Sumitomo Dainippon Pharma Co Ltd v. Macleods Pharma Ltd

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Sumitomo Dainippon Pharma Co., Ltd. (Japan) and Sunovion Pharmaceuticals Inc. (Delaware)
  • Defendant: Macleods Pharmaceuticals Ltd. (India) and Macleods Pharma USA, Inc. (Delaware)
  • Plaintiff’s Counsel: GIBBONS P.C.
• Case Identification: 2:18-cv-13833, D.N.J., 09/12/2018
• Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Macleods Pharma USA, Inc. resides in the district and maintains a regular and established place of business there. Further, both Defendants are alleged to have committed acts of infringement in the district, specifically the submission of Abbreviated New Drug Application (ANDA) No. 212124.
• Core Dispute: Plaintiffs allege that Defendants' filing of an ANDA for a generic version of the antipsychotic drug Latuda® constitutes an act of infringement of two patents covering a method of treating schizophrenia with reduced weight gain and specific pharmaceutical tablet formulations.
• Technical Context: The technology concerns treatments for psychotic disorders, a field where patient adherence is often compromised by significant side effects, such as weight gain, associated with conventional therapies.
• Key Procedural History: This is a patent infringement action filed under the Hatch-Waxman Act, triggered by Defendants' submission of an ANDA with a Paragraph IV certification, asserting that the patents-in-suit are invalid, unenforceable, or will not be infringed by the proposed generic product.

Case Timeline

Date	Event
2002-08-22	’827 Patent Priority Date
2005-05-26	’794 Patent Priority Date
2017-11-14	’827 Patent Issued
2018-03-06	’794 Patent Issued
2018-07-31	Date of Macleods's Paragraph IV Notice Letter
2018-08-02	Plaintiff Sunovion receives Notice Letter
2018-08-06	Plaintiff Sumitomo receives Notice Letter
2018-09-12	Complaint Filing Date

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

U.S. Patent No. 9,815,827 - Agent for Treatment of Schizophrenia, issued November 14, 2017

The Invention Explained

• Problem Addressed: The patent describes that conventional antipsychotic drugs used to treat disorders like schizophrenia are known to cause unwanted and serious side effects, with a particular focus on patient weight gain (’827 Patent, col. 1:57-63; Compl. ¶32).
• The Patented Solution: The invention is a method of treatment using a specific compound, lurasidone, administered orally once daily within a specific dosage range (20 mg to 120 mg). This method is claimed to effectively treat the psychosis without causing clinically significant weight gain, an outcome described as not being well understood or conventional in the art at the time (’827 Patent, Abstract; Compl. ¶43). The specification contrasts this with conventional antipsychotics known to cause such side effects (’827 Patent, col. 6:8-10).
• Technical Importance: The claimed method offered a therapeutic option for schizophrenia that addressed a major factor in patient non-compliance and long-term health complications.

Key Claims at a Glance

• The complaint asserts infringement of at least claim 40, which is an independent claim (Compl. ¶43).
• The essential elements of independent claim 40 are:
  • A method of treating a patient with an antipsychotic without a clinically significant weight gain, comprising:
  • orally administering once daily to the patient a pharmaceutical composition comprising 20 to 120 mg of lurasidone or a pharmaceutically acceptable salt thereof as the sole active ingredient;
  • such that the patient does not experience a clinically significant weight gain.
• The complaint also identifies dependent claim 43 as an exemplary asserted claim (Compl. ¶43).

