Helsinn Healthcare S.A. v. Dr. Reddy's Laboratories Ltd., --- F.Supp.3d ---- (2016)
`
`KeyCite Blue Flag – Appeal Notification
`
`Appeal Filed by HELSINN HEALTHCARE S.A. v. TEVA
`
`
`
`PHARMACEUTICALS USA, INC,
`
`Fed.Cir., April 4, 2016
`
`(cid:5)(cid:6)(cid:7)(cid:8)(cid:3)(cid:9)(cid:10)(cid:3)(cid:11)(cid:12)(cid:5)(cid:6)(cid:11)(cid:13)
`(cid:14)(cid:15)(cid:16)(cid:17)(cid:3)(cid:18)(cid:19)(cid:20)(cid:3)(cid:9)(cid:20)(cid:21)(cid:18)(cid:16)(cid:22)(cid:23)(cid:3)(cid:24)(cid:25)(cid:18)(cid:22)(cid:18)(cid:25)(cid:26)(cid:15)(cid:3)(cid:25)(cid:21)(cid:3)(cid:24)(cid:27)(cid:28)(cid:28)(cid:20)(cid:15)(cid:18)(cid:16)(cid:17)(cid:3)(cid:22)(cid:29)(cid:22)(cid:25)(cid:16)(cid:22)(cid:30)(cid:16)(cid:20)(cid:31)
`(cid:32)(cid:15)(cid:25)(cid:18)(cid:20)(cid:33)(cid:3)(cid:34)(cid:18)(cid:22)(cid:18)(cid:20)(cid:21)(cid:3)(cid:35)(cid:25)(cid:21)(cid:18)(cid:28)(cid:25)(cid:24)(cid:18)(cid:3)(cid:36)(cid:26)(cid:27)(cid:28)(cid:18)(cid:37)
`(cid:35)(cid:31)(cid:3)(cid:38)(cid:20)(cid:23)(cid:3)(cid:39)(cid:20)(cid:28)(cid:21)(cid:20)(cid:17)(cid:31)
`
`(cid:40)(cid:20)(cid:16)(cid:21)(cid:25)(cid:15)(cid:15)(cid:3)(cid:40)(cid:20)(cid:22)(cid:16)(cid:18)(cid:19)(cid:24)(cid:22)(cid:28)(cid:20)(cid:3)(cid:34)(cid:31)(cid:41)(cid:31)(cid:37)(cid:3)(cid:20)(cid:18)(cid:3)(cid:22)(cid:16)(cid:31)(cid:37)(cid:3)(cid:42)(cid:16)(cid:22)(cid:25)(cid:15)(cid:18)(cid:25)(cid:43)(cid:43)(cid:21)(cid:37)
`(cid:29)(cid:31)
`(cid:35)(cid:28)(cid:31)(cid:3)(cid:44)(cid:20)(cid:33)(cid:33)(cid:17)(cid:45)(cid:21)(cid:3)(cid:10)(cid:22)(cid:30)(cid:26)(cid:28)(cid:22)(cid:18)(cid:26)(cid:28)(cid:25)(cid:20)(cid:21)(cid:3)(cid:10)(cid:18)(cid:33)(cid:31)(cid:37)(cid:3)(cid:20)(cid:18)(cid:3)(cid:22)(cid:16)(cid:31)(cid:37)(cid:3)(cid:35)(cid:20)(cid:43)(cid:20)(cid:15)(cid:33)(cid:22)(cid:15)(cid:18)(cid:21)(cid:31)
`
`(cid:36)(cid:46)(cid:47)(cid:46)(cid:10)(cid:3)(cid:41)(cid:36)(cid:48)(cid:46)(cid:14)(cid:38)(cid:3)(cid:38)(cid:14)(cid:31)(cid:3)(cid:7)(cid:7)(cid:4)(cid:12)(cid:13)(cid:8)(cid:5)(cid:3)(cid:49)(cid:50)(cid:10)(cid:36)(cid:51)
`(cid:52)
`(cid:34)(cid:25)(cid:53)(cid:15)(cid:20)(cid:33)(cid:3)(cid:50)(cid:22)(cid:28)(cid:24)(cid:19)(cid:3)(cid:12)(cid:37)(cid:3)(cid:5)(cid:6)(cid:7)(cid:8)
`
`Synopsis
`Background: Assignees of patents covering intravenous
`solution for treating chemotherapy-induced nausea and
`vomiting brought action under the Hatch-Waxman Act
`against drug manufacturers that filed Abbreviated New
`Drug Applications (ANDA) with the Food and Drug
`Administration (FDA) seeking to market generic versions
`of the product and challenging those patents as invalid
`or unenforceable. Manufacturer raised a written description
`claim against the patents and asserted invalidity of the patents
`under the on-sale bar.
