Admissions and Mental Health

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By Nathaniel Counts

In our legal system, colleges may not make admissions decisions in order to ameliorate historical (or presumably other) inequalities, but may make decisions that take into account the particular situation of the applicant or that strive to create a diverse student body.  Justice Powell rejected the former two goals in Part IV of his Bakke opinion, which went uncontradicted in the Grutter opinion that followed it and, most recently, the Fisher opinion almost exclusively focused on the diversity justification.  Whether or not it appears in court opinions however, the issue of transformative justice is very much at stake – colleges, as the gatekeeper to many of the high honors and offices of our society, can control the distribution of a set of goods to the rising generation and decide how equally they are distributed among certain groups.  Here we will imagine that transformative justice is indeed the goal of affirmative action.

Colleges have two tools by which they can currently select among students based on disadvantage (historical or otherwise).  First, there is the demographic and socioeconomic information disclosed in the application.  Although these questions are optional, for those students who answer the questions, schools may use these answers as signals for disadvantage and take this into account.  Second, there is the essay questions, which frequently ask about an instance in which the applicant overcame adversity.  Here the applicant can demonstrate the degree of disadvantage experienced or explain some more nuanced disadvantage not revealed in the first part.

These two tools are far from perfect, but let us take our imagining further and envision a world in which colleges could accurately determine disadvantage.  If it decides to take on the latter, mental health may pose an insurmountable problem – individuals with intellectual disabilities may not be able to thrive in the setting offered by the institutions that select them.

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Smoke and Mirrors and Women, Oh My

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[Guest post by Katherine L. Record, JD, MPH, MA]

Last week the Supreme Court attracted lots of attention when it heard arguments about whether a corporation can exclude mandatory preventive benefits from its employee health plan, based on a religious objection to certain types of healthcare.  This is a tale as old as time; religion has long been the basis for opposition to reproductive (i.e., women’s) health – including the preventive healthcare now in question, contraception.

Yet this argument has nothing to do with government infringement on the practice of religion.

In fact, the corporation, Hobby Lobby, covered two of the four contraceptive devices in dispute until its lawyers were actually arguing the issue in court, apparently to little detriment to the company’s faith in God.  What’s more, Hobby Lobby’s 401(k) includes more than $73 million invested in the companies that produce these objectionable contraceptives (e.g., intrauterine devices, emergency contraception).

This has not stopped Hobby Lobby from arguing that the Affordable Care Act (ACA) is threatening its freedom, as a corporation, to practice religion.

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Is Medicare’s System for Challenging Coverage Determinations Unintentionally Unfair?

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On March 25, Susan Jaffe published a blog post in the New York Times about Medicare’s recent change to cover skilled therapy (e.g. physical therapy, nursing care) where it is “reasonable and necessary” maintain a patient’s condition and to prevent deterioration, even when it is not likely that the patient will improve. Jaffe notes that the revisions will likely have a substantial impact on thousands of Medicare beneficiaries even though the change has been largely unnoticed.

The revision highlights a potential problem with the system in place for challenging Medicare coverage. The revision itself is unremarkable, reflecting what national Medicare policies professed, but what local contractors sometimes ignored. What is remarkable is the time it took for Medicare to make the revision, from when the controversy appeared to when Medicare posted the change in its manuals. This delay is problematic because it reflects a dichotomy in how coverage decisions are challenged and changed under Medicare – due not to medical necessity but to political and financial circumstances beyond patient control.

Constituents can change Medicare coverage policies through two processes. One is through the litigation system. Judges can overturn Medicare coverage decisions after patients have exhausted Medicare’s internal adjudication process. Yet, litigation can take years and judges usually defer to Medicare’s judgment. National Coverage Determinations (NCDs) provide an alternative under which constituents can encourage Medicare to reconsider or overturn a prior coverage decision. NCDs supersede Local Coverage Determinations (LCDs) – coverage decisions that affect a region of the United States. When Medicare determines that the LCDs for a specific technology or service are “inconsistent or conflict with each other to the detriment of Medicare beneficiaries,” Medicare can decide to issue an NCD to provide uniform coverage.

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Liveblog of 4/2 panel on Hot Topics in European Bio-Patent Law, Part IV

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By Nicholson Price

Finishing up the event today is Tom Kowalski from Vedder Price, giving a US perspective on section 101 on patentable subject matter.  This post will encompass his presentation and general questions afterward.

