Myriad Outcome: Winds Shift Again For Gene Patenting In The US

In a long-awaited decision, a United States federal appeals court has decided that US companies can patent breast cancer genes, reversing a previous ruling. The decision was not unanimous, with one of the three judges dissenting. But despite the attention the case has received, the ruling may have little impact on the biotechnology industry, according to analysts.

The US Court of Appeals for the Federal Circuit gave its ruling on 29 July in a lawsuit that has been stirring public opinion for the past two years. The American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) represented a group of patients and scientists in the Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., lawsuit, filed in May 2009.

This decision partially reverses a 29 March decision from a New York district court (IPW, IP Live, 30 March 2010).

Myriad Genetics holds patents on BRCA genes (BRCA1 and BRCA2). Mutations along those genes are responsible for hereditary breast and ovarian cancers. The plaintiffs argued that women with a history of those types of cancer in their families should be able to undergo genetic testing to find out if the mutation is present in their BRCA genes, and Myriad’s monopoly hinders this ability.

“The patents granted to Myriad gave the company the exclusive right to perform diagnostic tests on the BRCA1 and BRCA2 genes and to prevent any researcher from even looking at the genes without first getting permission from Myriad,” according to ACLU. That prevents women from getting alternate tests or a second opinion, while also being charged a high price for the first test, they said.

In its decision [pdf], the court ruled that DNAs are patent-eligible, although one of the three judges dissented, but that methods to compare those gene sequences are not patentable.

The three Circuit judges were Alan Lourie, William Bryson and Kimberly Moore. They decided that they would reverse the district court’s grant of summary judgment with regard to Myriad’s composition claims to isolated DNAs, making them patent-eligible. They affirmed the district court’s judgment of invalidity regarding Myriad’s method claims to comparing or analysing gene sequences, and they reversed the district court’s grant of summary judgment with regard to Myriad’s method claim to screening potential therapeutics via changes in cell growth rates, deeming it valid.

In their discussion, the court said that “the ability to visualize a DNA molecule through a microscope, or by any other means, when it is bonded to other genetic material, is worlds apart from possessing an isolated DNA molecule that is in hand and usable. It is the difference between knowledge of nature and reducing a portion of nature to concrete form, the latter activity being what the patent laws seek to encourage and protect.”

They also said that their decision that isolated DNA molecules are patent-eligible is in line with “the longstanding practice” of the US Patent and Trademark Office. “The Supreme Court has repeatedly stated that changes to longstanding practice should come from Congress, not the courts,” they said.

Bryson Opposes Human Gene Patenting

Bryson said he concurred with the court’s judgment about the patentability of the cDNA claims and the patentability of the method claims but dissented from the court’s decision that Myriad’s BRCA gene claims to gene fragments are patent-eligible. He said that if the decision is sustained it could have broad consequences, “such as pre-empting methods for whole-genome sequencing, even though Myriad’s contribution to the field is not remotely consonant with such effects.” Complementary DNA (cDNA) is a product that is manufactured in laboratories from ribonucleic acid, which can be found as such in the human body.

Bryson said a human gene is not an invention. According to Bryson, Myriad was “not the first to map a BRCA gene to its chromosomal location.” That discovery was made by a group of researchers in 1990, he said. Myriad did not invent a new method of nucleotide sequencing, but rather applied “known sequencing techniques to identify the nucleotide order of the BRCA genes.”

“Myriad’s discovery of those sequences entailed difficult work, and the identified sequences have had important applications in the fight against breast cancer. But the discovery of the sequences is an unprotectable fact,” he said.

Arguing that “the isolated BRCA gene is patentable because in its native environment it is part of a much larger structure is no more persuasive than arguing that although an atom may not be patentable, a subatomic particle is patentable because it was previously part of a larger structure, or that while a tree is not patentable, a limb of the tree becomes a patentable invention when it is removed from the tree,” he added.

ACLU/PUBPAT Reaffirm Their Opposition

PUBPAT and ACLU, commented on the ruling. “The judges disagreed with each other on whether pieces of the human genome are patentable, and we agree with Judge Bryson who explained they are not because no one ‘invents’ genes. Inventions are things like new genetic tools or drugs, all of which can be patented because they are not genes themselves,” said Daniel Ravicher, executive director of PUBPAT and counsel for plaintiffs in the lawsuit.

