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Patent Update: Looking Beyond Section 101 and the Continued Murkiness of Method Patents

As the biotechnology community awaits the Federal Circuit’s decision in the Myriad Genetics patent litigation, attention has focused on the fundamental issue in that case: whether genes and methods for interpreting mutations are patentable subject matter under section 101 of the Patent Act—that is, whether they are the kinds of things that can be patented assuming that all of the other requirements of the Patent Act (pdf) are satisfied.

However, we have argued in several articles (see, e.g., here, here and here) that the real action is more likely to involve all of those “other requirements” as courts explore other ways to limit the patentability of scientific and technology progress without altering the threshold test of patentability under section 101.

A recent Federal Circuit case (Billups-Rothenberg, Inc. v. Associated Regional and University Pathologists, Inc.) decided under the written description requirement of section 112 illustrates this point yet again.

Billups v. ARUP Background. The Billups case involves a disorder called Type I hereditary hemochromatosis, which is characterized by excessive absorption of iron. The critical gene in the absorption process is called HFE, or “High Fe.” In 1994, Billups filed the application that led to a patent on methods for testing for hemochromatosis (U.S. patent number 5,674,681; “’681”). The court’s opinion reproduces this claim as “representative”:


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Filed under Featured Content, Genetic Testing/Screening, Industry News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation

Closer Scrutiny Ahead for DTC Genetic Testing Claims

The FDA’s public meeting on the future of clinical direct-to-consumer (DTC) genetic testing (which we have covered herehere and here) is continuing to draw significant attention from the media and other commentators. Most of the coverage, especially over the past 7-10 days, has added little that is new in the way of either reporting or analysis. One exception, however, comes from Robert VerBruggen of National Review in his column on “The FDA’s Genetic Paternalism.”

What’s new and interesting here is not the substance of VerBruggen’s analysis. Whether or not you agree with Verbruggen’s particular formulation, the “paternalism” critique of proposed FDA regulation of DTC genetic testing is not new. What caught our eye is a comment from deCODE genetics’ CEO Kári Stefánsson. When questioned by VerBruggen about his company’s marketing of its DTC genetic test offering, deCODEme (see screenshot) – which includes statements such as “your genes are a road-map to better health” – here is how Stefánsson responded:

“I think that is both cheesy and somewhat incorrect. I don’t know who came up with that, but whoever it is, is going to be duly punished,” [Stefánsson] said. “I think it’s safe to say we’ll probably be removing that statement and putting up something that at least sounds better.”

After its well-publicized 2009 bankruptcy, deCODE emerged in 2010 as a privately-held company and so it is unlikely the public will know whether Stefánsson follows through with his promise to “duly punish” the source of the “road-map” statement. On the other hand, whether and how deCODE follows through with Stefánsson’s not-quite-a-promise to change deCODEme’s marketing and claims is something that will happen in full view of the public.


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Filed under Direct-to-Consumer Services, FDA LDT Regulation, Featured Content, General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomics & Medicine, Genomics & Society, Industry News, Legal & Regulatory, Pending Regulation

Digging Deeper into the EEOC’s Final GINA Regulations

As we wrote yesterday, last week the Equal Employment Opportunity Commission (EEOC) issued definitive rules and regulations (pdf) with respect to Title II of the Genetic Information Nondiscrimination Act of 2008 (GINA). In our previous post we offered a brief overview of the new regulations, as well as some preliminary suggestions for employers just now coming to grips with GINA.

We also promised to take a closer look in today’s post at several substantive features of the EEOC’s new regulations.

Defining the Terms. The EEOC, the government agency generally responsible for enforcing federal employment nondiscrimination laws, was the logical choice to promulgate regulations under GINA’s Title II, which governs the use of genetic information by employers and similar entities. But not all of GINA’s statutory provisions were within the EEOC’s area of expertise.


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Filed under Badges, Featured Content, General Interest, Genetic Testing/Screening, GINA, Legal & Regulatory, Pending Litigation, Pending Regulation, Privacy

Consumer Genetics Needs More Transparency, Not Excessive Regulation

Editor’s Note: Daniel MacArthur, a researcher at the Wellcome Trust Sanger Institute in Cambridge, UK, and the author of Genetic Future, co-wrote this post, which originally appeared in Xconomy.

Are you ready for consumer genetics? Is your government?

Recent announcements of federal investigations into the budding direct-to-consumer (DTC) genetic testing industry suggest that authorities are preparing to increase regulation of companies offering consumers access to their own genetic data. However, rather than rushing in to clamp down on the industry, regulators should slow down and focus, first, on understanding this complex field.

An increasing number of individuals are exploring their genetic information using tests purchased directly over the Internet. For between $100 and $1,000 consumers can purchase a saliva collection tube, spit in the tube, and mail it back to the company. A few weeks later the results are available online. One DTC genetics company, 23andMe, recently announced that it had provided its test to over 30,000 customers.

Genetic tests can provide the consumer with personalized information ranging from eye color, to ancestry, to risk of common diseases such as diabetes. Many companies include all of these traits and more in a single product examining hundreds of thousands of genetic markers. For the moment, these tests are available to anybody with a computer and a sense of curiosity. But that could all change.

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Filed under Direct-to-Consumer Services, FDA LDT Regulation, Featured Content, Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, Industry News, Legal & Regulatory, Pending Regulation