At Stake: Gene-Based Patents

A patent case winding its way through U.S. District Court has the potential to hinder biotechnology R&D if the judge hearing the case rules in favor of the plaintiffs, led by the American Civil Liberties Union.

The ACLU’s complaint turns on a pair of patents that the U.S. Patent and Trademark Office granted Myriad Genetics in 1998 for isolated versions of the BRCA1 and BRCA2 gene sequences. Mutations in these tumor-suppressing genes have been shown to have links with both breast and ovarian cancers. A chief use of the sequences is for mutation screenings.

BIO has filed a friend-of-the-court brief siding with USPTO and Myriad, a Salt Lake City biopharmaceutical company that focuses on molecular diagnostics. “In many cases, gene-based patents are critical for a biotech company’s ability to attract the capital and investment necessary for the development of innovative diagnostic, therapeutic, agricultural and environmental products,” the brief notes.

The ruling could deal a major blow to the biotech industry because so many of its companies are small organizations that have yet to bring their products to market or to attain profitability, notes Hans Sauer, BIO’s associate general counsel for intellectual property.

“Unprecedented constitutional and statutory challenges to the patenting of isolated DNA molecules go far beyond the BRCA1 and BRCA2 genes at issue in this case,” he writes in the brief.

The ACLU argues that the government should not grant patents covering the most basic information tied to the human body’s natural programming. It suggests that the USPTO has erred in allowing these patents as an exception to its general rules that no naturally occurring substance can receive a patent.

A Natural Divide

But are Myriad’s isolated versions of BRCA1 and BRCA2 natural gene sequences? They definitely are not, Sauer points out. “The claimed isolated DNA molecules differ in structure, function, utility and information content from natural BRCA1 and BRCA2 sequences,” according to his brief. “So significant are these differences that the claimed DNAs have qualities that make them differ in kind from native sequences and are more than sufficient to confer patent eligibility.”

It is the isolation process itself that creates the break with nature. When a lab isolates a DNA molecule, the process imparts new utility, structure and function that do not exist in nature, Sauer says. Biotechnology companies isolate and purify the sequences to make them hardier for uses in further R&D and to limit control factors.

What’s more, the brief notes, precedent favors Myriad and USPTO.

“Since a landmark U.S. Supreme Court decision in 1980 related to gene patenting, the USPTO has granted tens of thousands of genetic and genetic-related patents, which cover a large number of lifesaving pharmaceutical and diagnostic products,” Myriad noted in a press statement last year.

Although the U.S. Supreme Court has never squarely addressed the patent eligibility of isolated and purified DNA molecules, other rulings in patent suits do illustrate a wide acceptance of such as patent eligible subject matter, Sauer says. “Respectfully, this court should refrain from altering the status quo.”

Filed last May, the suit recently reached the courtroom phase. U.S. District Judge Robert W. Sweet began hearing arguments in the case in January.