Burroughs Wellcome Co. has won sole ownership of its patentson the AIDS drug AZT, according to a ruling by federal JudgeMalcolm Howard last week. But the ruling has raisedfundamental questions about the definition of ownership andwhether it is possible to separate legally the conception of anidea from its reduction to practice.

The case, which will now proceed to the U.S. Court of Appeals,may well have far-reaching implications, including inbiotechnology.

The defendants, generic drug companies Barr Laboratories(ASE:BRL) of Pomona, N.Y., and Novopharm Ltd. of Canada hadargued that Burroughs' patents are invalid because they didnot name scientists at the National Institutes of Health (NIH) asco-inventors. They claimed that tests performed in the NIHlabs were critical to development of the drug as a treatment ofAIDS. (The NIH designated Barr Labs to represent it in thislitigation.)

But Howard ruled that "the evidence in this case isoverwhelming and conclusive" that only Burroughs Wellcomeinventors "... first conceived of the idea of using AZT as atherapy for treating persons infected with HIV."

According to patent law, inventorship really consists of twoseparate but normally inexorably intertwined parts: theconception of the invention and its reduction to practice. But inhis ruling in U.S. District Court in New Bern, N.C., Howardsingled out the aspect of conception, saying, "The law doesn'trequire that the inventor's idea be reasonable, scientificallyaccurate or capable of being proved."

And it's that definition of conception that prompted BarrLaboratories and Burroughs Wellcome to ask the judge to ruleon the case, even though it was only beginning. "The order ...paves the way for the U.S. Court of Appeals to hear the casebefore all evidence has been presented," said Barr Labs. "Anappeal ... allows the appellate court to resolve the key legalquestion in this case ... the definition of conception in patentlaw."

Conception of invention is a "fundamental question that iswrapped into almost any invention," said Kenneth Madsen, apatent law specialist with the New York firm Kenyon & Kenyon."Most of the time conception is not independent from reductionto practice," he continued, "but occasionally the concept of aninvention is completed before it has been reduced to practice."

In this case, Madsen said, Burroughs is claiming that "it had thecomplete invention in its head and all the NIH people did wascarry out the idea." Barr Laboratories' president, Bruce Downey(himself an attorney), echoed this thought. Burroughs wouldsay that "simply because you thought of it, that's good enough,"he told BioWorld. "We say there was no reasonable basis tobelieve that AZT would inhibit HIV replication until it wastested by the NIH scientists in a test tube."

Downey told BioWorld that his company believes that "theremust be some reasonable basis for believing this idea will beuseful." And that's the tricky part of this issue, said Madsen."How much does the inventor have to have in mind? The judgesaid it's subjective," Madsen told BioWorld. "If the inventor hasa clear idea, that's enough, even though the inventor hasn'tshown a reasonable way to get from the idea to the invention."

The AZT case now will be heard in the U.S. Court of Appeals forthe Federal Circuit, the ultimate arena for patent litigation inthe U.S. Howard has already acknowledged in his order that thefinal outcome of the case will be controlled by a resolution ofthe issue of conception of an invention.

And because this issue is a "fundamental proposition of patentlaw," it could affect all inventors, Madsen said. This certainlyincludes biotechnology, where the issue of conception isalready critically important in interference proceedings.

-- Jennifer Van Brunt Senior Editor

(c) 1997 American Health Consultants. All rights reserved.