Patent Riffs and Links – Vanda/Mayo Discussion

Opinion for “Vanda Pharm., Inc. v. West-Ward Pharm. Int’l Ltd, Appeal No. 2106-2707, -08 (Fed. Cir., April 18th 2018”

Federal Circuit Upholds Vanda Fanapt Personalized Method Claims Against Patent Eligibility Challenge | PHARMAPATENTSBLOG
Arguments: “The Federal Circuit decision was authored by Judge Lourie and joined by Judge Hughes. Chief Judge Prost dissented.

The Federal Circuit summarized the parties’ patent eligibility arguments as follows:

West-Ward argues that the asserted claims are ineligible under § 101 because they are directed to a natural relationship between iloperidone, CYP2D6 metabolism, and QT prolongation, and add nothing inventive to those natural laws and phenomena.
West-Ward contends that the asserted claims are indistinguishable from those held invalid in Myriad and Mayo.
Vanda argues that the claims are not even directed to a law of nature or natural phenomena (i.e., that the district court erred at step one of its Mayo/Alice analysis).
The Federal Circuit agreed with Vanda”

Federal Circuit Finds Personalized Medicine Invention Subject Matter Eligible | JDSUPRA
Dorsey & Whitney LLP: “Vanda Pharmaceuticals suggests that method-of-treatment claims, particularly those that recite administering a drug, and even more so those that recite administering specific doses of the drug, may be patent eligible. Patent applicants in these fields may increasingly seek to present claims as method-of-treatment claims (patent eligible in Vanda) rather than methods ‘of optimizing therapeutic efficacy for treatment (patent ineligible in Mayo). Including an affirmative step of administering a drug, especially a step of administering one or more specific dosages of the drug, may help render claims patent eligible. Note, however, that the Court in Mayo cautioned against ‘drafting effort[s] designed to monopolize the law of nature itself. Although drafting efforts seemed to help Vanda Pharmaceuticals in the present case, future decisions in this volatile area of patent law may come to a different conclusion.”

Federal Circuit Holds Vanda’s Method of Treatment Claims Pass Mayo/Alice’s Step One | JDSUPRA
Directed to… “The majority observed that the claims in Mayo were not directed to a novel method of treating a disease, but instead “a diagnostic method based on the relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.”[10]

Conversely, the majority explained that the claims in Vanda are “directed to a method of using iloperidone to treat schizophrenia”:[11]

The inventors recognized the relationships between iloperidone, CYP2D6 metabolism, and QTc prolongation, but that is not what they claimed. They claimed an application of that relationship. Unlike the claim at issue in Mayo, the claims here require a treating doctor to administer iloperidone in the amount of either (1) 12 mg/day or less or (2) between 12 mg/day to 24 mg/day, depending on the result of a genotyping assay.[12]

Eligibility: Preamble Does the Trick for Federal Circuit | PATENTLYO
Side-by-side comparison of the Vanda and Mayo claims – “Importance of the preamble: The majority (Judges Lourie and Hughes) took the other side – and argued that the claiming differences were important between Mayo and Vanda. Importantly, for them, the preamble in Mayo directed the claims toward ‘a method of optimizing therapeutic efficacy while the Vanda claims are directed to ‘a method for treating a patient.”

Skilled in the Art: The Latest 411 on Section 101 | LAW
No right answer: “Chief Judge Sharon Prost dissented, saying the dosing method is similar to the claims in Mayo in that they cite a law of nature and lack an inventive concept that transform it into patent-eligible subject matter. ‘My conclusion is not at odds with CellzDirect, she added.

Prost ought to know. She was the author of CellzDirect.

In short, Prost, Lourie and Hughes were proving Iancu right. ‘Multiple people looking at the same patent claims often have trouble agreeing on, and predicting, the outcome, he told the chamber last week.”

Federal Circuit Speaks on Patent Eligibility of Method-of-Treatment Claims: Key Takeaways from the Vanda v. West-Ward Decision | PAULHASTINGS
“The Vanda decision further builds on CellzDirect by consolidating the importance, at step one of the Mayo test, of not merely identifying a patent-ineligible concept, but determining ‘whether that patent-ineligible concept is what the claim is ‘directed to.’ CellzDirect, 827 F.3d at 1050. Given the general view among the Federal Circuit Judges that courts are bound by the Supreme Court’s strong language with respect to step two of the Mayo test (see, e.g., the Federal Circuit’s denial for rehearing en banc in the Ariosa case), practitioners can expect that crucial eligibility disputes will increasingly be played out at step one. Accordingly, we can expect future cases to test the limits of step one, and indeed Chief Judge Prost foreshadows this in her dissent in Vanda. See Vanda Dissent, at 1-2 (opining that the majority ‘conflates the inquiry at step one with the search for an inventive concept at step two).”

