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IEET > Rights > Economic > Life > Innovation > Vision > Technoprogressivism > Fellows > Randall Mayes

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In Defense of Patenting DNA: A Pragmatic Libertarian Perspective


Randall Mayes
By Randall Mayes
Ethical Technology

Posted: Jul 26, 2009

Although biotechnology patents existed prior to the 1980s as the biotechnology era officially began, they soon became a divisive public policy issue. Perhaps a culture war issue is more appropriate as the free market approach of using DNA patents in biomedical research is under fire from strange bedfellows, a bioconservative-technoprogressive axis. The bioconservative criticisms are on moral grounds and the technoprogressive criticisms for economic reasons based on values.

The United States Bill of Rights clearly outlines our individual rights; however, it has no references to the collective good or common ownership of public resources. Since the Constitution is silent on the collective good, some public policy issues are left to the three branches of government to resolve.

Our founding fathers promoted patents to provide economic benefits to inventors and to provide products that increase the quality of our lives.  In 1793, Thomas Jefferson wrote a statute, Article I, Section 8 of the U.S. Constitution, giving general guidelines of what is patentable.

Congress has the power to promote the progress of science and useful arts by securing for a limited time to authors and inventors the exclusive right to their respective writings and discoveries. Patents can be obtained for any new or useful art (replaced with process in 1952), machine, manufacture, or composition of matter, or any new or useful improvement thereof.

In Pasteur’s Quadrant, Donald Stokes outlines the historically different relationships between science and technology. Pasteur’s microbiology research on vaccines, fermentation, and Pasteurization was both basic and applied science. University research typically followed the Bohr model. Niels Bohr’s research on the atom is considered basic science research. After the Cold War era, science and engineering followed what Stokes refers to as Pasteur’s quadrant with both basic and applied science. Today, most industrial research has an emphasis on commercial inventions which falls into Edison’s quadrant.

The shift to a greater emphasis on applied science has resulted in increased patent protection. When the founders wrote the Constitution, clearly patenting DNA was not specifically addressed. In order for the public to receive benefits from biotechnology and biomedical research, the legal infrastructure is currently set up so that researchers invent useful commercial products, acquire a patent, and create profits for company stockholders. So, in theory everybody wins; the public, investors, and inventors.


Out of the Woodwork

DNA patenting is not currently perceived as a win-win situation by everyone. Over the past several decades, critics have come out of the woodwork in protest. Consequently, this has led to a movement advocating patent reform or eliminating the commercial model in favor of a commons model for moving forward with biotechnology and biomedical research.

Some researchers have developed innovative ways to compete with private sector patents.  During the Human Genome Project, researchers receiving government funding voluntarily placed findings in public databases such as GenBank under voluntary guidelines referred to as the Bermuda Principles and developed consortiums for SNPs and the HapMap. 

Researchers in the field of synthetic biology are also using public databases.  Tom Knight of MIT developed a Registry of Standard Biological Parts similar to the infrastructure of the microelectronics industry where engineers assemble computer circuit boards. Using synthesized pieces of DNA referred to as BioBricks, oligonucleotides that are 50-100 base pairs with specific functions, researchers can assemble genes and genomes.

Zinc fingers are the most common transcription factor family in humans. They bind to a set of three bases, called a codon, which determines if a specific gene is expression or inhibited. Engineered proteins called zinc finger nucleases bind to a specific gene, breaking both DNA strands, and stimulate recombination to repair a mutation in a gene. Some researchers are concerned that the biotech company Sangamo’s patents on a number of zinc finger proteins may hinder progress. In response, researchers have developed the Zinc Finger Consortium creating a public database for the scientific community and to circumvent Sangamo’s patents. 

Others are challenging the legal infrastructure. In 2007, Representatives Becerra and Weldon introduced a bill, The Genomic and Accessibility Act, that if enacted would ban patenting genes. The bill passed in the US House of Representatives, but did not receive enough votes in the Senate.

Recently, the ACLU filed a lawsuit against Myriad Genetics and the USPTO in the US Federal District Court in New York. The suit goes back to the 1980s, when the search for a genetic link to breast cancer led to the discovery of two susceptibility genes. Women with the mutated alleles, BRCA1 on chromosome 17 and BRCA2 on chromosome 13, which are DNA repair genes, have a significantly higher risk of inherited breast and ovarian cancer.

Christopher Hansen, a senior counsel for the ACLU lawsuit, said the problem is with the patent office not Myriad. Myriad Genetics patented both alleles, invented a screening test through swabs and blood tests performed by labs which are sent to Myriad’s Utah based labs.  The ACLU claims the patents are unconstitutional and that the $3,000 fee for the screening test is restrictive.

Listen to a 2007 talk by Dr. Koepsell on “Rights to One’s Own Genes: The Human Genome as a Commons” and an interview with IEET Executive Director James Hughes about his recent book

In a recently released book, Who Owns You?: The Corporate Gold Rush to Patent Your Genes, as the title indicates David Koepsell provides both moral and economic cases against patenting DNA. However, to date both cases have failed to convince the courts and the legislative branch to ban patenting DNA.



Why the Moral Case against Patenting DNA Fails

(1) The ownership of genes is immoral argument

In the 1980s, in an attempt to forbid the patenting of the BRCA1 and BRCA2, activists Jeremy Rifkin and Bella Abzug led campaigns on the grounds that a DNA patent meant ownership of part a person’s body.  The official press release on Representative Becerra’s website for the Becerra-Weldon Bill introduced to ban gene patenting claims 20 percent of human genes are owned by someone.  In a 2006 article in The New Atlantis titledOwns the Genome?, Angrist and Cook-Deegan wrote, we are still trying to figure out who owns the genome and what the owners actually own.