`
`[5] agreement between purchaser and assignee was not a
`“sale” under post-AIA on-sale bar to patentability;
`
`[6] claimed invention of asserted claims of patents were not
`“ready for patenting” as of critical date, as required under on-
`sale bar to patentability;
`
`[7] specification of patent provided an adequate written
`description of the efficacy of the invention claimed; and
`
`[8] ANDA specification for generic product with 0.075 mg /
`1.5 ml dosage strength did not infringe asserted claims of
`patent covering intravenous solution which included 0.25
`mg / 5 ml solution dosage.
`
`Ordered accordingly.
`
`West Headnotes (46)
`
`[1]
`
`Patents
`Patents
`
`Patent system represents a carefully crafted
`bargain that encourages both the creation and the
`public disclosure of new and useful advances in
`technology, in return for an exclusive monopoly
`for a limited period of time.
`
`Holdings: The District Court, Cooper, J., held that:
`
`Cases that cite this headnote
`
`[1] on-sale bar to patentability under America Invents Act
`(AIA) required public sale or offer for sale of claimed
`invention;
`
`[2]
`
`Patents
`In general; nature, purpose, and elements
`of statutory bar
`
`[2] agreement between purchaser and assignee constituted a
`sale pursuant to pre-AIA on-sale bar to patentability;
`
`[3] agreements between manufacturers and assignee for
`developmental batches of product for clinical trials and data-
`gathering were not sales or offers for sale under pre-AIA on-
`sale bar to patentability;
`
`[4] agreements between manufacturers and assignee for
`developmental batches of product for clinical trials and data-
`gathering were not “public” sales under post-AIA on-sale bar
`to patentability;
`
`“On-sale bar” serves as a bar to patentability if
`the claimed invention is (1) made the subject of
`a commercial offer for sale and (2) the invention
`is ready for patenting. 35 U.S.C.A. § 102.
`
`Cases that cite this headnote
`
`[3]
`
`Patents
`What Constitutes Sale
`
`A sale under the on-sale bar to patentability
`occurs when the parties offer or agree to reach a
`contract to give and pass rights of property for
`
` © 2016 Thomson Reuters. No claim to original U.S. Government Works.
`
`1
`
`Helsinn Healthcare Exhibit 2081
`Dr. Reddy's Laboratories, Ltd., et al. v. Helsinn Healthcare S.A.
`Trial PGR2016-00008
`
`Page 1 of 74
`
`

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`
`consideration which the buyer pays or promises
`to pay the seller for the thing bought or sold. 35
`U.S.C.A. § 102.
`
`Cases that cite this headnote
`
`common law meaning, absent anything pointing
`another way.
`
`Cases that cite this headnote
`
`[4]
`
`Statutes
`Clarity and Ambiguity; Multiple Meanings
`
`[8]
`
`Statutes
`Technical terms, terms of art, and legal
`terms
`
`Statutes
`Plain language; plain, ordinary, common,
`or literal meaning
`
`Court's first inquiry in interpreting a statute is
`to determine whether the language at issue has
`a plain and unambiguous meaning with regard
`to the particular dispute in the case; court's
`inquiry must cease if the statutory language
`is unambiguous and the statutory scheme is
`coherent and consistent.
`
`Cases that cite this headnote
`
`[5]
`
`Statutes
`Wisdom, practicality, and common sense
`
`Court is guided by common sense approach to
`statutory interpretation.
`
`Cases that cite this headnote
`
`[6]
`
`Statutes
`Plain language; plain, ordinary, common,
`or literal meaning
`
`In interpreting a statute, the court must begin
`with the assumption that the ordinary meaning
`of the language chosen by Congress accurately
`expresses the legislative purpose.
`
`Cases that cite this headnote
`
`[7]
`
`Statutes
`Technical terms, terms of art, and legal
`terms
`
`Statutes
`Common or civil law
`
`In interpreting a statute, the use of a term of
`art, or a “common-law term,” generally carries
`with it the assumption that the term comes with a
`
`For purposes of statutory construction, when
`Congress employs a term of art, it presumably
`knows and adopts the cluster of ideas that were
`attached to each borrowed word in the body of
`learning from which it is taken.
`
`Cases that cite this headnote
`
`[9]
`
`Patents
`Purpose and construction in general
`
`In the context of patent law, guidelines published
`by the United States Patent and Trademark
`Office (USPTO) are instructive in interpreting
`a statute as
`they provide a practitioner's
`perspective on a given issue.
