DCT
1:20-cv-03102
Mitsubishi Tanabe Pharma Corp v. Aurobindo Pharma USA Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Mitsubishi Tanabe Pharma Corporation (Japan); Janssen Pharmaceuticals, Inc. (Pennsylvania); Janssen Pharmaceutica NV (Belgium); Janssen Research and Development, LLC (New Jersey); and Cilag GmbH International (Switzerland)
- Defendant: Aurobindo Pharma USA, Inc. (Delaware)
- Plaintiff’s Counsel: Saul Ewing Arnstein & Lehr LLP; Quinn Emanuel Urquhart & Sullivan, LLP
- Case Identification: 1:20-cv-03102, D.N.J., 03/20/2020
- Venue Allegations: Venue is alleged to be proper as Defendant Aurobindo has a regular and established place of business in New Jersey and has or will commit acts of infringement in the district.
- Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for generic canagliflozin and metformin hydrochloride tablets constitutes an act of infringement of two patents covering a specific crystalline form of canagliflozin.
- Technical Context: The technology concerns a specific crystalline polymorph (a hemihydrate) of canagliflozin, an active pharmaceutical ingredient used as an SGLT2 inhibitor for the treatment of type 2 diabetes.
- Key Procedural History: The complaint notes the '582 and '202 patents are listed in the FDA's Orange Book for the brand-name drug Invokamet XR®. The '202 patent is a continuation of the application that led to the '582 patent and is subject to a terminal disclaimer. The complaint also certifies that related litigation involving one of the same patents has been previously filed in the District of New Jersey, indicating a history of enforcement of this patent family.
Case Timeline
| Date | Event |
|---|---|
| 2006-12-04 | Priority Date for '582 and '202 Patents |
| 2011-05-17 | Issue Date of U.S. Patent No. 7,943,582 |
| 2013-08-20 | Issue Date of U.S. Patent No. 8,513,202 |
| 2020-02-07 | Date of Aurobindo's notice letter regarding its ANDA filing |
| 2020-03-20 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,943,582 - “Crystalline form of 1-(β-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2- thienylmethyl]benzene hemihydrate,” issued May 17, 2011
The Invention Explained
- Problem Addressed: The patent describes difficulties in obtaining the active pharmaceutical ingredient, canagliflozin, in a pure, stable, and consistently reproducible crystalline form suitable for large-scale manufacturing and formulation into a final drug product ('582 Patent, col. 2:42-53).
- The Patented Solution: The invention is a specific crystalline form of canagliflozin known as a hemihydrate, meaning it incorporates water molecules into its crystal lattice. This specific form is described as having "good handling qualities and characteristics" and being producible "in a manner reproducible on a commercial scale" ('582 Patent, col. 2:8-12, 54-58). The '582 Patent's Figure 1 provides an X-ray powder diffraction pattern chart, a key analytical signature used to identify the specific crystalline structure of the claimed hemihydrate (Compl. ¶8, Ex. A).
- Technical Importance: For a pharmaceutical compound, achieving a stable and pure crystalline form is critical for ensuring consistent quality, bioavailability, and shelf-life, which are essential for regulatory approval and commercial viability ('582 Patent, col. 2:33-37).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 6 and 7 (Compl. ¶35).
- Independent Claim 1:
- A crystalline form of 1-(β-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethyl]benzene hemihydrate.
U.S. Patent No. 8,513,202 - “Crystalline form of 1-(β-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienyl-methyl]benzene hemihydrate,” issued August 20, 2013
The Invention Explained
- Problem Addressed: The '202 Patent addresses the same technical problem as its parent '582 Patent: the need for a stable, pure, and reproducible crystalline form of canagliflozin for pharmaceutical use ('202 Patent, col. 2:50-61).
- The Patented Solution: The invention is the same crystalline hemihydrate form of canagliflozin. This patent, however, claims the compound by reference to a different analytical characteristic—its infra-red (IR) spectrum—which provides an alternative method for identifying and distinguishing the patented crystalline structure ('202 Patent, col. 3:12-18).
- Technical Importance: As with the '582 Patent, the invention provides a commercially viable form of the drug substance, crucial for consistent manufacturing and therapeutic performance.
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 3-5 (Compl. ¶42).
- Independent Claim 1:
- A crystalline form of 1-(β-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethyl]benzene hemihydrate
- having an infra-red spectrum in mineral oil comprising the following main peaks: 1626, 1600, 1549, and 1507 cm⁻¹.
