WILLIAM S. PARKS
Medical research faces an interesting conundrum. Certain medical breakthroughs offer tremendous potential for detecting and treating various diseases, which can provide monetary returns mostly through related pharmaceuticals, analytical tests and medical procedures.
Thus, the ability to patent such breakthroughs to exclude others from direct medical competition can hold enormous commercial and financial benefits.
How far can legal monopolies on medical breakthroughs actually stretch? Recently, the U.S. Supreme Court was asked to determine the patentability of actual human genes.
Years ago, Myriad Genetics Inc. invested heavily in human genome analysis for clues why some women show a greater likelihood to develop breast and ovarian cancers. Myriad found such cancer-indicating gene signatures within chromosome numbers 13 and 17, with each chromosome possessing enormous amounts of genetic information.
Myriad also found two specific genes, known as BRCA1 and BRCA2. The company discovered that mutations of such genes increased cancer risks, thus paving the way for the development of a diagnostic test allowing for greater reliability in cancer diagnoses for women.
Myriad sought and received patent protection for this breakthrough, claiming rights to a number of related subject matter, including the actual genetic sequences of BRCA1 and BRCA2.
With various patents in hand, Myriad foreclosed competition in this area, leading to litigation against any other company that developed gene mutation tests of its own. Myriad was successful defending its gene patent claims at the federal Court of Appeals level.
However, the American Civil Liberties Union and other organizations challenged this, arguing before the Supreme Court that a naturally occurring compound should not be granted patent protection.
In Association of Molecular Pathology v. Myriad Genetics Inc., released in June, a unanimous Supreme Court agreed that Myriad cannot claim patent rights to naturally occurring materials. Although the law provides for new discoveries of “compositions of matter,” the nation’s high court determined that any naturally occurring material cannot be granted patent protection, regardless how it was discovered.
In essence, the court ruled that anything naturally occurring is in the public domain because it is already present in nature.
Although actions to modify natural substances can be the basis of exclusive rights, simply extracting a gene (or even a portion of a gene) or finding a new substance of any kind from nature does not rise to the level of patent protection that Congress had intended.
This Supreme Court decision allows others to use these genes to develop different and possibly more reliable tests for cancer detection, which potentially could drive costs down in the marketplace.
Myriad, however, continues to enjoy patent rights to modified genes and its own analytical tests using the BRCA1 and BRCA2 genes. The company will continue to make hefty investment returns, but now others have the opportunity to enter such commercial space, as well.
Parks is counsel to the regional law firm Wyatt, Tarrant & Combs LLP and is a member of the firm’s intellectual property service group.