`
`Cases that cite this headnote
`
`[10]
`
`Patents
`Purpose and construction in general
`
`While the United States Patent and Trademark
`Office (USPTO) guidelines typically serve as a
`guide to patent attorneys and patent examiners
`on procedural matters, a court may take judicial
`notice of guidelines in interpreting a statute so
`long as the USPTO's interpretation does not
`conflict with the statute; the guidelines are not
`binding on the court.
`
`Cases that cite this headnote
`
`[11]
`
`Statutes
`Language and intent, will, purpose, or
`policy
`
`Statutes
`Design, structure, or scheme
`
`In determining the meaning of a statute, court
`must give effect to congressional intent by
`looking not only to the particular statutory
`
` © 2016 Thomson Reuters. No claim to original U.S. Government Works.
`
`2
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`

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`Helsinn Healthcare S.A. v. Dr. Reddy's Laboratories Ltd., --- F.Supp.3d ---- (2016)
`
`language, but to the design of the statute as a
`whole and to its object and policy.
`
`Cases that cite this headnote
`
`Cases that cite this headnote
`
`[12]
`
`Statutes
`Reports and analyses
`
`In interpreting a statute, committee reports,
`which represent the considered and collective
`understanding of Congress in drafting and
`studying proposed legislation, are crucial when
`considering an issue of first impression.
`
`Cases that cite this headnote
`
`[13]
`
`Statutes
`Drafts and earlier versions
`
`In determining the meaning of a statute, prior
`versions of statutory provisions may supply
`evidence of congressional intent.
`
`Cases that cite this headnote
`
`[14]
`
`Statutes
`Legislative history
`
`When looking to prior versions of legislation
`in interpreting a statute, courts should not
`assume that Congress intended to enact statutory
`language that it has earlier discarded in favor of
`other language.
`
`Cases that cite this headnote
`
`[15]
`
`Statutes
`Context
`
`[17]
`
`Patents
`What Constitutes Sale
`
`Amended text of “on-sale bar” to patentability
`under the America Invents Act (AIA) requires
`a public sale or offer for sale of the claimed
`invention. 35 U.S.C.A. § 102.
`
`Cases that cite this headnote
`
`[18]
`
`Patents
`Sale
`
`Supply agreement between purchaser and
`assignee of patents covering intravenous solution
`for treating chemotherapy-induced nausea and
`vomiting, made more than one year prior to
`the application date of the patents for future
`commercial products that had not yet received
`Food and Drug Administration (FDA) approval
`at the time of contracting, constituted a sale
`pursuant to pre-America Invents Act (AIA) on-
`sale bar to patentability. 35 U.S.C.A. § 102;
`U.C.C. § 2-105(2).
`
`Cases that cite this headnote
`
`[19]
`
`Sales
`Nature and Essentials of Contract for Sale
`of Personal Property in General
`
`A “sale” is a contract between parties to give and
`to pass rights of property for consideration which
`the buyer pays or promises to pay the seller for
`the thing bought or sold.
`
`Meaning of statutory language, plain or not,
`depends on context.
`
`Cases that cite this headnote
`
`Cases that cite this headnote
`
`[16]
`
`Statutes
`Statutory scheme in general
`
`The importance of interpreting a statute in the
`context of the larger statutory scheme is crucial,
`as Congress does not alter the fundamental
`details of a regulatory scheme in vague terms or
`ancillary provisions.
`
`[20]
`
`Patents
`Sale
`
`Supply agreements between manufacturers and
`assignee of patents covering intravenous solution
`for treating chemotherapy-induced nausea and
`vomiting for developmental batches of product
`for clinical trials and data-gathering were not
`sales or offers for sale under pre-America
`Invents Act (AIA) on-sale bar to patentability;
`agreements were not for the commercialization
`
` © 2016 Thomson Reuters. No claim to original U.S. Government Works.
`
`3
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`Helsinn Healthcare S.A. v. Dr. Reddy's Laboratories Ltd., --- F.Supp.3d ---- (2016)
`
`of assignee's product or for the purpose of
`assignee conducting its own secret, personal use
`of its product, and agreements were not entered
`into for purpose of stockpiling commercial
`product while anticipating Food and Drug
`Administration (FDA) approval and commercial
`launch, rather, assignee entered into agreements
`for purpose of pursuing FDA approval, which
`included analytical development, formulation
`development, batches preparation for clinical
`trials, and stability data generation. 35 U.S.C.A.
`§ 102.