In spite of the title of Koepsell’s book, he acknowledges that gene patents are not a possessory right, rather a right to royalties. To own a person or DNA would violate the Thirteenth Amendment of the US Constitution adopted in 1865 which prohibits slavery. Patent holders own a patent, not DNA.  Myriad’s DNA patents for BRCA1 and BRCA2 simply exclude commercialization rights to other parties. These patents limit what other parties can do, which is exactly what they are intended to do. However, after the temporary period stated to exclude other parties, the invention then becomes public property. So, this is an ad hominem argument appealing to emotion, not the intellect.

In The Common Thread, John Sulston objects to patenting DNA on moral grounds since humans have a common genetic heritage The BRCA genes are mutated DNA repair genes, not the wild type gene or common form of the genes. BRCA mutations account for an estimated 6-7 percent of breast cancers. 



(2) The discovery, not invention argument

To many people, the idea that DNA sequences are inventions, rather than discoveries is counter intuitive. However, in patent law the interpretation of the framers use of discovery refers to inventions that are discoveries requiring human innovation. 

Shannon and Weaver made an important distinction regarding the computational communication of information, recognizing the difference between electronic signals and thoughts. These properties also are relevant to DNA. The dual nature of DNA consists of a chemical compound and a template for the transfer of information. DNA patents are on the molecule, not on the genetic code or the instructions encoded in the sequences of nucleotides.

Whether or not a chemical compound is patentable was settled almost a century ago. Parke-Davis developed and patented a pure form of adrenaline called epinephrine. The patent was challenged by a rival company in Parke-Davis v. H.K. Mulford (1911), on the grounds that a natural product is not patentable. The ruling in favor of Parke-Davis stated that isolated and purified forms are different from the naturally occurring chemical state and set the precedent for US patent law. Subsequently, the federal government’s penicillin, Genentech’s insulin, Parke-Davis’s epinephrine, Merck’s vitamin B12, and Amgen’s EPO have all received patent protection.

The Supreme Court has however established three categories which are not patentable: laws of nature, natural phenomena, and abstract ideas. Therefore, these categories belong in the public domain. 


(3) The patenting living things is immoral argument

In the 1920s, plant breeders sought patent protection for hybrid seed development. Congress passed the Plant Protection Act of 1930 making patents obtainable on asexually reproduced plants and The Plant Variety Protection Act of 1970 for sexually reproduced plants. The two plant acts made a distinction between breeders and inventors. Subsequently, scientists were able to cross breed and genetically modify agricultural and horticultural products for desired traits and receive patent protection. As a result, we enjoy human inspired flowers and foods that would not occur naturally. 

In 1873, the French government granted Louis Pasteur patents on a purified yeast cell and for a process for making beer. In 1941, the US government patented penicillin which is a naturally produced antibiotic. If patenting DNA is intrinsically bad, why weren’t activists viscerally opposed to earlier DNA patenting?

In spite of previous patents, the Supreme Court heard the case of Ananda Chakrabarty, a microbiologist working for General Electric, who developed bacteria capable of breaking down crude oil with the industrial application of cleaning up oil spills. Chakrabarty’s group discovered that plasmids, hereditary units physically separate from chromosomes, of certain bacteria are capable of degrading camphor and octane, two components of crude oil. In addition, they developed a process to transfer and maintain stably four different plasmids, circular DNA found in bacteria, that are capable of degrading oil to a single Pseudomonas bacterium, which itself has no capacity for degrading oil. 

Chakrabarty applied for two patents, one for a process to make oil eating bacteria and the other on the bacteria themselves. In 1980, the USPTO granted the patent claims for the process which produced the oil eating bacteria; however, the product patent was rejected by patent examiners on two grounds. In 1974, a patent examiner denied Chakrabarty’s patent claim on the bacteria because they are products of nature and are living, and the Patent Office Board of Appeals agreed with the examiner. The Court of Customs and Patent Appeals overturned the ruling of the Board of Appeals in 1976; reasoning because the bacteria were alive does not forbid patenting.

In Diamond v. Chakrabarty (1980), the U.S. Supreme Court upheld The Court of Customs and Patent Appeals ruling. The high court ruling stated the distinction is not between living and non-living things, but between products naturally occurring, whether living or not, and human made inventions. Citing the Patent Act of 1952, the court concluded nothing precludes the patenting of nature. Chief Justice Berger noted in the majority opinion, Congress intended anything under the sun that is made by man to be patentable. The product patent was issued in 1984. 


Why the Economic Case against Patenting DNA Fails

(1) The taxpayer funded inventions should remain in the public domain argument

Billions of dollars of funding, private and public, is allocated annually for medical research.  An argument for the commons model is that taxpayer funded inventions belong to the public. However, government funding of research is only covers part of the cost of developing drugs, therapeutics, and diagnostic tools. In the process of finding new drugs, and developing diagnostic tests and vaccines to treat human diseases, biotech companies rely on DNA patents for royalties for research and development costs.

For drugs, the cost for the twelve to fifteen years of discovery and approval through the clinical trials process is mind-boggling. According to Steven Burrill’s 2003 edition of Biotech Life Sciences: Revaluation and Restructuring: 17th Annual Report on the Industry the cost breakdown for drug development is:

     
  • discovery: $30,000,000
  •  
  • pre-clinical: $30,000,000
  •  
  • phase I and II clinical trials: $50-100 million
  •  
  • phase III clinical trials: more than $100 million



In 2003, J. A. DiMasi reported in The Journal of Health Economics, the average cost needed for the development of a blockbuster drug, one which has over $1 billion dollars in sales, was over $800 million. The costs do not stop with the release of a drug; manufacturers are required to follow the results of significant adverse reactions.

Since significant capital is required from investors for research & development to invent and manufacture drugs, and to precede through the regulatory approval processes, biotechnology companies will not take the risk of investing in drugs or diagnostic tools where they can benefit patients unless they can make profits from successful ones.


