S.D.N.Y. Holds That Patent Claims on Breast Cancer Genes Are Invalid

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Jake Meyer by Jake Meyer

On March 29th, 2010, Judge Sweet of the United States District Court in the Southern District of New York declared that the challenged patent claims, owned by Myriad genetics, that cover the BRCA1 and BRCA2 breast cancer genes are invalid.  The full opinion is available here.  I had previously blogged about the plaintiffs in the case here, and I previously blogged about Judge Sweet’s denial of the defendant’s motion to dismiss here.  This was the first case to raise the argument that gene sequences and correlations between gene mutations and disease are unpatentable subject matter under 35 U.S.C. section 101.

There were two types of claims at issue in the case:  1) claims to “isolated” DNA containing the BRCA1 or BRCA2 sequence or certain segments of those sequences, and 2) claims to methods of comparing two BRCA1 or BRCA2 sequences to determine whether a mutation that predisposes a subject to cancer is present.  Judge Sweet found that both of these types of claims were invalid subject matter.

U.S. patent law does not allow for the patenting of products of nature.  As Judge Sweet recognizes this in his opinion there is a “judicially created ‘products of nature’ exception to patentable subject matter, i.e. ‘laws of nature, natural phenomenon, and abstract ideas.'”  Judge Sweet applied analysis from the 1980 Supreme Court case Diamond v. Chakrabarty to determine whether the product claims directed to “isolated” DNA were patentable.  The Supreme Court in Chakrabarty held that a genetically engineered bacterium was patentable because the “patentee had produced a new bacterium with markedly different characteristics from any found in nature.”  Sweet found that the requirement that an invention have “markedly different characteristics” from a product of nature to be patentable had been stated (although using different language) in earlier cases as well, such as in the Supreme Court case American Fruit Growers and in the Court of Customs and Patent Appeals case In re Merz.

Judge Sweet held that the “isolated” DNA was not “markedly different” than DNA inside the human body.  The analysis focused on the DNA’s unique role as both a physical molecule and as information.  While the “isolated” DNA was removed from the body, the information embodied by the DNA was not changed:

In light of DNA’s unique qualities as a physical embodiment of information, none of the structural and functional differences cited by Myriad between native BRCA1/2 DNA and isolated BRCA1/2 DNA claimed in the patents-in-suit render the claimed DNA “markedly different.”  This conclusion is driven by the overriding importance of DNA’s nucleotide sequence to both its natural biological function as well as the utility associated with DNA in its isolated form.  The preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the challenged composition claims are directed to unpatentable products of nature.

The second types of claims to methods of comparing two BRCA1 or BRCA2 sequences to determine whether a mutation that predisposes a subject to cancer is present were found invalid because they involved a law of nature and did not satisfy the Federal Circuit’s machine-or-transformation.  When a method claim makes use of a law of nature, the claimed method must either use a specific machine or apply a transformation to be patentable.  Judge Sweet found that the method did not include a transformation and since the claims did not include the use of a specific machine the method claims were directed to an unpatentable law of nature.

When DNA Takes Center Stage

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Lori Andrews by Lori Andrews

In the wake of the September 11 attacks, Chicagoans Jamil Khoury and Malik Gillani took a unique approach to counter anti-Arab and anti-Muslim sentiment. They formed the Silk Road Theater Company, offering plays which show the complex, multifaceted experiences of people of Asian, Middle Eastern, and Mediterranean descent.  Their productions fight stereotypes with nuanced stories of human similarity and differences.

Now, eight years and multiple awards later, Khoury and Gillani have tackled another complicated and misunderstood phenomenon–genetic testing.  For their latest production, seven playwrights of Silk Road ancestry took genealogical DNA tests and wrote short plays, which are joined together in The DNA Trail.  Performances continue until April 4 at the Silk Road Theater Project, 77 W. Washington, Chicago.

