Association for Molecular Pathology v. United States Patent and Trademark Office: Meet the Plaintiffs

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Jake Meyer by Jake Meyer

Earlier this week, a lawsuit organized by the American Civil Liberties Union was filed challenging the validity and constitutionality of patents on the BRCA1 and BRCA2 breast cancer genes owned by Myriad Genetics.  The plaintiffs in this case include: women who wish to have testing for the BRCA1 and BRCA2 genes; researchers who have the capabilities to offer testing for these genes but are unable to because of Myriad’s patents on the BRCA1 and BRCA2 genes; medical organizations; and women’s health organizations.

The presence of the certain mutations in the BRCA1 or BRCA2 genes is associated with a predisposition to breast or ovarian cancer.  Women who have these mutations are much more likely to develop these cancers and men who have the mutation can pass the mutation to their daughter.  Women who learn they have these mutations will often opt for drastic surgeries, such as a mastectomy or oopherectomy (removal of the ovaries) to avoid a battle with breast or ovarian cancer.  However, Myriad Genetics owns patents that cover both the BRCA1 and BRCA2 gene sequences and mutations of the genes, which grant Myriad a monopoly over the gene sequences (for an example of one of Myriad’s patents click here). Myriad is the only company that offers genetic testing for BRCA1 and BRCA2 in the U.S. and therefore women cannot get second opinions before making decisions about major surgery.  Also, since Myriad has a monopoly on testing, it can charge whatever it wishes for the testing – currently the test costs over $3,000.  Many insurance plans don’t cover this testing and many people can’t afford the out of pocket cost of the test – so testing isn’t available to them.  Further, according to a 2006 study, Myriad’s test can miss certain mutations that help cause the disease.

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Chicago Takes A Stand: City Council Committee Unanimously Votes in Support of the BPA-Free Kids Ordinance

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SarahBlennerBy Sarah Blenner, JD, MPH

Bisphenol A (BPA), the controversial, toxic chemical found in many plastic food containers, is once again making headlines.  BPA is an estrogen-mimicking chemical that is used to make polycarbonate plastics.  Hundreds of studies have linked BPA to a variety of adverse health conditions, such as diabetes, insulin dependency, obesity, breast cancer, prostate cancer, hyperactivity, ADHD, autism, early onset of puberty, cardiovascular disease and liver enzyme abnormalities.

In January, Julie Burger argued that “the time to act is now.”  Leading scientists state that the potential health risks of BPA are too significant and the FDA’s determination that BPA is “safe” is simply the chemical industry’s creation of “manufactured doubt.”  With hundreds of studies linking BPA to adverse health conditions, the FDA relied solely on a limited number of studies funded by the chemical industry that showed “no harm.”

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Big Brother Is Watching–FBI, States Expanding Forensic DNA Databases by Millions

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Tim WelchBy Tim Welch

Last month, the FBI drastically changed its policy on whose DNA will be entered into and stored in the largest forensic DNA database in the world.  Previously, the FBI only collected DNA samples from convicts, i.e., people who have been declared guilty by a judge.  The FBI now plans to join 15 states in collecting DNA samples from people who have only been arrested or detained.  Law enforcement officials claim that including people in forensic DNA databases who have either been released without charges or declared not guilty in court will ultimately put more criminals in jail.  But the federal government's decision raises privacy issues as well.

Forensic DNA databases exist at the local, state, and federal level.  When a person is convicted of a crime, his or her DNA code is entered into a computer system, such as the Combined DNA Index System (CODIS), which allows investigators to compare biological specimens collected at crime scenes to DNA profiles of convicted criminals already stored in the database.  Even if no match is found, investigators can cross-check anonymous samples from different crime scenes to hopefully shed light upon unsolved crimes.  Law enforcement officials claim that their forensic DNA databases have helped convict thousands of criminals and have exonerated hundreds of innocent people who were wrongfully convicted.

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Nanobots!

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Jake Meyer by Jake Meyer

Nanotechnology is a vague term that encompasses a wide range of technologies.  Some of the technologies may be as mundane as a material used to strengthen a tennis racket, such as the carbon nanotubes used in the Babolat NS Drive Tennis Racket.  But the term nanotechnology is also used to include inventions that appear to be science fiction.  One possible use of nanotechnology is to create tiny robots that can be introduced into the human body to a number of medical procedures such as: deliver drugs, clean arteries of cholesterol, or to transport oxygen in the blood stream.  Although it may be many years before we have tiny robots coursing through our veins, advances in science and technology are bringing medical nanorobots closer to reality. 

An article in published in Nature last week, titled "Miniature Devices: Voyage of the Microrobots," describes how scientists at the Institute of Robotics and Intelligent Systems in Zurich, Switzerland may have overcome three obstacles in the way of realizing a future filled with medical nanorobots – "how to make, power, and steer them."  To propel the robot, the scientists created an artificial flagellum – a biological propeller that allows bacterium to swim.  The artificial flagellum is attached to a magnetic "head," and when the robot is placed in an oscillating magnetic field, the flagellum spins, propelling the robot through liquids at a blazing speed of 1-2 micrometers per second.  The magnetic field that provides the power for the robot also provides a method for controlling the robot.  By changing the direction of the magnetic field, the direction of the movement of the robot is changed. 

