The Niche

Stem cell patents may hold, even internationally

Chris Scott, who researches ethical and legal issues involving stem-cell research at Stanford had this to say about Jeanne Loring’s recent commentary on Nature Reports Stem Cells.

Jeanne Loring’s commentary on the WARF patent situation is an insider’s look at the motives and arguments for challenging one of biology’s most contentious and important set of patents. Her statements, “WARF has tried to get the same patent issued in multiple countries and failed. Other countries have not even allowed patenting of human ES cells,” give clues to the complexity of the international scene. In the EU, legal challenges to hESC patents can center on ethical, rather than technical arguments. Invoking so-called “morality clauses” contained in the European Union’s 1998 Directive on Biotechnological Inventions, some jurisdictions and agencies (including the European Patent Office and the German Intellectual Property Office) rule unpatentable any invention that results from

the uses of a human embryo “for industrial or commercial purposes.”

But other countries do not. The United Kingdom, for example, has granted patents using hESC lines to a number of for-profit and academic institutions. Sweden has issued one such patent. Even the EPO itself has been inconsistent in its rulings.

Therefore, the situation in Europe is quite fluid and not monolithic, because individual nations can interpret the Directive’s language in ways that are consistent with national frameworks of values and beliefs. As the US challenge unfolds, the enemy (or ally, depending on your point of view) is time. Patent reexaminations can take years to resolve. Here, time may favor the patent holders.

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