Washington Editor

The Federal Circuit giveth, and it taketh away in deciding a challenge to the patentability of Myriad Genetics Inc.'s BRACAnalysis, a breast cancer gene test.

In a split decision handed down Friday, the U.S. Court of Appeals for the Federal Circuit ruled that isolated DNA and complementary DNA (cDNA) can be patented, but it struck down method claims for a process that compares and analyzes nucleotide sequences because the method did not involve a "transformative" step.

"There are a number of companies out there breathing a sigh of relief" as a result of the decision, Jennifer Camacho, a partner with Greenberg Traurig, told BioWorld Today.

The Federal Circuit reversed a district court's decision that "Myriad's composition claims to 'isolated' DNA molecules cover patent-ineligible products of nature . . . since the molecules as claimed do not exist in nature," Judge Alan Lourie said in the majority opinion.

Had the appellate court ruled otherwise, thousands of patent claims on human genes could have been invalidated.

"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," Myriad President and CEO Peter Meldrum said in a press release.

While the Federal Circuit's ruling on gene patentability brought more certainty for composition claims, it should have biotechs closely reviewing their method claims, Courtenay Brinckerhoff, a partner at Foley Lardner, told BioWorld Today.

"The court drew a really fine line on the case here and Prometheus," Brinckerhoff said, referring to Mayo Collective Services v. Prometheus Laboratories Inc., which deals with method patents for calibrating the proper dosage of thiopurine drugs used to treat autoimmune diseases.

In The Association for Molecular Pathology v. Myriad Genetics Inc., the Federal Circuit held that Myriad's method claims directed to "comparing" or "analyzing" DNA sequences are not patentable because they include no transformative steps and cover only abstract, mental steps.

In Prometheus, the appellate court ruled the personalized medicine-type claims are patent-eligible because they cover a "determining" step, which includes the extraction and measurement of metabolite levels from a patient sample. (See BioWorld Today, July 6, 2010.)

Many biotechs were already changing how they pursued method claims in the wake of the Supreme Court's ruling last year in Bilski v. Kappos, Camacho said.

In that decision, the high court said the so-called "machine-or-transformation test" is not the sole test for determining the patentability of all business methods – an opinion many saw as leaving the door open for innovation. (See BioWorld Today, June 29, 2010.)

The Federal Circuit's decision in Myriad builds on Bilski, Camacho said.

More Guidance Expected from Supreme Court

However, more guidance on method claims, as well as DNA claims, may be in the works. The Supreme Court recently granted cert on Prometheus. And it may be asked to weigh in on Myriad. (See BioWorld Today, June 27, 2011.)

The American Civil Liberties Union (ACLU), which represented the plaintiffs in Myriad, is likely to appeal. "We are considering all of our options before making a decision as to how to proceed," Chris Hansen, senior staff attorney with the ACLU Speech, Privacy and Technology Project, told BioWorld Today.

The plaintiffs could ask the full Federal Circuit to review the case or appeal directly to the Supreme Court.

As for Salt Lake City-based Myriad, it is pleased with last week's decision and doesn't plan to appeal the ruling on its method claims. "We have over 232 other, more specific method claims, which we believe offer ample protection for the BRACAnalysis test," Myriad spokeswoman Rebecca Chambers told BioWorld Today. "Further, we believe our intellectual property position is as strong today as it was before the ACLU brought this case."

The lawsuit specifically challenged Myriad's patents on the BRCA1 and BRCA2 genes. Mutations on those genes are responsible for most cases of hereditary breast and ovarian cancers.

"Myriad's monopoly on the BRCA genes makes it impossible for women to access alternate tests or get a comprehensive second opinion about their results. It also allows Myriad to charge a high price for its tests," according to an ACLU statement.

Hansen called the Federal Circuit's ruling "a blow to the idea that patent law cannot impede the free flow of ideas in scientific research. 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 U.S. government partially sided with the ACLU, arguing before the Federal Circuit in April that while cDNA could be patented, isolated DNA should not be. The acting solicitor general said if the material is identical to what could be seen in nature, it shouldn't be patent-eligible. (See BioWorld Today, April 5, 2011.)

But Mary Webster, a patent attorney with Nixon Peabody who has experience as a molecular virologist, said a lot of work is involved in isolating DNA from cells and then manipulating it so it can be recognized and turned into a useful tool.

For example, the DNA has to be stripped of protein and other cellular constituents, cut and pasted into recombinant vectors, amplified, sequenced and so on.

"There is sound scientific basis for finding that isolated DNA is 'a product of human ingenuity having a distinctive name, character and use,'" Webster told BioWorld Today, quoting from the Federal Circuit opinion.