Summary: Understanding Gene Patenting

In “Patenting Life,” Michael Crichton argues that the government is mishandling the patenting office with the awarding of patents for human genes. Gene patenting is blocking the advancement of modern medicine and could be costing many patients their lives. The hold on research results in the discovery of fewer cures for modern diseases.

I really enjoyed your post as I did not know it was possible to patent a gene. I really liked the examples you gave as it helped me understand what it means for a gene to be patent and what it affects it can have on the patient and their family. I believe this is something that should not be legal as if someone else can find a cure for diseases instead of the organization who owns it they should be allowed to do so.

In 2004 Mayo Collaborative Services and Mayo Clinic Rochester (Mayo) announced that they would be releasing a diagnostic test that utilizes thiopurine drugs to treat autoimmune diseases. Mayo’s announcement came after they had purchased and utilized similar diagnostic tests based on Prometheus Laboratories, Inc. (Prometheus) patents. After Mayo’s Prometheus sued Mayo claiming patent infringement. This paper will examine the Mayo Collaborative Services v Prometheus Laboratories, Inc. case that refers to the patent infringement law. We will examine both sides of the case by exploring Diamond v. Diehr, Mackay Radio & Telegraph Co. v. Radio Corp. of America, Bilski v. Kappos, and Parker v. Flook’s relationship with the case. This paper will ultimately conclude in favor of Mayo because Prometheus’ patents effectively claim natural laws and are therefore not patent eligible.

Calfee on the other hand explains the opposite view from Crichton. Calfee thinks that human genes are able to be patented without relying on nature. “You have to isolate and purify the gene segment in a way that does not occur in nature, and you have to establish some sort of concrete use”utility”is the standard word to satisfy PTO (Patent and Trademark Office) standards.” (444). Which is a good explanation on how they would be able to patent another gene. Along with that, Calfee goes into giving more information using a scenario about what is something called “patent thicket”. “In which research is hemmed in by the possibility of bumping into all sorts of patents, such as those the researcher never knew existed.”

The Dr.’s view on gene patents is the halt they put on testing and studying of genes and current studies to find a major breakthrough for the disease. (441) It is not only fair to the researchers who spend their lives trying to develop a cure but also to the loved ones and

Although the treatment is costly and only available in clinical trials, gene therapy has treated some of the most known diseases, like Parkinson’s disease. People who are for gene therapy believe that it will change our world by getting rid of sickness. They think of a world without cancer and Parkinson’s disease. However, the people against gene therapy see a world with technology overtaking civilization. In their eyes, they think that gene therapy is wrong because of the side effects and the concept behind it. In addition, when thinking about gene therapy, the opposers conjecture that changing the genetic makeup of someone affected with genetic illness is wrong. I, on the other hand, believe that changing the genetic makeup of someone that is ill and suffering is exceptional because it is to their advantage. All in all, gene therapy is a heavily debated topic, but I believe that gene therapy can change our world in a positive

Gene therapy is defined as the medical replacement of defective genes in living human cells; its aim is to replace the activity of a defective gene by activating a dormant gene which has a similar function (Wheale & McNally, 212). Under gene therapy comes the politically controversial Human Genome Project, a fifteen-year, $3 billion federally-funded biology program. The goal of the project is to isolate the defective gene on the chromosomes which comprise the human genome (Fletcher, 2). In this manner, the Human Genome Project may be able to rid the cancer-ridden genes from human DNA, thereby curing cancer permanently. The project has been the focus of much scientific and political controversy over the past few years for its possible ramifications are extensive to all of human existence.

Competition amongst researchers intensified and instead of collaborating with each other, they kept their research restricted, in hopes of striking it rich someday. As an example, there are currently 4,875 U.S. patents for Lyme disease in comparison to 808 for Parkinson’s disease, or 2,148 for Alzheimer 's disease. (Due to the similarity in symptoms, and the unknown cause of both Parkinson’s, and Alzheimer’s disease, some believe it is really just Lyme disease.) Nevertheless, with all the interest in a “hard to catch and easy to cure” disease like Lyme, the number of patents cannot be ignored; patents equal money.

