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In Anti-Gene-Patenting Case, Myriad Files for Summary Judgment; USPTO Requests Court to Dismiss Charges

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By Turna Ray

Myriad Genetics, a defendant in the American Civil Liberties Union's ongoing anti-gene-patenting lawsuit, has filed a motion for summary judgment. Simultaneously, the US Patent and Trademark office has filed a motion for judgment on the pleadings, asking for the court to dismiss the ACLU's complaint against it.

These motions from the defendants follow a motion for summary judgment that the ACLU filed in August [see PGx Reporter 08-16-2009]. The New York Southern District Court will hear oral arguments for all summary judgment motions on Jan. 21. According to Chris Hansen, a staff attorney with the ACLU First Amendment Working Group, the organization plans to file a response to the USPTO's motion on Jan. 20.

At the time the ACLU filed for summary judgment, staff attorney Sandra Park told Pharmacogenomics Reporter that the motion was appropriate because "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. Similarly, the question of whether the challenged patent claims violate the Constitution is a legal question."

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].

In August, before the ACLU filed for summary judgment, the defendants 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]. Judge Robert Sweet denied the defendants' motion to dismiss later in the year, reasoning that there are novel circumstances and sweeping implications of the issues presented in the case [see PGx Reporter 11-04-2009].

In addition to Myriad and the USPTO's motions, Genetic Alliance has filed an amicus brief against the ACLU and the plaintiffs' positions, asserting that invalidating the gene-patenting system would impede investment in genetic research and harm other industries.

"Despite plaintiffs’ contention that various harms are caused by patents claiming isolated DNA molecules, Genetic Alliance believes that under appropriate conditions such patents can play a valuable and essential role in making diagnostic tests for genetic disease available," Genetic Alliance states in its brief. "Genetic Alliance believes that invalidating all such patents is an inappropriate vehicle for remedying the problems alleged by the plaintiffs, and that less extreme remedies may be available for the problems that the plaintiffs allege."

'Legal error, after legal error, after legal error'

In Myriad's motion for summary judgment, the company argues that there are not material facts in dispute, since the challenged patent claims are legal as granted by the USPTO and cover diagnostic methods using isolated DNA that are not laws of nature, natural phenomena, or abstract ideas.

Maintaining that isolated DNA has long been a patentable "composition of matter," Myriad asserts that "the law is clear, and has been for a hundred years or more, that isolated or purified products, even if they originate from 'natural' sources, are patent eligible.

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"Plaintiff's misguided approach is illustrated by the fact that their argument depends upon convincing this court that this long and consistent line of authority was the product of legal error, after legal error, after legal error," Myriad states in its motion.

The company cites as precedence the Federal Circuit court's decision last year in Prometheus Labs Inc. v. Mayo Collaborative, which found that diagnostic claims using a correlation occurring in nature — in this case involving methods for identifying metabolites of a drug for gastrointestinal disorders — were patentable.

"As to the method claims, the Supreme Court and the Federal Circuit have held that the key to determining the patent-eligibility of a method or process is that it transforms an article 'to a different state or thing,'" Myriad states in its filing. "In Prometheus, the Federal Circuit found that claims to a diagnostic method that utilized a correlation were not a mere 'law of nature,' but a patent-eligible application of a law of nature in a transformative fashion."

This so-called machine-or-transformation test is also being questioned in a pending Supreme Court case, Bilski v. Kappos. The Supreme Court Justices are expected to issue a ruling on Bilski this year. However, the Justices' comments during a November hearing suggest they are struggling to narrowly uphold a lower court's machine-or-transformation test and minimize the impact to other sectors, mainly the technology and medical device industries [see PGx Reporter 11-18-2009].

Furthermore, Myriad requests summary judgment on the grounds that its BRCA patents do not violate the First Amendment and do not impede the progress of science. In this regard, Myriad maintains that the plaintiff's First Amendment argument that its patent claims cover "information" and pure thought or speech, is based on a false assumption, since "isolated DNA" claims cover chemical compositions and diagnostic methods, which according to Myriad, do not constitute just information.

"These claims do not prevent anyone from thinking, speaking, or disseminating information," Myriad states.

Furthermore, Article 1, Section 8, Clause 8 of the US Constitution — empowering Congress to promote the progress of science and useful arts by giving inventors limited patent exclusivity on their inventions — doesn't restrict the USPTO from granting an individual patent. Even if that particular clause of the Constitution can be interpreted to show that the USPTO, in granting Myriad's patents, impeded the advance of science, legal precedence gives Congress "considerable latitude" in deciding if a specific IP determination promotes scientific progress, Myriad asserts.

In addition, the ability to patent the BRCA gene associations allowed Myriad to add to the body of scientific knowledge about hereditary breast and ovarian cancer, the company points out. "The availability of patents incentivized Myriad not only to discover the BRCA genes but also to invest heavily in disseminating BRCA testing to the public," the company states. "Moreover, since publishing its discoveries, Myriad has consistently promoted and subsidized research on the BRCA genes."

