EPO - Patentability of Animals
The European Patent Office (“EPO”) has, at last, issued its final decision on the Harvard Oncomouse case.
This application has one of the longest and most involved prosecution histories ever documented, encompassing over 20 years and thousands of documents filed with the EPO.
The application’s history was not unusual at first. The application was filed with the EPO on June 24, 1985, published on January 29, 1986, subjected to a summons to oral proceedings and, by November 1989, on appeal.
When third parties started submitting observations to the EPO under Article 115(1) EPC in December 1989, however, the application started to make history. The EPO acknowledged receipt of over 60 third party observations until the Appeals Board ruled favorably on the application. Grant of the resultant patent was published nearly seven years after filing, on May 13, 1992.
Under European practice, third parties had up to nine months after publication of grant, until February 13, 1993, to oppose the grant of a patent. At least 17 oppositions were filed against the new Oncomouse patent. Proceedings relating to these oppositions, including a whole new set of appeals proceedings, continued for the next 12 years. In March of 2005, the Technical Appeals Board issued a 140+-page decision in favor of the patentee.
The result of these twelve years of opposition may be summarized as follows:
The main product claim of EP 0 169 672 B1, granted in 1992, read “A transgenic non-human mammalian animal whose germ cells and somatic cells contain an activated oncogene sequence as a result of chromosomal incorporation into the animal genome, or into the genome of an ancestor of said animal, said oncogene optionally being further defined according to any one of claims 3 to 10.” [Emphasis added].
The Opposition Division found that the claims although in principle patentable were too broad and upheld the patent with claims restricted to rodents containing the specified genes rather than mammals in general on the ground that such laboratory animals as rats and mice are routinely used as test animals so that application of Rule 23d(d)'s harm/benefit analysis favored allowing use of such animals for research where permitted by the laws of the member states, whereas such considerations did not apply to other types of animals. [2003] OJ EPO 473. On appeal, the claim was limited to a mouse on the basis that the case contained no evidence that a medical benefit would be obtained by modifying all types of rodents to make them more susceptible to cancer. The Appeal Board held that since there were many species of mice, whatever the true meaning of “animal variety” might be, a claim to a transgenic mouse was not precluded as being to such a variety.
The patent that survived so many battles may now go abandoned at the EPO for failure to comply with minor formalities. The EPO sent a letter in May 2005 to the patentee advising that printing fees needed to be paid and amended claims submitted within a time-certain for the patent to reissue, and sent a reminder on November 23, 2005 with a final two-month term for completing the formalities. According to public record as of January 20, 2006, the fees and claims had not been received by the EPO.
