Cloning, Stem Cells, & Genes
Diamond v. Chakrabarty

Claim to determine whether a live, human-made micro-organism is patentable
o Bacteria that breaks down multiple components of crude oil

Three Types of Patent Claims
o 1) Process claims for the method of producing the bacteria
o 2) Claims for an inoculum comprised of a carrier material floating on water, such as
straw, and the new bacteria
o 3) Claims to the bacteria themselves
o First 2 claims allowed, third was not
 2 reasons why third wasn’t allowed were


1) Micro-organisms are “products of nature”
2) As living things they aren’t patentable subject matter

Issue  Whether respondent’s micro-organism constitutes a “manufacture” or
“composition of matter” within the meaning of the statute?

Manufacture – The production of articles for use from raw or prepared materials by giving
to these materials new forms, qualities, properties, or combinations, whether by hand-labor
or by machinery

Composition of Matter – All compositions of two or more substances and all composite
articles, whether they be the results of chemical union, or of mechanical mixture, or
whether they be gases, fluids, powders or solids.
o Court believes these were meant to be read broadly

The laws of nature, physical phenomena, and abstract ideas have been held not
patentable
o A new mineral discovered in the Earth or a new plant found isn't patentable
o In the same way Einstein couldn’t patent E=mc^2

Court  micro-organism qualifies as patentable subject matter judging in by this
o Micro-organism is a non-occurring manufacture or composition

Two Arguments Petitioner Uses that Court Finds Non-Persuasive
o 1) The passage of the Plant Patent Act and Plant Variety Protection Act
evidences congressional understanding that the terms “manufacture” or
“composition of matter” don’t include living things; if they did neither Act would have
been necessary

Relevant distinction isn't between living and inanimate things, but rather
between products of nature and human-made inventions, living or not
o 2) Micro-organisms can’t qualify as patentable subject matter until Congress
expressly authorizes such protection
 Congress performed its constitutional role in defining patentable subject
matter, now the court must construe that language

A rule that unanticipated inventions are without protection would conflict w/ the core
concept of the patent law that anticipation undermines patentability
 Ruling  Affirmed, it is patentable
Biogen v. Medeva

Patent at issue is for an artificially constructed molecule of DNA carrying a genetic code
which, when introduced into a suitable host cell, will cause that cell to make antigens of the
virus Hepatitis B
o Filed for patent in 1978

∏ sued ∆ in 1992 for infringement on a hepatitis B antivirus similar to ∏’s
o ∆ said the patent was invalid for the following reasons:
 1) the claimed invention was obvious
 2) ∏ wasn’t entitled to the priority date b/c it didn’t support the invention



claimed in the patent
3) the claimed invention wasn’t an invention
4) the description in the specification was insufficient
Discussion
o A lot turns on identifying the “inventive step” by ∏
 Sometimes this step can just be using something already around for a
purpose which it has not been used for before
o Patentable Invention 
 Patent may be granted only for an invention in respect of which the following
conditions are satisfied:




1) the invention is new
2) it involved an inventive step
3) it is capable of industrial application
4) the grant of a patent for it is not excluded by subjections (2) & (3)
 Holding - Patent is invalid due to obviousness
Class Notes 1/18
Cloning & Stem Cells

Look to nature of thing being protected and how you protect it’s use

Organism in Chakrabaty was world’s first genetically designed organism by man
o When he applied for patent, didn’t just apply for patent, had to apply everywhere b/c
patents are territorial
o British Patent office got it at the same time as USPTO
 Response b/w the two was very different
 US had huge issue with is, went to SCOTUS
 Britain just said it was OK to patent, no appeal
o Why is it such a big issue?

Could be concerned w/ patenting higher life forms
 13th Amendment protects human life forms from being patented

Concerns about the environment - Harvard Mouse Case


too easily, so wouldn’t help with cancer research
Must also look to whether it is immoral


Mouse wasn’t a useful invention at all b/c possibility it would get cancer
Whether we create a “parade of horribles”  mutant creatures
Dolly vs. Chakrabarty Bacteria
o Dolly cloned w/ mammary gland, not embryo splitting (natural cloning/twin)
o Embryo splitting is less patentable than mammary gland, why?
 Possibly b/c one happens naturally, other is a process manufactured
 Most patents are inanimate objects, they don’t reproduce themselves and
there are no changes that can happen naturally, this is different from
biological patents
 What if we made the mouse susceptible to cancer and it bred with
something else and on and on until humans were more susceptible to
cancer?

