hand with a pencil drawing on DNA results

Silver Spoons and Golden Genes: Designing Inequality?

A recent web series sparked controversy with the headline that “Designer babies aren’t futuristic. They’re already here.” The online articles make the case that disparate access to frozen embryo screening for debilitating diseases—sickle cell anemia, Tay-Sachs, or cystic fibrosis—is “designing inequality into our genes.”

The authors are right that reproductive technology isn’t open to everyone. A single cycle of in vitro fertilization (IVF)—the tool that combines sperm and egg in a lab—costs 57% of the average American’s annual income in 2018. The multiple cycles it usually takes to get a baby costs upwards of $100,000. Just fifteen states make insurers cover reproductive technology. Even these often limit coverage mandates to married couples unable to conceive, thereby denying equal benefits to non-traditional families.

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23 and me boxes

You Received Genetic Test Results from Direct to Consumer Companies or from Research – Will Your Doctor Be Happy to See You?

By Ellen W. Clayton

You recently responded to a TV advertisement by a direct to consumer (DTC) genetic testing company because you wanted to find more of your relatives. The company also offered to send you your genomic data.  Although not what you originally had in mind, you decided to send the data to another DTC company for interpretation to learn more about your health. Unfortunately, you were told that you are at risk for a condition you had never heard of.  Even though the company sent some educational information, you quickly decided to call your doctor for more information and to start prevention or treatment.

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Opportunities and challenges for user-generated licensing models in gene-editing

By Timo MinssenEsther van Zimmeren & Jakob Wested 

An earlier version of this contribution had been published in Life Science Intellectual Property Review (LSIPR).

A voluntary pool or clearinghouse model may give rise to a robust commercial ecosystem for CRISPR and could include special provisions for royalty-free research use by academics. Hence, there may be a path through the CRISPR patent jungle. But, there are many obstacles still in the way.

The revocation of Broad Institute’s patent EP2771468 reported and discussed here, marks the latest major development in a series of patent battles over the revolutionary and highly lucrative CRISPR-Cas9 technology (and other gene editing technologies) in the US and Europe.

While this is the first EPO decision in an opposition procedure concerning the Broad patent portfolio, the outcome may have implications for other related patents as the rationale for the revocation reflects a larger, systemic challenge based on the different rules regarding priority claims in different jurisdictions.

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Will the EPO’s Enlarged Board of Appeal step into the CRISPR patent battle?

By  Jakob Wested, Timo Minssen & Esther van Zimmeren

Another version of this contribution has been published in Life Science Intellectual Property Review (LSIPR).

The Broad Institute is facing a formidable task in defending the revoked CRISPR patent claims in their pending appeal at the European Patent Office (EPO). Ultimately, some of the issues might still be referred to the Enlarged Board of Appeal. However, this might require a significant amount of legal and rhetorical agility.

“The Opposition Division’s interpretation of the EPC [European Patent Convention] is inconsistent with treaties designed to harmonize the international patent process, including that of the United States and Europe.”

This was the rather strong reaction of the Broad Institute after the EPO’s Opposition Division’s (OD) decision to revoke one of their CRISPR patents. It could, however, also be argued that the case presents a simple failure of the patent applicants to comply with the long-standing European practice to apply an “all applicants” approach when claiming priority under article 87 of the European Patent Convention.

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DNA Donors Must Demand Stronger Privacy Protection

By Mason Marks and Tiffany Li

An earlier version of this article was published in STAT.

The National Institutes of Health wants your DNA, and the DNA of one million other Americans, for an ambitious project called All of Us. Its goal — to “uncover paths toward delivering precision medicine” — is a good one. But until it can safeguard participants’ sensitive genetic information, you should decline the invitation to join unless you fully understand and accept the risks.

DNA databases like All of Us could provide valuable medical breakthroughs such as identifying new disease risk factors and potential drug targets. But these benefits could come with a high price: increased risk to individuals’ genetic data privacy, something that current U.S. laws do not adequately protect. Read More

NEW REPORT: Ethical Issues Related to the Creation of Synthetic Human Embryos

Report Summary Authored by Robert D. Truog, MD (Center for Bioethics, Harvard Medical School) and Melissa J. Lopes, JD (Harvard University Office of the Vice Provost for Research)

The Harvard Embryonic Stem Cell Research Oversight (the “ESCRO”) Committee, an ethics oversight committee charged with reviewing research protocols involving human embryos, human embryonic stem cells, and certain activities with non-embryonic human pluripotent stem cells, recently issued a report exploring the ethical issues related to the creation of synthetic human embryos.