Lori DNA TrailAs the former chair of a federal advisory commission to the Human Genome Project, I was prepared to cringe at any genetic determinism in the plays. I’d been in countless meetings with scientists who tried to reduce complex people to genetic explanations.  One researcher made the controversial claim that, because Maoris were once warriors, he’d searched for and discovered a “warrior” gene in the Maori of New Zealand which makes them more aggressive and violent.  Tariana Turia, a co-leader of the Maori party, questioned why researchers were even looking for the warrior gene in their blood. “Once were warriors?” Turia said to the Daily Telegraph.  “Once were gardeners, once were astronomers, once were philosophers, once were lovers.”

Before the play began, I opened my printed program, which featured bios of the seven playwrights and a brief description of each play.  The first playwright, Elizabeth Wong, started her bio by saying, “I’m in the N9a haplogroup.”  She then went on to say that she thought she was pureblood Chinese, but that the test showed she was linked to a woman out of Africa.

Oh, oh, I thought.  I’d seen data showing that the genealogical tests are not very accurate.  When a journalist sent her DNA to two different companies, she got conflicting results and news that conflicted with her families’ oral history about her ancestry.  The snafu is that 99 percent of our DNA is like anyone else’s, including the people who lived thousands of years ago.  Depending what stretch of the three billion genetic bases the test scrutinizes, I could receive a test result that declares me related to anyone who currently lives or who ever lived.

When the performances began, though, my concerns about determinism vanished.  The playwrights had caught the nuances, complexities, heart-wrenching conflicts, and occasional zaniness of DNA testing.  Wong’s own play, “Finding Your Inner Zulu,” took two sisters on a journey through their DNA that showed how all of us have genetic strengths and weaknesses.  The plays added new twists to questions of identity (Jamil Khoury’s “WASP: White Arab Slovak Pole”) and family (Velina Hasu Houston’s “Mother Road”).  David Henry Hwang’s contribution, “A Very DNA Reunion,” is roaringly funny.  After a son who lives with his parents upsets them by charging a DNA test on their credit card, his purported ancestors–Ghengis Khan, a Ninja, and Cleopatra–show up in his bedroom to help him deal with his folks.  On the other end of the emotional continuum, Shishir Kurup’s captivating and well-acted “Bolt from the Blue” provides a gripping portrait of a family separated by distance dealing with suicide and the propensity to mental illness.

DNA Reunion

Featuring, left to right: Anthony Peeples, Fawzia Mirza, Clayton Stamper, and Khurram Mozaffar.
Photo by Michael Brosilow.

The complexities and significance of genetic testing are laid out in videos on the theater’s website and in essays that cover eight pages in the program.  With the same patience that the Silk Road Theater Project has sought to explain the dreams and goals of discriminated-against people, the Project gives audience members the tools to understand genetic testing.

The extraordinary Nancy Wexler, whose research was responsible for the discovery of the Huntington gene, once said that DNA tests are like card games.  It doesn’t matter what hand you are dealt, it is how you play it.  Once again, the Silk Road Theater Project has played its hand flawlessly.

Big School District is Watching You: A Webcam on a School’s Laptop Photographs a Student Eating Candy in His Home

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Jake Meyer by Jake Meyer
Most of us carry gadgets and use technologies that allow us to be tracked, recorded, and watched.  Cell phones contain GPS units that allow the user to be tracked.  Internet search engines record keystrokes and search queries.  Photos taken for the purposes of Google Maps have caught cheating husbands, when their car was found in a mistress’s driveway.  Almost all cell phones include a camera and allow for video recording, and a bystander can easily capture and post photo or video evidence of you in an embarrassing or compromising situation, but at least then you’d be in public, or aware of the bystander’s presence.  But what if your school district was snapping photos of you and your kids inside your home without you knowing?

