The Impact of Broccoli II and Tomato II on European patents in conventional breeding, GMO’s and Synthetic Biology: A grand finale of a juicy patents tale?

I am pleased to announce our recent paper entitled “The Impact of Broccoli II & Tomato II on European patents in conventional breeding, GMO’s and Synthetic Biology: The grand finale of a juicy patents tale?”, which is available on SSRN, and forthcoming in Biotechnology Law Report, Vol. 34, Number 3 (June 2015), pp. 1-18.

Our analysis deals with a seminal judgment on the controversial and sometimes even emotionally debated European “Broccoli” and “Tomato” patents, which has captivated the European patent and plant science communities for many years: On March 25, 2015, the EBA of the European Patent Office (EBA) finally issued its much awaited decisions on the consolidated referrals G2/12 (“Tomato II”) and G2/13 (“Broccoli II”), clarifying the exclusion from patentability of essentially biological processes, such as conventional crossing and selection, and in particular its impact on the patentability of claims for products resulting from such processes. The so-called “Tomato II” case concerned an invention entitled “method for breeding tomatoes having reduced water content and product of the method,” whereas the so-called “Broccoli II” case involved an invention of a “method for selective increase of the anticarcinogenic glucosinolates in brassica species”. Continue reading

Mini-conference on antibiotic incentives

If you will be in DC on Thursday, we have a great meeting about economic incentives for antibiotic innovation. Location is Capitol Hill. Register here.

Panelists include Rep. Peter Roskam (House Ways & Means), Sir Jim O’Neill, head of the UK AMR Review, Dr. Susan Coller Monarez, National Security Council and Christine Ardal, coordinator of WP2 (economic incentives) in DRIVE-AB.  I will present the first look at the long-awaited Chatham House report.

@koutterson

The Undue Burden Test in Texas Abortion Clinic Regulation

by John A. Robertson

[also published on Balkinization]

The Fifth Circuit decision in Whole Women’s Health v. Cole upholding Texas’ law requiring all abortions, including medication abortions, to be performed in a licensed ambulatory surgical center (ASC) by doctors with admitting privileges at nearby hospitals seems outrageous on several counts.  It defies a medical consensus that abortions performed in physician’s offices or licensed outpatient clinics are exceptionally safe.  With the risk of death less than 1% nationally and even lower in Texas, first trimester and many early second trimester abortions simply do not need the extensive sterility precautions and other operating room requirements needed for more invasive procedures. Indeed, colonoscopies, which have a higher morbidity and mortality rate, are permitted in non-ASC settings.

Nor does the admitting privilege requirement appreciably add to safety.  With hospitalists currently taking over care of most patients admitted to hospitals, the same doctor often does not provide both outpatient and hospital-based care, and emergency room doctors are trained to respond to any emergency.  Nor are admitting privileges necessarily an indication of a doctor’s clinical competence.  They are denied or awarded on many grounds unrelated to competency, i.e., likely frequency of future admissions, and thus do not usually impact the quality of outpatient care. Continue reading

How law professors helped the Supreme Court understand the Affordable Care Act

By Rachel Sachs

[Originally published on The Conversation].

In March, the Supreme Court heard oral arguments in King v Burwell, a case that could broadly impact the functioning of the Affordable Care Act (ACA). The central question in King v Burwell is whether the federal government may provide subsidies for citizens to purchase health insurance on exchanges that were established by the federal government, rather than by their own state. If the court rules for the government, these subsidies will remain in place. If the court rules against the government, subsidies may no longer be provided to people living in states that have not established their own exchanges.

A decision is expected by the end of June, and a ruling against the government could harm not only the 6.4 million people receiving these subsidies, but also the individual insurance markets in the 34 states that have not established their own exchanges. These markets would likely descend into an actuarial “death spiral,” in which healthier people exit the market in cycles, leaving sicker patients to pay ever-higher premiums. Continue reading

The South Dakota Effect: A Potential Blow to Abortion Rights

By Alex Stein

Many of us are familiar with the “California Effect.” California’s hydrocarbon and nitrogen oxide emission standards for cars are more stringent than the federal EPA standards and more costly to comply with. Yet, California’s emission standards have become the national standard since automobile manufacturers have found it too expensive to produce cars with different emission systems – one for California and another for other states – and, obviously, did not want to pass up on California, the biggest car market in the nation.

