Patents & IP
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.
Fabry Patients Ask for Rehearing of NIH March-in Petition
Back in December, the National Institutes of Health (NIH) refused to exercise the government’s “march-in” rights under the Bayh-Dole Act with respect to the patent-protected drug Fabrazyme® (agalsidase beta). A group of Fabry disease patients had petitioned NIH to grant licenses to other prospective producers of the enzyme replacement therapy because manufacturing problems at Genzyme, the exclusive licensee of patents held by Mount Sinai School of Medicine, had created severe supply problems.
When NIH refused to act, a larger group filed a class action lawsuit (pdf) in Pennsylvania federal court against Genzyme and Mt. Sinai for damages allegedly caused by their inability to get prescribed dosages of Fabrazyme®. As we reported last month, the suit raises novel legal theories and faces an uncertain future. (Earlier this month Genzyme filed a motion to dismiss (pdf) the lawsuit.)
Weekly Roundup: UK Insurance Genetics Moratorium Renewed & Breast Cancer Patents, Research in the News
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.
UK Insurers Continue Moratorium on Predictive Genetic Tests. In 2008 the United States passed the Genetic Information Nondiscrimination Act (GINA). Title I of GINA prohibits health insurers from using genetic information to deny coverage or to set premiums or payment rates. Title II of GINA addresses the use and misuse of genetic information by employers. In the United Kingdom, which provides universal health coverage through the government-funded National Health Service (NHS), discussion of genetic nondiscrimination has largely focused on the employment context (see, e.g., the 2009 report on Genomic Medicine from the House of Lords). To date, however, the United Kingdom has not enacted a formal prohibition on the use of genetic information by either employers or insurers.
What We Learned From The Myriad Oral Argument
Yesterday brought the long-anticipated oral argument in the Myriad gene patent litigation. After much speculation, the final panel consisted of Judges Lourie, Bryson and Moore. Following the Myriad argument, Judge Lourie was replaced on the panel for the remainder of the day’s cases by Judge O’Malley, lending support to speculation that Judge O’Malley recused herself from the Myriad argument because her lawyer-spouse filed an amicus brief in the case.
What We Learned from the Myriad Oral Argument. For all of the attention focused on the Myriad oral argument, most spectators have only one very practical question: did Monday’s argument provided any meaningful clues with respect to how the Federal Circuit might rule on appeal of the lower court’s startling ruling?
In a word: no. In a few more: we learned nothing from the Myriad argument that leaves us better able to predict how the Federal Circuit will rule in this case.
A Spectator’s Guide to the Myriad Oral Argument
On Monday at 10 a.m., the lawyers for both sides will argue the Myriad case (Association for Molecular Pathology v. USPTO) before a three-judge panel of the United States Court of Appeals for the Federal Circuit in Washington. Here are a few things about oral argument in general, and this case in particular, that interested observers may want to keep in mind.
Who’s on the Panel? Federal cases on appeal are almost always heard initially by a panel of three randomly selected judges. (In rare cases all the judges of a circuit will rehear the case together, or en banc—no way to predict if that will eventually happen here.) The Federal Circuit will announce the panel for this case on Monday morning on its website. As of now, all we know is that Myriad—and only Myriad—will be heard by “Panel B+.” The + means that the makeup of that panel will be different from that of Panel B, which will hear the three other cases also scheduled for this 10 a.m. session (a panel customarily hears four arguments in a session). The + designation sometimes means that one member of the regular panel (here, B) has recused (disqualified) him or herself from the case because of some conflict, necessitating a replacement.
Frustrated by NIH Inaction, Fabry Patients Attempt End Run Around Bayh-Dole
Back on January 18, 2010, we reported on the National Institutes of Health’s (NIH) refusal to exercise the government’s “march-in” rights under the Bayh-Dole Act with respect to the patent-protected drug Fabrazyme (agalsidase beta). The drug is an enzyme replacement produced from a recombinant mammalian cell line (i.e., a biologic) and is used to treat the symptoms of Fabry disease, a rare genetic condition that impairs the victim’s ability to metabolize fat and can lead to kidney failure and heart disease. Fabrazyme was developed at Mt. Sinai School of Medicine, which obtained two patents related to its manufacture and granted Genzyme an exclusive manufacturing license. After contamination at Genzyme’s facility led to a severe shortage and Fabrazyme rationing, a lawyer for three patients petitioned the NIH to march in and grant licenses to other manufacturers. As it has in all other cases, NIH denied the request.
