Since the completion of the Human Genome Project in 2000, we are already seeing changes in health care. As we better understand the genetic basis of disease, we are able to target therapies to these root causes of disease. This paper will consider how two nascent areas of genetic medicine, pharmacogenetics and biologies, interact with international intellectual property ("IP") law. Neither of these areas fits comfortably in the traditional intellectual property model we use for pharmaceuticals. Due to their growing importance, however, the implications for international law concerning these advances are great.
The first section of the paper will give a background on what biologies and pharmacogenetics are. section II will examine regulatory protections given to pharmaceuticals both nationally and abroad. section III will consider what patent protections have been awarded to pharmaceuticals in the US and internationally. section IV concludes.
I. WHAT ARE BIOLOGICS AND PHARMACOGENETICS, AND WHO CARES?
A. WHAT ARE BIOLOGICS?
Biologies are drugs manufactured through biological processes. They are some of the hottest drugs around today and are certainly among the most expensive. Unlike chemical drugs, which typically are comprised of several hundred atoms, biologies are complex proteins that contain thousands of atoms folded over onto themselves.1 This structural complexity makes them much more difficult to create, and consequently to duplicate.
Some biologies act as catalysts for biologic processes that subsequently occur in the patient's body. A major example of this type of biologic is insulin. Diabetics either do not make insulin properly or are desensitized to it, but bacteria can be manipulated to produce human insulin when injected with the human gene for insulin. Likewise, many vaccines are created by the biologic process.
Other biologies, called monoclonal antibodies, interfere with the adhesion of certain compounds to cell receptors. For example, rituximab is the generic name for a monoclonal antibody that adheres to a particular molecule found on the surface of the cells of abnormal B-cell lymphocytes that often occur in nonHodgkin's lymphoma. Rituximab binds to this molecule and causes the body to destroy the cancerous cell. In addition to treating cancer, monoclonal antibodies are useful for treating anemia, diabetes, hepatitis, and multiple sclerosis, and are an effective growth hormone (which is often prescribed to prevent AIDS-related wasting disease).
Because they are proteins and not chemicals, biologies must be manufactured through living organisms. This makes them expensive to produce, and consequently expensive for consumers.2 In 2001, 25 percent of all increases in US hospital expenditures (which themselves account for 30 percent of all medical expenses) were attributable to four products, three of which were biologies (epoetin alfa, infliximab, and rituximab).3 Biologic sales in the US may top $56 billion in 2006.4
B. WHAT ARE PHARMACOGENETICS?
The term pharmacogenetics (commonly called "personalized medicine" in the lay press), describes the process of targeting drug therapies to individual patients' genetic make-up. Unlike biologies and chemical compounds, it is not a drug product per se.
Pharmacogenetics aims to improve pharmaceutical safety and efficacy based on genetic variation. This variation can occur in two ways. The first way pharmacogenetics can be applied is to attack irregularities within the disease itself (for example, drug-resistant strains of HIV or differences in tumor type). A prominent example is Herceptin, which can effectively treat breast cancer, but only works in about 25 percent of all women with the disease. Patients need to be genetically screened before they are prescribed the medicine because there is no other way to distinguish responders from non-responders.
The second way pharmacogenetics can be effective is when a patient's genetic make-up affects interaction with a drug. …