WASHINGTON -- The National Institutes of Health onWednesday fulfilled its May 28 promise to assert inventorshipinterest in AZT by granting Barr Laboratories a non-exclusivelicense rights to the AIDS drug.

Burroughs Wellcome, which claims to be the sole patent holderand currently is the only company approved to market AZT,responded with a stinging rebuke. The company accused the NIHof "unwise intrusion by government" into a lawsuit thatBurroughs brought against Barr after Barr sought Food and DrugAdministration approval to market a generic version of AZT.

"The NIH has no rights in these patents, and therefore it hasnothing which can be licensed or sold to Barr," said Burroughsspokeswoman Sharon Haggerty.

The NIH's action will have little effect on Barr's ability tomanufacture AZT, an issue that will be decided by the lawsuit,although the NIH has offered its support to Barr. "NIH has alsogranted Barr Laboratories the right to litigate thegovernment's inventorship/ownership in the AZT patents andhas said it will cooperate with Barr Laboratories in the patentlawsuit brought by Burroughs Wellcome against Barr," saidLouis Guerci, NIH vice president of finance.

"We have provided Barr Laboratories with copies of relevantdocuments and are making our scientists who were involved inthe AZT study accessible to Barr," said Reid Adler, director ofthe NIH's office of technology transfer. He noted thatBurroughs has filed subpoenas that will also give it access NIHscientists and documents.

Burroughs Wellcome accused the NIH of "trying to rewrite therules" under which cooperative research on AZT, whichinvolved government and Burroughs scientists, was conducted."The NIH action raises a serious question about whetherprivate companies, the source of most new drugs, can continueto collaborate with government scientists if they risk havingproprietary rights and patents challenged years later,"Haggerty said.

"The NIH and Burroughs Wellcome did not have a writtenagreement to govern their collaboration, so I don't really feelthat NIH is trying to rewrite any agreements, since noneexisted," Adler said.

-- Kris Herbst BioWorld Washington Bureau

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