Patenting Isolated Human Genes: The Obvious Force Behind the Success of BRAC Analysis

By Sarah Riedl *

human genesThe Court of Appeals for the Federal Circuit recently reinforced previous holdings allowing patents on human genes, which has been the rule on gene patents since 1980.  The Court of Appeals reversed the District Court’s decision, which reasoned that the isolated DNA was no different from the natural DNA because of its function as an information carrier.  The Court of Appeals stated that the function of the chemical was immaterial to its patentability, only the chemical structure is relevant.  Since the gene was isolated to exist outside its natural state in the human body, the chemical structure had been altered warranting patentability.

Myriad Genetics currently holds the patents for BRCA1 and BRCA2, which are human genes that fall into the category of tumor suppressors.  Trials have demonstrated that individuals with mutations on BRCA1 or BRCA2 have a dramatically increased risk of developing breast and ovarian cancer.

BRACAnalysis logoBRAC Analysis is the current screening test that provides women with an assessment of their breast and ovarian cancer risks based on whether their genes carry recognized mutations.  BRAC Analysis involves a simple blood test that screens for Myriad’s patented genes.  Of course, Myriad could never get a patent for the blood screening test, because such a test is not novel.  Blood tests are commonly used throughout the field of medicine as screening procedures.  Therefore, Myriad had to look to its second patent option for protection – the genes themselves.

The requirements for patentability are that the subject matter be: 1) useful; 2) novel; and 3) non-obvious.  There can be no doubt Myriad’s patents are useful because both help to assess a woman’s risk level for cancer so the disease may be monitored and, if the cancer develops, treated early enough to save lives.  Similarly, Myriad is the first company to isolate the two genes from their natural forms and document the mutations, which satisfies the novelty requirement.

The third requirement, non-obviousness, may be a sticking point if the case is heard by the Supreme Court.  Where the subject matter contains even one or two differences from a similar subject already known, a patent may not be granted if the difference is obvious.  The Court of Appeals laid out the difference that was significant in its decision – the different chemical structures between the gene in nature and the gene in isolation. The question to be answered, however, is whether isolation of a gene alone is non-obvious where many geneticists use isolation techniques as standard procedure.

The Court of Appeals dealt with the non-obvious requirement as an afterthought, merely stating that the obvious form of the genes is part of the DNA sequence.  Such glancing judicial review often appears where larger policy issues are persuading the court.  A comparison to patented insulin reveals that the court might have had other policy issues supporting its decision.

One of the most notable examples of isolation of genetic material giving rise to patent protection is synthetic insulin for use in Diabetes patients.  Synthetic insulin is created by a process where laboratory methods bring genetic material together that would not be combined in nature. By combining genetic material, the scientists created an entirely new chemical substance that does not exist in nature.

MYRIAD logoThe process to create insulin adds an extra step that Myriad does not take – the combination of genetic material to create a new synthetic sequence.  By contrast, Myriad merely isolates the genetic material from its natural combinations, but makes no further alteration.  This isolation, which is a process most genetic specialists likely can perform, does not create a new sequence but merely cuts out the needed portion from the whole for use.  The fact that other genetic specialists use this isolation process could provide a basis for defeating the non-obviousness element of patentability.  After all, Myriad’s patent is on the genes, not on the diagnostic Brac Analysis test.

The Court of Appeals stated that judicial restraint was necessary to promote rather than impede medical and scientific innovation.  Providing patent rights protects scientific discoveries and offers profitability to companies providing medical advancement to the masses.  The benefits and usefulness of targeting breast and ovarian cancer risks early seems to heavily outweigh strict adherence to the non-obviousness of isolating human genes for the Court of Appeals.

* Sarah R. Riedl is a second year law student at Wake Forest University School of Law. She has a Bachelor of Arts in English from the University of Illinois. Upon graduation in May 2013, Miss Riedl intends to practice business litigation and intellectual property law.