Issues Clear in the U.K. Genentech Decisions

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 TPA in forms other Orlov, a dissident Soviet physicist, was released from internal exile following a prison sentence by the Soviet Union in October 1986. He is senior scientist at Cornell University, Ithaca, NY 14853. This is a shortened version of a talk “Human Rights and Peace,” on disarmament, trade and human rights, given at the annual meeting of the National Academy of Sciences, April 27, 1987, in Washington, D.C. than the naturally occurring substance. These claims to “artificial” TPA specify the product variously as free from other human proteins, as unglycosylated, as essentially pure, or as produced by recombinant DNA techniques. In the suit brought by Wellcome the court accepted that the discovery of the DNA coding sequence and de duced amino acid sequence of human plasminogen activator on which this patent was based was Genentech’s discovery, but noted that it has been also accepted by other workers as desirable to produce TPA in quantity by recombinant DNA methods. The expert witnesses had agreed to a 26-point statement on the state of the art at the date of the U.S. Genentech application (May 1982) on which the U.K. patent was based. Casting one’s mind back to what was a commonplace method for the skilled worker some years earlier is always difficult but is a frequent feature of patent litigation. In this case, one important issue was how well known the oligonucleotide priming and probing techniques for screening c-DNA li braries were. After much probing of the expert evidence, the judge concluded that although the use of this technology was by no means straightforward, the Genentech achievement would have justified only a limited process claim but not the broad product claims. The latter were too wide, being directed to “an obviously desirable and potentially possible end reached by routes on which only limited guidance is given.” Had Genentech been the first to discover TPA or its desirable properties, such broad product claims would have been acceptable. The judge decided the case under the 1977 Patents Act, but quoted legal precedents going back more than a century. These deal with the question of how far a patent can go in claiming a principle, as distinct from a particular method for carrying that principle into effect. The crucial problem for inventors and patent lawyers in this field is to learn how to draw the line between product definitions that, as in this case, are too broad and insupportable and those that are so narrow they can easily be avoided by competitors. Broad product patents of this kind have been issued in the United States in recent years, but the European Patent Office is known to take a much stricter line. If this decision is upheld on appeal, the case will be an important signpost for genetic engineering patents throughout Europe. This decision applies only to a naturally occurring protein previously isolated from cells in which it is produced naturally. Had Genentech produced a new and valuable variant of TPA, the judge stated that the company’s claim might have been honored. But to give it protection now would create a “monopoly which would stop others attempting to discover alternative, possibly wholly unknown and possibly better routes to that end” and the effect “would be to stifle research which, in the public interest, it ought to be open to other investigators to pursue.” It follows that protein engineering that adapts recombinant methods to produce new proteins would receive more sympathetic treatment under patent law. Crespi is patents controller at the British Technology Group, 101 Newington Causeway London SEl 6BU, UK.

Issues Clear in the U.K. Genentech Decisions

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