WASHINGTON -- The National Institutes of Health has enteredthe patent dispute over the AIDS drug AZT, reflecting anintensified desire to protect the government's interest infederally funded research, according to NIH officials.
NIH Director Bernadine Healy announced on Tuesday that"investigators at the National Cancer Institute (NCI) shouldhave been named as co-inventors" on the AZT-related patentsissued to Burroughs Wellcome Co. and that the NIH may act toacquire patent rights to AZT, the only Food and DrugAdministration-approved treatment for AIDS.
Burroughs and Barr Laboratories are sparring in federal courtover the validity of Burroughs' AZT patents. Barr has requesteda non-exclusive license for AZT -- to the extent that the NIHmay have rights to the AZT patents -- in connection with itsapplication to the FDA to manufacture and distribute a genericform of the drug.
"NIH is contemplating the granting of this license so that thecompany legally would be able to market AZT if it is ultimatelydetermined ... that the government is entitled to inventorshipstatus," Healy said.
"In that event," she said, competition would result in a lowerprice for AZT."
Representatives of the AIDS Health Group, as well as severalAIDS patients, also filed a lawsuit in March challenging thevalidity of Burroughs' AZT patents and seeking greater accessto the drug.
The AZT dispute is the first conflict between the NIH and theindustry over intellectual property rights, but it probably won'tbe the last, according to Reid Adler, head of the NIH's office oftechnology transfer.
"This case does not represent a sea change for NIH," Adler toldBioWorld. "The critical event in our technology transferinterests (was the) enactment of the Federal TechnologyTransfer Act in 1986, which encourages all government labs toenter into joint research projects with companies andaggressively license inventions made in the labs," said Adler.
"The AZT case really reflects NIH's obligations to assess itsintellectual property rights that arise in the course of itsongoing research programs. It was just a matter of time before... a government agency became involved in a difference ofopinion about inventorship," Adler said.
Although Healy has vowed to give preeminence to the publicinterest in commercial relationships between the NIH and theindustry, the AZT case does not mark the beginning of a moreadversarial relationship with the industry, according to Adler.The NIH has been trying privately to resolve its disputes withBurroughs for five months, he said.
"We are concerned about how we interact and how we areperceived by our industry collaborators," he added.
-- Steve Usdin BioWorld Washington Bureau
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