Final Statement
Although gene techonologies seem to be the way of the future, we have learned through our exploration that patents on the genome do have some pitfalls.
FAQ
What is a patent and how do they work?
According to the article, “Patents and Genetics,” a patent is issued when an invention is proved to be “practical”, “novel,” “non-obvious” and described in a way that enables others to use it.
For gene patents, the rules are different. You must discover a new genetic sequence and explain what its uses/effects are in nature. Products found in nature are typically not patentable since they are found, not invented. There is an exception for genes and other DNA discoveries.
Why has this exception been made?
The human genome is easily one of the most mysterious aspects of the natural world that modern science is trying to elucidate. Science is headed in the direction of personalized medicine that would involve genetic therapies and preventative medicine based on the genome.
Patents in general are granted as an incentive for innovation. (This comes in the form of exclusive rights to a part of the genome or a use of it.) In an attempt to catalyze the sequencing of the human genome, patents have been applied to the discovery of the genes themselves.
As seen in the article reviewing “Cancer Patients Challenge the Patenting of a Gene,” every company is reliant on financial stability. Monetary incentives are the only way to keep the company interested in investing in research as well as a viable source of profit.
Have the patents improved the way research on genes is conducted?
This is one of the most controversial questions surrounding genome patents. The patents are effective in initially sparking the interest of companies to do research on genes.
However, it is arguable that gene patents hinder research rather than incentivize it. The owners of patents charge royalties for others to access information and do research on the genes. Once the initial discovery of a gene has been made, is there enough economic incentive for companies to continue the research? Furthermore, when it comes to developing a therapeutic application for a gene, researchers must endure the cost of working with a patented product.
Due to the current state health care in the United States, it is also notable to factor in cost when it comes to testing these patented genomes. If genes were not patented, tests would be more affordable, not just for patients, but for the government and private insurance companies. Would private insurance companies fund genetic testing? Would the government healthcare? If genes could not be patented, the cost for such tests would lessen, making the whole healthcare aspect of this developing technology more affordable.
Are patents on the gene beneficial to the future of science?
After our exploration of patents on the genome, we have concluded that the area as it stands is a messy field. Critics argue that patents actually hurt the progress of science, reducing the process of science to nothing more than legalese, creating a “maze of patents.” Likewise, patents create a huge ethical debate — is a life form (and somethng so human!) able to be patented? If so, at what point is something able to be owned? On the other side of the fence, proponents argue that patents are actually increasing the creativity and productivity of genetic innovations. They argue that genomics is largely an economic endeavor, and without patents, the field would simply collapse.
What we have decided is that the US Trademark and Patent office has done a poor job in sorting out what should and shouldn’t be patentable. Our verdict:
In order to amend the given controversy, we should disallow patents on the genome itself, but allow (vigorously!) patents on the applications and uses of the genome, i.e. innovations and inventions. Genes are the building blocks of genomics and should not be patentable; the therapeutics and products derived from them should be, though.
A great similarity in science is the periodic table. The genomes should be listed in a table like the periodic table, but like the elements, the genomes themselves should not be patentable. Instead, the derivatives of the basics (genomes, elements), also known as inventions, should be able to be patented.
For clarification, diagnostic tests should be patentable – it is a process that must be found, and the first person to find/discover it (or refine it!) should be allowed to own the process. A company can futher refine it, or in the case of BRCA, Myraid could charge a royalty but still allow others to make diagnostics.
“Gene patents vital to biotech industry,” May 11, 2009
With almost everything, there is an infrastructure that needs to be built. A tree cannot support its leaves without its branches, just as a building cannot support people without the right foundation. Gene patenting is no exception. As Tim Dean states in his article “Gene Patents Vital to Biotech Industry” published on May 11, 2009 in Australian Life Science, gene patents are the support for progress in the field of genomics.
To many people, the logic seems greedy. So why do the drug companies hoard rights on a medicine then jack up the prices? (That is, why are there patents on the genes?) The reason goes back to the structure of the system: companies are fueled by investors, and investors would not invest in a product that can be stolen and consequently unprofitable. Companies create the patents to assure some fiscal return, which pleases investors and allows for future research and products. In short, patents hold up the research that funds new tests and genes. Without them, new innovation would fall to the ground like leaves of a sawed-up tree.
