CONSTITUTIONAL RIGHTS FOUNDATION
Bill of Rights in Action
WINTER 2008 (Volume 23, No. 4)
The U.S. Patent Office issues patents for new inventions. With the development of biotechnology, scientists are designing new bacteria, plants, and even animals for medical and other uses. The issue arises: Should patents be issued for these living things?
Patenting living things has always provoked controversy. Some of the controversy hinges on moral and ethical issues, and some on legal disputes. Another area of controversy is whether patenting cell lines, specific genes, and diagnostic tests actually helps or hinders medical care.
The Supreme Court has not considered this issue since 1980. Since that time, many revolutionary discoveries in biotechnology have occurred. Scientists, lawyers, and businessmen agree that the law on patenting life has not kept up with new discoveries and that it is time for Congress to act.
Can Living Things Be Patented?
Ananda Mahan Charkrbarty grew up in India. After finishing his PhD, he came to the United States and in the1970s was working for General Electric in genetic engineering. Charkrabarty invented a new kind of bacteria to which he added plasmids (small pieces of DNA, separate from the chromosome) from other bacteria. His multiplasmid bacteria grew faster and better on crude oil than any of the single plasmid bacteria. His new bacteria were good at cleaning up oil spills because they consumed oil so quickly. After meeting with a patent attorney, he decided to apply for a patent on his oil-eating bacteria.
The U.S. Patent and Trademark Office (PTO) denied Chakrabarty's patent application in 1973. The PTO ruled that Chakrabarty's bacterium was a "product of nature" and no one may get a patent for living things. Seven years later, the case made its way to the U.S. Supreme Court, which overruled the PTO.
In its decision, the Supreme Court analyzed the language of the Patent Act (35 U.S. Code 101), which states:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter . . . may obtain a patent therefore, subject to the conditions and requirements of this title.
The court held that the terms "manufacture" and "composition of matter" should be interpreted broadly and that no history or case law indicated otherwise. It cited a congressional committee report from1952 (when the Patent Act was amended) stating that Congress intended people to be able to patent "anything under the sun that is made by man." The court acknowledged that true "products of nature" may not be patented: "Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter." But Chakrabarty's bacteria had different DNA and different properties from any bacteria found in nature. "His discovery," the court ruled, "is not nature's handiwork but his own,"and therefore may be patented.
The decision in Diamond v. Chakrabarty did not place limits on what types of living organisms could be patented. And during the 1970s and 1980s biotechnology was exploding. New technologies were being developed to diagnose diseases and develop new drugs. One of those new technologies involved the use of human cell lines. A human cell line is made from cells taken from the body and modified so that they continue to reproduce indefinitely. Establishing a cell line from human tissue is extremely difficult and rarely succeeds. One scientist who developed a cell line was Dr. David Golde at the UCLA Medical center. Dr. Golde had a patient named John Moore who had leukemia. Golde took samples of Moore's blood and other bodily fluids, and in October 1976 removed Moore's spleen. After the surgery, Moore continued to visit Dr. Golde, who kept taking tissue and blood samples from his patient. By August 1979, Golde had established a cell line from Moore's T-lymphocytes, a type of blood cell. In 1983, the Regents of the University of California applied for a patent on the "Mo cell line." The patent was issued in March 1984, listing Golde and a colleague as inventors. The patent was licensed to a biotech company, which agreed to make sizable royalty payments to the Regents and to Dr. Golde. The cell line patent turned out to be a valuable invention for Golde, but Moore received nothing.
Much litigation occurred over who owned Moore's cells and whether he should receive some of the royalties from the patent. But the patent on his cell line was not disputed. And the Chakrabarty decision did not address the question of whether multicellular organisms (as opposed to unicellular organisms such as bacteria) could be patented.
New technologies were being developed during the 1970s and 1980s to create "transgenic" animals. (A transgenic animal is one that has DNA from another species injected into its genes.) Soon, patent applications were being filed. The first patent on a multicellular organism was granted in 1987 on a "polyploid" oyster in which more than one set of chromosomes had been induced. After the oyster patent was granted, the PTO issued a policy statement saying that people could get patents for non-naturally occurring, non-human multicellular organisms, including animals. One year later, a U.S. patent was issued on the "Harvard Oncomouse," one of the first transgenic animals to be produced.
Researchers at Harvard College had injected an "oncogene" into a laboratory mouse to make it more susceptible to cancer. Because the mouse was highly susceptible to cancer, it was ideal for identifying drugs that could be used to treat cancer. No litigation took place in the United States over the patent's validity. But a huge furor erupted in other countries where Harvard had filed for a patent. The patent was initially rejected by the Supreme Court in Canada (but later granted after an amendment). In Europe, the Patent Office considered the case at length. A particular problem that the patent faced was that the European Patent Convention excluded inventions "contrary to ordre public or morality." Seventeen third parties opposed the patent based on moral concerns. But the Patent Office used a balancing test and concluded that the usefulness of the mouse in furthering medical research outweighed any moral concerns about the suffering caused to the mice. It upheld an amended patent.