According to the First Patent Act passes in 1790, a patentable invention or discovery must be artificial, non-obvious, novel and useful. Current gene patents, refer to DNA sequences with a known function or use that are altered in some way from their form inside a cell.( Ricki Lewis (1997) So patented gene is different from its intracellular counterpart in that it is no longer part of a chromosome. When something was isolated from its original natural state, it’s no longer a natural product, something artificial is created. The isolated gene sequence is not nature anymore. Also, DNA sequence can be the protein –encoding portion of gene, gene on chromosomes, and patentable genes do not necessary come from human. For these reasons, I think the researchers or Biotechnology Company may patent DNA. Some argument about “gene patent” include potentially limited access, no second opinion opportunities, no price competition and less incentive to improve the gene test. (David H. Ledbetter (2008) These investigators are concerning about the accuracy and affordability of gene test.

The Association for Molecular Pathology and  several other medical associations, doctors and patients sued the United States Patent and Trademark Office and Myriad Genetics to challenge patents related to human genetics. Myriad argued that once a gene is isolated, and therefore distinguishable from other genes, it could be patented. By patenting the genes, Myriad had exclusive control over diagnostic testing and further scientific research for the BRCA genes. The district court granted summary judgment in favor of petitioners, holding that isolating a gene does not alter its naturally occurring fundamental qualities. The U.S. Court of Appeals for the Federal Circuit reversed, holding that isolated genes are chemically distinct from their natural state in the human body. In March 2012, Petitioners sought certiorari; the U.S. Supreme Court vacated the Federal Circuit judgment and remanded for further consideration in light of Mayo Collective Services v. Prometheus Laboratories. On remand, the Federal Circuit again upheld the patentability of the BRCA

“Patents versus patenting: implications of intellectual property protection for biological research”. Nature Biotechnology 27, 36 - 40

The patenting race takes advantage of the same computer technology that made the sequencing possible. Companies seeking patents have been using automated DNA-sequencing machines to identify genes easily and cheaply. At the time when they file for the patents,

One specific case was the Association for Molecular Pathology v Myraid Genetics case. For the last 20 years, Myraid Genetics has researched gene mutation. Myriad sequenced the BRCA1 and BRCA2 genes. The genes were associated with hereditary breast and ovarian cancer. In 1996, Myraid had obtained patents on both genes and it became profitable. The first molecular diagnostic test for breast and ovarian cancer were around $3000. In 2009, Myraid was sued by the Public Patent Foundation (PUBPAT), the American Civil Liberties Union (ACLU), and Breast Cancer Action. The court ruled that genes could not be patented as they are a natural occurrence. The court ruled: “a naturally occurring DNA segment is a product of nature and, as such, cannot be patented. In contrast, so-called complementary DNA - an artificial product designed to mirror the coding parts of genes - is eligible for patent protection because it is not naturally occurring.” Myraid could only patent the process of their findings not the actual gene itself. The solution to the problem of halting science that benefits the good of human kind is the verdict that nature cannot be

This is how Wikipedia explains what a biological patent is. What is doesn’t say is that when this refers to a gene, this actually came from a living organism and was created by nature (God from the beginning), yet when is patented, it becomes a human invention. What an irony!

Court decision on gene patents impacts GM crops by Mateusz Perkowski explores the issue of patenting genes and what are the standards for a genes to be patentable. This article is from the The Capital Press, which is a weekly agricultural newspaper covering the West Coast of the United States. Perkowski is a writer and journalist that graduated from Willamette University. This is a good resource for those who are researching about patents and its connection to law and what makes a gene patentable. It is not that long however, it uses quotes from reputable sources such as Chris Holman, a law professor, that make this article a valuable source for this topic in particular. This article is relevant towards my research paper since it provides evidence