March 1, 2010 (Vol. 30, No. 5)

Federal Judge Hears Arguments about Gene Patents for BRCA

On February 2, Judge Robert M. Sweet at the U.S. District Court in Manhattan heard oral arguments in the case of Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al.

In this case, filed May 12, 2009, the plaintiffs are: Association for Molecular Pathology, American College of Medical Genetics, American Society for Clinical Pathology, College of American Pathologists, Breast Cancer Action, Boston Women’s Health Book Collective, and certain gene researchers and individuals potentially affected by breast cancer. The lawyers for plaintiffs are with the American Civil Liberties Union (ACLU) and the Public Patent Foundation. The named defendants are: United States Patent and Trademark Office (USPTO), Myriad Genetics, and the directors of the University of Utah Research Foundation.

Concerned citizens and reporters swamped the courthouse in response to the ACLU’s mass mailings about the case and free screenings of “In The Family,” a documentary film on breast cancer that the ACLU has used as a platform to garner public support for this lawsuit.

The oral arguments heard by Judge Sweet were for the ACLU’s motion for summary judgment that the claims in seven U.S. patents covering BRCA genes associated with breast cancer are invalid under 35 U.S.C. § 101 and in violation of Article I, Section 8, Clause 8 (the IP clause) of the U.S. Constitution as well as the First Amendment.

The legal arguments also involved Myriad Genetics’ countermotion for summary judgment in its favor and the U.S. Patent and Trademark Office’s (USPTO) motion to dismiss the constitutional claims directed against it.

The humanities-oriented lawyers of the ACLU and counsel for the science-oriented defendants vehemently supported their differing positions on the meaning, scope, and implications of the patent claims in question. The process seemed to embody C.P. Snow’s famous theory of The Two Cultures, on the communications breakdown between the humanities and sciences.

Chris Hansen, an ACLU lawyer, opened with assertions that the “isolated DNA” recited in certain of the patent claims in question is not markedly different from DNA as it exists in the body and accordingly is simply a “product of nature.” Quoting the U.S. Supreme Court in the 1948 case of Funk Brothers Seed Co. v. Kalo Inoculant Co., Hansen said that a patent cannot be granted for “one of the ancient secrets of nature now disclosed.”

Hansen analogized isolated DNA to gold extracted from a mine and emphasized that, while counsel for Myriad has argued that isolation of DNA is a complex process, the end result is still a DNA sequence made not by man, but by nature.

Apparently borrowing from copyright law, Chris Hansen averred that patents are not awarded for effort. This principle of copyright law is rooted in Feist Publications, Inc v. Rural Telephone Service Co., Inc., in which the U.S. Supreme Court held that information compiled in a telephone directory does not constitute copyright-protectable creative expression.

Hansen argued that the method claims of the patents violate the First Amendment because they appear to cover the mere act of looking at one sequence of letters and another sequence of letters and thinking about or saying whether they appear to be the same. This, Hansen said, stifles the sharing of information between researchers who, without this obstacle, would be able to build upon existing research and potentially develop cures or treatments for BRCA1- and BRCA2-related cancer.

Under this reasoning, the patents do not “Promote the Progress of Science and the useful Arts” under the intellectual property clause of the U.S. Constitution.

Sandra Park, also with the ACLU, discussed Diamond v. Chakrabarty, wherein the U.S. Supreme Court held in 1980 that claims to a genetically engineered bacterium capable of breaking down oil recited subject matter eligible for patent protection. She also briefly summarized the  Funk Brothers v. Kalo case in which the U.S. Supreme Court held that claims to mixtures of naturally occurring bacteria that could extract nitrogen from the air were products of nature, and thus not patent-eligible under section 101 of the patent law.

Additionally, she mentioned American Fruit Growers v. Brogdex in which the U.S. Supreme Court held in 1931 that claims to fruit with a skin or rind that contains mold-resistant borax does not qualify as an “article of manufacture” under section 101. Park said that these cases clearly show that section 101 is satisfied only when the claimed subject matter has useful properties that it did not have in its natural form.

Park echoed Hansen’s assertions as to the purported insignificance of a DNA sequence being “isolated” and argued that the venerable Judge Learned Hand was wrong in concluding in the 1911 case of Parke-Davis & Co. v. H.K. Mulford Co. that isolated and purified adrenaline is patent-eligible subject matter in light of its commercial utility. To buttress this position, Park said that Chakrabarty, Funk Brothers, and American Fruit Growers impliedly overruled the Parke-Davis case.

