DCT

3:17-cv-05319

Mitsubishi Tanabe Pharma Corp v. Sandoz Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:17-cv-05319, D.N.J., 07/20/2017
  • Venue Allegations: Plaintiffs allege venue is proper in the District of New Jersey because both Sandoz and Zydus have a regular and established place of business in the state and have committed or will commit acts of infringement there.
  • Core Dispute: Plaintiffs allege that Defendants' filings of Abbreviated New Drug Applications (ANDAs) to market generic versions of the diabetes drugs Invokana® and Invokamet® constitute an act of infringement of three patents covering the active ingredient canagliflozin.
  • Technical Context: The technology relates to glucopyranoside compounds that function as SGLT2 inhibitors, a class of drugs used to treat type 2 diabetes by causing the kidneys to remove sugar from the body through urine.
  • Key Procedural History: This lawsuit was triggered by Defendants' submission of ANDAs to the FDA seeking approval to market generic drugs. The ANDAs included Paragraph IV certifications alleging that Plaintiffs' patents are invalid, which constitutes a statutory act of infringement under the Hatch-Waxman Act, allowing the patent holder to sue before the generic product is marketed.

Case Timeline

Date Event
2003-08-01 Earliest Priority Date for ’788, ’219, and ’403 Patents
2011-05-17 U.S. Patent No. 7,943,788 Issues
2012-07-17 U.S. Patent No. 8,222,219 Issues
2014-07-22 U.S. Patent No. 8,785,403 Issues
2017-07-20 Complaint Filing Date

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

U.S. Patent No. 7,943,788 - "Glucopyranoside Compound"

  • Patent Identification: U.S. Patent No. 7,943,788, titled "Glucopyranoside Compound", issued May 17, 2011 (’788 Patent).

The Invention Explained

  • Problem Addressed: The patent’s background section describes the limitations and side effects of existing antidiabetic agents, such as sulfonylurea and biguanide compounds, and highlights the progressive and harmful nature of chronic hyperglycemia in diabetes mellitus (e.g., retinopathy, nephropathy, and neuropathy) (’788 Patent, col. 1:20-46).
  • The Patented Solution: The invention is a novel class of glucopyranoside compounds that inhibit the sodium-dependent glucose transporter (SGLT) in the intestine and kidney. By inhibiting SGLT, particularly SGLT2 in the kidney’s proximal convoluted tubules, the patented compounds prevent the reabsorption of glucose from glomerular filtrate back into the blood. This mechanism causes excess glucose to be excreted in the urine, thereby lowering blood glucose levels (’788 Patent, col. 1:47-61). The core chemical structure is represented by Formula (I) (’788 Patent, col. 2:50-55).
  • Technical Importance: This therapeutic approach provides a mechanism for glycemic control that is independent of insulin secretion or action, offering a new treatment modality for diabetic patients (’788 Patent, col. 1:62-67).

Key Claims at a Glance

  • The complaint asserts claims 12 and 20 (Compl. ¶¶ 36, 44, 52, 68). Claim 12 depends from claim 9, which depends from claim 1.
  • Asserted Independent Claim 20: A compound having the specific chemical structure of what is known as canagliflozin:
    • A compound having the structure of 1-(β-D-glucopyranosyl)-4-chloro-3-[5-(4-fluorophenyl)-2-thienylmethyl]benzene.

U.S. Patent No. 8,222,219 - "Glucopyranoside Compound"

  • Patent Identification: U.S. Patent No. 8,222,219, titled "Glucopyranoside Compound", issued July 17, 2012 (’219 Patent).

The Invention Explained

  • Problem Addressed: The patent addresses the same technical problem as the ’788 Patent: the need for effective treatments for diabetes and its related complications due to chronic hyperglycemia, given the shortcomings of existing therapies (’219 Patent, col. 1:20-46).
  • The Patented Solution: The ’219 Patent claims methods of treating or delaying the progression of diabetes by administering a therapeutically effective amount of the same class of SGLT-inhibiting glucopyranoside compounds described in the ’788 Patent. The solution focuses on the therapeutic application of these specific compounds (’219 Patent, col. 27:8-23).
  • Technical Importance: The patent claims a specific therapeutic use for the novel compounds, connecting the chemical structure to a method for managing a significant public health issue.

