Human Gene Patenting, White Paper

This is a Policy White Paper I wrote on a topic of my choice, assigned for my sociocultural genetics course at PSU.  Thought it was interesting enough to share here.  Enjoy if you're into this sort of thing.

Human Gene Patenting

1. Introduction / Background

            The debate over gene patenting questions whether genes can be owned and how best to encourage innovation in this relatively new field.  This debate has grown especially contentious over the last year due to a few high-profile court cases, most notably against biotech companies Myriad Genetics Inc. and Monsanto Inc. (1). Since patent scope is determined not by the United States Patent & Trademark Office (USPTO) but instead by the judicial branch (5), these cases have been closely watched by the biotechnology industry, researchers, and the public for who will have access to which resources: private industry, the public, and/or scientific researchers.

2. Abstract / Business Case

            Gene patenting has become the focus of societal discourse over the developing biotechnology industry. Biotechnology promises treatments for many common genetic maladies, as well as potential enhancement of common genetic traits (2). This paper will explore some of the economic and ethical problems with gene patents and attempt to provide a solution that will best encourage innovation in the future. Arguments for and against gene patenting will be explored. Approaches attempted by foreign nations will be presented, as will a solution for the current debate in the United States.

3. Problem Statement / Introduction

            Gene patenting problems center on ethics and access to resources. Primarily, it is questionable that genes should be patented in the first place.  There has been much debate in the United States ever since the 1980 Supreme Court decision, Diamond v. Chakrabarty (3).  This landmark case stated that is was legal to patent “genetically modified organisms” (4). However, this has lead to the patenting of genes and gene fragments, based on the legal argument that genes are modified if isolated from the human body. There is no longer a clear distinction between naturally occurring and scientifically isolated, as articulated by the recent Myriad case.  Seven patents held by Myriad were invalidated on the basis that they involved laws of nature (3). To further confuse matters, USPTO uses suspect language in qualifying gene patents, such as “Step 1: Identify novel genetic sequence.”(4) If the sequence were truly new then it should be considered synthetic, and not something found naturally as a part of the human genome.

Private biotechnology industries such as Myriad and Monsanto argue gene patents retain exclusivity to their genetic product. For example, Myriad owns gene patents used to predict if women have an increased risk of developing breast and ovarian cancer. These industries say patents ensure profitability, and thus, attract initial capitol investment necessary for research and development (3).  However, attracting initial investment is a risk with any emerging industry, and the large initial research and development necessary to many biotechnology products and services, does not make the problem unique. The biotechnology industry claims that consumer demand may not answer industry investment, and therefore must be protected by exclusivity. Today, after thirty years of development, there is clearly no shortage of demand for the services of genetic testing and treatment. The exclusivity of these industries is being challenged by public interest for better and cheaper access to the technology, so there is clearly demand for the product.  Private interests argue that without the guarantee of the protection of such a patent, investors would not fuel future innovation. “The competition among researchers to find diagnostic mutations for cystic fibrosis and other common diseases flourishes, even though no company has exclusivity.” (2) Most scientific research is also funded publicly in the United States.  It is up to industry to compete in the free market; neither exclusivity, nor economic success can be guaranteed in a capitalist society.

            Public interest organizations, such as the American Civil Liberties Union (ACLU), are the largest opponent of gene patents, and also argue against inhibiting innovation.  They argue that the ability to patent genes keeps prices exorbitant and prevents free market competition of obtaining a second opinion on a person’s genetic test results (1).  In addition, patents on genes and patents on gene fragments impede future scientific discovery.  Gene fragments include expressed sequence tags (ESTs) and single nucleotide polymorphisms (SNPs). “Diagnostic laboratories are moving away from a dependence on individual gene patenting and towards multiple-genome analyses, with prominent articles (published as early as March, 2010) reporting that: ‘when hundreds or thousands of genes are being tested at once, patents on each individual gene can become a hindrance to innovation rather than a spur’” (2) Royalties on such “patent stacking” creates multiple barriers to free access to knowledge and therefore become costs that are likely passed on to consumers.  Advocacy organizations claim that private biotechnology firms who own certain sets of patents can effectively monopolize certain gene test markets, which then stifles innovation.  