In arguing against the validity of the method claims in the patents in suit, Park cited the recent case of In re Bilski, wherein the Court of Appeals for the Federal Circuit (CAFC) held that a claimed process is patentable if “ it is tied to a particular machine or apparatus, or it transforms a particular article into a different state or thing.”

Park asserted that neither prong of the test is met by the method claims in the disputed patents, because no particular machine is recited and because comparing one DNA sequence to another does not involve a transformation of an article into a different state or thing. Park sought to distinguish the claims at issue from those in Prometheus Laboratories v. Mayo, where the CAFC recently held that method claims for measuring the level of a drug in a blood sample involved a transformation under the “machine or transformation” test of the Bilski case.

Park said that in Prometheus, the claims included a first step of administering a drug to a subject, which induced a chemical transformation that is necessary for subsequently determining the level of the drug in a blood sample taken from the subject and that, by contrast, no transformative step is necessary for comparing one DNA sequence to another.

Myriad Replies

Brian Poissant, counsel for Myriad Genetics, took the podium and began by noting that history has a tendency to repeat itself. He elaborated, saying that the same level of controversy and media attention around this case also occurred 30 years ago when the Supreme Court considered the Chakrabarty case.

Poissant said that then, as now, some members of the public proclaimed that a “gruesome parade of horribles” would result if the Court were to decide that claims involving genetic technology could be patented. He added that the Court in 1980 wisely deferred these public policy issues to Congress, urging that Judge Sweet interpret the claims in question in light of the law as written.

Poissant invoked the language of section 101 of the patent law, directing the court’s attention to two of the four categories of patentable-eligible subject matter: processes and compositions of matter, and to the qualifier that they be “new and useful.” Focusing on “new,” Poissant said that the isolated nucleic acids recited in the patent claims to compositions of matter simply do not exist in nature. And an “isolated” polynucleotide having a particular sequence that’s “useful” takes a lot of work to come up with.

A critical portion of the cell’s undifferentiated DNA must be identified by the scientist. Such isolated nucleic acids are useful because they can be used as probes that find and attach to complementary sequences in a subject’s DNA, such as in diagnostic tests. The claimed nucleic acids may also potentially be used for gene therapy.

Poissant cast doubt on the ACLU’s contention that Parke-Davis was impliedly overruled by later case law and added that the patent-eligibility of isolated DNA sequences has long been recognized in the law and in USPTO rules and procedures. Poissant also urged the court to take the approach of the Supreme Court in J.E.M. Ag Supply v. Pioneer Hi-Bred and look to whether Congress has passed legislation that renders subject matter patent-ineligible when it otherwise appears to be patent-eligible. Now, as then, Poissant said, such legislation is absent.

Poissant also argued that many of the cases that the ACLU relies on are off-topic. He said that Funk Brothers dealt with anticipation under section 102, not patent-eligible subject matter under section 101. He also noted that American Food Growers was about whether the claimed subject matter was an “article of manufacture,” not involving either a process or a composition of matter, as here.

Applying the “machine or transformation test” for method claims stated in the Bilski decision of the CAFC, Poissant asserted that, as in the Prometheus case, the method claims of the patents at issue do involve a transformation. Elaborating on this, Poissant said that cells are taken from the body and are opened up; probes having the recited BRCA sequences are introduced; the probes traverse the DNA from the cell; and, if the DNA from the cell contains a sequence complementary to a probe, the probe attaches to the complement.

Poissant said that the claims are not about intangible information but about physical molecules. He added that thinking or talking about the DNA sequences are not precluded by the patents, despite what the ACLU would have the court believe.

Counsel for the USPTO, Ross Morrison, spoke briefly to state that under the Doctrine of Constitutional Avoidance, the court should decide the case on the basis of the ACLU’s Constitutional arguments only if it first finds that the patent claims are valid under section 101 of the patent statute. Morrison then said that the applicable test for a Constitutional challenge is whether Congress had a rational basis for establishing the patent system and that the rational basis was clearly to “Promote the Progress of Science and the useful Arts” as stated in the IP Clause of the Constitution.

In response to the First Amendment claim made by the ACLU, Morrison said that the patent system promotes the sharing of information under the “written description and enablement” requirements of section 112 of the patent law. Furthermore, when the first Patent Act was being passed by Congress in 1790, the First Amendment to the Constitution was in the process of being ratified, so that Congress at the time would have taken into consideration the interplay between the two.

Judge Sweet said that he wouldn’t issue his decision immediately, noting that the importance and complexity of the subject matter justifies careful deliberation.

Scott Rylan Powell and Gerry J. Elman are attorneys with Elman Technology Law ( Elman is also the founder and editor in chief of Biotechnology Law Report (, which is published by Mary Ann Liebert, Inc.

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