To patent or not to patent

WASHINGTON D.C.—While the U.S. Court of Appeals for theFederal Circuit ponders the fate of a landmark biotechnology patent case onisolated DNA in Association for Molecular Pathology, et al., v. UnitedStates Patent and Trademark Office, et al.,all that scientists, doctors and patients can do is wait until the court rulingcomes down later this year.

Attorneys familiar with the issues predict that the casewill ultimately be heard and decided by the U.S. Supreme Court.

On April 4, attorneys for Myriad Genetics Inc., the AmericanCivil Liberties Union (ACLU) and the U.S. government presented oral argumentsbefore a three-judge panel in Washington, D.C., in the case which is appealingthe March 2010 ruling by federal Judge Robert Sweet, who held that humangenetic material is not subject to patent protection.

Sweet tossed out seven patents held by biotech firm MyriadGenetics, that stemmed from genetic sequences directly linked to breast andovarian cancer, ruling that the patents were invalid based on a century-oldSupreme Court doctrine prohibiting patents for products found in nature,according to court records. Myriad appealed.

The Federal Circuit must address two questions on appeal: 1)whether plaintiffs had standing to file a declaratory judgment action againstMyriad seeking to invalidate its patents; and if so, 2) whether isolated DNA ispatent-eligible.

The case began in 2009 when the ACLU filed its complaintagainst Myriad on behalf of women who wanted to find out if they carried breastand ovarian cancer genes, but found the testing too expensive.

In presenting his arguments before the Federal Circuit, theACLU's Christopher A. Hansen stated that DNA is a natural phenomenon found innature, and thus not eligible for patenting under Supreme Court precedentbecause the changes made to the DNA in the lab do not give isolated DNA a distinctivename, character or use.

"The human gene is a product of nature and no morepatentable than a human kidney," Hansen told the Federal Circuit. "The districtcourt ruling striking down patents on human genes was a victory for the freeflow of ideas and information, and could lead to important medical andscientific advances. The appeals court should uphold that ruling."

Turning to the merits of the appeal, Gregory A. Castanias ofJones Day in Washington, D.C., argued for Myriad that isolated DNA does notexist in nature—and would not exist but for human ingenuity. Castaniasconcluded that the U.S. Patent and Trademark Office (USPTO) has been grantingpatents on this subject matter for decades; that the biotech industry is mooredon the notion that isolated DNA is patentable; and if the Federal Circuit wereto invalidate all of the patents directed to isolated DNA, the foundation ofthe biotech industry would be significantly damaged.

Kristin L. Yohannan of Morrison & Foerster inWashington, D.C., who attended the oral arguments, tells ddn, "In order for a declaratory judgment action toproceed, there must be an actual threat of litigation. Here, Myriad assertsthat it has not threatened patent infringement against any of the plaintiffsexcept one—and that was over 12 years ago. Therefore, there is no imminentthreat.

"As to the second issue, Myriad states unequivocally thatisolated DNA is patentable," Yohannan continues, "It looks to the USPTOGuidelines that state isolated DNA is patentable if isolated, purified and ifits corresponding protein is identified. Myriad contends that isolating aspecific piece of DNA takes hard work and human ingenuity—both things that thepatent system was designed to reward.

"The fatal flaw," in the ACLU's argument, Yohannan says, isthat there is human ingenuity in identifying and isolating a specific genesequence.

"This is recognized by the decades-old USPTO Guidelines onpatenting DNA. In my view, it would be difficult for the Federal Circuit tocircumvent decades of patents that cover isolated DNA," she says.

Furthermore, "if the ACLU were to prevail, I believe thatthe biotechnology industry would be adversely impacted," Yohannan adds. "Thatindustry has been built with the understanding that the DNA/genes that arebeing studied are patentable.

"It is worth the investment in isolating and characterizingDNA because the investment will be rewarded with 20 years of patent protection,she says. "That gives companies the opportunity to recoup its investment andperhaps invest in the study of a new gene sequence," Yohannan says. "This ishow cures for diseases and other genetic maladies are discovered."

But Dan Ravicher, executive director of the Public PatentFoundation (PUBPAT), takes the case back to the beginning.

"Since the beginning, this case wasn't about patentlaw," Ravicher states on the ACLU's website. "It was about the right of womento know what genetic mutations they might have in their own bodies, and theright of physicians to help them in doing so. We asked the Federal CircuitCourt of Appeals to apply patent law's longstanding prohibition on thepatenting of nature to protect these rights from patents that the governmentnow agrees should have never been issued in the first place."