Such regulatory spillover may also occur in the abortion regulation area as a consequence of the legislative reforms implemented by South Dakota and thirteen other states. These reforms include statutory enactments that require doctors to tell patients that abortion might lead to depression, suicidal thoughts and even to suicide. Failure to give this warning to a patient violates the patient’s right to informed consent and makes the doctor liable in torts. Continue reading

Frozen Embryo Disputes and Unwanted Parenthood

By David Orentlicher

[cross-posted at HealthLawProfs blog and orentlicher.tumblr.com]

For the second time, a state court of appeals has given a woman permission to use frozen embryos over the objections of her former partner who supplied the sperm. In both cases, the new one from Illinois, the previous one from Pennsylvania, cancer chemotherapy left the women infertile and therefore unable to create new embryos with another man.

The results seem reasonable. As a general matter, courts have not been willing to impose unwanted parenthood on people who participate in the creation of frozen embryos via in vitro fertilization (IVF). However, when the frozen embryos provide the only chance for one of the embryo creators to have a genetically-related child, the desire of one person to have a child can trump the desire of the other person not to have a child. Continue reading

Ariosa v. Sequenom Invalidates the Non-Invasive Prenatal Testing Patent

On Friday, the Court of Appeals for the Federal Circuit affirmed the district court’s judgment of invalidity of several claims in Sequenom’s diagnostic method patent on the grounds that they were not directed to patent-eligible subject matter under the relevant section of the Patent Act, 35 U.S.C. § 101.  The case, Ariosa v. Sequenom, is important not only to those who have been following the recent back-and-forth between the Federal Circuit and Supreme Court on patent-eligible subject matter, but also to those who study medical innovation, as it implicates questions of innovation incentives and of access to an important new technology.

The case involves a technology known as non-invasive prenatal testing, or NIPT.  Previously, pregnant women seeking to determine whether their fetuses possessed particular genetic abnormalities only had the option to undergo procedures, like amniocentesis, which pose a risk to the developing fetus.  The scientists in this case made a startling discovery: there is a small amount of fetal DNA circulating in the pregnant woman’s plasma and serum.  These portions of maternal blood samples had previously been discarded as medical waste, and the idea that genetic abnormalities could be discovered through a non-invasive procedure like a blood draw, which poses no risk to the health of the fetus, was groundbreaking.  A patent on the method of detecting the fetal DNA in the mother’s serum or plasma was obtained, and Sequenom commercialized a test to practice the patent.  Sequenom was soon embroiled in litigation with Ariosa and other companies which it believed were infringing its patent.

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Black Lives Matter To Human Research–Lessons From ‘On The Run’

On-the-Run-w-GoffmanIn her recent publication, On The Run, University of Wisconsin sociology professor, Alice Goffman writes about embedded research from 2002-2007 in a “ghetto” community she names 6th Street (located in Philadelphia).  The African American residents of this community are mostly poor and tethered to the  criminal justice system as parolees, on probation, and in and out of jail.  Goffman’s human research subjects comprised the jailed, imprisoned, and minors–IRBs generally describe these populations as “vulnerable.”

On The Run is hailed as original, creative, and transgressive because of Goffman’s lengthy stay in such a descriptively chilling, dangerous, and Black neighborhood–where frequent gun battles teach kids to dive for cover, the women are teen mothers or crack addicted, and law enforcement incessantly polices the community. Indeed, she moves into the neighborhood and lives with three of the 6th Street boys.  Much could be gained from documenting the challenges in such a community, particularly given the troubling patterns of mass incarceration in the U.S.  However, the book raises questions about what represents credibility, quality, and rigor in social science research; the book lacks an index, bibliography, and meaningful citations.  I write about these concerns and more in a forthcoming Texas Law Review essay, which can be found here.

