By Carmela DeLuca, Bereskin & Parr
Intellectual Property
Biomarker patents
where do we stand now? The scope of biomarker patents has been a troubling question for the diagnostics industry in recent years due to a series of controversial US court decisions that have narrowed the scope of patentable subject matter for diagnostic method patents.
T
he debate reached fever pitch earlier this year as the US Supreme Court handed down its decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. (“Mayo”), which found claims directed to the relationship between the concentrations of blood metabolites and response to a therapeutic unpatentable. Some good news arrived more recently in the United States Court of Appeals for the Federal Circuit (CAFC) decision in Association for Molecular Pathology (AMP) and ACLU v. USPTO and Myriad Genetics (“Myriad”), which found isolated DNA and process claims that include at their “heart” use of a man made material to be patentable. So where do we stand now? Generally, biomarker patents involve the use of information. Broadly speaking, a “biomarker” is any biological substance (proteomic, genetic or metabolic) that can be used as an indicator of disease, for example the level of a protein, nucleic acid molecule or metabolite whose concentration reflects the severity or presence of a disease. “Personalized medicine” generally refers to the use of biomarker profiles to individualize medical care. “Biomarker patents” therefore can include claims to isolated biomarker related products (e.g. isolated proteins and isolated DNA), claims to compounds for detecting biomarkers (e.g. antibodies) and method claims for assaying biomarkers and
diagnosing disease or prognosing outcome. “Biomarker patents” can also include personalized medicine type claims involving treating a disease or so called “test and treat” type claims. Distinguishing which uses of biomarker information meet the standard for patentable subject matter and which relate solely to “natural correlations” has been difficult for the courts to articulate, harder for the US patent office to apply and vexing for diagnostic patent holders to comprehend. The judicial narrowing of the patent eligibility of method claims began in 2008 with In re Bilski. The subject patent was a business method patent, however its effects were not limited to business patents. The CAFC held that the applicable test for patentable subject matter was the machine or transformation test which required the method be tied to a machine or result in a transformation to be patent eligible. Its effect was to narrow the scope of patentable subject matter for diagnostic method claims. In 2010 the US Supreme Court issued an opinion on appeal (Bilski v. Kappos) affirming the judgment of the CAFC but rejecting that the machine and transformation test was the sole test for pat-
ent eligibility for process claims. The court decided that the Bilski invention was not patent-eligible subject matter because it was an attempt to patent an abstract idea. At the same time Bilski was percolating through the courts, Mayo was being judicially considered. The patents in question in Mayo were directed to methods for determining optimal dosages of thiopurine drugs to treat autoimmune diseases. They involved administering the drug to the patient and determining the level of a metabolite. A level less than a predetermined amount indicated a need to increase the amount of drug subsequently administered to the patient and a level above a predetermined level indicated a need to decrease the amount of drug subsequently administered to the patient. The district court in Mayo found the claims were invalid for lack of patentable subject matter on the basis that the claims in question were directed to natural phenomenon. Later on appeal, the CAFC reversed and held that claims that include an “administering” step or “determining” step meet the machine or transformation test and are patent eligible. However, the decision
OCTOBER 2012 BIOTECHNOLOGY FOCUS 25