Are Genes Patentable Material?
Gregor Mendel was an Austrian monk who lived and worked at the time of our Civil War. Mendel grew pea plants in his abbey's garden and studied them to learn how traits (like the color and shape of the pea plant) are inherited. The units of heredity that Mendel studied are what we now call "genes." Genes exist in every living cell. In the 20th century, scientists learned that genes contain the instructions for building the proteins that make cells function and that genes are strung together as long strands of a chemical called DNA.
A large part of every cell's DNA has no known function (and has often been referred to as "junk"). Identifying the parts of DNA that constitute a "gene"--i.e., that code for a protein--requires research and sophisticated technology. It is that work--the isolation and purification of the gene--that the Patent Office relies on in issuing patents on specific genes.
Much controversy has broken out over whether anyone should be able to get a patent for genes. It is well established in U.S. case law that one may not patent the laws of nature or naturally occurring materials. As the Supreme Court stated in Diamond v. Chakrabarty, a discovery--such as a plant found in the wild--is not patentable subject matter. But a "non naturally occurring manufacture or composition of matter" that is the product of "human ingenuity" can be patented. Thus, inventions, but not discoveries, are patentable.
Many of the early gene patents were for genes that encoded for proteins that could be used for medical purposes. One example is the gene for erythropoietin (EPO), a protein that stimulates the production of blood cells. Scientists invented a way to manufacture the protein by isolating the gene for EPO and putting it into living cells that produce the protein in large quantities. The EPO protein is used to treat people with anemia (and sometimes misused by athletes to improve their performances). A patent for the EPO gene was issued to Amgen, a California company. On receiving the patent, Amgen sued Chugai, a competing drug company, for infringing on its patent. Chugai responded in court that Amgen's patent was not valid because it did not meet all the statutory requirements for a patent. In 1991, a Federal Circuit Court of Appeals upheld the patent. The court ruled that Amgen was the first to invent and describe a method for purifying, isolating, and obtaining the DNA sequence that codes for EPO.
Since the early 1980s, many human genes have been patented. A study in 2005 showed that at least 4,382 human genes are claimed in patents. (This represents about 20 percent of the genes in the human body). While courts generally agree that a gene that has been isolated and purified should qualify for a patent, many critics, including distinguished scientists, believe that there should be limits on patenting genes. Some critics argue that properties of the isolated gene, after purification, are not invented by the scientist but rather are the natural, inherent properties of the gene. And as the biotechnology revolution continues, the line between what occurs in nature and the products and processes used by man to make something useful continues to blur.
Legal Requirements for Patents
The law sets four basic requirements for patents. For something to be patented, it must be:
1. Patentable subject matter. Only a "process, machine, manufacture, or composition of matter" may be patented. The invention must fit under one of these broad categories.
2. New. The invention must not be generally known to the public or something that people have already thought of.
3. Non-obvious. The invention must be different from prior inventions and not something easily developed from existing inventions.
4. Useful. The invention must serve a useful purpose.
Dr. Golde's patented Mo cell line was developed with cells taken from Moore's body. When Moore learned about the patent, he sued Dr. Golde (and the company producing products from the cell line). He argued they were using his biopsied tissue without his consent. His case went to the California Supreme Court in 1990. The court ruled that Moore had no ownership right in his tissue and therefore no right to share in the proceeds of the patent. (The court did rule, however, that Moore could sue his physician for failing to obtain a valid "informed consent" because Dr. Golde had not disclosed his personal interests--research and economic--to his patient.)
In ruling that Moore had no ownership interest in the cells taken from his body--and the patent on the resulting cell line--the court could find no legal precedents on which to rely. It did note that the patent on the cell line indicated that the cell line was "factually and legally distinct from the cells taken from Moore's body." The court relied on this fact to support its decision that Moore had no ownership right to the patent.
Having concluded that under existing law Moore could not sue Dr. Golde for conversion (i.e., for interfering with an ownership interest in private property), the court considered whether it should create new law by extending conversion law to cover cell lines. It concluded that doing so would likely discourage important medical research, because it would be almost impossible for researchers who use cell lines in their laboratories to find out where the cell line had come from or whose cells had been used to create the line. Where such difficult policy issues are at stake, the court concluded, they should be decided by the legislature.
Do Gene Patents Promote the Progress of Science?
The purpose of the patent system is to provide incentives for research and innovation. But many critics believe that gene patents may be doing just the opposite. An example often cited is the issuance of patents for the breast cancer gene.
All cancers involve changes in genes called "mutations." In most cases, mutations occur after birth. But some cancers, including breast cancer, can be hereditary, which means that the cancer is caused by a mutated gene present at birth in all cells of the body. Two genes associated with breast cancer are called BRCA1 and BRCA2 (for breast cancer 1 and 2). Women with a family history of cancer who inherit a mutated form of BRCA1 have a much higher risk of developing cancer than women in the population at large.
