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Does Someone Hold a Patent Covering Your Genetic Composition?

November 23, 2011

Earlier this year, the Court of Appeals for the Federal Circuit made a monumental decision. They affirmed in part and reversed in part, an earlier decision that claimed patents on BRCA1 and BRCA2 genes were illegal because the occur in nature and are not eligible for patent. The mutations of such genes indicate a predisposition for breast and ovarian cancer.  In the recent reversal, the Court decided that isolated genes, ones that may exist in your body right now, are patentable subject matter. 

Judge Alan Lourie said that “the molecules as claimed,” referring to the “isolated DNA,” in fact “do not exist in nature.”  He further stated that because the genes are separated from surrounding biological materials, the DNA is patentable. However, the Court did decide that some patents held by Myriad Genetics (a self described “healthcare company focused on the development and marketing of novel molecular diagnostic products”), associated with analyzing DNA were found ineligible for protection. Nonetheless, the ruling is considered a victory for Myriad.

[For an article illuminating the differences between what was held patentable and what was not see]

In 2009, in a case brought by the Association for Molecular Pathology against the United States Patent and Trademark Office, the American Civil Liberties Union and others (including the Public Patent Foundation at the Benjamin N. Cardozo School of Law in New York, several individual patients and medical organizations) challenged patents on two human genes held by Myriad Genetics .  Myriad Genetics and the University of Utah Research Foundation hold the seven patents at issue related to the BRCA1 and BRCA2 genes.

Myriad asked Judge Sweet to dismiss the case, arguing that their patents cover “the process of identifying the existence of certain specific mutations” in the genes by analyzing the DNA sequences.    The applicable law, 35 U.S.C. §101 states that “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”  35 U.S.C. 101.  Therefore, a patent is restricted to a process, machine, article of manufacture, composition of matter, or any improvement of the previous. 

However, certain things are barred from being patented.  Among them, quite sensibly, are phenomena of nature.  Since the policy behind patents is motivating inventors to contribute to the useful sciences, it seems obvious that a naturally occurring element of nature would be ineligible for a patent.  Judge Sweet seemed to agree in his 152 decision on the issue, where he stated that the patents were “improperly granted” because they involved a “law of nature.”  

Myriad attempted to argue that their patent is for the process of determining the existence of certain genetic mutations, but their argument is weak and characterized by Judge Sweet as “a lawyer’s trick,” and aptly so.  Judge Sweet discussed the invalidation of Myriad’s patents at length, essentially stating that Myriad attempted to twist the words of 35 U.S.C. §101 in an effort to turn a profit, and at the detriment to a nation full of women at risk for two very serious cancers. 

“Process,” the term that Myriad seeks to apply to their patents in dispute, is described as a series of acts, which are performed upon subject matter to be transformed and reduced to a different state or thing.  Though it is conceivable that any decent attorney, or proponent of profits in medical research could make an argument that Myriad’s BRCA1 and BRCA2 testing methods are in fact processes, it is an unconscionable platform in application.  They seek to patent the process of testing for a certain gene, but their desired monopoly has created irreparable injury to the very patients they supposedly seek to aid.  Moreover, their claims completely contradict the purpose of patents and the policy behind them. 

This case raises the issue of the benefits versus the disadvantages of gene patenting.  Myriad’s case is perfect example for the comparison.  Myriad created an expensive monopoly on the testing kits, supplied the patients they were providing kits to with substandard testing methods, and prevented other labs and medical professionals from improving upon their substandard methods.

Because of their patent protection, Myriad prevented women like Patrice Fortune, Lisbeth Ceriani, and Vicky Thomason from obtaining cost effective test kits.   According to her declaration and Judge Sweet’s opinion, Patrice Fortune was diagnosed with breast cancer but due to Myriad’s monopoly on the BRCA1 and BRCA2 genetic testing market, she is unable to afford the single test kit available.  Ms. Fortune’s oncologist and genetic counselor recommended she be tested for the relevant genes but because she is on Medi-Cal insurance, an insurance Myriad will not accept, she has been prevented from obtaining the crucial genetic analysis she needs in order to determine her risk for ovarian cancer.  Like many medical tests and procedures, the out of pocket costs are exorbitant and Ms. Fortune cannot afford it.

In addition to Myriad’s expensive monopoly, their patenting of the genes at issue has resulted in substandard testing methods, as would be expected by permitting only one company to develop and profit from a single method in high demand. Ms. Runi Limary  is a patient mentioned in the patent opinion who exemplifies the problems with genetic patenting.  She was diagnosed with aggressive breast cancer in 2005.  When she obtained BRCA1/2 testing from Myriad, her results were less than helpful as they indicated a “genetic variance of uncertain significance.”  Because of Myriad’s restrictive patents, she is unable to pursue alternate testing venues. 

In 2006 The Journal of American Medical Association reported some disturbing information.  They stated that there was a serious margin of error in Myriad’s testing kits, including false negatives.   Myriad’s patenting of the BRCA1/2 genes mandated that their substandard testing become unavoidable for concerned patients. Myriad is the only testing facility with the laboratory capabilities to provide full BRCA1/2 sequencing. By preventing competition in the BRCA1/2 genetic testing field, Myriad has made it impossible for concerned patients to obtain second opinions regarding their potential genetic mutations..  Myriad’s monopoly in the industry is not only preventing the development of new and improved testing kits, it is directly working against the inherent policy of patents, to foster and reward scientific research that benefits society.

Myriad contends that their methods of testing are the “gold standard”  but the patients left with faulty results disagree. Myriad has prevented competent genetic researchers like Dr. Haig Kazazian & Arupa Ganguly Ph.D  from allowing high risk patients to benefit from the competition in research development that saves lives.  Until recently Dr. Kazazian and Arupa Ganguly Ph.D. were designing and providing women with quality BRCA1/2 genetic testing kits.  After receiving a cease and desist letter from Myriad, they were forced to refrain from their work, which provided kits to over 500 women a year starting in 1996. 

Sadly, while the arguments against gene patenting are clear and ethical, the arguments for gene patenting are weak and profit driven.  Kenneth Chahine, a visiting law professor from the University of Utah, the same University who owns the patents at issue with Myriad, submitted an amicus brief in support of validating the patents.   Mr. Chahine’s contention was that invalidating the BRCA1/2 patents could make it harder for young companies to raise money for investors and “[t]he industry is going to have to get more creative about how to retain exclusivity and attract capital in the face of potentially weaker patent protection.”

** Help raise money for ovarian cancer research by donating to or registering for the Run For Her 5K Run and Friendship Walk taking place on Sunday, November 13, 2011 in Los Angeles. Can’t make it up to L.A.? No problem! You can be a “sleepwalker” and run in your hometown.

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Among women who die before age 70…

77% of women with a BRCA1 mutation and 56% of women with a BRCA2 mutation (and no screening or medical interventions) who die before age 70 will die from breast or ovarian cancer. Only 11% of women in the US who die before age 70 will die from breast or ovarian cancer.[17]