Category: Genetics

Rethinking Biotechnology and Software Patents: A Myriad of Jurisdictional Issues Related to Subject-Matter Eligibility

abenedict Leave a comment

by Adriana Benedict

Today, Professor Glenn Cohen announced on this blog that he, in conjunction with two others, filed an amicus brief in AMP v. USPTO (Myriad), a case concerning Myriad’s patents on isolated DNA and cDNA. In a paper I have been writing on the natural phenomenon doctrine as applied to biotechnology patents, I arrived at this conclusion about the doctrine’s implications for Myriad:

According to Mayo v. Prometheus, the preemption rationale for the natural phenomenon doctrine suggests that any patent on a diagnostic biotechnology product or process should be limited to the inventive use of that product or process as defined by its associated process or product, respectively.  As applied to Myriad, this qualified interpretation of the natural phenomenon doctrine would suggest that ideally these patents ought to be limited to Myriad’s one remaining valid method claim, namely claim 20 of the ‘282 patent, “a method for screening potential cancer therapeutics.”  The unavoidable and unsettling problem with such a conclusion, of course, is that at this stage in litigation, it is not possible for the Court to limit Myriad’s gene patents in this way.  This procedural limitation sheds some light on the elephant in the natural phenomenon doctrine: If the doctrine was meant to exclude certain categories of discoveries from patentability before Congress had the opportunity to refine more specific patent validity rules, then perhaps it should be limited to carrying out that function at the outset of a patent prosecution.  The natural phenomenon doctrine serves the important purpose of ensuring that patents do not contravene their Constitutional objective by too broadly preempting the use of “basic tools of science.”  It does so by balancing the scope of preemption against the scope of invention, and ensuring that the scope of preemption does not exceed that which is justified by the inventor’s handiwork in applying natural phenomena.  At the patent prosecution stage, the natural phenomenon doctrine is a useful “catch-all” analytical tool that allows flexibility in promoting the spirit of patent law when the letter of patent law has not kept pace with the progress of science. But at the litigation stage, its Achilles heel is that it may prove too much: In the absence of a procedural option to limit a patent at this stage, the natural phenomenon doctrine is forced to err on either the side of all or nothing.  While the doctrine may be useful at the patent prosecution stage, it was not (as other statutory patentability requirements were) appropriately designed to assess the validity of patents once they’ve been issued in a way that is compatible with today’s patent litigation procedures.  As a doctrine of limitation, it must in this context either fall, and prove nothing at the expense of unwarranted preemption, or rise, and prove too much at the expense of patent holders who have been reasonably relying on guidance from the USPTO regarding gene patents for many years.  

I am unable to find any commentary exactly on this point, but some issues concerning the jurisdictional authority of §101 have been raised in response to both Mayo and CLS Bank v. Alice.  While these cases concern biotechnology processes and software, respectively, they are extremely relevant to Myriad if we consider isolated genes / cDNA to be the equivalent of biological software. Indeed, Professor Ronald Mann observed that “Though most of the attention to …[Mayo]  has focused on its immediate implications for medical providers, the broader effect of the case probably will be on the software industry.”

Read More

New Amicus Brief Filed on Behalf of Dr. Eric Lander in the Supreme Court in the Myriad (Gene Patent) Case

I. Glenn Cohen 3 Comments

I am pleased to announce that Gideon Schor, Vern Noviel, and I filed an amicus brief on behalf of Dr. Eric S. Lander in a pending Supreme Court case that will address whether human genes are patentable.  The case is Association for Molecular Pathology v. Myriad Genetics, No. 12-398 and will be argued April 15, 2013.  Lander is a leading genomics researcher and is President and Founding Director of the Broad Institute of Harvard and MIT. We think the brief will play a key role in helping the Supreme Court chart a path through this legal thicket.  The full brief can be downloaded here https://www.americanbar.org/content/dam/aba/publications/supreme_court_preview/briefs-v2/12-398_neither_amcu_lander.pdf. Here is an excerpt from the brief, the Summary of the Argument:

This case hinges on a scientific question: whether DNA fragments from a human chromosome are (1) products of Nature or (2) at least similar enough to products of Nature that they should not be considered “markedly different.” Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980).

