Biotech Building Blocks On Trial: ACLU, Myriad Battle Over BRCA Cancer Gene Patents

ACLU argues that isolated DNA molecules are like a carburetor taken from an engine, the same inside as outside the body; Myriad says they are new compositions of matter.

The American Civil Liberties Union told a federal judge that the question of whether the BRCA1 and BRCA2 breast and ovarian cancer genes can be patented turns on the question of whether DNA isolated from the body is markedly different from DNA in the body.

Speaking in a packed courtroom Feb. 2, ACLU attorney Christopher Hansen said it is clear that there is no difference between the two since Myriad Genetics determines whether someone has or is suppose to have gene mutations based on an analysis of DNA isolated from blood or saliva samples.

"They don't say DNA in our test tube has variations but we have no idea what DNA in the body looks like," Hansen said. "If the isolated DNA is different than that in the body they can't draw their conclusions."

At the hearing before Judge Robert Sweet of the U.S. District Court for the District of New York, Hansen argued for summary judgment that Myriad Genetics' patents on the BRCA1 and BRCA2 genes are unconstitutional (a free speech violation) and invalid. Myriad Genetics requested a ruling that the patents are valid.

The case, Association for Molecular Pathology v. United States Patent and Trademark Office, has ramifications on the patenting of all isolated DNA molecules. It is being closely watched by the medical community, biotech industry and the patent bar, which submitted numerous amicus briefs in the case. Many of those with a stake in the outcome were in the audience, including PTO General Counsel James Toupin, Biotechnology Industry Organization Associate General Counsel Hans Sauer, and one of the plaintiffs, Elsa Reich, a genetic counselor and professor in the Department of Pediatrics at New York University School of Medicine.

"This Could Unravel The Entire Foundation Of The Biotechnology Industry"

Myriad attorney Brian Poissant, a partner at Jones Day, argued that there is only one question before the court: how to construe the scope and applicability of Section 101 of the U.S. Patent Act which states that any new and useful process, machine, manufacture, or composition of matter is patentable. He said claims to isolated DNA molecules are new compositions of matter and are useful.

"To go beyond that, to consider the atmospherics put into the record ... could lead to the invalidity of thousands of gene patents," Poissant said. 'This could unravel the entire foundation of the biotechnology industry" and prevent the field of personalized medicine from seeing the light of day.

Assistant U.S. Attorney Ross Morrison argued on behalf of the PTO. He said the agency does not belong in the case and that the Patent Act is compatible with free speech because mental processes and abstract ideas are not patentable under Section 101.

Sweet asked few questions during the oral arguments and said he would consider the matter further before issuing a ruling. "This entire new area of molecular biology and gene processes is very challenging," Sweet said. "In a sense - not totally - I'm grateful to you for bringing this issue before me because it is interesting and challenging."

The judge indicated that the case was not a clear call in November when he denied the defendants' request to dismiss the case. He concluded then that "the facts alleged in the complaint are plausible, specific, and form a sufficient basis for plaintiff's legal argument" ('The Pink Sheet' DAILY, Nov. 3, 2009).

The ACLU and the Public Patent Foundation, a nonprofit group affiliated with Benjamin N. Cardozo School of Law, filed suit against Myriad and the PTO in May on behalf of several scientific organizations, breast cancer and women's health groups challenging claims in seven Myriad patents.

Myriad "Invented The Yolk"?

While the ACLU's novel argument that patenting the BRCA1 and BRCA2 genes is a violation of the First Amendment grabbed headlines, the association made that a secondary issue at the hearing. Instead Hansen emphasized the use of isolated DNA in method and composition claims. He said if the DNA in BRCA1 and BRCA2 genes in the body and those in the test tube are not markedly different then composition claims must be struck down.

Hansen said if he pricked his finger the blood on the podium would be isolated from his body but no different. Judge Sweet asked if there would be a chemical change and Hansen replied that the change would be in non-DNA parts but there would be no meaningful difference.

Hansen also likened isolated DNA to a carburetor, which when removed from an engine is not a different carburetor. He later used a different metaphor, saying that separating yolk from an egg does not create a new invention. "Essentially that's Myriad's position - that they invented the yolk," Hansen said.

As for the method claims in the gene patents, Hansen argued that the essence of the claims, comparing one piece of DNA to another, is thought - thinking they are the same or different. He said the First Amendment prohibits giving exclusive control over thought to a private company.

BIO's Sauer said after the hearing that this is the first time a court has been asked to look at whether there is a significant difference between isolated DNA molecules and those found in nature. This is the issue raised in the case that has been "least explored in the law," he said. For other arguments, such as over method claims, there is controlling precedent.

One of the precedential cases cited by both sides was the Supreme Court's 1980 ruling in Diamond v. Chakrabarty, involving a bacterium genetically engineered to break down crude oil. The Supreme Court ruled that a live artificially engineered microorganism is patentable. ACLU attorney Sandra Park argued that the principal in Chakrabarty was different than the current case since Myriad did not engineer DNA.

Poissant cited the Federal Circuit's ruling last year in Promethus Labs v. Mayo Collaborative Services that a test to measure a drug's metabolite in order to determine proper drug dosage is patentable (Also see "Biotech's Patent Suite Catches Sparks From Federal Circuit's Prometheus Decision" - Pink Sheet, 21 Sep, 2009.). Poissant said the decision was applicable to the Myriad case in which a blood sample was changed to analyze BRCA.

-Brenda Sandburg ([email protected])