Barriers to Patent Protection for Biotechnology and Alternatives for Removing Them

Martin L. McGregor

Baker & Botts
910 Louisiana
Houston, TX 70002-4995

[Abstract]

The tools of biotechnology now make it possible to produce naturally occurring, biologically active molecules in quantities never before possible. This feat is often accomplished by inserting DNA coded for the desired biologically active molecule into a microorganism, growing the organism in a fermentation medium, and then isolating the desired material from the fermentation mixture. The process is not very different from the ancient method of using yeast to produce alcohol. The availability of the active molecules by genetic engineering promises new treatments where none previously existed.

If the biologically active molecule has never been isolated and characterized, patent claims covering it are possible, and adequate protection is available for the product. However, when the biologically active molecule is already known, adequate protection becomes very difficult because the Patent Office often rejects claims to the process of producing molecules by genetic engineering. Congress has recently revised the patent statutes to give U.S. companies greater protection by barring the importation of products made by processes which would have infringed U.S. patents if practiced in the United States. However, when biotechnology companies are unable to obtain process claims for previously known but unavailable materials, there is no adequate patent protection for these companies. The Association of Biotechnology Companies, the Industrial Biotechnical Association, the Pharmaceutical Manufacturers Association, and the U.S. Patent Office have endorsed a proposal by Rep. Boucher to amend the patent statutes to extend patent coverage to processes utilizing novel starting materials, even if the process and products are otherwise old. While the Boucher bill is an attractive solution for the biotechnology companies’ dilemma, it may produce from time to time — not entirely satisfactory.

The biotechnology industry has at least two other alternatives if the Boucher bill continues to be rejected. One alternative is to convince the Court of Appeals for the Federal Circuit that biological processes are not as predictable as chemical processes, and therefore, producing molecules by genetic engineering is not always obvious. Amicus curiae briefs by the industry in a suitable test case might help the Court of Appeals to understand the importance of such a ruling.

A second alternative is to amend the Food, Drug and Cosmetic Act to provide registration exclusively for materials produced by host cells patented in the United States, even if the importation does not constitute patent infringement. Similar amendments could be made to the other federal statutes covering agricultural and pest control applications of biotechnology. By substituting regulatory exclusivity for patent protection, Congress might find a more precise remedy to biotechnology’s problems.