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Can ACLU Expect to Win Its BRCA Gene Patenting Case Before it Even Gets to Trial?

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By Turna Ray

In a counter move to Myriad Genetics' motion to dismiss its anti-gene patenting case, the American Civil Liberties Union has submitted numerous declarations of material fact to urge a district court judge to decide that Myriad's BRCA patents are invalid and unconstitutional even before the case even gets to trial.

The ACLU filed a motion for summary judgment on Aug. 26 in New York Southern District Court, asserting what it claims are "undisputed facts" in its case challenging the patentability of certain gene mutations since they occur in nature. Furthermore, the ACLU set forth the reasons why it believes that Myriad's practice of patenting certain BRCA gene mutations restricts research and limits thought, thereby violating the First Amendment. The district court judge on the case is Robert W. Sweet.

The push for summary judgment has little chance of success, according to John Conley, a law professor at the University of North Carolina – Chapel Hill. Conley specializes in intellectual property and civil litigation and is closely following the ACLU's challenge to Myriad's gene patents. ACLU's main goal with the request, he believes, may be to win in the court of public opinion rather than in district court.

ACLU Staff Attroney Sandra Park told Pharmacogenomics Reporter last week that the organization filed for summary judgment because "the case does not turn on factual disputes but on legal questions.

"The issue of whether the BRCA1/2 genes are patentable — in other words, whether they are products or laws of nature — is a legal determination," Park said. "Similarly, the question of whether the challenged patent claims violate the Constitution is a legal question.

"Given the importance of resolving these questions for the pathologists, physicians, and patients who brought the case, moving for summary judgment was appropriate," she said.

The lawsuit, Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al. — filed in May by the ACLU on behalf of scientific organizations representing numerous medical professionals, researchers, women's health groups, and individual women — alleges that the BRCA gene patents held by the University of Utah Research Foundation and exclusively licensed to Myriad "stifle research that could lead to cures and limit women's options regarding their medical care." Specifically, the lawsuit challenges the patentability and constitutionality of Myriad's patents on the BRCA1 and BRCA2 genes, linked to increased hereditary risk for breast and ovarian cancer [see PGx Reporter 05-13-2009].

Last month, the defendants, including Myriad, the US Patent and Trademark Office, and the University of Utah Research Foundation, filed a memorandum to dismiss the case, asserting that it was nothing but "a thinly veiled attempt to challenge the validity of patents," and presented no "actual dispute" over patent infringement [see PGx Reporter 08-05-2009].

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In addition to the motion of summary judgment, the ACLU has separately filed oppositions to the defendants' motion to dismiss its case. Myriad officials refused to comment on the case..

According to UNC's Conley, ACLU's main motivation may be to win the hearts and minds of the public, even if it loses in court. The ACLU is taking "every opportunity to bang away, publicly, at their core argument that these patents encroach too far on laws and products of nature," Conley told Pharmacogenomics Reporter this week.

"Realistically, the ACLU has to expect to lose at trial, pinning their hopes on the Federal Circuit and, maybe, the Supreme Court," added Conley, who writes on legal issues impacting the personalized medicine field in the blog Genomics Law Report. "The appellate arguments will probably be very much like the ones they're raising on summary judgment. So, at a minimum, they get a chance here to sharpen those arguments."

According to the ACLU's Park, if the Plaintiffs’ summary judgment motion is denied because the court decides there are open issues of material fact, then the case would proceed to discovery or other fact-finding.

Undisputed Facts?

In its brief, the ACLU presents "material facts" challenging the validity of 15 claims across seven of Myriad's patents: '282, '473, '999, '001, '441, '492, and '857. According to the ACLU, the patents either cover claims on the composition of matter for “isolated DNA,” or cover methods for comparing or analyzing genes.

In filing for a summary judgment, the ACLU is asking the district court to recognize as undisputed "fact" that genes and their alterations occur in the body, as caused by nature, and as a result, Myriad's BRCA patents are not valid.

The group explained in the filing that it is not taking any issue with Myriad's sequencing methods, since several of the company's patents at issue in this case "consist essentially of looking at genes" without specifying a particular method.

As examples, the ACLU cites Myriad's patent '999, which claims the act of looking at the patented BRCA1 gene, and patent '001, which covers the ability to compare a naturally occurring mutation with a patient's blood sample to confirm the presence of a gene mutation.

"The claim does not specify or claim any particular method of obtaining or comparing the sequences; it simply covers the act of looking at the two sequences and concluding they are the same or different," the ACLU states in its brief.

