Gene patents in the United States

A gene patent is a patent on a specific isolated gene sequence, its chemical composition, processes for obtaining or using it, or a combination of such claims. Gene patents are a prominent subset of the broader category of biological patents. Patents on genes have only been granted on isolated gene sequences with known functions.

History

The United States has been patenting chemical compositions based upon human extractions for over 100 years. The first patent for such a chemical was granted on March 20, 1906 for adrenaline. Judge Learned Hand justified permitting patents on purified natural substances on the rationale that they can become substantially more useful than their non-extracted or less-pure states. Insulin followed adrenaline as the second patent in 1923. Vitamin B12 was also patented (by Merck).

But prior to the 1970s it was almost unheard of to submit an application to the United States Patent and Trademark Office (USPTO) for an organism. The United States Supreme Court in Diamond v. Chakrabarty clarified that as long as the organism is truly "man-made," such as through genetic engineering, then it is indeed patentable. As a rule, raw natural material is generally rejected for patent approval by the USPTO. It is only after a DNA product is isolated and purified (or modified) that a patent is considered.

As of 2010, approximately 40,000 patents exist that relate to an estimated 2,000 human genes, or about 20 percent of the human genome. As noted above, these patents do not cover the genes in any human body as the genes in the human body are natural products and never have been patentable. The issued patents cover things like (i) isolated genes; (ii) methods of using the isolated genes (for instance, to manufacture protein drugs); (iii) methods to diagnose a disease based on an association between a gene and a disease.

Controversy

There is some political and ethical controversy over whether these patents advance technology by providing scientists at companies and universities with an incentive to create, or if they hinder basic bench research via litigation or threat of litigation. The case that there are negative effects on basic research appears to be mostly driven by academic law professors, and not by practicing university scientists. See for example this page at The Hastings Center's website and this document at the journal, Academic Medicine. There is data showing that gene patents have little to no effect on basic university research provided at the Science Progress Blog.

There is also controversy over whether and to what extent companies controlling gene patents clinical research . One of the points raised in the recent Myriad case, was that Myriad made efforts to prevent clinical trials to explore just how good their test was and that patents denied patients from receiving second opinions in regards their test results. Finally, there is controversy over the price of medical treatments.

While there is some controversy concerning the patenting of isolated genes and the way those patents are used, and there is controversy concerning patents on the diagnostic uses of genes (the real source of dispute in the Myriad court case), it is difficult to find controversy surrounding patents on genes that are used to manufacture therapeutic proteins (for an example of patents on therapeutic proteins, the drug candidate that is the subject of the early part of the movie 'Extraordinary Measures' was covered in part by a classic gene patent, US Patent 6,770,468.[1]) There is also little controversy concerning the role of gene patents in the chemical industry—for instance in the manufacture of enzymes used in consumer products or industrial processes.[2] In descriptions of the controversy over "gene patents", it is rare to find references to these everyday uses of genes and gene patents.

Gene patents ruled invalid by a U.S. federal court; ruling being appealed

A complaint against Myriad Genetics and the US Patent and Trademark Office filed in 2009 by professional medical organizations, doctors, and patients, all represented by the American Civil Liberties Union, sought to invalidate and discontinue all patents for naturally-occurring genes, which have thus far been issued on the grounds that such genes are "isolated and purified" to a non-naturally-occurring state. Myriad owns some of its patents; some were licensed from University of Utah. Specific claims, but not all claims, in seven of Myriad's 23 patents on BRCA1 and BRCA2 were challenged in the complaint. The challenged claims covered the isolated genes as well as diagnostic methods.

Many people working in the patent field had predicted that the courts would throw out this case.

However, the case was accepted, and all the challenged claims were ruled invalid on March 29, 2010 by United States District Court Judge Robert W. Sweet, a judge in the U.S. District Court for the Southern District of New York.

The claims that had not been challenged still stand.

Judge Sweet's 152–page decision ruled that the challenged claims to the isolated gene sequences had been "improperly granted" because they claimed unpatentable subject matter; the claims to the diagnostic methods were found invalid under the recent In re Bilsky decision. Because the case could be decided with patent law, Judge Sweet did not look at the challenge on First Amendment grounds and dismissed them without prejudice. In his decision handed down March 29, 2010, the judge rejected the legal equivalency between 'chemical compositions' like purified adrenaline and DNA. In his opinion [3] Judge Sweet said: "The information encoded in DNA is not information about its own molecular structure incidental to its biological function, as is the case with adrenaline or other chemicals found in the body...this informational quality (of DNA) is unique among the chemical compounds found in our bodies, and it would be erroneous to view DNA as 'no different' than other chemicals previously the subject of patents....DNA, in particular the ordering of its nucleotides, therefore serves as the physical embodiment of laws of nature - those that define the construction of the human body…the preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the challenged composition claims are to unpatentable products of nature."

The decision could prove far-reaching for the biotechnology field.

However, on March 30, 2010, Myriad announced that it will appeal the decision. On June 16, 2010, Myriad filed its Notice of Appeal.

See also

• Human Genome Project

External links

• Open and Public Debate on Gene Patents, sponsored by the Intellectual Property Research Institute of Australia and Center for Ideas and the Economy
• The Human Genome Project information pages
• Human Genome Project pages on Genetics and Patenting
• Council for Responsible Genetics
• Center for Genetics and Society
• Who Owns The Tree Of Life? by Neil Gross and John Carey, Business Week, November 4, 1996.
• Bioethics and Patent Law: The Cases of Moore and the Hagahai People by Anja von der Ropp and Tony Taubman, WIPO Magazine, September 2006.
• Gene Patents