4. Proposed Solution

4.1 Introduction of Solution   

            There are many different solutions to these complex and historically unique problems.  Many countries have addressed these issues in different ways.  The United States is unique in its “Patent first, ask questions later” approach (5).  Notably, both the European Union and Australia have also seen a recent resurgence of this political and ethical debate (2).  Thanks to peer countries examples of how this problem could be approached, there is a wealth of solutions.

4.2.a One solution is to simply maintain the status quo.

4.2.b Especially in today’s complex and quickly changing economy, many ethical and technological problems presented by other new technologies have been solved or become moot by the snowball effect of further development. However, like many arguments by industry that attempt to maintain the exclusivity of the status quo, there is little research to support the idea that gene patents actually promote innovation more than without patents (5).  Limiting patents might even increase competition and innovation. For example, a company cannot patent bottled water, but this remains a lucrative and competitive market.

4.3.a Another option would be to simply ban all gene patents on the basis of being naturally occurring.

4.3.b However, this too is inadvisable, since such a change would upset a 30-year precedent, and thereby set back the development of the biotechnology field (2).  With the accelerating pace of technological development and so much promise on the horizon, it is unlikely that banning all gene patents would put a complete end to the biotechnology industry.

4.4.a The third solution recommended is patenting only processes and not genes themselves to solve both of the ethical and economic problems.

4.4.b There are two core arguments against gene patenting: one economic and one ethical. The infringement of innovation (primarily due to cost, but also to institutional knowledge) is argued on both sides of the patent issue.  Gene patenting is also argued against because of its attempt to patent the natural world. Patenting only the process of gene isolation and manipulation, as has been proposed in Australia and the European Union (2), will continue to encourage the development of multiple approaches to the same gene, and not an exclusive monopoly to that one natural element. Some care would have to be considered so that this policy does not run rampant, thereby patenting common scientific practices.  The “non-obviousness” clause of USPTO patenting standards would continue to protect basic scientific processes from over-patenting as industry “trade secrets.” This clause states that patents should only be issued to “non-obvious” inventions that are “not an improvement easily made by someone trained in the relevant area” (4).

5. Results / Conclusion

            Since the sequencing of the human genome in 2003, genetic testing and treatment has become more widespread around the world. As with any burgeoning field, innovation is to be encouraged to promote growth and economic prosperity as well as population health and freedom from genetic disease.  Innovation requires a complex cooperation of research and industry. Problems of innovation and ethics have centered on gene patents, and the ability of private industry to own genes and gene fragments.  Private interests hold that patents spur innovation by encouraging investment in research and development, while others maintain that the patents inhibit progress, by creating unnecessary barriers to existing scientific knowledge.  At the core of the debate, a new area of policy consideration has developed: as technological capacity increases, the lines between natural and synthetic biological processes become blurred.

Patenting of scientific processes such as isolation, identification, and modification instead of patenting of natural genetic material would solve these problems.  Patenting processes instead of genes would eliminate the need for excessive bureaucratic oversight of patent enforcement and royalty extortion currently propagated by the exclusivity granted by gene patents.  Both oversight and royalties have been charged with inhibiting innovation. If only processes were patented, innovation could proceed to develop new methods for isolation and identification without fear of infringement.  In addition, patenting only processes would effectively end the debate of whether or not gene patents are actually patents on naturally occurring elements.

6. Bibliography

1. American Civil Liberties Union. (2011, December 07). ACLU Asks Supreme Court to Hear Gene Patents Case. Retrieved from http://www.aclu.org/blog/free-speech-womens-rights/aclu-asks-supreme-court-hear-gene-patents-case
2. Goh, R. (2010, February 24). Gene Patenting: Information on Gene Patenting. Retrieved from http://genepatents.info/
3. Schwartz, J., & Pollack, A. (2010, March 29). Judge invalidates human gene patent. New York Times. Retrieved from http://www.nytimes.com/2010/03/30/business/30gene.html?scp=1&sq=judge sweet myriad gene&st=cse
4. U.S. Department of Energy. (2010, July 07). Genetics and Patenting. Retrieved from http://www.ornl.gov/sci/techresources/Human_Genome/elsi/patents.shtml
5. Yu, P. (2007). Intellectual property and information wealth: Issues and practices in the digital age. (Vol. 2). Westport, CT: Praeger Publishers. Retrieved from http://books.google.com/books?id=z_tYraycQRAC&pg=PA239&lpg=PA239&dq=do patents necessarily lead to wealth&source=bl&ots=5Pfb_NTAqu&sig=Q7SffqU1ERCHkYgQOReqQTNFDU4&hl=en&sa=X&ei=ung9T5zlOsfq2AWnz9GQCA&ved=0CCIQ6AEwAA

Lent

It's sunny in Portland today.  Which means that people are walking around looking at the ground because they can't see with all of the brightest around that they're not used to.