Furthermore, the new technology seems a bit unappreciated by the public. Sure, people are excited that they could be tested, but they are also furious that they lack the means to be tested. Scientists finally find a test for breast cancer predictions, and the public tries to topple the very system that found it. Patents allowed for companies to find these new innovations, and patents might ultimately crush the companies, too.
While the tests for breast cancer are pricy, they are not completely out of reach. In general, any new technology is going to be expensive – the first prosthetics were not cheap; likewise, gene testing (e.g. at 23andMe) is not cheap. But the prices are going down. The tests are also not mandatory to breast cancer prevention. While they certainly are very helpful in warning a female of raised chances, regular visits to a doctor would presumably have a similar effect. Lastly, the tests are expensive, but not impossibly so. If the test is of the upmost priority, a person will be able to find a way to get the test done. Perhaps confronting insurance companies would be another place to go.
Also, addressing the restrictions allegedly emplaced by such patents, Dr. Tania Obranovich, patent attorney and former research scientist, states, “one per cent of American scientists reported that their research activities had been impeded by patents.” One percent is not a huge percent, especially if the proposed research has already been done.
Andrew Christie, Professor of intellectual property at the University of Melbourne, also addresses the “moral/non-economic” issue of the debate. He simply states the such anti-patent arguments are not strong. This section of the argument, however, would be interesting to delve further into.
In the end, though, I am left with the conclusion that gene patents are necessary with the current system. Still I venture to wonder, what if the system is able to change? What if a completely redone system of government and economics allowed innovations to be found without patents, a system where collaboration and financial assurance were stronger than patents? Therein would lie the solution to the gene patenting problem.
Judge OKs Challenge to Human-Gene Patents
http://www.wired.com/threatlevel/2009/11/genes/
This article written November 2nd, 2009 by David Kravets covers the recent ruling in the American Civil Liberties Union (ACLU) class action lawsuit. Through researching and reading articles about genome patenting, this one in particular struck me because it emphasized the political and legal issues that constantly surround healthcare.
Although I agree with the intention of the lawsuit, the research company, Myriad, is left with seemingly unfair consequences. Legally speaking, they have done nothing wrong, but they are dealing with negative PR and high priced lawyers. I think the PTO is mainly at fault, and a federal case against them is totally justified. Still, all of this money wasted on policy and bureaucracy is a huge hindrance for advancement in research, which should be the main concern.
In the healthcare industry, human life is at stake, and putting a price on medicine and therapy is tricky. Founding a business on profits from such therapy is even trickier. There is a moral problematic behind it all because, ethically, it seems that health should be put before money. However, this idea does not survive the principles of economics, and the incentives do not appear to be enough to economically sustain medical research without patents and a way to generate income.
Most of my responses to articles were about this lawsuit and what it entails. What is more important now is to think about what would actually improve the policy rather than simply focus on its adverse effects. In the case of genetic testing and therapy, what options are there to boost the economic incentive for research without hindering research? One option could be to patent methods of gene therapy rather than the genes themselves. Still, it is hard to predict how policy changes will affect a company’s performance.
The policy needs to be changed to accommodate new medical findings and processes. However, the more pressing question is how it should be changed. Although patenting the genome seems to be a flawed system, how could a company generate income through research without them?
ACMG Joins Lawsuit Challenging Patents On Breast Cancer Genes
http://www.medicalnewstoday.com/articles/150146.php
Two heads are better than one. This saying applies to almost every field, particularly research. Still, patents in medicine have worked in the past to make medical research effective and profitable. Pharmaceutical companies are operable because of the high returns provided by patents.
With medical advancements in the past decade, patents on human genes have become a cause for concern. Patenting information that still necessitates research creates a tricky situation. The argument that patents help incentivize research seems to be a moot point largely because they limit how many heads are able to collaborate and attempt to make the medical breakthroughs that many known genes still require. Nevertheless, there has been a race among companies to patent as many genes as possible for the potential profits that could ensue.
