Docstoc

U - Download as DOC

Document Sample
U - Download as DOC Powered By Docstoc
					THE GRANTING OF THE “ONCOMOUSE” PATENT BY THE EUROPEAN PATENT OFFICE
An overview of the decision T 315/03a of the Board of Appeal

Introduction
The “Oncomouse” patent has been one of the most fiercely debated issues and
controversial patents of the past decade, having caught the attention and sensibility of the
general public for its implication that life could be patented.

In actual fact, this is not the first patent protecting a form of life. Already in 1972, a
patent was applied for in the U.S. for a recombinant strain of Burkholderia cepacia, which
had been genetically modified to degrade a range of organic pollutants. Following
objections, the patent was eventually granted in 1981 with patent number US 4,259,444.
This decision helped open the way, in 1985, to the patenting of genetically engineered
plants, seeds and plant tissues, and subsequently (in 1987) of genetically modified “multi-
cellular living organisms, including animals” b.

Back in 1984, the oncomouse represented a major breakthrough in science. Philip Leder
and Timothy Stewart, of Harvard Medical School in Boston, had developed a transgenic
mouse, modified to contain a cancer-causing gene that would make the mouse susceptible
to develop a type of cancer that closely mimicked the human disease. This promised to be
a useful research tool, enabling researchers to gain better insight into the mechanisms of
the development of human cancer, to help devise a cure. The mice would also be used to
test possible cancer-curing drugs and new therapies.

The USPTO (U.S. Patent and Trademark Office) granted the patent (US 4,736,866) in
1988 conceding protection over “a transgenic non-human mammal all of whose germ cells
and somatic cells contain a recombinant activated oncogene sequence introduced into said
mammal, or an ancestor of said mammal, at an embryonic stage”. This particular patent,
for its broad scope of protection, has sparked controversies of its own, which however are
not relevant to this article.

The path that ultimately led to the granting of the European patent in its most recently
amended form, and which was filed in 1985, has been much more tortuous than its
American counterpart, and has seen many opponents seek (and obtain) substantial
limitations to its scope of protection. So much, in fact, that nineteen years later, the
granted patent now covers transgenic mice only. Along the way, this patent has become
the emblem of the conflicting interests of the large corporations and research groups who
wish to protect the fruits of their investments on the one side, and, on the other side, of
human and animal rights advocates who feel strongly about the moral issues of patenting
life.

The patent has been granted in Japan and Australia c also, but was rejected in Canada
over moral issues, where, however, a patent to cover the process by which the animal is
engineered, is still pursuabled.

The following table provides an outline of the history of the oncomouse European patent,
from the development of the invention in 1984 and the filing of an application for a patent
in Europe, to the most recent developments of July 2004. The adoption of the


                                                                                              1
Biotechnology Directive1 in 1999 in the European Union (EU), as the patent was still
pending, further complicated and delayed matters, as will be elucidated shortly.

