DCT

2:20-cv-08966

Takeda Pharmaceutical Co Ltd v. Norwich Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:20-cv-08966, D.N.J., 07/15/2020
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because the Defendants maintain places of business in the state, regularly conduct business there, and intend to market and sell the accused product in New Jersey.
  • Core Dispute: Plaintiff alleges that Defendants’ filing of an Abbreviated New Drug Application (ANDA) for generic lisdexamfetamine dimesylate capsules (a generic version of Vyvanse®) infringes eighteen patents related to abuse-resistant amphetamine compounds.
  • Technical Context: The technology involves creating a prodrug by covalently bonding amphetamine to a chemical moiety, such as the amino acid lysine, to create a compound that is pharmacologically inactive until metabolized in the body, thereby reducing its potential for abuse via injection or insufflation.
  • Key Procedural History: The complaint notes that the same eighteen patents-in-suit were previously litigated in Shire LLC v. Amneal Pharmaceuticals, LLC et al. in the District of New Jersey. In that case, the court granted summary judgment that key claims of the patents were not invalid and were infringed. The judgment was affirmed by the U.S. Court of Appeals for the Federal Circuit in 2015. The complaint also alleges that certain executives of the current Defendants were previously employed by a defendant in the prior litigation and were responsible for the failed challenge to the patents.

Case Timeline

Date Event
2002-02-22 Earliest Priority Date for U.S. Patent No. 7,105,486
2003-05-29 Earliest Priority Date for U.S. Patent No. 7,223,735
2006-09-12 U.S. Patent No. 7,105,486 Issued
2007-05-29 U.S. Patent No. 7,223,735 Issued
2010-02-02 U.S. Patent No. 7,655,630 Issued
2010-02-09 U.S. Patent Nos. 7,659,253 & 7,659,254 Issued
2010-02-16 U.S. Patent Nos. 7,662,787 & 7,662,788 Issued
2010-03-02 U.S. Patent Nos. 7,671,030 & 7,671,031 Issued
2010-03-09 U.S. Patent No. 7,674,774 Issued
2010-03-16 U.S. Patent Nos. 7,678,770 & 7,678,771 Issued
2010-03-30 U.S. Patent Nos. 7,687,466 & 7,687,467 Issued
2010-04-20 U.S. Patent No. 7,700,561 Issued
2010-05-11 U.S. Patent No. 7,713,936 Issued
2010-05-18 U.S. Patent No. 7,718,619 Issued
2010-05-25 U.S. Patent No. 7,723,305 Issued
2015-01-01 Federal Circuit affirms judgment in Shire LLC v. Amneal Pharm., LLC (approximate date based on citation)
2020-07-15 Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 7,105,486 - "Abuse-Resistant Amphetamine Compounds"

The Invention Explained

  • Problem Addressed: Amphetamines have a high potential for abuse, and prolonged use can lead to drug dependence (Compl. ¶35; "'486 Patent", col. 2:21-30). Illicit users often seek a rapid onset of euphoric effect ("rush") by administering the drug via parenteral routes like intravenous injection or intranasal "snorting," and conventional extended-release formulations can be crushed to make the full dose immediately available ("'486 Patent", col. 2:36-48).
  • The Patented Solution: The invention is a prodrug approach where amphetamine is covalently bonded to a "chemical moiety," such as an amino acid. This renders the amphetamine pharmacologically inactive until the bond is hydrolyzed by metabolic processes after oral administration ("'486 Patent", Abstract). This design is intended to provide a gradual, extended release of the active drug while preventing the rapid "rush" sought by abusers, as the covalent bond is not easily broken by simple physical manipulation or through parenteral administration routes ("'486 Patent", col. 3:58-65; col. 4:37-48).
  • Technical Importance: This technology creates a stimulant that is inherently abuse-resistant at a molecular level, a significant departure from physical formulation-based abuse-deterrence which can often be circumvented ("'486 Patent", col. 2:54-62).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" (Compl. ¶87) and specifically notes that claim 4 was previously upheld in prior litigation (Compl. ¶4). Claim 4 depends from independent claim 1.
  • Independent Claim 1:
    • A method for treating a patient having attention deficit hyperactivity disorder, narcolepsy, or obesity
    • comprising providing to the patient an amount of a compound ... effective for the treatment of said patient, said compound comprising:
    • amphetamine covalently bonded to a chemical moiety.
  • The complaint appears to reserve the right to assert additional claims, including dependent claims.

