DCT

3:20-cv-03106

Mitsubishi Tanabe Pharma Corp v. Aurobindo Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:20-cv-03106, D.N.J., 03/20/2020
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Aurobindo has a regular and established place of business in the district, has committed acts of infringement in the district, and will continue to do so upon approval of its generic product.
  • Core Dispute: Plaintiffs allege that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for approval to market generic versions of the diabetes drug Invokamet XR® constitutes an act of infringement of three U.S. patents.
  • Technical Context: The technology relates to glucopyranoside compounds, specifically the SGLT2 inhibitor canagliflozin, which is used to treat type 2 diabetes by causing the kidneys to remove sugar from the body through urine.
  • Key Procedural History: This litigation was triggered by Defendant Aurobindo’s submission of ANDA No. 213900 to the FDA, which included a "Paragraph IV Certification" alleging that Plaintiffs' patents listed in the FDA's "Orange Book" for the brand-name drug Invokamet XR® are invalid. The complaint was filed within the 45-day statutory window following receipt of Aurobindo's certification notice.

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
2020-02-07 Date of Defendant’s Paragraph IV Certification Notice Letter
2020-03-20 Complaint Filed

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

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

  • Issued: May 17, 2011 (Compl. ¶18)

The Invention Explained

  • Problem Addressed: The patent describes existing treatments for diabetes mellitus as often being insufficient or causing significant side effects, such as hypoglycemia (dangerously low blood sugar), weight gain, and gastrointestinal issues ('788 Patent, col. 1:24-34). Chronic high blood sugar (hyperglycemia) leads to severe long-term complications, necessitating new therapeutic approaches ('788 Patent, col. 1:35-40).
  • The Patented Solution: The invention provides a class of novel glucopyranoside compounds that function as inhibitors of the sodium-dependent glucose transporter (SGLT), which is present in the kidney ('788 Patent, col. 1:11-14). By inhibiting SGLT, the patented compounds block the reabsorption of glucose from the kidney back into the bloodstream, thereby promoting the excretion of excess glucose in the urine and lowering overall blood glucose levels ('788 Patent, col. 2:40-52). The general chemical structure of these compounds is depicted in Formula (I) ('788 Patent, col. 2:35-40).
  • Technical Importance: This therapeutic mechanism provides a means of controlling blood sugar that is independent of a patient's insulin secretion or sensitivity, offering a valuable alternative for patients with insulin resistance ('788 Patent, col. 2:59-65).

Key Claims at a Glance

  • The complaint asserts independent claim 20 and dependent claim 12 (Compl. ¶34).
  • Independent Claim 20 recites:
    • A compound having the specific chemical structure for 1-(β-D-glucopyranosyl)-4-chloro-3-[5-(2-thienylmethyl)-2-thienyl]methyl]benzene (canagliflozin).
    • Or a pharmaceutically acceptable salt thereof.

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

  • Issued: July 17, 2012 (Compl. ¶21)

The Invention Explained

  • Problem Addressed: As a member of the same patent family, the ’219 Patent addresses the same technical problem as the ’788 Patent: the need for new diabetes treatments with improved efficacy and fewer side effects compared to existing therapies like sulfonylureas and biguanides (’219 Patent, col. 1:22-34).
  • The Patented Solution: The patent claims methods of treating diabetes and related conditions by administering a therapeutically effective amount of a glucopyranoside compound, including the specific compound canagliflozin, that functions as an SGLT inhibitor (’219 Patent, Abstract; col. 2:50-53). The mechanism of action is identical to that described in the ’788 Patent.
  • Technical Importance: The patent claims the specific use of these novel compounds for treating a range of metabolic disorders beyond just diabetes, including obesity, hypertension, and atherosclerosis (’219 Patent, col. 27:8-13).

Key Claims at a Glance

  • The complaint asserts claim 22 (Compl. ¶42). Claim 22 depends on claim 20, which depends on claims 18 and 10. Claim 10 is an independent method-of-treatment claim.
  • Independent Claim 10 recites:
    • A method for treating a list of diseases including diabetes and hyperglycemia in a mammalian species.
    • The method comprises administering to the mammal a therapeutically effective amount of a compound of Formula (I) or a pharmaceutically acceptable salt thereof.
  • Dependent Claim 22 further specifies that the compound administered is 1-(β-D-glucopyranosyl)-4-chloro-3-[5-(2-thienylmethyl)-2-thienyl]methyl]benzene (canagliflozin).

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

  • Issued: July 22, 2014 (Compl. ¶24)
  • Analyst Note: This patent was presented in the complaint as a "Multi-Patent Capsule."

Technology Synopsis

This patent, also from the same family, is directed to pharmaceutical compositions that combine an SGLT inhibitor like canagliflozin with a second antidiabetic agent (’403 Patent, Abstract). The invention addresses the clinical need for combination therapies to manage complex metabolic diseases like type 2 diabetes (’403 Patent, col. 27:54-62).

Asserted Claims

Claim 26 (dependent) is asserted, which relies on independent claim 25 (Compl. ¶50).

Accused Features

The accused product is a generic version of Invokamet XR®, a fixed-dose combination of canagliflozin and metformin hydrochloride, an extended-release formulation (Compl. ¶¶27, 46). The patent claims specifically cover compositions comprising canagliflozin and a biguanide compound, a class to which metformin belongs (’403 Patent, cl. 26).

III. The Accused Instrumentality

Product Identification

Defendant Aurobindo’s proposed generic canagliflozin and metformin hydrochloride extended-release tablets, which are the subject of ANDA No. 213900 (Compl. ¶30).

