To patent or not to patent
WASHINGTON D.C.—While the U.S. Court of Appeals for the Federal Circuit ponders the fate of a landmark biotechnology patent case on isolated DNA in Association for Molecular Pathology, et al., v. United States Patent and Trademark Office, et al., all that scientists, doctors and patients can do is wait until the court ruling comes down later this year.
Attorneys familiar with the issues predict that the case will ultimately be heard and decided by the U.S. Supreme Court.
On April 4, attorneys for Myriad Genetics Inc., the American Civil Liberties Union (ACLU) and the U.S. government presented oral arguments before a three-judge panel in Washington, D.C., in the case which is appealing the March 2010 ruling by federal Judge Robert Sweet, who held that human genetic material is not subject to patent protection.
Sweet tossed out seven patents held by biotech firm Myriad Genetics, that stemmed from genetic sequences directly linked to breast and ovarian cancer, ruling that the patents were invalid based on a century-old Supreme 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 against Myriad seeking to invalidate its patents; and if so, 2) whether isolated DNA is patent-eligible.
The case began in 2009 when the ACLU filed its complaint against Myriad on behalf of women who wanted to find out if they carried breast and ovarian cancer genes, but found the testing too expensive.
In presenting his arguments before the Federal Circuit, the ACLU's Christopher A. Hansen stated that DNA is a natural phenomenon found in nature, and thus not eligible for patenting under Supreme Court precedent because the changes made to the DNA in the lab do not give isolated DNA a distinctive name, character or use.
"The human gene is a product of nature and no more patentable than a human kidney," Hansen told the Federal Circuit. "The district court ruling striking down patents on human genes was a victory for the free flow of ideas and information, and could lead to important medical and scientific advances. The appeals court should uphold that ruling."
Turning to the merits of the appeal, Gregory A. Castanias of Jones Day in Washington, D.C., argued for Myriad that isolated DNA does not exist in nature—and would not exist but for human ingenuity. Castanias concluded that the U.S. Patent and Trademark Office (USPTO) has been granting patents on this subject matter for decades; that the biotech industry is moored on the notion that isolated DNA is patentable; and if the Federal Circuit were to invalidate all of the patents directed to isolated DNA, the foundation of the biotech industry would be significantly damaged.
Kristin L. Yohannan of Morrison & Foerster in Washington, D.C., who attended the oral arguments, tells ddn, "In order for a declaratory judgment action to proceed, there must be an actual threat of litigation. Here, Myriad asserts that it has not threatened patent infringement against any of the plaintiffs except one—and that was over 12 years ago. Therefore, there is no imminent threat.
"As to the second issue, Myriad states unequivocally that isolated DNA is patentable," Yohannan continues, "It looks to the USPTO Guidelines that state isolated DNA is patentable if isolated, purified and if its corresponding protein is identified. Myriad contends that isolating a specific piece of DNA takes hard work and human ingenuity—both things that the patent system was designed to reward.
"The fatal flaw," in the ACLU's argument, Yohannan says, is that there is human ingenuity in identifying and isolating a specific gene sequence.
"This is recognized by the decades-old USPTO Guidelines on patenting DNA. In my view, it would be difficult for the Federal Circuit to circumvent decades of patents that cover isolated DNA," she says.
Furthermore, "if the ACLU were to prevail, I believe that the biotechnology industry would be adversely impacted," Yohannan adds. "That industry has been built with the understanding that the DNA/genes that are being studied are patentable.
"It is worth the investment in isolating and characterizing DNA because the investment will be rewarded with 20 years of patent protection, she says. "That gives companies the opportunity to recoup its investment and perhaps invest in the study of a new gene sequence," Yohannan says. "This is how cures for diseases and other genetic maladies are discovered."
But Dan Ravicher, executive director of the Public Patent Foundation (PUBPAT), takes the case back to the beginning.
"Since the beginning, this case wasn't about patent law," Ravicher states on the ACLU's website. "It was about the right of women to know what genetic mutations they might have in their own bodies, and the right of physicians to help them in doing so. We asked the Federal Circuit Court of Appeals to apply patent law's longstanding prohibition on the patenting of nature to protect these rights from patents that the government now agrees should have never been issued in the first place."