Genentech Patent Voided

LONDON—Genentech's British patent on the blood clot-dissolving tissue plasminogen activator (TPA) has been revoked after a three-week trial that featured some of the world's leading biotechnologists. But High Court Justice John Whitford was not persuaded by the assertion of Nobel laureate Paul Berg of Stanford that Genentech had a monopoly on the skills needed to make TPA by recombinant DNA techniques when it filed its patent application in May 1983. Biochemist WJ. Brammar of the Universit

Jul 27, 1987
John Stansell
LONDON—Genentech's British patent on the blood clot-dissolving tissue plasminogen activator (TPA) has been revoked after a three-week trial that featured some of the world's leading biotechnologists.

But High Court Justice John Whitford was not persuaded by the assertion of Nobel laureate Paul Berg of Stanford that Genentech had a monopoly on the skills needed to make TPA by recombinant DNA techniques when it filed its patent application in May 1983. Biochemist WJ. Brammar of the University of Leicester had told the judge, on behalf of Welicome, that all the techniques quoted in the patent were known to him on the application date.

"This patent should never have been granted," Whitford told a packed court. "I shall start [my judgment] by assuming that a [limited] claim to a process is possible. But in my view it cannot be spread to a broad claim." The one claim that may be acceptable, he said, is for a plasmid that Genentech has isolated in its development of a technique for producing TPA. The judge's ruling means Genentech cannot claim licensing fees from any company that decides to produce TPA, nor can it begin proceedings to seek such fees.

In a two-hour reading July 7 of his 87-page decision, the judge focused on the first three of Genentech's 20 claims, namely, that recombinant human TPA is essentially free of other proteins of human origin, unaccompanied by associated native glycosylation, and produced by recombinant DNA technology.

The first claim, he said, was ambiguous and overly broad. For example, he said, it would not cover human TPA that contained proteins not of human origin. The second, he said, was too broad under Patent Institute conventions, and the third was too wide.

Whitford described how both sides had agreed on some areas of knowledge that were widely known when the patent was filed. But he suggested that some decisions had been based more on legal than scientific grounds, referring to an admission from a scientist testifying on behalf of Genentech that his side's thinking on one point had changed very recently, perhaps within a few weeks of the opening of the case in June, as lawyers prepared for the trial.

In rejecting Genentech's claim that it was the only firm to use recombinant DNA to produce large quantities of TPA, the judge noted that New York's Cold Spring Harbor Laboratory is working with Wellcome on such a project. Joseph Sambrook, a former Cold Spring biochemist now at the University of Texas Health Sciences Center, testified that he had been interested in plasminogen activators since the late 1970s and had learned about TPA in 1980. Sambrook described a collaborative project, begun in January 1982 with Baxter Travenol and Genetics Institute, to try to produce TPA by gene cloning techniques.

Genentech is expected to appeal the decision. If it loses that appeal, which would normally not be heard for at least 18 months, it can take its case to the House of Lords.

Stansell is technology editor of Financial Weekly magazine in London.


Glaxo Stock Tracks Medical News

LONDON—Recent sharp swings in the share price of Glaxo demonstrate how the perceived value of a pharmaceutical company's products can affect its financial standing.

On June 18 the New England Journal of Medicine (vol. 316, pp. 1557-61) published a paper by Brendan Drumm and colleagues in Toronto indicating that duodenal ulceration may be linked to infection from the bacterium Campylobacter pylori. This news appeared to threaten sales of the company's Zantac, the world's best-selling prescription drug, which does not act against the bacterium in curing ulcers. As a result, the company's stock price that day dropped $1 (to £17.25) and continued to fall for several days.

On June 25, however, it rose nearly $1, to £17.40. The upturn reflected a favorable report in The Lancet (1987, vol.2, pp. 1461-2) about the use in two London hospitals of a product to prevent vomiting in patients undergoing chemotherapy for cancer.