Last July the United States intellectual property appeals court resolved whether a series of gene related molecules were patent eligible in Association for Molecular Pathology et al v. United States Patent &Trademark Office et al [hereinafter ‘Association’] The decision text was long and complex, but in large part can be reduced to a single question: are human breast cancer genes, extracted from a naturally occurring human chromosome, entitled to protection of the U.S patent law?
I have previously discussed the contours of patent eligibility in the United States. Subject matter must be a new composition of matter, a machine, a manufacture device, or a process. By judicial decisions it is sell settled that abstract ideas, natural phenomena and laws of nature are not patent eligible. For example, abstract economic processes, algorithms and Newton’s law of gravity are not patent eligible in and of themselves. However, these three exceptions can be incorporated into a concrete and tangible subject matter that is patent eligible. The rub often becomes: where do the natural phenomena “leave off” and where does an actual concrete application of the phenomena begin?
In Association the patent in dispute protects breast cancer gene molecular sequences ranging from extremely long sequences from the human chromosome to shorter portions of this long sequence. Patent protection also includes extremely small sequences of fifteen attached molecular components. Moreover, there are also short molecules that are distinguishable from this particular group of sequences, because researchers artificially altered these short molecules to remove non-expressed and non-coding components. Consequently in these artificially modified fragments, there is a ‘man made’ absence of portions within the molecular sequence. However, the actual genetic coding that exists in this altered form remains identical that of the naturally occurring gene.
The majority of the justices concluded that all these genetic segments are patent eligible, because the isolated gene sequences were chemically modified during laboratory isolation and extraction. The majority also relied upon the fact that chemical bonds were broken to remove the breast cancer genetic sequences from the original human chromosome. In particular, the majority concluded that the short molecules are patent eligible because non–coding sequences were artificially deleted in the laboratory and do not exist in nature.
The dissenting justice posed several observations on why the naturally occurring gene sequences were not patent eligible. By doing so he distinguished between the naturally occurring fragments and the segments in which naturally occurring non-coding sequences are artificially removed. First, even if the extraction method results in minor chemical alteration, the basic naturally occurring gene sequence remains the same. Secondly, the natural genetic sequences, although difficult to locate and remove, are nevertheless a natural phenomenon that was discovered, and therefore there is no an invention. Thirdly, the Patent Office is not a substantive law generating agency: This role belongs to Congress and the courts. In fact, this author notes that after a recent United States Supreme Court decision on patent eligibility, many patents were retro-actively invalidated although the patent office had issued such patents for over ten years.
Consequently, unless this issue is visited by the Supreme Court the medical community must grapple with private research and business entities that own human genes!
© 2012 Adrienne B. Naumann
Ms. Naumann does not endorse or sponsor the advertisements at adriennebnaumann.wordpress.com and linked in sites.