Key Claims at a Glance

  • The complaint asserts claim 22 (Compl. ¶¶ 60, 76). Claim 22 depends from claim 21, which depends from claim 20.
  • Asserted Independent Claim 20: A method for treating or delaying the progression or onset of a disease selected from a specific group, comprising:
    • administering to a mammal in need thereof
    • a therapeutically effective amount of a compound of formula (I) or a pharmaceutically acceptable salt thereof
    • wherein the disease is selected from diabetes mellitus, diabetic retinopathy, diabetic neuropathy, diabetic nephropathy, delayed wound healing, insulin resistance, hyperglycemia, hyperinsulinemia, elevated blood levels of fatty acids, elevated blood levels of glycerol, hyperlipidemia, obesity, hypertriglyceridemia, Syndrome X, diabetic complications, atherosclerosis, or hypertension.

U.S. Patent No. 8,785,403 - "Glucopyranoside Compound"

  • Patent Identification: U.S. Patent No. 8,785,403, titled "Glucopyranoside Compound", issued July 22, 2014 (’403 Patent).
  • Technology Synopsis: The ’403 patent belongs to the same family as the ’788 and ’219 patents. It claims pharmaceutical compositions containing the SGLT2 inhibitor compound canagliflozin in combination with another antidiabetic agent, thereby providing a multi-faceted approach to treating diabetes.
  • Asserted Claims: The complaint asserts claim 26 (’403 Patent, col. 221:22-26), which depends on claim 25 (’403 Patent, col. 221:13-21).
  • Accused Features: The complaint alleges that Zydus's ANDA No. 210542 for a generic version of Invokamet® infringes claim 26. Invokamet® is a combination drug product containing canagliflozin and metformin, another antidiabetic agent (a biguanide compound) (Compl. ¶¶ 29, 80-84).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are the generic drug products for which Defendants seek FDA approval via four separate ANDAs:

  • Sandoz ANDA No. 210297 for generic canagliflozin tablets (100 mg and 300 mg), a generic version of Invokana® (Compl. ¶32).
  • Sandoz ANDA No. 210481 for generic canagliflozin and metformin hydrochloride combination tablets, a generic version of Invokamet® (Compl. ¶40).
  • Zydus ANDA No. 210541 for generic canagliflozin tablets (100 mg and 300 mg), a generic version of Invokana® (Compl. ¶¶48, 56).
  • Zydus ANDA No. 210542 for generic canagliflozin and metformin hydrochloride combination tablets, a generic version of Invokamet® (Compl. ¶¶64, 72, 80).

Functionality and Market Context

The ANDAs describe pharmaceutical products containing canagliflozin as an active ingredient, intended for the same therapeutic uses as Plaintiffs' branded products, Invokana® and Invokamet® (Compl. ¶¶ 28-30). The filing of an ANDA with a Paragraph IV certification is a statutory act of infringement under 35 U.S.C. § 271(e)(2), which allows for litigation prior to the commercial launch of the generic product (Compl. ¶35).

IV. Analysis of Infringement Allegations

’788 Patent Infringement Allegations

Claim Element (from Independent Claim 20) Alleged Infringing Functionality Complaint Citation Patent Citation
A compound having the following structure: [structure of 1-(β-D-glucopyranosyl)-4-chloro-3-[5-(4-fluorophenyl)-2-thienylmethyl]benzene] The active pharmaceutical ingredient in Defendants' proposed generic products, canagliflozin, is the compound having the structure recited in the claim. ¶32, ¶40, ¶48, ¶64 col. 139:20-40

