The Certified Original Human – by “Nathan B”

There may never be another you,” notes the website of the DNAid art project, “but if there ever should be, would you have any legal rights to the original design?” The answer seems like it should be simple enough: of course we own the rights to our own DNA- it’s a part of ourselves that helps fundamentally define who we are. And even if we didn’t necessarily own the rights to our personal genetic code, it’s not like anyone else could.

Experimental artist Larry Miller, however, disagrees. Miller was alarmed by the emergence of genetic patents following the Supreme Court’s 1980 decision in Diamond v. Chakrabartry, which held that living beings and their DNA could be patented under U.S. law; he worried that as genetic technology became more and more prevalent, our rights over the code which makes us us would erode. As a response in 1989, Miller became the first person on record to copyright his own DNA.

Larry Miller's Genetic Copyright Certificate (click the image to make your own)

He was now a Certified Original Human- a man whose genome was no one’s but his own.

Miller wasn’t content to stop with just protecting his own genes- several years later he made the “Genetic Copyright Certificate” and encouraged others to assert their ownership over their DNA. He sought to generate dialogue over the expanding role that genetic engineering was playing in a society where GMOs were doing everything from feeding us to curing disease.  His genomic rights evangelism expanded as thousands “copyrighted” their genes and word spread via the internet, news media and even, for a time, coffee cups (which is all well and good until Starbucks decides the next logical step in expansion is to do to your DNA what they’ve done to every street corner in NYC).

Who owns your DNA?

The work of genetic artists like Larry Miller certainly raises questions, but does it offer us any answers? The copyrights he helped create have never been legally tested, but would they hold up if they were? The Register of Copyrights explains that “copyright exists from the moment the work is created,” but does that mean we’ve always owned our genes and Miller was just the first to point that out?

Further, supposing that these were enforcible, how would that happen? If someone creates a genetic copy of us (or any other derivative work based on our genome), can they claim fair use? Can we send a cease-and-desist letter (and what would it mean for an organism to “cease and desist” using another’s genes)?  Can we ask them for royalty checks?

These are confusing questions, to be sure, but that’s Miller’s whole idea. He wants to make us ask the awkward and unclear questions about where genetic intellectual property is leading us. He wants us to be confused. He wants us to be concerned.

Even the moniker offered by DNAid, “Certified Original Human,” ends up offering more questions than it answers. If our genes are derived from our parents, can any of us be considered “original?” Even if we can, why should we claim copyright over our DNA if we didn’t create it? After all, it’s our genes that make us- not the other way around.

At least, not yet.

Patent Trolling 2.0 – by “Benjamin G”

According to this NPR article, 86% of wild canola plants in North Dakota contain genetically modified genes. This isn’t a problem for the environment; the pesticide-resistant plants are no more fit in the wild. They basically behave like normal canola unless someone sprays pesticides on them. On the other hand, it is a huge problem for patent law.

Monsanto, the company that developed Roundup Ready Canola, holds a patent on it, and 86% of North Dakota’s wild canola fields are infringing that patent. Patent liability doesn’t require intent, or even knowledge; if you are using a composition of matter that someone else patented, you can be sued. Percy Schmeiser found that out the hard way when Monsanto took him to court for planting Roundup Ready Canola on his farm in 1998.

In 1997 Schmeiser found that some of his crops were resistant to Roundup. He didn’t intentionally plant Monsanto’s product – some seeds might have fallen off a truck or blown on to his property from a neighboring farm. Discovering this happy accident, Schmeiser saved the seeds from those plants and replanted his fields the following year using the resistant seeds. Monsanto sued him for patent infringement and won; luckily for Schmeiser the court found that, since he hadn’t used Roundup on his crops he had received no benefit from the infringement and so owed no damages.

The specific facts of the Schmeiser case are a bit more complicated than that and it happened in Canada, so the legal details of the decision are not important. The main issue, however, is very relevant. U.S. statute and case law explicitly permits patenting living things. And it is one of the defining attributes of a living thing that it can reproduce itself. What happens when a patented organism comes into your posession literally on its own volition? As I said, it’s no defense to show you didn’t know you were infringing a copyright.