The company claims that more than 18,000 scientists have researched BRCA1 and BRCA2, and published over 7,000 papers on the genes. And Myriad further said it has invested more than $200 million in promoting patient access to BRCA testing, resulting in 400,000 people being tested for BRCA mutations in the US.

Taking a swipe at the numerous medical professionals, researchers, women's health groups, and individual women represented in the ACLU's lawsuit, which alleges that Myriad's exclusive licensing practices restrict access to tests and inhibit research, Myriad asserted that the "plaintiff's anecdotal allegations ring hollow in the face of all the scientific progress that has been spurred by the BRCA patents."

Free Speech Doesn't Mean Free of Charge

The plaintiffs in the case have claimed that the USPTO's policy of issuing gene-related patents violates Article I, Section 8, Clause 8 of the Constitution, or the "IP Clause," and the First Amendment of the Constitution. In its motion for judgment on the pleadings, the USPTO is requesting the judge to dismiss these charges, arguing that "if the Court finds against defendant Myriad on plaintiffs’ statutory claims, then the Court should not reach the constitutional claims under the well-established principle that courts do not adjudicate unnecessary constitutional issues."

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USPTO is not taking issue with ACLU's claims against other defendants that the patents in question do not meet statutory requirements and therefore are invalid. However, the patent office is urging the court to dismiss the claims against it by practicing "constitutional avoidance," a doctrine that requires courts to attempt to resolve a case on statutory or regulatory grounds before interpreting the Constitution as a last resort.

The court will only need to address the Constitutional IP Clause and the First Amendment Claims against the USPTO if it determines that the patents were issued under appropriate statutes. In that case, the USPTO argues, Congress has "the power under the IP Clause to establish a patent system as it saw fit, subject only, at most, to rational basis review.

"Moreover, there can be no reasonable dispute that Congress had a rational basis to believe that a statutory scheme that established broad categories of subject matter eligible for patenting, and which allowed for the patents at issue in this case, would promote innovation and research." As such, the USPTO feels that the plaintiffs' claim that the BRCA patents violate the "IP Clause" should be dismissed.

The plaintiffs also claim that the defendants' patents violate the First Amendment, because they limit “abstract ideas or thought” by restricting a person from studying or thinking about the genes at issue and because the patents do not allow researchers to "invent around" these patents. However, the USPTO has asked the court to reject this claim, since plaintiffs' assertions presuppose that the First Amendment provides "a substantive limitation on Congress’s authority to enact patent laws." The USPTO does not believe the First Amendment imposes such limitations.

"The patent system, like the copyright system, expanded the amount of knowledge available to the public, and therefore serves the same interests protected by the First Amendment," the USPTO maintains. In support of this argument, the USPTO points out that many patents have been issued in the telecommunications and computer networking sectors that, in effect, allow the patent holder to control the speech of others by exacting a fee for the right to use the patented information. Morse's patent on the telegraph and Alexander Graham Bell's patent on the telephone are the main examples given in this regard.

"In each case, individuals wishing to use these devices to communicate their thoughts or to gain access to new knowledge could do so only subject to the rights of the patentholder," the USPTO states. Furthermore, "Nothing in the First Amendment requires that the exercise of First Amendment rights be cost free," the USPTO points out in its brief in a footnote.

Additionally, the USPTO points out that the very purpose of the patent system is to make it difficult for non-patent-holders to "invent around" the patent. Thus, the plaintiffs' claim that the patents at issue restrict free speech since others cannot "invent around" them is moot and should be dismissed. "Although the Federal Circuit has acknowledged the benefits of a patent system that encourages 'inventing around,' it has never suggested that there is an absolute right to successfully 'invent around,' nor that this right in turn limits the sort of subject matter upon which patents can be granted."

What is Information?

Ultimately, the USPTO and Myriad's defense rests on the claim that patents on isolated and purified genes are not patents on "information," and therefore cannot violate the First Amendment. The USPTO points out that the US Court of Appeals for the Federal Circuit has held that “a gene is a chemical compound, albeit a complex one," and as such, the Patent Act lists "chemicals" as patentable subject matter.

"Plaintiffs attempt to blur the line between genes, which are chemical compounds, and genetic sequences, which are human-created representations that identify one of the gene’s properties: the arrangement of nucleic acids in the gene," the USPTO points out. "Plaintiffs fail to cite — nor is the USPTO aware of — any case law supporting the notion that a chemical (or machine or any other physical structure) that is capable of conveying information no longer qualifies for patent protection based on the fact that it has informational content."

Even though the ACLU points out that the chemical structure of genes is "represented by a series of letters," and as such the mutations in genes are recognized like "typographical errors," allowing one to compare the genes "like proofreading a book," this is not enough to deem isolated and purified genes as "information," according to the USPTO. "The fact that a chemical can be represented using an alphanumeric formula does not mean that the chemical itself is 'information.'"

The ACLU's Hansen would not comment on the ACLU's rejoinder to the defendants' newest filings and claims but said that the organization intends to file a reply on behalf of the plaintiffs this week.

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