NOT FOR PUBLICATION
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`CIVIL ACTION NO. 11-3962 (MLC)
`
` MEMORANDUM OPINION
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`HELSINN HEALTHCARE S.A., et al.,
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`Plaintiffs,
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`v.
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`DR. REDDY’S LABORATORIES,
`LTD., et al.,
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`::
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`Defendants.
` :
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`COOPER, District Judge
`
`This is an action arising under the Hatch-Waxman Act, 35 U.S.C. §
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`271(e)(2)(A). Plaintiffs, Helsinn Heathcare S.A. (“Helsinn”) and Roche Palo Alto
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`LLC (“Roche”) (collectively, “plaintiffs”), are assignees of U.S. Patents No. 7,947,724
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`(“‘724 patent”), No. 7,947,725 (“‘725 patent”), No. 7,960,424 (“‘424 patent”), and No.
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`8,598,219 (“‘219 patent”). The four patents-in-suit are listed in the FDA “Orange
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`Book” as covering plaintiffs’ product Aloxi®, which is a pharmaceutical composition
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`containing the active ingredient palonosetron. The version of Aloxi® currently
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`marketed by plaintiffs is an intravenous solution with approved indications for
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`preventing or treating cancer chemotherapy-induced nausea and vomiting.
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`Plaintiffs brought this action, and related consolidated actions, against generic
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`drug manufacturers, Dr. Reddy’s Laboratories, Ltd., Dr. Reddy’s Laboratories, Inc.
`Dr. Reddy’s Laboratories, Ltd., et al.
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 9,(cid:20)(cid:26)(cid:22),(cid:28)(cid:23)(cid:21)
`Reddy Exhibit 1041
`
`Exh. 1041
`
`
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`CIVIL ACTION NO. 11-3962 (MLC)
`
` MEMORANDUM OPINION
`
`:
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`:
`:
`:
`
`::
`
`:
`
`HELSINN HEALTHCARE S.A., et al.,
`
`Plaintiffs,
`
`v.
`
`DR. REDDY’S LABORATORIES,
`LTD., et al.,
`
`::
`
`:
`Defendants.
` :
`
`COOPER, District Judge
`
`This is an action arising under the Hatch-Waxman Act, 35 U.S.C. §
`
`271(e)(2)(A). Plaintiffs, Helsinn Heathcare S.A. (“Helsinn”) and Roche Palo Alto
`
`LLC (“Roche”) (collectively, “plaintiffs”), are assignees of U.S. Patents No. 7,947,724
`
`(“‘724 patent”), No. 7,947,725 (“‘725 patent”), No. 7,960,424 (“‘424 patent”), and No.
`
`8,598,219 (“‘219 patent”). The four patents-in-suit are listed in the FDA “Orange
`
`Book” as covering plaintiffs’ product Aloxi®, which is a pharmaceutical composition
`
`containing the active ingredient palonosetron. The version of Aloxi® currently
`
`marketed by plaintiffs is an intravenous solution with approved indications for
`
`preventing or treating cancer chemotherapy-induced nausea and vomiting.
`
`Plaintiffs brought this action, and related consolidated actions, against generic
`
`drug manufacturers, Dr. Reddy’s Laboratories, Ltd., Dr. Reddy’s Laboratories, Inc.
`Dr. Reddy’s Laboratories, Ltd., et al.
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 9,(cid:20)(cid:26)(cid:22),(cid:28)(cid:23)(cid:21)
`Reddy Exhibit 1041
`
`Exh. 1041
`
`
`
`(“DRL”), Sandoz, Inc. (“Sandoz”), Teva Pharmaceuticals USA, Inc., and Teva
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`Pharmaceutical Industries, Ltd. (“Teva”). Plaintiffs alleged that each group of
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`defendants had filed an Abbreviated New Drug Application (“ANDA”) containing so-
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`called “Paragraph IV” certifications asserting that the claims of the patents-in-suit were
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`invalid and/or not infringed. The asserted claims are claims 2 and 9 of the ‘724 patent,
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`claim 2 of the ‘725 patent, claim 6 of the ‘424 patent, and claims 1, 2, and 6 of the ‘219
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`patent. The pertinent limitations of the first three patents are “reducing emesis...,” the
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`“0.05 mg/mL” concentration, and “EDTA.” The pertinent limitations of the ‘219
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`patent are “reduce ... cancer chemotherapy-induced nausea and vomiting,” “0.25 mg”
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`dose in “5 mL ... solution,” and “EDTA.”
