Valley of the genes:gene patents 2

Especially in biological industries, the tension between subject matter as a non-patent eligible discovery, or a patent eligible new composition of matter is never ending. This dichotomy is evident in the United States patent appeal Association decision of my previous article. It is also interesting that a U.S. Supreme Court decision has previously addressed whether naturally occurring bacteria, albeit in a new mixture with improved commercial properties, is patent eligible.

In my last article I reviewed this appeals court decision addressing patent eligibility of isolated human breast cancer genes. It is well established that artificially modified genes fall within the patent eligible statutory category of new compositions of matter. The Association court concluded that these particular breast cancer gene sequences are new compositions and patent eligible, in large part because of (i) chemical alteration of the gene sequences during laboratory extraction; and (ii) breaking of chemical attachments within the naturally occurring genome in the laboratory.

Another question upon appeal was whether certain diagnostic methods that designate these gene sequences are also patent eligible. Methods and processes comprise a separate patent eligible category under U.S. patent law. However, the scope of patent eligible ‘processes’ and ‘methods’ under patent law is much narrower than that of everyday speech and writing. For example, processes and methods are not patent eligible if they consist of solely or primarily abstract ideas, phenomena of nature or laws of nature.

Often the patent eligibility criteria of processes and methods overlap with those of new compositions of matter, especially for phenomena of nature. For example, in Association the judges analyzed whether certain gene sequences are (i) painstaking discoveries of naturally occurring phenomena, or (ii) truly new compositions of matter. Similarly, for the diagnostic methods the court considered whether these methods designate practical applications of natural phenomena. The court observed these diagnostic methods “compare” a reference breast gene sequence to a patient’s breast gene sequence. They also noted that this single mental comparison determines whether the patient’s sequence contains a genetic change for a higher probability of developing breast cancer. The majority of judges then agreed that these diagnostic methods of comparing gene sequences are not practical applications of a natural phenomenon.

The judges then applied the abstract idea test under which mental steps are regarded as abstract ideas. Because abstract ideas are never patent eligible by themselves, this test applies to processes and methods that (i) include abstract ideas, or (ii) solely consist of mental processes. Using this second test these judges concluded that these particular diagnostic methods (i) include a single mental process, and (ii) no additional tangible activities implement this single mental process. Consequently, on this second basis a diagnostic method in which the sole step is mental comparison of human gene sequences is not patent eligible.

The court also applied the machine or transformation test. Under this test for a process or method to be patent-eligible there must be (i) a physical change in the subject matter of the process, or (ii) a machine to implement the process. However, a single mental comparison of two gene sequences does not involve their physical transformation or a machine for implementation. Consequently, on this third basis the court again concluded that these diagnostic methods are not patent eligible.
© 2012 Adrienne B. Naumann
Ms. Naumann does not sponsor or endorse the advertisements at or linked in sites.


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