Tension between the broad language of 35 U.S.C. § 101 and limitations of its scope is an emerging issue in recent court decisions attempting to resolve the issue of whether patent claims preempt a natural phenomenon. These decisions significantly impact the patentability of personalized medicine inventions that rely on discovery of correlations between biomarkers and the safety and efficacy of therapeutic treatment in an individual. While a "business methods" case, the Federal Circuit's In re Bilski decision may have a profound impact on medical diagnostics and personalized medicine patents by altering the ability of personalized medicine companies to protect the technology behind their products. A patent law that identifies the unique specificities of a particular industry will better serve the advancement of biotechnology and personalized medicine.
Michael J. Shuster and Juleen Konkell,
Of Babies and Bathwater - The Impact of In Re Bilski on Life Science Patents,
1 Hastings Sci & Tech. L. J. 153
Available at: https://repository.uchastings.edu/hastings_science_technology_law_journal/vol1/iss2/2