Drug Companies Object as Columbia U. Asks Powerful Alumnus to Push Patent-Law Change By JEFFREY BRAINARD
Washington
Columbia University has drawn criticism from pharmaceutical companies for asking Sen. Judd Gregg, a Columbia alumnus, to push for a change in patent law that could help it to extend a patent for a biotechnology-manufacturing process -- a change that could bring the institution more than $35-million.
Mr. Gregg, a Republican from New Hampshire, inserted the sought-after language at Columbia's request in the Senate version of the bill that finances the Agriculture Department. He sits on the Appropriations Committee, which approved the bill, S. 2536, last week.
Spokesmen for two associations of pharmaceutical manufacturers on Thursday called the change unjustified. Mr. Gregg's action short-circuited the hearing process, which would allow for public debate about Columbia's request, said G. Thomas Long, legislative director for the National Pharmaceutical Alliance, an organization of generic-drug makers.
However, Michael M. Crow, executive vice provost at Columbia, said that Columbia was seeking the same benefit that makers of patented drugs already enjoy -- to extend patent protection for products whose commercialization has been delayed because of regulatory review. He said the university hoped to extend the patent, which expires in August, for an additional 18 months.
The university has collected royalties of 1 percent, or about $280-million, on sales totaling $28.3-billion since 1988, Mr. Crow said. Twenty percent of the royalties are given to four faculty members who invented the process, which is called "co-transformation."
Thirty-four companies have developed 14 drugs based on genetically engineered proteins using the manufacturing process. The products are used to treat breast cancer, hemophilia, multiple sclerosis, and several other conditions.
The statutory change sought by Columbia would amend a 1984 law, known as the Hatch-Waxman Act, that aided drug manufacturers. It gave makers of patented drugs extensions of up to five years on patents of new brand drugs. The extensions were meant to offset delays in the Food and Drug Administration's approval process that stymied the products' arrival on the market.
Columbia first patented the manufacturing process in 1983, and it licensed the patent nonexclusively to several manufacturers. But the companies did not win F.D.A. approval to begin marketing new pharmaceuticals developed using the process until about 1988, Mr. Crow said.
Columbia is seeking an extension based on the same F.D.A. formula that governs extensions for patented drugs. Mr. Crow estimates that the formula could allow the university an additional 18 months of longevity for its co-transformation patent.
Enter Mr. Gregg. Although Columbia was certainly aware of his alma mater -- he was in the Class of 1969 -- the university also requested Mr. Gregg's help because of his senior position in Congress's Republican leadership. The New York senators and congressman who represent Columbia are all Democrats, and thus lacked the same influence in the G.O.P.-controlled Congress, Mr. Crow said.
"We talk to everyone we can talk to" to advance the university's research mission, he said. Columbia reinvests all of its royalty income in its research activities, unlike corporations, which reap profits, he noted.
Before coming to Columbia in 1991, Mr. Crow was an administrator at Iowa State University, where he became renowned for his skill at securing Congressional support for that institution's research activities. Iowa State received millions of dollars in earmarks -- noncompetitively awarded funds provided for specific projects -- that were inserted into appropriations bills by members of Iowa's Congressional delegation.
Because Mr. Gregg did not include the change in a bill separate from the appropriations process, the proposal may not have the opportunity to go through the same scrutiny that surrounded the Hatch-Waxman Act, said Mr. Long of the National Pharmaceutical Alliance. Members of his group sell versions of name-brand pharmaceuticals at reduced rates, and thus oppose undue extensions of patents. Such extensions often translate into higher prices for consumers, he said.
Mr. Long also worried that the change would encourage makers of patented, name-brand drugs to ask members of Congress to include language extending patents on those products. Individual lawmakers have supported such requests in recent years, although the proposals have not passed the full Congress.
"This is the wrong way to go about introducing a concept that is more complex than it appears on its face," he said. "To be done correctly, this should be done in a full and public way."
Mr. Crow, however, views the proposed change as a "technical correction" of the Hatch-Waxman Act. He said the language does not raise broad policy questions that merit a full hearing. The proposed language was narrowly crafted to apply to Columbia's situation, he added. It does not mention Columbia by name, but applies only to nonprofit owners of patents similar to the university's.
Other universities have patents on manufacturing processes. But Louis P. Berneman, immediate past president of the Association of University Technology Managers, said he did not know how many institutions might benefit from the language sought by Columbia.
A spokesman for Mr. Gregg, Edmund M. Amorosi, said the senator viewed Columbia's request as justified and as a special case, in part because the patent will expire soon.