Kowalski starts with a brief review of patentable subject matter, and states his view that after Prometheus and Myriad, “the fabric of the patent system has been torn.”  His view is that isolated DNA is a separate chemical entity, and that the Supreme Court simply got it wrong.  Read More

Liveblog of 4/2 panel in European Bio-patent Law, Part III

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By Nicholson Price

Third up is Dr. Maaike van der Kooij, discussing medical use claims at the EPO.

In general, methods of medical treatment aren’t patentable under Art. 53(c) of the EPC, but the way around is to claim a relevant product either for medical use (if the substance is known but not medically used (Art. 54(4)) or for a specific medical use (Art. 54(5)).  (From my point of view, this seems like another way that the EPO is trying to address its innovation mandate by working around what appears to be pretty clear language in the EPC, a pattern which we certainly see in the US in both PTO and Federal Circuit practice). Read More

Liveblog of 4/2 panel on Hot Topics in European Bio-Patent Law, Part II

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By Nicholson Price

Next up is Dr. Anja Schmitt, comparing Myriad and Mayo to EPO practice, and describing gene patents and diagnostic method patents in the EPO.

Human gene patents

The basic question of human gene patents–as will be familiar to those who followed the Myriad litigation–is whether isolated DNA is a product of nature/mere discovery, or a man-made product with technical character.  In the Myriad case, claims covered isolated DNAs for the BRCA1 and BRCA2 genes which are useful for identifying a predisposition to breast cancer.

At the EPO, on the other hand–using the same sources of law as Dr. Nichogiannopoulou mentioned before–genes are patentable as long as they disclose the industrial applicability and the function of the gene and/or its encoded protein. Read More

Liveblog of 4/2 panel on Hot Topics in European Bio-Patent Law, Part I

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By Nicholson Price

I’ll be liveblogging today’s panel on Hot Topics in European Bio-Patent Law (co-sponsored by the Broad Institute), with several guest speakers from the European Patent Office (EPO).

Ben Roin, Heiken Assistant Professor of Patent Law here at HLS, is moderating.  Speakers will be Dr. Aliki Nichogiannopoulou on stem cells, and Dr. Anja Schmitt on gene patents, Dr. Maiake van der Kooij, all of the EPO, followed by Tom Kowalski of VedderPrice.

Dr. Nichogiannopolou begins by talking about stem cells, and opens with a few background points about the EPO.  The agency has its own implementing legislation separate from the EU, and includes 38 member states – 10 more than the EU itself, including industry-important Switzerland.  The EPO supports innovation, competitiveness, and economic growth for the benefits of European citizens, and has the mandate to grant European patents for inventions. Read More

Introducing Student Contributor Elizabeth Guo

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Elizabeth Guo is a first year student in the JD/MPH Program at Harvard Law School and the Harvard School of Public Health. Her interests lie at the intersection of law, health care reimbursement, and biopharmaceutical regulation. Elizabeth graduated from Harvard University with a BA in social studies, focusing on the bioethics of assisted reproduction in China. Prior to law school, she was a senior associate at Avalere Health, working with life science clients on a range of health policy topics, including Medicare coverage and reimbursement, biosimilar regulation, and healthcare quality programs. Elizabeth is a student editor of the Journal of Law and Technology and a member of the Mississippi Delta Project’s Food Policy Initiative.

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Japanese Whaling and the International Court of Justice

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Yesterday, the International Court of Justice ruled that the Japanese government must halt its whaling program in the Antarctic pursuant to its obligations under the International Convention for the Regulation of Whaling.

At issue in this case was Article VIII of the Convention, which allows a member state to issue permits authorizing the killing of whales when it is done “for purposes of scientific research.”   (Commercial whaling has been prohibited since the International Whaling Commission, which implements the Convention, adopted a moratorium in 1982).

Under the Article VIII exception, Japan had established a research program that issued permits for the lethal sampling of Antarctic minke whales, fin whales, and humpback whales.  The program was meant to serve four research objectives: monitoring of the Antarctic ecosystem, modeling competition among whale species and future management objectives, elucidating temporal and spatial changes in stock structure, and improving the management procedure for Antarctic minke whale stocks.   Under the program, Japan had set a kill target of 850 minke whales, 50 humpback whales, and 50 fin whales.   Most of the whale meat from the hunts was sold in Japan, where it is considered a delicacy.

Australia brought suit against Japan in the International Court of Justice, alleging that its program simply cloaked commercial whaling in the veil of science, and the Court agreed.  It is worth noting, however, the Court did not base its decision on a rejection of the scientific merit of the program’s objectives or methods.  (On this score, it held that the program could “broadly be characterized as ‘scientific research” and that lethal methods of sampling could be justified).  Rather, the Court based its decision on its determination that the permits were not issued “for purposes” of scientific research. Read More