Saturday, June 29, 2013

Canadian Apocalypse

Seth Rogan, Jay Baruchel, and Michael Cera all figure prominently in the new film This Is The End.  Aside from being Hollywood stars, all three are also Canadians.  The film is mad, bad, and dangerous to know, in the best Byronian sense.  Ostensibly, it is about the apocalypse and the end of days.  However, the film is actually about something much more mundane.  This Is The End is a parable about the cultural dangers that befall Canadians who venture south seeking fame, fortune, and the Beverly Hills lifestyle.  In the film, Baruchel represents resistance to assimilation into the Hollywood Borg, Michael Cera plays a Canadian who has been completely absorbed into the stereotypical lifestyle Baruchel resists, and Rogan is situated between the two extremes, though, much to Baruchel's consternation, he is clearly heading towards full Yankification.   Canadians Jim Carrey, Mike Myers, Ellen Page, Shenae Grimes, Ryan Reynolds, Will Arnett, Dan Ackroyd, Kim Cattrall, Elisha Cuthbert, Corey Haim, Rick Moranis, and Ryan Gosling may understand this better than most.

Friday, June 28, 2013


In 1997, Princeton geneticist and bioethicist Lee Silver published a brilliant and prescient book entitled Remaking Eden: Cloning and Beyond in a Brave New World.  In it, Silver revealed a genetic fantasia of the future, including the the possibility of children with more than two biological parents.  The future appears to have arrived first in the United Kingdom, where the government, on advice from its Human Fertilisation and Embryology Authority, announced "its decision to proceed with draft regulations which will enable the use of mitochondria replacement techniques to be used for patient treatment."  The techniques would involve the transfer of the nuclear genome of an embryo fertilized by a father and first mother into the cell of a second mother.  The intent of doing so would be to ensure that the resulting child possessed healthy mitochondria from the second mother, along with the healthy nuclear genome of its father and first mother.  Such a child would be a direct genetic descendant of three parents.  Three for one, and one for three!

Tuesday, June 25, 2013

Parental Rights And Wrongs

The United States Supreme Court decided Adoptive Couple v. Baby Girl on June 25, 2013, an adoption dispute over custody of a very young child.  As summarized by the Court, here are the basic facts of the case:
While Birth Mother was pregnant with Biological Father’s child,  their relationship ended and Biological Father (a member of the Cherokee Nation) agreed to relinquish his parental rights. Birth Mother put Baby Girl up for adoption through a private adoption agency and selected Adoptive Couple, non-Indians living in South Carolina. For the duration of the pregnancy and the first four months after Baby Girl’s birth, Biological Father provided no financial assistance to Birth Mother or Baby Girl. About four months after Baby Girl’s birth, Adoptive Couple served Biological Father with notice of the pending adoption. In the adoption proceedings, Biological Father sought custody and stated that he did not consent to the adoption. Following a trial, which took place when Baby Girl was two years old, the South Carolina Family Court denied Adoptive Couple’s adoption petition and awarded custody to Biological Father. At the age of 27 months, Baby Girl was handed over to Biological Father, whom she had never met. The State Supreme Court affirmed, concluding that the ICWA [Indian Child Welfare Act of 1978] applied because the child custody proceeding related to an Indian child; that Biological Father was a “parent” under the ICWA; that §§1912(d) and (f) barred the termination of his parental rights; and that had his rights been terminated, §1915(a)’s adoption-placement preferences would have applied.
The Court reversed and remanded the case, holding that
Assuming for the sake of argument that Biological Father is a“parent” under the ICWA, neither §1912(f) nor §1912(d) bars the termination of his parental rights.
This decision will be viewed by many as a blow to Native American legal rights.  Others may focus instead on its implications for child welfare law.  Whatever legal perspective one supports, one hopes that the young girl at the heart of the dispute soon ends up in a stable and caring home where she can grow up healthily, and well beyond the public glare of the law.

Monday, June 24, 2013

Preemption Prescription

In its June 24, 2013, decision in Mutual Pharmaceutical Co., Inc. v. Bartlett, the United States Supreme Court elucidated a new aspect of drug regulation in which the federal Food, Drug, and Cosmetic Act ("FCDA") preempts state drug regulation.  As the Court described in its opinion,
New Hampshire law imposes a duty on manufacturers to ensure that the drugs they market are not unreasonably unsafe, and a drug’s safety is evaluated by reference to both its chemical properties and the adequacy of its warnings.
The Court held that
State-law design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted by federal law...
A recent trend has witnessed the FDCA used to justify the preemption of state laws that attempt to regulate drugs.  Although the Court noted that not all state drug regulation is preempted, both states and plaintiffs are left guessing where the borders of preemption lie.