UPOV, Plant Variety Protection Act says that it must not be naturally
occurring but must be a stable plant and not one that is going to die
immediately and be used for nothing
o What is big issue if we allow embryo altering and mammogram altering?
 Much easier to control what you create with mammary gland, the embryo you
cannot control, you are changing the organism itself and changing the
environment

Cripps  “If you mess around with embryos then you could be messing
around with the entire gene pool, very large consequences”

Because the mammary gland is a sematic cell, it doesn’t alter future
generations because it wont reproduce itself
 If you alter embryo then it has the possibility to significantly and directly
affect future generations
o EU says that they don’t think things that can alter the human gene pool should
be patentable
 Dangerous from an environmental view (technically dangerous), not for
religious purpose of “playing God”
o Both the embryo splitting and the mammary gland are cloning, but the mammary
gland doesn’t require natural process, age, woman, etc.
 All goes back to the point that it wont affect future gene pools
Class Notes 1/25

Patent Requirements
o Novelty
o Non-Obviousness (inventive step)
o Utility

Chakrabarty
o Cut up the cell so that it no longer resembled something that is created in nature
o S/Ct. found that it was now a product of man having been altered by Chakrabarty


Cloning
o Can clone DNA at a low level, or clone an entire organism (Dolly the Sheep)
o What are the arguments for novelty and non-obviousness in relation to a clone in
terms of the patents on the cloning of the entire organism?

Not novel b/c there was already a sheep just like this one
 Could also say she is novel b/c she is the first cloned sheep, but it
looks most like an origin novelty, not the sheep itself
 Important  no problem w/ patenting the process of cloning the
organism, problem is just w/ patenting the organism itself

Sematic Cloning - From a cell that isn't an embryo, such as mammary gland
 Don’t need a creature of reproductive age or even a female
Genetics Issues
o Think about possibility of Article 1st rights  Life, Liberty, Pursuit of happiness; could
this affect that by making it more expensive to get health insurance by people that
are predisposed to genetic abnormalities?
o SCOTUS has ruled that cloning and genetic issues are patent issues
o Whether purification of nucleotide sequence is sufficient for patentability?
 What are “isolation” and “purification” in these contexts?

When you isolate a DNA sequence outside of the purified entity of the human
body, then it is hard to see it having a meaning at all, except for providing
information, and we don’t patent information or ideas
 Cripps - At this level, becomes almost a juris prudential, philosophical
question of “what is it that is actually being protected by IP law in these
cases?” W/ unmodified gene sequences?


What are you protecting w/ unmodified sequences?
o Cant patent characteristics, so what is the meaning of the
sequence?
Only want to give patents when they are limited b/c otherwise it may
limit and hinder innovation and production through competition

Also want limited fees to use the patents
Harvard College v. Canada

Background
o Harvard researchers developed a process by which it could breed genetically altered
mice that would possess a cancer-promoting gene.
o School applied for a patent for genetically altered mice they called oncomouse as
well as a patent for process by which they created oncomice.
o Commissioner of Patents rejected application to patent mice on grounds that higher
life forms were not inventions under section 2 of the Canadian Patent Act
 Defines an invention as any new and useful improvement, in an art, process,
machine, manufacture or composition of matter.

Ruling
o Court found for ∆, ruling higher life forms are not patentable.
o Sole issue before the Court was whether the word “manufacture” and “composition
of matter” found in Patent Act include higher life forms.
o In its analysis, Court found a mouse is not composed solely of matter.
o Higher life forms possess qualities that transcend genetic materials that they were
composed of.
o Court interpreted patenting of such life to be outside of the purpose and
objectives of the Patent Act.
o To read-in higher life into act would be beyond the authority of the Court and would
be a massive change in current patent regime.
o Given significant public policy issues it would be best settled by the legislature. Only
through direct legislation should such an interpretation of the Act be applied.
Greenberg v. Miami Children’s Hospital

Facts
o Doctor was sued for isolating and patenting a gene causing disease (Canavan) from
received tissue and fluids from donors  Found in Chromosome 17  Same as
Myriad
o ∏ thought it would just be used for research purposes to help w/ Canavan
o After gene sequence was identified, w/o ∏’s knowledge, ∆ applied for patent

Ruling
o Court finds no property interest in body tissue and genetic information voluntarily
given to the ∆ by the ∏
o Property rights in blood and tissue samples evaporates when it is voluntarily given to
a third party
Bilski v. Kappos

∏ denied patent application for method of hedging risk in field of commodities trading in the
energy market based on lack of patent-eligible subject matter

Patent Act specifies 4 independent categories of inventions or discoveries
o 1) Processes
o 2) Machines
o 3) Manufactures
o 4) Composition of Matter

