Push For “March-In Rights” To Prevent Myriad From Asserting Patents On Cancer Test

Despite last month’s United States Supreme Court decision on a case involving Myriad Genetics, which struck down some of Myriad’s patents related to human genes, Myriad has filed infringement suits against two companies that had announced they would begin offering lower-cost tests for the breast cancer genes in question.

In light of this, Vermont Democratic Senator Patrick Leahy, chair of the Senate Judiciary Committee, has urged the US National Institutes of Health (NIH) to utilise “march-in” rights to ensure access to Myriad’s genetic tests.

Leahy’s 12 July letter to NIH Director Francis Collins is available here.

March-in rights provisions under the US Bayh-Dole Act can be used to ensure greater access to new inventions by requiring the patent holder to grant a licence “upon terms that are reasonable.” The use of such rights in the case of Myriad Genetics could allow wider access to the company’s breast and ovarian cancer testing technologies.

Despite the Court’s ruling against Myriad’s patent claims on the isolated deoxyribonucleic acid (DNA) for BRCA (breast cancer) genes, Myriad’s claims to complementary DNA (cDNA) are still patentable. Leahy points out that as a result, Myriad “may continue to be the only company able to provide” the genetic testing for breast and ovarian cancer.

The public health motivation behind using march-in rights against Myriad is the benefit of genetic testing for breast and ovarian cancer. Early testing can identify markers that can lead to earlier diagnosis and treatment. Myriad has patent protection on this test, and as a result is the sole provider of this potentially life- and cost-saving tool.

The Bayh-Dole Act pertains to government-funded intellectual property. The act says the objective of Congress is to use the patent system to “promote the inventions arising from federally supported research or development” and also to “protect the public against nonuse or unreasonable use of inventions,” in addition to other stated objectives.

The patents in question in the Myriad case were “based in part on federally-funded research,” according to Leahy. Thus, the Bayh-Dole Act can allow the US government to utilise march-in rights to achieve “greater access to the subject invention in appropriate situations.”

Leahy states in his letter that if the patent owner refuses to grant the licence, the government can directly licence the patent in “limited circumstances,” including those under which it is “necessary to alleviate health or safety needs which are not reasonably satisfied by the patentee.”

In its motion for preliminary injunction relief, Myriad said that its reliance on patents has led to an “extensive database of genetic variant information.” Myriad purports that this information has led to improved test quality (BRCAnalysis), which is not seen with competitor Ambry’s test, BRCAPlus.

Part of Myriad’s argument in its case against Ambry is that the difference between the quality of tests will be lost on consumers, should Ambry be allowed to enter the market with its own BRCA test. Myriad says that it has “significantly advanced” the knowledge of hereditary cancer and “improved patient health-care.”

By investing in research to improve its tests, Myriad reports that its test percentage of “variants of unknown significance” is less than 3 percent, compared to 25-30 percent in public databases. This means that over 97 percent of the patients that Myriad tests will receive a result indicating whether they have a genetic variation that increases the patient’s risk of breast or ovarian cancer. Myriad claims in its motion that Ambry’s percentage of “variants of unknown significance” is between 25-30 percent.

Myriad fears that if Ambry is allowed to continue selling its tests, “which have a higher error rate than Myriad’s and will result in many more variants of unknown significance,” consumers will receive “inconclusive or even flatly incorrect results from those tests, and those consumers are likely to associate those flawed results with Myriad.”

Brittany Ngo is currently completing her Master’s in Health Policy and Global Health at the Yale School of Public Health and previously obtained a Bachelor’s of Arts in Economics from Georgetown University. Through her studies she has developed an interest in health-related intellectual property issues. She is a summer intern at Intellectual Property Watch.