidentiality agreement, they would not have been in a position to pass the prototypes on or even inspect them themselves.

Such trials are to be distinguished from trials where a large number of patients are given tablets to take home with them and for use over a longer period of time. It has been acknowledged by the US court that not all of the unused study drugs were returned. Therefore, it appears that after having handed out the drugs the [patent proprietor] effectively lost control over them as the participants in the clinical trials were in no way barred from disposing of the drugs as they wanted.

In view of these circumstances, the board comes to the conclusion that the handing out of the drugs to the participants made them became (sic) publicly available.

[3.4] The [patent proprietor] has also argued that the participants could not be bound by confidentiality as this would have been “unethical”. The US court had established that it would have been unethical to bind patients by confidentiality provisions as they should have been in a position to discuss the medication with their spouses and doctors.

The board has difficulties in reconciling this argument with the argument that there was an implicit secrecy agreement. Either there was an implicit secrecy agreement or there was not. The finding of the US court rather confirms that there was indeed no obligation of confidentiality.

Nor can the line of argument that it would have been unethical to have asked the participants to sign a secrecy agreement lead to a conclusion other than that the drugs had become publicly available before the priority date. If a product has become publicly available, it is irrelevant why it has so unless one of the exceptions in A 55(1) applies which is not the case here.

[3.5] A further argument brought forward by the [patent proprietor] is that the clinical trials were to be classified as “trade secrets” within the meaning of Article 39 TRIPS. While the TRIPS agreement is not binding on the EPO, it is an element that can be taken into consideration when interpreting provisions of the EPC which admit of different interpretations (G 2/02 and G 3/02). The [patent proprietor] has not stated which provision of the EPC is so ambiguous that an interpretation in the light of TRIPS would be appropriate.

Even if the TRIPS agreement were applicable, the purpose of its Article 39 is to clarify the obligation of WTO members under Article 10bis of the Paris Convention to provide for protection against unfair competition. Article 39, paragraph 2, TRIPS merely states that
“Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices…”.
This means that national authorities should allow natural and legal persons to keep particular information secret. In the present appeal the [patent proprietor] was in a position to keep information secret, but decided to distribute the product to selected members of the public before it had secured patent protection.

Under Article 39, paragraph 3, TRIPS, the authorities of WTO members are obliged to keep information submitted to them confidential. This provision too is of no relevance for the present case as the prior use does not concern the disclosure of information by a national authority.

[3.6] As the oral contraceptive used for the clinical trials was publicly available before the effective filing date of the contested patent and as the assertion that it comprises all the features of claim 1 of the main request was not contested by the [patent proprietor], it remains to be examined whether the skilled person was in a position to analyse its content and structure. In particular, it has to be evaluated whether he was able to determine the micronized state of drospirenone, which is an item of information that was not communicated to the women participating in the clinical trials.

According to G 1/92, the chemical composition of a product is state of the art when the product as such is available to the public and can be analysed and reproduced by the skilled person, irrespective of whether or not particular reasons can be identified for analysing the composition (see [headnote 1]). If it is possible for the skilled person to discover the composition or the internal structure of a product and to reproduce it without undue burden, then both the product and its composition or internal structure become state of the art (see point [1.4]). The Enlarged Board emphasises that there is no support in the EPC that the public should have particular reasons for analysing a product put on the market in order to identify its composition or internal structure (see point [2]).

This means for the present case that, in order for the oral contraceptive used in the clinical trials to be publicly available, the skilled person does not need any motivation for investigating the micronized structure of drospirenone. The only question is whether he is able to analyse the structure and composition of the product without undue burden. Regarding the composition of the prior use, the board notes that it belongs to the general knowledge of the skilled person to identify the active agents drospirenone and ethinylestradiol and to determine their concentrations within the tablet. This has not been contested by the [patent proprietor]. On the contrary, the [patent proprietor] has even acknowledged that this information had been passed on to the women participating in the clinical trials. Moreover, it does not require inventive skill to identify at least one excipient.

However, there was a long discussion at the oral proceedings as to whether it was possible to determine the micronized structure of drospirenone which had undergone a compression step during tablet formation. The [patent proprietor] argued that in principle such an analysis was possible via Raman spectroscopy. However, a large number of samples were necessary in order to calibrate the system. As the number of unreturned samples of the clinical trials was not known, there was no guarantee that the skilled person would have sufficient material for analysing the particle size of drospirenone.

The board cannot agree with this argumentation. As was correctly pointed out by the [opponent], it is not necessary to take tablets from the clinical studies for calibrating the system. This can also be done by using a different material. Once the system is calibrated, a single tablet from the clinical studies should be sufficient for determining the particle size of drospirenone.

The [patent proprietor] further argued that the contraceptive used for the clinical trials comprised 21 hormone- containing tablets and 7 placebos. As a consequence, it was not certain that the unreturned samples contained any drospirenone at all. This argument is not convincing either, for the following reason: in view of the fact that the women participating in the clinical trials were not bound to secrecy, the public availability of the prior use was not restricted to the unreturned samples but included all the tablets handed out to them. As the tablets and placebos were not randomly administered but follow a well-defined distribution scheme (e.g. 21 hormone containing tablets followed by 7 placebos), the participants had to be able to identify the two types of tablets. The skilled person therefore had no problems in selecting the hormone-containing specimens for his analysis. As a consequence, it was possible for the skilled person to discover the composition or the internal structure of the product Yasmin® used in the clinical trials mentioned above and to reproduce it without undue burden.

The subject-matter of claim 1 of the main request therefore does not meet the requirements of A 54.

To download the whole decision, click here. The file wrapper can be found here.

NB: Le blog du droit européen des brevets provides a French summary (here).