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Pharmaceutical and biotech companies constantly search for "biology of disease"-based patents. SCI Pharmaceuticals, Inc. was founded in 1998. The company produces and licenses intellectual property, specifically, patents relating to the biology of disease. Who needs such patents? Pharmaceutical and biotech companies constantly search for "biology of disease"-based patents. Consider the following statements by such companies on the significance of biology in drug discovery. According to Merck, "In Basic Research, biochemists and molecular and cell biologists with an understanding of the pathophysiology of human diseases play a key role in the drug discovery process by identifying the right targets on which to concentrate our research efforts" (1). According to Mark C. Fishman, Global Head of Research at Novartis, "To develop a drug that is both effective and well tolerated, you need to understand the molecular mechanism that causes a disease" (2). According to Joshua Boger, President & CEO of Vertex (a biotech company), "We do not go into projects where the biology is uncertain ... We look for the biology to be well-understood. We look for the chemistry and the biophysics to be doable in a short period of time" (3). Today, good "biology of disease"-based patents are in short supply. Biologists discover the disruption (mutation, pathogen, toxin, etc.) that causes the disease. Chemists find the compounds that eliminate the disruption and cure the disease. Traditionally, pharmaceutical scientists play the role of the chemists. When good "biology of disease"-based patents are in short supply, the chemists are lost and the pharmaceutical industry experiences a crisis in productivity. In BusinessWeek, Amy Barrett writes, "After a golden age in the 1990s, when drugmakers launched what seemed to be an endless stream of blockbusters, the industry has hit a disastrous dry spell ... productivity in drug labs is falling. The trade group Pharmaceutical Research & Manufacturers of American say the R&D spending it tracks for its big drug company members soared from $21 billion in 1998 to an estimated $32 billion in 2002. But new drug approvals fell from 35 in 1999 to 17 last year" (4). R&D spending is up but new drug approvals are down. Diane Jorkasky, Vice President of Clinical Sciences at Pfizer laboratories in Groton, Connecticut was interviewed about the crisis in The Scientist. Jorkasky said, "'There is a greater sense of urgency because of the profound economic impact that the lack of productivity is having ... If we can't increase the productivity we can't get drugs in the market. This is a huge problem'" (5). SCI owns several good "biology of disease"-based patents. SCI's patents are based on the discovery that the most common cause of many chronic diseases is starved, not injured (mutated) genes . In fact, starved genes are the leading cause of many chronic diseases such as atherosclerosis, cancer, obesity, osteoarthritis, type II diabetes, alopecia, type I diabetes, multiple sclerosis, asthma, lupus, thyroiditis, inflammatory bowel disease, rheumatoid arthritis, psoriasis, atopic dermatitis, graft versus host disease, and other chronic diseases. This discovery was recently published in a book, Microcompetition with Foreign DNA and the Origin of Chronic Disease, by Hanan Polansky, PhD. The book describes the effect of gene starvation on gene expression, cell function, and the health of the individual. See an non-technical explanation of the discovery on the www.causeofcancer.org website. The book has been sent to leaders in the scientific community for review. The response was great. The publisher's website (www.cbcd.net/reviews.htm) includes more than 30 of these reviews. According to the reviewers, the book describes a real breakthrough in the biology of chronic disease. The website also includes the biographies of the reviewers. SCI Pharmaceuticals' patents describe how measuring the intensity of gene starvation can be used to determine the risk of developing a chronic disease, and how a decrease in this intensity can be used to treat the disease. The following references are available by clicking on the links below: (1) http://merck.com/mrl/research/areas/basres.html (2) http://www.businessweek.com/magazine/content/03_21/b3834028_mz044.htm (3) Werth, Barry. The Billion Dollar Molecule, One Company's Quest for the Perfect Drug. New York, Simon and Schuster. 1995;360-361. (4) http://www.businessweek.com/magazine/content/03_19/b3832089.htm (5) http://www.the-scientist.com/yr2003/may/prof1_030519.html
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