In 1996, Dolly the Sheep made headlines all over the world. Dolly the Sheep was the first mammal to have been cloned from an adult cell using somatic cell nuclear transfer, in which a cell is placed in a de-nucleated ovum, the two cells fuse and then develop into an embryo. Although, Dolly the Sheep was eventually euthanised on February 14, 2002, her legacy is alive and well.
In the US, the Roslin Institute obtained patent protection for the cloning method as defined in U.S. Patent No. 7,514,258. This initial patent will expire in 2016. Various other related patent applications were filed including U.S. Patent Application No. 09/225,233 which covers products of the cloning method, including for example, claim 155 directed to “a live-born clone of a pre-existing, nonembryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats”. On 8 May 2014, as many of our US colleagues have reported, the US Federal Circuit Court affirmed the decision that the claims of U.S. Patent Application No. 09/225,233 are not patentable eligible subject matter under 35 U.S.C. § 101. The US Federal Circuit Court held the claims were invalid on the basis that Dolly the Sheep which is a “product of nature” does not exhibit “markedly different characteristics” from the donor mammal. It is interesting to note that the Court did not reject the claims on the basis that they related to “a product of nature” per se. The specific rejection was on the basis of the (unsurprising) identity of the clone to the donor mammal and could be argued to be a further extension of last year’s Myriad decision by the Supreme Court.
This new decision is in contrast with the approach taken in Europe where it is established jurisprudence that biotechnological inventions are essentially patentable. There are some specific exceptions arising from EU Biotechnology Directive 98/44/EEC and Article 53(b) EPC. However, in Europe it is accepted that any exclusion to patentability must be construed narrowly.
In line with Article 53(b) EPC, Rule 27(b) EPC now specifically confirms that plants or animals are patentable if the technical feasibility of the invention (e.g. a genetic modification) is not confined to a particular plant or animal variety. One of the earliest test cases on this issue was the early Oncomouse case, which covered a mouse containing the myc oncogene used in cancer testing, and was eventually held patentable. Although, the patent for the Oncomouse has long expired, this case confirmed that in principle it is possible to obtain a European patent for a non-human transgenic animal produced by genetic modification. This case led to the development of the “Oncomouse test” which involved a morality type assessment of whether the process for making the transgenic animals would be likely to cause the animals suffering without any substantial medical benefit to man or animal. Further to the implementation of the EU Biotechnology Directed, this test is now recited in the EPC as Rule 23d(d) EPC. Thus, in Europe the patenting of transgenic animals is permitted.
This is in line with the patents obtained in Europe relating to the Dolly the Sheep technology which covered both the cloning method and any cloned animals produced as a result, see for example European patent no. 0,849, 990, GB patent no. 2,318,578 and GB patent no. 2,331,751.
Although, it is not necessarily the end of the road for Dolly the Sheep in the US, as an appeal may still be filed with the US Supreme Court, this decision highlights the ever growing differences between US and European Patent Practice when dealing with the post-Myriad patent eligibility of so-called natural products.