T 0019/90 - The "Onco mouse" - #45

Citation rank: 45
No. of citations: 101

The case underlying T 19/90 was one of the most controversial patent cases that the instances of the EPO ever had to deal with. It concerned the so-called "onco mouse", a genetically modified laboratory mouse, which was genetically modified to have a predisposition to develop cancer. The onco mouse could be used as a test subject for testing anti-cancer drugs.

The application contained a claim 1 directed to a method of producing a "transgenic non-human mammalian animal", and independent product claim 17 directed to the genetically modified "non-human mammalian animal" itself.

The patent application was refused by the Examination Division. The grounds given for refusal were that the application did not meet the requirements of Articles 53(b) EPC (exclusion from patentability of "plant and animal varieties") and 83 EPC (insufficiency of disclosure).

Regarding insufficiency of disclosure, the Examining Division found it unlikely that the invention (which was demonstrated to work only in a single species, namely in mice) would work over the entire claimed scope, i.e., also in species having a very different "genetic make-up", such as apes and elephants. The Examining Division concluded that the requirements of Art. 83 EPC were not fulfilled.

Regarding the exclusion from patentability of "plant and animal varieties" under Art. 53(b) EPC, the Examining Division considered that it must have been the legislators intent not only to exclude "animal varieties" from patentability, but to exclude "animals" in general. The Examining Division therefore decided that Art. 53(b) EPC was infringed.

The Board of Appeals took a different view.

Regarding insufficiency of disclosure, the Board conceded that the claims were significantly broader than what was demonstrated to work in the examples. They stated:

"However, the mere fact that a claim is broad is not in itself a ground for considering the application as not complying with the requirement for sufficient disclosure under Article 83 EPC. Only if there are serious doubts, substantiated by verifiable facts, may an application be objected to for lack of sufficient disclosure.

Although the Examining Division was right in saying that certain non-human mammals other than mice have very different numbers of genes and different immune systems, it does not necessarily follow that the invention cannot be carried out on such animals. On the contrary, at least one source (Palmiter & Brinster, Ann. Rev. Genet. 1986, 20; 465-499) suggests that those skilled in the art might very well be able to carry out the invention on non- human mammals other than mice. Nor is the Board itself aware of any verifiable facts which could cast serious doubt on the possibility for a skilled person to carry out the invention as claimed." (point 3.3 of the reasons)

The Board concluded that - in the absence of substantiated, verifiable facts to the contrary - the invention was sufficiently disclosed.

Regarding the exclusion from patentablity of plant and animal varieties under Art. 53(b), the Board also did not agree with the Examining Division. The Board pointed out that Art. 53(b) EPC was an exception, and exceptions should generally be "narrowly construed" (point 4.5 of the reasons). They argued that Art. 53(b) clearly referred to "animal varieties", "races animales" and "Tierarten", and nothing suggests that in reality "animals" (in general) were meant to be excluded.

As a consequence, the Board concluded that Article 53(b) EPC was not infringed and the case was remitted to the Examining Division for further prosecusion.

Remark: When the patent proceeded to grant, seventeen (17) parties filed an opposition against it. The oppositions were i.a. based on Art. 53(a) (exclusion of inventions contrary to "ordre public" or morality). The patent was maintained in amended form by the Opposition Division. That decision was again appealed (T 315/03). The Appeal Board remitted the case back to the Oppostion Division with an order to maintain the patent in further amended form. At that stage, however, the proprietor decided not to file translations of the amended claims and not to pay the required fees under Rule 58 EPC1973. The patent was revoked, more than 20 years after its filing date.

Further remark: While the controversial nature of this case clearly lies in its aspect regarding the exclusions from patentability (Art. 53(a)/(b)), that aspect is not the reason why T 19/90 made it to the present top-100 list. Interestingly, the vast majority of citations of T 19/90 concern other aspects of the decision, namely its statement that insufficiency-objections must be based on "serious doubts, substantiated by verifiable facts".

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Headnote:

1. The exception to patentability under Article 53(b) EPC applies to certain categories of animals but not to animals as such.
2. In particular in the case of genetic manipulation of animals involving, as in this case, the insertion of an activated oncogene, there are compelling reasons to consider the provisions of Article 53(a) EPC in relation to the question of patentability.