Monsanto Hitting a Genetically Engineered Rough Patch

Patrick-Bickleyby Patrick Bickley

Although it may be hard to feel bad for a $44 billion company dominating its industry with over $11 billion in sales last year, poor Monsanto has had a rough couple of months.  Monsanto has dominated the seed market through its sales and licensing of its genetically modified seeds.  In the 1970’s, Monsanto patented a new herbicide called Roundup that quickly killed weeds and any other plants prior to planting seeds.  In the 1990’s, Monsanto isolated a gene, called CPS4, from Roundup resistant bacteria found in the company’s waste ponds and placed the gene into its patented soybeans and corn.  These Roundup Ready seeds allowed farmers to continue using Roundup even after planting.

First, in September, Judge Jeffery S. White in the Northern District of California ruled that the U.S. Department of Agriculture failed to assess the environmental impact of genetically engineered sugar beets before approving the crop for farmers to use, according to The New York Times.  The next issue to be decided in the case is what remedy should be imposed.  One possible option is ban on planting the crops until the Department of Agriculture completes the environmental impact statement.  The ban is possible, even though the plants have already been widely adopted by farmers (one survey indicated that 95% of all sugar beets planted this year were genetically engineered), a ban on planting the crops until an environmental impact statement is complete is possible.  In 2007, a different judge in the Northern District of California ruled that genetically modified alfalfa could no longer be planted until the environmental impact statement was completed.  Today, the statement has still not been completed, and the modified alfalfa is, “with rare exceptions,” not being grown.

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Supreme Court Ponders A Method of Keeping Students Awake in Anti-Trust Class and a Method of Whispering to Horses

Jake Meyer by Jake Meyer

On November 9, 2009, the U.S. Supreme Court heard oral arguments in the case Bilski v. Kappos.  This important patent case asks the question: what is the proper test for determining what is patentable subject matter for a process?  Patents are not supposed to be granted on mental processes, but Bilski’s claims are directed to a method of hedging risk in commodities trading, which the Federal Circuit has states is a “process wherein all of the process steps may be performed entirely in the human mind.”

In In re Bilski, the Federal Circuit announced that the proper test to determine whether a process was patentable subject matter under 35 U.S.C. § 101, was the machine-or-transformation test, stating that: a “process is surely patent-eligible under 101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.”  The Federal Circuit has since applied the machine-or-transformation test in a biotechnology case, Prometheus v. Mayo, which I previously blogged about.

Under the test, the Federal Circuit held that Bilski’s claims were not patentable because the claims were not tied to a machine and did not transform an article into a different state or thing.  Claims such as Bilski’s, are considered “business method” claims, and so the Court was also asked the question “[w]hether the Federal Circuit’s ‘machine-or-transformation’ test for patent eligibility, which effectively forecloses meaningful patent protection to many business methods, contradicts the clear Congressional intent that patents protect ‘method[s] of doing or conducting business.'” 35 U.S.C. § 273.  The Justices made many interesting quotes during the oral argument which shed light on the interesting and fundamental patent law question: what is patentable subject matter?

At oral argument, Bilski’s attorney, J. Michael Jakes, argued for a less rigid rule than the machine-or transformation test.

MR. JAKES: . . . I think the question can be avoided, because we don’t need a rigid test of this type based on machine-or-transformation. The question we are looking at and should be looking at is: Are we trying to patent an abstract idea?

At oral argument, the Justices pushed Bilski’s attorney, J. Michael Jakes, by giving seemingly ludicrous examples of things that would be patentable under a more liberal test that did not require a machine-or-transformation.

JUSTICE BREYER: So you are going to answer this question yes. You know, I have a great, wonderful, really original method of teaching antitrust law, and it kept 80 percent of the students awake. They learned things –
JUSTICE BREYER: It was fabulous. And I could probably have reduced it to a set of steps and other teachers could have followed it. That you are going to say is patentable, too?
MR. JAKES: Potentially.

Scalia searched for some historical context.

JUSTICE SCALIA: You know, you mention that there are all these — these new areas that didn’t exist in the past because of modern business and what-not, but there are also areas that existed in the past that don’t exist today. Let’s take training horses. Don’t you think that — that some people, horse whisperers or others, had some, you know, some insights into the best way to train horses? And that should have been patentable on your theory.
MR. JAKES: They might have, yes.
JUSTICE SCALIA: Well, why didn’t anybody patent those things?