Friday, June 21, 2013

Stanford Deextinction Movie Revue

Video recordings of De-Extinction: Ethics, Law & Politics, the conference on deextinction held at Stanford Law School on May 31, 2013, are now available for viewing on the Stanford Center for Law and the Biosciences website.  Here are all the presentations, organized by topical session:
Welcome and Introduction  (Hank Greely) / Science (Beth Shapiro) 
Environmental Law and Related Issues 
International plus US GMO (Andrew Torrance)
US federal (Alex Camacho)
State fish and wildlife (Chuck Bonham) 
Other Legal Issues 
Animal Welfare (Matthew Liebman)
Liability Issues (Dan Farber)
Property issues (Jake Sherkow) 
Lunch with Stewart Brand
De-Extinction and Conservation Biology 
Conservation Uses of De-Extinction (Stanley A. Temple)
Conservation Biology and Priorities (Kate Jones)
Politics of De-Extinction (Jamie Rappaport Clark) 
Justice, Hubris, and Moral Issues 
Justice (Hilary Bok)
Hubris and Naturalness (Jay Odenbaugh)
Species Ethics (Ronald Sandler)
This conference brought together scholars and practitioners from around the world whose expertise spanned the law, science, ethics, and policy of deextinction.  Hank Greely, one of the founders of the field of biolaw, and his associates at the Stanford Center for Law and the Biosciences deserve tremendous thanks for making such a complete record of De-Extinction: Ethics, Law & Politics available.

Wednesday, June 19, 2013

Rock Chalk Trademark

On June 17, 2013, the Lawrence Journal-World published an article entitled "Trademark protection a constant concern for KU" that explores the efforts the University of Kansas ("KU") exerts to protect its trademarks, including the famous KU Jayhawk.  Reporter Matt Erikson interviewed me about trademark law for the article.  Here is an excerpt:
It’s up to trademark holders to make sure their marks aren’t used improperly, Torrance said. If someone uses your trademark without your permission, it’s up to you to put a stop to it. And if you go too long without doing so — especially if there’s a reasonable chance you know it’s going on — there’s no going back.
Winners of the NCAA men's basketball national championships in 1952, 1988, and 2008, holders of many records (e.g., most winning seasons - 95 - in NCAA history), and perennially ranked as one of, and often the very best of, the top men's NCAA basketball teams, the hoops Jayhawks confer tremendous value to KU's trademarks.  However, both fans and entrepreneurs often express their enthusiasm for the Jayhawks by reproducing Jayhawk logos or phrases without permission.  It is a delicate balancing act for KU to police its trademarks sufficiently to preserve their value without alienating the very people whose support is the very lifeblood of these trademarks.

Tuesday, June 18, 2013

Academic Post-Op Of Myriad

The leading patent law blog, Patently-O, solicited short reactions to the U.S. Supreme Court's June 13, 2013, AMP v. Myriad decision from patent law professors.  Patently-O published these micro-opinions hereHere is mine:
Looking at the trend over the past decade, Andrew Torrance (Kansas) writes: "For better or worse, the Supreme Court's AMP v. Myriad decision caps a decade-long trend away from the patentability of the human body, human embryonic stem cells, human physiology, diagnosis of human disease, human thoughts, and, now, human genes."
Ironically, even though the Supreme Court left open the possibility that cDNA sequences might remain patent-eligible, those same sequences will often be patently-o(bvious) in light of existing genomics knowledge and the routine molecular biological techniques used to produce cDNA.

Friday, June 14, 2013

Myriad Ado About Myriad

Never before has the media made more fuss about a patent law court decision. Since the United States Supreme Court issued its opinion in AMP v. Myriad on June 13, 2013, newspapers, radio, television, and the web have been delirious about DNA. For those brave few who care about patent law, this has been wonderful. I have had a lot of fun doing a number of interviews about the Myriad decision over the past day. Two National Public Radio stations - KPR and KCUR - broadcast a story that included parts of an interview with Bryan Thompson, a very talented health reporter. Here is the audio of the story. Here is an excerpt of the transcript:
Professor Andrew Torrance specializes in biotechnology patent law at the University of Kansas. He says the ruling falls hardest on companies that have invested billions of dollars, hoping to profit from patents on human gene fragments like those that help reveal a person’s risk for breast cancer. 
“I think that its practical effect will be to lop many tens of billions of dollars off the investments that a lot of biotech and pharmaceutical companies—and even some universities—made in locating and sequencing and patenting these natural-source genomes," he says.
The Kansas City Star also conducted an interview, and ran an article about the landmark Myriad decision on its frontpage. Here is an excerpt from the June 14, 2013, edition of the newspaper:
"The decision was a little confusing," said Andrew Torrance, a law professor and genetics expert at the University of Kansas. "The court said that isolated, unmodified DNA is patentable, but it hinted at patentability of modified DNA and methods or processes used with synthetic DNA."