3 Exceptions to Patent Act’s Eligibility Principles
o 1) Laws of nature
o 2) Physical phenomena
o 3) Abstract ideas

Even if an invention qualifies as one of the 4 eligible categories, in order to receive
protection, the claimed invention must also be:
o 1) Novel
o 2) Non-Obvious
o 3) Fully & Particularly Described


Patent eligible process may include at least some methods of doing business
Holding  Claimed invention that explained how buyers and sellers of commodities in
energy markets could protect, or hedge, against risk of price change and that reduced this
concept of hedging to a mathematical formula was an “abstract idea” and not patentable
Washington University v. Catalona

∏ bringing claim for donated biological materials against the participants saying that ∏
owned materials and participants couldn’t order transfer of materials to a new University
 Participants had present intent to make a gift of the materials
 Court finds that the donation was an inter vivos gift to ∏
 Release forms signed by participants gave the material away to ∏ and it was ∏’s property
Class Notes 1/30



Videos - DNA & Genetic Proteins  These are same facts as Biogen
With gene splicing, aren’t we all just infringing by “being” b/c we all have the product in us?
What about isolated genes outside of the body that have been spliced?
o These all deal with unmodified DNA
 Method for gene splicing is obvious but even if not then it isn't nearly as controversial
Class Notes 2/1

Big issue of the movies was to show how we can construct things that occur naturally in
nature and therefore looks like Chakrabarty

Prof  If just taking a sequence of interest that we’ve identified and putting a capping
piece on each end isn't sufficient “making” to make it novel and non-obvious, then we must
look for something else to distinguish it from a discovery  What could this be?
Association for Molecular Pathology v. USPTO

∏ to patent isolated DNA containing breast cancer susceptible genes & for methods of
analyzing gene sequences to identify mutations w/ predisposition to breast cancer

Must first see what type of discovery is sought to be patented before you can determine
whether the discovery is new or obvious

Isolated DNA wasn’t patentable b/c it didn’t possess markedly different characteristics than
DNA found in human cells

DNA's existence in an 'isolated' form alters neither this fundamental quality of DNA as it
exists in the body nor the information it encodes. Therefore, the patents at issue directed to
'isolated DNA' containing sequences found in nature are unsustainable as a matter of law
and are deemed un-patentable under 35 U.S.C. §101."

Ct/App  Holdings
o Method claims for comparing or analyzing isolated DNA sequences were not
patentable
Didn’t include step of determining DNA sequence by isolating genes from
blood sample and sequencing them, or any other necessary transformative
step, rather, the comparison b/w sequences could be accomplished by mere
inspection alone
o Method claim for screening potential cancer therapeutics via changes in cell growth
rates was patentable
 This had a transformative step of growing cells in presence or absence of
potential cancer therapeutic and determining cells’ growth rate via physical
manipulation  Not merely abstract scientific principle

Class Notes 2/6

Difference b/w patenting the product and the process

Prof agrees w/ Chakrabarty b/c it was novel/non-obvious, etc.
o But w/ Synthia prof things the process is patentable but maybe not the product
o Synthia had watermarks but that may not be enough
o W/ a product, when it is out in nature already, then we shouldn’t allow patents of that

Chakrabarty Dissent
o Talks about how it is un-patentable b/c Congress has said forms of nature aren’t
o Class and prof think that it should be patentable

Harvard Mouse
o Two Issues  If mouse got out and bred w/ other mice, also that mouse would grow
painful tumors
o Court talks about how it doesn’t want to allow the patenting of whole organisms

Is this right? Prof thinks it is hard to see this as a “whole organism”
 Prof thinks it is better to show that the mouse is more than just the sum
of its parts, that it is rather a personality, etc.  This could show that if
we allow IP protection, is it overbroad?
Class Notes 2/8

Importance of genetic screening w/ healthcare and in terms of cost
o Discussion of breast cancer gene  In regards to Myriad case
o Looking at the distinction b/w how expensive it is to find cancer as opposed to treat it

Are BRCA 1 and 2 different?
o Is one of the claims less defensible than the other in Myriad Case
o If Myriad is a valid claim then “we are all infringing just by living” because we are
using the gene in our own bodies

Where we are sticking is the unmodified nucleotide sequences
o Wouldn’t patenting this be like patenting grass or a mushroom?
o One thing to modify it, but another to patent unmodified
Class Notes 2/13

Myriad
o D/Ct  Isolated DNA sequences are products of nature and therefore aren’t
patentable
o Ct/App 
 1. Method claims for comparing or analyzing isolated DNA sequences are
NOT patentable
 2. Method claims for screening potential cancer therapeutics via changes in
cell growth rates IS patentable
o 1st Amendment Argument
 The limitation on information that is found in the human body
 We don’t allow patenting on information itself, but can patent ways of
displaying and organizing information  Bilski


