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June 12, 2018

Comments

"However, it is important to note that decisions such as this one have increased relevance in light of the Supreme Court's refusal to recognize that there may be solid grounds to reconsider their thinking on patent eligibility, as illustrated by their most recent refusal (yesterday) to grant certiorari in Cleveland Clinic Foundation v. True Life Health Diagnostics."

Hey Kevin,

That is an understatement. And I'm not so kind as you to suggest that SCOTUS wants the lower courts to "flesh out" patent-eligibility doctrine. Frankly, the Royal Nine has taken the cowardly route of copping out, as witnessed by this latest denial of cert in Cleveland Clinics.

Thanks Kevin.

I'm asking myself, Would anyone have couched such an argument in 101 terms prior to the Myriad-Mayo-Alice debacle? And I'm answering myself, No, of course not, they would have said that the (alleged) failure to recite a specific dosing regimen causes the claim to fail under 112.

I'm happy to see that common sense prevailed here, but it's pathetic that this question was raised under 101, and that the outcome wasn't a foregone conclusion.

Excellent decision in the spirit of the remarks by Director Iancu delivered to the IPBC Global Conference, June 11, 2018, see https://www.uspto.gov/about-us/news-updates/remarks-director-andrei-iancu-ipbc-global-conference

Indeed, this is good news. As Atari Man suggests, I see 112 problems here, but not 101 problems (except in the strained and insane sense in which Mayo/Alice makes *all* problems into 101 problems). It is good to see the court resist the temptation to make 101 into the one-requirement-of-patentability-to-rule-them-all.

Does this mean that Pernix will mo4e than likely win the patent case?

A PK (pharmacokinetic) comment on the failure to recite doses in the ‘760 patent (claim 12): It is not necessary in this case because AUC (0-∞) is an indirect or comparative reference to a dose.
AUC (0-∞), area under the curve (0-infinity), is an index of exposure to the drug in a subject and is related to the bioavailable dose (which, in the oral case may be less than or equal to the administered dose). In the simplest relationship (e.g., “linear drugs”), AUC (0-∞), is directly proportional to the bioavailable dose; it appears the inventors are implicitly making this assumption; see claim 17(1) which states “. . . AUC (0-inf) per/20 mg of hydrocodone bitartarate . . .”. To avoid dealing with sometimes complex or unknown relationships between AUC (0-∞) and bioavailable dose, the same (i.e., equal doses) are administered, as in bioavailability studies. In this case, each subject in all three treatment groups, namely, subjects with no, mild or moderate hepatic impairment received a dose of 20 mg of the drug see (Figure 4, the ‘760 patent). Hope this helps.
Other than 101 issues mentioned, I am not sure the patent can withstand a 103 challenge, given that the technology used in the ‘760 patent would be obvious to a PHOSITA.


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