`
`Cases that cite this headnote
`
`[21]
`
`Patents
`Sale
`
`Supply agreements between manufacturers and
`assignee of patents covering intravenous solution
`for treating chemotherapy-induced nausea and
`vomiting for developmental batches of product
`for clinical trials and data-gathering were not
`“public” sales under the post-America Invents
`Act (AIA) on-sale bar to patentability, given
`that the agreements were entirely subject to and
`performed under confidentiality restrictions. 35
`U.S.C.A. § 102.
`
`Cases that cite this headnote
`
`[22]
`
`Patents
`Attempts to sell; offers
`
`Patents
`Completion of sale; acceptance and
`delivery
`
`An agreement that relates specifically to a supply
`of worldwide requirements for what are clearly
`commercial purposes constitutes an offer to sell
`that has been accepted, within meaning of on-
`sale bar to patentability. 35 U.S.C.A. § 102.
`
`Cases that cite this headnote
`
`[23]
`
`Patents
`What Constitutes Sale
`
`Determinative factor under the sale prong of the
`on-sale bar to patentability is the contractual
`language of the agreement. 35 U.S.C.A. § 102.
`
`Cases that cite this headnote
`
`[24]
`
`Patents
`Attempts to sell; offers
`
`Agreement may not be considered a sale or offer
`for sale under the on-sale bar to patentability
`if the agreement lacks material terms that are
`common to commercial documents. 35 U.S.C.A.
`§ 102.
`
`Cases that cite this headnote
`
`[25]
`
`Patents
`Sale
`
`Supply and purchase agreement between
`purchaser and assignee of patents covering
`intravenous solution for treating chemotherapy-
`induced nausea and vomiting was not a
`“sale” under post-America Invents Act (AIA)
`on-sale bar
`to patentability; although
`the
`product had not yet received Food and Drug
`Administration (FDA) approval, agreement
`contained contractual terms relating to quantity
`of product that would be sold and at which
`price, and specified the exact dosages and
`concentrations that were in the pending FDA
`filings, and therefore the agreement was not
`indefinite or uncertain, and agreement did not
`make the claimed invention available to the
`public. 35 U.S.C.A. § 102.
`
`Cases that cite this headnote
`
`[26]
`
`Patents
`Number of uses or sales
`
`Post-America Invents Act (AIA) on-sale bar to
`patentability requires that the sale or offer for
`sale make the claimed invention available to the
`public; it is not sufficient that a sale or offer for
`sale merely occur. 35 U.S.C.A. § 102.
`
`Cases that cite this headnote
`
`[27]
`
`Patents
`Reduction of Invention to Practice
`
`Patents
`
` © 2016 Thomson Reuters. No claim to original U.S. Government Works.
`
`4
`
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`

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`Helsinn Healthcare S.A. v. Dr. Reddy's Laboratories Ltd., --- F.Supp.3d ---- (2016)
`
`Demonstration of utility; tests
`
`Written Description Requirement
`
`To demonstrate reduction to practice, for patent
`purposes, a party must prove that the inventor
`(1) constructed an embodiment or performed
`a process that met all the limitations and (2)
`determined that the invention would work for its
`intended purpose.
`
`Cases that cite this headnote
`
`[28]
`
`Patents
`Presumptions and burden of proof
`
`Patents
`Weight and Sufficiency
`
`As patents are presumed valid, the patent
`challenger must prove by clear and convincing
`evidence that the claimed formulation was
`“ready for patenting” at the time of the critical
`date, for purposes of on-sale bar to patentability.
`35 U.S.C.A. § 102.
`
`Cases that cite this headnote
`
`[29]
`
`Patents
`Questions of law or fact
`
`Whether a claimed formulation has been reduced
`to practice, for patent purposes, is a fact-driven
`analysis that may require an analysis of the
`parties' claim construction.
`
`Cases that cite this headnote
`
`[30]
`
`Patents
`Sale
`
`Claimed invention of asserted claims of patents
`covering
`intravenous solution
`for
`treating
`chemotherapy-induced nausea and vomiting
`were not “ready for patenting” as of critical date,
`as required under on-sale bar to patentability,
`where trial testing and preliminary data of
`solution were insufficient at that time to support
`any valid scientific knowledge of efficacy as
`claimed. 35 U.S.C.A. § 102.
`
`Hallmark of written description requirement for
`patents is disclosure. 35 U.S.C.A. § 112(a).
`
`Cases that cite this headnote
`
`[32]
`
`Patents
`Disclosure as directed to one skilled in the
`
`art
`
`To meet written description requirement for
`patents, the disclosure must allow one skilled
`in the art to visualize or recognize the identity
`of the subject matter purportedly described. 35
`U.S.C.A. § 112(a).
