How did Myriad Genetics get the patents of BRCA1 and BRCA2 genes?

Myriad Genetics is one of the leading Genomics companies of USA. They are dedicated to research on the roles of genes in human life. In 1994, Myriad affiliated scientists first discovered BRCA1 (BReast CAncer gene 1), which when mutated results in pronounced predisposition to breast, ovarian and certain other cancers. In the next year, the scientists of Myriad again discovered BRCA2 (BReast CAncer gene2). The scientists of Myriad declared that a woman who inherited these types of genes from heredity had a much higher risk of developing of breast or ovary cancer. It was a groundbreaking invention in the history of cancer treatment. Myriad patented its discoveries and got the sole rights of commercial testing of BRCA1 and BRCA2 in USA. The company has also created a private database of DNA variance and the information regarding BRCA1 and BRCA2 test analysis.

The patent law of US has empowered Myriad to control the database of DNA variance. The researchers and patients are strongly interested in ensuing full access to the database. The proprietary of the private database can share the full information with others in various methods. The common methods of sharing the private information are charging a fee for the commercial utilization or promoting voluntary information to the non-commercial users.The partial unofficial information can impede the clinical analysis of genomic medicine. US patent laws do not allow the data sharing of patented information. However, Myriad shared data with the others until 2004. From 2005, the company stopped the data sharing following the company’s new trade secret policy. The new policy of Myriad created a major controversy among the interested organizations and the patients who were related with the BRCA tests. Some justified the decision of Myriad on the ground that the financial gain of Myriad is the reward of their innovation. Others said that the decision would deprive the patients from the proper treatment due to lack of comparative study of the test. Moreover, the decision will also hamper the further development.

In this scenario, American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) filed a lawsuit against Myriad Genetics, the U.S. Patent and Trademark Office (USPTO) on 12th May 2009, alleging that the patents of two genes BRCA1 and BRCA2 associated with the breast and ovary cancer are unconstitutional. The plaintiff argued that the genes are the products of the nature, so it cannot be patented. They also said that the patents had curbed the further research and development in the field of BRCA and the plaintiff had limited the women patients’ options regarding their treatment.

On 11th July 2011, the court ruled that company can get the patent of genes but cannot get the patent on the method to compare those gene sequences.

In March 2012, US Supreme court vacated the decisions of appeal court and instructed the court to reconstruct the case in the line of Mayo vs Prometheus case in which Supreme Court unanimously rejected patents on methods for evaluating a patient’s response to a drug.

In August 2012, federal appeals court again rejected the patent on the method to compare those gene sequences.

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