By Lisa Seachrist
WASHINGTON - A controversial extension of a Columbia University patent failed to ride into law on a supplemental spending bill passed shortly before Congress left for its July 4th recess.
As Congress returns from that break, the patent provision has a second chance to become law, where it first popped into existence in the appropriation bill for the Agriculture Department. That bill has cleared the appropriations committee and is set to be considered by the full Senate.
"The patent extension could come up in the agriculture appropriations bill next week," said Michael Werner, director of federal government relations and bioethics counsel for the Biotechnology Industry Organization (BIO). "We are still watching it and trying to persuade [the legislators] not to include this language. But we could have a floor fight."
The source of this potential Senate battle is a Columbia University patent for the cotransformation of mammalian cells - the process of introducing foreign genes into mammalian cells to produce proteins. That process enables the production of at least 18 currently marketed products, including Amgen Inc.'s Epogen, Genzyme Corp.'s Cerezyme and Genentech Inc.'s Pulmozyme.
The Columbia University patent is set to expire on Aug. 16, but Columbia alum Sen. Judd Gregg (R-N.H.) has included language in the agriculture appropriation bill to extend the patent by extending the Drug Price Competition and Patent Term Restoration (Hatch-Waxman) Act to Columbia's process patent.
The biotechnology industry, the generic drugs industry, patient organizations and some consumer representatives have all come out against the bill as a dead-of-the-night rewrite of Hatch-Waxman, the law that created the generic industry and provided patent term restoration for delays at FDA.
Sens. Edward Kennedy (D-Mass.) and Richard Durbin (D-Ill.) are on record as vehemently opposing the measure. In addition, Republican Sens. Jim Jeffords (R-Vt.) and Olympia Snowe (R-Maine) also are against the patent extension. Werner said the senators were considering implementing parliamentary motions to prevent the measure from being included in the appropriations bill. (See BioWorld Today, May 19, 2000, p. 1; and June 20, 2000, p. 1.)
The Senate operates under 43 rules governing the conduct of business. Rule 16 allows any member of the Senate to raise a point of order against a measure in an appropriation bill when the measure proposes new law. Once that point of order has been raised, 60 members of the Senate must vote to include the measure in the bill or it is removed. Werner said it was unlikely the measure would win such a vote with both Democrats and Republicans opposing it. However, it still is possible.
"[Sen.] Gregg could still try to slip it into another bill," Werner said. "We really have to make sure we stay on top of this one."
Study Highlights Biotech Contributions To Economy
Even though most biotech companies have yet to earn a profit, the industry contributes significantly to the U.S. economy.
A study commissioned by BIO and conducted by Ernst & Young Economics and Qualitative Analysis shows the biotech industry was responsible for adding $47 billion in revenues to the U.S. economy in 1999 - a figure that has doubled since 1993.
"This report is another important arrow in our quiver in our ongoing campaign to provide information to our key audiences: the media, legislators and ultimately the public," said Dan Eramian, vice president of communications for BIO. "This really helps us get a better handle on the number of jobs and both the direct and indirect revenues we supply to the economy."
According the report, titled "The Economic Contributions of the Biotechnology Industry to the U.S. Economy," the biotech industry is responsible for creating 437,400 U.S. jobs. Biotechnology companies directly employed 150,800 people in 1999, while the remaining jobs were generated by companies supplying goods and services both to the biotech industry and their employees. This level of job creation outpaces the toy and sporting goods industry and falls just behind the cable industry.
In addition, the industry produced $20 billion of direct revenues in 1999. Indirect revenues - those generated by companies supplying goods and services to both the industry and their employees - represented an additional $27 billion.
Uncle Sam even benefited from the industry in the form of $10 billion in state and federal taxes collected. Because most biotech companies aren't making a profit, the tax revenue comes largely from employee income taxes.
The industry also contributed $11 billion in research and development spending. These numbers are impressive for an industry still trying to venture into profitability. BIO intends to use the report to help persuade legislators that the industry is too important to jeopardize with price controls on its products.
"You don't want to slow down our continued growth with price controls," Eramian said. "We're hoping to show [legislators] how valuable we are. It should help us in our case against price controls on the Hill."
While supporting prescription drug coverage for Medicare beneficiaries, BIO has opposed any proposals that use government price controls to meet that end. BIO, however, hasn't endorsed any single plan.
FDA Sets Up Cancer Drug Web Site
The FDA's Center for Drug Evaluation and Research has expanded its web site with a page dedicated to providing oncology drug information to patients and health care professionals. The site, called Oncology Tools (http://www.fda.gov/cder/cancer), can be searched by the specific type of cancer or by approved therapies. The site also will contain information about clinical trials and patient support groups.
For health professionals, the site will offer specialized information including references for performing clinical studies, drug-dose calculators and other cancer-related regulatory tools.