’219 Patent Infringement Allegations

Claim Element (from Independent Claim 20) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating or delaying the progression or onset of a disease selected from the group consisting of diabetes mellitus... The proposed product labeling for Defendants' generic products will allegedly instruct medical providers and patients to use the products for the treatment of diabetes mellitus. ¶56, ¶72 col. 256:22-24
which comprises administering to a mammal in need thereof... The proposed product labeling will allegedly instruct administration to humans. ¶56, ¶72 col. 256:10-11
a therapeutically effective amount of a compound of formula (I)... The proposed generic products contain canagliflozin, a compound of formula (I), in dosages alleged to be therapeutically effective for treating diabetes. ¶56, ¶72 col. 256:11-13

No probative visual evidence provided in complaint.

Identified Points of Contention

  • Validity vs. Infringement: The complaint states that Defendants filed Paragraph IV certifications asserting the patents are invalid (Compl. ¶¶ 33, 57, 73, 81). In such Hatch-Waxman cases, the central dispute is typically over patent validity (e.g., obviousness, written description) rather than infringement, especially for compound claims where the generic active ingredient is identical to the patented one.
  • Scope of Method Claims (Inducement): For the method-of-use claims in the ’219 patent, a potential point of contention could be whether the instructions in the Defendants' proposed product labels will induce infringement of every claimed method. This raises the question of whether a defendant might use a "skinny label" to omit patented indications, although such a defense is not mentioned in the complaint.

V. Key Claim Terms for Construction

’788 Patent

The asserted claims of the ’788 Patent are directed to a specific chemical compound (canagliflozin) and its pharmaceutically acceptable salts. As claim 20 recites a specific chemical structure, it may not present significant claim construction disputes.

’219 Patent

  • The Term: "therapeutically effective amount" (from claim 20)
  • Context and Importance: This term defines the dosage required to achieve the claimed therapeutic effect. Its construction is important for determining the scope of the method claim. Practitioners may focus on this term to assess whether the specific dosages outlined in the defendants' ANDAs fall within the scope of what the patent teaches as being "therapeutically effective."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification discloses a broad dosage range, stating the compound "is usually in the range of about 0.1 to 50 mg/kg/day, preferably in the range of about 0.1 to 30 mg/kg/day" (’219 Patent, col. 27:40-43). This language may support an interpretation covering a wide variety of potential dosages.
    • Evidence for a Narrower Interpretation: The specification qualifies the dosage, noting that it "may vary according to administration routes, ages, body weight, conditions of patients, and kinds of diseases" (’219 Patent, col. 27:37-40). This language could support a narrower, context-dependent interpretation where the "effective amount" must be tailored to specific patient characteristics.

VI. Other Allegations

Indirect Infringement

Plaintiffs allege that if Defendants commercially launch their products, they will induce and/or contribute to infringement of the asserted claims (Compl. ¶¶ 36, 60, 84). The basis for inducement of the method claims (e.g., claim 22 of the ’219 Patent) is the allegation that Defendants' product labeling will instruct physicians and patients to administer the generic drug in an infringing manner.

Willful Infringement

The complaint does not explicitly allege "willful infringement." However, it repeatedly alleges that each instance of infringement constitutes an "exceptional case" and requests an award of attorneys' fees pursuant to 35 U.S.C. § 285 (Compl. ¶¶ 38, 46, 54, 62, 70, 78, 86). Such a request is often predicated on allegations of litigation misconduct or the weakness of the infringer's non-infringement or invalidity positions.

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

  • A primary issue will be patent validity: As this is a Hatch-Waxman action triggered by Paragraph IV certifications, the central legal battle will likely focus on whether Defendants can prove by clear and convincing evidence that the asserted claims of the ’788, ’219, and ’403 patents are invalid, for reasons such as obviousness over the prior art.
  • A secondary issue may be the scope of induced infringement: For the method-of-use claims of the ’219 patent and the combination therapy claims of the ’403 patent, a key question will be evidentiary: does the specific language in the Defendants’ proposed product labels provide sufficient instruction and encouragement to physicians and patients to use the generic drugs in a manner that directly infringes the patented methods?