Federal Circuit Circumvents Mayo/Alice Rule in Vanda v. West-Ward | NATLAWREVIEW
Questions left unanswered: “Apart from the fact that the ‘610 patent claims are ‘method-of-treatment claims, Vanda was able to convince the majority of the panel that the claim was not a covert attempt to claim a natural law. (Actually, there are two correlations in the ‘610 claims – the correlation between mutations in the CYP2D6 gene and normal or ‘poor metabolizer activity of the gene product (an enzyme) and the correlation between normal and poor metabolizer enzymes and the risk of a particular heart condition if the patient is treated with Ilo.)

And is genotyping patients and putting them into a plurality of distinct treatment groups even reasonably characterized as a ‘natural phenomenon? Would Prometheus have prevailed in Mayo if the claim had ended with a method of treatment step for some but not all of the patients? And would have helped if, in the preamble, the patient was recited to be experiencing a poor response or toxic side-effects prior treatment with the drug, so that the doctor was required to alter the dosing based on the patient’s condition to bring their 6-TG into the optimal range?”


The Federal Circuit Addresses Patent Eligibility of Methods of Treatment For First Time Post-Mayo | JDSupra | K&L Gates
“…the holding of the majority in Vanda indicates that claims reciting treatment ‘for specific patients using a specific compound at specific doses to achieve a specific outcome’ have a strong position regarding patent eligibility … Furthermore, the statements of the majority in Vanda distinguishing the claims at issue (and also those of CellzDirect) from those found ineligible in Mayo are insightful. In this regard, the majority in Vanda emphasized that the ‘end result’ of the claims in Mayo was simply observation or detection, even though the claimed method there began with an ‘administering’ step. To the contrary, the methods of Vanda and CellzDirect end with a tangible step that could not be conducted merely mentally. Accordingly, in addition to the specificity of an ‘administering’ step, the role of the ‘administering’ step may be critical for eligibility, i.e., whether it is the basis for mere observation or detection or instead a tangible application of the alleged natural law… Moreover, the holding of the majority in Vanda suggests that disclosures in the specification regarding the benefits of the actual treatment…”

Did the Supreme Court Bless Claims to Methods of Treating? | LEXOLOGY
Banner & Witcoff discusses Oral Argument (Jan): “West-Ward, the patent challenger, told the court that Vanda’s claims were just like the claims at issue in Mayo. Both Judge Hughes and Judge Prost seemed to find that assertion surprising. Judge Hughes asked, ‘How can you make that statement so broadly? We have dozens of cases that permit treatment. Judge Prost countered West-Ward’s assertion of similarity between the Prometheus claims at issue in Mayo and Vanda’s ’610 claims saying, ‘Mayo didn’t have any specificity as to what the method of treatment was….it didn’t go to the dosing.

Vanda latched onto Judge Lourie’s statement and reiterated without explanation that Mayo exempts method-of-treatment claims. It also advanced its own novel theory for subject-matter eligibility of its claims based on the presence of not one, but three separate laws of nature. It urged that this made it ‘fail the Mayo step 1 analysis (i.e., not directed to a law of nature).2 Vanda did not explain how three natural laws would extricate a claim from the Mayo step 1 analysis.”

Federal Circuit Holds Vanda’s Method of Treatment Claims Pass Mayo/Alice’s Step One | MORGANLEWIS
District Court was close but… “Following a bench trial, Judge Gregory Sleet of the US District Court for the District of Delaware held that the asserted claims were not invalid under 35 USC § 101, despite concluding that ‘the asserted claims depend upon laws of nature, specifically, ‘the relationship between iloperidone, CYP2D6 metabolism, and QTc prolongation.[2] The district court explained that the asserted patent ‘addresses natural relationships to which the claims add conducting CYP2D6 genotyping tests to determine the appropriate dose of iloperidone to reduce QTc-related risks.[3] The court found that ‘while it may have been conventional to investigate for side-effects, [West-Ward] has not proven by clear and convincing evidence that the precise test and the discovered results were routine or conventional.[4]”