This article appeared in Medical News Today on May 15th, 2009, one day after an article announcing that the Association for Molecular Pathology (AMP) would also be siding with the American Civil Liberties Union (ACLU) in the lawsuit against Myriad. It is clear that many medical organizations, including The American College of Medical Genetics (ACMG), the AMP, the College of American Pathologists and the American Society for Clinical Pathology, have practically been waiting for a lawsuit that could change the policy on gene patents.
The ACMG and the AMP both had stated their position that gene patents were adversely affecting the cost and advancement of gene therapies. Additionally, an interesting point brought up in this article is that, not only is research hindered by this policy, but future healthcare workers will also be less efficient due to the retention of important information:
“Ramifications of gene patents, however, extend beyond direct patient care. As stated in the ACMG Position Statement, ‘gene patenting] affects the training of the next generation of medical and laboratory geneticists, physicians and scientists in the area enveloped by the patent or license.’ ”
If companies have a monopoly on genetic information, patients are extremely limited in their options when it comes to making informed decisions. For women checking for the BRCA-1 and -2 genes, indicators for breast and ovarian cancer, the test from Myriad is the only one available. This flaw in the system faces women who have the genes linked to breast and ovarian cancer with decisions that are new to the healthcare. For example, if you are prone to breast cancer, do you get your breasts removed preemptively? This is a huge decision to make without a second opinion, and yet many women are forced to choose because of the patent. Preventative healthcare is becoming the future of medicine, but how can you support such decisions by a single test?
Influenza Genome
http://www.patentlens.net/daisy/influenza/4132.html
This article, published in the web blog patentlens.net, considers the event of patenting the influenza genome. Already, over half of all patents concerning genomes are related to influenza. The benefits of effectually owning that information are obvious in today’s world of avian and swine flus.
“The most strongly voiced concern is whether patents claiming influenza genomes, genes or proteins will compromise equitable access to products that are derived from them.” Essentially, professionals are concerned that once these patented genes are developed for a therapeutic purpose against the pandemic influenza, those with lesser means will not have access to the product.
However, such concern may be irrelevant if these influenza genes are patented before a product is even developed. How can multiple labs push to research a cure for a pandemic when only one has the legal right to? The capitalist machine that is driving this process of patenting is effectually then cutting out it’s very own life blood, competition. Patenting any genes for that matter puts an intellectual cap on what ground breaking research could be accomplished if the information were readily available rather than horded away in one company.
Moreover, this article address the effects of patenting genomes other than our own, which raises some interesting ethical questions – mainly do humans have the right to place patents on other living organisms, let alone ourselves?
Genome Scientists: Gene Patents Are Bad
http://www.forbes.com/2002/06/26/0626targets.html
The article, Genome Scientists: Gene Patents are Bad, was written by Matthew Herper in June of 2002. At first glance, I found this article appealing because it was published by Forbes, a business company, rather than a scientific or health related company. I also found the title of the article intriguing. I was surprised to read that genome scientists, the very people who work for companies that own gene patents, believe that these patents are “bad.”
Craig Venter and Eric Lander, are two leading scientists who have facilitated the mapping of the human genome. Venter is the founder of Celera Genomics and Lander was the first author whose paper was published by the Human Genome Project; he is also the head of the Genome Center at the Whitehead Institute. Venter and Lander are each other’s greatest competition in the push towards mapping the human genome. Because they are both huge contributors to the Human Genome Project, it was misleading to discover that they both strongly agree that the “gold rush” to patent genes will yield small profits.
Why has there been this “gold rush” to patent genes? Venter explains that it is not the genes themselves that people want ownership of, but the proteins derived directly from the genes. These proteins are the valuable products in biotechnology that make the big bucks. This article clarified a lot about the significance of patenting genes. It was effective to hear the incentives of these patents from Lander and Venter, the leaders of biotech companies. They believe that patents are essential only when the gene is the sole producer of a protein that can be effectively used as a drug. When this is not the case, patenting the gene prevents other companies from trying to come up with a cure for disease that is related to that specific gene, which is detrimental to research and medical advancements.
For example, there is a single gene that is linked to erythropoietin, which controls red blood cell production. Since this specific gene is directly related to the synthesis of erythropoietin, the patent on this gene can be considered effective. By giving Amgen exclusive rights to this gene, Amgen was willing to invest the time and money to develop Epogen without fear of another company beating Amgen to it. Because of this patent, there is now a treatment for anemic patients.
