A Dangerous Import

In 1999, a patent was issued to the University of Edinburgh (EPO Patent No. 0695351) for a method of isolating and/or enriching and/or collectively propagating stem cells. As issued by the European Patent Office, the patent covered all stem cells, including embryonic stem cells. Fourteen parties opposed the patent, including Greenpeace, the Alliance for the Right of Life, and the Green Party of Germany on morality grounds, which is not an avenue for opposition in the United States. Some of the opponents also argued that the granting of the patent should be revoked because of lack of novelty, inventive step (a combination of prior art references that allegedly makes the invention obvious), and sufficiency (the invention as claimed is not sufficiently supported by the specification).

Edinburgh ultimately had to amend its claims to cover only animal stem cells other than embryonic stem cells. The patent office's opposition board found that claims to all embryonic stem cells violated the morality clause and that such claims did not meet the sufficiency requirement. The board approved claims amended to exclude embryonic stem cells. Edinburgh appealed the decision, stating that the decision on sufficiency was made with an eye on moral issues. The patent was initially granted in 1999, and a final decision has still not been reached some six years later.

In Europe, patents can be opposed on ethical grounds such as in the Edinburgh case and are referred to as ethical oppositions. If considered by the governing patent body, these oppositions have a chilling effect on the value of the intellectual property (IP): Whatever the final outcome, while the case is being reviewed, the IP is not considered settled. A move is now underway to bring oppositions to the United States.

As everyone is aware, numerous groups in the United States oppose research in embryonic stem cells and hence would oppose these patents. There have also been a number of opponents to transgenic food and the patenting of portions of the human genome. An opposition filed on moral grounds by itself would not likely cause a problem if the third parties did not look for other grounds such as enablement (a person of ordinary skill in the art can make and use the invention without undue experimentation) and descriptive support, and prior art issues (anticipation and obviousness). However, problems could arise if the third party also argued on these other grounds. Even if a patentee believes an opposition is frivolous, the opposition must be taken seriously because it cannot take the chance that it will lose. In Europe, a fully contested opposition can now take about seven years. Even if one ultimately prevails, the patent is under a cloud during this time, and this can cause serious consequences in terms of the ability to license, partner, raise money, or otherwise proceed.

Currently in the United States, the ability to have a third party argue against the patentability of a patent is limited. A procedure called reexamination allows a third party to argue before the US Patent and Trademark Office (PTO) that prior art would render the patent invalid. However, one cannot bring up issues regarding enablement and descriptive support.

An opposition process similar to that in Europe is part of proposed legislation by the PTO and IP groups. The change is sought to offer an inexpensive alternative to litigation. Third parties who believe that a patent should not be granted could go before a tribunal and provide reasons why the PTO erred in allowing the patent. This could be done without the substantial cost that occurs in the United States during litigation. But, the harms to the system protecting the value of IP and the progress in biotechnology could outweigh any perceived benefits.

Ronald I. Eisenstein is a partner engaged in IP connected with biotechnology in the Technology and Intellectual Property Group at the law firm Nixon Peabody in Boston. The views expressed in this column represent those of the author and do not represent those of Nixon Peabody or its clients.