The “grunt work” is increasingly being protected by IP
After Bilski it seems that we may be able to patent information, this changes
how we can look at this case and patent law
 Argument  Different in human body, outside human body just information,
inside it is something working and much more than info
 Prof  Not any different in or out of human body
o Prof  feels that isolation of insulin was a more real discovery than isolated DNA
 Prof thinks that if Association for Mol Pathology and other ∏s had done the
argument on novelty, non-obvious, utility, they could have won, at least it
would have been more valid than the 1st amendment argument

Dr. Sledge Speaking
o 1 in 5 of the genes in the human genome have been patented
o If you have a BRCA mutation you have a much higher chance of getting breast and
ovarian cancer
o Once you figure out what chromosome the mutation is on, it is all “grunt work”
o Believes every gene in our body is technically owned by Myriad, doesn’t think this
should be allowed, believes that we should be free to know about our own genes
o Difference b/w patent system (rewarding drugs over diagnostics)
o Prof  Believes that modified DNA should be patentable subject matter
 Unmodified gets into trouble w/ novelty, non-obviousness, etc.
Class Notes 2/15

Greenberg case and Myriad both deal w/ Chromosome 17
o Prof thinks this is very interesting b/c
o Racial issues in Greenberg  More Jewish people are prone to Canavan disease
o Think about possible insurance and employment issues for this group


This will be covered later in the course
Importance of depositories of biological tissues in Greenberg and Catalona
o Homologous blood is rare and here you must pay or get insurance to pay
o It is now felt that if you can use your own blood before operations then it will be
highly beneficial for the patient  Can have your own stored blood, but costs more
o Easy to store embryos, cannot store eggs in same way due to reactions to freezing
 Why does it matter sociologically, demographically, legally, that you can
easily freeze a couple’s embryo and sperm but not the eggs?


As women age, their eggs become less viable, but if we cant preserve
them then we are forcing them to risk the egg or have children earlier
Possible to take the nucleus (holds genetic material) from an old
woman into a sturdy outer-cell wall from younger women



Despite the age of the nucleus, the cell will thrive
Issue  Who has property rights in it?
Property Rights
o Moore compared to Greenberg


Can’t have a successful conversion action w/o ownership of property
Moore - Man had surgery on his spleen and they ended up keeping materials

w/o his consent
 Court held no property interest here, when he gave up the tissue he
didn’t know anything about the research value
Greenberg - Patients gave up tissue samples for a study


 Voluntarily given here, so court said there was no property interest
Patent ownership from research is very different from tissue ownership itself
Court in Moore sidestepped the big issue of whether there was proper
consent to give up a property right
 Greenberg also states they aren’t going to go into the property interest
o Prof  Do we have a property in our nucleotide sequences, cell lines, tissue, etc.?
 Issue  Think about unjust enrichment, i.e. if someone took a piece of your
hair or tissue and made a medicine out of it, do you own anything, are they
unjustly enriched?
 Do we abandon our tissue and therefore lost property right?
 Can always think separately about the assault tort if someone were to

take tissue or hair from you w/o your consent
Courts many times will balance the economics and the interests of the
parties  This doesn’t even take into account the conversion tort
Class Notes 2/20

Unjust Enrichment (Moore, Greenberg, Catalona)
o Issue is someone using something you have “sewn” (aka your body) and profiting
from the use of it  Based in equity
o Comparing Moore w/ Greenberg on Equitable Issue


Moore  Turned on informed consent
Greenberg  Turned on unjust enrichment
o Prof  Did Moore court duck main issues by only focusing on informed consent?
 Did Greenberg possibly duck the issue of property interest?
o What about how courts looked into property interest?


In Moore they are less inclined to recognize this interest than in Greenberg
Prof  Can have a central property interest while the same time allowing
people to do things with your property
o Catalona  This case dealt w/ voluntary donation of genetic materials for research
purposes (court found that it was an inter vivos gift by donators)

Policy  Was Catalona simply given possession of the tissues and not a
property interest? (patients still have a property interest)
 “Renewable” argument  Your tissue is constantly being remade,
therefore not giving property interest in that, rather just a temporary

possession  Also could say that you didn’t give a property interest
due to the fact you just gave up a particular “block” and not all of it
Argument of if patients can just “pop up” and ask for their tissue
samples back, isn't this a major policy issue?
 Catalona Court 
o Issues of undue influence in doctor patient relationships w/ donation of tissue
 Prof  Doesn’t think the court would find this so overbearing an influence as
to strike down the contract (would have to be extreme)
o To what extent does the “sweat of the brow” argument go towards the property issue
of you having property interests and economic interests in your cancer tissues
Class Notes 2/27