U.S. Patent No. 9,907,794 - Pharmaceutical Composition, issued March 6, 2018

The Invention Explained

• Problem Addressed: The patent addresses the difficulty of creating solid oral drug formulations that exhibit consistent dissolution behavior across a wide range of dosage strengths, particularly for slightly water-soluble active ingredients like lurasidone. Achieving this consistency is necessary to ensure bioequivalence, a key regulatory requirement for multi-dose product lines (’794 Patent, col. 1:41-54, col. 2:11-18).
• The Patented Solution: The invention is a specific tablet formulation that includes lurasidone, a pregelatinized starch, a water-soluble excipient (such as mannitol), and a water-soluble polymer binder. This specific combination of ingredients is purported to yield a tablet that dissolves rapidly and, critically, maintains a similar dissolution profile even when the dosage of lurasidone is changed (’794 Patent, Abstract; col. 2:44-54).
• Technical Importance: This formulation technology enables the development of a family of drug products (e.g., 20 mg, 40 mg, 80 mg tablets) that are interchangeable from a bioavailability perspective, facilitating flexible dosing for physicians.

Key Claims at a Glance

• The complaint asserts infringement of at least claims 1 and 15, both of which are independent claims (Compl. ¶58).
• The essential elements of independent claim 1 are:
  • A tablet for oral administration comprising: lurasidone (20-120 mg), a pregelatinized starch, a water-soluble excipient, a water-soluble polymer binder, and a lubricant.
  • The lurasidone content ratio is between 20 to 45% (wt/wt).
  • The tablet has a dissolution rate of 80% or more at 30 minutes under specified test conditions.
  • The tablet has a "similar dissolution profile" (defined as a similarity factor f2 value of 50 or more) to a second tablet that is prepared with the same method and excipient ratios but has a different lurasidone content.

III. The Accused Instrumentality

Product Identification

• Defendants' proposed generic lurasidone hydrochloride tablets, to be offered in 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg strengths, as described in ANDA No. 212124 (the "Proposed ANDA Product") (Compl. ¶59).

Functionality and Market Context

• The Proposed ANDA Product is an atypical antipsychotic intended for treating schizophrenia and depressive episodes associated with bipolar I disorder (Compl. ¶64).
• The act of infringement alleged is the submission of the ANDA to the FDA seeking approval to market this generic product prior to the expiration of Plaintiffs' patents (Compl. ¶1, ¶59).
• Plaintiffs allege that the proposed label for the generic product will instruct physicians and patients to use it in a manner that directly infringes the ’827 patent, and that the physical composition of the tablets will directly infringe the ’794 patent (Compl. ¶66, ¶70).

IV. Analysis of Infringement Allegations

’827 Patent Infringement Allegations

Claim Element (from Independent Claim 40)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A method of treating a patient with an antipsychotic without a clinically significant weight gain...	Defendants' Proposed Macleods Label allegedly will encourage and instruct physicians to administer the generic product to treat, among other things, schizophrenia and manic depressive psychosis, without the patient experiencing clinically significant weight gain.	¶66	col. 10:52-56
...comprising: orally administering once daily to the patient a pharmaceutical composition comprising 20 to 120 mg of [lurasidone]...	The Proposed ANDA Product consists of oral tablets in strengths of 20, 40, 60, 80, and 120 mg, falling within the claimed dosage range. The label will allegedly instruct once-daily administration for the indicated conditions.	¶64	col. 10:57-61
...such that the patient does not experience a clinically significant weight gain.	The complaint alleges, on information and belief, that the Proposed Macleods Label will contain clinical study data demonstrating that patients do not experience clinically significant weight gain. The complaint references the innovator's (Latuda®) label, which shows minimal weight gain (+0.43 kg) in short-term schizophrenia studies. Table 9 in the complaint's visual evidence shows this data from the Latuda® Prescribing Information.	¶51, ¶65, p. 13	col. 10:60-61

• Identified Points of Contention:
  • Scope Questions: The infringement analysis for the ’827 patent will likely focus on the negative limitation "without a clinically significant weight gain." A central question for the court will be how to construe this phrase and whether the data and instructions in the Defendants' proposed label satisfy this limitation.
  • Technical Questions: What evidence will the Defendants' ANDA and proposed label provide regarding weight gain? Does it, in fact, contain data and instructions that "encourage" or "instruct" a method of use that avoids "clinically significant" weight gain, or does it merely report on clinical trial outcomes?