Torrance agreed that “pharma and biotech will continue to make money.… The natural-source DNA money stream is coming to an end. It actually peaked in about 2001. Now you have to do more hard work to design genes and get them to do what you want them to do.”
Read more here:
Although the importance of the Myriad decision will take years to reveal itself, the public and the media both appear to sense its importance to innovation, biotechnology, and medicine.  Patent law should bask in its brief time in the limelight, for it will soon return to its usual position well outside the public eye.

Thursday, June 13, 2013

Due Diligence On The Myriad Decision

Today (June 13, 2013), Due Diligence, a daily afternoon news program on Voice Of Russia Radio, broadcast a story entitled "Supreme Court decision AMP v. Myriad SCOTUS rules that human DNA cannot be patented."  I had the honor of being interviewed by Due Diligence host Carmen Russell-Sluchansky.  Here is a recording of the broadcast.

Patents And Patients

Owners of patents claiming isolated or purified DNA sequences plucked from naturally-occurring genomes are justified in suffering from triskaidekaphobia.  Today, June 13, 2013, they suffered a bodyblow when the United States Supreme Court declared these types of patents invalid as claiming unprotectable subject matter.  The decision, in AMP v. Myriad, caps a long trend in which patents claiming aspects of humans, their bodies, their physiology, and their thoughts, have been struck down as patent-ineligible.  I was asked to write about this trend earlier this year by SCOTUSblog.  Myriad Genetics owns several patents that claim variants of the BRCA gene (that is, BRCA1 and BRCA2) indicative of heightened risk for breast or ovarian cancer.  By necessity, the patents in suit claim variants with the same nucleotide sequences as those occurring within their human genome sources.  The Court minimized any inventive contribution made by the "inventors" of Myriad's claimed sequences:
Myriad did not create anything.  To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.
Although this analysis seems to mix concepts of patent subject matter with those of novelty and nonobviousness, the result is that
A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated...
The Court appeared to contemplate the patentability of synthetic DNA, even minimally-modified cDNA.  In addition, it explicitly noted that the patentability of methods using isolated or purified DNA were not at issue in the case, perhaps because the Court had already considered the patent-eligibility of similar methods in its 2012 Mayo v. Prometheus decision.

One highly-distinctive feature of the decision was a very short concurrence by Justice Antonin Scalia, where he expressed how overwhelmingly difficult and complex the molecular biology underlying the Court's decision is.  There, he confessed that
I am unable to affirm those details on my own knowledge or even my own belief.
Although lack of mastery of scientific facts is seldom admitted by judges, it is most admirable that a member of the Supreme Court has been so candid.

Although the world did not end today for the biotechnology and pharmaceutical industries, they and their stock prices now feel a chill wind blowing.  Shares of Myriad Genetics alone traded down more than 5% on the day of the decision, June 13, 2013, lopping off many millions of dollars in market capitalization.  More ominously for gene patent owners, within hours of the Court's decision, alternative providers of the BRCA1 and BRCA2 diagnostic tests, such as DNATraits, a division of Gene By Gene, Ltd., began to advertise substantially lower prices to patients.

It is a brave new world for genes.  Patents remain a strongly-viable option for modified or designed synthetic DNA sequences.  However, the gene rush of patenting unmodified DNA sequences plucked from human genomes has come to an end.

Wednesday, June 5, 2013

Stanford Deextinction On PBS

The website of San Francisco PBS television station, KQED, featured a discussion of the Stanford Deextinction conference that took place on May 31, 2013, at Stanford Law School. Here is an excerpt:
“I think one of the reasons this issue has bubbled to the surface so quickly is that the technology is converging with the coolness of the idea of bringing things back, mixing with a sense of guilt we feel with driving things extinct,” University of Kansas law professor Andrew Torrance told me. But de-extinction raises several “definitional conundrums,” he said in this talk. Are de-extinct organisms GMOs? Invasive species?
There will be much more to come on deextinction.

