JOLT Digest

Federal Circuit Hears Oral Arguments for Myriad Gene Patent Case

By Elina Saviharju – Edited by Esther Kang
Ass’n for Molecular Pathology v. USPTO, No. 2010-1406 (Fed. Cir. Apr. 4, 2011)
Oral Argument Recording

The Court of Appeals for the Federal Circuit heard oral arguments on April 4, 2011, for Ass’n for Molecular Pathology v. USPTO. The court focused on the issues of jurisdiction and patent-eligible subject matter under 35 U.S.C. §101, although it also briefly addressed the nature of the process claims.

The Digest has covered the earlier course of the proceedings on several occasions. The oral arguments before the court have also been discussed in Patent Docs, PatentlyO and by the Electronic Frontier Foundation, among others.  (more…)

­­The U.S. Government’s View on Gene Patentability Likely Changed
By Harry Zhou — Edited by Matt Gelfand

Brief for the United States as Amicus Curiae Supporting Neither Party, Association for Molecular Pathology v. USPTO, No. 10-1406 (Fed. Cir.)
Brief hosted by the New York Times

On October 29, the U.S. Department of Justice (“DOJ”) filed an amicus curiae brief in the U.S. District Court for the Federal Circuit in Association for Molecular Pathology v. USPTO, No. 10-1406. In its brief, the DOJ advocates for a change in policy for the patentability of genomic DNA.

The DOJ brief draws a distinction between “human-engineered DNA molecules” and “isolated but otherwise unmodified genomic DNA.” While recognizing engineered DNA molecules as patentable “human invention,” the DOJ nonetheless argues that genomic DNA isolated from human cells without further manipulation or alternation should not constitute patentable subject matter. This bifurcated position of the DOJ is in conflict with the Patent and Trademark Office’s longstanding practice of granting patents for isolated genomic DNA.

JOLT Digest previously reported on the district court’s opinion and examined the decision’s possible implications. Summaries of the DOJ brief are available from Patently-O and The Patent Prospector. The New York Times provides coverage of the patent law community’s reaction to the brief. (more…)

DC District Court Orders a Halt to Federally Funded Embryonic Stem Cell Research
By Jessica Palmer – Edited by Ryan Ward

Sherley v. Sebelius, 2010 U.S. Dist. LEXIS 86441 (D.D.C. August 23, 2010)
Memorandum Opinion

On August 23, the United States District Court for the District of Columbia granted a preliminary injunction blocking the implementation of the National Institutes of Health (NIH)’s July 2009 guidelines for human embryonic stem cell (hESC) research. Judge Royce Lamberth held that “because the Guidelines allow federal funding of ESC [Embryonic Stem Cell] research, which involves the destruction of embryos,” federal funding for hESC research “clearly violate[s]” the Dickey-Wicker Amendment.

The Dickey-Wicker Amendment, an appropriations bill rider originally passed in 1996 and renewed each appropriations cycle thereafter, prohibits the use of appropriated funds for “research in which a human embryo or embryos are destroyed.” P.L. 111-8 § 509 (2009). Judge Lamberth rejected the government’s argument that, under Dickey-Wicker, NIH could support research on hESCs, as long as federal funding did not support the initial derivation of the stem cell lines from human embryos. Judge Lamberth reasoned that the NIH’s interpretation of the Dickey-Wicker Amendment did not deserve Chevron deference because the statute is unambiguous: “the language of the statute reflects the unambiguous intent of Congress to enact a broad prohibition of funding research in which a human embryo is destroyed. This prohibition encompasses all ‘research in which’ an embryo is destroyed, not just the ‘piece of research’ in which the embryo is destroyed.”

Professor Glenn Cohen of Harvard Law School criticized the order at Concurring Opinions, arguing that “it is hard to find that the statute is ‘unambiguous’ in Chevron terms in the way Lamberth says.” Professor Russell Korobkin of UCLA, writing at The Volokh Conspiracy, found the grant of a preliminary injunction “troubling” because “the balance of hardships tilts strongly in the direction of hESC researchers and the patients who hope their work will lead to cures, not in the direction of the plaintiffs who might see their chances of winning a grant reduced.” Both Cohen and Korobkin predicted that the Court of Appeals for the District of Columbia Circuit will reverse the district court’s grant of an injunction. (more…)

Court Invalidates Gene Patent
By Elizabeth Akerman – Edited By Davis Doherty

Assn. for Molecular Pathology, et al. v. USPTO, et al. Case no. 09-CV-4514 (S.D.N.Y. Mar. 29, 2010)
Slip Opinion (hosted by PatentlyO)

The United States District Court for the Southern District of New York held the patents issued to Myriad Genetics for isolated versions of two human genes to be “directed to a law of nature,” and therefore invalid pursuant to 35 U.S.C. § 101.

Judge Sweet granted the Plaintiffs’ motion for summary judgment to invalidate 15 claims in 7 patents relating to the BRCA1 and BRCA2 genes.  The court reasoned that isolated DNA containing naturally occurring sequences is not markedly different from the native DNA, and thus falls within the “product of nature” exception to patentable subject matter under § 101. Additionally, Judge Sweet held that the claims regarding comparisons of BRCA sequences to determine whether a mutation is present are invalid under § 101, as they only refer to “abstract mental process.”  The court further notes that even if the claims-in-suit included the physical transformations associated with isolating DNA, this would merely constitute a data-gathering step and would not satisfy § 101.

A brief review of the decision is available at Patent Docs Biotech & Pharma Patent Law & News Blog. PatentlyO suggests that this decision is likely to be reversed by the Federal Circuit. (more…)

By Natalie Ram
Editorial Policy

A full version of this article, published in the Fall 2009 issue of the Harvard Journal of Law & Technology, is available here.

Today, more than 300 million tissue samples from more than 178 million individuals are stored in the United States, and this number has been growing by more than 20 million samples every year. Through genetic analysis, researchers hope to identify disease-related and other genes and to measure the frequency of such genes’ occurrence across large populations. This kind of research requires population-wide bio-repositories of samples available for study.

Yet, individuals providing tissue for research may hesitate to do so if they fear that their interests will not be respected. Tissue providers may have concerns that their cells and genetic material — materials with which they may strongly self-identify — will be used for research they find morally repugnant or about which they were not informed. Unanticipated disclosure of genetic information may negatively impact the ability of unwitting tissue providers and their close genetic relatives to obtain insurance coverage or appropriate medical treatment. Tissue providers may also have strong interests concerning the commercialization of their cells and genetic material, especially if they are not permitted to share in the profits. And tissue providers have a further interest in the progress of science and medicine.

Researchers and society both also have strong interests in how tissue is used. Scientific research using human cells can be (and has been) immensely beneficial. Inappropriate or onerous restrictions on human tissue research may negatively impact the progress of science and medicine—a concern about a tragedy of the anticommons clearly articulated by several courts that have presided over disputes about the ownership and control of human tissues used in research. Moreover, permitting tissue providers to commercialize their cells may divert tissue from worthwhile research, diminish the necessary incentives for research funders to invest in research and development, or undermine societal dignitary interests.

Failing to mediate tensions between tissue providers, researchers, and society may cause individuals to avoid research participation. The solution is not, however, to compel such participation by dispensing with consent altogether and generally conscripting tissue left over from, for example, blood draws or biopsies. Indeed, doing so might cause individuals concerned about the future use of their genetic material to forego routine medical care in order to prevent their cells from being so conscripted. Rather, the interests of tissue providers, of researchers, and of broader society each demand respect and protection. (more…)