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Patenting Genes

May 31, 2010 | A version of this story appeared in Volume 88, Issue 22

“Gene Patents Ruled Invalid” reveals a lot of wishful thinking on the part of those who isolate and purify natural products (C&EN, April 5, page 9). “[P]lucking out the genes relevant to predicting breast and ovarian cancer” is nothing more than “the discovery of some of the handiwork of nature and hence is not patentable” according to the U.S. Supreme Court in Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948).

According to the U.S. Constitution, the patent system is intended to promote progress of the useful arts. It is not intended to cater to “our and likely most investor expectations,” as stated by a Morgan Stanley analyst, but rather to secure to inventors the exclusive right to their inventions for a limited time. Investors do not promote progress of the useful arts; inventors do.

This decision by U.S. District Court for the Southern District of New York Judge Robert W. Sweet is not a “preliminary step in the legal process.” Instead, it is a final judgment by a federal court and cannot be overruled by “how the Patent & Trademark Office evaluates patent applications related to DNA-based inventions.” The court held the patent issued by the office was invalid and of no effect.

It is likely that the decision will be appealed to the U.S. Court of Appeals for the Federal Circuit, which has a terrible record in deciding product-of-nature issues. Three out of every four decisions of the Federal Circuit and its predecessor patent court are overturned when the Supreme Court reviews the patent court decision.

The Supreme Court has consistently held that products of nature are not patentable, and those decisions, including Funk Brothers, have never been overruled. Isolating and purifying a natural product, be it a gene, a stem cell, or another part of the handiwork of nature, is not patentable subject matter, no matter how much industry wishes it to be.

John P. Sutton
Grass Valley, Calif.

As a former medicinal chemistry student and a current patent attorney, I read with interest the news item “Gene Patents Ruled Invalid,” by Glenn Hess and Lisa Jarvis. The concise piece accurately captured the main dispute in the gene patent case. I commend the reporters for their diligent work.

I write to point out an issue in the 
case that may be of wider interest to C&EN readers. The reasoning of Judge Sweet casts doubt on the patentability of all natural products, not just DNA. In Sweet’s view, Supreme Court precedent does not allow a scientist to obtain a patent on “products of nature,” which could be interpreted as including naturally occurring compounds isolated and shown by the scientist to be useful in treating a medical condition. This may come as a surprise to many readers, as the pages of C&EN are replete with examples of naturally occurring, often complex, compounds having potentially life-saving properties. An example is described in Rick Mullin’s article “Breakthroughs in Spanish Biotech” (C&EN, Nov. 23, 2009, page 19).

Sweet’s decision does not directly answer the question of whether a natural product is patentable, but his reasoning leads us down the road. This is not to say such a path is necessarily errant. It is an important issue and vital to certain companies and to researchers who might want broader access to natural products. The more important point, however, is that more chemists and businesses have a stake in the outcome of the gene patent dispute than they may have thought. 
The outcome may impact anyone involved in the research, development, and use of natural products.

When Sweet’s decision is appealed to the U.S. Court of Appeals for the Federal Circuit (and possibly the Supreme Court), interested companies, scientists, and investors ought to consider sharing their views with the court—whether supporting or opposing—by filing an amicus brief.

Matthew J. Dowd
Washington, D.C.

James C. Greenwood, president and CEO of the Biotechnology Industry Organization, is quoted as saying that “preparations of isolated and purified DNA molecules ‘are patentable because they are fundamentally different from anything that occurs in nature.’ ”

If he is correct, then the issue seems to be one of semantics. 
A patent thus is not on a “gene” but on a characterized molecular entity. The term “gene,” as commonly used and understood, should be avoided in the patent; the patented entity should be designated with a unique name, as any patented chemical would be. Clearly, the patent would not apply to any gene and would 
not limit medical or scientific methods associated with genes in any way.

Robert M. Hadsell
Plano, Texas



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