In 1997 and 1998, the U.S. Patent Office issued patents to Myriad Genetics, a company in Salt Lake City, Utah. One patent covered the BRCA1 gene sequence and any method of diagnosing the likelihood of breast cancer using that sequence. The European Patent Office granted a similar patent to Myriad in 2001. That patent was one of the most controversial ever granted. It drew immediate opposition in Europe. After six years of legal wrangling, the European Patent Office revoked the patent in October 2007.
Opposition to the Myriad patent was based in part on cost and access to medical care, and in part on the limitations the patent put on research and new medical discoveries. Under patent law, the patent holder has the right to prevent anyone else from making, using, or selling the invention for 20 years. The holders of the Myriad patent have a laboratory where they use the patent information to screen for mutations in the BRCA genes. But they refused to license the test to any other companies. So doctors anywhere in the world were required to send all samples for testing to Myriad's laboratory. Doctors in France were angry with this (in part because Myriad charged a fee of approximately $3,000 per test, three times what a French laboratory charged.) And perhaps more important, French scientists discovered that the Myriad test failed to detect 10 to 20 percent of probable mutations in the BRCA1 gene. The patent barred researchers from developing alternative (and better) diagnostic tests. Thus, critics pointed out, a gene patent, like the BRCA patent, can raise the costs of genetic services, diminish the quality of genetic tests, and interfere with access to health care.
Should Congress Act?
The Supreme Court's decision in Diamond v. Chakrabarty to allow the patenting of living things was not unanimous. Justice Brennan, joined by Justices White, Marshall, and Powell, filed a dissent based on amendments to the Patent Act in 1930 and 1970. Brennan wrote that these amendments were clear evidence of "Congress' understanding . . . that 101 does not include living organisms." The dissent concluded: "It is the role of Congress, not this Court, to broaden or narrow the reach of the patent laws. This is especially true where, as here, the composition sought to be patented uniquely implicates matters of public concern." The majority's decision echoed the belief that the concerns about patenting living things should be addressed by Congress, which, it said, could simply exclude organisms produced by genetic engineering from patent protection, or could "craft a statute specifically designed for such living things."
Many experts in biotechnology and gene patenting agree that it is time for Congress to pass legislation to address the many issues regarding biotech patents. One of those issues is the patenting of human biological materials, including the question of whether donors of human tissues and cells should be compensated for their donation. A second issue concerns the negative effects on medical research of patenting gene sequences. Many experts believe that while processes and products (e.g., a new drug or a diagnostic test kit) should be patented, the actual gene/DNA sequence should be available for use by all researchers. A third issue concerns the patent process. In Europe, a third party can file an opposition to a patent. It was this process that resulted in the European Patent Office revoking the patent on the BRCA1 gene. Many believe that a similar process should be put in place in the United States, since existing U.S. law does not allow challenges to patents (except for lawsuits asserting that a patent has been infringed).
Congress will soon have a chance address some of these issues. A bill titled the Genomic Research and Accessibility Act was introduced in February 2007 and is now before the House Judiciary Subcommittee on Courts, the Internet and Intellectual Property. If the bill passes out of committee, our representatives will have a chance to decide whether the current patent law is "promoting Science and useful arts," or in fact impeding progress in medical and scientific research and the development of new technology.
For Discussion and Writing
1. What is a patent? What purpose do you think patents serve?
2. What issue did the U.S. Supreme Court decide in 1980 case of Diamond v. Chakrabarty? What did the court hold? Do you agree with its decision? Why or why not?
3. Why was the Harvard Oncomouse developed? Seventeen third parties objected to the patent in Europe. What is meant by a "third party"? What was the controversy about? Do you agree with the decision made by the European Patent Office? Explain.
4. What is the controversy over gene patents?
5. Why did the patient John Moore sue Dr. David Golde? How did the California Supreme Court rule in this case? Do you agree with the ruling? Explain.
For Further Reading
Magnus, David, Arthur L. Caplan, and Glenn McGee, editors. Who Owns Life. Amherst, N.Y.: Prometheus Books, 2002.
A C T I V I T Y
The House Acts
Imagine that a U.S. House of Representatives subcommittee is considering legislation on issues related to patenting life. The subcommittee will consider the following issues:
1. Should donors of human tissues and cells be compensated for their donation if a patent is issued from research on these cells?
2. Should it be legal to patent actual gene/DNA sequences or should these be made available to all researchers?
3. Should a third party be able to file a objection to a patent? Current law does not allow third parties to object to the granting of patents.
All three of these issues are briefly discussed above in the three paragraphs under "Should Congress Act?"
Form small groups. Each group will role play members of a congressional subcommittee and will decide the three issues above.
Each group should do the following:
1. Select a chair to run the committee meeting.
2. Discuss the first issue, list the pro and con arguments, and decide the issue. Repeat this process for the remaining two issues.
3. Have the chair assign one of the issues to different members of the group for reporting back to the class.
4. Be prepared to report the decisions and reasons for them.
Have the groups report back on each issue and then have the class, role playing the House of Representatives, vote on each issue.