At the Merion School District in Eastern Pennsylvania, each of the 2,300 high school students receive a laptop.  The students are required to pay a $55 insurance fee with a $100 deductible if the laptops are damaged or lost.  Because the laptops are frequent targets for theft, each laptop had tracking-security software installed that could be activated remotely to capture images of the user via the laptop’s built-in webcam.  When a laptop is reported lost or stolen, a technician can remotely activate the software which records photos from the webcam and screen shots of what the computer user is doing. School officials report that the software was activated 42 times this school year.

In at least one instance where the software was activated, the school did not observe a theft, but instead peered into the home life of one of their students.  On November 11, 2009, Blake Robbins, a 15 year old sophomore was told by assistant principal Lindsey Matsko, that she thought he was engaging in improper behavior at home.  The school district had captured images from the web camera attached to Robbins’ laptop that appeared to show him handling pills.  Matsko was mistaken, however, as Robbins was eating Mike and Ike’s candy.

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Should We Clone Neanderthals?

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Lori Andrews by Lori Andrews

In 1856, workers in a limestone mine in the Neander Valley in Germany made a startling discovery.  They came across an assortment of bones — a skull cap, a rib cage and certain leg and arm bones — that they initially believed came from a bear.  But when the bones were examined by anatomist Hermann Schaaffhauesen, the field of paleoanthropology was born.  The bones belonged to a distant relative of humans — a Neanderthal.

Now, a century and a half later, the Neanderthals are again in the news.  A group of scientists have completed the rough draft of the genetic sequence of the Neanderthal and compared it to the genetic sequence of modern humans.  The scientists are asking now asking the question:  What legal and ethical issues would be raised by cloning a Neanderthal?

Neanderthals are the closest relatives of humans and lived from at least 350,000 years ago until about 30,000 years ago.   They survived for about 15,000 years after modern humans appeared.  They lived in Europe, where fossils have been discovered from Spain to Southern Siberia.

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The Lancet Can Erase Its Pages But Can’t Put out the Fire — Exploring the Retraction of Wakefield’s 1998 Study Connecting Childhood Vaccination with Autism

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Keith Syverson by Keith Syverson

This month, The Lancet retracted a 1998 study conducted by Andrew Wakefield that demonstrated a connection between the MMR vaccine and autism.  The Lancet made the retraction in response to the findings of a UK General Medical Council’s Fitness to Practice Panel, which found that Wakefield falsely claimed that the study participants were referred by routine methods and that the investigations were approved by local ethics committees.  The Lancet retraction reignited the debate over whether vaccines cause autism and invites a brief history of the Wakefield paper and a discussion on the more recent debate over the connection between mitochondrial disorders, autism, and vaccines.

In 2004, The Lancet published results of its own investigation of Wakefield's alleged professional misconduct concerning the 1998 study.  The editors reviewed all available documentary evidence and interviewed the study's authors to determine the validity of six claims of misconduct: (1)that the study falsely claimed it received ethics approval; (2)that the study was completed under the ethics approval of an entirely different study; (3) that the children involved were invited to participate directly by Wakefield and his co-authors, rather than through outside referrals; (4) the children from the study were also part of a Legal Aid Board funded project led by Dr. Wakefield with the goals to investigate the "grounds for pursuing a multi-party legal action on behalf of parents allegedly vaccine-damaged children;" (5) that the results of the study were passed to lawyers to justify the legal action; and (6) that Wakefield received £55,000 from the Legal Aid Board to conduct the study and that, "since there was a substantial overlap of children in both the Legal Aid Board funded pilot project and the Lancet paper, this was a financial conflict of interest that should have been declared to the editors and was not."

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DIY Genetics-Biotechnology by Parents, Artists, and…Potential Terrorists

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Lori Andrews by Lori Andrews

When geneticist Hugh Rienhoff's daughter Beatrice was born six years ago, he noticed a few traits that differed from his other children.  She seemed a little floppy, her feet were slightly bigger than usual, and her fingers didn't seem to stretch completely open.  In the months to come, she ate well, but didn't gain a commensurate amount of weight.  Although Rienhoff had left clinical genetics to join the venture capital and commercial biotech worlds, concern about his daughter pulled him back in.  After consultations with experts didn't bring a satisfactory answer about the cause of her disease, he took matters in his own hands.  He built a lab in his attic and started sequencing her DNA. 