The members of the Federal Circuit panel below agreed that the DNA of a whole human chromosome was a product of Nature. But the majority held that isolated DNA fragments of a human chromosome were not products of Nature.

Because the majority made (without citing scientific support) a foundational assumption that isolated DNA fragments of the human genome do not themselves routinely occur in Nature, it considered whether they are similar enough to products of Nature. Employing analogies, the panel members debated whether isolated DNA cleaved from a chromosome was akin to a leaf plucked from a tree, or a kidney surgically removed from a human body.

Read More

Family, Privacy, Secrets, & The Law

Michele Goodwin Leave a comment

By Michele Goodwin

The Family, Privacy, Secrets, & The Law Roundtable (March 7-8. 2013) was a great success.  Kudos to the brilliant presenters and commentators who came together for this important, groundbreaking session, including Lori Andrews, Glenn Cohen, June Carbone, Laura Rosenbury, Camille Gear Rich, Martha Field, Deborah Epstein, Martha Ertman, Gaia Bernstein, Taunya Banks, Naomi Cahn, Michael Pinard, Karen Czapanskiy, and Eleanor Brown.  Thanks to all who attended and contributed to this excellent meeting.    Coverage can be found here and here.

Family, Privacy, Secrets & The Law

Michele Goodwin Leave a comment

Join us for an important meeting:

Roundtable: Family, Privacy, Secrets & the Law  March 7-8, 2013

March 7-8, 2013
University of Maryland
Francis King Carey School of Law
500 West Baltimore Street
Baltimore, MD 21201

March 7, 5 p.m. – Book Reading and signing by Jonathan Odell, author of The Healing

March 8, 9 a.m. – 4 p.m. – Roundtable discussions

Eventbrite - Family, Privacy, Secrets & The Law Roundtable

Family, Privacy, Secrets & the Law roundtable engages the intersections of medicine, criminal law, family law, and constitutional law. The conference faculty will chart contemporary issues that span genetic privacy, disclosure of parental identity in assisted reproduction cases and DNA conscription to domestic violence and child sexual abuse.

There are times in which the law protects secrets, such as between a lawyer and client, doctor and patient, or clergy and congregant.  Yet, there are times when the law demands that secret-keepers reveal their confidences such as the increasing demand on doctors to disclose confidential medical information on pregnant women to law enforcement. How should we understand the contours and boundaries of these dynamics within the law?  On one hand, law tends to address secrets through the lens of legal duties to protect the vulnerable via its regulations governing abuse and neglect. On the other hand, this set of laws captures only a small percentage of secrets held by family members and other trusted “secret keepers” (doctors, clergy, extended family, neighbors) who, for a variety of reasons elect not to inform the state.

This roundtable interrogates states’ obligations to protect the vulnerable and at what cost. It considers the ways in which the law promises/owes protection and the success, failure or harms it brings about when endeavoring to intervene and offer protection. Against that backdrop, the law also has the obligation to honor individual and family autonomy and privacy.

Schedule

Read More

Israeli High Court of Justice Allows Sperm Donor to Take Back His Sample

I. Glenn Cohen Leave a comment

As Ha’aretz reports, (H/T Melanie Mader and Nir Eyal) the Israeli High Court of Justice has just decided a fascinating reproductive technology case. As the article reports:

Galit is a 39-year-old single mother who has a three-year-old daughter conceived through a sperm donation. After giving birth, Galit (who preferred that her real name not be revealed) purchased five more samples of sperm from the same donor and paid an annual fee to store them for her. When Galit, who lives in Florida, decided to try to become pregnant again she bought a plane ticket to Israel for that purpose. But one night, she got a surprising phone call. “I was told coldly that the donor had changed his mind. He had changed his lifestyle, become religiously observant and had written a letter to the Health Ministry confirming this. The caller ended by saying, ‘Of course we will return the payment for storing the sperm’ – a small, negligible amount.” At first, Galit continues, “I thought someone was playing a prank on me. I felt that my feelings were being totally ignored. This was about my future children. Maybe I wouldn’t be able to have more children from that donor, and therefore my daughter would not have biological siblings.”