`
`Cases that cite this headnote
`
`[33]
`
`Patents
`Disclosure as directed to one skilled in the
`
`art
`
`Patents
`Possession of claimed invention
`
`To satisfy written description requirement for
`patents, the disclosure need not contain either
`examples or an actual reduction to practice,
`rather, the critical inquiry is whether the patentee
`has provided a description that in a definite
`way identifies the claimed invention in sufficient
`detail that a person of ordinary skill would
`understand that the inventor was in possession
`of it at the time of filing; this is an objective
`inquiry into the four corners of the specification.
`35 U.S.C.A. § 112(a).
`
`Cases that cite this headnote
`
`[34]
`
`Patents
`Written Description Requirement
`
`A claim that recites a property that is necessarily
`inherent in a formulation that is adequately
`described is not invalid as lacking written
`description merely because the property itself is
`not explicitly described. 35 U.S.C.A. § 112(a).
`
`Cases that cite this headnote
`
`Cases that cite this headnote
`
`[31]
`
`Patents
`
`[35]
`
`Patents
`
` © 2016 Thomson Reuters. No claim to original U.S. Government Works.
`
`5
`
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`

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`Helsinn Healthcare S.A. v. Dr. Reddy's Laboratories Ltd., --- F.Supp.3d ---- (2016)
`
`Presumption of correctness in general
`
`Patents
`Degree of proof
`
`A patent is presumed valid, and this presumption
`can be overcome only by facts supported by
`clear and convincing evidence to the contrary. 35
`U.S.C.A. § 282.
`
`Cases that cite this headnote
`
`[36]
`
`Patents
`Particular products or processes
`
`Specification of patent relating to intravenous
`solution for
`treating chemotherapy-induced
`nausea and vomiting provided an adequate
`written description of the efficacy of the
`invention claimed; in light of public disclosure
`at conference of actual data from clinical study,
`a skilled artisan would have knowledge that the
`inventors were in possession of the invention at
`the time of the patent application. 35 U.S.C.A. §
`112(a).
`
`Cases that cite this headnote
`
`[37]
`
`Patents
`Filing of applications for drug approval
`
`Under the Hatch-Waxman framework, the filing
`of an Abbreviated New Drug Applications
`(ANDA) constitutes an artificial act of
`infringement for purposes of creating case
`or controversy jurisdiction; this artificial, or
`technical, act of infringement does not in and of
`itself constitute a literal infringement. U.S.C.A.
`Const. Art. 3, § 2, cl. 1; 35 U.S.C.A. § 271(e)(2)
`(A).
`
`Cases that cite this headnote
`
`[38]
`
`Patents
`In general; comparison with patent claims
`
`Patents
`Filing of applications for drug approval
`
`Once jurisdiction has been established under
`framework of Hatch-Waxman Act by technical
`act of infringement by filing Abbreviated New
`Drug Application (ANDA), traditional patent
`
`law principles control and a court must conduct
`a traditional infringement analysis; this analysis
`requires a comparison of the asserted patent
`claims against the product that is likely to be
`sold following ANDA approval. 35 U.S.C.A. §
`271(e)(2)(A).
`
`Cases that cite this headnote
`
`[39]
`
`Patents
`Degree of proof
`
`When alleged infringer files Abbreviated New
`Drug Application (ANDA), patentee must prove
`infringement of the asserted patent claims by a
`preponderance of the evidence. 35 U.S.C.A. §
`271(e)(2)(A).
`
`Cases that cite this headnote
`
`[40]
`
`Patents
`Filing of applications for drug approval
`
`If a product that an Abbreviated New Drug
`Application (ANDA) applicant is asking the
`Food and Drug Administration (FDA) to approve
`for sale falls within the scope of an issued patent,
`a judgment of infringement must necessarily
`ensue. 35 U.S.C.A. § 271(e)(2)(A).
`
`Cases that cite this headnote
`
`[41]
`
`Patents
`In general; comparison with patent claims
`
`If any claim limitation is absent from the accused
`device, there is no literal infringement as a matter
`of law.
`
`Cases that cite this headnote
`
`[42]
`
`Patents
`Drugs and medicines
`
`Abbreviated New Drug Application (ANDA)
`specification for generic product with 0.075 mg /
`1.5 ml dosage strength did not infringe asserted
`claims of patent covering intravenous solution
`for treating chemotherapy-induced nausea and
`vomiting, which included 0.25 mg / 5 ml solution
`dosage. 35 U.S.C.A. § 271(e)(2)(A).
`
` © 2016 Thomson Reuters. No claim to original U.S. Government Works.