PDF Article - Disclosure of Individual Genetic Data to Research Participants
o Passive Disclosure - When patient decides whether or not they want the info
 People are autonomous, should be given this information if they want it
 Don’t want to give people this information if they don’t want it (could tell them
about predispositions to certain diseases, some may not want to know)
o Active Disclosure - Automatically giving the patients this information
 Possible burden on research facilities knowing that they must give this info to
all participants
o Issue  Whether or not society should allow contracts around disclosure?
o Bargaining Power
 Clinical studies (being referred by doctor) vs. seeking out paid studies
o Researchers possible overstating benefits of enrollment?
 Researchers’ goal isn't to provide care, rather just to observe data
 Possibly analogy to Moore and Greenberg
 “Truth in advertising”
o Genetic Counseling
 This will release a lot of information that will affect you and relatives



Do we provide counseling? Possible legal and medical liabilities
 Liability of failure to provide appropriate counseling
Possible hindering of the research process, expensive for the research facility
 Facility may not even have means to counsel patients
Could show them that there is a potential problem and then refer them to Dr.
o Costs of Re-Testing
 If you are going to tell someone that they have a genetic disorder, you must
be sure, so would have to retest, this would add large cost on researchers
 Possibly requiring patients to pay for the retesting
o Disclosure Feasibility
 Not necessarily impossible, just may be a time burden on the researchers
 What is “adequate disclosure?”

Cripps - In many cases, patients don’t want to know details about an illness
 Rather just would want to hear what doctor wants to do
o Outside Commercial Gain
 Greenberg and Moore issues


 Unjust enrichment and profit motive of researchers
Should possibilities of such profits alter the view of what is proper to disclose?
What about reciprocity of disclosure, disclosure counting as compensation?
 Reward for participating is learning something about yourself and your
health

Don’t generally go into research in order to figure out about yourself


What about research that studies your own genome?
o Cripps  Possibility that it would skew views on genetic
testing, would get a “different set of customers”
 May not be interested in any other types of
research, but just for this type
 This could make research disproportionate
Class  Want to move away from model of giving information as
compensation for patients
o Doctor Knowledge
 Are we comfortable allowing doctors to have information that patients don’t
know about themselves?
 Class seems to be comfortable with this in certain contexts
o Research vs. Clinical Care
 Blurring b/w research and clinical care, maybe isn't necessarily a bad thing
 Are researchers even able to give clinical care?
 What about patients’ expectations, if they go in as patient and become
research participant, or vice versa


Book Reading - Furrow
o CB Ch. 17  Raises issue of potential damages (Safer & Pack CB 1361)
 Ex CB 1366  Family w/ sickle cell trait
 May and Must the doctor inform the wife?
 May and must he inform the sister?
 Would the doctor be liable in damages if the family later had a baby w/
sickle cell and he had not counseled them?

Possible competing fiduciary doctor/patient confidentiality
requirement by doctor  Wouldn’t have to tell others

HPA doesn’t have specific requirements for disclosure of
genetic requirements
o Possibly b/c when it was drafted we were only first
discovering genome sequencing?
o Original purposes of HPA wasn’t privacy


Safer Holding - 1364
 Duty to warn always satisfied w/ just informing patient
 Pate court says the opposite, not always satisfied
 Cripps - Possibly looking to establishing emergency informing to others
in the case of serious pandemics
Buck & Bell Case  People involuntarily sterilized

Perceived discrimination against African Americans
o CB 1359 - Georgia Statute
 33-54-4  Prohibited Use of Information
 Any insurer that is given information through genetic testing cannot use
it for anything other than therapeutic purposes
 33-54-7  This statute is narrowly tailored to individual health insurance
providers (don’t want people to be denied insurance due to genetic info)
o Summary  Cripps thinks the conclusion of the paper is that it would be wrong to
give no information, but they weren’t in favor of a full-scale duty to disclose
Class Notes 2/29

Bio-banks
o One reason we have these is b/c we want to do genetic testing/screening
o GINA - Genetic Information Nondiscrimination Act
 Genetic discrimination occurs when people are treated differently by their
employer or insurance company because they have a genetic change that
causes or increases the risk of an inherited disorder
 2 parts to GINA

Employment - GINA makes it illegal for employers to use your genetic
information in the following ways:


To make decisions about hiring, firing, promotion, pay,
privileges or terms


To limit, segregate, classify, or otherwise mistreat an employee
It is also illegal for an employer to request, require, or purchase
the genetic information of a potential or current employee, or his
or her family members. There are a few exceptions to when an
employer can legally have your genetic information. If an
employer does have the genetic information of an employee, the
employer must keep it confidential and in a separate medical file.
Insurance - GINA makes it illegal for health insurers to request,
require, or use genetic information to make decisions about:

Your eligibility for health insurance

Your health insurance premium, contribution amounts, or
coverage terms

Consider family history or a genetic test result a pre-existing
condition



Ask or require that you have a genetic test
Use any genetic information they do have to discriminate
against you, even if they did not mean to collect it
What if you are discriminated by an employer or insurer?