The Mandate for Private Transfer

In the absence of patents, one alternative scenario is trade secrets. Although known for his vaccines, Louis Pasteur was unable to obtain patents on them due to an 1844 French law. Without patents for his vaccines, Pasteur had a monopoly indefinitely and used the profits to keep the Pasteur Institute financially independent. The Pasteur Institute was under no obligation to reveal its vaccine to the public after a stated period of time. However, a requirement for a patent is a written description that enables skilled persons to practice the invention assuring the public receives the benefits in exchange for the temporary exclusive rights.

Without clearly defined property rights, another scenario that can occur is medical applications are not pursued because of the lack of incentives. In 1928, Scottish bacteriologist Alexander Fleming accidentally discovered penicillin after leaving a Petri dish of Staphylococcus bacterial culture uncovered for several days and later found it covered with mold. Fleming then discovered the mold was dissolving all the bacteria surrounding it. Fleming did not file for a patent or pursue drug development. The antibacterial properties produced by molds in penicillin did not become commercially available until 1941 after the U.S. government sponsored research for mass production. Subsequently, penicillin was used to treat infections on wounded soldiers during World War II.

Scientists have an incentive not to share with others because of the free-rider problem. Other parties can benefit from an invention although they did not share the costs of product development. When inventions are underutilized because public goods or services are not developed, a government failure occurs. Patents provide an economic incentive to commercialize products and ensure they are made available to the public rather than developing trade secrets or not pursuing them. 

At the end of the 1970s, federal agencies held roughly 28,000 patents; however, they had licensed fewer than 5 percent of them, according to Lila Feisee of the Biotechnology Industry Association. Consequently, citizens were not receiving benefits, a government failure. Part of the public sector’s role is to reduce barriers that cause private companies to fail.

This led to government intervention through legislation mandating the private transfer of biotechnology research to provide of a more efficient infrastructure.  Congress intervened by passing the Bayh-Dole Act (1980) requiring researchers receiving federal funding to patent and commercialize important discoveries.  The Cohen-Boyer genetic engineering process patent is a classic model of technology transfer described in the Bayh-Dole Act.  This patent led to a number of blockbuster drugs including insulin, EPO, interferon, and human growth hormone.

Technical knowledge and capitol are necessary to ensure the success rate of biotech companies. Congress passed The Federal Transfer Technology Act of 1986 to amend the Stevenson-Wydler Technology Innovation Act of 1980 which requires federal government laboratories to seek opportunities to transfer technology. This led to public- private partnerships with industry, universities, and state and local governments through technical assistance, grants, and the licensing of government owned patents. In addition, Congress passed revisions in the Federal Tax Code to encourage investment in private and university research through limited partnerships.

Prior to 1980, only a few biotechnology companies existed. In the 1970 and 1980s, a booming biotech industry began and the number of new drugs and diagnostic tools would increase significantly. Financing from the v enture capital firm Kleiner & Perkins was important in a number of the West Coast startups near San Francisco.  Beginning with Cetus and Genentech, a cluster later formed referred to as Silicon Valley. Then, the Boston cluster began with Biogen.

In 1981, the North Carolina Biotechnology Center, the first state sponsored initiative to develop biotechnology, opened in Research Triangle Park, NC. Its mission is to strengthen academic and industrial research institutions, educate the public, and develop partnerships to move research to commercialization. These three clusters located near government funded research universities remain the top biotech hubs today.  According to the Biotechnology Industry Association, the number of American biotechnology companies grew to 1,452 in 2006.

The combination of shifting norms, favorable legislation, venture capital, and government failures led to the birth of the biotech industry and a mandate for private transfer which has led to the current paradigm which supports a free market, capitalistic biotechnology infrastructure.

Defining property rights provides an efficient economic system. Scott Kieff, a Patent Law Professor at Washington University who studies institutional economics i.e. how institutions, laws, and norms make a difference, points out industrialized nations have accumulated wealth through intellectual property rather than from resources. This is how Japan, a small island with limited resources, became an economic superpower.



(2)  The temporary monopoly pricing argument

A legitimate concern of DNA patenting for libertarians, bioconservatives, and technoprogressives is how reasonable pricing is determined on a temporary monopoly of drugs or diagnostic tools such as the BRCA test.


(a) reasonable pricing of ethically questionable and illegally patented DNA

According to James Hughes and Koepsell’s book, which take the technoprogressive stand on patenting DNA, the philosophical argument for a commons is an argument for public property, and putting people before profits unlike corporations. During the Clinton Administration several government agencies filed for DNA patents.

In 1991, a group of scientists led by Stanford’s Luca Cavalli-Sforza initiated The Human Genome Diversity Project (HGDP). The project proposed the Morrison Institute for Population and Resource Studies at Stanford University would collect blood and tissue samples, and cell lines from around the world with a representative database of human genetic diversity. 

In the 1990s, Ron Brown, Clinton’s Secretary of Commerce filed a patent claim on a cell line of a twenty-six year old Guyami woman from Panama. She had a unique virus that made her antibodies useful in AIDS and leukemia research. When the DNA samples were collected, researchers did not acquire the consent of the appropriate parties to use their DNA for commercial reasons. Ron Brown’s responded to the protests declaring that under American law, what is patentable is not dependent on the source of the cells. Despite objections from activists, the USPTO granted the patent. Further protests by a number of groups including the Guyami people, advocates for indigenous populations including the NGO Rural Advancement Foundation International (RAFI) now known as ETC Group, and the World Council of Indigenous Peoples (WCIP) led to the withdrawal of the patent claim.

The Department of Commerce filed for a second patent on a cell line from a native of the Solomon Island also for potential vaccines or diagnostic tools relating to viruses. After protests from the Solomon Island government, this patent application was withdrawn.

In 1993, the US Department of Health and Human Services and the National Institutes of Health filed for a patent on a virus found in the Hagahai people in Papua, New Guinea in hopes of developing a vaccine for a specific type of leukemia. The Hagahai patent produced little financial rewards, so the rights to the patent were withdrawn.