I'm not Catholic but I've always liked the idea of Lent.  Mary Helen says that it is about giving something up so that you can then be free to go after something you want.  It sounds to me like a more realistic version of New Year's Resolutions: there's a trial period, if it doesn't work out, you can always come back to what you gave up at the end of the 40 days, and there is a fundamental understanding that to get something, you've got to give something up in return.

In thinking about and preparing to apply to med schools this spring, I'm thinking a lot about what I want.  It's simultaneously humbling, daunting, and empowering to realize that, where I am right now, the only thing standing in between me and getting into A medical school, even not the one of my dreams, is me.  If I buckle down and do everything that I know needs to be done and I throw myself into it, there is no way that I will fail.

Yesterday during Fat Tuesday I got a slap-in-the-face reminder of that when I got a lower grade on a paper than I wanted.  But during Fat Tuesday the world is supposed to be turned upside down, to remind us which way is up and why we want to keep it that way normally.  That's why I'm giving up video games for Lent this year.  So I can go after what I want, and not stand in my way.

Whistle While You Work

ben's rules of making drudgery bearable:

1. work 45, take 5-15.  Personally I can only go through three hours of this before I need at least a 15 minute, if not 30 minute break, or switching subjects/projects.  hold yourself to this.  ONLY reward yourself with a 5-15 min break if you stayed focused and on task the whole 45.

2. breaks should not involve the same medium as the work: if the 45 was working outside, go inside, and vice versa.  if the 45 was spent looking at a computer, sitting in a chair, get up and walk around, and go look at something that's not on a computer screen for your break.

3. as often as possible, make it a game: if i can get X done in this 45, let's see if i can get Y done in this 45. if i can get X done in this 45 I'll buy myself a pastry with my coffee, if not, only the coffee

4. STOP at the 45!  this can be hard, because maybe you're right in the middle of something, but stopping when you're supposed to (within reason), will keep you in a better mood, and better organized.

5. As often as you can, eliminate distractions and listen to music that helps you concentrate (unless this is a contradiction for you).  either way, figure out what works best for you and stick to it.

Neutral Chi

qi |CHē|(also chi or ki )

noun

the circulating life force whose existence and properties are the basis of much Chinese philosophy and medicine

I was introduced to this concept in college.  The difficult piece to teach, and understand, from a scientific, Western perspective, was that once you gave any kind of definition to the word you immediately misunderstood its meaning.  It is specific, and it is not specific.  It is everything, and it is nothing.

We're all familiar with positive and negative energy in the universe: positive and negative chi, electrons and protons, optimism and pessimism, hope and doubt, trust and fear.  Same ideas, different explanations for reality.  My favorite part about the concept was the flowing metaphor of something that was a connecting force, that did not isolate my body from the world, or from disparate parts of itself: for example, mind & body & spirit; respiratory & circulatory systems.

But as I get older and experience continually reminds me what values tried to teach me long ago, that life isn't as simple as negative and positive.  The bright spots in my life aren't islands, lonely in a sea of dispair, or vice versa.  Positivity can just as likely give rise to negativity or to more positivity, because there are just too many variables in the perspective equation to consider.  Let me give an example: ever hear of the book "That's Good! That's Bad!" by Margery Cuyler? If you haven't its a great book.  It begins: "One day a little boy went to the zoo with his mother and father. They bought him a shiny red balloon."  That balloon then takes the little boy through a series of adventures throughout the zoo, into the hands of a baboon, narrowing escaping the jaws of a giant snake, etc.  At each turn, the narrator(s) seem to be confused in his decision of the outcome, exclaiming: "That's good!  No!  That's bad!"or the other way around.  The narrator can't decide if the outcome will ultimately turn out well or not for the little boy.  Ultimately, what assurance do any of us have?