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`Defendant Sandoz was dismissed from the action by consent, on December 31,
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`2014. (Dkt. 247.) The Court issued a memorandum opinion construing certain
`1
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`preamble language in the ‘219 patent claims, on April 22, 2015. (Dkt. 290.) An 11-
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`day bench trial was conducted in June, 2015, with closing arguments presented on
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`August 12, 2015. (Dkts. 320, 322, 324, 326, 328, 330, 331, 337, 340, 342, 344, and
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` The Court will cite to the documents filed in this case in the Electronic Case Filing
`1
`System (“ECF”) by referring to their docket entry numbers by the designation of “dkt.”
`References to docketed materials are to their ECF pagination. The two later-filed actions that
`have been consolidated into this lead case are Civil Actions No. 11-5579 and No. 13-5815.
`Copies of the four patents-in-suit are attached as exhibits to the pleadings, and are trial
`exhibits. We will simply cite to the patents by page or column and line number.
`
`2
`
`Exh. 1041
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`
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`353.) Defendant DRL was dismissed on stipulation on October 16, 2015. (Dkt. 355.) 2
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`Thus, the current parties in this case are plaintiffs and Teva.
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`Teva asserts that the asserted claims of each of the four patents-in-suit are
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`invalid as obvious under 35 U.S.C. § 103. Teva also raises a written description claim
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`against those patents under 35 U.S.C. § 112. Teva further asserts invalidity of those
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`patents under the on-sale bar provision of 35 U.S.C. § 102. The on-sale bar issue
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`presents not only underlying factual questions, but also a statutory interpretation
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`question addressing the amended text of § 102(a)(1) under the America Invents Act
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`(“AIA”), Pub.L. No. 112-29 (2011). Plaintiffs oppose each of Teva’s points on those
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`issues, asserting that the patents are valid and enforceable.
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`There is also an infringement issue. Teva filed one consolidated ANDA,
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`seeking approval for products at two different dose levels (0.25 mg and 0.075 mg), and
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`two different treatment indications (chemotherapy-induced nausea and vomiting
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`(“CINV”) for the 0.25 mg dose, and post-operative nausea and vomiting (“PONV”) for
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`the 0.075 mg dose). The concentration of both proposed Teva products is 0.05 mg/mL,
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`because the 0.25 mg dose solution is 5 mL and the 0.075 mg dose solution is 1.5 mL.
`
` DRL and plaintiffs have a related action, actively pending in this Court, pertaining to
`2
`the ‘724 patent and DRL’s pending 505(b)(2) New Drug Application under 21 U.S.C. §
`355(b)(2). See Helsinn Healthcare S.A., et al. v. Dr. Reddy’s Laboratories, Ltd., et al., Civil
`Action No. 12-2867. In that case, the Court issued a Memorandum Opinion and Order on
`April 2, 2015, construing the ‘724 claim term “a chelating agent.” (Civ. Action No. 12-2867,
`dkt. 91 (Order) and 92 (SEALED Mem. Op.).)
`
`3
`
`Exh. 1041
`
`
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`The asserted ‘219 patent claims only specify a 0.25 mg dose, in a 5 mL volume (i.e.,
`
`concentration 0.05 mg/mL), for CINV. Plaintiffs assert that if the ‘219 claims are held
`
`to be valid, those claims are infringed by Teva’s ANDA filing itself, according to the
`
`Hatch-Waxman Act, and therefore both generic products applied for in Teva’s ANDA
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`must infringe and be enjoined. Teva disputes plaintiffs’ legal position and seeks a
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`declaration that its 0.075 mg dose PONV product will not infringe the asserted ‘219
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`patent claims.