Table 1

1984      Oncomouse is developed by Philip Leder and Timothy Stewart of Harvard
          University
June 24,  Harvard University applies for a European patent claiming a priority date of
1985      June 22, 1984.e The application contained inter alia independent claims
          directed to “1. A method for producing a transgenic eukaryotic animal having
          an increased probability of developing neoplasms, said method comprising
          introducing into an animal embryo an activated oncogene sequence” and 17.
          “A transgenic non-human eukaryotic animal whose germ cells and somatic
          cells contain an activated oncogene sequence introduced into said animal, or
          an ancestor of said animal, at an embryonic stage, said oncogene optionally
          being further defined according to any one of claims 3 to 10, said animal
          preferably being a rodent”.a
1989      The European Patent Office (EPO) rejects the application mainly on the basis
          that animals are unpatentable under the EPC (Art. 53(b) EPC 2), as well as for
          its unjustified scope of protection (Art. 83 EPC3).f
1990-1991 Harvard appeals. The Board of Appeal holds that Art. 53(b) EPC excludes
          animal varieties from patentability, not animals and remits the case to the
          Examining Division to determine whether the claims covered animal varieties.
          The Examination Division thus decides to grant the patent, albeit upon
          limitation of its scope.f
          A Patent Concern coalition is formed including Greenpeace, Royal Society for
          the Prevention of Cruelty to Animals (RSPCA) and British Union for the
          Abolition of Vivisection (BUAV).
May 13,   European patent granted (under publication number EP 0169672) for “non-
1992      human mammalian animals”.
December Formal oppositions initiated, by seventeen parties, alleging variously several
18, 1992- grounds under Articles 100(a) and 52 to 57 EPC5 including lack of industrial
February  application, lack of novelty and inventive step, the absence of an invention, a
13, 1993  non-patentable method for treatment of the animal body, that exploitation of
          the invention would be contrary to morality or “ordre public”, and that the
          patent claimed animal varieties. Also, there were objections of insufficient
          disclosure under Articles 100(b) and 83 EPC. 5,a
          European Parliament votes overwhelmingly for the withdrawal of the patent.
November Oral proceedings are held by the Opposition Division. The proceedings are
21-24,    continued in writing as some aspects were unclear. b
1995
1995      European Parliament rejects a patenting directive which would have allowed
          animal patenting. g
September The European Patent Convention (EPC) implements the EU Directive on
1, 1999   Biotechnology (Directive 98/44/EC) through Rules 23b to 23e EPC. 5,h
2000      New Rules 23b to 23e EPC invalidate previous opposition discussions
November Oral proceedings take place again. In its decision the Division rejects the
6,7, 2001 patent’ proprietor’s objections to the admissibility of the oppositions and

                                                                                            2
            rejects all the opponent’s objections to the patent except those under Art.
            53(a) EPC. Patent maintained in amended form, directed to transgenic
            rodents, in accordance with the proprietor’s fourth auxiliary request filed on
            April 24, 1997. It was also decided that Rules 23b to 23e EPC applied to the
            present case.a

March 25,   Some opponents appeal.
2003
July 6,     Decision is taken (Case T 315/03). The case is remitted to the first instance
2004        with the order to maintain the patent in a newly amended form, further
            restricting its scope to transgenic mice.

Outline of the arguments
The collective arguments brought forward by the opponents and the respondent (the
patent proprietor) in the course of the most recent appeal, can be summarized as in Table
2 that follows:




                                                                                             3
Article                      Opponents                                                   Respondent
Art. 54 EPC (novelty)        An animal and its natural progeny or offspring cannot be    Critical intervention steps of a technical nature were acknowledged to
                             defined as a technical solution to any technical problem.   change the overall nature of the process so that it was no longer
                                                                                         essentially biological. The transgenic rodents could not have been
                                                                                         provided without such intervention.
Art. 56 EPC (inventive       It was to be expected that the introduction of an oncogene At the priority date the available bacterial test systems for studying
step)                        would result in its integration into the genome of at least suspected carcinogens were inappropriate. Experimentation in mice
                             some of the animals. No inventive merit could thus be       was not so advanced that the outcome of the introduction of an
                             seen.                                                       activated oncogene could be predicted.

Art. 57 EPC (industrial      Only mice could be considered to have an industrial           Industrial application as a test had to be pitched broadly enough to
application)                 application, not other rodents such as squirrels, beavers,    encompass industry devoted to medical treatments.
                             etc.