But I digress.  Neutral chi is the action of inaction, not just a description of a balancing point between two opposing forces, but a force within itself.  In leadership development, this concept was introduced to me as 'stepping back, and letting someone fail' so that they might also learn from the best teacher: experience.  There is a leap of faith involved.  None of us know if/that we will land safely on the other side.  But stepping back and letting the situation run its course is sometimes the best action we can take.  That which we fight to change, sometimes is not ready until inertia has taken it as far as it can go.

Take Apple as an example.  They market their products just like everyone else.  Sure you could say that they were ahead of their time because they were simple in a world of complexity, but think about what complexity they made simple for a second: in order to pull it off they had to spend years and lots of money on R&D (a practice I'm voting they aren't going to follow as strictly, as evidenced by the faultiness of both Lion and iCloud, post-Jobs), to make a product that is integrated and, for the general user "just works."  But then they had to rely on all their own parts, all their own design, all their own rules.  Politically, Apple is the monopolized dictatorship of technology.  I love the functionality as much as the next person, but are those my values?  At that point they don't need to have programs like "Refer a friend and get $100" because they've successfully created a clique. A clique that everyone can join for the right price.  They don't have to appeal to anyone positively, or negatively, their ads just show you the product, and we can't wait to get our hot little hands on that shiny red balloon.

Eugenics today

This is a short position paper that I wrote for my genetics and society class at portland state.  It is meant to be a persuasive paper only, mostly not reflective of any of my personal views.  The topic fascinated me, which is why I posted it here.  Enjoy.

1/24/12

SPP #2: Why did eugenics fail?

As genetics became a scientifically viable field, public discourse struggled to define this new science. Many new thinkers were attracted to the topic, many with their own agendas. If the fundamental principles of the development of species could be understood, surely they could also be controlled and manipulated. Control of human biological destiny developed into what is now known as eugenics. Culminating in the idealogical purging of Nazi Germany, eugenics was based on tenuous scientific principles at best, and quickly transformed into political rhetoric. Because of the catastrophe of the Holocaust, the word 'eugenics' may have fallen out of favor, and with it the metaphor of animal stock-breeding, but as a social concept eugenics still influences political rhetoric.

Political discourse, especially in today's 24-hour news cycle, thrives on controversy, even without truth. “The dynamics of reductive simplicity and full-blown complexity persist in the public discourse because each features substantial, though different, rhetorical advantages.” (Condit, 1999: 56) Both modern American political narratives, the “conservative” and “liberal” agendas are guilty of reductive simplicity and paralyzing complexity for political victories. Both sides blame each other of seeking homogeneity, which at its core, is what eugenics is all about: “The ambiguous notion of the germ-plasm, with its connotations of cohesion and homogeneity...” (Condit, 1999: 54) Conservatives accuse liberals of threatening individual freedom and traditional values through dilution of the gene pool. Liberals accuse conservatives of threatening freedom of expression and inclusive values through similarly over-simplistic views of the gene pool. “Clearly, the scientific findings did not drive the public discourse to new anti-eugenic positions but merely supported reorientations urged by other forces.” (Condit, 1999: 55) Politics drives itself. Under eugenics, science was just a guise for a racist agenda: “...In public rhetoric, it matters little whether the true believers learn from new data and correct themselves, for the balance of public opinion is built... from members of the broader public who serve as audience and judge of these doctrines.” (Condit, 1999:55) Eugenics may have enjoyed a brief wink of scientific validity, but that is dwarfed by its historical importance as political rhetoric.