Debra Harry, an activist and a member of The Indigenous Peoples Council on Biocolonialism, an advocacy group called for a boycott of the HGDP. The opposition Luca Cavalli-Sforza and his colleagues received from these groups led to the programs demise. In 1997, a report from the National Academy of Sciences recommended that the National Science Foundation and the NIH no longer fund the HGDP.

Also, in a number of cases the medical community and educational institutions have patented DNA without informed consent which in the United States is ethically questionable if not illegal depending on the state.

In 1976, John Moore was diagnosed with hairy cell leukemia. His physician, David Golde at the UCLA Medical Center, advised Moore to have splenectomy, the removal of his large spleen, to slow down the progress of the disease. Moore’s T-lymphocytes (a type of white blood cell) overproduced a type of T-lymphokine which potentially had therapeutic properties and commercial value. In 1981, the University of California filed for a patent on his cell line, and the USPTO approved the patent in 1984. In 1983, Moore had signed a consent form as a research study participant, but refused to grant the University of California any rights to cell lines developed from tissue samples.

In Moore v. Regents of the University of California, Moore claimed his physician had failed to disclose his economic interests in the donated tissue and wanted a share of the royalties. In 1990, the California Supreme Court recognized Moore’s rights of informed consent, but denied his claims of property rights to the cell line. So, Moore had no rights to any profits. Moore’s conversion claim, the unauthorized right of ownership over goods belonging to another, failed since Moore had no expectation of retaining possession of his tissues and showed no interference with his right of possession of his cells without title or possession. In addition, the court ruled the products derived from Moore’s cells are distinct from his tissues.

Canavan disease is an inherited and fatal neurological disorder found in 1/40 Ashkenazi Jews caused by a defective enzyme gene. Dr. Reuben Matalon and Miami Children’s Hospital received funding from the Canavan Foundation to identify the disease gene and a screening test. The hospital and Dr. Matalon secretly obtained a patent on the gene and began charging for testing. The families donating tissue samples and organizations donating money alleged they were not aware of the commercial intentions, rather they understood the diagnostic tests would remain in the public domain. In Greenberg v. Miami Children’s Hospital Research Institute (2003), the Florida district court dismissed the informed consent claim ruling that research subjects should not dictate how medical research progresses.

In these cases, the pricing of drugs and diagnostic tests became a secondary issue compared to a greater awareness of the need for informed consent. 


(b) reasonable pricing of legally patented DNA

In 1988, James Watson and NIH sold the Human Genome Project to Congress to advance medical understanding and treatments as well as a tremendous boost to the biotechnology and pharmaceutical industries. In Origins of the Human Genome Project, Robert Cook-Deegan, a Duke University professor and outspoken critic of gene patenting and proponent of the commons wrote:

Science administrators and members of Congress who shepherded the budgets for genome research (and their counterparts in other nations and international organizations) supported the project not only because of its medical benefits, but also because they saw it as a vehicle for technological advance and creation of jobs and wealth. The main policy rationale for genome research was the pursuit of gene maps as scientific tools to conquer disease, but economic development was an explicit, if subsidiary, goal.

The ACLU lawsuit targets the $3000 cost which restricts access to Myriad’s BRCA test. Although the test is covered by health insurance, Myriad holds a temporary monopoly. Under the current infrastructure, the government can require a reasonable pricing clause. Under the Bayh-Dole Act, a federal agency has the right to march-in and force a recipient of a federal grant to non-exclusively license patented technology to meet society’s needs. The government has chosen not to exercise its march-in rights.



(3) The tragedy of the anticommons argument

Critics of the commercial model complain that patents hinder progress because of prohibitive fees and a backlog of patent applications slows the process of discovering cures for diseases. Michael Heller and Rebecca Eisenberg argue competing patents in biomedical research can also prevent the creation of useful products. Heller refers to multiple property claims to a single gene or licensing royalties as the Tragedy of the Anticommons because a resource may be underutilized.

The federal government intervened to eliminate economic barriers for academic researchers and specific situations for private companies. The Hatch-Waxman Act (1984) provides a narrow experimental use exception providing exemptions on patent infringement on pharmaceuticals and medical devices regulated by the Food and Drug Administration to researchers when not used for commercial gain.

Congress did not intend for the exemption to be so broad it violates the patent holder’s right to totally exclude others companies. In Madey v. Duke University (2002) and Merck v. Integra (2005), exemptions from patent infringement were denied. In both cases, the research was not conducted solely for the purposes related to the development and submission of information to the FDA as the statutory exemption in the safe harbor provision requires.

According to a Biotech Industry Association study, if a tragedy of the anti-commons took place, this would result would in a decrease in scientific research. However, the exact opposite has occurred. R & D in academia and biotech companies is increasing.

The NIH asked the NAS to study the effects of patenting DNA on research and innovation. A 2003 National Academy of Sciences study found that patents rarely prevented the pursuit of worthwhile projects, rather researchers managed to adopt solutions or work around the problems through licensing, going offshore, using public data, legal action, and infringement.

A 2005 National Academy of Sciences study found that the number of projects abandoned or delayed as a result of difficulties in technology access is reported to be small, as is the number of occasions in which investigators revise their protocols to avoid intellectual property issues or in which they pay high costs to obtain intellectual property. Thus, for the time being, it appears that access to patented inventions or information inputs into biomedical research rarely imposes a significant burden for biomedical researchers. In fact, only 1 percent of the 414 biomedical researchers interviewed reported suffering delays because of patents.


Ad hoc  patent reform

The economic objections to are a result of a number of government failures, not market failures as claimed. Specifically, in the past the United States Patent and Trademark Office has been in the position of having to make decisions under out of date regulations when granting patents. Government regulations which have led to government failures require revised government regulations to correct the situation.

The United States Patent and Trademark Office decides on which patent applications to approve using the criteria of novelty, utility (usefulness), and non-obvious to those skilled in the art. Following are three examples of patent reform that were required to provide a balance between innovation and IP protection to inventors. 