Although his work hasn't yet established a definitive diagnosis or cure, his increased understanding of his daughter's biological pathways did lead her doctor to put her on a drug which strengthened her skeletal muscles.  He's also created a digital community at mydaughtersdna.org where other parents of children with unusual syndromes can share information.   According to an article in Wired, when a Bulgarian man posted information about his 12-year-old daughter's symptoms–inability to shed tears, speech problems, and weak limbs–a geneticist responded by correctly suggesting that the girl should be tested for Triple A syndrome.

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What Do Genetic Testing, Sweaty T-Shirts, and Prairie Voles Have to Do With Love?

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Jake Meyer by Jake Meyer

The internet revolutionized every facet of our lives – work, play, and even our relationships.  With the invention of the internet came numerous matchmaking sites that helped two people find each other for a relationship or marriage.  Match.com allows users to browse through personally created profiles and contact each other, while Eharmony.com matches users based on a test that covers "29 dimensions."  But how is the biotechnology revolution changing relationships?  And how will these technologies alter how we view love and marriage?

One way the biotechnology revolution is changing marriage is through the screening of potential mates to see whether they both carry the genes of a particular disease.  This way the potential mates know whether their children would be more likely to be born with a particular disease and can then make informed decisions about procreation.  For example, in the Ultra-Orthodox Jewish community of New York, where arranged marriages among Ashkenazim (Jews of Eastern European descent) are still common, match makers screen potential matches for a genetic disease known as Tay-Sachs.

People who are of Ashkenazi descent have a one-in-25 chance of having a Tay–Sachs genetic mutation; if two such carriers marry, each child has a one-in-four chance of having the devastating disease.  A child with Tay–Sachs appears normal at birth, but soon loses motor functions, suffers massive neurological deterioration has seizures, and generally dies by age three.  To prevent couples having children with this devastating genetic disease an organization known as Chevra Dor Yeshorim (Association of an Upright Generation) offers Tay–Sachs carrier screening to Ultra-Orthodox Jewish adolescents.  Before a marriage is arranged, the matchmaker calls the program with the identification numbers of the two individuals.  If both individuals are carriers for Tay-Sachs, they are found to be "genetically incompatible."  The program has added screening for other disorders, such as cystic fibrosis, which has generated controversy because these diseases are not necessarily fatal in childhood.

But what about using genetic screening on a mate not to determine whether they carry the genes for a disease, but instead to discover whether mates are genetically compatible?  GenePartner.com does just that –- setting up couples based on genes that would make the couple more naturally attractive to each other.  According to the GenePartner website, the GenePartner project was inspired by a study by Dr. Claus Wedekind at the University of Bern in Switzerland.  Wedekind had female volunteers smell T-shirts that had been worn by men for three consecutive days and then rate the smell of the T-shirts for attractiveness.  Wedekind then analyzed the part of the DNA of the men and women that codes for HLA (human leukocyte antigen) molecules.  HLA molecules control the activation of immunological effectors during an immune response, making them essential for immune resistance.  Wedekind found that the women were most attracted to men with HLA DNA different from their own.  According to GenePartner.com compatible couples have different HLA DNA, leading to varied HLA molecules that allow immunity to a wider variety of diseases.  GenePartner.com also claims that this "gene compatibility" also results in an increased likelihood of forming an enduring and successful relationship, more satisfying sex life, and higher fertility rates.