Within the modern conservative narrative, traditional values are under attack by progressives and liberals attempting to control the America citizenry via federalized institutions and mandates. The truth is that this was the aim of many eugenicists at the beginning of the 20^th century, in order to encourage the re-education of the “unfit.” However, “[eugenicists] eventually bowed to the conditions of feasibility generated by innate [biological] complexity.” (Condit, 1999:57) Scientific understanding had not yet advanced to enable sufficient control for breeding out the “unfit” in exchange for the genetically “superior.” According to French Strother: “The most [the eugenic scientist] hopes is that some day he will have so many facts, so clearly proven, that only the very ignorant will not know how nature deals with human heredity, and only the fools will be rash enough to try to beat nature. But that's a century or two ahead yet.” (1924:170-171) Now, nearly a century later, according to conservative political narrative, eugenics is thriving in the form of population and reproductive control via advances in medicine: the morning after pill, abortion, and birth control. Simultaneously, the paradigm continues the victim stance by decrying the scientific research of global climate change as a 'liberal agenda.' Literally, Strother's vision has manifest as “nature deals with human heredity” and the industrial choices Western culture has made in the name of superiority.

At the same time, the conservative narrative has used the eugenic argument to its advantage. The power of the individual in the context of American capitalism to “lift himself up by his bootstraps” (Lakoff, 2004) has cast the poor on the losing side of the superior/unfit dichotomy. However, the modern Great Recession has limited the argument, similar to how the Great Depression “...cast doubt on the proposition that the unemployed were out of work because of their incapacities rather than because of factors in the social structure.” (Condit, 1999:52) Despite, the economic realities, this type of polarizing rhetoric continues even through the current Republican Presidential Debates.

Eugenics was only briefly scientifically relevant. The science of eugenics quickly got replaced as methods and knowledge advanced. But as public and political rhetoric, eugenics by many other names, is alive and well.

• Lakoff, George (2004) Don't Think of an Elephant!: Know Your Values and Frame the Debate. White River Junction, Vermont: Chelsea Green Publishing.

• Condit, Celeste M. (1999) The Meanings of the Gene: Public Debates about Human Heredity. Madison, Wisconsin: The University of Wisconsin Press.

Thoughts to get started.

Hello all,

In a new year's effort to examine my life, keep things in perspective and well, keep in touch better, I'm going to be kickstarting this blog thing again. The resolution? Stop worrying so much about what you'll be defined as if you do anything. Do something, and if it doesn't work out, do something else.

In a broad introductory effort to remember this, I'm starting with two lists based on one of my favorite mantras: [That which goes by many names and is beyond all naming], grant me the serenity to accept the things I cannot change, courage to change the things I can, and the wisdom to know the difference.

Things I can change:
Now.
Myself, and my attitude.


Things I can't change:
Time.
Others, more than they want to be changed.

I took a walk in the snow covering Portland last night and was exhilarated both by the joyous novelty of the weather and what it brought out in my neighbors. People were playing in the streets, greeting each other as we walked past, things that normally don't happen. It was a good reminder to simply "Be the change you wish to see." Because although being friendly is sometimes exhausting, its still easier than doing nothing and complaining.

Ambulance Ride Along

Following are the text messages between myself and Jenn during the Ambulance ride-along that I completed as a requirement for my EMT-Basic certification. I have deleted any names of people, places, and other identifying information in order to protect the patients and people that I worked with. Thank you for the opportunity, I had an amazing experience with the professionals I worked with, and please contact me directly with any concerns or questions.


Jenn: hope you're able to stay awake :-)

19:18 me: Hehe. Stayed up till 5am last night, then slept to 3pm. I hope so too

19:19 Jenn: whoa

19:20 me: We were just at a tbone car accident, guy was fine but complaining of hip pain. Hit an icy patch. Car door w a 6 in indent

19:21 Now we're going to a nursing home. Possible GI bleed

23 minutes

19:45 Jenn: whoa

crazy night

how are you liking it so far?

19 minutes

20:04 me: Ya, interesting

Tons of protocols tho

20:05 Jenn: yeah i bet there's a BUNCH of stuff you're not allowed to do

5 minutes

20:11 me: Oh yea

Lots of paperwork. They're doing the care report on a heavyduty ipad looking thing

20:12 We've been on the move ever since we started bc of the icy roads tonightI love the camaraderie too

20:13 Jenn: ah that makes sense

the other guys are cool?

13 minutes

20:26 me: One guy paramedic, one lady paramedic

They're fun

Make fun of each other a lot

20:28 Jenn: haha fun

20:31 me: I'm going to keep msging you all shift if that's ok, mostly just to document :)

You can read it in the morning

5 minutes

20:36 Jenn: haha ok

9 minutes

17 minutes

21:03 me: Could def see myself doing this. I like the movement

21:06 Jenn: nice

what's the work week like?

