Archive for the ‘ACLU’ tag

The Policy of Gene Patenting – Are the Courts the Appropriate Venue for this Debate?

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Last week, following the denial of its petition for a panel rehearing, the ACLU announced that it will seek to bring the much-debated Myriad Genetics case before the Supreme Court.  Among other things, the case involves the patentability of isolated DNA – pieces of natural human DNA that have been chemically cleaved from the chromosome.  Myriad Genetics holds patents over two isolated DNA genes, BRCA1 and BRCA2, which are linked to susceptibility to breast cancer and may be used for clinical screening.  According to Myriad, women with mutations in these genes have an 82% risk of developing breast cancer, compared to about a 10% chance in the general population.

The history of the Myriad Genetics case has been tumultuous.  The U.S. District Court for the Southern District of New York unsettled the biotech industry when it ruled that isolated DNA was not patent eligible under 35 U.S.C. § 101.  This decision went against the long-standing tradition of the U.S. Patent and Trademark Office, as well as the Supreme Court’s history of interpreting § 101 broadly.  However, although the statute is broad, it does have certain established limitations.  The one at issue here is the restriction on patenting “products of nature” unless they are “markedly different” from naturally occurring ones. See Diamond v. Chakrabarty, 447 U.S. 303 (1980).  In a 2-1 decision in July, the U.S. Court of Appeals for the Federal Circuit reversed the district court’s ruling, restoring the status quo by finding isolated DNA patent eligible under § 101.  The court based its decision on the finding that isolated DNA is “markedly different” from DNA occurring in nature because the act of cleaving it from the chromosome gives it a new chemical composition.  The court also stressed the importance of deferring to Congress regarding potential changes in the scope of patentable material.

While the waters may currently seem calm, there is a good chance that this case will move forward, and a Supreme Court decision could have an historical impact on the future of biotechnology.  First, the decision itself is not beyond critique.  The dissent makes a strong case against patenting isolated DNA.  It compares the extraction of natural DNA to plucking a leaf from a tree or isolating the element lithium, since lithium only occurs in nature as part of chemical compounds.  Judge Bryson argues that isolated DNA is no different from naturally-occurring DNA except for the chemical changes that necessarily result from its extraction.  Consequently, he finds unconvincing the majority’s argument that isolated DNA is “markedly different” from natural DNA based solely on this minor chemical difference.

Secondly, the Myriad case exposed a tension within the government.  Although the ACLU brought the case against Myriad Genetics and the U.S. Patent Office, the Department of Justice actually submitted an amicus brief in support of the plaintiffs.  This uncertainly on the federal level suggests that the Supreme Court may hear the case and perhaps even restore the lower court’s ruling.  If the case goes forward, it will be interesting to see whether the Court rules narrowly or decides to expound more broadly on the patentability of other biotech products.

The Myriad case has received a lot of attention because of its policy implications.  On the one hand, the plaintiffs argue that the patents stifle patient access to clinical tests and suppress related DNA research.  They also raise ethical issues regarding the “ownership of what some view as our common heritage.” Ass’n for Molecular Pathology v. U.S. Patent and Trademark Office, 702 F. Supp. 2d 181 (2010).   Strong policy arguments exist on the biotech side as well, since companies rely on their patents when developing new products.

Do patents on isolated DNA restrict patient access to care any more than patents on new medications? Although clinical screening based on genetic code is an emerging field of medicine, access to affordable health care is far from a new debate.  There are also some who say that patents are preferable to their alternatives.  If a company is unable to rely on a patent for exclusive rights to a newly discovered gene or product, it will be forced to rely on trade secrets to keep its discovery private.  Thus, it is argued that patents actually encourage the free exchange of information and thereby incite other parties to conduct related research.

Many also fear the repercussions from a decision finding isolated DNA patent ineligible.  Would this restrain a growing biotech industry during a time when the last thing we want to do is stifle the job market?  What would happen to those who already hold DNA patents and rely on these patents for their work?  Would a Supreme Court decision reverberate beyond isolated DNA and prevent patents relating to stem cells and proteins?

With all of these worries and uncertainties at stake, it seems that maybe the U.S. Court of Appeals for the Federal Circuit was right in deferring to Congress. For even if the majority’s “markedly different” holding is weak, isn’t the concurrence correct in finding that “the judiciary is ill-suited to determine whether the claims at issue pro­mote or inhibit science”?

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October 23rd, 2011 at 10:22 pm

Harsh Illinois Eavesdropping Statutes Send Citizens to Prison


Ignorance of the law is not a defense, as two Illinois citizens have recently discovered. Christopher Drew and Tiawanda Moore are both facing up to fifteen years in prison for crimes that they did not realize they were committing.  The New York Times recently highlighted the harsh eavesdropping statutes in Illinois by using these two citizens as examples.

