Battle Over (Human) Genes

Excerpt from a fantastic HuffPo article by Wake Forest University Law Professor explaining the legal issues surrounding our new biotechnology capabilities…

Courts need to be the keepers of the Constitution. But the Federal Circuit has failed its duty in the current battle over the patentability of isolated genes and gene sequences that are crucial to the fight against breast and ovarian cancer.

First some history.

The BRCA genes, which contain proteins that inhibit tumor growth, currently occupy center stage in the legal fight over the patentability of isolated genes and gene sequences.

Scientists at the University of Utah first cloned these genes after it was found that mutations in the BRCA1 and BRCA2 genes were linked to various types of breast and ovarian cancer.

Myriad Genetics is the exclusive licensee of the family of patents relating to these isolated genes and genes sequences. As a result, the company controls all sequencing of the BRCA genes as well as the diagnostic testing for the BRCA mutations.

Myriad, however, refuses to grant any licenses for second-opinion BRCA testing. The limited research licenses it has granted are severely restrictive and often prevent research scientists from disclosing the BRCA test results to their test subjects.

As a result of this restrictive licensing, the Association for Molecular Pathology, a non-profit scientific society, along with research scientists, women’s organizations and individuals, challenged the validity of the BRCA isolated gene patents in federal court on Feb. 4, 2010.

The plaintiffs argued that they were unable to access these unpatentable “products of nature” without being subject to an immediate lawsuit for patent infringement. The female plaintiffs further argued that the BRCA isolated gene and method patents gave Myriad an unconstitutional monopoly of this subject matter that prohibited them from acquiring access to life-saving information about their own genes.

In the initial ruling, the United States District Court of the Southern District of New York invalidated the isolated gene patents as patent-ineligible products of nature under the Patent Act since they were not “markedly different” from their naturally occurring counterparts, as required by the leading Supreme Court case, Diamond v. Chakrabarty.

Unfortunately, on July 29, 2011, the Federal Circuit Court of Appeals reversed the District Court. It held that the breaking of chemical bonds during the isolation process produces genetic material that constitutes “a distinct chemical entity” which is smaller and allows for the “new utility” of detecting the BRCA mutations. As such, the BRCA isolated genes and sequences are “markedly different” from the naturally occurring or “native” genes and are patent-eligible subject matter.

The majority and concurring opinions gave great weight to the Patent Office’s long-standing position that isolated genes are patentable. Judge Kimberly Moore’s concurring opinion further emphasized that to hold otherwise would be detrimental to the biotechnology industry that has relied on gene patenting — 20 percent of the human genome is currently patented — to fund continued genomic research and development.

Read Full Story Here

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