Art. 53 EPC (“ordre public” Art. 53(a) EPC                                                 Art. 53(a) EPC
and morality)               1) The article was to do with the patenting as well as the     1) Art. 53(a) EPC was not about the morality of patenting. Publication
                                exploitation of the invention.                                 and exploitation of the invention would not be in breach of “ordre
                            2) This case would create a precedent for patenting                public” and morality, thus satisfying the article. Similarly, it was
                                animals.                                                       argued, a new form of chisel would not be denied a patent just
                            3) The opinions of the four members of the Division could          because it can be used to harm.
                                not be considered representative.                          2) Appellants were using the proceedings as a vehicle for a general
                            4) The implementation of Rules 23b to 23e EPC was                  objection to the patenting of life forms and to change the law. The
                                considered to be unacceptable, as they were                    appellants’ argument that animal subject-matter was non-technical
                                introduced during the course of the granting of the            and non-patentable was incorrect.
                                patent and were not there when the patent had been         3) The Board had no burden to be representative in their views: their
                                originally filed for application                               procedures depended upon the evidence given.
                            5) Rule 23d(d)EPC4, concerned with animal suffering, was       4) The respondent agreed that the introduction of the new Rules into
                                not correctly applied. The Opposition Division failed to       the proceedings was wrong thus Rule 23d EPC should not apply
                                consider other morality issues concerning the patent.          retrospectively.
                                In its establishment of the European public’s view of      5) Exclusions, such as in Art. 53(a) EPC should be interpreted
                                the morality the Division had used laws and                    narrowly and objectively. Evidence not focused on the effective
                                regulations but not opinion polls. No balance between          date (i.e. the date of application filing) was irrelevant. The
                                animal suffering and medical advance could possibly            appellants had given no evidence of current attitudes to animal
                                be sought. Although the English text of Rule 23(d)             testing at the effective date. Evidence produced after the effective
                                reads “likely to cause suffering”. The German text uses        date was not admissible. Any judgement as to moral standards of
                                the word “geeignet”, meaning “suitable”. The question          the public must be done with an understanding of the technology,
                                as to whether an alternative to the invention was              care must be taken in relying on media views.
                                available must be assessed. The date of assessment         6) Animal experiments were widespread practices: by providing more
                                and the extent of animal suffering should also be taken        sensitive tests, both the number of animals and the duration of

                                                                                                                                                                  4
                               into account.                                                  the experimentation would be reduced. A decision as to what was
                            6) The acts of the EPO in this case were considered to            right and normal should not be based on a set of religious beliefs.
                               depart from the European Judaeo-Christian tradition.           Patents do not encourage the trade of animals: a patent
                               The patent would have no moral basis but only the              discourages the activities of others. The present invention is
                               principle of the maximization of profit for those who          remarkably unprofitable.
                               had an interest, therefore it should be revoked.

                            Art. 53(b) EPC                                                Art. 53(b) EPC
                            Plant and animal species were to be interpreted as            This article did not exclude the patenting of animals as such. This
                            meaning the actual animals and plants, as material            interpretation was in agreement with Rule 23c(b) EPC stating that an
                            manifestations, belonging to that variety. The transgenic     invention was not restricted to any particular species. Chromosomal
                            mouse inherited a specific technical characteristic and was   incorporation into mice of an oncogene did not create a new species
                            thus a new animal species.                                    as such.
                            The method claimed was a biological process.

Art. 83 EPC (sufficiency of Given that the examples concerned mice only, it was           Rodents were a reasonable extrapolation from the specific work
disclosure):                unacceptable to grant protection to such a large animal       carried out. Rodents showed no important differences in their
                            group. Even more so given that rodents were not a             metabolic and immunologic systems. The oncogene used (myc) was
                            uniform group.                                                involved in the regulation (interference) of cell division, a function
                                                                                          which was the same in all rodents.




                                                                                                                                                                    5
Appellants asked that the decision under appeal be set aside and that the patent be
revoked.

The respondent requested that the patent be maintained on the basis of its main request
(containing the claims based on rodents allowed by the Opposition Division) or
alternatively one of its auxiliary requests 1 to 3 (auxiliary request 1 having the subject-
matter limited to mice).

The Board’s decision:

In its lengthy and detailed decision (about 150 pages long), the Board decided that the
first auxiliary request, having the subject-matter of the claims limited to mice only, was
patentable.

Before going on to the reasons for the decision, the Board clarified some of the issues that
had been raised during the Appeal procedure and the oral proceedings and which were
found to be relevant to the case. In summary:

1) Art. 53 (a) EPC is concerned with the morality and “ordre public” of publication and
exploitation of an invention, not its patentability. The article thus raises no question as to
the morality of patenting a particular invention or of the morality of that invention per se.
According to Art. 53(b), and in agreement with the Decision of G1/98 regarding plant
varieties, claims directed to a single animal variety (or species or race, depending on
which language text of the EPC is used) are not patentable. However, claims which
enompass several varieties but not a claim to a specific variety should be allowed.

