Wednesday, December 3, 2008

WARF Unable to Persuade EPO Enlarged Board of Appeal to Allow Human Embryonic Stem Cell Claims

On November 25, 2008, the European Patent Office (EPO) Enlarged Board of Appeal (EBA) affirmed a Technical Board of Appeal (TBA) decision refusing a Wisconsin Alumni Research Foundation (WARF) patent application claiming cultured primate embryonic stem cells. (The EBA can be analogized to the Supreme Court of the EPO.) The corresponding US patent, No. 5, 843,780, has been the subject of controversy in the US, but nonetheless recently survived an ex parte reexamination challenge. The inter partes reexamination of a related WARF stem cell patent was discussed in a previous post. An appeal of that decision is currently pending.

In its decision, the EBA held that WARF’s stem cell claims violate Rule 28(c) of the Implementing Regulations to the European Patent Convention, which states “[u]nder Article 53(a), European patents shall not be granted in respect of biotechnological inventions which [uses] human embryos for industrial or commercial purposes.” The EBA based its decision on the fact that, at the time the application was filed, production of the claimed stem cells necessarily entailed the use and destruction of a human embryo, which the Board characterized as an industrial purpose within the meaning of Rule 28 (c). WARF argued that the claims are directed to cells, not embryos, but the EBA found that Rule 28(c) applies not only to subject matter of the claims but rather to the invention as a whole, which includes the methodology required to make the claimed invention.

WARF argued that the claimed embryonic stem cells could be used for research purposes, and that research is not “industrial or commercial” in nature. However, the EBA pointed out that Article 28(c) traces its origin to Article 6(c) of the Directive 98/44/EC of 6 July 1998. As originally drafted, Article 6(c) would have banned the patenting of any method in which human embryos are used. However, in order to allow the patenting of inventions which could be used to treat human embryos, i.e., procedures designed to benefit a human embryo, the Article 6(c) was amended to recite “uses of human embryos for industrial or commercial purposes.” In other words, the industrial or commercial purposes limitation was intended to allow for the patenting of inventions intended to benefit a human embryo, not to permit the patenting of inventions which exploit (let alone destroy) human embryos for research purposes. The EBA found that European legislators were concerned with preventing misuse in the sense of a commodification of human embryos, and that one of thire essential objectives was the protection of human dignity. The Board also pointed out that, consistent with its interpretation of legislative intent, the European Community excludes funding for research which results in the destruction of human embryos, including for the procurement of stem cells.

WARF further argued that the term “embryo” as used in Rule 28(c) should be interpreted as limited to embryos of 14 days or older. However, the EBA found that this narrow interpretation would be inconsistent with the intent of European legislators, pointing out that under German law an embryo is defined as including a fertilized egg, and UK law defines an embryo so as to encompass a two cell zygote and an egg in the process of fertilization. The EBA rejected also characterized WARF’s proposed narrow definition of embryo as inconsistent with a legislative intent to protect human dignity and prevent the commercialization of embryos.

WARF, and other interested parties who voiced their opinions in the case, urged the EBA to find the invention patentable based on “balancing the benefits of the invention for humanity against the prejudice to the embryo.” However, the EBA found that it was not the proper forum to decide such policy issues, particularly given the clear legislative intent to exclude inventions such as the one at issue from patentability.

Finally, WARF argued that the claims should be patentable because today the claimed human embryonic stem cells could be derived directly from other human embryonic cell lines, thereby avoiding the necessity for further destruction of human embryos. But the EBA rejected this argument also, finding that when assessing whether a claim contravenes Rule 28(c), technical developments which became publicly available only after the filing date cannot be taken into consideration. To hold otherwise, according to the EBA, could unduly prejudice the rights of a third party who might later provide an innocuous way to carry out the invention (presumably a method not involving the destruction of human embryos).

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