Monsanto is certainly not a nice company, but they seem to be just protecting their core business. There are other people out there who are not so benevolent, and the current patent law presents a serious liability issue. We have patent trolls in the tech industry- is it so far fetched to imagine one of them patenting a computer virus? Suppose it actually helps your computer run more efficiently, but is impossible to detect. The troll could come in and sue you for copyright infringement and collect damages for all the benefits you gained from his program.

If it can happen in software, why not in biology? Surely someone could create and patent a new organism whose main goal was to spread itself as widely as possible and implicate as many people as possible in patent infringement. He would of course have to be clever about how he worded his patent application, but I have no doubt it could be done. Depending on how good his organism was, pretty soon he could sue anyone he wanted.

Patents grant their owners a temporary monopoly on their inventions. When we allow patents on things that you can “use” without your knowledge, though, we open the door to people forcing you to pay for goods you didn’t want in the first place. I’m not really sure what the best solution to this problem is. I do think organisms should be patentable, so I guess I would have to take a look at the strict liability aspect of the law. In copyright, for example, if you can prove you never knew about the copyrighted work then you are not liable for infringement. There may be a good reason why patent law is different, though – I just don’t know what it is.

Drug Patents Stifling Innovation by Financially Straining Pharmaceutical Companies – by “Kendall W”

New York Times article

Generally speaking, patents were established to foster innovation and to incentivize creativity.  With most people financially benefiting from patents, this reasoning still holds true.  A patent allows the creator to be the sole seller and profiteer of their product.  A patent allows a company to edge out its competition.  And in the case of biotechnology, a patent allows a biotech company to reap massive financial rewards.  In one year alone, Pfizer yields $10 billion dollars from a single patented drug – Lipitor.  Yet unique to this industry, virtually every dollar made on these mega-brand drugs goes back into research and development to produce other life-saving pharmaceuticals.  Although these drugs are expensive for consumers, this industry as a whole perfectly exemplifies the aforementioned rationale behind establishing patents.  But, with more than 10 drugs, from various pharmaceutical companies, with a combined annual revenue of $50 billion losing their patents this year, the productive cycle may come to a halt.  The Director of the Center for the Study of Drug Development at Tufts University, Kenneth Kaitin, said, “I don’t think there’s a company out there that doesn’t realize they don’t have enough products in the pipeline or the portfolio, don’t have enough revenue to sustain their research and development.”  Without the funds for research and development, pharmaceutical companies can’t test cancer-curing drugs or reduce the symptoms of heart disease.  Some are even going so far as to engage in mergers and acquisitions with smaller companies, which have patents lasting for a few more years, in order to attempt to fund their research and development endeavors.  Even these M&A transactions stifle creativity and the development of new pharmaceuticals by drastically decreasing the number of companies in the industry.

This article and the scenario as a whole raises the question, in the field of biotechnology, are patents hindering what they are supposed to foster, innovation?


America doesn’t run on Dunkin. – by “Sarah C”

We run on Monsanto. Soon, the world probably will too unless government finally gets out of bed with them. Monsanto is a biotech company specializing in genetically modified organisms, or GMOs as they have come to be known. Lately, Monsanto has been credited with ruining the lives of farmers and developing a practical monopoly on most corn, soybean, cotton, wheat, canola and sugar cane crops. Recent statistics show that about 80% of all genetically modified foods originate from Monsanto.

Here’s a little background information on Monsanto and an introduction to their “mission and accomplishments.” Monsanto has a patent on their genetically modified crops that they tout as factors in saving world hunger and making our world “greener.” Monsanto and many other big agriculture companies use bacillus thuringiensis (BT) in their crops, which is a biological alternative to pesticide and insecticide , thus preventing creatures from destroying a large portion of the crop. BT also increases the crops’ stress tolerance to acidity, drought, etc. Monsanto’s BT cotton saves 2 million gallons of pesticides annually in the US alone. As a result of all biotech crops combines, nearly 300,000 metric tons of pesticides have been avoided and 15 billion kilograms of carbon dioxide saved.

Another example: rice-dependent cultures face major problems with their diets because milled rice has virtually no vitamin A. Hello, “golden rice.” Golden rice is a genetically modified species of rice that includes vitamin A and could potentially save the lives of 200 million people who have deficiencies and over 500,000 victims of blindness each year. So this evidence suggest that agribusiness companies like Monsanto couldn’t be all that bad, right? Especially when you have people like Bill Gates as a member of the support crew.

