Most intellectual property court decisions do not catch the attention of the popular press in a major manner. However, the recent United States Supreme Court decision in Association for Molecular Pathology et al v. Myriad Genetics, Inc. et al. was publicized in on-line media, as well as in metropolitan print newspapers and even radio broadcasts. What made this decision different from other patent law court decisions that significantly affected inventors and economic fortunes but nevertheless only attracted a low public profile?
Of course, part of the answer lies in the mystique of the term “gene patents” to lay persons. The term “gene patents” inspires scenes of (eccentric) scientists at work in mysterious laboratories creating and distributing miraculous, and perhaps dangerous, life forms. For intellectual property attorneys and scientists, many gene patents were always controversial, because the patent owners acquired a monopoly on naturally occurring genes. In fact, U.S. courts prohibited patenting of naturally occurring phenomena even after genetically altered bacteria appeared before the U.S. Supreme Court in Diamond v. Chakrabarty. In that decision the Court concluded that the bacteria were not naturally occurring because their genetic and cellular components were artificially altered. The Court also concluded that the bacteria were patent eligible because (i) they were new compositions of matter and (ii) the U.S. patent statute allows the patenting of new composition of matter. In contrast, patenting of biological discoveries, without more, only qualifies as the no-patent eligible result of sophisticated research. Consequently, the query from commentators became: How could discovery of a naturally occurring gene is awarded a patent when that discovery was not a new composition of matter?
Despite the controversy, the medical communities previously received numerous patents on naturally occurring genetic and other biological entities. In the case before the Supreme Court, Myriad Genetics owned patents that exclude others from access to naturally occurring breast cancer gene fragments. Testing of these genes informs patients whether they are more at risk to experience breast cancer and/or ovarian cancer. As a result of this patent ownership and its wide scope Myriad acquired a monopoly on the tests for these genes. Not surprisingly, this monopoly had enormous economical consequences to the health care community, as well as access, affordability and life/death issues for patients. Consequently a single physician, prohibited form testing his own patients for these patented genes, brought this challenge in the federal courts several years ago.
The Court’s decision is actually straightforward and logical to persons (i) with a degree in biology and (ii) familiar with laboratory isolation and purification procedures. Myriad Genetics, Inc. asserted that two kinds of genetic material were properly characterized as patent eligible: (i) naturally occurring breast cancer genetic (DNA) sequence fragments isolated in the laboratory and (ii) breast cancer genetic sequence fragments (cDNA) with genetic components artificially removed in the laboratory. For naturally occurring fragments the Court held that chemical artifacts from the laboratory (i) did not produce a new genetic material when (ii) the fragments contained the exact genetic sequence of the original intact genetic material. However, the Court found the cDNAs to be new compositions of matter because (i) the original genetic sequence was deliberately physically altered (ii) to provide different chronology of genetic units.
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