In Myriad, Court Rules Gene Patents Are Invalid

Senniger Powers attorney Tim McBride's analysis of Assoc. for Molecular Pathology (ACLU) v. USPTO (Myriad Genetics), appears in the article "Court Rules Gene Patents Invalid," published in the July 2010, Volume 16, No. 4 issue of IVD Technology. Excerpts appear below. The Court ruled that Myriad's gene composition and method claims are unpatentable subject matter. Myriad is appealing the decision.

To say that the District Court’s ruling in the Myriad case is ground-breaking would be an understatement. For approximately 25-30 years, the United States Patent and Trademark Office has been issuing patents directed to genes and nucleic acid sequences. Thus, the ruling in this case comes as what can only be described as a shock to the biotech community.

With respect to the DNA claims, I think the Federal Circuit will likely overturn, or at the very least curb, the breadth of the district court’s ruling. In particular, the district court refers to the fact that the DNA as claimed does not have ‘markedly different characteristics’ from the natural form of the DNA such that it has ‘a new or distinctive form, quality, or property.’ However, there is no clear indication of what, if anything, with respect to DNA would constitute a modification sufficient to confer ‘markedly different characteristics.’

How will this ruling affect IVD manufactures and the industry as a whole? In the short term, I do not think it will have any substantial or real effect. In particular, since the decision is going to be appealed and since a majority of those familiar with the decision, particularly those in the legal field, believe the decision will likely be overturned or curtailed in some fashion on appeal, I do not believe that IVD manufacturers or the IVD industry generally will radically change or be affected by the district court’s decision. But if the decision were affirmed, the effect on the IVD industry depends heavily on the degree of necessity of the use of DNA for IVD purposes. If IVD manufacturing and the industry as a whole can effectively utilize means other than comparisons of isolated human genes for IVD purposes, then the effect could be minimal.