U.S. Patent No. 7,223,735 - "Abuse Resistant Lysine Amphetamine Compounds"

The Invention Explained

  • Problem Addressed: The patent addresses the same problem as the "'486 patent": the high potential for abuse of amphetamines, particularly when diverted from their intended oral use to parenteral routes that provide a rapid euphoric effect ("'735 Patent", col. 1:15-20, col. 2:36-42).
  • The Patented Solution: This invention narrows the broader concept of the "'486 patent" to a specific composition. It claims a pharmaceutical composition that includes L-lysine-d-amphetamine (lisdexamfetamine) or a salt thereof, combined with a pharmaceutically acceptable carrier ("'735 Patent", Abstract). By specifying L-lysine as the carrier covalently bonded to d-amphetamine, the patent claims the specific molecular entity that became the active ingredient in the commercial drug Vyvanse® ("'735 Patent", col. 4:52-58).
  • Technical Importance: The invention defines a specific, commercially viable prodrug compound and its formulation, providing a concrete embodiment of the abuse-resistant amphetamine concept.

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" of the "'735 patent" (Compl. ¶97). Independent claim 1 is representative.
  • Independent Claim 1:
    • A pharmaceutical composition comprising
    • L-lysine-d-amphetamine or a salt thereof, and
    • a carrier.
  • The complaint appears to reserve the right to assert additional claims, including dependent claims.

U.S. Patent No. 7,655,630 - "Abuse-Resistant Amphetamine Prodrugs"

  • Technology Synopsis: This patent claims the specific compound L-lysine-d-amphetamine dimesylate ("'630 Patent", Abstract). This is the specific salt form of the lisdexamfetamine prodrug used in the commercial Vyvanse® product and the accused generic product.
  • Asserted Claims: Claims 1-4 were upheld in prior litigation (Compl. ¶4). Claim 1 is the independent claim covering the compound.
  • Accused Features: The "Norwich Proposed Product" is identified as "generic lisdexamfetamine dimesylate capsules" (Compl. ¶53).

U.S. Patent No. 7,659,253 - "Abuse-Resistant Amphetamine Prodrugs"

  • Technology Synopsis: This patent claims crystalline lisdexamfetamine dimesylate ("'253 Patent", Abstract). The claims define a specific solid-state form of the active ingredient, which can be important for stability, manufacturing, and dissolution properties.
  • Asserted Claims: Claims 1-12 were upheld in prior litigation (Compl. ¶4). Claim 1 is an independent claim covering the crystalline form.
  • Accused Features: The accused product is a solid capsule formulation of lisdexamfetamine dimesylate, which may comprise the claimed crystalline form (Compl. ¶53, 115).

Editor's Note: The complaint asserts 18 patents in total. In the interest of conciseness, and as the remaining patents claim related subject matter (e.g., additional compositions, methods of treatment for specific disorders, and other salt/crystalline forms), capsules for the 14 other patents have been omitted. Their core technology and accused features are substantially similar to those analyzed above.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the "Norwich Proposed Product," which is a generic version of the drug Vyvanse® described in Defendants' jointly prepared Abbreviated New Drug Application (ANDA) No. 214547 (Compl. ¶53).

Functionality and Market Context

The product is identified as "generic lisdexamfetamine dimesylate capsules" for oral administration, available in 10, 20, 30, 40, 50, 60, and 70 mg dosages (Compl. ¶53). Lisdexamfetamine dimesylate is a prodrug of d-amphetamine. The product is intended to be a generic substitute for Takeda's Vyvanse® product, which is approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and moderate to severe binge-eating disorder in adults (Compl. ¶30, 54).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint alleges that the act of submitting ANDA No. 214547 to the FDA constitutes infringement under 35 U.S.C. § 271(e)(2)(A), and that the future commercial manufacture, use, or sale of the product would constitute infringement under 35 U.S.C. § 271(a), (b), and/or (c) (Compl. ¶87-88, 96-97).

