Cloning, Stem Cells, & GenesDiamond v. Chakrabarty

Claim to determine whether a live, human-made micro-organism is patentableo Bacteria that breaks down multiple components of crude oil

Three Types of Patent Claims o 1) Process claims for the method of producing the bacteriao 2) Claims for an inoculum comprised of a carrier material floating on water, such as

straw, and the new bacteriao 3) Claims to the bacteria themselveso 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

patentableo A new mineral discovered in the Earth or a new plant found isn't patentableo In the same way Einstein couldn’t patent E=mc^2

Court micro-organism qualifies as patentable subject matter judging in by thiso 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 patentableBiogen 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 obviousnessClass 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

Mouse wasn’t a useful invention at all b/c possibility it would get cancer too easily, so wouldn’t help with cancer research

Must also look to whether it is immoral 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 poolsClass 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 natureo 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 issueso 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 patentsHarvard College v. Canada

Backgroundo 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/ Canavano 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) Processeso 2) Machineso 3) Manufactureso 4) Composition of Matter

3 Exceptions to Patent Act’s Eligibility Principleso 1) Laws of natureo 2) Physical phenomenao 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) Novelo 2) Non-Obviouso 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 Holdingso 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 producto Synthia had watermarks but that may not be enougho W/ a product, when it is out in nature already, then we shouldn’t allow patents of that

Chakrabarty Dissento 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 Mouseo Two Issues If mouse got out and bred w/ other mice, also that mouse would grow

painful tumorso 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 caseo 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 sequenceso 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 1 st 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 geneso 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 diseaseo 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 moreo 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 equityo 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 propertyo 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 retestingo 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 contextso 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 requirementso 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/screeningo 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 26o 2. Created provision whereby you can’t exclude people from coverage due to

preexisting conditionso 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 residentsClass 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 inventiveo Going back to Chakrabarty we saw SCOTUS uphold patent b/c the bacteria was

modified by mano Prometheus - SCOTUS says the patent isn't modified by mano Court appears to be feeling that they only want to patent what is novel, non-obvious,

products of man, and not products of natureo 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 inventiveo 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

commerceClass Notes 3/28

Three Main Things of ACA o Removal of the insurance lifetime capo Extended coverage to under 26o Removed ban on coverage of preexisting conditions

ORGAN TRANSPLANTSClass 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 healthcareo Compare this section to ERISA and Judge Hamilton’s talk

Discrimination against prisoners Two sides from books CB 76o Class very divided, Cripps says she would always give the prisoner the organo I disagree, I think that you have to look to the other person who may get the organo 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 organo 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 systemo Opt-out increases the available organso 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 Deatho 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 incentiveo Big factor People not giving full chance to recover from coma or to get full care in

ER b/c someone needs their organClass 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 necessaryo Must have either pre-approval insurance or your own $ to actually get on the listo Issue Should we just say Medicaid & medicare shouldn’t cover organ transplants

Cripps Medicaid and medicare are going to cover lessClass 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 outo Presumed consent could also give a problem w/ procedural due process

Newman case in CBo 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 senseo 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 ito 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 themselveso 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 Networko Uniform Anatomical Gift Act of 2006o Organ Donation and Recovery Improvement Act of 2004o United Network for Organ Sharing (manages OPTN)

Transplant Tourism People going state to state and shopping for organso 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/Medicaido Medicare Covers kidney transplants (b/c it also covers dialysis)

Could be cheaper to provide a new kidney rather than dialysisDEFINITION 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 skillso 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 movieo 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

1/12/12 2:20 PM

Judge Hamilton - ERISA 3/5/12Themes 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 practiceThree 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 complicatedo Limitations on remedies can be very frustratingo 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 himselfo 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 decisionFranklin 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 transplanto Takes a year before insurance company agrees to pay for transplant

Insurance company claimed that the issue was that ∏ didn’t need transplanto 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