But, now that I’ve at least mentioned the potential benefits of Monsanto’s efforts, I can begin discussing the much longer list of problems that these efforts are causing. A court case that received huge media attention was Monsanto vs. Schmeiser. Percy Schmeiser was an organic Canadian farmer against GMO crops. However, his neighbor was growing Monsanto’s GMO crops and wind, water, or something swept some of his neighbor’s seeds into his crop. The seeds cross-pollinated and on one of Monsanto’s routine spying sessions, they discovered Schmeiser’s farm contained their patented seeds and Monsanto sued Schmeiser. Schmeiser had no idea this was happening, not did he want it to happen Though Monsanto seeds contaminated his crop, he was sued for patent violation. The court initially ruled that the seed was Monsanto’s property and it did not matter how it ended up on Schmeiser’s farm. In the end, Monsanto paid for clean up on Schmeiser’s farm, but he had already gone practically bankrupt spending his life savings on litigation.

Since this case, over 2000 Canadian farmers have been sued by Monsanto and over 1000 have filed suit against them for contaminating their crops. The seed patent prevents anyone from making, saving, using, or developing the patented product. Monsanto requires that farmers buy seeds each year and forbids the saving of seeds. A farmer saving seed is treated as an intellectual property thief even if his land is unknowingly contaminated. So, basically Monsanto has control of the seed through patents, and control of the rest of the food through contamination.

Fun Fact: Monsanto sets aside $510 million a year to pay for investigations and suits against farmers who aren’t paying their patent royalties. The company literally sends detectives to collect samples from farms and have helicopters that roam over farmers’ land to inspect.

If what Monsanto is doing to small farmers is legal, what does this say about our patent system? Despite not knowing about their accused infringement, farmers are charged and prosecuted for something that was entirely out of their control. It appears that companies like Monsanto are simply using the patent system to acquire monopoly control of products that we have used for hundreds of years. Who would have thought we would actually start patenting our food? And when a corporation clearly in search of profit is controlling something necessary to sustain human life, this becomes a much more serious issue than patenting software, etc.

And despite the scale of this issue, government has yet to take action and has left it up to small farmers to try and make any changes. Obviously, small farmers do not have the deep pockets to litigate against big corporations like Monsanto and are forced back into submission. Hopefully now that Monsanto’s patent abuse is on the national and international radar and their patent term is coming to a close, the government may be more willing to reform.

As more bad media attention targets Monsanto, people have hope that they might actually get a slap in the face. In 2009, Forbes named Monsanto Company of the Year. After America had a collective aneurism, Forbes retracted their selection and admitted its mistake. Regardless, Monsanto is currently encouraging farmers to commit to planting their second version of soybeans, because its existing patent on the first version will expire in 2014. We’ll see what happens there.

Biotech in Thailand: How patents can change a developing nation. – by “Alexander F”

With the ever-increasing controversy and importance of biotech patents here in the United States, the biotech patent world outside of this country gets forgotten sometimes. While biotech is only one small component of the patent application pool each year in America, there are some nations in the world where Biotech patents are surging ahead as one of the principle patent application types. One important example of a nation such as this is Thailand.

Having only the 33rd largest economy in the world, Thailand has been boasting one of the most robust and explosive biotechnology patent growths of the past decade. These types of patents, which are usually extremely difficult and expensive to develop, have been seen by Thailand’s government as a ticket to becoming a world player with serious international clout and economic influence. Despite the meager economic strength when compared to other biotech powerhouses like the US and Japan, Thailand’s government has encouraged the filing of of biotech patents in Thailand with substantial monetary incentives. Taking some lead from Singapore’s great biotech success, the patent growth in Thailand was initially funded by direct government investment in state-of-the art research facilities to attract foreign researchers and businesses. The attractive facilities, tax incentives, and internationally aligned patent policies soon brought in foreign investment and development.

This shift has been reflected in numerous ways on Thailand. The country now sits third behind the US and Japan in terms of estimated biotech patents, and biotech enjoys a much larger ratio of the overall Thai patent application pool than either of the two leading nations. These patents have been in a wide variety of biotech fields but two of the most striking are agricultural biotech patents, and, of course, drug patents. On the agricultural side, the now great success has been with their genetically modified resistant rice. This helped the Thai agricultural economy expand rapidly and has made Thailand the largest exporter of rice in the world. Beyond this, Thailand is one of only five nations in the world with net food exports. This transformation into an agricultural powerhouse has had a ripple effect by also increasing employment rapidly and consuming land in the nation so that today, over 50% of the arable land in Thailand is used for rice production.

