Battle Over Gene Patents Most Likely Headed to Supreme Court

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.
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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.

As a former registered Patent Attorney, one question immediately came to mind after reading the Federal Circuit's majority and concurring opinions.

How can the court allow chemical differences to supersede biological equivalence when the specific utility of the invention, namely detecting mutations linked to breast and ovarian cancer, depends on biological identity? Chemically modifying an isolated gene does not alter its biological heart (nucleotide sequence). Accurately detecting BRCA mutations would be impossible without this biological identity.

Although promoting innovation is a laudable goal, the Federal Circuit's broadening of what constitutes patent-eligible subject matter missed the bigger Constitutional target.

The Intellectual Property clause of the Constitution empowers Congress to grant exclusive rights, such as patents and copyrights, for "limited timed times to promote Progress of Science and the Useful Arts."

The Constitutional mandate to promote progress includes more than stimulating innovation and must include balancing any grant of exclusive rights against providing access to basic knowledge. Patenting products of nature such as isolated genes and gene sequences prevents access to these basic research tools during the term of the patent. This impedes rather than promotes progress and is therefore in direct violation of the IP clause.

It is the role of Federal Courts, as the keeper of the Constitution, to ensure that any analysis of the plain language of Section 101 of the Patent Act and controlling case law is in harmony with the Constitutional mandate to promote progress of the useful arts.

The Federal Circuit should have taken this role seriously and upheld the lower court's invalidation of the BRCA isolated genes and gene sequence patents as patent-ineligible subject matter. Viewing these genes as chemically different despite their biological equivalence is cheating the system.

If the BRCA gene patents were invalidated, Congress could then step in and legislate a new "Constitutional" framework of exclusive rights for this subject matter. Congress would likely gather industry, academic and public stakeholders together to craft a hybrid statute that would promote innovation as well as provide much-needed access to these basic upstream research tools.

Given the strong desires of the plaintiffs in the Molecular Pathology case to gain greater access to the isolated BRCA genes for the public, an appeal for an en banc hearing by the Federal Circuit or an appeal directly to the Supreme Court is likely.

I remain hopeful that the reviewing Court will be mindful of its role as the keeper of the Constitution and interpret the Patent Act's subject matter limitation to exclude the BRCA genes as patent-ineligible products of nature. Only then, can we begin the appropriate legislative dialogue on drafting a "progress-promoting" isolated bioproducts statute which properly balances access against innovation.

This is going to be a long conversation and the courts must ensure that the public gains uniform access to these much-needed basic research tools.

Wake Forest University Law Professor Simone Rose's research specializes in the intersection of patent law with biotechnology and stem cell research.

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