Looking Back at Myriad: A User’s Guide
The Genomics Law Report has provided ample coverage throughout the litigation over Myriad Genetics’ BRCA1/2 patents. The saga had a rather lengthy procedural history, so a timeline of key landmarks with hyperlinks to GLR coverage as appropriate (in the “where” column) may be useful.
| When | Where | Action | Citation |
| 1997 | USPTO | US Patent 5693473 issued to Myriad Genetics Inc. | |
| March 2010 | SDNY | US Patent 5693473 invalidated | AMP v. USPTO, 702 F.Supp.2d 181 |
| July 2011 | Fed Cir NY | SDNY decision affirmed in part, reversed in part | AMP v. USPTO, 653 F.3d 1329. |
| March 2010 | SCOTUS | Certiorari granted, Fed Cir NY judgment vacated, case remanded to Fed Cir NY | AMP v. Myriad, 132 S.Ct. 1794 |
| August 2012 | FedCir NY | Subsequent determination made (in light of Mayo v. Prometheus) | AMP v. USPTO, 689 F.3d 1303 |
| November 2012 | SCOTUS | Certiorari granted | AMP v. Myriad, 133 S.Ct. 694 |
| April 2013 | SCOTUS | Heard oral arguments | |
| June 2013 | SCOTUS | Fed Cir decision affirmed in part, reversed in part | AMP v. Myriad, 569 US – |
DNA Fingerprinting as Routine Arrest Booking Procedure Upheld as Anticipated
Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.
Oral arguments in Maryland v. King were held on February 26, 2013, as reported previously here on GLR. Following oral arguments, I stated, “If forced to predict, I would anticipate a split decision that uses a broad definition of ‘identification’ and upholds this ‘fingerprint for the 21st Century;’ however, I haven’t the foggiest as to whether a biometric identification exception will be created or whether a balancing test will be applied to reach that decision.”
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EEOC Files and Settles Its First GINA-based Employment Discrimination Lawsuit on May 7, 2013
Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.
The Equal Employment Opportunity Commission (EEOC) issued a statement that it had filed a lawsuit against Fabricut, Inc. on May 7, 2013 in the U.S. District Court for the Northern District of Oklahoma, making it the first lawsuit brought by the agency to enforce genetic nondiscrimination rights afforded by Title II of the Genetic Information Nondiscrimination Act of 2008 (GINA). A consent decree was filed concurrently, thereby settling the lawsuit on the same day.
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All Eyes on Maryland v. King: Recapping the Supreme Court Oral Argument
Seating was in short supply to hear oral arguments before the Supreme Court in what J. Alito referred to as “the most important criminal procedural case that this court has heard in decades,” Maryland v. King. Eager spectators –including this contributor for the Genomics Law Report – lined up along the marble steps of the Supreme Court building and waited amidst biting winter temperatures in excess of four hours before being allowed inside. [I thought to myself, “if I can brave the cold for football, I can brave the cold to see our nation’s highest court in action.”] The second of two cases scheduled for the morning of February 26, 2013, oral arguments for Maryland v. King were already underway when the fortunate final spectators were ushered inside. Katherine Winfree and Michael Dreeben argued for the Petitioners (the State of Maryland) and Kannon Shanmugam argued on behalf of the Respondent (Alonzo King).
The Genomics Law Report has covered the brewing constitutional controversy of DNA fingerprinting upon arrest previously, as U.S. v. Mitchell tentatively settled the matter in the 3rd Circuit, as the 9th Circuit continued to wrestle with Haskell v. Harris, and as various state courts, including Minnesota and Colorado [pdf], faced similar questions.
Background on Maryland v. King. Alonzo Jay King, Jr. was arrested in 2009 and charged with first- and second-degree assault. As part of his initial arrest, King submitted to DNA fingerprinting collected by law enforcement under the Maryland DNA Collection Act. More than half the states [pdf] have statutes similar to Maryland’s, and there is also a similar federal statute (the DNA Fingerprint Act of 2005 [pdf]). King admitted to his involvement and was ultimately convicted of second-degree assault, a misdemeanor and an offense not qualifying on its own for DNA collection upon arrest under Maryland’s law.
ENCODE, CODIS, and the Urgent Need to Focus on what is Scientifically and Legally Relevant to the DNA Fingerprinting Debate
Sara Huston Katsanis, MS is an Associate in Research at the Institute for Genome Sciences & Policy at Duke University.
On September 5, 2012, a coordinated release of 30 articles in Nature, Cell, Science, Genome Research, Genome Biology and other journals published the long-awaited findings of The Encylopedia of DNA Elements (ENCODE) Consortium. The press coverage of ENCODE data is deafening at this point, and ENCODE’s relevance to GLR readers may not be immediately apparent.
