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The OncoMouse or Harvard mouse is a type of laboratory mouse that has been genetically modified using modifications designed by Harvard University and DuPont 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.

Patent applications on the OncoMouse were filed back in the mid-1980s in numerous countries such as in the United States, in Canada and in Europe through the European Patent Office (EPO).

Contents 1 Patent procedures 1.1 Canada 1.2 Europe (through the EPO) 1.3 United States 2 References 3 Further reading 4 See also

In Canada, the Supreme Court 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. On 7 October 2003, CA patent 1341442 was issued to Harvard College covering, in part, methods of using the transgenic animals for testing compounds. CA 1,341,442 expires in 2020.

European patent application 85304490.7 was filed in June 1985 by "The President and Fellows of Harvard College". It was initially refused in 1989 by an examination division of the European Patent Office among other things on the grounds that the European Patent Convention (EPC) excludes patentability of animals per se. The decision was appealed and the Board of Appeal held that animal varieties were excluded of patentability by the EPC (and especially its Article 53(b)), while animals (as such) were not excluded from patentability. ^[1] The examination division then granted the patent in 1992 (its publication number is EP 0169672).

The European patent was then opposed by several third parties, more precisely by 17 opponents, notably on the grounds laid out in Article 53(a) EPC, ^[2] according to which "inventions, the publication or exploitation of which would be contrary to "ordre public" or morality are excluded from patentability. After opposition proceedings took place in November 2001, the patent has been maintained in amended form. This decision was then appealed and the appeal decision was taken on July 6, 2004. ^[3] The case was remitted to the first instance, i.e. the opposition division, with the order to maintain the patent on a newly amended form.

In 1988, the United States Patent and Trademark Office (USPTO) granted U.S. Patent 4,736,866  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 (U.S. 5,087,571) and testing methods using transgenic mice expressing an oncogene (U.S. 5,925,803). U.S. 5,925,803 expires in July 2016.

• Andrew Sharples, The EPO and the Oncomouse: good news for whales, giraffes and patent examiners, The CIPA Journal, April 2003

• Biological patent