Now, those same patients, joined by eight others, have sued Genzyme and Mt. Sinai (which the complaint erroneously describes as part of the public City University of New York, when in fact it is affiliated with the private New York University) over the shortage. The complaint (pdf) was filed on March 9, 2011 in the federal district court in Pittsburgh. The plaintiffs are represented by C. Allen Black, the same Pennsylvania patent lawyer who filed the NIH march-in petition.
Twitter Roundup: FDA DTC Edition (and a new format)
Beginning this week, we are unveiling a new format for the Genomics Law Report’s regular Twitter Roundup. In addition to cataloging Dan’s @genomicslawyer tweets, we will also be offering short summaries of several key developments pulled from those tweets which, for one reason or another, did not find their way into a full-length post. Think of this as a combination between the always informative Friday Links posts at Genomes Unzipped and The Cross-Border Biotech Blog’s semi-regular feature “This Week in the Twitterverse,” which was the original inspiration for the GLR’s Twitter Roundup.
How Will Myriad Respond to the Next Generation of BRCA Testing?
Robert Cook-Deegan contributed to this commentary. Dr. Cook-Deegan is Director of the Center for Genome Ethics, Law & Policy at Duke University Institute for Genome Sciences and Policy’s and is currently on leave at the Fondation Brocher in Hermance, Switzerland.
The past few months have brought a number of significant research and commercial developments in the BRCA diagnostic testing market, particularly in Europe. These developments have been met by enigmatic comments from the management of Myriad Genetics, the sole provider of commercial BRCA diagnostic testing in the United States and a defendant in ongoing and closely-scrutinized gene patent litigation. What can these recent developments tell us about Myriad’s future plans in both Europe and the U.S.?
The Next Generation of BRCA Testing. Myriad’s current BRCA diagnostic test, BRACAnalysis (pdf), uses a combination of two traditional technologies—Sanger sequencing and PCR—to identify mutations associated with a significant risk of breast cancer and/or ovarian cancer in the BRCA1 and BRAC2 genes. Although Myriad has dabbled with next-generation sequencing technologies, Myriad has yet to announce any concrete plans to apply any of the increasingly numerous and powerful next-generation sequencing technologies to its BRACAnalysis testing.
Others, however, are moving rapidly in exactly this direction.
Personalized Medicine Regulation Needs More Than Band-Aids
[Editor's Note: This post originally appeared as a guest column at Xconomy.]
Last week, New York State assemblyman J. Gary Pretlow introduced the descriptively named “act to amend the insurance law, in relation to requiring coverage for genetic testing in accident and health insurance polices.”
While not accompanied by a press release, or widely covered by media outlets, the bill merits close attention. While the substance of the bill is striking, its greater import lies in what it reveals about the United States’ current framework for personalized medicine regulation and in what the bill portends for the future of personalized medicine innovation and investment in this country.
Government Refuses to March-In Under Bayh-Dole—Again
The Bayh-Dole Act was in the news at the end of 2010. Three patients suffering from Fabry disease, a rare genetic condition that impairs the victim’s ability to metabolize fat and can lead to kidney failure and heart disease, petitioned the National Institutes of Health (NIH) to exercise the government’s “march-in” rights under Bayh-Dole (pdf) and compel the holder of the patent on the only FDA-approved Fabry treatment to grant licenses to other manufacturers. Just as it has in response to every previous march-in petition, the NIH refused the march-in request (pdf).
Bayh-Dole, From the Beginning. Enacted in 1980, Bayh-Dole was intended to promote the commercialization of government-funded research by allowing universities and other non-profits that receive federal grants—rather than the government itself—to own any resulting patents. This then-radical change in the law gave rise to the practice of technology transfer, whereby universities conduct sponsored research, patent the results, and then license the use of the patented inventions to spin-offs (which often involve the faculty inventors as principals) and other private companies.