2) The assertion that before the introduction of Rules 23b to 23e EPC, patenting of
animals was not possible is quite simply erroneous.

3) The Board is under no obligation to be representative of the views of the European
society on morality issues. Its task was, quite differently, to assess whether or not the
exploitation of the invention conformed with conventionally accepted standards of conduct
in European society.

4) New legislation normally does apply to pending cases and does not apply
retrospectively. Therefore the new Rules 23b to 23e do apply to the present case as they
took effect on the date provided for by the legislator and the opposition proceedings were
pending on that date.

5) As for the balancing test between animal suffering and medical benefit, the date of
assessment should be the effective date (filing or priority date) of the patent. Any later
date would be inconsistent with other areas of patent law. Rule 23d(d) EPC4 test requires
to establish whether animal suffering is likely, whether substantial medical benefit is likely,
and the necessary correspondence between the two in terms of the animal in question.
The relevant date is the effective date of the patent.

The reasoning that ultimately led the Board to decide on the patentability of the claims of
the first auxiliary request can be summarized as follows:


                                                                                                 6
Prior to the introduction of the Directive in 1999, and thus prior to Rules 23b to 23e, the
only authoritative pronouncement on Art. 53(a) EPC had been in the case T 19/90 f, which
provided a valuable test for the assessment of an invention in terms of morality and “ordre
public”. In the case, which concerned genetic manipulation of animals, it was pronounced
that “The decision as to whether or not Article 53(a) EPC is a bar to patenting the present
invention would seem to depend mainly on a careful weighing up of the suffering of
animals and possible risks to the environment on the one hand, and the invention’s
usefulness to mankind on the other.”
With the introduction of Rules 23b to 23e, particularly Rule 23d(d), in relation to Article
53(a) EPC, a new test was introduced for the assessment of inventions in terms of
morality and “ordre public”. According to Rule 23d(d) European patents shall not be
granted in respect of biological inventions which concern processes for modifying the
genetic identity of animals which are likely to cause them suffering without any substantial
medical benefit to man or animal, and also animals resulting from such processes.
The new test, in actual fact, imposed a two-steps assessment in the decision of the
present case: first, it had to be assessed whether the invention passed the Rule 23d(d)
test (i.e. whether the suffering caused to animals could be outweighed by the resulting
medical benefits) and, only upon a positive outcome, could it be assessed whether it also
passed the Article 53(a) EPC, which accounted for other moral issues (such as the
environment, for example).
In this case, it was decided that animal suffering was certain, not only likely. Moreover, no
evidence of medical benefit could be found, with relation to all rodents and therefore the
likelihood of substantial medical benefit required by Rule 23d(d) EPC was not satisfied for
all rodents. The main request of the respondent was thus not allowable.
The first auxiliary request, on the contrary, as it limited the animals in question to mice
only, was found to satisfy Rule 23d(d) EPC.
As it was concluded that there was no evidence to support the other morality objections
raised, Art. 53(a) EPC was found not to constitute a bar to the patentability of the subject-
matter of the first auxiliary request.
Art. 53(b) EPC was also found not to exclude from patentability the first auxiliary request.
Similarly, Articles 123(2) (3) EPC, 84 EPC, 54 EPC, 56 EPC, 83 EPC, and 57 EPC 5 were
found to be satisfied by the main auxiliary request.

To conclude, in cases similar to the present one, three essential points must be assessed
in order to decide over the patentability of genetically modified animals: firstly, whether
suffering on the part of the animal is likely, secondly, whether there is substantial medical
benefit to man or animal, and finally, whether there is a correspondence between the two
in terms of the animal in question. This last point was crucial to the patent in question
because the Board found that, although they were satisfied that transgenic mice were
likely to bring about medical benefit, they were not equally convinced that there was
enough supporting evidence to claim the same about other rodents. It follows that, when
seeking a patent in Europe for a trangenic animal, it is advisable to ensure that there is a
proven and convincing correspondence between the extent of the subject-matter and the
benefits claimed.