Functionality and Market Context

The accused products are intended to be generic equivalents of Plaintiffs’ Invokamet XR® brand drug, which is approved for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (Compl. ¶27). The functionality of the accused product is therefore to provide the combined therapeutic effects of canagliflozin (an SGLT2 inhibitor) and metformin (a biguanide) in a single extended-release tablet (Compl. ¶30). The complaint alleges that Aurobindo seeks FDA approval to market its generic product prior to the expiration of the patents-in-suit (Compl. ¶30).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that Aurobindo’s submission of its ANDA constitutes an act of infringement under 35 U.S.C. § 271(e)(2)(A), which makes it an act of infringement to submit an ANDA for a drug claimed in a patent or for a use claimed in a patent (Compl. ¶¶33, 41, 49). The infringement theory is that the product specified in the ANDA, if approved and marketed, would directly infringe the asserted claims.

’788 Patent Infringement Allegations

Claim Element (from Independent Claim 20) Alleged Infringing Functionality Complaint Citation Patent Citation
A compound having the following structure: [1-(β-D-glucopyranosyl)-4-chloro-3-[5-(2-thienylmethyl)-2-thienyl]methyl]benzene] The active pharmaceutical ingredient in Aurobindo’s ANDA product is identified as canagliflozin, the compound having the claimed chemical structure. ¶30; ¶34 col. 133:15-50
or a pharmaceutically acceptable salt thereof Aurobindo’s ANDA product necessarily contains the claimed compound or a pharmaceutically acceptable salt thereof to be bioequivalent to the branded product. ¶30; ¶34 col. 133:51-52

’219 Patent Infringement Allegations

Claim Element (from Independent Claim 10, as limited by Claim 22) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating diabetes... which comprises administering to said mammalian species... a therapeutically effective amount Aurobindo’s ANDA seeks approval for its product to be used for the treatment of diabetes, and its proposed product label will allegedly instruct medical providers and patients to administer it for this purpose. ¶38; ¶42 col. 248:45-50
of a compound... wherein the compound is 1-(β-D-glucopyranosyl)-4-chloro-3-[5-(2-thienylmethyl)-2-thienyl]methyl]benzene, or a pharmaceutically acceptable salt thereof. The active ingredient in Aurobindo’s ANDA product is the specific compound recited in claim 22. ¶38; ¶42 col. 250:20-25
  • Identified Points of Contention:
    • Evidentiary Questions: The complaint makes conclusory allegations of infringement, which is common at the pleading stage of an ANDA case. The central factual question will be whether the specifications and proposed labeling submitted to the FDA in ANDA No. 213900 describe a product containing the claimed compound and instruct its use for the claimed methods.
    • Scope Questions: In an ANDA case, infringement analysis is often less contentious than validity, as the generic product is intended to be the same as the branded product. However, disputes could arise if Aurobindo's product uses a novel salt or crystalline form of canagliflozin, raising the question of whether that form is covered by the term "pharmaceutically acceptable salt thereof."

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail to identify specific claim construction disputes. However, based on the technology and the nature of pharmaceutical litigation, certain terms may become focal points.

  • The Term: "pharmaceutical composition" (from ’403 Patent, claim 25)
  • Context and Importance: This term is foundational to the ’403 patent, which claims a combination of canagliflozin and another antidiabetic agent (metformin) in a composition. The scope of "composition" will determine whether different formulations, particularly those with different excipients or extended-release mechanisms, are covered. Practitioners may focus on this term to determine if Aurobindo’s specific generic formulation, with its unique set of inactive ingredients and release profile, falls within the claim's scope.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides a non-exhaustive list of potential formulations, stating that "Suitable pharmaceutical preparation for oral administration includes, for example, solid preparation such as tablet, granule, capsule, powder, or solution preparation" (’403 Patent, col. 27:47-53). This language suggests the term is meant to be interpreted broadly to cover various conventional dosage forms.
    • Evidence for a Narrower Interpretation: A party seeking a narrower construction might point to the specific examples in the patent as defining the outer bounds of the term. However, without explicit limiting language or a disclaimer in the specification, such arguments often face challenges.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon FDA approval, Aurobindo will induce infringement of the method claims (e.g., ’219 Patent, claim 22) by providing a product with a label that instructs physicians and patients to use it in the patented manner for treating diabetes (Compl. ¶42).
  • Willful Infringement: The complaint does not use the word "willful" but does allege that the case is "exceptional" and seeks attorneys' fees pursuant to 35 U.S.C. § 285 (Compl. ¶¶36, 44, 52). This allegation is predicated on Aurobindo's filing of its ANDA with knowledge of the patents-in-suit, as demonstrated by its submission of a Paragraph IV certification specifically challenging those patents (Compl. ¶¶31, 39, 47).

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

As is typical in ANDA litigation, the primary legal and factual battle is unlikely to be over infringement, but rather over the validity of the asserted patents. The central questions for the court will therefore be:

  • A core issue will be one of patent validity: what specific theories of anticipation or obviousness, based on prior art chemical compounds and therapeutic methods, will Aurobindo present to overcome the patents’ presumption of validity, and can the Plaintiffs successfully rebut those challenges?
  • A secondary issue may be one of compositional scope: does the specific formulation of Aurobindo’s proposed generic product, including its particular extended-release mechanism and inactive ingredients, fall within the scope of the term "pharmaceutical composition" as claimed in the ’403 patent, or can it be distinguished as a non-infringing alternative?