Reviewers lauded the rigor and ignored ethics of the book, agreeing with Goffman’s Princeton advisor, Professor Mitchell Duneier, and his NY Times assessment that  “[t]he level of immersion is really unusual,” because “[s]he got access to the life of the ghetto and came to understand aspects of it we don’t ever get to see.”  Yet, therein resides a significant problem. Fascination with the ghetto and perceptions that life in inner-cities is so bad that researchers can’t possibly expose those human subjects to risks and harms may have blinded the book’s many reviewers to the fact that Black lives matter, including in human research.  It might have also implied a lower standard for rigor; it is rare that an academic book lacks a bibliography and index.  Goffman also destroyed her field notes. These concerns becomes starkly relevant when she writes about her desire and collaboration with “Mike” to kill a man from the neighboring 4th Street.

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Check out the latest news from the Petrie-Flom Center!

Check out the June 12th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:

NOW HIRING!

Petrie-Flom Center/Harvard Catalyst Fellow in Clinical Research Ethics

This is a newly created full-time position for a post-doctoral employee fellow in clinical research ethics to support the work of the Petrie-Flom Center at Harvard Law School in its collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst, Harvard’s Clinical and Translational Science Center. The fellow must have strong knowledge of clinical research and its regulation, with particular interest in the regulatory, ethical, and practical aspects associated with recruitment and retention of research participants. The position will provide the opportunity to interact with a wide range of stakeholders, such as IRB members, administrators, investigators, institutional leadership, patient advocates, and other community members. This position allows for a maximum of 10% effort in furtherance of the fellow’s own research agenda(s) in related fields. Illustrative projects include the following:

  • Defining the clinical trials recruitment problem, including cataloguing various barriers to recruitment, outstanding data needs, and possible solutions, and developing a research agenda
  • Evaluating whether there are ways to prioritize trials and allocate research participants as a scarce resource
  • Considering innovative trial designs as a potential mechanism to address the recruitment problem
  • Developing a recruitment/retention toolkit to help investigators develop successful recruitment/retention plans
  • Addressing the proper parameters of remuneration to subjects
  • Developing surveys to learn more about participant motivations, expectations, and concerns
  • Conducting additional empirical research to develop knowledge that can improve clinical trial recruitment/retention

For more information and to apply, view the full job description!

For more on news and events at Petrie-Flom, see the full newsletter.

Let’s Stamp Out Perversion

A cross-posting by Senior Fellow Amanda Pustilnik, which first appeared on the Cato Unbound Blog.

The civil commitment of sexually violent predators (SVPs) is designed to protect society’s vulnerable from a group of perverts and monsters. What could be wrong with this? Only everything.

The current SVP civil commitment regime is itself a perversion – of facts, of medical ethics, and of justice. Cato Unbound usually curates excellent debates, representing a range of opinions. But in this case, we contributors, from a spectrum of backgrounds and ideological commitments, all agree: This regime is abominable. Continue reading

A Test For Overpayment Liability

By Zack Buck

The eyes of practitioners, compliance officers, and providers have been trained on the Southern District of New York as many await a decision on a motion to dismiss in Kane v. Continuum Health Partners, No. 11-2325. Kane has grabbed recent attention because of what it could represent: a new era in fraud enforcement.

The facts are straightforward. Throughout 2009 and 2010, three hospitals operating under the Continuum Health Partners umbrella (which is now Mount Sinai Health System) submitted erroneous Medicaid claims seeking reimbursement due to what has been described as a “computer glitch.” The New York Comptroller’s Office notified Continuum of the incorrect claims in the fall of 2010, and Continuum launched an internal investigation.

Relator Robert Kane was asked to investigate any erroneously submitted claims. By early 2011, he had created a spreadsheet containing around 900 claims he thought were erroneously submitted. He emailed the spreadsheet to superiors on February 4, 2011. On February 8, 2011, Kane’s employment was terminated.

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‘The Week in Health Law’ Podcast

By Nicolas Terry

twihl 14x14

This week we are joined by Leslie Francis for a wide-ranging discussion of Privacy, Big Data and EU Law. Check out some of Leslie’s publications here and here.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy.

Subscribe at iTunes, listen at Stitcher Radio and Podbean, or search for The Week in Health Law in your favorite podcast app.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Marriage Equality, Health, and Life Extension

Health care analysts have long studied the effects of relationships on health, e.g., married men live longer than unmarried.   Professor Debra Umberson, a sociologist at the University of Texas Sociology Department has researched deeply into these issues.  She opened my eyes recently with insights as to how denial of marriage equality is a public health hazard because of the beneficial effects of marriage on health and life extension.