Galit launched a legal battle, which ended two weeks ago with a High Court of Justice ruling rejecting her request to receive the sperm she had paid for. The court found that the donor’s right to change his mind after making the donation takes precedence over the recipient’s right to use the sperm in order to give birth to biological siblings for her daughter.

As it happens, these are the exact issues I wrote about in 2008 in a pair of articles, The Constitution and The Rights Not to Procreate, 60 Stan. L. Rev. 1135 (2008) and The Right Not to Be a Genetic Parent, 81 S. Cal. L. Rev. 1115 (2008). I have yet to get a hold of a translation of the new judgment into English, but from the reporting it seems as though the Court agreed in part and disagreed in part with the analysis I offer in these papers (particularly the latter one):

They agree with me that there is a “Right Not to Be a Genetic Parent” and my argument that it is best conceived of as a right to avoid a kind of emotional distress from what I call “attributional parenthood” — the attribution by oneself, third parties, and/or the resulting child of unwanted parenthood. Where we seem to part ways is that I view this as a right capable of waiver, and argue that it should clearly be waiveable by contract, which there appears to be in this case, while the Israeli High Court appears to treat it more as an inalienable right.

I may have more to say once I’ve read the whole opinion in English, but for now one sociological fact: As Ellen Waldman among others has noted, and born out by my own time teaching there, Israel is an incredibly pro-natalist society that strongly funds and favors the use of reproductive technology and family formation in general. This case is thus interestingly at variance with others the Israeli judiciary has decided in the reproductive technology context, such as the Nachmani v. Nachmani case (involving a dispute over frozen pre-embryos) where the court has been more disposed to favoring the right to be a genetic parent and allowing reproduction despite disputes.

The article reports that Galit will seek rehearing in front of a larger panel of the High Court soon, so perhaps this is not the end of the litigation.

Twitter Round-Up (2/16-2/23)

caseyt Leave a comment

By Casey Thomson

This week’s round-up discusses the upcoming cases relevant to bioethics in the Supreme Court, the benefits of the Physician Payment Sunshine Act, the surprisingly low effectiveness rate of this year’s flu vaccine, and the problems with ACA’s Accountable Care Organizations. See below for details and more summaries:

  • Frank Pasquale (@FrankPasquale) shared a post on what’s being called the “alcoholism vaccine” being developed at the Institute for Cell Dynamics and Biotechnology at Universidad de Chile. The vaccine, which would have to be administered every 6 months or year, would mimic the alcohol intolerance mutation that prevents the breaking down of acetaldehyde and produces an instant “hangover-type” state. (2/16)
  • Dan Vorhaus (@genomicslawyer) retweeted a timeline from the Center for Law and Bioscience at Stanford Law’s blog giving dates for the upcoming Supreme Court cases relating to biosciences. (2/17)
  • Frank Pasquale (@FrankPasquale) additionally included a piece on the Physician Payment Sunshine Act, a provision of the Affordable Care Act that would “[require] manufacturers of drugs, medical devices and biologics to report the monetary value of gifts and payments to doctors and teaching hospitals on a publicly accessible website.” The author of the piece, a family physician with 15 years of experience, discussed his support for the plan. (2/17)
  • Michelle Meyer (@MichelleNMeyer) retweeted a link explaining the scientific foundations of the Brain Activity Map Project, namely how it aims at “reconstructing the full record of neural activity across complete neural circuits” to better understand “fundamental and pathological brain processes.” (2/18)
  • Arthur Caplan (@ArthurCaplan) posted a news story on police arresting those involved in the illegal harvesting of eggs from women in Bucharest, Romania. The police reports claim that 11 suspects have been implicated in the trafficking, which would harvest the eggs to be sold to Israeli couples with fertility problems. (2/19)
  • Alex Smith (@AlexSmithMD) retweeted a link to his post on asking about a patient’s PPD (preferred place of death), noting that this is not one of the concerns often cited as part of advanced planning procedures. Such a practice was considered “vital” in the UK, in contrast. (2/20)
  • Alex Smith (@AlexSmithMD) shared a link to a post on the blog he co-runs, GeriPal, on “Five Things Patients and Physicians Should Question in Palliative Care and Geriatrics.” The post shares the two lists posted by the American Academy of Hospice and Palliative Medicine (AAHPM) and the American Geriatrics Society (AGS), which Smith claims “provide targeted, evidence-based recommendations to help physicians and patients have conversations about making wise choices about their care in order to avoid interventions that provide little to no benefit.” (2/21)
  • Arthur Caplan (@ArthurCaplan) also included a link reviewing the low effectiveness of this year’s flu vaccine: there was evidence that it was only effective in 56% of the cases, on the low end of the usual 50-70% effectiveness rate. His tweet noted that this was strong evidence in favor of mandating the vaccine for healthcare workers. (2/21)
  • Michelle Meyer (@MichelleNMeyer) posted an op-ed piece by The Wall Street Journal about the problems with Affordable Care Act’s Accountable Care Organizations (ACOs), namely their false assumptions: that success can come without changing doctor behavior, and without changing patient behavior, in a way that will save money. (2/23)

Twitter Round-Up (1/27-2/7)

caseyt Leave a comment

By Casey Thomson

Even the surprisingly resurrected Richard III (on the Twitter-sphere, anyway) appreciates bioethics concerns. Read on to find out more about Richard III’s eagerness for patient confidentiality and other updates in this week’s (extended) Twitter round-up:

  • Stephen Latham (@StephenLatham) included a link to his blog post challenging Andrew Francis’ recent claim that penicillin was the central drug spawning the sexual revolution of the 1960s. While penicillin may have facilitated the widespread acceptance of pre-marital relations, it was The Pill that “translat[ed] that newfound sexual freedom into sexual equality.” (1/28)
  • Dan Vorhaus (@genomicslawyer) posted a summary video regarding the Neanderthal baby story that rocked the internet in the past few weeks, as reported by Taiwan’s Next Media animation. (1/28)
  • Michelle Meyer (@MichelleNMeyer) shared a news report on Israel’s recent admittance to giving birth control to Ethiopian Jewish immigrants, frequently without either consent or knowledge. Concerns first arose after an investigative journalist began to explore why birth rates in the community had fallen so drastically and seemingly inexplicably. (1/28)
  • Arthur Caplan (@ArthurCaplan) linked to a piece explaining the future implications and consequences of the guidance requiring schools to make “reasonable modifications” in order to include students with disabilities in either general athletic programs or provide them with parallel opportunities. The guidance, while a potential huge move forward for individuals with disabilities, nonetheless will be nothing without “tough and honest conversation about financing and revenue – and soon.” (1/28)
  • Michelle Meyer (@MichelleNMeyer) retweeted an article showing the return of the “invisible gorilla” from the 2010 book, but this time in the fake CT scans shown to both expert radiologists and volunteers alike. The gorilla was large in size compared to the typically indicative nodules, and was unmistakably a gorilla, but yet 20 out of the 24 radiologists failed to see the gorilla. It’s a frightening real-life example of what the original study’s jargon terms as “inattentional blindness.” (1/29)
  • Kevin Outterson (@koutterson) live tweeted the Pew meeting concerning new antibiotic development pathways for limited populations. See the string of tweets on his Twitter page for further details of how the meeting proceeded. (1/31)
  • Daniel Goldberg (@prof_goldberg) shared a link describing the first scientific evidence suggesting that doctors can “truly feel” their patients’ pain. The study, done by Harvard researchers, used brain scans to indicate activated regions of physicians’ brains during a simulated interaction with patients. (2/1)
  • Frank Pasquale (@FrankPasquale) linked to a story on the problems associated with over-prescribing amphetamine-based medications, particularly to teenagers and young adults. While focusing on the individual story of an aspiring medical student named Richard Fee, the author delves into the underexposed side effects of often overzealous prescribing and the surprisingly casual attitude that most Americans hold towards this medication. (2/3)
  • Frank Pasquale (@FrankPasquale) also posted a piece inspired by the talk surrounding World Cancer Day on the problems related to cancer treatment in developing countries. Contrary to being solely a problem of so-called developed nations, cancer remains an issue globally – including such cancers that are caused by an infectious agent. Fighting the false notions – that cancer in developing nations is minimal, that it is always not “catchable,” and that enough care (particularly vaccines) is being delivered – is essential to reducing the global inequity in cancer treatment. (2/4)
  • Michelle Meyer (@MichelleNMeyer) retweeted the (supposedly resurrected and technologically adept) Richard III’s tweet regarding publication of details surrounding his newly-identified bones: “Hmmm not so happy about my physical attributes being discussed in public. What happened to patient confidentiality ???” (2/4)
  • Daniel Goldberg (@prof_goldberg) shared a report on a new study that found a correlation between low self-esteem and female body representation and obsession in “chick lit.” The report noted that the results suggested a possible “intervention tool” by having characters seek support from friends and family for such body concerns. (2/5)
  • Michelle Meyer (@MichelleNMeyer) retweeted a graphic eloquently summarizing one of the simplest and most potent arguments in favor of vaccination, and arguably the greater biopharmaceutical industry. (2/6)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