Breyer brought up concerns of the costs of patents on information.

JUSTICE BREYER: That’s exactly what I -maybe I can get you to inadvertently help my — my hypothesis you don’t like. That’s why I say it’s inadvertent.
You said there are two things. There are actually four things in the patent law which everyone accepts. There are two that are plus and two that are minus. And the two that are plus is by giving people a monopoly, you get them to produce more. As you said, you get them to disclose.
The two minuses are they charge a higher price, so people use the product less; and moreover, the act of getting permissions and having to get permission can really slow things down and destroy advance. So there is a balance.
In the nineteenth century, they made it one way with respect to machines. Now you’re telling us: Make it today in respect to information. And if you ask
me as a person how to make that balance in respect to information, if I am honest, I have to tell you: I don’t know. And I don’t know whether across the board or in this area or that area patent protection will do no harm or more harm than good.
So that’s the true situation in which I find myself in respect to your argument. And it’s in respect to that, I would say: All right, so what do I do?

Sotomayor was also concerned with the cost patents exact on the free flow of information.

JUSTICE SOTOMAYOR: But a patent limits the free flow of information. It requires licensing fees and other steps, legal steps. So you can’t argue that your definition is improving the free flow of information.

Sotomayor gave some attention to amici’s concern that a broad ruling in Bilski may hurt the biomedical world.

JUSTICE SOTOMAYOR: How about if we say something as simple as patent law doesn’t cover business matters instead of what the Federal circuit has begun to say, which is technology is tied to a machine or a transformation of the substance, but I have no idea what the limits of that ruling will impose in the computer world, in the biomedical world, all of the amici who are talking about how it will destroy industries? If we are unsure about that, wouldn’t the safer practice be simply to say it doesn’t involve business methods?

Justices Breyer and Sotomayor are right to be concerned about the effect of patents on the free flow of information.  This is particularly troublesome when patents are on information itself.  For example, with patents on gene sequences, the “invention” is the information.  It’s the A’s, C’s, T’s, and G’s that make up the sequence that are of value, and the disclosure of this information is meaningless because the patent prevents it from being built upon.

At oral argument in Bilski, the lawyer representing the patent office, Malcolm L. Stewart, argued for keeping the machine or transformation test, but to leave it open to an exception for unforeseen technologies.

MR. STEWART: Well, I think the Court could say — could do essentially what was done in Benson and Flook, namely acknowledge that there had never been a case up to this point in which a process had been held patent eligible that didn’t involve a machine or a transformation. It could leave open the possibility that some new and as yet unforeseen technology could necessitate the creation of an exception.

The government is right to be concerned about limiting unforeseen technologies, and the machine-or-transformation test could be an effective test for determining patentable subject matter of processes.  However, the Federal Circuit’s decision in Prometheus showed that the Federal Circuit considers the machine-or-transformation test to be a low hurdle, by holding that the physical step not central to the claim was transformative.  If the Supreme Court decides to keep the machine-or-transformation test, the Court shall have to give guidance to the Federal Circuit on what is to be considered transformative and what is to be considered a machine or else clever claim drafting can add a computer (machine) or other non-essential step (which could potentially be argued to be transformative) to any process claim and make it patentable, which would come with the high cost of limiting the free flow of information.

CSI Meets PhD: Should Universities Require DNA Testing of Job Applicants?

Lori Andrews by Lori Andrews

If you're applying for a job at the University of Akron, you may have more to worry about than the old adage of publish or perish.  Whether you want to work as a secretary or a tenured professor, a new university policy empowers the college to require job applicants to submit DNA.  Laurie Massie, a spokesperson for the University of Akron, told CBS News that the board decided to include DNA testing in the policy because "there have been national discussions that indicate that in the future, reliance on fingerprinting will diminish and DNA for criminal identification will be the more prominent technology." 

But Massie’s statement obscures the difference between a DNA sample and a fingerprint.  Taking DNA is more intrusive, even if it is just done through a cheek swab.  A recent criminal case, Friedman v. Boucher, 580 F.3d 847 (9th Cir. 2009), found that police exceeded their authority when they subjected an unwilling suspect to a cheek swab.  Plus, DNA contains far more information than does the fingerprint.  Testing an applicant’s DNA could provide information about whether the applicant, while healthy now, was likely to develop a costly-to-treat genetic disease.  Even if the DNA was only used to see if an applicant’s DNA was in the federal DNA databank because he or she had committed a crime, adding employment searches to the investigative searches of the databank would result in even greater backlogs than currently exist.

