Although the recent decision of the British High Court to revoke Genentech’s U.K. patent covering human tissue plasminogen activator is open to appeal, the legal issues have been clearly drawn in a lengthy judgment by Mr. Justice Whitford (THE SCIENTIST, July 27,1987, p. 4). The basic question is whether the first group to produce a particular known protein by genetic engineering methods is entitled to broad product protection that, in effect, covers all such ways of making the same product or a product so similar in composition that it has essentially the same biological activity.

In the TPA patent, the invention is said to be “based on the discovery that recombinant DNA technology can be used successfully to produce human tissue plasminogen activator... m amounts sufficient to initiate and conduct animal and clinical testing as prerequisites to market approval.”

The patent contains a series of product claims covering human...

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