(a) ESTs and the utility clause

In the early 1990s, Craig Venter and other researchers at NIH filed for patents on thousands of partial sequences of genes called expressed sequence tags (ESTs). Reid Adler, the head of NIH’s Transfer Technology Office approached Venter and told him that NIH was obligated under The Bayh-Dole Act to try to patent his ESTs.  The sequences research utility is that of a probe in order to find the full length gene.  ESTs are also used to isolate promoters, polymorphisms, and as a markers on genetic maps. In 1994, the NIH agreed to retract its patent applications. However, in 1998 the USPTO issued the first EST patent to Incyte on a human kinase. In 2001, the USPTO revised the utility guidelines requiring a potential patent’s utility is significant and substantial. So, the use as a probe no longer satisfies the utility criteria. 


(b) stem cells and the non-obvious clause

In 1998, James Thomson, a biologist at the University of Wisconsin, isolated human embryonic stem cells. Geron Corp. and the Wisconsin Alumni Research Foundation supported Thomson’s research since it was ineligible for federal funding. Three broad patents awarded to Thomson in 1998 covering much of the work on human embryonic stem cells were owned by WARF, but sold to Geron Corp. They do not require academic researchers to pay royalties, but charges commercial users. If embryonic stem cell research is not controversial enough, The Public Patent Foundation and the Foundation for Taxpayer and Consumer Rights have challenged the patent on human embryonic stem cells.

The groups challenging the patents argue the methods used for isolating a primate stem cell line were obvious from a 1990 paper and two textbooks. Potential patents are required to pass the USPTO’s novelty test. Novelty or non-obvious is a significant advance over what was known previously to a person in the field. The technique used by Thomson was the same method used to make mouse embryonic stem cell lines in 1981.In 2008, the USPTO reexamined the patent held by WARF and upheld it.


(c) the OncoMouse and broad patents

In 1988, the USPTO granted the first patent for a transgenic animal to Harvard University and DuPont for the OncoMouse. The OncoMouse has a DNA sequence making it prone to cancer which researchers may use for a licensing fee. Critics of the patent claim that a gene inserted into any life form was already obvious. Harvard University biologists Philip Leder and Timothy Stewart developed the OncoMouse inserting a known oncogene into a preexisting strain of mice using an already known technique, the microinjection of DNA.

In addition, the licensing agreement contained a reach-through provision that required royalty payments on sales of products that were developed from subsequent downstream discoveries .  DuPont has offered noncommercial research licenses on terms that give DuPont the right to develop commercial products resulting from the use of the licensed mouse. In addition, the USPTO issued a broad patent which includes the patents on similar inventions which has angered activists and researchers. The OncoMouse patent applies to any non-human mammal containing an activated oncogene although a mouse and one particular activated oncogene were used. The USPTO no longer grants patents that are as broad as the OncoMouse patent. 


Policy Recommendations

The private and public sectors both play important roles in patenting, biotechnology, and delivering goods that increase the quality of our lives. It is important that each sector plays their role in the process. The legal process has determined that the idea of placing DNA in a commons is a value and not patent law.

If patent reform is to occur, it should promote innovation not deter it, through a more efficient regulation. To balance innovation and the public’s concerns, I advocate the continuation of ad hoc patent reform under the current infrastructure for biomedical research.

To address the need for reasonable pricing for drugs and medical devices such as BRCA tests which result from patents, it is the government’s role to enforce existing policies or create new ones to address the problem.


Links

2003 National Academy of Sciences study
Effects of Research Tool Patents and Licensing on Biomedical Innovation

2005 National Academy of Sciences study
Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health

Koepsell, David. 2009. Who Owns You?: The Corporate Gold-Rush to Patent Your Genes. Wiley-Blackwell.


Randall Mayes served as a 2009 IEET Fellow. He is a science writer and policy analyst with a focus on enhancement and emerging biotechnologies.
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COMMENTS


1.  Your description of zinc finger transcription factors is incorrect.

2.  What you do not say about the Venter/NIH patent attempt is that it proposed to patent not only the ESTs, but also the genes and proteins they represented.  This is the equivalent of someone saying “I invented an oil drill—so all oil drills, oil wells and subterranean oil ‘are belong to us’.”  The NIH saw reason only when the rest of the world threatened to shut down their public databases to US researchers.

Given these two points, I wonder what else might be inaccurate in your account.  On a more general note, as a working scientist, I find that patenting exerts a chilling effect and drives the price of research up, resulting in a negative feeback loop.  And I’m not alone by far in this conclusion.





I’m going to craft a lengthy response to the many disagreements I have with this text, but to point out quickly two important points:

1) Athena is right, and it’s not just her feelings… Fiona Murray of MIT has demonstrated an actual <a href=“http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6V8F-4MV0M6X-9&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_acct=C000050221&_versi>chilling effect</a> from these patents on basic science.

2) any so-called “libertarian” who supports patenting is experiencing cognitive dissonance because a) there is no natural right to IP, and b) patents are a government-sponsored monopoly, which a libertarian would oppose if he were being honest about his ideological stance.

much more to come shortly… Thanks, Randall, for putting the effort and time into these arguments, I’ll do the same in picking them apart. grin

best,
David





Athena- The ESTs are used as an example to show that government failures occured on the utility clause. There exists no requirement that I include proteins or genes in that minor point to support my majot thesis of why your side is losing a legal battle My understanding of zinc fingers is from talks by Fiona Murray and Drew Endy at Duke. Altough it is possible my desription may contain an error (which you hopefully will elaborate on at some point), it does not take away from the major thesis of why your side is losing a legal battle.

Your seem to be using tactics similar to the Discovery Institute with evolution which have gone no where and is probably why you are frustrated and are defensive.

Daivid- Thanks for your response. It’s possible you are confusing libertarians with civil libertarians. For example using a case study of genomics and health insurance discrimination, civil libertatians support ELSI, whereas libertarians support free markets and are not in support of subsidizing others.

