Oncomouse
Encyclopedia
The OncoMouse or Harvard mouse is a type of laboratory mouse that has been genetically modified
using modifications designed by Philip Leder
and Timothy A Stewart
of Harvard University
to carry a specific gene
called an activated oncogene
. The activated oncogene significantly increases the mouse’s susceptibility to cancer
, and thus makes the mouse suitable for cancer research
. The rights to the invention are owned by DuPont
. "OncoMouse" is a registered trademark.
Patent
applications on the OncoMouse were filed back in the mid-1980s in numerous countries such as in the United States
, in Canada
, in Europe
through the European Patent Office
(EPO) and in Japan
.
in 2002 rejected the patent in Harvard College v. Canada (Commissioner of Patents)
, overturning a Federal Court of Appeal
verdict which ruled in favor of the patent by overturning a lower court's rejection. However, on 7 October 2003, Canadian patent 1,341,442 was granted to Harvard College. The patent was amended to omit the "composition of matter" claims on the transgenic mice. The Supreme Court
had rejected the entire patent application on the basis of these claims, but Canadian patent law allowed the amended claims to grant under pre-GATT rules and the patent remains valid until 2020.
application 85304490.7 was filed in June 1985 by "The President and Fellows of Harvard College
". It was initially refused in 1989 by an Examining Division of the European Patent Office
(EPO) among other things on the grounds that the European Patent Convention
(EPC) excludes patentability of animal
s per se. The decision was appeal
ed and the Board of Appeal
held that animal varieties were excluded of patentability by the EPC (and especially its ), while animals (as such) were not excluded from patentability. The Examining Division then granted the patent in 1992 (its publication number is ).
The European patent was then opposed
by several third parties, more precisely by 17 opponents, notably on the grounds laid out in , according to which "inventions, the publication or exploitation of which would be contrary to "ordre public
" or morality
are excluded from patentability
. After oral proceedings took place in November 2001, the patent was maintained in amended form. This decision was then appealed and the appeal decision was taken on July 6, 2004. The case was eventually remitted to the first instance, i.e. the Opposition Division, with the order to maintain the patent on a newly amended form. However, revocation of the patent was eventually published on August 16, 2006, more than 20 years after the filing date (the normal term of a European patent under ), for failure to pay the fees and to file the translations of the amended claims under .
(USPTO) granted (filed Jun 22, 1984, issued Apr 12, 1988, expired April 12, 2005) to Harvard College claiming
“a transgenic non-human mammal whose germ cells and somatic cells contain a re-combinant activated oncogene sequence introduced into said mammal…” The claim explicitly excluded humans, apparently reflecting moral and legal concerns about patents on human beings, and about modification of the human genome
. Remarkably, there were no US courts called to decide on the validity of this patent. Two separate patents were issued to Harvard College covering methods for providing a cell culture from a transgenic non-human animal and testing methods using transgenic mice expressing an oncogene .
Genetic engineering
Genetic engineering, also called genetic modification, is the direct human manipulation of an organism's genome using modern DNA technology. It involves the introduction of foreign DNA or synthetic genes into the organism of interest...
using modifications designed by Philip Leder
Philip Leder
Philip Leder is an American geneticist. He was born in Washington, D.C. and studied at Harvard University, graduating in 1956. In 1960, he graduated from Harvard Medical School....
and Timothy A Stewart
Timothy A Stewart
Timothy A Stewart is a molecular biologist. He graduated from the University of Otago Stewart was born in Christchurch, New Zealand. He was a pioneer in the technique of transferring recombinant genes to mice and in 1988 he and Philip Leder were granted a patent on a genetically engineered mammal...
of Harvard University
Harvard University
Harvard University is a private Ivy League university located in Cambridge, Massachusetts, United States, established in 1636 by the Massachusetts legislature. Harvard is the oldest institution of higher learning in the United States and the first corporation chartered in the country...
to carry a specific gene
Gene
A gene is a molecular unit of heredity of a living organism. It is a name given to some stretches of DNA and RNA that code for a type of protein or for an RNA chain that has a function in the organism. Living beings depend on genes, as they specify all proteins and functional RNA chains...
called an activated oncogene
Oncogene
An oncogene is a gene that has the potential to cause cancer. In tumor cells, they are often mutated or expressed at high levels.An oncogene is a gene found in the chromosomes of tumor cells whose activation is associated with the initial and continuing conversion of normal cells into cancer...