Across the U.S., numerous groups are challenging the integration of CODIS profiles (sometimes called “DNA Fingerprints”) into the routine booking procedures upon arrest for certain crimes (depending on the state), placing genetic profiling among other standard procedures such as fingerprinting and mug shot photographs. The GLR has covered these legal challenges previously (including here, here, and here).
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The Burden of Enforcing GINA: EEOC v. Nestle Illustrates One Challenge in Pursuing Genetic Discrimination Claims
The Genetic Information Nondiscrimination Act of 2008 (GINA) is a federal law making it illegal for insurers and employers to acquire and to use genetic information in certain contexts. Specifically, Title II of GINA prohibits employers with more than 15 employees, employment agencies, labor organizations, and joint labor-management training and apprenticeship program committees from using genetic information when making employment decisions (e.g. hiring, firing, promotions, placement, compensation, privileges, seniority, etc).
The employment discrimination provisions took effect on November 21, 2009, with an air of uncertainty, as the Final Rules implementing Title II of GINA were not issued by the Equal Employment Opportunity Commission (EEOC) until a year later (See 75 Fed Reg 68912-68939 [pdf], issued November 9, 2010) and did not take effect until January 10, 2011. (See previous GLR coverage of GINA Title II here and of GINA generally here).
Courts in Unsettled Territory turn to the Map Available: United States v. Mitchell
We recently covered the Ninth Circuit’s split decision in Haskell v. Harris,1 which found DNA Fingerprinting of arrestees pursuant to California’s Prop 69 to be constitutionally sound. We also reported the Minnesota Supreme Court findings in In re Welfare of M.L.M. and State v. Johnson, rejecting challenges of DNA Fingerprinting based on 4th Amendment and Equal Protection grounds.
An Update from Colorado. An ongoing prosecution, United States v. Fricosu,2 became the most recent constitutional challenge to DNA fingerprinting upon arrest. The defendant, Ramona Fricosu, had her DNA sampled as part of her arrest pursuant to the DNA Fingerprinting Act of 2005, 42 U.S.C. §14135(a). She filed a motion challenging the constitutionality of the practice, requesting that the court order her DNA sample and CODIS profile be destroyed. Fricosu challenged the constitutionality of the practice on Fourth Amendment grounds. On February 22, 2012, Colorado District Judge Blackburn denied the motion (pdf).
On Genetic Rights and States: a Look at South Dakota and Around the U.S.
SD H.B. 1260, introduced in South Dakota on January 26, 2012, is an act that would govern the use of genetic information. By any standards – and especially by legislative standards – the two-page bill (pdf) is succinct and should not be considered a state variation of GINA, as the bill does not speak to non-discrimination issues.
The bill’s brevity should not, however, be mistaken for a narrowness of purpose. In under 200 words, the South Dakota bill, if passed, would (1) grant property rights to individuals in their DNA samples and genetic information, (2) prohibit surreptitious testing, (3) call into question many forensic and law enforcement uses of DNA, (4) eliminate newborn blood spot screening without explicit consent and (5) impose broadly worded informed consent requirements on all collections and uses of individual genetic data. So much for inefficient government.
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Ninth Circuit Issues Long-Awaited Ruling on Constitutionality of DNA Fingerprinting
Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.
In December 2009 the Northern District of California upheld the constitutionality of California’s Prop 69, which authorizes DNA fingerprinting as part of the routine booking process of individuals charged with felonies. There, in Haskell v. Brown, the defendants challenged California’s Prop 69 by arguing it violated both the 4th and 14th Amendments since, respectively, DNA fingerprinting upon felony arrest was, according to defendants, an unreasonable search and a violation of informational privacy.
Minnesota the Latest to Weigh in on DNA Fingerprinting of Arrestees
Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.
There is an increasingly apparent absence of national consensus on whether the practice of collecting a DNA sample and creating a CODIS profile as part of the routine arrest booking procedures (i.e., “DNA fingerprinting”) conforms to the constitutional proscription of unreasonable searches and seizures articulated as the 4th Amendment. We mentioned this topic at the Genomics Law Report previously here, here, and here.
In July 2011, the 3rd Circuit upheld the federal DNA Fingerprinting Act of 20051 in United States v. Mitchell.2 Perhaps perceiving this ruling as a judicial green light, Pennsylvania’s General Assembly, as we recently noted, seems motivated to authorize the practice of DNA fingerprinting upon felony arrest. While the Pennsylvania Senate passed S.B. 775 and referred the matter to the House Judiciary Committee in December 2011, no apparent action has been taken on the measure since then.
