Magazine article Science News

Of Judges, Genes and Genetic Engineers: Biotech Attorneys Approach the Bench

Magazine article Science News

Of Judges, Genes and Genetic Engineers: Biotech Attorneys Approach the Bench

Article excerpt

Of Judges, Genes and Genetic Engineers

Is litigation becoming the premier product of the biotechnology revolution? Biotech patent disputes are multiplying like clones, and with more than 6,000 new biotech patents currently pending in the United States alone, the case load is destined to grow. Indeed, as biotech companies move from basic research into full-scale production and marketing of their first products, patent protection is becoming an increasingly important--and contentious--cornerstone of corporate well-being.

Although only five genetically engineered products have so far been approved for sale in the United States, biotechnology companies are already staking their claims to the dozens of diagnostic, pharmaceutical and agricultural products that are expected to emerge from the industry in the next few years. The roster of resulting patent disputes reads like a Who's Who of biotechnology:

Hoffmann-LaRoche and Eli Lilly are suing Genentech over patent rights to genetically engineered human growth hormone.

Amgen and Cetus are in court over their rights to market interleukin-2.

Genetics Institute recently beat out rival Amgen for the first U.S. patent on erythropoietin, although Amgen claims it developed the product first.

Hybritech successfully defended a patent infringement suit brought by Monoclonal Antibodies, and was recently granted a preliminary injunction to prevent Abbott Laboratories from selling certain diagnostic assays.

Scripps Clinic is suing Genentech over rights to genetically engineered Factor VIII, the clotting factor that's missing in hemophiliacs.

The stakes in these and other ongoing cases are substantial; with biotech budgets depleted after years of preliminary research, and a number of companies racing to produce some very similar products, patent lawyers are anxious to win for their companies the lucrative market monopolies provided by U.S. patent law. But attorneys are facing some crucial questions about how to apply America's 197-year-old patent laws to the ultramodern biotechnology industry.

United States patent law was first written in 1790, and its principal author, Thomas Jefferson, didn't have much to say about monoclonal antibodies, erythropoietin or tissue plasminogen activator. As revised in 1861, the law grants to "inventors and authors' a 17-year monopoly over the production, use and sale of their products--with the condition that the applicant supply to the public a detailed description of the invention so that others may immediately learn from and build upon that knowledge. In this and other respects the law was designed to "promote the progress of science and the useful arts,' with the 17-year limit being settled upon by Congress as the amount of time it might take to train two apprentices to make the new concoction.

But with the increasing rate of technological change, and with skyrocketing investments in research and development, patent protection has taken on added significance. According to Jack Doyle, an attorney with the Environmental Policy Institute in Washington, D.C., "In modern corporate terms, patents are often viewed as a way to maintain and expand a company's market share.' And in the biotechnology industry, market share can easily translate into hundreds of millions of dollars per year.

Recently, for example, Genentech Corp. of South San Francisco lost a crucial round in its legal battle with London-based Wellcome PLC over British patent rights for its genetically engineered human tissue plasminogen activator. Analysts estimate that the clot-dissolving drug (SN: 1/17/87, p.42), which is expected to gain Food and Drug Administration approval later this year, may be worth more than $1 billion in sales world-wide--to the company or companies that win appropriate patents.

In the Wellcome-Genentech case, the dispute boils down to the question of how broad a patent claim can reasonably be: Can the original developer of a new product get patent protection for a broad family of related products, or only for a very specific form of that product? …

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