OncoMouse comes home to roost just in time to expire!
Enlarged Board of Appeal T0315-03 (July 2004)
Setting the Scene - 1985
The case related to European Patent EP0169672, entitled "Method for producing transgenic animals", but it is now commonly referred to as the Harvard Onco-Mouse Patent and is concerned with the process for producing mammals having an increased pre-disposition to neoplasms. The patent application had a filing date in 1985 (European patents last 20 years from the filing) and whilst the title refers to animals, the patent was opposed after grant by a number of parties and was restricted to the production of transgenic mice.
Patent Granted - 1992
The European Patent Office (EPO) initially refused the application on the grounds that the European Patent Convention (EPC) did not consider animal varieties to be of patentable subject matter. However the decision was successfully appealed and the patent application was granted on the basis of a main claim to "A method of producing a non-human mammalian animal..."
Patent Opposed 1992-2003
Within a period of 9 months from the grant of a European patent, third parties can file an opposition to the decision of the grant of a patent. In this case, an almost unprecedented seventeen oppositions in total were filed against the patent on various grounds from a variety of interested parties and the proceedings lasted almost 10 years. After opposition proceedings, the patent was still maintained, albeit in a further amended state and on the basis of a main claim to "A method of producing a transgenic rodent..."
Decision of Opposition Appealed - 2003
Appeals against the decision of the Opposition Division were then filed on various grounds, ranging from the invention being obvious, lacking industrial application and the invention being contrary to ordre public and morality. During the Appeal, the Applicant also referred a number of questions to the Enlarged Board of Appeal.
The Decision from the Enlarged Board of Appeal - 2004
The patent was maintained as per the claims allowed during the Opposition Proceedings and the Appeal was set aside. The Board of Appeal also clarified a number of points regarding exclusions to patentability in the arena of Biotechnology:
Excluded Subject Matter
- An invention falling within one of the four categories is ipso facto excluded from patentability under Rule 23d EPC. The categories are as follows:
(a) Processes for cloning human beings;
(b) Processes for modifying the germ line genetic identity of human beings;
(c) Uses of human embryos for industrial or commercial purposes; and
(d) Processes for modifying the genetic identity of animals which are likely to cause them suffering without substantial medical benefit to man or animals, and also animals resulting thereof.
- but a case not falling within one of those categories must be considered further by the EPO
- An objection due to a "Rule 23(d) type" is to be made as of the filing or priority date of the patent or application in suit. However, evidence arising thereafter may also be taken into account provided it is directed to the position at that date.
- The last category, i.e. Rule 23d(d) EPC, requires only three matters to be considered: animal suffering, medical benefit and the necessary correspondence between the two in terms of the animals in question.
- The level of proof is the same for both animal suffering and substantial medical benefit, namely a likelihood.
Inventions Contrary to "Ordre Public" or Morality
- In the assessment of a objection under Article 53(a) EPC, that the invention is contrary to "ordre public" or morality, there is no single definition of morality based on e.g. economic or religious principles that represent an accepted standard in European culture. Opinion poll evidence is of very limited value.
- On the basis of assessment, other arguments as to the appropriate standard of morality or "ordre public" can additionally be considered but all arguments must be supported by evidence.
- Assessment of a Article 53(a) EPC objection is made as of the filing or priority date; evidence arising after that date may be taken into account provided it is directed to the position at such date.
Definition of "Animal Varieties"
- Under Article 53(b), "plant or animal varieties or essentially biological processes for the production of plants or animals to be excluded", the assessment of an "animal variety" should be followed as per previous case law (G 1/98 (OJ EPO 2000, 111)) concerning plants and "plant varieties": a patent should not be granted for a single animal variety (or species or race, depending on which language text of the EPC is used) but can be granted if varieties may fall within the scope of its claims.
- The definition of animal variety (or species or race) by reference to taxonomical rank would be consistent with the position in relation to plant varieties and in the interest of legal certainty, allowing assessment under Article 53(b) EPC as interpreted by Rule 23c(b) EPC to be made by considering whether the technical feasibility of the invention is not confined to a particular animal variety (or species or race).
Having made it this far however, the patent is set to expire shortly on 24th June 2005.