As we’ve learned in class, there are various types of cholesterol controlling drugs, such as Lipitor (by Pfizer) and Zocor (by Merck). Statins all work to different extents by blocking the same drug target. Had a biotech or pharmaceutical company patented the gene related to the enzyme that statins block, the other companies would have been prevented from discovering drugs that could be more effective.
I found this article to be the least biased one that I’ve come across so far, which helped me gain greater insight to the topic of patenting genes. It helped me develop a deeper understanding as to why the patenting of some genes is less controversial than others. For example, patenting genes that are markers for cancer, such as BRCA1 and 2, is detrimental to finding a cure for cancer. Because the genes themselves are markers for breast cancer and not a protein that may prevent cancer, the patent inhibits other companies from collaborating to help find a cure. By doing so, only the company that owns of these genes may freely conduct research.
I think there should be a greater focus on what types of genes should and shouldn’t be patented. For example, approving the patent on the gene that led to the production of Epogen was effective. The company had the incentive to invest in a patent for exclusive rights to this gene and used the protein synthesized by the gene to create an effective marketable drug. On the other hand, a patent on a target for a drug is far more controversial and detrimental towards medical advancements.
ACLU Sues Over Patents on Breast Cancer Genes
http://www.cnn.com/2009/HEALTH/05/12/us.genes.lawsuit/
Most of the articles that I have come across so far have been focused around the morality of claiming exclusive rights and ownership to a gene. This the first article that I found that deals with the legality of the patents.
Myriad Genetics’ faced a legal challenge to its patents on BRCA1 and BRCA2, two human genes that have been correlated to breast and ovarian cancer. The American Civil Liberties Union has filed a lawsuit that challenges the constitutionality of Myriad’s patent, arguing that patents are a violation of the First Amendment. ACLU reasoned this claim by explaining that gene patents restrict research and the free flow of information, which infringes on the First Amendment. Given that there are no substitutes for analyzing a patient’s genetic makeup, the owner of the patent inevitably has a broad monopoly in the market for medical research, medical services and patient care.
This following video is a clip from CNN news that summarizes the case and addresses the issues around patenting genes. Dr. Sanjay Gupta does a great job with clarifying the ethical and legal issues with patenting genes.
If the American Civil Liberties Union is successful, this case has the potential to rule all patents on genes unconstitutional, which would be a tremendous feat. The executive director of the Public Patent Foundation, Dan Ravicher, states that it is his goal win this case so that other patents can be invalidated as well. This specific case had been chosen because of the prevalence and awareness of breast cancer. By turning the controversy over patenting the human genome into a legal matter, there is a more tangible method to approach the debate over genetic patenting.
If knowledge about our current and future health is available, is it a right or a privilege to have this information? Furthermore, to what extent is healthcare a right?
“One Fifth of Human Genes Have Been Patented,” October 13, 2005
The National Geographics article “One-Fifth of Human Genomes Have Been Patented” published on October 13, 2005 and written by Stefan Lovgren, elucidates the debate over genome patenting.
MIT professor Fiona Murray states, “While [genome patenting] does not quite boil down to [the patent holders] owning our genes … these rights exclude us from using our genes for those purposes that are covered in the patent.” So the companies do not own the genome, but a function of it. And, yes, while the genome is a part of human life, plants — a derivative of many patented medicines — are too part of life. They own the applications of the genome, not the genome itself.
Moreover, patents on the genome seem comparable to patents on pharmaceutical medicines. Ownership of an invention prevents outside development, and also inhibits inside development — patents on the whole seem to prevent growth. Patents on simple pharmaceuticals prevent cheaper alternatives from being made and from curing the sick; this property is not unique to genome patents. While Myriad Genetics would be able to help more people by withholding the patent, such a move is neither financially sensible nor precedented. What if releasing the patent puts Myriad under? It could be just another biotech failure, as opposed a strong business model.
The article also says that a patent on a gene doesn’t mean the gene cannot be used by other companies. The patent is restrictive but not exclusive — if a company finds a new use for a gene, it can patent the discovery. The current model does indeed leave room for some exploration.
