The OncoMouse or Harvard Mouse is a type of laboratory mouse that has been genetically modified utilizing modification designed by Philip Leder and Timothy A. Stewart, of Harvard University, to carry a certain gene called an activated oncogene. The activated oncogene considerably increases the mouse’s vulnerability to cancer, therefore making the mouse suitable for cancer research. The rights to the invention were owned by DuPont until recently. The USPTO found that the patent expired in 2005, meaning that the OncoMouse is now free for use by other parties.

Patent applications on the OncoMouse were filed back in the mid-1980s in a number of countries such as the United States, Canada, Europe and Japan.

In Canada, the Supreme Court rejected the patent in 2002 in Harvard College v. Canada (Commissioner of Patents), overturning a Federal Court of Appeal verdict which ruled in favor of the patent. However, on October 7, 2003, Canadian patent 1,341,442 CA 1341442 was granted to Harvard College. The patent was modified to exclude the “composition of matter” claims on the transgenic mice. The Supreme Court had rejected the whole patent application on the basis of these claims, but Canadian patent law enabled the modified claims to grand under pre-GATT rules and the patent remains valid until 2020.

European patent application 58304490.7 was filed in June of 1985 by “The President and Fellows of Harvard College”. It was, at first, refused in 1989 by an Examining Division of the European Patent Office among other things on the basis 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, while animals were not excluded from patentability. The Examining Division then granted the patent in the year 1992.

The European patent was then opposed by several third parties, more specifically by 17 opponents, especially on the grounds laid out in Article 53(a) EPC, 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 occurred in November of 2001, the patent was maintained in a modified form. This decision was then appealed and the appeal decision was taken on July 6, 2004. The case was ultimately remitted to the first instance, with the order to maintain the patent on a newly modified form. However, revocation of the patent was finally published on August 16, 2006, more than 20 years after the filing date, for failure to pay the fees and to file the translations of the modified claims under Rule 58(5) EPC 1973.

In 1988, the United States Patent and Trademark Office granted U.S. Patent 4,736,866 to Harvard College claiming “a transgenic non-human mammal whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal…” The claim clearly excluded humans, apparently reflecting moral and legal concerns about patents on human beings, and about modification of the human genome. Surprisingly, there were no US courts called to decide on the legitimacy of this patent. Two separate patents were issued to Harvard College covering techniques for providing a cell culture from a transgenic non-human animal and testing techniques using transgenic mice expressing an ontogeny. The patent has been found to expire in 2005 by the USPTO. DuPont is presently bringing suit in the Eastern District of Virginia.

Image Caption: Common house mouse (Mus musculus), wild type. Credit: Wikipedia