And so now with the help of genetics you’ve found your genetic compatible mate –- someone with a differing HLA gene and sweaty T-shirts you find irresistible –- but what can genetics do to make the relationship last?  Well perhaps with a little help from genetics you could give your mate a drug — a love potion of sorts — or alter their genes to make them more monogamous.  Dr. Larry Young has studied prairie voles, one of the five percent of mammals that, like humans, are monogamous.  A hormone in the voles, vasopressin, creates urges for bonding and nesting when it is injected in male voles.  Male voles with a genetic mutation that caused a weaker vasopressin response were less likely to find mates.  The same thing has been found in humans as well –- Swedish researchers have reported that human males with a genetically caused weak vasopressin response were also less likely to find a mate.

Armed with this knowledge, it’s possible that we could engineer our mates and ourselves to have a stronger vasopressin response and in turn be more monogamous.  Or if an individual or society decided that monogamy was not desirable, we could engineer ourselves to have less of a vasopressin response.

So as you look in to the eyes of your significant other this Valentine's day, you may find yourself wondering whether you should both get genetic testing, or whether you find his sweaty T-shirt attractive, or if he's more like a vole or more like the 95% of other mammals in the world.  At this point you may realize that genetics (and the internet) have made you think about love and relationships just a bit differently.

In the Year 2025, if Man and Woman are Still Alive, They’ll Be Vertical Farmers and Body Part Makers

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SarahBlennerBy Sarah Blenner, JD, MPH

From Arthur C. Clarke’s 2001: A Space Odyssey to the 1969 hit song by Zager and Evans In the Year 2525, humans have pondered what life will be like in the future.  A 2010 report called “The Shape of Jobs to Come,” published by Fast Future, as a part of the Science: [So what? So everything] campaign, once again predicts the future—this time focusing on new and soon to be invented jobs and industries that will boom between the years 2010 and 2030.

Some of the professions that made the top 20 job forecast list for 2030 include: body part makers, nano-medics, vertical farmers, weather modification police, social “social networking” workers, time brokers, and space tour guides.

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Thicket of Uncertainty in the Gene Patent Debate

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Keith Syverson by Keith Syverson

In 1998, Michael Heller and Rebecca Eisenberg wrote that the proliferation of biotechnology patents created a tragedy of the anticommons where "people underuse scarce resources because too many owners can block each other."  This phenomenon is also referred to as a "patent thicket" where there are multiple different patents from different owners.  Over the past 12 years, many studies have been published evaluating the effect of intellectual property rights in medical research and diagnostic testing.  In October 2009, a group of European scientists led by Isabelle Huys investigated whether the proliferation of gene patents or patents on diagnostic methods created a patent thicket.  The article, Legal Uncertainty in the Area of Genetic Diagnostic Testing, concluded that there was no patent thicket with regard to claims that actually claim DNA sequences, but that there were enough different claims on diagnostic methods to create a chilling effect on medical diagnoses and restrict access to care.

The authors provide an empirical analysis of the nature, extent, and scope of patents relating to 22 of the most commonly tested for genetic diseases in Europe which include cystic fibrosis, breast cancer, and colon cancer.  They then compared the claims to the best practice guidelines in Europe and the United States for testing of susceptibility to these genetic disorders to determine if the patents had any effect on access to genetic testing in either country.  The authors concluded that there was not a "thicket" of patents covering only genes because most of these patents could be easily invented around.

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Sorry Darwin, It’s Not All In the Genes.

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Lori Andrews by Lori Andrews
time magazine cover - dna not destinyThis week’s Time features a cover story, “Why Your DNA Isn’t Your Destiny.”  This is a far cry from the sentiment twenty years ago at the start of the Human Genome Project.  At that time, a prominent psychiatrist announced, “The war is over in the nature/nuture debate” — implying that everything was due to genes (nature).  Or when, during the Monica Lewinsky scandal, Time itself ran a cover story proclaiming “Infidelity–It May Be In Our Genes.”

In the intervening two decades, scientists have learned that human traits and behaviors are caused by a complex array of factors.  When researchers begin searching for a gene related to height, they found variations at 20 different points in the genome that were related to a person’s stature.  And even if all 20 were analyzed, that only accounted for 3% of the variation between people in height.

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