Did Matt Lauer Err by Calling a Negative Test for Down Syndrome “Good News” on the Today Show?

I. Glenn Cohen Leave a comment

A new non-invasive genetic test (using blood draw), MaterniT21 Plus, claims it can detect Down Syndrome at 10 weeks of pregnancy. Matt Lauer, inadvertantly no doubt, stepped into the controversy of genetic testing and abortion during a Today Show segment with two parents who had undergone the testing and had a live reveal of the sex and also the Down Syndrome status of their baby. Lauer referred to the negative Down Syndrome result as “good news” (his exact phrase “Let’s get right to the good news,”) with the mother-to-be saying “[w]e are safe. The baby does not have Down syndrome,” giving rise to controversy among the disability rights community. To be fair, later in the segment there is a discussion of the fact that the couple had stated that should they find out the child had Down Syndrome they would not abort but instead see “specialists” and “get more information.”

A couple of reactions: While I do not think it per se unethical and certainly not illegal (wait did Matt Lauer just make a HIPAA joke on TODAY, that’s a first?!!!) there is certainly something unsavory about having a “Down Syndrome reveal” on live television. I wonder if TODAY would have broadcast the segment if the test was positive and the emotional reaction of the parents had been less warm? Second, I think the dust-up over the “good news” language points to a deeper set of issues. On the one hand, disability rights advocates reasonably chafe on America’s heavily watched morning program hammering home the message that it is “bad news” to have a child with Down Syndrome. On the other hand, this may be an accurate reflection of where we, as a country, currently are on the issue, rightly or wrongly.

Read More

Are You Ready for Some . . . Research? Uncertain Diagnoses, Research Data Privacy, & Preference Heterogeneity

mmeyer 2 Comments

By Michelle Meyer

As most readers are probably aware, the past few years have seen considerable media and clinical interest in chronic traumatic encephalopathy (CTE), a progressive, neurodegenerative condition linked to, and thought to result from, concussions, blasts, and other forms of brain injury (including, importantly, repeated but milder sub-concussion-level injuries) that can lead to a variety of mood and cognitive disorders, including depression, suicidality, memory loss, dementia, confusion, and aggression. Once thought mostly to afflict only boxers, CTE has more recently been acknowledged to affect a potentially much larger population, including professional and amateur contact sports players and military personnel.

