Patented genes impede cancer diagnosis

Amanda D. Francoeur, amanda.francoeur@laurin.com

What if you requested a genetic test to check your risk of having a hereditary form of cancer but were turned down by the company that has a monopoly on that test?

Genae Girard of Austin, Texas, faced that dilemma when she was diagnosed with breast cancer in 2006. Concerned that her genes might put her at risk for ovarian cancer as well, she underwent genetic testing, which turned up positive. Before making the irreversible decision to have her ovaries removed, however, Girard decided to seek a second opinion.

At that point, the situation became complicated. Myriad Genetics, a Salt Lake City biopharmaceutical company, owns the patents not only for the BRCA1 and BRCA2 genes – biomarkers for breast and ovarian cancer – but also for the related genetic testing. The company charges $3,000 for the testing and does not accept all types of insurance. In seeking a second opinion, Girard encountered a huge financial hurdle.

Fighting back

In alliance with other outraged cancer patients, genetic researchers and various medical organizations, including professional societies representing more than 100,000 pathologists, Girard filed a Section 1983 action against Myriad as well as the directors of the University of Utah Research Foundation and the US Patent and Trademark Office.

The lawsuit, which was organized by the American Civil Liberties Union and filed in federal court, alleges a breach of constitutional rights, patent law and lawful medical practice. The litigants claim that Myriad’s patents related to the BRCA gene violate the First Amendment and Article I, section 8, clause 8 of the Constitution: “Because human genes are products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought, the challenged claims are invalid under Article I, section 8 of the Constitution and 35 U.S.C. Section 101.”

Myriad maintains that it isolated and purified the DNA, creating something that does not exist in nature. Yet, argue its opponents, the patented product still corresponds to an actual gene sequence; the patented method simply removes genes from their natural location – the body and cell that contain them – but the end result is still the product of a natural phenomenon.

Genes have been patented for decades. Today more than 50,000 patents related to DNA have been issued by the US Patent and Trademark Office and, according to the DNA Patent Database, more than 70,000 additional applications have been filed. Twenty percent of the human genome is represented in current patents, which means that public access to thousands of individual genes is at issue. From the beginning, controversy has swirled around the patenting of genes, but this lawsuit is considered a landmark case.

Uncertain outcomes

Genetic testing is a complex procedure that can yield uncertain results. Many feel that, if testing were more accessible and affordable for patients, they would be more likely to seek second opinions, and diagnoses would become more accurate. Moreover, making genetic material more available would advance research and medicine more quickly. A company’s DNA patent can make it illegal for another business to perform testing on the same genes.

A panel of government experts has looked into this litigation and determined that no critical problems related to research or medical care are necessarily the outcome of gene patents. Therefore, whether the case will favor the plaintiffs is still unknown; if it is successful, however, the decision could accelerate the generation of new treatments.