By Turna Ray
A New York federal district court has denied Myriad Genetics’ motion to dismiss a lawsuit challenging its patents covering BRCA gene mutations associated with hereditary breast and ovarian cancer based on the novel circumstances presented in the case and the sweeping implications of the issues involved.
The American Civil Liberties Union filed the lawsuit in May on behalf of four scientific organizations — representing more than 150,000 medical professionals, researchers, women's health groups, and individual women — alleging that the BRCA gene patents held by the University of Utah Research Foundation and exclusively licensed to Myriad stifle research and limit women's treatment options. Additionally, the lawsuit, Association for Molecular Pathology, et al. v. US Patent and Trademark Office, et al., challenges the constitutionality of Myriad's patents on the BRCA1 and BRCA2 genes, by asserting that Myriad’s exclusive licensing practices hinder the free flow of information and therefore obstruct the First Amendment protecting free speech [see PGx Reporter 05-13-2009].
However, Myriad and other defendants challenged the plaintiff’s ability to bring the lawsuit, by filing a motion-to-dismiss memorandum, calling ACLU's case "a thinly veiled attempt to challenge the validity of patents" [see PGx Reporter 08-05-2009].
In deciding to dismiss Myriad's motion to dismiss on grounds that it lacked technical merit, Robert Sweet, the federal district court judge on the case, recognized the "uniqueness" of the plaintiffs' case with regard to "scope and significance of the issues presented, and the consequences of the remedy sought." Furthermore, the court acknowledged the right of the plaintiffs, particularly "women facing the threat of breast cancer … who are in the midst of their struggle with the illness," to challenge the practice of gene patenting.
"The challenges to the patents-in-suit raise questions of difficult legal dimensions concerning constitutional protections over the information that serves as our genetic identities and the need to adopt policies that promote scientific research," the court said in its decision.
In its decision, the court cited the example of Plaintiff Wendy Chung, a professor of molecular genetics at Columbia University who studies genetic and environmental factors linked to hereditary breast and ovarian cancer. Although Chung's lab sequences BRCA1/2 genes of research participants, researchers cannot inform subjects of their mutation status because of Myriad's patents.
Additionally, the court cited numerous examples provided by the plaintiffs where academic studies that would essentially improve BRCA sequencing methods were stopped by Myriad, who informed researchers that their work would infringe the firm's patents.
For example, according to court documents, in 2005, Yale DNA Diagnostics Laboratory asked Myriad for permission to perform genetic screening of BRCA genes looking for large rearrangement mutations correlated with cancer risk. Studies had previously shown that Myriad's full sequencing test missed some large gene rearrangements associated with disease risk. However, Myriad informed Yale that BRCA testing could not be done by the university's laboratory as it would infringe the company's patents.
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"The widespread use of gene sequence information as the foundation for biomedical research means that resolution of these issues will have far-reaching implications, not only for gene-based health care and the health of millions of women facing the specter of breast cancer, but also for the future course of biomedical research," the NY Southern District Court said in an opinion explaining the reasons for denying Myriad’s motion to dismiss the case.
"The novel circumstances presented by this action against the USPTO, the absence of any remedy provided in the Patent Act, and the important constitutional rights the Plaintiffs seek to vindicate establish subject matter jurisdiction over the Plaintiffs' claim against the USPTO."
If the case is ruled in favor of the plaintiffs, it has the potential to impact the entire process of gene patenting. ACLU’s challenge to Myriad’s BRCA patents has certainly reignited debate on the question of whether gene associations are patentable subject matter, and the issue is being considered in policy circles, as well.
USPTO, Courts, or Congress Can Do It
"We hope this [court] challenge is the beginning of the end to patents on genes, which limit scientific research, learning, and the free flow of information," Chris Hansen, a staff attorney with the ACLU First Amendment Working Group, said in a statement. "No one should be able to patent a part of the human body."
However, the courtroom isn't the only place gene patenting is currently being debated.
A government advisory group is planning to recommend that the HHS Secretary support statutory and regulatory changes that would limit the practice of patenting claims on genes. However, due to strong opposition from a few committee members, as well as interest groups representing the biomedical industry and academic research, the HHS Secretary’s Advisory Committee on Genetics, Health, & Society has held off on finalizing its recommendations until dissenting opinions are incorporated in the report [see PGx Reporter 10-14-2009].
