by Dennis Crouch
Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018) offers an example of a claim on the cusp of eligibility. In a 2-1 decision, Vanda’s schizophrenia treatment claim was found eligible with Judge Lourie penning the majority and Chief Judge Prost in dissent. Judge Hughes was the swing vote here.
I have several thoughts on the patents at issue here, but they boil down to the following (1) Vanda’s claims should be patent eligible; (2) but the claims are not patent eligible under Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012) and Alice Corp. Pty. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014).
Now, West-Ward has filed its petition for rehearing en banc on the following question*:
1. Whether adjusting a dose of an old drug based on a patient’s genetic risk of poorly metabolizing it is eligible for patenting under 35 U.S.C. § 101.
A brief in support has been filed by Inventia and Mylan.
I previously wrote that “the majority’s approach appears to latch onto simple patent drafting tricks as the basis for distinguishing Mayo — an approach directly rejected by the Supreme Court in Mayo.”
The claim in Vanda is directed toward a method of treating a patient suffering from schizophrenia with the drug iloperidone. The drug was already known as a schizophrenia treatment prior to the invention here, but some individuals did not tolerate the drug well (risk of “QTc prolongation”). The major discovery of the inventors here was that a genetic difference (the “CYP2D6 genotype”) led to those folks likely being poor metabolizers of iloperiodon. The patent then has two basic steps:
- Determining whether the patient is genetically a poor metabolizer of the drug (i.e., has the CYP2D6 genotype)
- Administering iloperidone to the patient (<12 mg per day if express CYP2D6 genotype; otherwise 12-24 mg per day) in order to reduce the risk of “QTc prolongation” for poor metabolizers.
The basics here is that the inventors discovered the relationship between the genetic expression, a potential risk, and a safe drug level. That discovery itself is clearly not patentable and so the patentee added
The Supreme Court’s Mayo decision also involved a personalized treatment approach (this time for IBD) based upon metabolization rate with the following two steps:
- Administering the drug (6-thioguanine) to treat the GI disorder; and
- Measure (“determine”) the level of the drug (6-thioguanine) in the blood — with low levels (<230 pmol per 8×108 red blood cells) indicating a need to increase the next drug dosage and high levels (>400 pmol per 8×108 red blood cells) indicating a need to decrease the next drug dosage.
In distinguishing these claims the majority explained that
Mayo was a diagnostic method while Vanda is a treatment method. The reality is though that both are diagnostic and treatment oriented. What the majority suggests, but does not say, is that Mayo’s claims would be patent eligible if they added one more step of injecting the new dosage. To me added injection sounds like the type of non-inventive post-solution activity that cannot transform an ineligible law of nature into a patent eligible invention.
Stepping back a little bit — One way to think about this case is as the flip side of Sequenom. In that case, the Federal Circuit followed Mayo, but expressly called for the Supreme Court to revisit its eligibility doctrine. In his en banc denial concurring opinion, Judge Lourie wrote: “I find no principled basis to distinguish this case from Mayo, by which we are bound.” However, the Supreme Court did not grant certiorari in Sequenom. Rather than following that same approach — asking for help from the Supreme Court — The court in Vanda decided to make it happen themselves. In my view, an en banc denial here will be a high flaunting of Supreme Court precedent — the question then will be what – if anything – will the Supreme Court do about it?