7 minute read
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.
the 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?
Advertisement
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 patent 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
of the CAFC was vacated and the CAFC was asked to reconsider the decision in light of the US Supreme Court’s determination in Bilski, that the machine and transformation test was not the only test for patent eligibility of process patents. The CAFC again upheld the claims.
The US Supreme Court, interested in this outcome, agreed to review the decision and consider the question whether the test for patentable subject matter is satisfied by a claim that covers observed correlations between blood test results and patient health.
In a decision that stunned the diagnostics industry, the US Supreme Court reversed the CAFC’s twice finding of patent eligibility and held that certain personalized medicine claims were directed to a natural law and unpatentable even though the rejected claims contained both an administering step and a determining step. The US Supreme Court, in rejecting the claims, indicated that its conclusions rested upon examination of the particular claims in light of the Court’s precedents stating that “[t]hey warn us against upholding patents that claim processes that too broadly preempt the use of a natural law.” The court considered the claimed steps to be conventional, well-known and routine. Something more, according to the US Supreme Court was needed to render a natural correlation patent eligible. The decision however contained little guidance on what was “the something more.”
One thing was clear - the bar for patentable subject matter for diagnostic claims had been significantly raised.
A partial reprieve came in August 2012 when the CAFC handed down its decision in Myriad. At issue in Myriad were composition claims directed to isolated DNA, specifically the BRCA-1 and BRCA-2 genes linked to breast and ovarian cancer, and method claims directed to screening for gene mutations or potential therapeutics.
Method claims directed to screening for mutations recited only “comparing” or “analyzing” DNA sequences were found to be patent ineligible as such claims included no transformative steps and covered only patent ineligible abstract mental steps.
However, Myriad’s right to patent isolated DNA of BRCA1 and BRCA2 was affirmed. The CAFC stated that “[p]ermitting patents on isolated genes does not preempt a law of nature. A composition of matter is not a law of nature.”
The CAFC also reversed the district court’s decision that Myriad’s method claim to screening potential cancer therapeutics was directed to patent ineligible scientific principle. The CAFC reiterated that the screening claim required in addition to the step of comparing the cells’ growth rates, the steps of growing transformed cells, and determining those growth rates. The CAFC relied on the fact that those steps were transformative stating: “Although the Court has held that certain transformative steps are not necessarily sufficient … if the recited steps only rely on natural laws, we once again even in light of Mayo, arrive at the same conclusion of patent eligibility because at the heart of the claim is a transformed cell, which is made by man, in contrast to a natural material.”
The CAFC added performing “operations, even known types of steps, on, or to create, novel, i.e., transformed subject matter is the stuff of which most process or method invention consists. In situations where the objects or results of such steps are novel and nonobvious, they should be patent-eligible.”
Based on the above case law it seems clear process patent claims that include only mental steps such as “analyzing” or “comparing” do not meet the test for patent eligibility. Isolated DNA is patentable and claims that involve at their “heart” a man-made product may meet the requirements for patentable subject matter. Similarly claims that “create novel, i.e., transformed subject matter… where the objects or results of such steps are novel and nonobvious” as in the case of a novel biomarker, particularly where the determination is tied to a specific method would seem to be patent eligible.
Can Mayo and Myriad be reconciled? Perhaps. Although Mayo claims involved administering a drug, the “heart” of the claims in question involved determining the level of the metabolite to determine the optimal dosage of the drug. The determining step however was not novel or nonobvious as the level of metabolite was routinely assessed to assess toxicity. What was new in Mayo was the precise metabolite level associated with toxicity. Further, although determining the metabolite level arguably involves a transformation, specific steps for determining the metabolite level and the transformation produced in such steps was not claimed. In Myriad, the screening claim found patentable involved several steps which arguably did not pre-empt all methods. Accordingly it would seem that the cases can be reconciled. Whether these distinctions should affect patentability is however a different question. Although it is too early to assess the extent of the full impact of the Myriad decision on process claims, reassurance that isolated DNA remains patentable and guidance on what can transform a natural correlation to a patent eligible application are welcome developments. It also remains to be seen whether the diminished scope of patent protection will affect investment into the discovery and development of new biomarkers.
Carmela DeLuca, Ph.D. (Exp. Med.), J.D. is an associate lawyer with Bereskin & Parr LLP’s Biotechnology and Pharmaceutical Practice group. Carmela can be reached in Montréal at 514.871.2929 or cdeluca@bereskinparr.com.
For more Intellectual ProPerty information visit our COMMERCIALIZATION Web Portal at