. The activated oncogene significantly increases the mouse’s susceptibility to cancer
Cancer
Cancer , known medically as a malignant neoplasm, is a large group of different diseases, all involving unregulated cell growth. In cancer, cells divide and grow uncontrollably, forming malignant tumors, and invade nearby parts of the body. The cancer may also spread to more distant parts of the...
, and thus makes the mouse suitable for cancer research
Cancer research
Cancer research is basic research into cancer in order to identify causes and develop strategies for prevention, diagnosis, treatments and cure....
. The rights to the invention are owned by DuPont
DuPont
E. I. du Pont de Nemours and Company , commonly referred to as DuPont, is an American chemical company that was founded in July 1802 as a gunpowder mill by Eleuthère Irénée du Pont. DuPont was the world's third largest chemical company based on market capitalization and ninth based on revenue in 2009...
. "OncoMouse" is a registered trademark.
Patent
Patent
A patent is a form of intellectual property. It consists of a set of exclusive rights granted by a sovereign state to an inventor or their assignee for a limited period of time in exchange for the public disclosure of an invention....
applications on the OncoMouse were filed back in the mid-1980s in numerous countries such as in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
, in Canada
Canada
Canada is a North American country consisting of ten provinces and three territories. Located in the northern part of the continent, it extends from the Atlantic Ocean in the east to the Pacific Ocean in the west, and northward into the Arctic Ocean...
, in Europe
Europe
Europe is, by convention, one of the world's seven continents. Comprising the westernmost peninsula of Eurasia, Europe is generally 'divided' from Asia to its east by the watershed divides of the Ural and Caucasus Mountains, the Ural River, the Caspian and Black Seas, and the waterways connecting...
through the European Patent Office
European Patent Organisation
The European Patent Organisation is a public international organisation created in 1977 by its contracting states to grant patents in Europe under the European Patent Convention of 1973...
(EPO) and in Japan
Japan
Japan is an island nation in East Asia. Located in the Pacific Ocean, it lies to the east of the Sea of Japan, China, North Korea, South Korea and Russia, stretching from the Sea of Okhotsk in the north to the East China Sea and Taiwan in the south...
.
Canada
In Canada, the Supreme CourtSupreme Court of Canada
The Supreme Court of Canada is the highest court of Canada and is the final court of appeals in the Canadian justice system. The court grants permission to between 40 and 75 litigants each year to appeal decisions rendered by provincial, territorial and federal appellate courts, and its decisions...
in 2002 rejected the patent in Harvard College v. Canada (Commissioner of Patents)
Harvard College v. Canada (Commissioner of Patents)
Harvard College v. Canada [2002] 4 S.C.R. 45, 2002 SCC 76 is a leading Supreme Court of Canada case concerning the patentability of higher life forms, in particular, the Harvard oncomouse.- Background :...
, overturning a Federal Court of Appeal
Federal Court of Appeal (Canada)
The Federal Court of Appeal is a Canadian appellate court that hears cases concerning federal matters arising from certain federal Acts. The court was created on July 2, 2003 by the Courts Administration Service Act when it and the Federal Court were split from its predecessor, the Federal Court of...
verdict which ruled in favor of the patent by overturning a lower court's rejection. However, on 7 October 2003, Canadian patent 1,341,442 was granted to Harvard College. The patent was amended to omit the "composition of matter" claims on the transgenic mice. The Supreme Court
Supreme Court of Canada
The Supreme Court of Canada is the highest court of Canada and is the final court of appeals in the Canadian justice system. The court grants permission to between 40 and 75 litigants each year to appeal decisions rendered by provincial, territorial and federal appellate courts, and its decisions...
had rejected the entire patent application on the basis of these claims, but Canadian patent law allowed the amended claims to grant under pre-GATT rules and the patent remains valid until 2020.
Europe (through the EPO)
European patentEuropean Patent Organisation
The European Patent Organisation is a public international organisation created in 1977 by its contracting states to grant patents in Europe under the European Patent Convention of 1973...
application 85304490.7 was filed in June 1985 by "The President and Fellows of Harvard College
Harvard College
Harvard College, in Cambridge, Massachusetts, is one of two schools within Harvard University granting undergraduate degrees...
