Federal Circuit’s Decision on Myriad Says Certain Methods are Patent Ineligible

The impact of the Federal Circuit decision in the Myriad case on the biotech industry should be minimal, says biotech IP lawyer Roberte Marie D. Makowski, Ph.D.  “At least for now, this decision provides a level of certainty for the industry's existing patents and research endeavors.  It remains to be seen whether this decision will be appealed and whether the Supreme Court will want to weigh in.  The Federal Circuit decision in the Myriad case did not upset the long-standing practice of the U.S. Patent and Trademark Office of issuing patents on ‘isolated DNA sequences’ (i.e. isolated genes).  Certain types of methods that simply ‘compare’ and ‘analyze’ two sequences were found to be patent ineligible.  However, screening methods that would include some type of transformative step such as growing cells or determining cell growth rates are still patentable subject matter.  The biotech industry will need to keep this in mind when designing their screening methods,” said Dr. Makowski, whose early writing about this gene patenting issue, in 2003, was cited by the District Court in its initial decision, and it continues to be referenced.

Dr. Makowski is a Partner in Connolly Bove Lodge & Hutz’s Intellectual Property Group.  She represents clients in a variety of areas including patent counseling and opinions, interferences, prosecution and reissue and reexaminations in the life sciences areas. She is available for interviews to discuss the Myriad case and the implications to the biotech industry, and to author bylined articles. [07/29/2011]