Weekly Twitter Roundup

Each week there are a number of stories and developments that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here’s a recap of what I was Tweeting this week @genomicslawyer:

Filed under General Interest, Industry News

Personal Genomics in the News: Desmond Tutu and the GET Conference

GET2010It’s been a busy twenty-four hours in the world of personal genomics. Yesterday, as announced in the journal Nature, the number of individuals who have had their genomes sequenced and made publicly available increased by two. Archbishop Desmond Tutu and !Gubi, a tribal elder from a Bushman (or Khoisan) community in Namibia, joined the ranks of personal genomics pioneers that include scientific and cultural luminaries such as James Watson, George Church, Skip Gates, Jr. and Stephen Quake.

Hot on the heels of the Nature paper (which has been exceptionally well-covered elsewhere, including  by Not Exactly Rocket Science, the Technology Review, and the New York Times) comes this morning’s announcement that many of those same genomics pioneers, including Watson, Church, Gates, Quake and others, will be sharing the stage together at the inaugural GET (Genomes Environments Traits) Conference. From the conference announcement:

“The GET Conference 2010 marks the last opportunity in history to gather a majority of individuals in the world with public personal genome sequences in a single venue,” says George Church, founder and principal investigator of the Personal Genome Project and professor of genetics at Harvard Medical School. “With rapid advances in technology, the number of individuals with personal genome sequences is expected to rise dramatically, from dozens today to thousands by 2011 and a million or more individuals within the next few years.”

The morning portion of GET Conference 2010 will feature wide-ranging discussions during which personal genome pioneers and globally recognized leaders of genomic science and industry, including Misha Angrist, George Church, Jay Flatley, Henry Louis Gates, Jr., Rosalynn Gill, Seong-Jin Kim, Greg Lucier, James Lupski, Stephen Quake, Dan Stoicescu and James Watson, will share their experiences and discuss the future of personal genomics. Award-winning science journalists Carl Zimmer and Robert Krulwich will moderate the discussions.


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Filed under General Interest, Genomic Sequencing, Genomics & Society, Industry News

Problems with Problem Employees

Fresh from a top biochemistry Ph.D. program, Beth was your fifth employee. Her technical expertise and ability to charm investors, lenders and prospective customers made her the obvious choice when, as the company burgeoned, you decided to formalize a roster of senior officers. As Executive Vice President for Biotechnology, Beth has since had a hand in every aspect of company business and operations.

Over the last year or so, however, Beth has moved from core asset to affirmative liability. She has missed critical internal and client meetings, and may go days without responding to calls or e-mails. According to her direct reports, she’s become largely invisible to them as well. You have no hint of what may be behind the situation.


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Filed under Badges, Bench to Market

GLR Update: Australia Tackles Disclosure of Genetic Information without Consent

ClipboardLast fall, the Genomics Law Report reviewed new medical confidentiality guidance from the U.K. General Medical Council (GMC) and wondered whether the “public interest” was a sufficient justification for the disclosure of patients’ genetic information without their consent.

Since that time, Australia’s National Health and Medical Research Council (NHMRC) has tackled the same issue, publishing new privacy guidelines for health practitioners on the disclosure of genetic information (pdf).

In each case, the basic thrust of the guidance for medical practitioners is the same – there are certain circumstances where a patient’s genetic information may be disclosed against his or her wishes. However, the guidance from the GMC and the NHMRC does differ in several important respects.

First, while the GMC’s guidance applies to all doctors in the United Kingdom, the NHMRC’s guidance is restricted to Australian doctors in private practice. The NHMRC’s guidance also restricts its applicability to the disclosure of genetic information to living genetic relatives for medical purposes. Disclosures relating to unborn children (e.g., information related to embryos or carrier status), to legal but non-genetic relatives (e.g., adopted children or spouses) or for genetic research are all outside of the scope of the NHMRC’s guidelines. The GMC’s guidelines, on the other hand, contain no such specific limitations, referring only to the practitioner’s responsibility to balance the patient’s interests against those of others, and to disclose genetic or other information when justified in the public interest.


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Filed under Genetic Testing/Screening, Genomic Policymaking, Genomics & Medicine, Informed Consent, International Developments, International News, Legal & Regulatory, Privacy

Weekly Twitter Roundup

Each week there are a number of stories and developments that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here’s a recap of what I was Tweeting this week @genomicslawyer:

Filed under General Interest, Industry News

Raising Private Capital Redux

Bench to Market (article)Now that you’ve decided to raise private capital, what’s your next move? How do you go about finding and signing up investors for your business?

Unfortunately, fundraising is a difficult, frustrating and lengthy process for most entrepreneurs. The path to financing does not end with a strong patented technology, a solid business plan and model, and an experienced and talented management team. Of course, a company that lacks any of these things likely will go unfunded. But in most situations, even a well positioned company needs the requisite relationships to make a financing happen, and it must navigate cumbersome federal and state securities laws to ensure it remains legally compliant.

