Bioinformatics/IT

Are Software Patents Dead?—Alice’s Implications for Life Sciences

Not too long ago, getting patents on software and business methods was all the rage. And concern about their effects was profound. In fact, in 2003 I spoke at a Federal Reserve Bank conference devoted to the question of whether such patents were an existential threat to the financial industry. Now, after a series of Supreme Court cases that brought about a dramatic shift in the approach taken by the lower courts and the Patent Office, the question is whether those patents are still alive. The answer is that they are, but barely, and their prognosis is bad.

Do these developments matter to people in the life sciences? The answer is a resounding yes. If we then ask why software patentability matters, the answer is that life sciences are increasingly focused on software-dependent data analysis.

These points were brought home to me when I spoke at another, more recent conference—the Bio-IT World Conference in Boston this past April.
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Biometrics: A Developing Regulatory Landscape for a New Era of Technology

eyeball_nJames Bond and Ethan Hunt have been using facial recognition, fingerprint scanning, and optical readers for years on the silver screen. In the real world, the use of technology that identifies unique physical characteristics of individuals (“biometrics”) is rapidly becoming more prevalent. In fact, the Department of Homeland Security uses facial scanning to identify potential terrorists, federal agencies have adopted fingerprint technology to confirm the identity and immigration status of aliens, and private entities have begun implementing palm and retina scanners and other identifiers to complete financial transactions or control access to secure information. Even the new iPhone 5 contains “Touch ID” technology, where a sensor quickly reads the user’s fingerprint and automatically unlocks the phone for the correct fingerprint.
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Filed under Bioinformatics/IT, General Interest, Privacy

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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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.


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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.


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Filed under Biobanking, Bioinformatics/IT, General Interest, Genomic Policymaking, Genomics & Society, Industry News, Legal & Regulatory, Pending Litigation, Privacy

Pennsylvania Seeks Expansion of its Forensic DNA Database

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.

Last month, the Pennsylvania General Assembly voted in favor of a bill that would expand the Commonwealth’s criminal database. PA Senate Bill 775 authorizes law enforcement to begin DNA fingerprinting of individuals upon arrest or charge for certain specified crimes (as opposed to only upon conviction) and authorizes familial searching of the state’s forensic database. After third consideration, the amended version of PA Senate Bill 775 passed by a vote of 42-6. The bill has been referred to the judiciary.

The bill had been introduced in March of 2011 by Pennsylvania Senate Majority Leader Dominic Pileggio, who was later joined by a dozen colleagues (including nine Republican and three Democratic sponsors). It immediately garnered the attention of genetics law scholars, including Penn State Dickinson’s School of Law Professor David Kaye, who submitted a thorough statement (pdf) for the Pennsylvania General Assembly’s consideration.


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More News on DNA in Forensics

We recently noted that DNA profiling has greater public approval in the UK than in America. The UK presently operates the largest DNA database in the world with over 5 million profiles. Nevertheless, that country has just taken a giant step in the opposite direction. New civil liberties legislation, dubbed “the freedom bill,” will require authorities to remove hundreds of thousands of unconvicted people from the database, following a ruling from the European Court of Human Rights that “the blanket retention of DNA from people arrested but never convicted of any offence [i]s unlawful.” There are 1.1 million people without convictions presently profiled in the database; however, some of these profiles will not be removed as a result of an exception for “unconvicted terror suspects who have been released.”

Here in the U.S., the Supreme Court will consider the post-conviction DNA testing landscape in the Texas case of Henry Skinner. Thousands of convicts are requesting new DNA testing in light of the increasing number of exonerations based on DNA evidence. Skinner was convicted 15 years ago of murdering his girlfriend and her two developmentally disabled adult sons. At the recommendation of his attorneys, he declined DNA testing for his trial. Texas courts said he doesn’t currently qualify under a state law that grants DNA testing to some convicts, and federal courts refused to overrule Texas. The last time the Supreme Court considered this issue, in 2009, a divided court decided to let Congress and the state legislatures make the rules. Therefore, rules vary from jurisdiction to jurisdiction as to how requests for post-conviction DNA testing are handled. Perhaps this time the Supreme Court will decide to lay down some firmer ground rules.

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Recent Developments in Forensic DNA

The use of DNA in forensics continues to expand. Last year, James Cass reviewed the current system of forensic DNA profiling in the U.S., including CODIS (the Combined DNA Index System, the FBI’s integrated DNA profiling program), the controversial practice of partial/familial searching, and calls from President Obama and others to collect DNA profiles for all Americans in a national database. He posted follow-up pieces focused on advance DNA collection under Katie’s Law, the growing backlog of DNA samples, and familial DNA database searching, which gained support after it facilitated the arrest of the elusive serial killer in California known as the Grim Sleeper.

A number of newer developments have caught our attention.


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2011 Personal Genomics Preview: It’s Déjà Vu…

Last January we kicked off the new year by posing “Five Questions for Personal Genomics in 2010.” Here were the five questions we asked:

1. Will the $1,000 genome live up to the hype?

2. Will personal genomics stay DTC?

3. How will the ongoing gene patent debate affect the progress of personalized medicine?

4. When and where will the next regulatory shoe fall?

5. Who will control the data?

A year later the question that comes first to mind is, has anything really changed?

The short answer is no, not fundamentally, although that is not meant to imply that nothing of note happened in 2010. Far from it, as significant legal, regulatory, policy and technological developments continued to reshape the personal genomics landscape.

With that in mind, we welcome 2011 with a look back at the year that was, and a look ahead at what to expect from 2011 and beyond.


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Filed under Bioinformatics/IT, Direct-to-Consumer Services, FDA LDT Regulation, General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Genomics & Medicine, Genomics & Society, GINA, Industry News, International Developments, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation, Pending Regulation

Induced Infringement Heads to Supreme Court Amid Myriad Takeover Speculation

On Monday we wrote about the Salzberg Screen—a do-it-yourself alternative to Myriad’s BRACAnalysis test to identify deleterious mutations in the BRCA genes. We wondered whether the Salzberg Screen, which is intended to allow users to “circumvent [Myriad’s] gene patents,” could expose its designers to indirect patent infringement liability.

In a related development, this week the Supreme Court decided to hear a case (Global-Tech Appliances, Inc. v. SEB S.A.) that asks whether the legal standard for the ‘state of mind’ element of an inducement of infringement claim under Section 271(b) of the Patent Act requires “purposeful, culpable expression and conduct” or merely “deliberate indifference.” The Court’s decision, which will not come until next year, will bear on the degree of knowledge of an alleged infringer required to make out a claim for inducement of infringement.


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