Ultimately, in setting forth these "facts," the ACLU has to convince the deciding judge that the "isolation" of genes, when genes are separated from the body for analysis in a laboratory environment, is not patentable, a process for which the USPTO has granted numerous patents.

However, the ACLU maintains that the "isolation" of genetic material "means nothing more than a gene that has been removed from the body and separated from surrounding cellular material." Since the isolated gene is still "functionally and informationally" identical to the gene occurring naturally in the body, it is not valid patentable material, the ACLU claims.

Furthermore, the ACLU points out that the defendants will attempt to assert that in the process of "isolating" DNA, they have created unique, patentable material by changing the gene from DNA to complementary DNA. However, the ACLU points out that although there are structural differences between DNA and cDNA, they still function identically in the body.

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"Although there are certain structural differences, such as removal of the regions that are not used in creating the protein, the cDNA structure simply mirrors the RNA structure in the body, both of which are dictated by nature," the ACLU states. "Moreover, structural differences are irrelevant to the function of the gene in the body or in the lab or when used by medical professionals or researchers to determine if the gene has variants of clinical significance."

Research Under the First Amendment

The facts in this case, as presented by the ACLU, suggest that Myriad's BRCA "patents should never have been granted" by the USPTO. Furthermore, in granting these patents, ACLU claims that the defendants have in effect violated researchers' First Amendment rights, by restricting research and thought.

"It is clear that the First Amendment limits the reach of intellectual property laws," the ACLU states in its brief. "In copyright … various doctrines, such as fair use, exist to accommodate the First Amendment’s values.

"The copyright doctrine most relevant to this case is the distinction between ideas and their expression," the ACLU states. "The former is not copyrightable; the latter is."

The ACLU points out six claims in which the defendants restrict the ability of researchers to look at and draw conclusions about patented genes, without specifying any particular method of analyses. This restricts the researchers from drawing any conclusions on patented BRCA genes, even if they used unpatented methods to look at the genes, according to the ACLU.

"A medical professional or researcher who paid a fee to utilize the gene itself and then used unpatented methods to sequence the gene so that he or she could look at it, would infringe on these claims if, after looking at it, he or she thought any conclusions about it," the ACLU states. "Put another way, if the medical professional or researcher was given a piece of paper with both sequences and mentally compared them, that would constitute infringement.

"The USPTO may not give exclusive control over certain thoughts to a single company," the ACLU asserts. "That it has done so is a violation of the First Amendment."

The ACLU predicts that as much as 20 percent of human genes are patented. "The effect [of granting these patents] has been harmful for science, medicine, and women’s health," the ACLU concludes in its brief. "The patents should be declared invalid."

Easy for the ACLU to Say!

In Conley's view, the claim that Myriad's patents violate the First Amendment is a weak, but creative, argument that can only come from an entity outside of the business community, such as the ACLU.

"They're going directly after gene patents, in part because they don't have their own patents to worry about. They can also play the PR game with abandon, without risk of damaging their own 'business' reputation," Conley said.

"Business competitor litigants tend to play by a tacitly agreed set of rules of engagement, because they may be defendants in the next case," he told Pharmacogenomics Reporter over e-mail. "So, the ACLU is making arguments that no one else has had the imagination/nerve/recklessness to make before."

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The ACLU is making seemingly audacious arguments, Conley predicts, precisely because it is trying to set the stage and influence public opinion for when it challenges gene patenting in higher courts.

"Everyone knows the ACLU and loves 'em or hates 'em," he said. "Judges could perceive them, because they're outside the box in every sense, as being ideologues, gadflies, or even crackpots. A 'real' business might have more credibility in this sense."

The ACLU itself is not a plaintiff in the case. It filed the lawsuit on behalf of four scientific organizations representing more than 150,000 geneticists, pathologists, and laboratory professionals, as well as individual researchers, breast cancer and women's health groups, genetic counselors, and individual women.

Conley predicts that if the ACLU's bid for summary judgment fails, and the case goes to trial in district court, the ACLU will take a lot of depositions from Myriad employees, to try to portray the company as singularly profit driven, without concern for how their patenting practices have harmed patients and other researchers. "But, these will be more for show [and likely won't] have a direct effect on the legal arguments," Conley said. "This isn't like an antitrust conspiracy case, where you're looking for factual smoking guns."

On the other hand, the very fact that the challenge to Myriad's patents is coming from outside industry can work to the ACLU's advantage. "They don't have a direct economic interest, so they are more likely to make long-shot arguments, any one of which could conceivably succeed," Conley said.

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