’794 Patent Infringement Allegations

The complaint does not provide sufficient detail regarding the composition of the Proposed ANDA Product to construct a claim chart for U.S. Patent No. 9,907,794. The complaint explicitly states that Plaintiffs have been unable to obtain a copy of the ANDA and are therefore alleging infringement based primarily on information and belief and the representations in Defendants' notice letter (Compl. ¶72, ¶74). The core of the infringement theory is that for the Defendants' product to be bioequivalent to Latuda®, it must necessarily adopt a formulation that falls within the scope of the ’794 patent claims (Compl. ¶59, ¶70). The resolution of this claim will depend entirely on discovery of the ANDA's contents.

V. Key Claim Terms for Construction

• Term: "clinically significant weight gain" (’827 Patent, Claim 40)

  • Context and Importance: This term is the central point of novelty and the primary limitation differentiating the claimed method from the prior art. Its definition will be dispositive for infringement of the '827 patent.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent does not provide an explicit numerical definition for the term, which may support an argument that its meaning should be determined by the understanding of a person of ordinary skill in the art (e.g., a clinician) at the time of the invention.
    • Evidence for a Narrower Interpretation: The specification and the incorporated Latuda® Prescribing Information disclose specific, small amounts of weight change observed in clinical trials (e.g., +0.43 kg vs. placebo) (Compl. p. 13, Table 9). A party may argue that "clinically significant" should be construed narrowly in light of this data, limiting the claim scope to methods that produce similarly minimal weight gain.

• Term: "a similar dissolution profile" (’794 Patent, Claim 1)

  • Context and Importance: This term, defined in the claim by "a similarity factor f2 value of 50 or more," is critical for establishing infringement of the formulation patent. It links the claimed tablet to another tablet of a different strength, which is the basis for the patent's solution to the bioequivalence problem across a product line.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: While the f2 value of 50 provides a clear mathematical floor, the overall context relates to regulatory standards for bioequivalence, which could be argued to inform the term's meaning beyond the simple number.
    • Evidence for a Narrower Interpretation: The claim explicitly quantifies the term with "f2 value of 50 or more" under specific test conditions (’794 Patent, col. 25:27-28). This provides a precise, objective metric. The patent's figures also provide graphical examples of dissolution curves that meet this standard, which could be used to argue against any interpretation that deviates from these demonstrated examples (’794 Patent, Fig. 1, 3).

VI. Other Allegations

• Indirect Infringement: The complaint alleges that Defendants will induce infringement of the ’827 patent. The basis for this allegation is the Proposed Macleods Label, which will allegedly instruct and encourage physicians and healthcare providers to administer the generic drug in a way that practices the claimed method (Compl. ¶66, ¶94, ¶97).
• Willful Infringement: Willfulness is alleged based on Defendants' knowledge of the asserted patents. The complaint claims Defendants knew or should have known of the patents no later than their issuance and listing in the FDA's Orange Book (Compl. ¶78, ¶111). It is alleged that Defendants' continued actions to seek approval for their generic product, despite this knowledge, constitute willful infringement that makes the case exceptional under 35 U.S.C. § 285 (Compl. ¶107).

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

• A core issue for the '827 patent will be one of definitional scope and factual application: can the term "clinically significant weight gain," a negative limitation, be construed to read on the effects described in the proposed label for Defendants' generic product? This will require the court to first define the term and then determine if the label instructs a method meeting that definition.
• The central question for the '794 patent is purely evidentiary: what is the precise formulation of the Proposed ANDA Product? The case will turn on whether discovery reveals a composition that includes a pregelatinized starch and other claimed elements, and whether that formulation exhibits the "similar dissolution profile" required by the claims.
• A broader strategic question is one of inevitable infringement: Plaintiffs' case for the '794 patent appears to rest on the theory that to be approved as a bioequivalent generic, Defendants' product must inevitably be formulated in a way that infringes. The viability of this argument, in the absence of pre-discovery facts, will be an early focus of the litigation.