A natural right for patenting DNA is obviouslly not in the constitution. So, the branches of our government have decided that patenting DNA is legal and have set up an infrastructure allowing companies to have a temporary monopoly so that society will benefi from the invention.

Thanks for pointing Fiona’a article. I will read it . Based on her talk at Duke though, in my opinion she is not objective, and more credibility will be given to the objective NAS studies which have opposite conclusions. If in fact Fiona is correct, perhaps she is pointing out the obvious and the scientists that are effected will have to be more creative and get around the patents. Patents are meant to excude others i.e. with certain academic exceptions.

I wish there was a paradigm so both sides could be happy. Unfortunately, ad hoc reform seem to be the answer.





Equating a practicing scientist who is also a publicly avowed atheist with someone from the Discovery Institute is an obvious attempt to silence by threat of tainting.  Telling only part of the story to torture facts into fitting your preconceived conclusions is a well-known tactic of desperate sophists.

I’m under no obligation to spend time educating you over basics that you should have researched before writing the article.  Besides, I’m really busy filing a patent for the periodic table and all its elements.





“an obvious attempt to silence”

How does one silence another on a blog??





My reference to the Discovery Institute is pointing out that you are using ad hominem arguments as a tactic to advance your side of the debate. This piece conveys my perspective through six points on why your side has failed on the DNA patenting issue.

I was invited to an MIT-Duke conference held here in Durham, NC. on pateneting and synthetic biology, and Drew Endy discussed
zinc fingers. What ever problems you have about this technical point are not going to sway the courts or leigislature in your favor.
Your side has a number of huge obstacles and you have not helped your case at all.

Thanks for mentioning Fiona’s article.

This is her first paragraph.
In the early 1980s, Professor Philip Leder, recently recruited to head the new Genetics department at the Harvard Medical School, developed the first genetically engineered mouse with cancer, dubbed the Oncomouse. Leder and his post-doc Tim Stewart had used novel transgenic techniques to insert an oncogene into a mouse embryo; the result was a mouse that was highly susceptible to cancer. In his pursuit of a deeper understanding of cancer, Leder came to recognize that “it could serve a variety of different purposes, some purely scientific others highly practical” (Kelves, 2002, p. 83). This research was published in Cell in 1984, and in 1988 a broad patent for the Oncomouse was granted by the US Patent Office (USPTO). The Oncomouse patent was more controversial than most; not only was the Oncomouse the first living mammal to be patented, but Du Pont, as the patent’s exclusive licensee, aggressively enforced the property rights. Du Pont’s strategy included demands for “reach-through” rights and review of publications that used the Oncomouse in further scientific research (Murray, 2006). Ideas that are simultaneously of value as a scientific discovery and inventive construct, such as the Oncomouse, are frequently generated in the disciplines that underpin modern biotechnology (Stokes, 1997).

Here is an e-mail from Dr. Leder himself.

Good to hear from you.. All of ours used the mutant gene injection. Best wishes,  Phil


Dr. Leder

Would you be kind enough to clarify an aspect of your work with the OncoMouse?

Numerous articles indicate you used genetic engineering, but from what I understand you used microinjection of mutated gene(s) which is not the classical sense of ge using reverse transcriptase. Did you create more than one OncoMouse and they were created by different procedures?

Phil Benfey is a graet teacher by the way.


Randy Mayes
randy.mayes@duke.edu


Philip Leder, MD
77 Avenue Louis Pasteur
Boston, MA 02115

Note: Dr. Benfey was Leder’s doctoral student and taught the first genomics class at Duke which has molded my knowledge of this topic.

On p.4 of David Koepsell’s article Individual Collective Rights in Genomic Data in JET, he correctlty refers to Chakarabarty’s patent as genetic engineering. I have an e-mail from Daniel Kevles of Yale acknowledging David is wrong. X-rays were used

In the Ethics of Genetic Engineering, which is a position paper for the Center for Inquiry, David incorrectly discusses the OncoMouse and the Chakrabarty patent as genetic engineering (see pp. 11-12).

I have been a guest speaker in several classes at Duke and used David’s articles pointing out the incorrect use of genetic engineering in the media. Now, I have another article to use.

These are more examples of technical points. Is this what you want to discuss or do you want to discuss the six points in my article which, in my opinion and not IEETs explain why to date your side has failed?

After reviewing Fiona’s article, I conclude, if this is your ace up your sleeve, you guys are hurting





On p.4 of David Koepsell’s article Individual Collective Rights in Genomic Data in JET, he [substitute incorrectly in the previous post] correctlty refers to Chakarabarty’s patent as genetic engineering. I have an e-mail from Daniel Kevles of Yale acknowledging David is wrong. X-rays were used





Yes, it was directed mutation… this was crude engineering, in the sense that the bacteria were exposed to a mutagen, and ones that were suitable were selected and bred.  I am not wrong, this was the product of human direction and creation, although crude.  This is why the SCOTUS approved the patent.





David

My response was not directed at you. Don’t worry about it. It’s a compicated concept, and I would like to have a civilized discussion with you, not her.

If you were a molecular biologist it would be an issue, but as an attorney and philosopher you are forgiven for not understanding the distinction. My background is developmental biology and science policy analysis. However, this is not a discussion about who knows the most about biology, rather two different perspectives on the future of biotechnology public policy, and I consider you an expert in this field or I would,t waste my time with this discussion.





Randall,

I contend that for the purposes of patent, Chakrabarty involved an engineering process in the sense that man altered nature purposefully to achieve a particular result.  That result was a product of man, not of nature.  In all my descriptions and discussions of the case, as far as I know, I do say he “bred” the bacterium, and never do I claim he spliced genes as in traditional genetic engineering.  I don’t really require “forgiveness” as the legal and philosophical issue at hand is the alteration of nature (which creates something patentable).