`
`6
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`

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`Helsinn Healthcare S.A. v. Dr. Reddy's Laboratories Ltd., --- F.Supp.3d ---- (2016)
`
`Cases that cite this headnote
`
`Attorneys and Law Firms
`
`[43]
`
`Patents
`Level of Ordinary Skill in the Art
`
`In context of obviousness analysis
`for
`patentability conducted from the perspective of
`a person of ordinary skill in the prior art, the
`hypothetical person of ordinary skill is presumed
`to be aware of all the pertinent art at the time the
`invention was made. 35 U.S.C.A. § 103(a).
`
`Cases that cite this headnote
`
`Angela Cheryl Ni, Eric W. Dittmann, Isaac Samuel
`Ashkenazi, Paul Hastings Janofsky & Walker LLP, Mark E.
`Waddell, Loeb & Loeb LLP, New York, NY, Charles Michael
`Lizza, William C. Baton, Saul Ewing, LLP, Newark, NJ,
`Jason Todd Christiansen, Paul Hastings LLP, Houston, TX,
`for Plaintiffs.
`
`Mayra Velez Tarantino, Michael E. Patunas, Lite DePalma
`Greenberg, LLC, Newark, NJ, for Defendants.
`
`OUTLINE OF SUPPLEMENTAL OPINION
`
`[44]
`
`Patents
`Level of Ordinary Skill in the Art
`
`COOPER, District Judge
`
`In context of obviousness analysis
`for
`patentability conducted from the perspective of
`a person of ordinary skill in the prior art, the
`person of ordinary skill is a person of ordinary
`creativity, not an automaton. 35 U.S.C.A. §
`103(a).
`
`Cases that cite this headnote
`
`PRELIMINARY STATEMENT
`
`I. Findings of Fact .... ––––
`
`A. Medical treatment for emesis .... ––––
`
`B. The patents-in-suit .... ––––
`
`C. Factual chronology .... ––––
`
`[45]
`
`Patents
`Level of Ordinary Skill in the Art
`
`In context of obviousness analysis
`for
`patentability conducted from the perspective of a
`person of ordinary skill in the prior art, the person
`of ordinary skill may be a composite of various
`types of individuals. 35 U.S.C.A. § 103(a).
`
`Cases that cite this headnote
`
`[46]
`
`Patents
`In general; utility
`
`US Patent 7,947,724, US Patent 7,947,725, US
`Patent 7,960,424, US Patent 8,598,219. Valid
`and Infringed.
`
`Cases that cite this headnote
`
`1. Syntex and the genus '333 patent .... ––––
`
`2. Roche Syntex further development process .... ––––
`
`3. Helsinn license from Roche .... ––––
`
`4. The Oread agreements .... ––––
`
`5. FDA meeting March 10, 1999 .... ––––
`
`6. Phase III protocol .... ––––
`
`7. Commencement of Phase III trials .... ––––
`
`8. The SP agreements .... ––––
`
`9. The MGI agreements .... ––––
`
`10. Status of Phase III clinical trials on January 30,
`2002 .... ––––
`
`11. Status as of patent application date, January 30,
`2003 .... ––––
`
`12. Issuance of patents-in-suit .... ––––
`
` © 2016 Thomson Reuters. No claim to original U.S. Government Works.
`
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`Helsinn Healthcare S.A. v. Dr. Reddy's Laboratories Ltd., --- F.Supp.3d ---- (2016)
`
`13. Claim construction rulings regarding prosecution
`history .... ––––
`
`b. Applied legal standards .... ––––
`
`14. ANDA filings by Teva and others .... ––––
`
`II. Conclusions of Law .... ––––
`
`A. On-sale bar .... ––––
`
`standards
`1. Legal
`construction .... ––––
`
`and post-AIA
`
`statutory
`
`a. Historical analysis .... ––––
`
`b. Parties' arguments regarding on-sale bar .... ––––
`
`c. Interpreting the legal standard .... ––––
`
`1. Statutory construction .... ––––
`
`2. Agency guidelines .... ––––
`
`3. Legislative history .... ––––
`
`4. Public policy considerations .... ––––
`
`d. Application of legal standards .... ––––
`
`1. Statutory construction .... ––––
`
`2. Agency guidelines .... ––––
`
`3. Legislative history .... ––––
`
`4. Public policy considerations.... ––––
`
`1. Parties' arguments .... ––––
`
`2. Expert opinions .... ––––
`
`3. Analysis .... ––––
`
`5. Conclusions as to on-sale bar claims .... ––––
`
`B. Written Description .... ––––
`
`1. Legal standards .... ––––
`
`2. Findings and conclusions on written description ....
