Search Team

Search by Last Name
A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z

Pernix Ireland Pain v. Alvogen Malta Operations

Representative Claim(s)

‘760 1. A method of treating pain in a patient having mild or moderate hepatic impairment, the method comprising:

administering to the patient having mild or moderate hepatic impairment a starting dose of an oral dosage unit having hydrocodone bitartrate as the only active ingredient, wherein the dosage unit comprises an extended release formulation of hydrocodone bitartrate, and wherein the starting dose is not adjusted relative to a patient without hepatic impairment.

‘499 1. A method of treating pain in a patient having mild or moderate hepatic impairment, the method comprising:

administering to the patient having mild or moderate hepatic impairment an oral dosage unit having hydrocodone bitartrate as the only active ingredient, wherein the dosage unit comprises an extended release formulation of hydrocodone bitartrate, wherein the dosage unit provides a release profile of hydrocodone that:

does not increase average hydrocodone AUC0-inf in subjects suffering from mild hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 14%; and

does not increase average hydrocodone AUC0-inf in subjects suffering from moderate hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 30%.

Posture:

Motion for Summary Judgement

Exception Category: Law of Nature

“Alvogen argues that the asserted claims of the ’760 and ’499 patents are ineligible for patent protection under section 101 because they are ‘premised on the relationship between [hepatic impairment] and the bioavailability of hydrocodone in the body after administration of Devane’s [extended release hydrocodone] prior art formulation—namely that the response of the human body to this formulation is similar in patients with and without mild or moderate [hepatic impairment].’”

“The independent claims asserted in this case are indistinguishable from the representative claim discussed in Vanda. Claim 1 of the ’760 patent recites a ‘method of treating pain in a patient having mild or moderate hepatic impairment,’ and teaches using an extended release formulation of hydrocodone bitartrate wherein the ‘starting dose is not adjusted relative to a patient without hepatic impairment.’ Claim 12 of the ’760 patent and claim 1 of the ’499 patent each recites a ‘method of treating pain in a patient having mild or moderate hepatic impairment,’ and teaches using a specific extended release formulation of hydrocodone bitartrate that has a particular release profile. Although the inventions recited in those claims were based upon a natural law—the physiological response to hydrocodone in individuals with or without mild or moderate hepatic impairment—the claims do more than merely report those physiological responses. Rather, like the claim discussed in Vanda the claims asserted in this case describe a specific dosing regimen to treat a specific condition based on the patient’s medical status.”

Significantly More: Not Decided

Not Decided.