Tuesday, June 4, 2013

Barack Obama: Troll Hunter

United States President Barack Obama announced on June 4, 2013, a series of proposals aimed at defanging organizations euphemistically called "patent assertion entities" and derisively titled "patent trolls."  Among other steps announced in a press release published by the White House - "Fact Sheet: White House Task Force on High-Tech Patent Issues" - are three "Executive Actions" of particular note:
1.  Making “Real Party-in-Interest” the New Default. Patent trolls often set up shell companies to hide their activities and enable their abusive litigation and extraction of settlements. This tactic prevents those facing litigation from knowing the full extent of the patents that their adversaries hold when negotiating settlements, or even knowing connections between multiple trolls. Today, the PTO will begin a rulemaking process to require patent applicants and owners to regularly update ownership information when they are involved in proceedings before the PTO, specifically designating the “ultimate parent entity” in control of the patent or application. 
2.  Tightening Functional Claiming. The AIA made important improvements to the examination process and overall patent quality, but stakeholders remain concerned about patents with overly broad claims — particularly in the context of software. The PTO will provide new targeted training to its examiners on scrutiny of functional claims and will, over the next six months develop strategies to improve claim clarity, such as by use of glossaries in patent specifications to assist examiners in the software field. 
3.  Empowering Downstream Users. Patent trolls are increasingly targeting Main Street retailers, consumers and other end-users of products containing patented technology — for instance, for using point-of-sale software or a particular business method. End-users should not be subject to lawsuits for simply using a product as intended, and need an easier way to know their rights before entering into costly litigation or settlement. Today, the PTO is announcing new education and outreach materials, including an accessible, plain-English web site offering answers to common questions by those facing demands from a possible troll.

That cinematic classic Abraham Lincoln:  Vampire Hunter may have inspired a sequel:  Barack Obama:  Troll Hunter.

Monday, June 3, 2013

Cheeky Police And DNA

The United States Supreme Court decided a criminal case, Maryland v. King, on June 3, 2013, that hinged on whether or not a DNA sample obtained while processing an arrested crime suspect can pass muster as reasonable under the Fourth Amendment of the U.S. Constitution.  The Court held that, like fingerprinting and photographing, a DNA sample derived from a routine cheek swab can be a reasonable part of the process of booking a suspected criminal.  The Court described the facts of the case as follows:
After his 2009 arrest on first- and second-degree assault charges, respondent King was processed through a Wicomico County, Maryland, facility, where booking personnel used a cheek swab to take a DNA sample pursuant to the Maryland DNA Collection Act (Act). The swab was matched to an unsolved 2003 rape, and King was charged with that crime. He moved to suppress the DNA match, arguing that the Act violated the Fourth Amendment, but the Circuit Court Judge found the law constitutional. King was convicted of rape. The Maryland Court of Appeals set aside the conviction, finding unconstitutional the portions of the Act authorizing DNA collection from felony arrestees.
Here is a summary of what the Court decided:
When officers make an arrest supported by probable cause to hold for a serious offense and bring the suspect to the station to be detained in custody, taking and analyzing a cheek swab of the arrestee’s DNA is, like fingerprinting and photographing, a legitimate police booking procedure that is reasonable under the Fourth Amendment.
A good criminal defense attorney routinely advises her client to keep her mouths shut to avoid inadvertently saying things damaging to her assumed innocence.  Now, the Supreme Court has given criminal defendants another excellent reason not to open their mouths.

Saturday, June 1, 2013

Deextinction In The San Jose Mercury And The Australian

Interest in the Stanford deextinction conference held on May 31, 2013, reached from Silicon Valley to Australia. In one article entitled "Extinct Species Revival Raises Hopes, Fears," in the San Jose Mercury, and a sister article entitled "Extinct Species Revival Raises Hopes," in The Australian, various issues raised during the conference were discussed. Here is an excerpt:
Passenger pigeons once numbered in the billions, blackening the skies and inspiring naturalists like John James Audubon, John Muir and Aldo Leopold. 
They had vanished by the first World War, victims of hunting and habitat loss. 
But resurrected flocks reintroduced into a modern environment could be an invasive species, noted Andrew Torrance of the University of Kansas Law School. 
They would also be genetically modified organisms, subject to federal regulation.
Deextinction is growing in the Valley, Down Under, and beyond.

Deextinction In USA Today

One of the big five newspapers, USA Today, reported on the May 31, 2013, Stanford conference on deextinction. Here is an excerpt:
The legal issues that will surround revived species are very unclear, said Andrew Torrance, a law professor at the University of Kansas and former biotech patent lawyer. But in general, he thinks "there are no solid legal barriers yet to de-extinction.
Interest in deextinction continues to accelerate.