The article, however, ends on a dissonant note, cautioning against patents. Says Murray, “We worry about the costs to society if scientists—academic and industry—have to walk through a complex maze of patents in order to make more progress in their research.” While the ethics on patenting life and on denying healthcare are outlandish, the patents seem to perpetuate the selfish nature of modern science, bringing it into the realm of politics and business. Ideally, innovations should be shared in a cloud of information, easily accessible to anyone and able to be further developed. The future of science, after all, seems to rely in the collective body of knowledge as opposed to the individual mind.
But clearly this could never be the case. The revenue generated allows companies to make new discoveries and more patents, increasing revenue and thus increasing discoveries. Without patents, it would be difficult for companies to generate enough money to make new discoveries. And without the discoveries the patents wouldn’t exist. Patents seem to be a necessary evil to (counterintuitively) encourage growth.
“Is Everything for Sale?; Patenting a Human Gene As if It Were an Invention”
When I was first looking for an article on genome patenting, I had trouble finding the right one because I was searching through the “Health” section of the New York Times database. I was surprised that one of the more pertinent articles I found was actually in the “Business” section. This distinction is a focal point of the controversy surrounding such patents. At what point is business and profit from healthcare research and advancement unethical?
This article entitled “Is Everything for Sale?; Patenting a Human Gene As if It Were an Invention” was written by Andrew Pollack and published on Wednesday, June 28, 2000. I did not know much about patenting genes before this project, and I still find the concept difficult to grasp. To me, it seems that patents should be given for inventions and creations, not facts of nature. An interesting quote from the article elucidates how gene patenting seems somewhat arbitrary: “Some compare it to granting ownership of the alphabet, rather than of a novel or play.”
However, sequencing these genes requires research and money, so having an outcome that could generate income is obviously necessary. As crooked and unethical as it seems, advancements in medicine are mainly propelled by the massive returns that can be generated in the healthcare industry.
The article was written a relatively long time ago, and brings up the Patent and Trademark Office’s change in criteria for gene patenting that occurred around the time of the article (2000). Because sequencing a gene is only the first step in discovering its uses, functions, implications etc., patents are now awarded with more prudence.
Still, it seems that the controversy and the ethical concerns surrounding the issue are continuing today and have escalated to a possible change in policy with activism like the ACLU lawsuit. Personally, the idea of some company or person owning the rights to information that goes beyond abstract knowledge and is vital for future research seems counter-intuitive.
Patenting Life
http://www.nytimes.com/2007/02/13/opinion/13crichton.html
As we have learned from class, genes are one of the most influential components in a person’s life; specific markers in our genetic sequences may indicate things ranging from personality traits and minor health risks to fatal diseases and neurological disorders. Since the human genome still is not completely understood, there is a major push towards understanding this genetic make up for the human species, making the human genome project easily one of the single largest mysteries in modern science.
I came across “Patenting Life,” an op-ed written by Michael Crichton in February of 2007, while searching for controversial issues concerning human gene patenting. As an op-ed, this article denounces the practice of patenting the human genome but brings up great points that I agree with. For example, if patents are designed to promote innovation in technology, how can it being applied towards human genes, a natural and fundamental aspect of life? If genes can be markers for disease and patents are granted to give ownership to genes, patents are effectively given people and companies ownership to a disease.
While reading this article, I started questioning when advances in science should take priority over a person’s health. Although it would be a tremendous accomplishment to decode the entire genome, how is this useful if the information isn’t readily accessible to doctors, researchers, and the public? Providing economic incentive to this project inadvertently puts a price on health and even life. In addition, the exclusivity that gene patents provide its owners slow the pace of medical advances because of expensive royalties and genetic testing.
Why should a woman pay $3,000 to pay for a test for breast cancer if it could easily be done for $1,000? Why should royalty fees deter hospitals from providing free tests for Canavan disease, a disorder that paralyzes children who are fated to die by adolescence? Although providing patents for genes may work as incentives towards demystifying the human genome, they are granted at the expense of providing affordable and vital information that affects the current state of health of the human population.
Patents on the Genome 