“Today’s ruling is a blow to the idea that patent law cannot impede the free flow of ideas in scientific research,” said Chris Hansen, a staff attorney with the ACLU Speech, Privacy and Technology Project. “Human DNA is not a manufactured invention, but a natural entity like air or water. To claim ownership of genetic information is to unnecessarily block the free exchange of ideas.”

“The PUBPAT/ACLU lawsuit challenges the whole notion of gene patenting,” they said. “Its outcome could have far-reaching effects beyond the patents on the BRCA genes. Approximately 20 percent of all human genes are patented, including genes associated with Alzheimer’s disease, muscular dystrophy, colon cancer, asthma and many other illnesses.”

“The court has made the wrong decision for a woman’s health,” said Sandra Park, staff attorney with the ACLU Women’s Rights Project. “No corporation should be able to claim ownership of women’s own genetic information.”

Industry Content with Court’s Decision

In a 29 July press release, Peter Meldrum, president and CEO of Myriad Genetics, said Myriad “strongly support the court’s decision that isolated DNA and cDNA are patent-eligible material as both are new chemical matter with important utilities which can only exist as the product of human ingenuity.”

“Furthermore, we believe this decision is in the best interests of the agriculture, biotechnology and pharmaceutical industries, as well as the hundreds of millions of people whose lives are bettered by the products these industries develop based on the promise of strong patent protection,” he said.

The court found that five out of six of Myriad’s method claims that were challenged did not satisfy Section 101 of the Code of Laws of the United States of America, they said, However, “Myriad has 237 method claims for BRACAnalysis which were not affected by this ruling and remain in full force and effect providing Myriad with equally strong method of use patent protection,” they said.

The Biotechnology Industry Organization also expressed satisfaction. “We’re still reviewing the decision,” Lila Feisee, vice president for global intellectual property policy told Intellectual Property Watch. “Preliminarily, we are heartened that the court affirmed that isolated DNA is patent-eligible subject matter.”

Little Impact Seen for Biotech Industry

According to Roberte Makowski, a partner in the intellectual property group at Connolly Bove, the impact of the ruling on the biotech industry should be minimal. “At least for now, this decision provides a level of certainty for the industry’s existing patents and research endeavours,” she said. “It remains to be seen whether this decision will be appealed and whether the Supreme Court will want to weigh in.”

The patents that were challenged in this lawsuit will begin to expire in 2014 and 2015, according to Robert Cook-Deegan, director of the Center for Genome Ethics at Duke University (US). “This case is a big deal for public discussion and to some extent a chance to get a bit of information about what kinds of DNA-based claims will withstand court challenge. But not much practical impact,” he told Intellectual Property Watch.

“This case mainly matters in the US,” Cook-Deegan said, as “in every other jurisdiction except the United States, the patents are pretty much either being ignored or unlicensed testing is allowed as a matter of policy (Canada, United Kingdom, Australia, and New Zealand), or claims are so narrow (Europe) they may secure revenues but are not broad enough to establish a monopoly like the one Myriad has in the US.”

Courtenay Brinckerhoff, vice chair of Foley & Lardner LLP’s Chemical, Biotechnology & Pharmaceutical Practice, wrote in a blog that “the way the court drew a line between ‘isolated DNA’ and other ‘purified’ products of nature would be a departure from current USPTO practice if implemented as an interpretation of §101.”

“It is likely that at least Plaintiffs-Appellees will request rehearing en banc at the Federal Circuit and/or petition for certiorari to the Supreme Court,” she wrote, “so I doubt that this is the last word on the Myriad claims.”

[Update:] The Biotechnology Industry Organization issued a statement on the decision. “The decision upholding the patentability of DNA-based inventions is in accordance with longstanding law and decades of practice at the U.S. Patent and Trademark Office, and is a positive development for patients and other consumers who benefit from biotechnology innovation,” Hans Sauer, BIO deputy general counsel for intellectual property, said in a statement. “Biotechnology firms have long relied on these patents to secure the private investment necessary for the research and development of innovative diagnostic, therapeutic, environmental and agricultural products.”