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Motion to Dismiss Denied in Breast Cancer Case: The USPTO is a Defendant in a Case Challenging the Constitutionality of Patents Granted by the USPTO

Jake Meyer by Jake Meyer

November 1, 2009, Judge Sweet of the United States District Court in the Southern District of New York issued an opinion in Association for Molecular Pathology v. United States Patent and Trademark Office.  The plaintiffs in the case, which were previously blogged about here, challenge the constitutionality and validity of patents on the BRCA1 and BRCA2 breast cancer genes owned by Myriad.  The defendants — the U.S. Patent and Trademark Office (USPTO), Myriad Genetics, and the Directors of the Utah Research Foundation — moved to dismiss the case for standing and jurisdictional issues.  Judge Sweet denied all motions to dismiss, finding there was both standing and jurisdiction.

The inclusion of the USPTO as a defendant in this case is unique to this case, as the USPTO has never been a party to a lawsuit in which the constitutionality of patents issued by the USPTO were brought into question.  The USPTO moved to dismiss for lack of subject matter jurisdiction (the USPTO also moved to dismiss for lack of standing) arguing that it had a comprehensive statutory scheme in place to redress violations of the Patent Act.  However, the cases the USPTO cited involved claims that alleged statutory violations that the Patent Act provided a remedy for.  Judge Sweet found that there was no comparable statutory scheme that provided remedies for constitutional violations.  Judge Sweet found that there was subject matter jurisdiction over the USPTO citing the novel circumstances of the action, the absence of any remedy provided in the Patent Act, and the importance of the constitutional rights asserted by the plaintiffs.

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The Story of a Sperm with a Bad Heart

Keith Syverson by Keith Syverson

A study published in last week's issue of the Journal of the American Medical Association (JAMA) raises concerns about regulation of sperm banks.  The study describes the case of a 23-year-old man in good health who donated sperm to a U.S. sperm bank almost a hundred times over a two year period.  The sperm bank followed protocols standard in the industry at the time of the donation: doctors gave the donor a comprehensive medical evaluation including a complete personal and family medical history in addition to laboratory testing for communicable diseases. Several years later, a woman inseminated with the donor's sperm gave birth to a child diagnosed with Hypertrophic Cardiomyopathy (HCM) — a heart disease characterized by the thickening of the heart muscle.  The sperm bank notified the donor and all other recipients of his sperm that their children were at risk for HCM.  Twenty-two children were born using the donor's sperm in addition to two children born to the donor's wife.  Five children showed evidence of HCM including one two and a half year old child who died waiting for a heart transplant.

This case study underscores the need for more stringent testing protocols for gamete donation.  The American Society for Reproductive Medicine has published recommendations on genetic screening for gamete donors, but compliance with these guidelines is voluntary.  Studies have shown that most gamete donor agencies do not follow these protocols.  For sperm banks, only half of programs surveyed performed a chromosome analysis and about a quarter of egg donor agencies reported that they do not screen egg donors.  Moreover, the authors of the JAMA article note that it is a surprise that the sperm bank was able to contact the donor and everyone who received the sperm because this is uncommon in the industry.

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I.B.M. Seeking to Make Sequencing of Personal Genome Available for the Low Low Price of $1,000 (Plus Millions in Royalties to Patent Holders)

Jake Meyer by Jake Meyer

I.B.M. recently announced its plans to join the race to sequence the genome for $1,000.  I.B.M. joins seventeen other companies in the race to sequence the gene.  Currently the cost to sequence the human genome ranges between $5,000 and $50,000, but these companies are yet to successfully sequence the entire genome of an individual.  I.B.M. hopes to ultimately bring the price as low as $100 to sequence an individual's entire genome.  The goal is to build a machine that can sequence an individual's genome – three billion base pairs – in several hours.  This will provide the genetic information needed by an individual for personalized diagnostic and treatment uses. 

I.B.M. is using its expertise in semiconductor manufacturing, computing, and material science to design a gene sequencer with increased speed and accuracy.  I.B.M.'s sequencer revolves around a nanoscale electric device.  The device uses an electric field to pull the DNA strand through a 3 nanometer hole in a surface, at which point the electric field holds the DNA in place for a fraction of a second while the order of the nucleotide bases (adenine, guanine, cytosine, or thymine) is determined.  After the nucleotide bases are determined, the DNA strand is pulled further through the hole and the order of the next nucleotide bases are determined.

