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PERSONALIZED MEDICINE: THE FUTURE IS NEAR

by David L. Fox

A brave new world, in which your physician knows the sequence of all of your genes, and from this, provides "personalized medicine," including individualized preventative and therapeutic care, is virtually upon us. Indeed, as remote as it may seem now, experts generally agree that this transformative medical care milestone will be the standard of medicine across the country in as little as five years.

So-called "personalized medicine" is based on harnessing the explosive developments in DNA (gene) sequencing of recent years with the rapidly advancing science of genomics, the correlating of gene sequences with disease susceptibility and treatments. This affords disease prevention and care that is quite literally personalized to each individual patient. Many believe that this transformation of medical care will be among the most significant developments of all time in healthcare, akin to the discovery of vaccination or antibiotics.

A major driving force behind "personalized medicine" is the astonishing reduction in the time and cost of determining a person's genetic (DNA) sequence. Soon, it will be possible to do so at a cost that is within reach of virtually every patient in the United States. Each person's DNA comprises 20,000 to 25,000 genes and 3 billion chemical base pairs of DNA. In 2003, the landmark Human Genome Project determined for the first time entire genetic sequence of humans. This enormous work took 13 years, $3 billion, and the efforts of laboratories across the globe. Then, just four years later, Dr. James Watson (the Nobel laureate co-discoverer of the DNA double helix, and a leader of the Human Genome Project) was the first person to have his personal genome sequenced entirely. This work took $1 million, and two months. Currently, commercially available DNA sequencing machines can determine an individual's entire genetic sequence for less than $50,000. Most experts agree that within the next two to three years it will be possible to sequence an individual's entire genome for about $1,000. At that point, determining every patient's genetic sequence will likely become a routine part of everyday healthcare.

However, the potential of personalized medicine lies not just in knowing a patient's genetic sequence, but in using that knowledge to prevent and treat diseases. The study of genetic sequences and how they relate to disease susceptibility and treatment (the field of genomics) is also advancing rapidly, in parallel with genetic sequencing. The ultimate goal of personalized medicine is to use a patient's individual, "personalized," genetic sequence both to determine a healthy patient's susceptibility to specific diseases, allowing for prevention of disease by targeted personalized preventative medicine, and in disease patients, to target more effective treatment of disease based on a patient's individualized strengths and weaknesses relative to a disease. Thus, the days of one-size-fits-all generalized preventative care and one-pill-treats-all disease treatment may soon be over.

However, the promise of personalized medicine has been set back recently by discoveries in genomics that many diseases are not caused by a few common genetic sequences, as had widely been thought to be the case. Instead, genomics is showing that disease susceptibility and treatment is linked to a far larger number of unexpectedly rare genetic markers. This makes it more difficult to accurately tie a person's genetic sequence to their susceptibility to a disease or to personalize their treatment of a disease.

Yet, researchers and clinicians remain hopeful that these issues will be resolved quickly, and that personalized medicine will soon transform medical care, leading to a greater focus on preventative medicine and targeted therapies to diseases.

From an intellectual property perspective, the practice of personalized medicine requires advanced machines and techniques for sequencing genomes and screening for specific genetic sequences, as well as the management of enormous amounts of data. For example, it is estimated that personalized medicine will generate billions of data points for each patient, all of which must be carefully maintained and manipulated to be of practical use.

Osha Liang is at the forefront of IP relating to personalized medicine. The firm has a highly coordinated and integrated interdisciplinary team of biotech, mechanical, and IT patent professionals, with the knowledge and experience necessary to protect fully our clients' intellectual property rights in all matters related to the breakthrough art of personalized medicine.

 

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