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The Patent-Eligibility of a Human Gene

BioWorld Perspectives Contributing Writers

Editor's note: Paul M. Rivard is a shareholder at Banner & Witcoff and can be reached at Part 1, and here to read Part 2.

The long-awaited decision in the Myriad case finally arrived on July 29, 2011. Sitting as a panel of three judges, the Federal Circuit narrowly decided — 2 to 1 — that isolated DNA molecules are eligible for patent protection under 35 U.S.C. 101, the section of the patent laws that operates as a gate-keeper for patentability.

The Myriad case was brought by the American Civil Liberties Union on behalf of a collection of research universities and physicians. The basis for the researchers' suit was to have the court address the question: Who owns genes? Human-made inventions are patent-eligible. But products of nature are excluded from patent protection. So the key legal question before the Court was where isolated DNA falls on the spectrum between human invention and a product of nature.

The Supreme Court guidelines for determining patent eligibility require a comparison between the product of nature and alleged invention. To be patent-eligible, the invention needs to have "markedly different" characteristics and uses compared to the product of nature.

Does Breaking a Bond Make the Claim?
Consistent with his questions at oral argument, Judge Lourie focused on the breaking of covalent bonds between DNA in the genome to arrive at isolated DNA as basis for patent-eligibility. (See BioWorld Perspectives, April 22, 2011.) In his view, this chemical difference is enough to make DNA isolated from a chromosome patent-eligible. Judge Bryson dissented on this point, contrasting breaking covalent bonds with breaking ionic bonds, and noting that breaking ionic bonds of a lithium salt to arrive at pure lithium would not permit the lithium to be patented. This difference of views suggests a fertile area for argument on appeal.

The Judges Agree cDNAs are Patent-Eligible
Notably, however, Judge Bryson's dissent did not extend to cDNAs, and all three judges agreed that cDNAs were patent-eligible. Judge Lourie did not distinguish between isolated DNA and cDNAs. Judge Moore readily found that cDNAs were patent-eligible based on chemical differences between the RNA versus DNA, as well as removal of introns compared to genomic DNA. Judge Bryson grounded cDNA patent eligibility on two bases: The utility of the cDNA when inserted in cells to drive protein expression, and, like Judge Moore, that the cDNA structure is distinct from chromosomal DNA because the introns are removed.

Isolated DNA and Fragments of Genes Are a Tougher Sell
While the judges agreed cDNAs are patent-eligible, they disagreed about isolated DNA fragments as well as isolated DNA similar in size to the genomic DNA. For Judge Lourie, breaking the covalent bonds was sufficient to confer patent-eligibility, but neither Judge Moore nor Judge Bryson was persuaded.

In contrast to her reasons for finding cDNAs patentable, Judge Moore's opinion was more nuanced when it came to isolated DNAs. She did not consider the chemical differences between isolated DNA and genomic DNA enough to make isolated DNA patent eligibility. Dividing isolated DNAs into two categories — small fragments and longer DNAs closer in size to the gene in the chromosome — Judge Moore focused on the utility of each category. For small fragments their use as primers was sufficient to establish patent-eligibility. But she based patent-eligibility for longer isolated DNAs on the long-standing practice of the Patent Office to issue claims to them, and concluded that changing this practice now would be too disruptive to industry stakeholders. Focusing on policy issues, Judge Bryson rejected claims to both the smaller fragments and larger sequences as too broad and thus likely to have adverse effects on research and treatment in the field.

What Makes a Diagnostic Method Claim Patentable?
In contrast to the composition claims, analysis of Myriad's method claims met with general agreement. Method claims that required comparing two sequences and looking for a mutation, without more, were invalid as attempts to claim abstract mental processes. But claims were found valid if they also required a step of "growing" cells or some other form of manipulating cells or the cell medium.

A Moot Point?
The conflicted reasoning of the judges regarding DNA underscores the legal and policy complexities of the case. The consensus that cDNAs are patentable is good news for the industry. Nevertheless, a request for rehearing by the Federal Circuit en banc (by all judges) seems likely, and, if that is not granted or fails, an appeal to the Supreme Court seems sure to follow. But there remains an interesting procedural issue. The sole physician found to have standing to sue the patent owner recently changed employment and apparently is no longer in a position to carry out potentially infringing activities. The Federal Circuit may therefore vacate its July 29 opinion, meaning a decision on the merits would not be reached. Myriad has won this battle, but the war may not be over yet.

Notes

  1. Association for Molecular Pathology v. USPTO, Myriad Genetics and Betz et al., Fed. Cir. No. 2010-1406, 7/29/2011.