8 minutes

21:14 Jenn: did you know in-state tuition for the med school at ucsf is $0?!?!?!?

i may or may not be looking at med school rankings...

21:15 i've been thinking that i'd like some book recommendations (books that are readable and interesting to me) so i can be conversant with you while you're in the med school process

13 minutes

21:28 Jenn: holy shit

21:29 all of the UC medical schools are zero tuition for in-state residents

dude you should totally do that

10 minutes

21:39 Jenn: oOoh but there's like 30k in required fees...?

weird

51 minutes

22:30 me: Yea that is weird and I did not know that!

22:31 I would love to get in to a UC med school

All of them are some of the best in the country

22:34 We just did a patient transfer

Jenn: there's so much hierarchy in medicine

5 minutes

22:47 me: I know dude. Its my biggest problem with it

And one of the biggest factors in considering NOT doing medicine

13 minutes

23:01 me: We just dropped off the nurse back at his hospital. He was finishing a 16 hr shift

7 minutes

23:08 me: I want to be a healer. I want to treat people, not just patients. I want to not wipe my hands clean of the situation when dropping the patient off at the ER. I want to understand, and I want to cure, not just triage with all my time. I didn't like that about the [ ] model either. It sometimes felt superficial, and like triage: who's the best and let me spend most of my time with them, instead of setting down roots. That's why I'm much more attracted to public health

10 minutes

23:19 Jenn: yeah

do you think you'd get that from being a doctor?

although a huge complaint from doctors (and patients) is that they don't spend enough time with each other

23:20 me: Yes and no, depending on what I do

Jenn: if you were an ER doc, no

me: Depending on where you work

Jenn: yeah

23:22 me: Also, that's why I'm looking into md/mph programs, then maybe work for the WHO or UN or county or state, or open my own practice/clinic

And DO

23:23 There's a really cool integrative care model in seattle that I went to once while I lived there. I'm forgetting the name right now.

Most models are based on doctors meeting w dozens of patients a day, some are not

23:24 Jenn: yeah

phew big decisions comin up

23:27 me: I know dude..

Welcome to my life, and partially why its taken me this long to start applying in the first place

23:28 Jenn: yeah

23:30 me: Chillin in the firefighter clubhouse right now :)

23:32 Jenn: cool!!!

is it weird that you keep texting on your phone....? i wouldn't want you to get a negative review from the current EMTs

23:34 me: Nah, they're on their on phones too, or diriving, etc

8 minutes

14:59 me: It was incredibly interesting

15:00 Stopped msging you bc they were on their phones less

Altho now sleeping all day I kinda wish id kept it up, this off sleep schedule sucks

15:02 Let's see we had a few more calls

15:03 One was a fire standby just in case anyone got hurt, which no one did, and it was fun listening to the firefighter radio chatter

15:04 Our final call was a possible stroke, probably TIA if you're interested in looking it up, had woken up at 5am not being able to find his nose and with diminished movement in the left side of his body, slurred speech, this came and went.

15:06 When we got him to the hospital, they had new protocol where the doc did a preliminary diagnosis in the hall and they sent him directly to the CT brain scanner from the ambulance gurney

7 minutes

15:14 me: We also got a call from a patients father, his daughter was staying at [ hotel ] which the hospital had paid for after holding her in psych for the past three weeks. She had had a seizure and called him. She didn't want to come to the hospital so the cop that was there put her under POH- Police Officer Hold, which is usually used for suicide threats, bc there was some discrepancy about how many of her pills she had actually taken (which there were a ton of bottle from various dates all around the room). It took 3 firefighters to help her walk down the stairs in her postseizure daze (post-ictal phase). In the ambulance she told us she'd been kicked out of her house by her husband and kids bc they didn't know what to do with her, she had a tumor the size of a fist right in the lower center of her brain and some behavioral/emotional thing called [ ].

15:19 Jenn: Dude I bet you learned so much

And learned how much you still don't know

15:20 That poor woman with the brain tumor

Sounds so sad. How are you emotionally after all that?

6 minutes

15:27 me: I'm ok. Tho probably still digesting

Thanks

15:28 For askin

I'm stoked for my ER rotation tonight