III. The Accused Instrumentality
Product Identification
The accused products are Aurobindo’s proposed generic versions of Invokamet XR® extended-release tablets, in 50 mg/1000 mg and 150 mg/1000 mg dosages, which contain canagliflozin and metformin hydrochloride (Compl. ¶1). The action arises from Aurobindo's filing of ANDA No. 213900 with the FDA (Compl. ¶1).
Functionality and Market Context
The products are intended for use as an "adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus" (Compl. ¶14). The complaint alleges that the claims of the Patents-in-Suit cover the polymorphic form of canagliflozin present in the branded Invokamet XR® product, and by extension, the generic equivalent for which Aurobindo seeks approval (Compl. ¶1, ¶15).
IV. Analysis of Infringement Allegations
The complaint alleges that infringement will be shown through discovery and testing (Compl. ¶29). The core theory is one of literal infringement: that the canagliflozin active pharmaceutical ingredient (API) in Aurobindo's ANDA product is the specific crystalline hemihydrate form claimed in the patents.
'582 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A crystalline form of 1-(β-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethyl]benzene hemihydrate. | The canagliflozin API contained in the Aurobindo ANDA Products is alleged to be the claimed crystalline hemihydrate form. | ¶1, ¶15, ¶35 | col. 2:25-30 |
'202 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A crystalline form of 1-(β-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethyl]benzene hemihydrate | The canagliflozin API contained in the Aurobindo ANDA Products is alleged to be the claimed crystalline hemihydrate form. | ¶1, ¶15, ¶42 | col. 2:25-30 |
| having an infra-red spectrum in mineral oil comprising the following main peaks: 1626, 1600, 1549, and 1507 cm⁻¹. | The complaint's allegation implies that testing will show Aurobindo's canagliflozin API exhibits the claimed infra-red spectral peaks. | ¶29, ¶42 | col. 3:12-18 |
- Identified Points of Contention:
- Factual Question: The central dispute will be a factual one, determined by analytical testing: does the canagliflozin API in Aurobindo's product actually exist in the specific crystalline hemihydrate form claimed in the patents? The complaint acknowledges this will be a matter for discovery (Compl. ¶29).
- Scope Questions: Do the claims cover any and all crystalline canagliflozin hemihydrate, or are they implicitly limited to a form that precisely matches the analytical data (e.g., XRPD peaks, IR spectrum, thermogravimetric analysis) detailed in the patent specifications? This raises the question of how much deviation from the patents' exemplary data is permissible before a product is considered non-infringing.
V. Key Claim Terms for Construction
- The Term: "crystalline form ... hemihydrate"
- Context and Importance: The definition of this term is the crux of the infringement analysis. The case will turn on whether Aurobindo's product falls within the scope of this term. Practitioners may focus on this term because polymorph patents are often defined by their specific, measurable physical characteristics, and the scope of the claims relative to those characteristics is paramount.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: Plaintiffs may argue that claim 1 of the '582 Patent, which simply recites the chemical name of the crystalline hemihydrate without reference to analytical data, should be given its plain meaning. They may point to specification language stating that experimental patterns can vary to argue against a rigid, numerically-limited construction ('582 Patent, col. 2:55-59).
- Evidence for a Narrower Interpretation: Defendant may argue that the patents define the invention by its unique, measurable characteristics. They could point to dependent claim 2 of the '582 Patent (which recites specific X-ray diffraction peaks) and independent claim 1 of the '202 Patent (which recites specific IR peaks) as evidence that the inventors intended to claim a specific polymorph defined by this data, thereby distinguishing it from other potential (or prior art) forms.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Aurobindo will induce and contribute to infringement by selling its generic product with instructions for its use in treating diabetes, thereby encouraging doctors and patients to perform acts of direct infringement (Compl. ¶35, ¶42).
- Willful Infringement: The complaint does not use the term "willful," but it alleges that Aurobindo has had knowledge of both the '582 and '202 patents "since at least the date it submitted the Aurobindo ANDA" (Compl. ¶36, ¶43). This allegation of knowledge, stemming from the ANDA certification process, forms the basis for a potential future claim of post-suit willfulness should infringement be found.
VII. Analyst’s Conclusion: Key Questions for the Case
- A central evidentiary question will be one of physical characterization: Will discovery and analytical testing (such as XRPD and IR spectroscopy) demonstrate that the canagliflozin API in Aurobindo's proposed generic product is, in fact, the specific crystalline hemihydrate claimed in the '582 and '202 patents?
- A dispositive issue will be one of claim scope: Will the court construe the term "crystalline form ... hemihydrate" broadly based on the chemical composition, or narrowly, limiting it to a polymorph that exhibits the specific analytical data detailed in the patents' specifications and dependent claims? The outcome of this construction will likely determine infringement.