The recommendations were met with resistance from several committee members who criticized the recommendations as inactionable for the HHS Secretary, charged that the task force had paltry evidence to support its recommendations, and warned that the recommendations were so broad they would be disruptive to the entire US patent system.
"Of course it is legitimate to criticize the [SACGHS'] recommendations, but to criticize them for not having examined the issue carefully seemed unfair to me," Hansen told Pharmacogenomics Reporter this week.
SACGHS specifically recommended the HHS Secretary support and work with the Secretary of Commerce to promote statutory changes that would exempt from infringement liability anyone developing or selling a test based on patent claims on genes for patient care or for research. Recognizing that these recommendations may take time to be enacted, SACGHS proposed intermediary proposals urging industry and academia to practice ethical licensing practices; discouraging and restricting single-laboratory exclusive licenses; creating an advisory body to assess the impact of gene patenting and licensing practices; and clarifying whether the Bayh-Dole Act gives agencies the power to influence how patent holders license their inventions.
"I don't agree with everything that [SACGHS] decided and lots of people don't agree with what they decided but you can't fairly criticize the process," Hansen said. "It strikes me that the process was very careful and very thoughtful."
The ACLU estimates that approximately 20 percent of all human genes are patented, including genes associated with Alzheimer's disease, muscular dystrophy, colon cancer, asthma, and many other illnesses.
However, gene patent holders argue that there isn't sufficient evidence that patents widely restrict access to treatments or curtail research. If anything, gene patent holders maintain that the inability to garner IP protection for gene associations would deter investors and stifle innovation.
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According to Hansen, the practice of patenting genes in this country can be changed in one of three ways. The USPTO can decide to stop granting gene association patents, Congress can promulgate statutory changes to limit gene patents, or the courts can deem gene association patents illegal.
"If the courts find that [gene patents] are valid, then the only remedy is Congress," Hansen said. "Ultimately, the question of whether genes are patentable subject matter is a question on which the patent office has the authority to make the first determination. The patent office has issued formal policy saying they will grant patents on isolated and purified genes, and certainly has the authority to change its own policies."
According to USPTO policy, naturally occurring genes can be patented if they are "isolated from their natural state and purified." However, the court acknowledged in its decision that "the information dictated by the gene is identical whether it is inside or outside the body, and an 'isolated and purified' human gene performs the same function as the human gene in a person's body."
In the unlikely event USPTO did decide to change this policy, it could invite lawsuits from industry stakeholders whose gene patents would be invalidated as a result, Hansen noted.
In a countermove to Myriad Genetics' motion to dismiss its anti-gene patenting case, ACLU submitted numerous declarations of material fact to urge federal district court Judge Sweet to decide the case even before it gets to trial. In this regard, the NY district court has ruled that the defendants' motion for summary judgment in the case will be due Dec. 2; the plaintiffs' reply due Dec. 9; and hearings will be held on Dec. 11.
"This can go one of three ways," ACLU's Hansen said. "The judge can grant summary judgment to the plaintiffs, in which the case is over. He can grant summary judgment to the defendants if they cross move, in which the case is over. Or he can deny summary judgment on the grounds that there are facts in dispute and we need to have a trial."
In denying Myriad's motion to dismiss, the judge has only determined that ACLU's case cannot be thrown out on technical grounds. But that doesn't mean that the case will necessarily go to trial. "So, they [defendants] can lose completely, or we can lose completely, or we can both lose and we'd have to have a trial," Hansen said.
"We look forward to proving in court that human gene patents should never have been granted in the first place," Daniel Ravicher, executive director of the Public Patent Foundation and co-counsel in the lawsuit, said in a statement. "Companies should not able to own the rights to a piece of the human genome. Specific tests or drugs can be patented, but not genes themselves."
Plaintiff attorneys on the case include Hansen and Aden Fine of the ACLU First Amendment Working Group; Park and Lenora Lapidus of the ACLU Women's Rights Project; and Ravicher of PUBPAT. Tania Simoncelli, ACLU's science advisor, provides guidance on the case.