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

New Diagnostic Guidelines and DTC Testing for Alzheimer’s Disease

Last month, the National Institute on Aging and the Alzheimer’s Association issued new diagnostic guidelines that divide Alzheimer’s disease into three distinct stages, reflecting recent evidence that the disease begins to affect the brain years before symptoms become evident. The expanded definition of Alzheimer’s includes two new phases of the disease:

(1) presymptomatic and (2) mildly symptomatic but pre-dementia, along with (3) dementia caused by Alzheimer’s. This reflects current thinking that Alzheimer’s begins creating distinct and measurable changes in the brains of affected people years, perhaps decades, before memory and thinking symptoms are noticeable.

At least for the moment, the new guidelines are intended to be used only with patients enrolled in clinical trials, making them more of a work in progress and not a standardized method of determining disease onset in Alzheimer’s patients.

Federal Alzheimer’s Activity. The revisions to the diagnostic guidelines – the first in nearly three decades – indicate how far scientists have come in understanding the disease and are reflected in new legislation introduced in both the Senate (S.738) and the House (H.R.1386) that would expand Medicare coverage of Alzheimer’s to cover “comprehensive Alzheimer’s disease diagnosis and services,” including for individuals who fall under stage (1) or (2) of the new guidelines.

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

The Next Social Media Revolution Will Occur In…Personalized Medicine?

Social media – including Facebook, Twitter and other social networking platforms – are widely credited with fundamentally altering the nature of political discourse and, in some instances, credited as catalysts of political revolution. But social media’s ability to affect change need not be limited to politics, as recent developments in the arena of personalized medicine and consumer genomics continue to demonstrate.

Social Media as a Research Tool. Last month, PatientsLikeMe, an online patient community, made headlines with a study published in Nature Biotechnology in which the company analyzed self-reported data from nearly 600 patients to demonstrate that the use of lithium had no effect on the progression of amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease).

The study’s findings are valuable for ALS patients, who frequently experiment with unproven treatments in an attempt to slow progression of the degenerative disease for which there is not yet an effective therapy. But the long-term impact of the study’s methodological approach, which suggests “that data reported by patients over the internet may be useful for accelerating clinical discovery and evaluating the effectiveness of drugs already in use,” should be felt far beyond the ALS community.

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Filed under Direct-to-Consumer Services, General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Genomics & Medicine, Genomics & Society, Industry News

News Roundup: Biotech Funding and LDT Regulation

With so many developments at the intersection of genomics and the law, there is often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. In this post we recap several recent key developments and, at bottom, round up all of the recent tweets from @genomicslawyer.

Biotech Funding: No Bubble, New Models and the IPO Option. Despite speculation that a recent rise in venture capital investments is indicative of a bubble, to be followed soon by a plunge in available investment capital, venture capital investments in the life sciences are holding steady, both in total dollars and in the size of an average financing. Thus, says Bruce Booth, a partner at Atlas Venture and author of Life Sci VC, there appears to be no bubble to debate, at least not in the life sciences. Booth observes that overall funding is “down considerably from the recent highs in 2007 and 2008” and, while other industries may be experiencing fewer but larger financings, “the data doesn’t support a frothy market for LS venture financings these days.”

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Filed under General Interest, Genomic Policymaking, Genomics & Medicine, Genomics & Society, Industry News, Legal & Regulatory, Pending Regulation

Forensic DNA Fights Terrorism

The big news from the past 24 hours is the death of Osama Bin Laden, which was reported late Sunday evening by President Barack Obama. That’s front page news the world over. But Genomics Law Report readers might be interested to note that DNA appears to have played a significant role in confirming that it was, in fact, Bin Laden who was killed in a shootout with U.S. military forces yesterday in Pakistan.

As reported by The Telegraph earlier today, Bin Laden’s identity was confirmed by government officials only after they matched DNA taken from the body in Pakistan with DNA extracted from a preserved tissue sample from Bin Laden’s sister, who died of brain cancer several years ago.  The identification happened rapidly, but, according to Christie Wilcox in a guest post at Scientific American, that’s not all that surprising. Wilcox outlines, step by step, how such an ID could have easily occurred in under 5 hours.

We have covered the use of forensic DNA techniques numerous times here at the GLR, and regular readers know identification through partial or familial DNA matching is not without both social and scientific critics. However, lest there be any doubt, CNN reports that the Obama administration used several methods, including facial recognition and eyewitness corroboration, to positively identify Bin Laden.

Filed under General Interest, Genetic Testing/Screening, Genomics & Society, International News