`––––
`
`C. Infringement .... ––––
`
`1. Legal standards .... ––––
`
`2. Findings and conclusions on infringement .... ––––
`
`a. Parties' arguments .... ––––
`
`b. Analysis .... ––––
`
`D. Defining the Person of Ordinary Skill in the Art ....
`––––
`
`1. Expert testimony .... ––––
`
`2. Analysis .... ––––
`
`2. Findings as to sale or offer to sell pre-AIA .... ––––
`
`CONCLUSION .... ––––
`
`a.. Applicable legal standards .... ––––
`
`SUPPLEMENTAL OPINION
`
`b. Parties' arguments .... ––––
`
`c. Analysis .... ––––
`
`3. Findings as to sale or offer to sell post-AIA .... ––––
`
`a. Legal standard .... ––––
`
`b. Parties' arguments .... ––––
`
`c. Analysis .... ––––
`
`4. Findings on ready for patenting .... ––––
`
`a. Legal standards .... ––––
`
`*1 This is an action arising under the Hatch-Waxman
`Act, 35 U.S.C. § 271(e)(2)(A). Plaintiffs, Helsinn Healthcare
`S.A. (“Helsinn”) and Roche Palo Alto LLC (“Roche”)
`(collectively, “plaintiffs”), are assignees of U.S. Patents
`No. 7,947,724 (“the '724 patent”), No. 7,947,725 (“the
`'725 patent”), No. 7,960,424 (“the '424 patent”), and No.
`8,598,219 (“the '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.
`
` © 2016 Thomson Reuters. No claim to original U.S. Government Works.
`
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`Helsinn Healthcare S.A. v. Dr. Reddy's Laboratories Ltd., --- F.Supp.3d ---- (2016)
`
`Plaintiffs brought this action, and related consolidated
`actions, against generic drug manufacturers, Dr. Reddy's
`Laboratories, Ltd., Dr. Reddy's Laboratories, Inc. (“DRL”),
`Sandoz, Inc. (“Sandoz”), Teva Pharmaceuticals USA, Inc.,
`and Teva Pharmaceutical Industries, Ltd. (“Teva”). Plaintiffs
`alleged that each group of defendants had filed an
`Abbreviated New Drug Application (“ANDA”) containing so
`called “Paragraph IV” certifications asserting that the claims
`of the patents-in-suit were invalid and/or not infringed. The
`asserted claims are claims 2 and 9 of the '724 patent, claim
`2 of the '725 patent, claim 6 of the '424 patent, and claims
`1, 2, 6, and 7 of the '219 patent. The pertinent limitations of
`the first three patents are “reducing emesis...,” the “0.05 mg/
`mL” concentration, and “EDTA.” The pertinent limitations of
`the '219 patent are “reduce... cancer chemotherapy-induced
`nausea and vomiting,” “0.25 mg” dose in “5 mL... solution,”
`and “EDTA.”
`
`Defendant Sandoz was dismissed from the action by consent,
`on December 31, 2014. (Dkt. 247.) 1 The Court issued a
`Memorandum Opinion construing certain preamble language
`in the '219 patent claims, on April 22, 2015. (Dkt. 290.)
`An 11-day bench trial was conducted in June 2015, with
`closing arguments presented on August 12, 2015. (Dkts. 320,
`322, 324, 326, 328, 330, 331, 337, 340, 342, 344, and 353.)
`Defendant DRL was dismissed on stipulation on October 16,
`2015. (Dkt. 355.) 2 Thus, the current parties in this case are
`plaintiffs and Teva.
`
`*2 Teva asserts that the asserted claims of each of the four
`patents-in-suit are invalid as obvious under 35 U.S.C. § 103. 3
`Teva further asserts invalidity of those patents under the on-
`sale bar provision of 35 U.S.C. § 102. The on-sale bar issue
`presents not only underlying factual questions, but also a
`statutory interpretation question addressing the amended text
`of § 102(a)(1) under the America Invents Act (“AIA”), Pub.L.
`No. 112–29 (2011). Teva also raises a written description
`claim against those patents under 35 U.S.C. § 112. Plaintiffs
`oppose each of Teva's points on those issues, asserting that
`the patents are valid and enforceable.
`
`There is also an infringement issue. Teva filed one
`consolidated ANDA, seeking approval for products at
`two different dose levels (0.25 mg and 0.075 mg), and
`two different treatment indications (chemotherapy-induced
`nausea and vomiting (“CINV”) for the 0.25 mg dose, and
`post-operative nausea and vomiting (“PONV”) for the 0.075
`mg dose). The concentration of both proposed Teva products
`is 0.05 mg/ml, because the 0.25 mg dose solution is 5 ml
`
`and the 0.075 mg dose solution is 1.5 ml. 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 must infringe and be enjoined.
