Back in April, the Court of Appeals for the Federal Circuit (CAFC) handed down a split decision that breathes life into an otherwise suffocating Mayo/Alice world. This case, Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd. has been contrasted and compared to the Supreme Court’s original Mayo finding, since both Mayo and Vanda related to drug dosing and involved a law of nature. However, the comparison ends there, as the underlying patent in Vanda was deemed subject matter eligible, whereas the patent in Mayo was not. The Mayo decision, in conjunction with the Alice decision of course, led to the creation of the current two-step patent eligibility test that has proven difficult to consistently apply. Three key differences likely led to the divergence between the Vanda and Mayo decisions: (i) the focus of the innovation, (ii) the actual method steps recited, and (iii) the clarity in presenting the result of the application of the method. Furthermore, the USPTO recently issued a guidance memorandum analyzing the decision.
As background, Vanda Pharmaceuticals sued West-Ward Pharmaceuticals for filing an Abbreviated New Drug Application (ANDA) for a generic form of Fanapt, an iloperidone treatment for schizophrenia. Initially, two patents were asserted to have been infringed: US Patent 8,586,610 and Reissue Patent RE39,198. The proceedings focused on the ‘610 patent. The ‘610 patent deals with a method of determining a safe dosage of the drug in schizophrenia patients by identifying those at risk of experiencing an adverse cardiac side effect.
The patent in Vanda took a proactive approach, reciting a method of treatment.
- Diagnostic Assessment (to identify those patients at risk for an adverse cardiac effects)
- Dose Determination
The main patent at question in Mayo (Patent No. 6,355) claimed a treatment paradigm for an “immune-mediated gastrointestinal disorder” that involved 3 steps.
- Diagnostic Assessment
- Dose Adjustment
Although these cases have several similarities, highlighting their differences gives a better insight into why one patent was found eligible and the other ineligible.
Focus: The focus of the Mayo patent is on the drug metabolism and subsequent dose adjustment, while the focus of the Vanda patent is on how to safely treat a patient by prescreening for those patients at higher risk for an adverse effect. As stated by Judge Lourie,
“Although the representative claim in Mayo recited administering a thiopurine drug to a patient, the claim as a whole was not directed to the application of a drug to treat a particular disease.” (Mayo Collaborative Services v. Prometheus Laboratories, Inc.566 U.S. 66 (2012))
This provides guidance as to how to pass the Alice/Mayo test by developing innovative ways to treat specific diseases, instead of diagnostic tests and treatment paradigms in response to drug treatment.
Method: The method developed in the Mayo patent is reactive. The patent relies on observing a natural phenomenon, namely the administration and metabolism of a drug, and reacting in a predictable way to adjust the drug dosage. The method in the Vanda patent, conversely, is proactive. In taking the step to identify those patients at higher risk and applying that information to establish an appropriate dosage level, the claim is not directed to a law of nature the way it is in Mayo. The CAFC highlights the finding in Rapid Litigation v. CellzDirect, which also involves the application of a natural phenomenon to a new method. It is this application, and not the treatment changes themselves, that distinguish these two cases.
Clarity: It is important to remember that although experts in fields are responsible for the research, innovation, and drafting of patent applications, those reviewing or ruling on the validity of those patents will, by necessity have less expertise. This difficulty in simply conveying complicated information was not made easier with the Mayo/Alice test. The initial summary of the invention in Mayo describes it as:
“a method of optimizing therapeutic efficacy of 6-mercaptopurine drug treatment of an immune-mediated gastrointestinal disorder”.
To an inexpert observer trying to determine eligibility of a new invention, optimization suggests that the basics have been discovered, and the rest is small, obvious tweaks. In fact, clinicians frequently optimize drug doses on their patients. The novelty of the concept has been surrendered by its own application. Conversely, the Vanda patent clearly explains that
“the discovery that treatment of a patient, who has lower CYP2D6 activity than a normal person, with a drug that is pre-disposed to cause QT prolongation and is metabolized by the CYP2D6 enzyme, can be accomplishing more safely by administering a lower dose of the drug than would be administered to a person who has normal CYP2D6 enzyme activity.”
Instead of focusing on small changes or modifications in drug dosing, it is important to note that Vanda focused on a method in an innovative way to treat a disease.
The USPTO further clarified this distinction in their memo. In it, they make clear that the “arguably conventional genotyping and treatment steps” were not patent ineligible because the claim, as a whole, was not directed to the link between genotype and adverse reaction. It should be noted, however, that this clarification only “addresses the limited question of how to evaluate the patent eligibility of ‘method of treatment claims’,” and its scope should be limited to that.
After the Vanda case, we can say that the key to a healthy patent application is the same as that of a healthy diet – stay focused (on patient health), stay active (develop proactive instead of reactive methods), and be clear about goals (in your preamble); in other words, hold the Mayo.