Striking down breast cancer related gene patent may not impact industry, says New York attorney

The recent decision in a Federal District Court in New York to strike down a patent for the breast cancer related BRCA-1 gene may not have the broad impact on the technology industry it had originally been feared to, says a New York attorney.

“Footnote 51 on page 123 of the opinion is the only place where Judge Sweet addresses the policy implications of his decision to strike down the patent because the DNA sequence was not patentable subject matter”

Ted Sabety, an intellectual property attorney in New York, notes that Judge Robert W. Sweet's opinion in the Southern District of New York case In the Association for Molecular Pathology, et al, v. the United States Patent and Trademark Office, et al., relies heavily on case precedent that not only pre-dates the 1952 patent statute, but was established prior to the discovery of DNA's structure and function.

"Footnote 51 on page 123 of the opinion is the only place where Judge Sweet addresses the policy implications of his decision to strike down the patent because the DNA sequence was not patentable subject matter," notes Sabety a patent attorney with Sabety+associates in New York.

"This is one of those footnotes likely to be highly litigated in the future, as it appears to limit the holding to the 'patentability of isolated DNA.'"

In the footnote, Judge Sweet writes: "The conclusions reached in this opinion concerning the subject matter patentability of DNA, however, are based on the unique properties of DNA that distinguish it from all other chemicals and biological molecules found in nature."

Court's decision to grant summary judgment was based on the notion that a patent claim over an isolated DNA sequence that expresses the BRCA-1 gene is not patentable subject matter because it is a discovery of a naturally occurring phenomenon, not an invention and that the isolated form of the DNA sequence was not a purification that made it "markedly different" from its natural state.

Among the plaintiffs wishing to strike down this patent are the ACLU and women who claim Myriad's diagnostic test for screening breast cancer are too expensive.

"The devil is in the details," says Sabety of Judge Sweet's 152-page opinion. "The decision to strike down a patent claim over an 'isolated' DNA sequence because it is not 'markedly different' from the natural state appears to be a matter of line drawing in a specific factual context. The footnote appears to acknowledge this."

SOURCE Sabety+associates PLLC