I look forward to a civilized discussion.  I am crafting a lengthy response now to point out your many errors, both legal and philosophical.

best,
David





Randall,

Scientific American confirms that the bacterium in Chakrabarthy was “genetically modified,” which I claim is legally speaking the same thing as “engineered” for the purposes of the patent law: http://www.scientificamerican.com/article.cfm?id=gene-patents-breast-cancer-lawsuit-myriad

Now, if you wish to distinguish for some other reasons between engineering and modification, that’s fine, but for patent purposes, there is no relevant difference.  So kindly point this out while you are telling people I am wrong, I use the terms interchangeably because, for the purposes of patent, there is no distinction.  Anything altered by man, which is useful, non-obvious, and novel, is patentable.  If you simply wish to make me look foolish, then go right ahead and try.  My meaning is clear in context.

best,
David





David

In the class where I discussed this topic there was a mixture of philosophy, law, and, med students. Part of the problem is semantics and thus the need for protocols in interdisciplinary studies. So, I began to ask the students for their definition of genetic engineering. Most people had no answer and the few that did were not even close to each other.

What genetic engineering means in molecular biology is using reverse transriptase to recombine DNA from two organisms. Cohen and Boyer received the process patent for this procedure.
So, when pharma used the process to make EPO, HGH, interferon etc. they paid royalties to Cohen and Boyer and received product patents for their drugs.

Leder injected mutated genes and did not pay royalties.

Chakrabarty used X-rays and received a process patent and eventually product patents as well.

Unless you payed royalties to Cohen and Boyer, yiou were not using genetic engineering. I beleive their patent has now expired.

In the social sciences, there are different versions of reality to what genertic engineering means. I think at our level of discussion we should use the scientific meaning and not some popular notion which varies depending on the conversation.

Is it possible we can agree on that?





Randall,

Law and philosophy are all semantics, which is the connection between words and meanings.  It’s not trivial to misunderstand or misrepresent one’s meanings when they pertain to particular contexts.

While the CFI paper says Chakrabarthy involved “genetic engineering” (as a result of editing by the review committee to simplify my original wording) my recent book Who Owns You?is quite explicit and correct in saying throughout that Chakrabarthy involved “genetic modification.”  I do say correctly in that book that the case stood for the legal principle that made genetically engineered life forms patentable, but never do I claim in my book (I hope you’ll read it) that Chakrabarthy involved genetic engineering.

The important legal issue is modification by humans of natural products.  I make a number of analogies in the book to types of modifications that would not amount to patentable inventions (like drawing lines around natural features on maps), and argue at length (bits that you seem to have missed or at least misunderstood) that patenting genes is the same ontologically speaking, and never arises to patentability under the current US patent law.

Still working on my response, should be done next week.  Stay tuned.

-David





I read your book soon after James posted it on the IEET website. The Duke Law Library purchased a copy of it. I find your book very similar to your JET article.

This topic is huge at Duke. Arti Rai and James Boyle in the Duke Law School are involved with the Science Commons and Wes Cohen of the Fuqua Business School was involved in the NAS studies. Robert Cook-Deegan in Genomics and Public Policy is also very involved. Each school has held numerous conferences.

I’m suprised I haven’t seen you here.





I can’t see how your position can be construed as libertarian or anarchist.

If you define libertarian/anarchist activity as individual and group activity with minimal government intervention, you are on shaky ground, obviously, and you don’t have to be a lawyer, political theorist or expert in any field to understand why.

I hardly know where to begin but I might as well begin with the concept of The Corporation which is defined by the law and defended by the government.  Patents that protect corporations from competition from other corporations and individuals are also defended by the government.

As I said, I don’t know where to begin except IN MEDIA RES and using common sense.

The lines are already drawn, of course, and the enemies know each other quite well, but the corporations and their lawyers have all the cards.  The trouble is, they have little logic and less reason.

Expertise in the field is irrelevant.  The battle is going on in computer science too and you don’t need to be an expert in computer science to see that monopoly patent rights over hundreds of thousands of subroutines which produce popular interfaces and other platforms used by the monopoly operating systems of Microsoft, have left their creators spinning in the winds of Linux and open software, or as millionaires living off their royalties.

Bill Gates has more wealth (money) than the bottom 40% of Americans, as a result.  The inventor of the Internet, let’s see, what’s his name?, lives a relatively modest life—- but with the respect of the computer science community. 


To cite an extreme example to prove a point, what would have happened to scientific progress if Einstein had formed a corporation by patenting Relativity Theory for making atomic bombs?

The question answers itself.

Only a totalitarian government could have the means to hunt down all the pirates using Relativity Theory and the experimental results needed to make atomic bombs.  The United States hasn’t been able to do it and neither has China or Russia.

It was impossible.  Why because - so far - liberty triumphed over totalitarianism.

Governments rarely get smaller or give up influence and they show no signs of shrinking in the United States.  The same is true about corporations.  But both can go bankrupt, as history shows.

The only hope for continued scientific progress we Americans have is that we continue to have the liberty to use all scientific and mathematical knowledge freely to make new discoveries and theorems

Finally, science and mathematics do not form a belief system, or the cogs in the wheels of an ideology or faith,  but a body of knowledge each part of which can be verified by anyone using logic and experiment. 

When the path to verification is mostly closed by secrecy and law, scientific inquiry will be stifled and America will cross a threshold into a scientific and technological dark age.

Access to knowledge will be under the control of corporations and their government servants. 

Americans can then safely forget about science and technology and dedicate themselves to making movies, music and sports for the entertainment of the rest of the world.

We can hope that the torch of science will be passed to another, younger and wiser civilization.





Just a quick personal note, and I don’t mean this to be emotional: It’s pretty clear (and was clear before I wrote my post) that you will neither allow my previous post on your site or respond to it.

Why?  Because you don’t consider ME to be a valid member of your discourse space.

It’s not unusual.  After all, scientific journals have similar bars called judges or experts who determine whether a paper should be allowed into their journal.

