Tag Archives: Breast Cancer

As I wrote previously, one interesting aspect of the recent Federal Circuit decision in Association for Molecular Pathology v. USPTO, is the apparent scientific basis for the differing opinions of Judge Lourie and Judge Bryson on the patent-eligibility of isolated genomic DNA claims. Unlike many concurring and dissenting opinions that are spurred by a different view of the law, Judge Lourie and Judge Bryson also appear to part ways based on different views of the science.

In this second part of a three-part series, I focus on the views of Judge Bryson.

Judge Bryson’s Dissent

Judge Bryson joined the court’s decision regarding standing, the method claims, and the cDNA claims, but disagreed with the holding that the “BRCA gene claims” are patent-eligible.

Judge Bryson read the Supreme Court’s Chakrabarty decision as requiring consideration of two factors:

1. [T]he similarity in structure between what is claimed and what is found in nature and
2. [T]he similarity in utility between what is claimed and what is found in nature.

(This appears to be the same test that Judge Moore applies, although she finds that the isolated genomic DNA claims are patent-eligible for policy reasons.)

Considering genomic DNA, Judge Bryson finds its to be “the same, structurally and functionally, in both the native gene and the isolated form of the gene.” Thus, Judge Bryson believes that claims directed to isolated genomic DNA (as opposed to cDNA) do not satisfy § 101.

The Insignificance Of Breaking Covalent Bonds

Judge Bryson acknowledges that covalent bonds are broken to obtain isolated genomic DNA from its natural state, but does not believe that this difference answers the patent-eligibility question. Quoting Linus Pauling, Judge Bryson writes,

[T]here is no magic to a chemical bond that requires us to recognize a new product when a chemical bond is created or broken, but not when other atomic or molecular forces are altered. . . . A chemical bond is merely a force between two atoms or groups of atoms strong enough “to make it convenient for the chemist to consider [the aggregate] as an independent molecular species.”

Judge Bryson criticizes Judge Lourie’s test for conferring patent eligibility based on the breaking of covalent bonds, but not other types of chemical bonds such as hydrogen bonds or ionic bonds, finding no logical reason or precedent for drawing such a distinction.

Using Genetics, Not Chemistry, To Evaluate The Claims

Judge Bryson suggests that Judge Lourie’s analysis took a wrong turn when it used principles of chemistry to evaluate the claimed subject matter. Judge Bryson explains that the both the language of the claims at issue and the focus of the claimed invention warrant the use of genetic principles instead.

For example, Judge Bryson points out the that the broadest gene claims do not recite specific DNA sequences, but rather recite isolated DNA coding for specific amino acid sequences. Because those claims encompass “[a]n almost incalculably large number” of DNA molecules that “share only one unifying characteristic,” they should be evaluated based on that shared, genetic characteristic—encoding the naturally occurring BRCA1 gene.

Applying such a framework, isolated genomic DNA is no different from the naturally occurring gene:

The isolated BRCA genes are identical to the BRCA genes found on chromosomes 13 and 17. They have the same sequence, they code for the same proteins, and they represent the same units of heredity.

Judge Bryson also emphasizes that isolated genomic DNA has been isolated according to its natural boundaries:

In the case of the BRCA genes . . . nature has defined the genes as independent entities by virtue of their capacity for protein synthesis and, ultimately, trait inheritance. Biochemists extract the target genes along lines defined by nature so as to preserve the structure and function that the gene possessed in its natural environment. In such a case, the extraction of a product in a manner that retains the character and function of the product as found in nature does not result in the creation of a human invention.

Similar Function More Important Than Different Structure

Judge Bryson’s views on the relative importance of structure and function are completely opposite from Judge Lourie’s. While Judge Lourie found structural differences alone sufficient to support patent-eligibility, Judge Bryson reached the opposition conclusion:

The structural differences between the claimed “isolated” genes and the corresponding portion of the native genes are irrelevant to the claim limitations, to the functioning of the genes, and to their utility in their isolated form. The use to which the genetic material can be put, i.e., determining its sequence in a clinical setting, is not a new use; it is only a consequence of possession. In order to sequence an isolated gene, each gene must function in the same manner in the laboratory as it does in the human body. Indeed, that identity of function in the isolated gene is the key to its value.

Judge Bryson concludes:

The naturally occurring genetic material thus has not been altered in a way that would matter under the standard set forth in Chakrabarty. For that reason, the isolation of the naturally occurring genetic material does not make the claims to the isolated BRCA genes patent-eligible.

The Hypothetical Analogies Are Instructive

While Judge Lourie was not concerned with the analogies of a “leaf plucked from a tree” or elemental lithium, Judge Bryson indicates that these analogies should not be ignored.

Judge Bryson believes that “extracting a gene is akin to snapping a leaf from a tree,” and so does not confer patent-eligibility.

[T]o argue 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.

Thus, Judge Bryson bases his decision that the isolated, genomic DNA claims do not satisfy § 101 on his understanding that an isolated gene does not exhibit a materially different function from a native gene. Judge Bryson also would have invalidated the claims reciting fragments of genomic DNA, because the claims use open-ended language that encomasses naturally occurring, full-length sequences.