Medical Device Daily Washington Writer
WASHINGTON — The American Civil Liberties Union (ACLU), joined by a coalition of patients, pathologists, genetic researchers and other scientists, filed a lawsuit Tuesday challenging the government's decisions to grant patents for the BRCA gene, which is associated with breast and ovarian cancers, to Myriad Genetics (Salt Lake City) and the University of Utah Research Foundation (also Salt Lake City).
The lawsuit, filed in the U.S. District Court for the Southern District of New York in Manhattan, charges that gene patents stifle research and competition and limit options for medical care. The plaintiffs are arguing that the patents are invalid and unconstitutional under the First and Fourteenth Amendments.
By granting exclusive rights for genes, the government is in essence giving patent holders complete control over those genes and the information contained within them, the lawsuit asserted.
The U.S. Patent and Trademark Office (PTO) has granted thousands of patents on human genes, with about 20% of human genes now patented, according to the ACLU.
A gene patent holder has the right to prevent anyone from studying, testing or even looking at a gene. As a result, scientific research and genetic testing has been delayed, limited or even shut down due to concerns about gene patents, the plaintiffs contended in their suit.
Because Myriad Genetics holds the patents for the BRCA 1 and BRCA 2 gene sequences and any mutations along those genes, the company has the right to control all research and testing on or involving the BRCA genes. Myriad currently is the only firm in the U.S. where diagnostic testing can be performed on BRCA. The company charges more than $3,000 for the test.
Women with the BRCA mutations have up to an 85% chance of developing breast cancer and up to a 60% chance of ovarian cancer, according to the National Cancer Institute. BRCA mutations are also linked to breast and prostate cancer in men.
The lawsuit charged that Myriad's monopoly on the BRCA genes makes it impossible for patients to access other tests or get a second opinion about their results. Affordability also has played a role in some patients not seeking the test.
Plaintiff Lisbeth Ceriani, who was diagnosed with bilateral stage IIA breast cancer in May 2008 at age 42, said two genetic counselors and her oncologist all agreed that she should have Myriad's BRCA analysis test, but the company has refused to sign a contract with her insurance provider, MassHealth, a form of Medicaid, even though the state said Ceriani would be fully covered.
Ceriani said Myriad refused the contract because the state's reimbursement rate of $1,599 was much lower than the $3,225 the company charges.
"Myriad holds my fate and future in its administrative hands," she said in a statement, adding that she is unable to afford the out-of-pocket costs on her own.
Myriad reportedly said it would fight the suit in court. The PTO had no comment Wednesday.
Jan Nowak, president of the Association for Molecular Pathology (Bethesda, Maryland), also a plaintiff in the suit, said gene patents can be a disincentive to innovation in molecular testing, "because they deny access to a vital baseline of genomic information that cannot be 'invented around.'"
Moreover, he said, the threat of enforcement from a patent holder and ensuing litigation costs lead to a "chilling effect as clinical laboratories and manufacturers are reluctant to develop new tests that could directly benefit patients."
Regardless of the outcome, the lawsuit has the potential to significantly clarify the extent of protection provided by gene patents, Nowak said.
The American College of Medical Genetics (also Bethesda), another plaintiff, argued that genes and their mutations are "naturally occurring substances that should not be patented."
But Tom DiLenge, general counsel for the Biotechnology Industry Organization (Washington), disputed the lawsuit's claims that gene patents stifle innovation and research or create access and cost issues with respect to diagnostic tests and therapeutic products.
He pointed to a 2006 report from the National Academy of Sciences, which concluded that intellectual property restrictions rarely impose significant burdens on biomedical research.
DiLenge also noted that a draft report from the National Institutes of Health determined that there is little consistent evidence of a price effect directly related to patents to which Myriad holds exclusive versus nonexclusive rights.
The NIH report also found that there was little empirical data to support or refute that Myriad's exclusivity under the patents on the BRCA genes stifled further basic research.
"The reports speak for themselves," DiLenge told Medical Device Daily's sister publication, BioWorld Today.
However, NIH added that although Myriad maintained that it has not enforced its patents against researchers, the company has not stated in a written, actionable form that it would not do so, with the exception of a 1999 memorandum of understanding with the NCI.
"This ambiguity may be a factor in stifling research, to the extent that any research has been impeded," the authors of the NIH report wrote.
The National Academy's report also said there are reasons to be apprehensive about the future impact of IP restrictions on scientific advances in the area of drugs and other disease therapies.
Both reports concluded that, although the evidence to date suggests that the number of difficulties created for researchers by human DNA and gene patenting is currently small, the complexity of the patent landscape is worrisome and may become considerably more complex and burdensome over time.
Nonetheless, DiLenge asserted the issues involving reimbursement, access or costs have nothing to do with patenting and licensing and are red herrings arguments.
Patents, however, are "critical" to the development of drug therapies that treat many diseases, such as cancer and rare genetic disorders and other debilitating diseases, he insisted.
Rulings in favor of suits like the one brought against the PTO and Myriad, DeLenge said, could push innovation back 30 years, before the landmark 1980 Supreme Court case that allowed for the patenting of biologicals and the Bayh-Dole Act, which allowed for federally funded inventions to be patented.
The combination of those two 1980s actions, he declared, unleashed a wave of biotech innovation.
"If we want biotech innovation to continue, you can't say we are not going to allow patenting or exclusively licensing of the basic foundational biotech patents," DiLenge argued.
Piper Jaffray & Co. (Minneapolis) analyst Edward Tenthoff said that while he was uncertain of the merits of the lawsuit and any timelines for resolution, he viewed the suit as a "long-term incremental overhang" for Myriad.
However, he noted that Myriad has successfully defended the BRCA patents in court in the past and that the firm's analysis test is protected both by composition of matter and method of use patents and by trade secrets that present formidable barriers to entry.