`DISTRICT OF NEW JERSEY
`
`HELSINN HEALTHCARE S.A. and
`ROCHE PALO ALTO LLC,
`
`Plaintiffs,
`
`v.
`
`DR. REDDY’S LABORATORIES, LTD.,
`DR. REDDY’S LABORATORIES, INC.,
`TEVA PHARMACEUTICALS USA, INC.,
`AND TEVA PHARMACEUTICAL
`INDUSTRIES, LTD.,
`
`Defendants.
`
`Civil Action No. 13-5815 (MLC)
`(DEA)
`Civil Action No. 11-3962 (MLC)
`(DEA)
`(Consolidated)
`
`Hon. Mary L. Cooper, U.S.D.J.
`Hon. Douglas E. Arpert, U.S.M.J.
`
`FINAL PRETRIAL ORDER
`
`This matter having come before the Court for a pretrial conference
`pursuant to Fed. R. Civ. P. 16; and Saul Ewing LLP having appeared for
`Plaintiffs Helsinn Healthcare S.A. (“Helsinn”) and Roche Palo Alto LLC
`(“Roche”) (together, “Plaintiffs”), Paul Hastings LLP having appeared for
`Plaintiff Helsinn, and Loeb & Loeb LLP having appeared for Plaintiff Roche,
`and Lite DePalma Greenberg, LLC and Winston & Strawn LLP having
`appeared for Defendants Teva Pharmaceuticals USA, Inc. and Teva
`Pharmaceutical Industries, Ltd. (collectively “Teva”), and Budd Larner P.C.
`having appeared for Defendants Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s
`Laboratories, Inc. (collectively, “DRL”) (with Teva and DRL together referred
`to as “Defendants”); the following Final Pretrial Order is hereby entered:
`
`- 1 -
`
`Helsinn Healthcare Exhibit 2015
`Dr. Reddy's Laboratories, Ltd., et al. v. Helsinn Healthcare S.A.
`Trial PGR2016-00007
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`Page 1 of 4
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`DEFENDANTS’ CONTESTED FACTS
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`A.
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`Defendants Teva and DRL intend to prove the following contested facts with
`regard to liability:1
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`1 Defendants’ listing of “Contested Facts” is not a concession that Defendants bear the burden of
`proof on the recited facts or any other fact. In addition, Defendants’ listing of “Contested Facts”
`is not a concession that there is any genuine dispute with respect to the cited facts.
`
`DC:771275.5
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`Page 2 of 4
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`upright and inverted for 3, 6, 16.5, 24, and 36 months) and under accelerated conditions (40°C,
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`upright and inverted for 1, 3, and 6 months).
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`306. The 24- and 36-month real-time stability data was available on or about October
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`13, 2000 and October 13, 2001, respectively, and confirmed that the FD77A-001 formulation of
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`batch number 1669911 was stable for greater than two years at room temperature.
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`307. Similarly on May 20, 1999, clinical lot number 1737321 was tested under real
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`time conditions (25°C/60%RH, upright and inverted for 3, 6, 9, 12, 18, 24, 30, and 36 months)
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`and under accelerated conditions (40°C, upright for 1, 3, and 6 months).
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`308. The 24- and 30- month real-time stability data was available on or about May 20,
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`2001 and November 20, 2001, respectively, and confirmed that the FD77A-009 formulation of
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`lot number 1737321 was also stable for greater than two years at room temperature.
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`309. Based on this real-time stability testing, Helsinn reported to the FDA that:
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`The stability studies demonstrated satisfactory physical and
`chemical stability for up to 36 months when stored in Type I flint
`glass vials at 25oC/60%RH and for up to 6 months when stored at
`40oC. The product retained full potency and no significant
`degradation was observed.
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`310. The stability of a formulation is an inherent property and/or characteristic of that
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`formulation that is governed by the particular makeup of formulation components,
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`concentrations, and conditions.
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`311.
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`If the concentrations of the palonosetron API and the inactive excipients of a
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`particular intravenous palonosetron formulation match those of the claimed formulations, the
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`same improved stability also will be inherently present in that particular formulation.
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`312. The Example 4 formulation will exhibit whatever stability profile it inherently has
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`once the formulation is made.
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`46
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`Page 3 of 4
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`palonosetron concentration (or any other limitation or feature of the claimed formulations) and
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`any alleged unexpected efficacy of Helsinn’s Aloxi® brand product.
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`2.
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`Pharmaceutical Stability was Not an Unexpected Result
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`1239. It would have been obvious based on disclosures in standard textbooks and prior
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`art references that the claimed formulations would have increased pharmaceutical stability.
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`1240. There was no teaching in the prior art that palonosetron could not have achieved a
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`5-year shelf life when formulated as claimed, or that palonosetron formulated with the claimed
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`excipient system would provide decreased stability.
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`1241. Any stabilizing effect attributable to any component in the claimed formulations,
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`including the low concentration of palonosetron, the pH buffer (e.g., a citrate buffer), the
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`tonicifying agent (e.g., mannitol), or the chelating agent (e.g., EDTA), would not have been
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`surprising to a POSA.
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`1242. If comparing the Example 13 formulation of the ‘333 patent to the claimed
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`formulations that include EDTA as a stabilizing agent, a POSA would have expected the claimed
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`formulations to exhibit improved stability over the Example 13 formulation of the ‘333 patent.
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`1243. A POSA would have understood that the prior art Example 13 formulation was a
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`non-optimized formulation that did not include a stabilizing agent.
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`1244. There was no actual clinical or stability data for the Example 13 formulation of
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`the ‘333 patent.
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`1245. There was no actual stability data for any intravenous palonosetron formulation
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`known in the prior art.
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`1246. There is no nexus between the 5-year shelf life of Aloxi® and the claimed
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`inventions of the ‘724, ‘725, and ’424 patents. The claimed formulations of the ‘724, ‘725, and
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`176
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`Page 4 of 4