No private right of action, requires enforcement by federal gov’t
Great idea, but little in the idea of actual protection
 Federal Gov't is unlikely to look at each cause of action
Exceptions to GINA
 If a medical condition manifests, then nothing to stop insurer from
discriminating in terms of the policy setting

 Only protects against pre-dispositions not manifestations
Can discriminate if it is going to be for the good of the employee


Such as not allowing someone to play in NFL if they have a
predisposition to heart disease
It is ok for employers to have “wellness programs”

This is a “massive exception” b/c employer can discriminate
provided they have a wellness program going on

Particularly if the industry is for the employee’s protection (i.e.
NFL players not playing due to predisposition to heart disease)
Class Notes 3/19

3 Things Affordable Care Act Did
o 1. Extended coverage to people under age of 26
o 2. Created provision whereby you can’t exclude people from coverage due to
preexisting conditions
o 3. Removed position whereby insurance companies had lifetime cap on coverage

Cripps  Feels delays are the biggest problem with public healthcare systems


Large administrative costs in US  Advertising costs for insurance plans
ACA is an interference w/ private system b/c it may affect how much insurance companies
can charge

Why might healthcare not operate very well as a private market?
o People can’t really plan for or decide when and how much to spend on healthcare
 Don’t know when you need healthcare or how much an emergency will cost
o Switzerland has a good model of what the ACA could lead to

Some argue that the answer to prices being so high due to insurance companies interfering,
the answer is to let people pay for the “minor” things and insurance to pay for large things
o Problem  No one will get preventative care, will wait until a large problem
 50% of total US healthcare cost is generated to respond to 5% of US residents
Class Notes 3/21
 Video on Affordable Care Act
Class Notes 3/26

Prometheus
o Case involving medical treatment, SCOTUS decided that patented matters were
products of nature and therefore not novel and inventive
o Going back to Chakrabarty we saw SCOTUS uphold patent b/c the bacteria was
modified by man
o Prometheus - SCOTUS says the patent isn't modified by man
o Court appears to be feeling that they only want to patent what is novel, non-obvious,
products of man, and not products of nature
o Linking of Myriad by SCOTUS in this decision, is a significant signal on how the
court views the Myriad patents  Cripps thinks this isn't revolutionary, rather is just
normal patent law
o Hold  Cannot patent what is made in nature, not inventive
o Cripps  Helps show that in Myriad, unmodified human genes are un-patentable,
but if you modify it then it is highly patentable and inventive

Constitutionality of “Obamacare”
o If SCOTUS were to find Obamacare unconstitutional, do you think the entire
Affordable Care Act would fall or just the part to do with individual mandate?
 Cripps  courts seem to let the consequences follow instead of striking them
down as well
o Cripps  Thinks that it will be voted constitutional b/c republicans are worried about
backlash to things like Citizens United and Bush v. Gore
o How could they debate to legally say the individual mandate is unconstitutional?

1. Is this a tax for purposes of Anti-injunction Act? B/c if so then there is no
standing to sue until the tax has actually been paid by someone



The act is specifically aimed at internal revenue taxation
Cripps  This likely wont cause it to be unconstitutional, this isn't the
type of tax that was meant to be covered by this act
2. Debate of active vs. inactive, such as making people who drive get car
insurance  Don’t necessarily have to drive
 Also w/ mandatory immunizations
 Mandatory selective service registration
o Arguments For & Against Individual Mandate
 For
 1. Commerce clause comes into play b/c we have to regulate it by how
much it costs the country
 Against

1. Commerce clause says that we can’t mandate that people enter into
commerce
Class Notes 3/28

Three Main Things of ACA
o Removal of the insurance lifetime cap
o Extended coverage to under 26
o Removed ban on coverage of preexisting conditions
ORGAN TRANSPLANTS
Class Notes 4/2
Organ Transplants - Furrow Ch. 1, 18

In a background where insurance companies have both lifetime and annual caps, these
transplants can be very expensive
o Some policies have outright exclusions (some say organ transplants are excluded
due to price)
o Nothing stopping us from knowing our genetic makeup, but insurance companies
cant, so what about individualized insurance (“cancer insurance”)

