Archive for the ‘biotechnology’ tag

Biotechnology, Bioterrorism & the First Amendment

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Last year, two teams of researchers funded by the National Institutes of Health (NIH) succeeded in genetically modifying the H5N1 avian flu virus.  The modified virus is capable of respiratory transmission between ferrets, suggesting that it would also be transmittable between humans and potentially capable of causing a “pandemic of disastrous proportions” with mortality rates exceeding 50%. The central controversy arose around attempts to prevent publication of the research findings, which some considered a “blueprint for bioterrorism.  The U.S. National Science Advisory Board for Biosecurity (NSABB) met to discuss the issue and adopt a solution that would both protect national security and be consistent with scientific freedom and the First Amendment.  While the NSABB recommended redacting details from the paper, the international community came to a different conclusion.  At a meeting convened at the World Health Organization in Geneva, international experts felt that the papers should be published in full. On the domestic plane, preventing publication of scientific research raises issues of free speech and the First Amendment.  The Supreme Court has consistently read the First Amendment broadly, as evidenced by the landmark Pentagon Papers case.  In New York Times v. United States, the government sought to prevent the New York Times from publishing a top secret study on the U.S.’s policy in Vietnam.  This marked the first time that the federal government sued the press to prevent it from disclosing information for reasons of national security. The Supreme Court recognized that there was a “heavy presumption against” restraints on the press, and found that the government did not meet this burden. Even in instances – as with the H5N1 research – where the U.S. government has funded research, this does not give it the power to censor publication.  In Board of Trustees of Leland Stanford Jr. University v. Sullivan, the Court ruled that federally funded scientific research should not be subject to prior restraint.  That is, the government may choose whether or not to fund research, but if it chooses to fund a certain study, it may not restrain the dissemination of findings from that research without a compelling state interest. Although First Amendment jurisprudence is strong, freedom of speech does not extend to every situation.  The Court ruled in Chaplinisky v. New Hampshire that certain utterances may be of such low value “that any benefit that may be derived from them is clearly outweighed by the social interest in order and morality.”  Since New York Times v. United States, courts have found themselves judging cases in which it is necessary to balance the value of free speech against other interests, such as security.  In 1979, the Court in United States v. Progressive, Inc. recognized that “First Amendment rights are not absolute,” and enjoined the press from publishing an article with technical details on constructing a hydrogen bomb.  The Court ruled that the threat to national security met the standard established in New York Times v. United States. In the case of the H5N1 research, a redacted publication may survive a First Amendment challenge under the reasoning of the court in Progressive.  In both instances, free speech must be balanced against the potential threat to life and security.  The government could evoke the war on terror to argue that heightened restraints on speech are necessary when it comes to issues of biosecurity during wartime. Another possible solution to the H5N1 controversy is for Congress to legislate in this domain.  One of the Supreme Court’s main reservations in New York Times v. United States was that the judges did not want to legislate from the bench; they saw this as an issue of separation of powers.  In recent years, Congress has considered expanding legislation to protect national security over freedom of the press.  After the upheaval caused by Wikileaks, the Securing Human Intelligence and Enforcing Lawful Dissemination (SHIELD) Act was introduced in Congress.  This proposed legislation would amend the Espionage Act, providing greater protection for classified government information. Unfortunately, as the H5N1 controversy has shown, problems relating to security and free speech do not end with domestic law.  The two researchers who led the H5N1 study were from universities in the U.S. and the Netherlands, and the international community and the World Health Organization have already become heavily involved.  Even if redacting the articles would survive a First Amendment challenge in the U.S., these efforts would be fruitless if other countries chose to publish the data in science journals abroad.  With increasing international collaboration in scientific research and greater security risks posed by research findings, it may soon become necessary to create a set of international standards for biosecurity. One major problem with international standards to suppress speech in the interests of security is determining who decides when these standards have been met.  In the case of the H5N1 research, would the U.S. and the Netherlands be the sole decision makers?  This seems certain to displease other nations who have an interest in the sensitive information or in voicing their opinions.  On the other hand, if all nations had a say in weighing the benefits of publication against security interests, then the risk of sensitive information getting out could grow even greater. Threats to biosecurity like the H5N1 research will continue to present themselves in the years to come, and political leaders should seek to address these issues both domestically and internationally.  While First Amendment jurisprudence may pose an obstacle to preventing the dissemination of dangerous information, a coordinated effort on the international level is also necessary.  With clear standards for undertaking research and withholding sensitive findings from the press, threats to biosecurity may be contained without prejudice to scientific freedom.

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March 21st, 2012 at 1:40 pm

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

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