7,105,486 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating a patient having attention deficit hyperactivity disorder... Defendants' ANDA seeks approval for a product that is the bioequivalent of Vyvanse®, which is approved for treating ADHD. The proposed product label would instruct for such use. ¶30, ¶53-54, ¶88 col. 5:40-44
...comprising providing to the patient an amount of a compound... effective for the treatment of said patient... The Norwich Proposed Product consists of capsules containing therapeutically effective amounts (10-70 mg) of the active ingredient for oral administration to a patient. ¶53 col. 5:40-44
...said compound comprising: amphetamine covalently bonded to a chemical moiety. The active ingredient in the Norwich Proposed Product is lisdexamfetamine dimesylate, which is d-amphetamine covalently bonded to the amino acid L-lysine. ¶30, ¶53 col. 4:2-8

7,223,735 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical composition... The Norwich Proposed Product is a pharmaceutical composition formulated as capsules for oral administration. ¶53 col. 15:47-50
...comprising L-lysine-d-amphetamine or a salt thereof... The Norwich Proposed Product is explicitly identified as "generic lisdexamfetamine dimesylate capsules," which is a dimesylate salt of L-lysine-d-amphetamine. ¶53 col. 4:52-58
...and a carrier. As a finished pharmaceutical dosage form (capsule), the product necessarily contains pharmaceutically acceptable carriers and/or excipients in addition to the active ingredient. ¶53 col. 15:53-57

Identified Points of Contention

  • Validity and Estoppel: A primary issue will be whether Defendants can raise any invalidity or non-infringement arguments that are not precluded by the legal doctrine of collateral estoppel, given the Federal Circuit's affirmance of summary judgment against a prior generic challenger on the same patents. The question for the court is whether Defendants have new evidence or legal theories that were not, and could not have been, raised in the prior Amneal litigation.
  • Claim Scope: For the "'486 patent", the scope of "chemical moiety" could be a point of contention, though Defendants' use of L-lysine falls squarely within the patent's examples. For the "'735 patent" and related composition patents, infringement appears to be literal, raising the question of whether any viable non-infringement defense exists beyond challenging the patents' validity.

V. Key Claim Terms for Construction

The Term: "chemical moiety" ("'486 Patent", claim 1)

  • Context and Importance: This term defines the scope of the invention in the "'486 method patent". Its construction is central to determining what types of amphetamine prodrugs are covered. A broad construction would cover a wide range of potential prodrugs, while a narrow one could limit the patent's reach to the specific examples disclosed.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides a broad definition, stating the chemical moiety "may be for instance, amino acids, peptides, glycopeptides, carbohydrates, nucleosides, or vitamins" ("'486 Patent", col. 3:62-65).
    • Evidence for a Narrower Interpretation: A defendant might argue that the term should be construed more narrowly in light of the specification's repeated emphasis on amino acids, and particularly L-lysine, as the preferred embodiment ("'486 Patent", col. 4:49-58), suggesting the broader list is not fully enabled or described.

The Term: "a carrier" ("'735 Patent", claim 1)

  • Context and Importance: This term is a standard component of pharmaceutical composition claims. Its definition is necessary to establish the presence of all claim elements in the accused product.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides an extensive and non-limiting list of conventional pharmaceutical carriers, including lubricants, colorants, binders, and excipients, consistent with the term's ordinary meaning in the art ("'735 Patent", col. 15:47 - col. 16:44).
    • Evidence for a Narrower Interpretation: It would be difficult to argue for a narrow construction, but a defendant could potentially argue that the term should be limited to only those excipients that do not materially alter the release profile of the active ingredient, though this is not explicitly required by the claim language.

VI. Other Allegations

Indirect Infringement

The complaint alleges inducement of infringement for the method-of-use patents. The basis is that Defendants' proposed product label will instruct physicians to prescribe and patients to take the generic product for the treatment of ADHD, which would constitute direct infringement of the patented methods (Compl. ¶87).

Willful Infringement

The complaint alleges that Defendants were aware of the patents-in-suit and of the prior litigation in which key claims were found not invalid and infringed by another generic manufacturer (Compl. ¶4, 89). The complaint further alleges that some of Defendants' executives were previously involved in the failed challenge to the same patents while at another company, suggesting a particularly high degree of knowledge and potential objective recklessness (Compl. ¶6, 69, 76). These allegations form the basis for the claim that the infringement is willful and the case is "exceptional" under 35 U.S.C. § 285 (Compl. ¶89).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A central issue will be one of preclusion: to what extent does the prior Federal Circuit-affirmed judgment of validity and infringement against another ANDA filer on the same patents and product bar the current Defendants' defenses? The case may turn on whether Norwich can present new prior art or arguments sufficiently distinct from those already adjudicated to survive a motion for summary judgment.
  • A key question will be one of objective recklessness: given the extensive litigation history of these patents and the alleged direct knowledge of that history by Defendants' executives, can Defendants establish a good-faith, reasonable basis for believing their generic product would not infringe a valid patent? The answer will be critical to the determination of willfulness and whether the case is "exceptional."