Discrimination based on predisposition to disease in insurance (CB 76)
o Cripps is against this, she thinks these may be the people who need it most
o Perhaps we should make it more affordable for these people?
o CB 81-83  Racial discrimination and insurance selection process
 Even information on how doctors discriminate on how people dressed
 Subconscious reaction to race and other things making discrimination
 This is a big issue with healthcare
o Compare this section to ERISA and Judge Hamilton’s talk

Discrimination against prisoners  Two sides from books CB 76
o Class very divided, Cripps says she would always give the prisoner the organ
o I disagree, I think that you have to look to the other person who may get the organ
o No right answer, always going to be outliers that screw up the makeup of the law

Things to think of when deciding who gets the organ
o Framing things such as whether alcoholism is a disease or lifestyle choice


Big Issue  who will we put in the position to make these decisions
Possibility of increasing # of available organs
o Opt-out instead of opt-in donor system
o Opt-out increases the available organs
o We currently have a national list  What about a state list?
 Could possibly do a comparison if it was a state list b/w two states, one opt-in
and one opt-out and see what works better

Ch. 18 - Definition of Death
o One thing about making more organs available is having to decide that the person is
actually dead before you take the organs (vegetables, etc.)
o Not giving people a full chance to recover in the ER if they are borderline, perhaps
doctors just say that you are gone a lot sooner and therefore let you die
 This would make it so there are more organs, but negative incentive
o Big factor  People not giving full chance to recover from coma or to get full care in
ER b/c someone needs their organ
Class Notes 4/4
Organ Transplants

The hope is that someday we won’t need organ transplants from human beings to have
viable organs, rather possible synthetic organs
NOTA - National Organ Transplant Act - CB 78


Made a national organ transplant list and made it illegal to sell organs
Good that we did it on the national level, if we did it on state then it could make a surplus in
that state or some sort of state competition

UNOS - United Network of Organ Sharing - CB 76
o This is the national list that helps organs go where they need to

How does it work?
o Initially the doctor decides whether a transplant is medically necessary
o Must have either pre-approval insurance or your own $ to actually get on the list
o Issue  Should we just say Medicaid & medicare shouldn’t cover organ transplants
 Cripps  Medicaid and medicare are going to cover less
Class Notes 4/9

Presumed consent w/ organ donation  Same result but aren’t we possibly being more
limited in our freedom b/c you didn’t have chance to “check the box” and opt-out?
o Must give people information and only then allow them to opt out
o Presumed consent could also give a problem w/ procedural due process
 Newman case in CB
o Arguments
 For - Get more organs
 Against - Imposes on liberty, “sneak taking”
o Examples of State and Federal opt-out systems (not w/ organs tho)
 Some states have presumed consent w/ some organs, but not all organs


Fed Example: No Child Left Behind Act - Opt-out of giving names, phone
numbers, and addresses of all school children to military recruiters
CB 83 - Increasing supply of organs for transplants
o Authors ask whether the organs are “property” in the legal sense
o Newman v. Sathyavaglswaran


Removed deceased children’s corneas w/o consent
Uniform Anatomical Gift Act  CA had it’s own statute here
 Allows for transfer of organs from deceased as long as not for $

Case decided on due process grounds
 Just b/c you cant sell them doesn’t mean they aren’t property
 State repealed the Act
Were the corneas property?



Court said families have a common law interest in bodies of deceased
Don’t just whether there is property or not just b/c you can’t sell the
organs, that isn't a sign that there is no property in it
o Moore v. Regents of California - Spleen Case


SCOTUS said that there was no informed consent
Selling Organs
o Class divided
o For  Opens the market, allows people in tough situations to help themselves
o Against  Could lead to many negative consequences
 No more donors
 Only rich can afford
 People selling for short-term reasons that then become in bad health
Class Notes 4/11

Read Buck & Bell

Things to Know About
o OPTN - Organ Procurement Transplant Network
o Uniform Anatomical Gift Act of 2006
o Organ Donation and Recovery Improvement Act of 2004
o United Network for Organ Sharing (manages OPTN)

Transplant Tourism  People going state to state and shopping for organs
o Has national system solved this problem?


