The pharmaceutical, biotech, hardware, and software industries are exploring new ways to share complex biomedical data and to accelerate the pace of discovery in the area of life sciences. A new discipline, known as Bio-IT, has emerged from this process.
One area of Bio-IT that is evolving particularly quickly is "personalized medicine". Personalized medicine refers to the concept that managing a patient's health should be based on the individual patient's intrinsic genetic information (genotype) so that medical care can be tailored to the patient's needs. Several approaches to personalized medicine have been discussed in medical practice, but the genotype-centered approach is not yet in widespread use clinically. At the heart of personalized medicine are diagnostic and theranostic tests that reveal, for example, a patient's risk of developing a particular disease or likely response to a particular drug.
In the area of patents, personalized medicine provides many business and humanitarian opportunities, but also raises some challenges. For example, recent court decisions in the United States and Patent Office practice in Canada make it more difficult to get patent protection for diagnostic methods and other Bio-IT related inventions, unless the claims clearly recite a "process" that is tied to a particular machine or apparatus, or transform a particular article into a different state or thing.Without taking these factors into consideration, many patents in the Bio-IT field may be invalid and pending patent applications will consistently be rejected for failing to meet the criteria for patentability.
Experienced patent agents and counsel can assist Bio-IT companies in defining scope of patents claims in the most appropriate fashion and to ensure that a granted patent has value.