CTE is diagnosed by the deterioration of brain tissue and tell-tale patterns of accumulation of the protein tau inside the brain. Currently, CTE can be diagnosed only posthumously, by staining the brain tissue to reveal its concentrations and distributions of tau.[1] According to Wikipedia, as of December of 2012, some thirty-three former NFL players have been found, posthumously, to have suffered from CTE. Non-professional football players are also at risk; in 2010, 17-year-old high school football player Nathan Styles became the youngest person to be posthumously diagnosed with CTE, followed closely by 21-year-old University of Pennsylvania junior lineman Owen Thomas. Hundreds of active and retired professional athletes have directed that their brains be donated to CTE research upon their deaths. More than one of these players died by their own hands, including Thomas, Atlanta Falcons safety Ray Easterling, Chicago Bears defensive back Dave Duerson, and, most recently, retired NFL linebacker Junior Seau. In February 2011, Duerson shot himself in the chest, shortly after he texted loved ones that he wanted his brain donated to CTE research. In May 2012, Seau, too, shot himself in the chest, but left no note. His family decided to donate his brain to CTE research in order “to help other individuals down the road.” Earlier this month, the pathology report revealed that Seau had indeed suffered from CTE. Many other athletes, both retired and active, have prospectively directed that their brains be donated to CTE research upon their death.[2] Some 4,000 former NFL players have reportedly joined numerous lawsuits against the NFL for failure to protect players from concussions. Seau’s family, following similar action by Duerson’s estate, recently filed a wrongful death suit against both the NFL and the maker of Seau’s helmet.

The fact that CTE cannot currently be diagnosed until after death makes predicting and managing symptoms and, hence, studying treatments for and preventions of CTE, extremely difficult. Earlier this month, retired NFL quarterback Bernie Kosar, who sustained numerous concussions during his twelve-year professional career — and was friends with both Duerson and Seau — revealed both that he, too, has suffered from various debilitating symptoms consistent with CTE (but also, importantly, with any number of other conditions) and also that he believes that many of these symptoms have been alleviated by experimental (and proprietary) treatment provided by a Florida physician involving IV therapies and supplements designed to improve blood flow to the brain. If we could diagnose CTE in living individuals, then they could use that information to make decisions about how to live their lives going forward (e.g., early retirement from contact sports to prevent further damage), and researchers could learn more about who is most at risk for CTE and whether there are treatments, such as the one Kosar attests to, that might (or might not) prevent or ameliorate it.

Last week, UCLA researchers reported that they may have discovered just such a method of in vivo diagnosis of CTE. In their very small study, five research participants — all retired NFL players — were recruited “through organizational contacts” “because of a history of cognitive or mood symptoms” consistent with mild cognitive impairment (MCI).[3] Participants were injected with a novel positron emission tomography (PET) imaging agent that, the investigators believe, uniquely binds to tau. All five participants revealed “significantly higher” concentrations of the agent compared to controls in several brain regions. If the agent really does bind to tau, and if the distributions of tau observed in these participants’ PET scans really are consistent with the distributions of tau seen in the brains of those who have been posthumously-diagnosed CTE, then these participants may also have CTE.[4]

That is, of course, a lot of “ifs.” The well-known pseudomymous neuroscience blogger Neurocritic[5] recently asked me about the ethics of this study. He then followed up with his own posts laying out his concerns about both the ethics and the science of the study. Neurocritic has two primary concerns about the ethics. First, what are the ethics of telling a research participant that they may be showing signs of CTE based on preliminary findings that have not been replicated by other researchers, much less endorsed by any regulatory or professional bodies? Second, what are the ethics of publishing research results that very likely make participants identifiable? I’ll take these questions in order. Read More