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UNITED STATES DISTRICT COURT
`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
`
`Page 1 of 4
`
`

`
`DEFENDANTS’ CONTESTED FACTS
`
`
`A.
`
`Defendants Teva and DRL intend to prove the following contested facts with
`regard to liability:1
`
`
`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
`
`
`
`Page 2 of 4
`
`

`
`
`
`upright and inverted for 3, 6, 16.5, 24, and 36 months) and under accelerated conditions (40°C,
`
`upright and inverted for 1, 3, and 6 months).
`
`306. The 24- and 36-month real-time stability data was available on or about October
`
`13, 2000 and October 13, 2001, respectively, and confirmed that the FD77A-001 formulation of
`
`batch number 1669911 was stable for greater than two years at room temperature.
`
`307. Similarly on May 20, 1999, clinical lot number 1737321 was tested under real
`
`time conditions (25°C/60%RH, upright and inverted for 3, 6, 9, 12, 18, 24, 30, and 36 months)
`
`and under accelerated conditions (40°C, upright for 1, 3, and 6 months).
`
`308. The 24- and 30- month real-time stability data was available on or about May 20,
`
`2001 and November 20, 2001, respectively, and confirmed that the FD77A-009 formulation of
`
`lot number 1737321 was also stable for greater than two years at room temperature.
`
`309. Based on this real-time stability testing, Helsinn reported to the FDA that:
`
`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.
`
`310. The stability of a formulation is an inherent property and/or characteristic of that
`
`formulation that is governed by the particular makeup of formulation components,
`
`concentrations, and conditions.
`
`311.
`
`If the concentrations of the palonosetron API and the inactive excipients of a
`
`particular intravenous palonosetron formulation match those of the claimed formulations, the
`
`same improved stability also will be inherently present in that particular formulation.
`
`312. The Example 4 formulation will exhibit whatever stability profile it inherently has
`
`once the formulation is made.
`
`
`
`
`46
`
`
`
`Page 3 of 4
`
`

`
`
`
`palonosetron concentration (or any other limitation or feature of the claimed formulations) and
`
`any alleged unexpected efficacy of Helsinn’s Aloxi® brand product.
`
`2.
`
`Pharmaceutical Stability was Not an Unexpected Result
`
`1239. It would have been obvious based on disclosures in standard textbooks and prior
`
`art references that the claimed formulations would have increased pharmaceutical stability.
`
`1240. There was no teaching in the prior art that palonosetron could not have achieved a
`
`5-year shelf life when formulated as claimed, or that palonosetron formulated with the claimed
`
`excipient system would provide decreased stability.
`
`1241. Any stabilizing effect attributable to any component in the claimed formulations,
`
`including the low concentration of palonosetron, the pH buffer (e.g., a citrate buffer), the
`
`tonicifying agent (e.g., mannitol), or the chelating agent (e.g., EDTA), would not have been
`
`surprising to a POSA.
`
`1242. If comparing the Example 13 formulation of the ‘333 patent to the claimed
`
`formulations that include EDTA as a stabilizing agent, a POSA would have expected the claimed
`
`formulations to exhibit improved stability over the Example 13 formulation of the ‘333 patent.
`
`1243. A POSA would have understood that the prior art Example 13 formulation was a
`
`non-optimized formulation that did not include a stabilizing agent.
`
`1244. There was no actual clinical or stability data for the Example 13 formulation of
`
`the ‘333 patent.
`
`1245. There was no actual stability data for any intravenous palonosetron formulation
`
`known in the prior art.
`
`1246. There is no nexus between the 5-year shelf life of Aloxi® and the claimed
`
`inventions of the ‘724, ‘725, and ’424 patents. The claimed formulations of the ‘724, ‘725, and
`
`
`
`
`176
`
`
`
`Page 4 of 4

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