WASHINGTON -- U.S. lawmakers are considering two pieces ofbiotechnology-related legislation.

The Biotechnology Patent Protection Act is expected to bereported out of the Senate Judiciary Committee next Thursday,and voted on shortly thereafter. And Rep. Ron Wyden, D-Ore., isfloating a bill that would require the federal government andits private grantees to negotiate a pricing formula beforesigning grant agreements. The bill would also require theNational Institutes of Health, whenever possible, to stimulatecompetition by co-licensing more than one company to developand market a product.

The patent protection legislation would close a loophole thatallows foreign companies to market products in the U.S. thathave been patented in the U.S. It would also clear up confusionengendered by two patent cases on the Federal Circuit, in reDurden and in re Pluderman, which has made processpatenting extremely difficult.

Late last year, the patent protection act passed the Senateunanimously; the House never had a chance to vote on the bill.

Before the House acts this year, the bill must be reported out ofthe House Judiciary Committee. Rep. William Hughes, D-N.J., thecommittee chairman, told BioWorld that he considers the billimportant. But he is waiting to act on it until another FederalCircuit case, in re Ochai, is decided. He said that case couldresolve the conflict between Durden and Pluderman. If it doesnot, "or if it's not resolved in an expeditious fashion, then weare going to move ahead with hearings," he said. He declined toplace a time frame on when this might take place.

The Industrial Biotechnology Association strongly supports thelegislation. "IBA has made numerous suggestions to (thesponsor and the various co-sponsors), and so we think this billwill be extremely helpful to the biotechnology industry inprotecting biotechnology inventions from foreign-basedinfringement," said Lisa Raines, IBA's vice president forgovernment relations.

But Wyden's bill, which currently is being circulated forcomment, has drawn considerable ire from the biotechindustry. The requirement for multiple licensing "would drivethe industry away from NIH the way it did in the early 1960s,"said Peter Barton Hutt, former chief counsel to the FDA.

At that time, "the government policy was not to grantexclusive licenses, and as a result, the National Cancer Instituteand other institutes were unable to find corporate partners,"Hutt said. "NIH found they had to change the policy."

"It's a totally dumb idea," agreed Raines. "We have suggestedthat a better approach is for the government to license drugs inexchange for a royalty on sales. If the government then wantsto use some or all of the proceeds to fund access programs forpeople who do not have health insurance, or to subsidize theproduct for some patients, the government would have thefunds to set up such a program, and we would have noobjection to that."

Nor is there a way to establish rational pricing formulas beforedrug development takes place, Raines and Hutt agreed.

But Abbey Meyers, executive director of the NationalOrganization for Rare Disorders, looks more favorably on thebill. "I'm not sure it's the right solution," but the industrybrought the problem upon itself, she said. "There are peoplewho have told me that they would rather die than take(Genzyme Corp.'s Ceredase)" because the drug's $350,000annual cost "would leave their families impoverished.

As for Taxol, Meyers said she doesn't know whether or not theprice is right, but she blames the controversy surrounding it onBristol-Myers Squibb's "stubbornness in not going public withthe amount of money they have spent."

-- David C. Holzman Washington Bureau

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