Before an entrepreneur hits the road looking for money, he or she should be familiar with some basic legal principles applicable to raising capital. A new company must be cautious and thoughtful when seeking investments. As we explained in our earlier post on Raising Private Capital, every offering of securities must comply with the registration requirements of federal and state securities laws or qualify for an exemption from these requirements. Many companies structure private equity investments to comply with the Rule 506 exemption promulgated under Regulation D of the Securities Act of 1933, because it is the only federal exemption that preempts state securities laws and allows a company to raise unlimited amounts of money. As a result, it is a very attractive exemption without many of the restrictions and limitations imposed by other exemptions.


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Filed under Badges, Bench to Market

SACGHS Gene Patent Recommendations Still Controversial

918333_u_s__capitol_buildingThe Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) for the Department of Health and Human Services (HHS) convened again on Friday for a snow-shortened session. One of several items on the Committee’s agenda was a report that the GLR has covered several times (see here and here): Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests. With the threat of a blizzard looming, the meeting was unexpectedly short, with only a pair of public comments followed by the Committee’s vote to approve the report.

The report itself will not be available for several weeks, but the six recommendations on gene patenting and licensing approved by the Committee this past October continue to provoke a heated response. The Biotechnology Industry Organization (BIO), along with former Senator Birch Bayh (of Bayh-Dole Act fame) and others, held a Friday press conference to denounce – again – the report’s recommendations.

The SACGHS Recommendations. Most of the recommendations are uncontroversial, urging the Secretary of HHS to convene stakeholders to “explore” and “encourage” strategies to improve access to genetic testing, enhance patent licensing and ensure that the USPTO is “kept current with the latest scientific and technological developments related to genetic testing and technology.”

So what prompted Bayh’s charge that the recommendations represent “an attempt to send us back to a time when it appeared that American innovation was on its last legs and our economy was in deep distress”?
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Filed under Badges, Genomic Policymaking, Genomics & Medicine, Genomics & Society, Myriad Gene Patent Litigation, Patents & IP, Pending Regulation

Weekly Twitter Roundup

Each week there are a number of stories and developments that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here’s a recap of what I was Tweeting this week @genomicslawyer:

Filed under General Interest

Up Next in Gene Patents: Waiting for a Ruling (Again) and SACGHS Meets (Again)

GenomeWeb has a recap of today’s hearing in the Myriad case, including the not-at-all-surprising decision that there was no summary judgment decision issued from the bench. From all accounts the case appears to have been argued along the lines set forward by the parties in their briefs, with no obvious surprises presented by either party during oral argument. As for a decision, according to GenomeWeb, “Judge Sweet did not say today when he expects to make a decision in the case.” Interested observers, including the Genomics Law Report, can expect to wait some time – at least several weeks, if not months – before a decision is handed down. That decision, no matter which way it falls, is likely to produce an appeal to the Second Circuit.

In the meantime, those that simply cannot get enough of the gene patent debate are reminded that the Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) is convening again this week to finalize its report on biotechnology patent and licensing policy. As previously reported by the GLR, the last SACGHS meeting reviewed and approved several recommendations (pdf) from its Gene Patents and Licensing Task Force, including proposed exemptions from liability for infringing patents when (i) making, using, ordering, or selling tests for patient care purposes or (ii) “in the pursuit of research.”

While the SACGHS approved the recommendations, final review and approval of the Committee’s report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests was tabled until the February meeting. The recommendations and the draft report generated some pushback last fall so, Friday morning, the Committee will be reviewing those additional comments and “coming to closure” (pdf) on the report. The GLR will be listening in. Interested readers can find information about the SACGHS meeting here.

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Filed under Badges, Genomic Policymaking, Genomics & Society, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation, Pending Regulation

Final Words from the Sidelines as Courtroom Arguments Begin in Gene Patent Litigation

Yesterday, on the eve of summary judgment arguments in the Myriad case, The Boston Globe editorialized—strongly—against patenting isolated genes. This is an issue in which the Globe has a natural interest, given the concentration of biotech companies in and around Boston. The Globe’s editorialists may or may not be right on the merits, but they are surely too glib.

First, they wrongly blame the Patent Office for what they see as bad policy: “The US patent office assumes that granting one firm the exclusive right to profit off of a gene is the best way to encourage further research.” No, the Patent Office doesn’t “assume” this—it’s in the U.S. Constitution (Art. I, sec. 8, cl. 8), which allows Congress to grant exclusive rights to inventors to promote the progress of science and the useful arts. That is, the Constitution states an economic rationale for patents: the Framers believed that the promise of monopoly returns was the best way to motivate inventors to invent and then to disclose their technology (which you have to do to get a patent). So even if you disagree with this policy, you shouldn’t say that the Patent Office dreamed it up or has any authority to change it.


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Filed under Badges, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation