On June 13, 2013 the U.S. Supreme Court ruled in connection with the case Association for Molecular Pathology case vs. Myriad Genetics Inc. (known as the Myriad case) that naturally occurring DNA sequences should be considered products of nature which cannot be patented, even when limited in their isolated form. This is a major change in the practice of the US Patent and Trademark Office (USPTO) which has granted patents with claims to these products per se for decades.
On the other hand, the Supreme Court considers that complementary DNA sequences (cDNA) that, as a rule, only include exons or coding gene fragments and are not commonly found in nature, but synthesized in the laboratory generally from messenger RNA, are patentable.
This Supreme Court decision does not deal with the patentability of other natural products, such as proteins that are currently being used extensively in therapy. As a consequence, at least for the moment it seems that this decision does not affect the validity of claims directed to such products. In any case, this decision does not shield the patentability of these biomolecules, since their patentability was not discussed in this decision. The same reasoning used for the genes could be applied to proteins, if this was the intention of the Court.
Possibly the isolated gene fragments, such as probes or primers, may be placed at the borders defined by this decision. Our view is that, for the moment, it is worth protecting these inventions pending further developments.
This Supreme Court decision seems to fit into the trend started by the same Court in the decision related to Mayo Collaborative Services vs. Prometheus Laboratories, of March 20, 2012 (Prometheus decision) concerning diagnostic methods and drug therapy optimization. In Mayo it was considered that the association between a biological signal (biomarker) and a result or conclusion (predisposition to a disease, response to treatment, disease diagnosis) was a discovery of a natural phenomenon and could not be patented. The consequence is that these inventions could be only validly protected if they included additional features. The Supreme Court did not specify these additional features, but it seems that the claims would have to include specific reagents or special steps in the method of data association.
The new landscape imposed by the Prometheus and Myriad decisions represents a radical change in the practice held until recently by biotechnology companies.
The Prometheus decision, with the limitation imposed to the protection of clinical diagnostic methods, opened the door to the launch of generic alternatives to those patented by changing reagents or other process parameters. However, in some cases, protection was still effective as patents also claimed gene sequences per se used in the method. The Myriad decision further limits the protection by eliminating the general protection given by the sequence itself, and seems to open the possibility of non-infringing alternatives also in these cases.
In summary, in the absence of tribunal experience confirming our conclusions, it now seems almost impossible in the US to comprehensively protect inventions relating to methods to determine diagnoses, susceptibility to disease, response to treatment, etc.. Thus, industry based on these inventions will suffer significantly by this new practice. However, this frame does not affect, for the moment, most patents directed to the protection of biomolecules used as medicaments (eg antibodies and other proteins), although the argument used in Myriad opens the door to a more restrictive application of the patent system also for these products. In any event, it would be necessary to assess the situation on a case by case basis in order to determine whether an effective protection for a given invention can be obtained.
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