It should also be stressed that Art. 53(a) EPC concerns the moral implications of the
exploitation or publication of the invention, and not those of the invention per se. Again,
this was cause of controversy throughout the oral proceedings, as the opponents argued
that the Board should decide over the morality of the patenting of the invention per se. As

                                                                                                7
the Board made perfectly clear, it is the morality of publication or exploitation that should
be assessed. Opinion polls and national laws and regulations laws thus cannot be accepted
as supporting evidence.

According to Art. 53 EPC, in fact, the assessment of whether or not particular subject-
matter is to be considered contrary to “ordre public” is not dependent upon any national
laws and regulations. Similarly, an invention cannot be considered automatically in
compliance with Art. 53(a) EPC on the basis of its being permitted in one or all of the
Contracting States. Although it may appear contradictory to grant a patent over an
invention that cannot be exploited on the territory where it is granted, the article in actual
fact takes into account that national laws and moral perceptions are bound to change or
evolve over time.



Relevant Legislation

1
  The Biotechnology Directive (http://europa.eu.int/eur-
lex/pri/en/oj/dat/1998/l_213/l_21319980730en00130021.pdf), which had first been
proposed in 1988 to bring consistency to the European patent system, came into force on
July 30, 2000 having been adopted by the EPO on September 1, 1999. The Netherlands
had voted against it and Italy and Belgium had abstained.
The Directive provides clear guidelines as to what cannot be patented: plant and animal
varieties; essential biological processes for the production of animals and plants; the
human body at various stages of its formation and development and the discovery of one
of its elements (e.g. a gene sequence); and, inventions the commercial exploitation of
which would be contrary to ordre public and morality. However, an invention based on an
element isolated from the human body or otherwise produced by means of a technical
process, which is industrially applicable, is patentable, even if that element is identical to
one in nature. Thus, an isolated gene or gene sequence is patentable when its function is
known, as well as industrial applications that can be derived from it. The Directive also
allows for the patenting of plants and animals when the application of the invention is not
confined to a single variety of such plant or animal. Genetic modification to animals is thus
clearly patentable under the Directive, under certain conditions. These latter inventions
had previously been excluded from patentability under the EPC.
2
  Art. 53 EPC
European patents shall not be granted in respect of:
(a) inventions the publication or exploitation of which would be contrary to “ordre public”
or morality, provided that the exploitation shall not be deemed to be so contrary merely
because it is prohibited by law or regulation in some or all of the Contracting States.
(b) plant or animal varieties or essentially biological processes for the production of plants
or animals; this provision does not apply to microbiological processes or the products
thereof.
3
 Art. 83 EPC
The European patent application must disclose the invention in a manner sufficiently clear
and complete for it to be carried out by a person skilled in the art.


                                                                                                 8
4
  Rule 23d EPC
Under Article 53(a), European patents shall not be granted in respect of biotechnological
inventions which, in particular, concern the following:
(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;
(d) processes for modifying the genetic identity of animals which are likely to cause them
    suffering without any substantial medical benefit to man or animal, and also animals
    resulting from such processes.
5
    http://www.european-patent-office.org/legal/epc/index.html


References
a
 T315/03:
http://legal.european-patent-office.org/dg3/pdf/t030315ex1.pdf
b
    www.shef.ac.uk/aps/level3modules/ aps326/aps326ip-lecture2.pdf

c
    http://www.hms.harvard.edu/news/releases/125oncomouse.html
d
 Check, E. (2002) Canada stops Harvard’s oncomouse in its tracks, Nature, vol 420 (12
December 2002)

e
 http://register.epoline.org/espacenet/regviewer?AP=EP19850304490&PN=&CY=ep&LG=
en&DB=REG

f
T19/90 OJ EPO 1990:
http://legal.european-patent-office.org/dg3/biblio/t900019ep1.htm
g
    http://www.angelfire.com/nb/arcnorth/pdf/patenting.pdf
h
 Decision of the Administrative Council 16.06.99, Official Journal EPO, 1999, pp. 101 and
573.




                                                                                             9

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:50
posted:3/3/2010
language:English
pages:9
Description: U