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Purdue Pharma L.P. v. Alvogen Pine Brook, LLC

United States District Court, D. Delaware

May 10, 2017

PURDUE PHARMA L.P., PURDUE PHARMACEUTICALS L.P., THE P.F. LABORATORIES, INC., and GRUNENTHAL GMBH Plaintiffs,
v.
ALVOGEN PINE BROOK, LLC, and ACTAVIS LABORATORIES FL, INC., Defendants.

          ORDER CONSTRUING THE TERMS OF U.S. PATENT NOS. 6, 733.783, 8, 361, 499, 8, 551, 520, 8, 647, 667, 9, 023, 401, 8, 309, 060, 8.529.948, 8, 808, 740, 9, 056, 052, 9, 060, 940, 9, 084, 816, 9, 095, 614. 9.096.615. 9.198, 863, AND 9, 205, 056

         After considering the submissions of the parties and hearing oral argument on the matter, IT IS HEREBY ORDERED, ADJUDGED, and DECREED that, as used in the asserted claims of U.S. Patent Nos. 6, 733, 783 ("the '783 patent"), 8, 361, 499 ("the '499 patent"), 8, 551, 520 ("the '520 patent"), 8, 647, 667 ("the '667 patent"), 9, 023, 401 ("the '401 patent), 8, 309, 060 ("the '060 patent"), 8, 529, 948 ("the '948 patent"), 8, 808, 740 ("the '740 patent"), 9, 056, 052 ("the '052 patent"), 9, 060, 940 ("the '940 patent"), 9, 084, 816 ("the '816 patent"), 9, 095, 614 ("the '614 patent"), 9, 095, 615 ("the '615 patent"), 9, 198, 863 ("the '863 patent"), and 9, 205, 056 ("the '056 patent"):

         1. The term "controlled release material, " as used in the '783, '499, '520, '667, '401, '052, and '940 patents, is construed to mean "a material other than the active ingredient that causes the release of the drug (e.g., hydrocodone) at such a rate that blood concentrations are maintained within the therapeutic range but below toxic concentrations over a period of time of about 12 hours or longer."[1]2. The term "matrix, " as used in the '783, '499, '060, '520, '667, '052, '056, '740, '816, '614, and '615 patents, is construed to mean "pharmaceutical preparation that incorporates a dispersed/embedded active ingredient/agent".[2]

         3. The term "matrices, " as used in the '401 patent, is construed to be the plural version of "matrix"-"pharmaceutical preparations that incorporate a dispersed/embedded active ingredient/agent."[3]

         4. The term "controlled release matrix material" in the '740 patent is construed to mean "a material other than the active ingredient that is in a matrix and causes the release of the drug (e.g., hydrocodone) at such a rate that blood (e.g., plasma) concentrations are maintained within the therapeutic range but below toxic concentrations over a period of time of about 12 hours or longer."[4]

         5. The term "controlled release matrix material" in the '060 patent is construed to mean "a material other than the active ingredient in which the active ingredient is embedded that also serves to control the release of the active ingredient from the dosage form."[5]

         6. The term "steady state, " as used in the '667 patent, is construed to mean "the amount of the drug reaching the system is approximately the same as the amount of the drug leaving the system."[6]

         7. The term "a C24/Cmax ratio, " as used in the '783, '499, '520, '667, and '940 patents, is construed to mean "the ratio of the plasma concentration of the drug at 24 hours after administration to the highest plasma concentration of the drug attained within the dosing interval."[7]

         8. The term "A C24/Cmax hydrocodone ratio, " as used in the '863 and '056 patents, "the ratio of the plasma concentration of the drug at 24 hours after administration to the highest plasma concentration of the drug attained within the dosing interval."[8]

         9. The term "a relatively flat serum plasma profile, " as used in the '499 patent, is construed to mean "the plasma level of the drug provides a "C24/Cmax ratio of about 0.55 to about l.O."[9]

         10. The term "obtaining a serum profile, " as used in the '940 patent, is construed to mean "establishing a blood plasma serum profile in a patient."[10]

         11. The term "thermoformed dosage form, " as used in the '060 patent, is construed to include the use of subsequent heat.[11]

         12. The term "breaking strength of at least 500 N, " as used in the '060 patent, is construed to mean "only separates into two or more pieces when exposed to a force of at least 500 N."[12]

         13. The term "viscosity-increasing agent, " as used in the '060 patent, is construed to mean "at least one substance that increases the thickness of the dosage form by forming a gel when exposed to a liquid, said substance being different from the synthetic or natural polymer (C) of claim 1 of the '060 patent."[13]

         14. The term "necessary minimum quantity of an aqueous liquid, " as used in the '060 patent, is construed to mean "an aqueous liquid in a necessary minimum quantity."[14]

         15. The term "combining said [opioid/hydrocodone] or pharmaceutically acceptable salt thereof with each of said low molecular weight polyethylene oxide and said high molecular weight polyethylene oxide to form at least one blend, " as used in the '816, '614, and '615 patents, is construed to mean "forming at least one blend comprising said opioid or pharmaceutically acceptable salt thereof, said low molecular weight polyethylene oxide, and said high molecular weight polyethylene oxide."[15]

         16. The term "a gelling agent comprising polyethylene oxide in an effective amount to impart viscosity of at least about 10 cP when the dosage form is subjected to tampering by dissolution in from about 0.5 to about 10 ml of an aqueous liquid, " as used in the '948 patent, is construed to mean "dissolving the dosage form in from about 0.5 to about 10 ml of an aqueous liquid, causing the resulting mixture to have a viscosity of at least about 10 cP."[16]

         17. The term "viscosity of at least about 60 cP, " as used in the '948 patent, is construed to mean "dissolving the dosage form in from about 0.5 to about 10 ml of an aqueous liquid, causing the resulting mixture to have a viscosity of at least about 60 cP."[17]

         18. The terms "based on rheological measurements, . . . molecular weight" and "molecular weight... based on rheological measurements, " as used in the '816, '614, and '615 patents, are construed to mean "a measurement of the mass of a molecule based on rheological measurements."[18]

         19. The term "average molecular weight, " as used in the '863 and the '740 patents, is construed to mean "the average of the molecular weights."[19]

         20. The term "weight-average molecular weight, " as used in the '863 and '948 patents, is construed to mean "the weighted average of the molecular weights."[20]

         21. The phrase "wherein the polymer (C) has a molecular weight of at least 0.5 million according to rheological measurements, " as used in the '060 patent, is construed to mean "wherein the mass of the molecules of polymer (C) is at least 0.5 million according to rheological measurements."[21]22. The phrase "a shell encasing the core, " as used in the '740 patent, is construed to mean "the outer layer of the dosage form surrounding the core."[22]

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