`Teva disputes plaintiffs' legal position and seeks a declaration
`that its 0.075 mg dose PONV product will not infringe the
`asserted '219 patent claims.
`
`The Court issued a Memorandum Opinion on November 13,
`2015, and entered judgment declaring that:
`
`(1) 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;
`
`(2) the asserted claims of the '219 patent are valid and are
`infringed by Teva's proposed 0.25 mg generic product; and
`
`(3) the asserted claims of the '219 patent are valid and are
`not infringed by Teva's proposed 0.075 mg generic product.
`
`(Dkt. 360; dkt. 361.)
`
`This Supplemental Opinion constitutes the Court's findings
`of fact and conclusions of law on the issues of the on-sale
`bar under 35 U.S.C. § 102, statutory interpretation of the on-
`sale bar after the passage of the American Invents Act under
`35 U.S.C. § 102(a)(1), written description under 35 U.S.C. §
`112, and infringement under 35 U.S.C. § 271. The Court now
`makes the following findings of fact and conclusions of law
`pursuant to Federal Rule of Civil Procedure 52(a)(1).
`
`1. FINDINGS OF FACT
`
`A. Medical treatment for emesis
`Medical science has long recognized that the human body has
`an elaborate and multifaceted defense system against trauma
`and toxins. (Dkt. 328 at 29.) Part of that defense system is
`called emesis, referring generally to the reflexive reaction
`experienced as nausea and vomiting. (Id. at 27, 31-32.) Its
`purpose is essentially to get rid of toxins in the body. (Id. at
`26.)
`
`The parties presented undisputed medical background
`information on the scientific field of the claimed inventions.
`(Id.; see also dkt. 320; dkt. 324; dkt. 326; dkt. 331; dkt. 337;
`dkt. 340; dkt. 342; dkt. 344.) For example, Teva's expert
`
` © 2016 Thomson Reuters. No claim to original U.S. Government Works.
`
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`Helsinn Healthcare S.A. v. Dr. Reddy's Laboratories Ltd., --- F.Supp.3d ---- (2016)
`
`clinician Dr. David Frame provided a basic overview of the
`mechanisms in the body that lead to emesis, at least as related
`to chemical stimuli. 4 As he explained, the gastrointestinal
`tract and the brain are the two primary systems involved
`in creating emesis. (Dkt. 328 at 25-26.) If a person ingests
`a toxin directly into the stomach, or if a toxin is injected
`into the blood, the noxious substances go into the GI tract.
`(Id. at 26.) The GI tract then releases certain molecules
`called neurotransmitters. (Id.) Those neurotransmitters will
`bind to receptors, causing signals to transmit up a nerve
`called a vagal nerve that leads to a specific spot located in
`the brain but just outside the blood-brain barrier (the trigger
`zone or essentially the vomiting center). (Id.) When those
`neurotransmitter signals arrive there, they will activate one or
`more neurotransmitters that will carry the signal back down
`the vagal nerve to the GI tract and produce the contractions
`of nausea and vomiting. (Id. at 27.)
`
`*3 Scientists have identified approximately 20 to 30
`types of neurotransmitters that play a role in prompting
`the emesis reaction. (Id. at 28.) Those neurotransmitters
`bind to cells called receptors, found in various places in
`the body. (Id. at 28-29.) In other words, several different
`neurotransmitters and corresponding receptors are involved
`in most causes of nausea and vomiting. (Id. at 29.) Also,
`depending on what kind of toxic stimulus is introduced, there
`may be different amounts and types of neurotransmitters
`activated, and different locations within the body where the
`corresponding receptors are concentrated. (Id. at 28-29.) All
`of this is part of that elaborate defense system against various
`toxic substances that is inherent in the body. (Id. at 26, 29.)
`
`One of the neurotransmitters known to play a role in causing
`emesis is serotonin (5-hydroxytryptamine). (Id. at 28.) It can
`bind to many different types of receptors, but the one that
`it binds to that is most responsible for nausea and vomiting
`is a specific “hydroxytryptophan” receptor, called the 5-
`HT3 receptor. (Id. at 29.) Indeed, there are different types
`of hydroxytryptophan receptors, and the number 3 type (the
`“5-HT3 receptor”) is known to be specific in binding with
`serotonin to release those nausea and vomiting signals. (Id.)
`
`Some of the other types of neuro