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DNA Evidence – A Boon to Law Enforcement, but the Start of a Storage Nightmare

Lori Andrews by Lori Andrews

When I spoke a national meeting of law enforcement personnel and prosecutors, I was fascinated by the new forensic tools spanning every type of evidence – from photographs to footprints, from gum to guns.  But, in the hallways, between the scientific and legal presentations, the men and women working in the criminal justice system sounded a lot like 20somethings complaining about their first apartment.  Sure, there were changes in technologies.  But there was a bigger problem:  Where were they going to store all the evidence?
With the advent of DNA technologies, forensic officials who had been pack rats were able to convict people of old crimes. This past weekend, for example, a suspect was arrested for the 1989 murder of an elderly woman; modern DNA technology allowed old evidence to be analyzed.   Evidence from decades ago has also been retested through efforts like the Innocence Project, letting many innocent men go free. In fact, yesterday, the Richmond Times Dispatch announced six training sessions for volunteer lawyers on how to contact the 881 Virginia felons whose old cases included evidence ripe for potentially-exculpatory genetic testing.

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Michael Jackson’s DNA Will Be Used to Make Jewelry

Lori Andrews by Lori Andrews

During his life, Michael Jackson's hair was at the center of a legal dispute.  When he filmed a Pepsi commercial, the pyrotechnics on the set set his hair aflame, leading to a lawsuit against the soft drink company.  In that case, Jackson donated his $1.5 million settlement to the burn unit that treated him.

Now, after his death, his hair is raising an issue central to bioethics:  What right do people have to control the use of their tissue?

During the ill-fated commercial–which some commentators think led to the singer's use of painkillers–executive producer Ralph Cohen picked up charred hairs from the floor.  John Reznikoff, a hair collector, purchased the hair and now has an arrangement with an Elk Grove Village, Illinois company, Life Gems, to create man-made diamonds out of the carbon in Jackson's hair.

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Did I Say I was 16? I meant 20. The MLB tries DNA Testing to Thwart a New Generation of Cheaters.

Keith Syverson by Keith Syverson

Another testing controversy has arisen in the world of baseball.  This time it was not Alex Rodriguez or Roger Clemens testing positive for performance enhancing drugs, but rather it was an amateur baseball player from the Dominic Republic named Damian Arredondo "failing" a DNA test as part of an investigation to confirm his age.  It does not come as a big surprise that in an era where Bud Selig, the Commissioner of Major League Baseball (MLB), is trying to clean up the sport's image and punish cheaters such as those who use performance enhancing drugs, that the MLB is also testing to prevent other forms of cheating such as misrepresenting one's age.  A young prospect is valuable because it gives the potential signing team more time to develop the player and teach him how to be a successful hitter or pitcher in the Major League.  Additionally, as players age, they become more injury prone and are less productive as hitters.  Teams usually take a players age into account when offering a contract extension later in life.  For example, a 30-year-old player will generally be paid more and receive a longer contract then a 34-year-old player.

 Most baseball fans remember when Miguel Tejada, a Dominic Republic native, announced to the Houston Astros that he was in fact 33 years old and not 31, or when investigators discovered that a Washington Nationals prospect assumed an alter ego that was four years younger then his actual age.  In the aftermath of the steroid scandal, the MLB has established an investigative team taking extreme measures to ensure that this does not happen again by subjecting potential players and their family members to bone scans and DNA testing.

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Lawsuits in Pink and Blue: Sex Selection Cases Hit the Courts

Lori Andrews by Lori Andrews

On-line genetic testing companies offer to provide people with information regarding their family tree; their relative chances of developing a disease, condition, or trait; their nutritional profile; and their response to a particular drug.  For example, at HairDX, individuals can be tested for a susceptibility to hair loss, or their response to a particular hair loss prevention aid.  If a customer wishes to learn whether his Y-chromosome shares any similarity with the Jefferson Y-chromosome, he can visit

Initially, the testing focused on illness and ancestry.  But now companies are reaching out to pregnant women with promises to predict the sex of their child.  The pregnant woman pricks her finger, then collects three drops of blood on a test card and sends it to the company for testing.  For $275, Acu-Gen Biolab, Inc. offers pregnant women such a test which analyzes fetal cells circulating in maternal blood to make the assessment.

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