". It was initially refused in 1989 by an Examining Division of the European Patent Office
European Patent Office
The European Patent Office is one of the two organs of the European Patent Organisation , the other being the Administrative Council. The EPO acts as executive body for the Organisation while the Administrative Council acts as its supervisory body as well as, to a limited extent, its legislative...
(EPO) among other things on the grounds that the European Patent Convention
European Patent Convention
The Convention on the Grant of European Patents of 5 October 1973, commonly known as the European Patent Convention , is a multilateral treaty instituting the European Patent Organisation and providing an autonomous legal system according to which European patents are granted...
(EPC) excludes patentability of animal
Animal
Animals are a major group of multicellular, eukaryotic organisms of the kingdom Animalia or Metazoa. Their body plan eventually becomes fixed as they develop, although some undergo a process of metamorphosis later on in their life. Most animals are motile, meaning they can move spontaneously and...
s per se. The decision was appeal
Appeal
An appeal is a petition for review of a case that has been decided by a court of law. The petition is made to a higher court for the purpose of overturning the lower court's decision....
ed and the Board of Appeal
Appeal procedure before the European Patent Office
Decisions of the first instances of the European Patent Office can be appealed, i.e. challenged, before the Boards of Appeal of the EPO, in a judicial procedure , as opposed to an administrative procedure. These boards act as the final instances in the granting and opposition procedures before the...
held that animal varieties were excluded of patentability by the EPC (and especially its ), while animals (as such) were not excluded from patentability. The Examining Division then granted the patent in 1992 (its publication number is ).
The European patent was then opposed
Opposition procedure before the European Patent Office
The opposition procedure before the European Patent Office is a post-grant, contentious, inter partes, administrative procedure intended to allow any European patent to be centrally opposed...
by several third parties, more precisely by 17 opponents, notably on the grounds laid out in , according to which "inventions, the publication or exploitation of which would be contrary to "ordre public
Public policy (law)
In private international law, the public policy doctrine or ordre public concerns the body of principles that underpin the operation of legal systems in each state. This addresses the social, moral and economic values that tie a society together: values that vary in different cultures and change...
" or morality
Morality
Morality is the differentiation among intentions, decisions, and actions between those that are good and bad . A moral code is a system of morality and a moral is any one practice or teaching within a moral code...
are excluded from patentability
Patentability
Within the context of a national or multilateral body of law, an invention is patentable if it meets the relevant legal conditions to be granted a patent...
. After oral proceedings took place in November 2001, the patent was maintained in amended form. This decision was then appealed and the appeal decision was taken on July 6, 2004. The case was eventually remitted to the first instance, i.e. the Opposition Division, with the order to maintain the patent on a newly amended form. However, revocation of the patent was eventually published on August 16, 2006, more than 20 years after the filing date (the normal term of a European patent under ), for failure to pay the fees and to file the translations of the amended claims under .
United States
In 1988, the United States Patent and Trademark OfficeUnited States Patent and Trademark Office
The United States Patent and Trademark Office is an agency in the United States Department of Commerce that issues patents to inventors and businesses for their inventions, and trademark registration for product and intellectual property identification.The USPTO is based in Alexandria, Virginia,...
(USPTO) granted (filed Jun 22, 1984, issued Apr 12, 1988, expired April 12, 2005) to Harvard College claiming
Claim (patent)
Patent claims are the part of a patent or patent application that defines the scope of protection granted by the patent. The claims define, in technical terms, the extent of the protection conferred by a patent, or the protection sought in a patent application...
“a transgenic non-human mammal whose germ cells and somatic cells contain a re-combinant activated oncogene sequence introduced into said mammal…” The claim explicitly excluded humans, apparently reflecting moral and legal concerns about patents on human beings, and about modification of the human genome
Human genome
The human genome is the genome of Homo sapiens, which is stored on 23 chromosome pairs plus the small mitochondrial DNA. 22 of the 23 chromosomes are autosomal chromosome pairs, while the remaining pair is sex-determining...
. Remarkably, there were no US courts called to decide on the validity of this patent. Two separate patents were issued to Harvard College covering methods for providing a cell culture from a transgenic non-human animal and testing methods using transgenic mice expressing an oncogene .