But in this case, I am part of the American universe of discourse which the Internet embodies.  I am an American citizen without any degree, university position, credentials or employment (that you are aware of.)

And I have not presented any unusual or novel facts, perspectives or ideas.

But the kind of control that your policy exemplifies is exactly the kind of control that stifles scientific inquiry. 

Only free, random, friendly and honest thought can produce dialogue (and science) worthy of the name.

Monopoly capitalism stifles that.  I sincerely hope that we don’t have a civil war to decide this question, but I believe it would be preferable to a descent into irreversible cultural and intellectual decline.

Please don’t answer this post.  I’ll be much happier if you answer another one like it in the future.





If anyone develops a drug, procedure, treatment or anything having to do with that specific gene, whoever owns the patent to it will make money from it. I guess companies are thinking ahead if they are doing research on the gene, they don’t want someone else beating them to their intended outcome.





Should Human Genes Be Patented? US Federal Court Hearing
05 Feb 2010  

This week a US federal court heard a case that may decide whether it is legal to patent human genes.

On Tuesday 2nd February, a Manhattan court presided by Judge Robert Sweet heard attorneys argue for and against a federal lawsuit filed by American Civil Liberties Union (ACLU) and the Public Patent Foundation against the Patent and Trademark Office, Myriad Genetics and the University of Utah Research Foundation.

The lawsuit challenges the government’s granting of control of patents on BRCA1 and BRCA2 to Myriad Genetics. The BRCA1 and BRCA2 genes are implicated in inherited breast and ovarian cancers. Myriad Genetics have developed a genetic test where for a fee, a person can have their blood tested to see if they carry mutations of those genes that put them at higher risk of developing those cancers.

The ACLU is representing 20 plaintiffs, including the American College of Medical Genetics, the Association for Molecular Pathology, and various individuals, including Lisbeth Ceriani, a 43-year-old woman from Massachusetts whose doctors last year suggested she have a genetic test for BRCA1 and BRCA2 mutations following a breast cancer diagnosis.

When they submitted her blood to Myriad Genetics, they refused to do the test because they didn’t accept her insurance. Ceriani couldn’t afford to pay for the test herself (according to a report in Discover magazine it costs in the region of $4,000), so in the end she didn’t have one. Since Myriad hold all the relevant patents, there is only one test for the BRCA mutations, and the company also holds power over who can and can’t research the genes.

The essence of the lawsuit is that the plaintiffs contest the right of companies to be able to patent “products of nature” and “laws of nature”.

Both sides agree on a number of points: researchers should be free to patent new drugs, new treatments, devices, and even specific DNA sequencing methods. And both sides agree that patent law forbids the patenting of natural phenomenal and laws of nature since these weren’t invented by humans and patent law does not allow the patenting of something that occurs in nature.

According to an ACLU press statement, both sides also agree that DNA in the body is also a product of nature and therefore should not be patented. However, at this point they part company: the defendants claim that “isolation” of the BRCA genes from the rest of the DNA (they have to be separated from the rest of the DNA to study and test them), makes them patentable.

The plaintiffs refute this claim and say that patents on human genes should never have been granted because “genes are identified, not invented”. They argue that no matter how ingenious the isolation process is, it does not alter the structure of the DNA itself and so the genes essentially remain “products of nature”.

They also refute Myriad’s patent claims over the correlations between mutations and cancer because mutations are a “law of nature”: Einstein discovered that e=mc2 but he would not have been allowed to patent it.

Also involved in this case are issues around the First Amendment and the constitution, where by granting patents on the genes themselves, the government has essentially given Myriad exclusive control of all knowledge about the gene, which the plaintiffs argue is a clear violation of the First Amendment.

It is not like a patent for a carburettor, where someone else can invent another kind of carburettor; other researchers cannot “invent around” a gene that has been patented, said the ACLU, which argues that this goes against Article I of the Constitution since gene patents do not “promote the progress of science and useful arts”. Instead, they hamper research, testing and development, they said.

Myriad argues that patents are a necessary incentive for researchers to discover the BRCA genes and develop commercial tests. Also, to disallow them would wreck the basis on which the entire biotech industry is based. According to a CNN report the company is also pushing the point that court precedent is on its side.

The plaintiffs refute these claims. For instance, on the incentive angle, they pointed out that researchers were doing BRCA testing before the patents were granted and Myriad stopped anyone else doing research once it got the patents.

Today, said ACLU, thousands of researchers and clinicians who could be doing BRCA testing and give women the results they want can’t do it because of the patents. Six of the plaintiffs are individual women who say they have been pre-empted from knowing about their gene status because of the patents.

At the end of the 2-hour hearing, after hearing the arguments for both sides, Judge Robert Sweet thanked the attorneys for their clarity and skill, acknowledged the sharp difference of opinion, and touched on the fact this case is of great concern to science and industry and anyone concerned about breast cancer, pointing out that nearly everyone has been affected by the disease in one way or another either directly or because they know people who have, or they care for them.

A ruling is expected in the next few months, according to a statement on the ACLU website.

As we get to know more and more about breast cancer, a disease that affects one woman out of every eight, we are learning that it is not one disease but many, and perhaps even specific to individuals. The chances are that we will need to know more and more about the genetic basis of the disease so treatments can be tailored to suit individual patients.

Should ACLU and the plaintiffs they represent win the case, it could mean a huge change in the field of genetic research, where the race is on daily to patent more and more genes.

About 20 per cent of human genes are now covered by patent claims (including genes linked to Alzheimer’s disease, muscular dystrophy, colon cancer, asthma and many other conditions).

Sources: ACLU, CNN, Discover Magazine.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

Article URL: http://www.medicalnewstoday.com/articles/178399.php

Main News Category: Genetics

Also Appears In:  Breast Cancer,  Litigation / Medical Malpractice,  Regulatory Affairs / Drug Approvals, 

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