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Access to Easy Abortions Skew Sex Ratio in China–Leads to Nearly 33 Million More Males than Females Under Age 20

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JulieBergerBy Julie Burger

A study examining China's 2005 census report estimates that there are 33 million more males than females under the age of 20 in China.  The sex ratio started skewing sharply in the late 1980's with the introduction of low cost and portable ultrasounds which would be followed by abortions if the fetus were female.  Then the couple would try, try again until a penis was finally observed on the machine's screen.  Now, the birth sex ratio stands at 124 boys for every 100 girls.  (Worldwide the ratio is 100 girls to 103-107 males.)  While the Chinese government's policy may be that couples cannot be told the sex of their baby before it is born, until the government comes up with a better way to enforce this policy, it is going to get population control from a method it didn't expect–-fewer women left to have babies and generations of men who cannot find spouses.  In addition, rural areas in China have reported increases in crime and instability–thought to be the result of the growing population of unmarried men.

In Re Kubin: Federal Circuit’s Decision Sounds the Death Knell for Gene Patents

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Joshua SarnoffGUEST BLOGGER Joshua D. Sarnoff

The U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) has decided an important case regarding the application of the obviousness requirement to gene patents.  In re Kubin, No.2008-1184 (Fed. Cir. Apr. 3, 2009).  That case upheld the rejection by the U.S. Patent and Trademark Office (USPTO) of typical claims to gene sequences as unpatentable because they were obvious.

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Patent Law Reforms Could Lead to More Money for the Patent Office, Better Patents

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Jake Meyer by Jake Meyer

Previously, I discussed a proposed reform to the patent system: changing from a first-to-invent regime to a first-to-file regime.  This is just one of many proposed reforms being considered by Congress, as a part of two different bills.  An article published this week in Nature highlights how current proposed reforms to the U.S. patent system may appropriately address criticisms of U.S. patent quality.  The U.S. Patent and Trademark Office (USPTO) is understaffed and underfunded, which contributes to decreased patent quality.  Proposed changes to the U.S. patent system should help the USPTO to accumulate more resources, which should lead to higher patent quality.

An increasing number of patent applications are filed with the USPTO every year (from 355,000 in 2003 to about 495,000 in 2008).  The USPTO has a high turnover rate, where for every two examiners hired, one examiner leaves.  An examiner at the USPTO has about 20 hours to examine a patent application, which includes reading the patent application, searching through databases to determine if the subject of the application is novel and non-obvious, and to write a twenty page report on whether the subject of the application is patentable.  Despite the limited time spent on each patent application, an understaffed USPTO cannot examine the increasing number of patent applications filed which has lead to a growing backlog of unexamined patent applications (770,000 patents in 2008).  Currently it takes about 2 years to before a patent application is examined.

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Twins Foil DNA Forensic Test

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Tim WelchBy Tim Welch

On January 25, 2009, masked intruders stole about €5 million worth of jewelry and watches from an upscale department store in Berlin, Germany.   Surveillance cameras caught the crime on tape, and police found a glove containing identifiable DNA at the scene.   After the DNA was analyzed, the police were surprised to find that the DNA was linked to two men with criminal records, a pair of German twins identified as Hassan and Abbas O.   The twins were arrested on February 11, 2009.

Despite the DNA evidence, German police were forced to release Hassan and Abbas O. on March 18, 2009 because their DNA codes are virtually indistinguishable from each other using analysis methods accepted in German courts.   According to a Times Online report, "German law stipulates that each suspect must be individually proven guilty of a crime."   Since the DNA could not point to a specific suspect, German authorities were forced set the twins free.

Senate Considering a Big Change to the U.S. Patent System

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Jake Meyer by Jake Meyer

The U.S. Patent System has always been a first-to-invent system, which means that the first inventor of an invention will be awarded the patent.  Most other countries in the world are a first-to-file system, which means that the first inventor to file a patent application will be awarded the patent.  This has always been one of the large differences between the U.S. patent system and patent systems in other countries, but an amended bill before the U.S. Senate may eliminate this difference. If it is signed into law, S.515 will change the U.S. patent system from first-to-invent, to first-to-file.

In a first-to-invent patent system, the current U.S. system, disputes sometimes arise over who invented the subject of the patent first.  To resolve the dispute, the parties must first go to the U.S. Patent and Trademark Office’s Board of Patent Appeals and Interferences.  If a party objects to the Board’s decision, the party can appeal the decision to the United States Court of Appeals for the Federal Circuit.  This is a lengthy and expensive process.

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Teaching Law Through Fiction

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Lori Andrews by Lori Andrews

Last weekend, the Association for the Study of Law, Culture, and the Humanities met in Boston.  Along with panels on constitutional theory, human rights, criminal law, and same sex marriage, there were panels on novels and movies–Billy Budd, Twelve Angry Men, Notes from the Underground, even Harry Potter.

Since I was speaking at the session on "Law and Contemporary Fiction," I prepared by reading the novels written by my co-panelists Alafair Burke (Hofstra University School of Law), Kermit Roosevelt (University of Pennsylvania Law School), and Marianne Wesson (University of Colorado Law School).  They were all law professors by day, mystery writers by night.  But unlike CSI or the usual thriller, their books tried to stay true both to the law and the emotions of being a lawyer.   It struck me that their novels could be used to teach subjects as wide-ranging as First Amendment Law, Criminal Procedure, Corporate Law, and Professional Responsibility.  But their books involved more than just a clever use of a legal construct.  They'd captured the ethical challenges that lawyers face, the insane hours, and the feeling in the pit of one's stomach when a life, a business, or a principle of value is on the line. 

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