Here is a link to her Huff Post essay on this topic and a word version of the same:

http://sites.la.utexas.edu/mharp/2015/06/09/one-benefit-to-same-sex-marriage-that-nobody-is-talking-about/

 In Sickness As In Health

As the U.S. Supreme Court decides whether the Constitution requires recognition of same-sex marriage, many have speculated about the real-world consequences of marriage equality.  On at least one front the answer is clear.  Extending marriage rights to same-sex couples will improve the nation’s health. Continue reading

How Institutional Review Boards Can Support Learning Health Systems While Providing Meaningful Oversight

This new post by Mildred Solomon appears on the Health Affairs Blog as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

Increasingly, health systems are studying their own practices in order to improve the quality of care they deliver. But many organizations do not know whether the data they collect at the point of care constitutes research, and if so, whether it requires informed consent. Further, many investigators report that institutional review boards (IRBs) place unreasonable burdens on learning activities, impeding systematic inquiry that is needed to enhance care.

As a result, some commentators have argued that our human research participant protection regulatory framework needs a dramatic overhaul. Yet, it is not the regulations that must change.

Instead, IRBs should educate themselves about quality improvement and comparative effectiveness research, exempt studies that qualify for exemption, and provide waivers to informed consent, when that is appropriate. At the Department of Health and Human Services, the Office for Human Research Protections (OHRP) must clarify the regulations that have an impact on this type of research, create better guidance about how IRBs should regulate such research, including illustrative case studies to guide IRBs.

Read the full post here.

Of Competence and Referrals: When a Doctor’s Failure to Refer a Patient to another Physician Constitutes Malpractice?

By Alex Stein

Four days ago, the Supreme Court of South Dakota delivered an important decision on when a physician’s failure to refer a patient to another doctor constitutes malpractice. St. John v. Peterson, — N.W.2d —- (S.D. 2015), 2015 WL 3505401. This decision hides in the Court’s rulings on the admissibility of evidence, and so it’s important to give it the publicity it deserves.

The Court decided—correctly, in my opinion—that a physician has a duty to refer her patient to another doctor when she is not competent to carry out the procedure the patient needs or when the referral is part of the customary practices and protocols followed by her peers. The availability of other, more experienced, better skilled and better performing doctors is not a good reason in and of itself for imposing a referral obligation on the physician.

The Court had very good reasons for making that decision. Continue reading

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of May. The selections feature topics ranging from the true cost of drug development, to the cost-effectiveness of providing full coverage for preventive medications after a heart attack, to the impact of the FDA’s ban on chlorofluorocarbon albuterol inhalers on out-of-pocket costs faced by patients with asthma.  A full posting of abstracts/summaries of these articles may be found on our website.

  1. Avorn J. The $2.6 billion pill–methodologic and policy considerations. N Engl J Med. 2015 May 14;372(20):1877-1879.
  2. Iglehart JK, Sommers BD. Medicaid at 50–from welfare program to nation’s largest health insurer. N Engl J Med. 2015 May 28;372(22):2152-2159.
  3. Ito K, Avorn J, Shrank WH, Toscano M, Spettel C, Brennan T, Choudhry NK. Long-term cost-effectiveness of providing full coverage for preventive medications after myocardial infarction. Circ Cardiovasc Qual Outcomes. 2015 May;8(3):252-259.
  4. Jena AB, Ho O, Goldman DP, Karaca-Mandic P. The Impact of the US Food and Drug Administration Chlorofluorocarbon Ban on Out-of-pocket Costs and Use of Albuterol Inhalers Among Individuals With Asthma. JAMA Intern Medicine. 2015 May 11. [Epub ahead of print]
  5. Kornfield R, Alexander GC, Qato DM, Kim Y, Hirsch JD, Emery SL. Trends in exposure to televised prescription drug advertising, 2003-2011. Am J Prev Med. 2015 May;48(5):575-579.
  6. Lexchin J. Health Canada’s use of its priority review process for new drugs: a cohort study. BMJ Open. 2015 May 11;5(5):e006816.
  7. Sarpatwari A, Avorn J, Kesselheim AS. Progress and Hurdles for Follow-on Biologics. N Engl J Med. 2015 May 6. [Epub ahead of print]