The drug advancements have also been extraordinary in the past few years. Major investments from foreign pharmaceutical corporations have made many of the drug patents be held by foreigners, but thankfully the Thai patent laws graciously allow this especially for biotech patents. The success of the drug patent development came last year, when the World Health Organization approved Thailand as a principle producer of the H1N1 Flu Virus vaccine.

The implications of this success may serve as a lesson, or prediction perhaps, for the future of biotech patent law around the world. In Thailand, a developing nation, the government adjusted and augmented patent law to encourage biotech patent growth. This expensive yet high-value growth, in turn, added substantially to Thailand’s economy and world significance. Other nations in Southeast Asia and further abroad may try to follow suit and encourage patent regulation in manners similarly to Thailand. This could be a new key stepping stone for developing nations to not only harness their natural resources, but also their intellectual ones in order to gain world standing and economic expansion.

While it is unclear if there is an overall causation for the economic growth here to be found in the increased number of biotech patent filings, the correlation is striking. The theoretical power of relatively few biotech patents being able to jump start an agricultural economy en masse is undoubt an exciting prospect for the development of biotech patent law and its influence on the developing world.

OncoMice revisited – by “Merlyn D”

I apologize for the lateness of my post, but I wanted to talk to some scientists about their perspectives on OncoMouse.  Mainly, this is to de-mystify some of the questions that we came up with during class.

A disclaimer: The scientist I interviewed is my father, Chuxia Deng.  He did his postdoc with Phil Leder, who designed the modifications for the OncoMouse.   He is the Chief of Mammalian Genetics at NIH, and develops animal models.  I thought he’d be able to inform us on some of our misconceptions about how patents work in the Biotech industry.

Our discussion on Wednesday focused primarily on whether you can own life forms.  The primary disagreement that all of us have had is that patenting life also means ownership over the progeny of these life forms, which is a problematic distinction because the owner did not independently create these progeny.  And, if profits go toward the owner of these patents, that would seem counter-intuitive promoting scientific innovation.

To delve further into the issue of how the scientific field operates with biotech patents, Dr. Deng said that one further distinction we should make is how patents work differently in the industry and in academia.

The OncoMouse, for example, access to both processes and actual animals do not require a license.  “For scientific research only, you can get it for free,” he said.  But the scientist must state that “he will request the tool to only use in his laboratory and for research purposes only, and it will not be transferred to any third party without your permission.”  The barriers to reaching others’ scientific data are far fewer in the academic industry, as well.  He states, “For academic purposes, there are almost no limitations.  In theory, you are prevented from doing it, but they are not going to hunt down academic institutions, since there are too many.”

But if you’re a for-profit company like Dupont (who owns the patent to OncoMouse), a license is necessary for obtaining legal use of the mouse.  He says, “For profit purposes, you must pay taxes.  You have to pay and buy a license, because you are using it for your own benefit.”

The additional dimension to the discussion helps to address the problems of owning transgenic mice who reproduce (addressed in Logan’s earlier post). Indeed, the beauty of having a patent on life forms is that you cannot curb scientific innovation that scientists control themselves; heterozygote oncomice who mate have progency that are 75% oncomice.

To tie this post back to intellectual property, let us return to the question about the ethics of patenting human genes.  If the spirit of patenting is about stimulating scientific innovation and academic progress benefits from these developments, then is the act of patenting justified?  For example, should it be the scientist who profits from the cultivating the cancerous cell line (HeLa) from a patient (Henrietta Lacks’s picture to the right)?   The trade-off is that for-profit industries must apply for a license in order to profit themselves, but the ethical implications go beyond scientific innovation and begs the question: why should a scientist benefit from what a person was born with?  Is it not her contribution to the scientific world that matters?

A world that disallows scientific patenting would mean the downfall of the private industry. This means that all research and innovation must be funded through the government, which would change the landscape of biotech drastically: no more sex-performance enhancing drugs, but no stem cells, either.