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`This Memorandum Opinion constitutes the Court’s findings of fact and
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`conclusions of law, pursuant to Federal Rule of Civil Procedure 52(a). For the reasons
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`set forth herein, the Court finds: (1) the person of ordinary skill in the art (“POSA”)
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`would be defined as plaintiffs proposed, including skills of a clinician, marketing
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`person, formulator, and pharmaceutical development scientist; (2) the framing of the
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`obviousness issue would be whether it would have been obvious to a POSA in January,
`
`2003 to develop an improved intravenous antiemetic formulation containing
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`palonosetron and (in particular) EDTA; (3) based on the prior art, the selection of
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`palonosetron for development would not have been obvious; (4) based on the prior art,
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`the selection of dosage 0.25 mg for CINV would not have been obvious; (5) based on
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`the prior art, the selection of 0.05 mg/mL concentration would be dose-dependent and
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`would not be obvious; (6) the asserted claims would not have been arrived at by
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`“routine experimentation”; (7) evidence including commercial success attributable to
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`4
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`Exh. 1041
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`
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`the claimed formulation, industry skepticism, and long-felt need supports the finding
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`of non-obviousness; (8) the asserted claims are not invalid for lack of written
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`description; (9) the asserted claims were not ready for patenting as of January, 2002;
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`(10) all three pre-January 2002 Helsinn contracts (including the MGI contract, which
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`we find was a contract) meet the “sale or offer for sale” criteria under the pre-AIA on-
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`sale bar test; but (11) none of the three pre-January 2002 Helsinn contracts meet the
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`post-AIA on-sale bar test, as the Court interprets and applies the amended statutory
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`language of 35 U.S.C. § 102(a)(1), because the Oread and SP contracts were entirely
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`confidential, and although the existence of the MGI contract was announced publicly,
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`the claimed invention itself was not disclosed; (12) the asserted claims of the ‘724,
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`‘725, and ‘424 patents would be infringed by sale of Teva’s proposed 0.25 mg/5mL
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`CINV product and 0.075 mg/1.5mL PONV product, as the parties have stipulated; (13)
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`the asserted claims of the ‘219 patent would be infringed by sale of Teva’s proposed
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`0.25 mg/5mL CINV product, as the parties have stipulated; and (14) the asserted
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`claims of the ‘219 patent would not be infringed by sale of Teva’s proposed 0.075
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`mg/1.5mL PONV product.
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`Based on these factual findings, the Court concludes (under the applicable
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`standards of proof on each issue) as follows: (1) Teva did not prove that the ‘724, ‘725,
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`‘424, or ‘219 patents are invalid as obvious under § 103, or for lack of written
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`description under § 112; (2) as to Teva’s on-sale bar claim of invalidity of the ‘724,
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`5
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`Exh. 1041
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`
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`‘725, and ‘424 patents under the pre-AIA § 102(b), Teva proved the “sale or offer to
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`sell” prong as to the Oread, SP, and MGI contracts, but Teva did not prove that the
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`claimed invention was “ready for patenting” as of January 30, 2002; therefore, Teva
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`did not prove that the ‘724, ‘725, and ‘424 patents are invalid under the on-sale bar; (3)
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`Teva did not prove that the ‘219 patent is invalid under the post-AIA § 102(a)(1) on-
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`sale bar; (4) assuming that the ‘724, ‘725, and ‘424 patents are valid as the Court has
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`found, the Court agrees with the parties’ stipulation that both the 0.075 mg dose and
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`the 0.25 mg dose generic product specified in Teva’s ANDA will infringe those three
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`patents; (5) assuming that the ‘219 patent is valid as the Court has found, the Court
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`agrees with the parties’ stipulation that the 0.25 mg dose generic product specified in
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`Teva’s ANDA will infringe the ‘219 patent; and (6) assuming that the ‘219 patent is
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`valid as the Court has found, the Court further finds that plaintiffs did not prove that
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`the 0.075 mg dose generic product specified in Teva’s ANDA will infringe the ‘219
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`patent.
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`Based upon these findings and conclusions, the Court will enter judgment
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`declaring that:
`
`(1)
`
`(2)
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`the asserted claims of the ‘724, ‘725, and ‘424 patents are valid and are
`infringed by both Teva’s proposed 0.25 mg and 0.075 mg generic
`products;
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`the asserted claims of the ‘219 patent are valid and are infringed by
`Teva’s proposed 0.25 mg generic product; and
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`6
`
`Exh. 1041
`
`
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`(3)
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`the asserted claims of the ‘219 patent are valid and are not infringed by
`Teva’s proposed 0.075 mg generic product.
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`This Memorandum Opinion will be filed under temporary seal, and will be
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`unsealed on or after December 1, 2015, unless a motion to seal is filed by any party.
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`The Court will enter an appropriate judgment.
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`Dated: November 13, 2015
`
` s/ Mary L. Cooper
`MARY L. COOPER
`United States District Judge
`
`7
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`Exh. 1041
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