Ethical committees such as the Harvard ESCRO occasionally receive inquiries to deliberate upon the ethical implications of emerging research technologies where there is no existing or established guidance to rely upon. Deliberating in these gray areas is not a simple task, but the Harvard ESCRO has developed a general framework for navigating this ethical terrain in real time. In these instances, the Harvard ESCRO generally consults with its peer oversight bodies, reviews data from the scientific and bioethical literature and from other scientists and ethicists in the field and, from time to time, convenes symposia to broaden the discussion around such emerging technologies.  Read More

What’s in a name? Why metaphors matter for genetics research

By Mildred K. Cho, PhD

In 2017, the US FDA approved a gene therapy for the first time. However, it’s important to remember that the term “gene therapy” has been an optimistic misnomer for nearly 30 years, since the first clinical trial of a gene-based intervention was initiated in 1990.  Although the FDA has now approved a handful of gene-based therapies, there are concerns about the viability of the approach in actual clinical practice.

Because of the decades-long struggles of the technology to live up to its hype, the term “gene therapy” has been heavily criticized for encouraging the “therapeutic misconception” and for conveying unwarranted “therapeutic optimism.” In addition, there is evidence of how clinical trial participants and investigators both overestimated benefits from research but also how research was framed as treatment.  As a result, many recommended the alternative term “gene transfer” to more accurately represent the purpose and benefit of the intervention.  We may never know exactly how much the use of the term “gene therapy” contributed to potential bias in perceptions of effectiveness and intent, but it does highlight the potential impact of language on the ethical conduct of research.

Similarly, the rhetoric surrounding the genetic “revolution” has been justly criticized. Our research published in Genetics in Medicine, the peer-reviewed journal of the American College of Medical Genetics and Genomics (ACMG), suggests that researchers and advocates should not only avoid hyperbole, but also be more cautious and reflective about the use of metaphors.  We asked patients in a Northern California health system to tell us what the word biobank made them think of, and received a range of notable responses.  Some people associated the term with financial banks or gold mines, and others expressed suspicion of commercial motives of pharmaceutical or insurance companies for collecting and using biosamples.  Others associated the term with computers or databases, and some may have been misled by the association of biobank with the concept of electronically-accessible information, saying that a benefit of a health system’s research biobank-linked database was that patients could look up personally-relevant information in it directly and therefore not have to see a doctor. Read More

Call for Papers: Wiet Life Sciences Scholars Conference

Loyola University Chicago’s nationally acclaimed Beazley Institute for Health Law and Policy is pleased to invite original research submissions for the annual Wiet Life Science Law Scholars Conference to be held on Friday, September 7, 2018.

The conference is designed to provide an intellectual venue for life science professors, scholars, and practitioners to convene and discuss current research and scholarship.  The phrase “life science law” intends to capture diverse disciplines that involve significant issues of life science research and development, spanning food and drug law, health law, intellectual property (IP) law, biotechnology law, environmental law, administrative law, and antitrust law.  Our goal is to foster recognition of life science law as a cohesive, dynamic area of legal study and strengthen connections among national life science law scholars.

Loyola is currently soliciting 750-1,000 word abstracts reflecting early or mid-stage ideas for the purpose of workshopping with other conference scholars.  Modeled after successful events for law professors and scholars in other areas, we will organize scholars in topical panels of three to five authors with approximately 15 minutes allotted to each abstract presentation, followed by 15 minutes of intensive discussion with scholar attendees.  Author abstracts will be distributed one week prior to the conference to scholar participants; authors may also submit draft articles for distribution.  Scholars are expected to review materials of fellow panel members.

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Considering Direct-to-Consumer Genetic Testing? Spit with Caution

By Gali Katznelson

A friend and I had been vaguely entertaining the idea of ordering genetic testing kits for some time. Then, Black Friday happened. My friend called me to share that 23andMe was on sale, 50% off, for 1 more hour! Typing our credit card information into Amazon, we tossed around some half-reasoned arguments in favor of our impulsive purchases: “this’ll be a fun science experiment”, “what if we catch something preventable in time to make lifestyle changes?” and, “we really should be contributing our data to research for the public good.” Within minutes, two kits were ordered and thanks to the magic powers of Amazon Prime, these boxes appeared on our doorsteps within days. Few things in life are as exciting as receiving a mail delivery, but as we unwrapped our packages, finding the words “Welcome to You” plastered on our shiny white Pandora’s boxes, somehow our excitement began to dwindle. One month later, our boxes remain unopened.

Genetic testing is clearly something we should have given more thought before the marketing geniuses got the best of us. Here are some questions anyone considering taking a direct-to-consumer (DTC) genetic test should answer (ideally before buying the test):

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Limited Seats Still Available, Register Now! 12/12: Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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