Some states try to keep organs in their own states

Billboard Campaigns - can make a national appeal on internet for organs
Medicare/Medicaid
o Medicare  Covers kidney transplants (b/c it also covers dialysis)
 Could be cheaper to provide a new kidney rather than dialysis
DEFINITION OF DEATH

Arcturus Case
o Could he have been declared dead at the scene of the accident?
 If so the consequences would have bee much different
 Uniform Determination of Death Act
 For death to be shown, must show that either:


 Whole brain isn't working
 Entire respiratory system (heart & lung) have failed
He wasn’t breathing and had no pulse, so under second prong he was dead
They made the call that he wasn’t dead, so he was kept alive at a great cost
Class Notes 4/18

Never Let Me Go
o Nature vs. Nurture
 Chimpanzee test: Real Mother vs. Stuffed Animal Mother
 Orphans get same thing, don’t develop normal social interactive skills
o Slavery argument
 Possibility that they just accept the conditions
 Seen as lower beings
o Never socially recover, some people in class said we could just take one organ
 I disagree, why only make them “part of a person”
o She stated that “we would never go back to how things were because it is useful in
current society with the donations, so out of sight out of mind”
o Issues that this movie brings up
 When does life begin
 What makes a person a “person”
 If someone doesn’t fit in, are they still a person?
 If someone is different, or cloned, are they different and therefore less of a
person?


If they were in a coma state for life, could we just farm them?
 Brings us to the definition of death & life
Utilitarianism vs. Personal Autonomy

Buck v. Bell thinking in this movie
o Cripps
 Doesn’t think this novel is about clones at all, rather it is about all of us and
how we believe what we are told and how we give in to our daily lives
 Tells us not to blindly follow orders, but rather to question and not just believe
everything we are told

Reason they didn’t try to run away is because we don’t, everyone lives life in
their own little holes and don’t question or speak out
9/20/2012 10:55:00 PM
Judge Hamilton - ERISA
3/5/12
Themes Today

1. Rationing
o Controversial label to not committing unlimited resources to healthcare


2. Consequences of reliance on US of private employers to provide insurance
3. Medical innovation
o Who pays & benefits, how do innovations make go from lab to practice
Three Cases
 Jackson v. Service Engineering
 Franklin Case
 Rimond Case - Multi-visceral transplant
ERISA - 1974



Employee Retirement Income Security Act
Enacted in 1974 in response to scandals in private corporate pensions
Vesting requirements, fiduciary standards, elaborate rules on prudence in
investment and security of accounts




Health insurance, disability insurance, and life insurance are covered
Provides civil remedies under federal law for employees and families
Non-discrimination and non-retaliation provisions
Federal jurisdiction for disputes, powerful statutory preemptive course

Limits on remedies, if covered by ERISA plan, generally cant sue employer
under state law for breach of K, tort, and can’t get punitive damages

Hamilton - ERISA provides specialized case study in challenges of legislation
o In favor of ERISA, says not perfect but is very helpful
o High administrative costs, preemption is complicated
o Limitations on remedies can be very frustrating
o Employer’s ability to change insurance plans is vital  can be problem
for employees that are already retired or close to retirement
 Core Target  Pension plans; Side Targets  Health insurance, disability
Americans’ With Disabilities Act

Prohibits discrimination against a covered employee based on a known
disability to a person with which that employee is close with
 Unlike ERISA, this does allow punitive damages
Jackson v. Service Engineering



Small employer (<100 employees) providing insurance for employees
Mrs. Jackson needs very expensive liver transplant (∆ has trouble covering)
∆ has good policy, subject to annual renewal (part of the problem)

∆ ends up firing ∏ for a small reason, ∏ sues for ERISA and ADA violations
o ∆ would have been severely burdened to cover ∏’s wife




ERISA retaliation claim says you can’t retaliate employee for asserting ERISA
ADA prohibition of discrimination based on person employee is associates w/
Holding - Denied SJ, parties then settled
Hamilton - I put employer in an incredibly difficult position, he must either not
shift the loss to the ∏ but also he cannot really cover it himself
o Next time, best approach may be to put all employees on their own

Hamilton  Jackson helps illustrate that employment based system of
healthcare financing is difficult, creates powerful incentives for employer to
fire employers for the betterment of the greater good
o Congress put the burden on employer to make impossible decision
Franklin v. H.O. Wolding


∆ offers modern and good insurance policy that covers liver transplant
∏ diagnosed w/ liver disease w/ mortality rate of 50%, gets treatment that is
covered  17 mo. later her doctors say she needs liver transplant
o Takes a year before insurance company agrees to pay for transplant

Insurance company claimed that the issue was that ∏ didn’t need transplant
o Insurance co. never submitted the files to liver specialist



∏ appeals, doctors speak with insurance, still denied
Holding - ∆ settles w/ ∏
Hamilton - Problem w/ ERISA is that survivors can’t bring a wrongful death
claim, so therefore if the insurance co. would have waited until she died, there
may have not been any remedy to ∏’s family
Rimon Case



∏ had liver cancer that has spread to other organs, very high mortality rate
Insurance said treatment was experimental and therefore wouldn’t cover
∏ sued under ERISA to get insurance to pay for the treatment

Hamilton - We all pay through taxes and other ways for innovations in
technology, the cost of discovery is high but we all benefit from innovations