FDA’s Non-Response Response to My New York Times Op-Ed on Gay Blood Ban

On May 21, along with my frequent co-author Eli Adashi, I published an op-ed in the New York Times raising some questions about FDA’s proposed guidance recommending a ban on taking the blood on any man who has had sex with another man in the past year, or in other words imposing a one year celibacy requirement on gay men if they want to donate blood. This built on our critique last July in JAMA, wherein we argued that FDA’s then-lifetime ban on gay men and MSM donating blood was out of step with science and the practice of our peer countries, as well as potentially unconstitutional.

Thanks to our work, and a concerted effort by public health, medical, and gay rights groups, FDA has finally moved off of that prior policy and recognized that it was unjustified, and discriminatory.

Just to put this in context It took more than 30 years to convince FDA that it was problematic to ban blood donation for a lifetime any man who ever had sex with another man, even if both have repeatedly tested negative for HIV, while it imposed only a one year ban on people who had sex with individuals known to be HIV positive or a sex worker. FDA is appropriately a conservative agency, but on this issue of the lifetime ban its willingness to listen and reconsider has gone beyond conservatism to the point of lunacy. [By the way to be clear, I *love* FDA. I represented them while at the DOJ and have a new book coming out about FDA in the fall. You can think highly of an agency but think they have a bad track record on an issue. This is critique not hater-aide].

Well with that background, one should be not so quick to assume that a move to a one year ban — a de facto lifetime ban for any gay man who is sexually active, even one who is monogamously married with children — is the best policy. To put it bluntly, refusing to change a lifetime ban for such a long period makes me skeptical we should accept a “just trust us” line on their new restrictive policy.

The question we raised in our op-ed was whether FDA had adequately justified retaining a one year ban in light of the evidence from places like South Africa (with a much shorter time period ban), Italy (which does individualized risk assessment instead of stigmatizing all gay men as high risk for disease), etc.

Well FDA responded…sort of … through a NY TImes Letter To the Editor.

Here is what FDA said with my analysis in bold:

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Who needs to be involved in creating community health?

A slew of organizations, including most notably the Robert Wood Johnson Foundation, are talking about creating a “culture of health” as a new way forward in US health policy. The underlying thinking assumes that legislative fixes, including the Affordable Care Act, will continue to be vehemently fought if attitudes towards health do not in some ways fundamentally change. Inherent in the idea of building a culture is incorporating unconventional actors and voices into discussions about how to improve outcomes at a local level. This has led public health strategists to ask new questions about who to involve in community health building efforts with an eye towards employers, small businesses, social service organizations and community institutions.

With this in mind, I recently spoke with Peter Doliber, Executive Director of the Alliance of Massachusetts YMCA about how he sees the Ys fitting into a plan to create health. His background is in public health and hospital administration, having worked in a range of communities to develop programs that increase access to health care, improve health outcomes and create a return on investment. Here’s an abbreviated version of our conversation.

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Surrogacy, Israel, and the Nepal Earthquake

The Nepal earthquake has shocked with the devastation and suffering inflicted on a long suffering people.  Foreigners in Nepal were also affected, but most of them will be able to leave and carry on their lives without the poverty, housing, and health care deficits the Nepalese will be dealing with for years.  One sub-group of foreigners were Israelis awaiting the birth of children carried by Nepalese surrogates or the legal papers needed to bring home those infants who had already been born.  They have, of course, no moral priority over others hit by the earthquake, but their situation shines yet another light on the complexities of national surrogacy policy and surrogacy tourism.

Nepal has become a major surrogacy destination for Israelis who because they are unmarried or gay cannot obtain surrogacy in Israel.  India and Thailand had been the prime choice for surrogates, but those countries two years ago restricted surrogacy to married couples.  Indian women already pregnant with children commissioned by unmarried persons then went to Nepal to give birth.   With surrogacy available in Nepal for $30,000-$50,000, rather than $150,000 in the United States, Israeli surrogacy agencies started arranging surrogacy births there, even while Indian rather than Nepalese women are usually the carriers. Continue reading