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Classen Immunotherapies, Inc. v. Biogen

Representative Claim(s)

The ‘139 Patent
1. A method of immunizing a mammalian subject while reducing the risk of said subject thereby developing at least one chronic immune-mediated disorder, which comprises:

(I) screening a plurality of immunization schedules, by

(a) identifying a first group of mammals and at least a second group of mammals, said mammals being of the same species, the first group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a first screened immunization schedule, and the second group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a second screened immunization schedule, each group of mammals having been immunized according to a different immunization schedule, and

(b) comparing the effectiveness of said first and second screened immunization schedules in protecting against or inducing a chronic immune-mediated disorder in said first and second groups, as a result of which one of said screened immunization schedules may be identified as a lower risk screened immunization schedule and the other of said screened schedules as a higher risk screened immunization schedule with regard to the risk of developing said chronic immune mediated disorder(s), where the first dose of at least one infectious disease-causing organism associated immunogen given to both groups is given sooner after birth according to one or more of the screened immunization schedules than according to one or more of the other screened immunization schedules, each such immunogen so administered being hereafter referred to as an “early” immunogen regardless of its time of administration in the latter schedule(s), where at least one of said chronic immune-mediated disorders is diabetes, where said mammalian subject is or said mammals are humans, where at least one of said early immunogens is one other than BCG or pertussis immunogen, and

(II) immunizing said subject according to a subject immunization schedule, according to which at least one of said early infectious disease-causing organism-associated immunogens is administered to the subject at about the same dates, relative to the date of birth as it was administered to the mammals in said lower risk screened immunization schedule, which administration is associated with a lower risk of development of said chronic immune-mediated disorder(s) than when said immunogen was administered according to said higher risk screened immunization schedule.

Posture:

Motion to Dismiss

Exception Category: Law of Nature

“GSK contends that, like the [Mayo] patents, Classen’s patents ‘simply recite a law of nature and then add the instruction ‘apply the law.’ ’…. Though that sweeping statement arguably encompasses the facts here, [Mayo’s] reasoning does not apply.”

Significantly More: Yes

“In [Mayo], the patent acknowledged that ‘scientists routinely measured metabolites as part of their investigations into the relationships between metabolite levels and efficacy and toxicity of thiopurine compounds.’ … The Supreme Court was thus able to conclude that the steps involved ‘well-understood, routine, conventional activity previously engaged in by scientists who work in the field.’ … There is no information in the record here that allows the Court, on a motion to dismiss for failure to state a claim, to conclude that the Classen patent claims involve ‘well-understood, routine, [or] conventional activity.’ ”

“The patents at issue here include the mandatory application step that was missing in [Mayo]. Rather than ‘at most’ suggesting a general course of action after the data-gathering step, …the Classen claims require immunizing according to a particular schedule in addition to the data-gathering step….”