Christopher Drew was arrested for selling art without a permit in downtown Chicago, which he intended to do in order to protest the city ordinance requiring permits. However, he now faces Class 1 felony charges, due simply to the presence of a digital video recorder in one of his bags during the arrest. He explains the encounter, in which police officers discovered that the recording device was on and had been recording the entire incident, in this video. The Illinois Eavesdropping Act contains various levels of offenses. Drew was charged with a Class 1 offense, which prohibits audio-recording of a law enforcement officer, state’s attorney, assistant state’s attorney, attorney general, assistant attorney general or judge in the performance of his or her duties.

Tiawanda Moore filed a sexual harassment claim against a police officer.  Naturally, she was already feeling leery of law enforcement and did not trust the Internal Affairs investigators, so she decided to record her meeting with them “to show how they’re not helping her.” She used her Blackberry, and was subsequently arrested under the Illinois Eavesdropping Act once the recording was discovered by the investigators.

While the penalty for recording public officials is the harshest, other offenses under the Act could easily affect many Illinois citizens without knowledge of the law. Audio-recording a private or public conversation with a civilian, without the consent of all parties to the conversation, is a Class 4 felony punishable by up to three years in prison.  The ACLU filed a lawsuit to challenge the Illinois Eavesdropping Act in federal court, but it was dismissed for the second time on January 10th.

These harsh penalties present challenges to modern technology. Most cell phones now have audio and/or video recording capabilities, and many people also utilize digital video recorders.  In fact, uploading videos to YouTube, Facebook, or blogging sites is common, and people are enticed to share their experiences with others.  However, quickly turning on a video recording device to capture the moment could put Illinois citizens in prison. In this era, where legitimate news organizations like CNN or local newspapers encourage citizens to become reporters by taping and publishing “eyewitness news,”  Illinois’ eavesdropping statutes could put these citizen-reporters in prison.

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January 30th, 2011 at 9:45 pm

Students’ Cell Phone Data – Private?

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With cell phone communication among teenagers rising, public school administrators are confronting new challenges such as sexting and cyberbullying, with little assistance from the legal system on how to handle these behavioral problems. While the Supreme Court has addressed the application of Fourth Amendment protection from unreasonable searches and seizures to schools’ searches of student, it has yet to apply this school search standard to cell phones and similar technology in schools.  Additionally, it is uncertain whether the First Amendment provides any extra protection to students’ expectation of privacy in the contents of their cell phones.

A recently settled case, which the ACLU brought on behalf of a female student in a Pennsylvania high school, highlights the major consequences and intrusion of privacy that could arise when school officials choose to search through a student’s phone.  The student, N. N., brought a lawsuit against Tunkhannock Area School District, alleging that both her First and Fourth Amendment rights had been violated after the school performed an unreasonable search and seizure of her cell phone, which led to private information being given to law enforcement. N.N. was caught using her phone during school hours, a violation of school rules, and her teacher rightfully seized the phone and turned it over to the principal.  However, rather than simply maintain possession of the phone, the principal searched through the phone and accessed the phone’s camera function.  He discovered naked pictures of the student and contacted law enforcement officials.  At the end of the school day, N.N. reported to the principal’s office where she was told that her phone would not be returned to her, because he had found the photos and turned her phone over for criminal prosecution instead.

Although school policy stated that the punishment for misusing a cell phone once on school property was a one-day confiscation and one Saturday detention, N.N. was suspended from school for three days. The Wyoming County District Attorney’s Office did not formally charge N.N., but the district attorney did threaten to bring felony child pornography charges against her unless she undertook a five-week re-education program. N.N. agreed to take the course, which was designed for victims of sexual violence and abuse. N.N. was forced to write papers about how her conduct was wrong, although she maintains that the photographs were private and sent only to her boyfriend.

In response to the N.N. case and other cases involving cell phone searches of students, the ACLU has drafted a proposed cell phone policy for school districts to utilize and adopt.  The policy allows cell phones on campus, but prohibits their use during class hours, to exchange naked pictures, and generally the use of cell phones “in a manner that poses a threat to academic integrity, disrupts the learning environment, or violates the privacy rights of others. Notably, the policy prohibits any search performed on the phone by school officials without student or parental consent.  If school officials reasonably suspect that a student’s cell phone contains content that violates criminal laws or has been used in a criminal manner, they must confiscate the device, contact law enforcement authorities, and surrender the device to these authorities if they produce a valid warrant.

While the ACLU’s efforts to protect student speech and privacy are admirable, there are many potential difficulties that schools would encounter by adopting this policy. A policy that completely forbids searches may cause harm to students or go too far in eliminating reasonable, searches performed with good intentions.  For example, if a teacher found a cell phone in a classroom, he would be forbidden from accessing the phone’s directory or information in order to determine its owner. If a student has an emergency or accident, the teacher would be forbidden from searching the cell phone for contact information in the event that the emergency contact on file could not be reached. Additionally, subjecting students to immediate criminal repercussions for their private content rather than conduct an independent search could undermine schools’ efforts to maintain order.  Criminal proceedings could put students through dramatic, frightening ordeals that could fail to produce results and only create more stigma and embarrassment for the student. Thus, while the ACLU policy recognizes students’ rights to privacy, its ban on searches and immediate turnover to law enforcement are too severe and have the potential to backfire and cause harm to students.

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January 11th, 2011 at 4:23 pm