DCT

1:19-cv-00131

Genentech Inc v. ScieGen Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-00131, D. Del., 01/23/2019
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Bactolac is a Delaware corporation, and its subsidiary, Defendant ScieGen, consented to jurisdiction and venue in the district.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs' drug Esbriet® (pirfenidone) constitutes an act of infringement of two patents covering specific formulations of pirfenidone.
  • Technical Context: The technology concerns pharmaceutical formulations of the active ingredient pirfenidone, which is used to treat Idiopathic Pulmonary Fibrosis (IPF), a rare and fatal progressive lung disease.
  • Key Procedural History: This patent infringement action was initiated under the Hatch-Waxman Act following Defendants' notification to Plaintiffs on December 10, 2018, of the submission of ANDA No. 212078. This ANDA included a Paragraph IV certification, asserting that Plaintiffs' patents are invalid, unenforceable, or will not be infringed by the proposed generic product. The complaint notes that Plaintiffs' drug, Esbriet®, received FDA approval on October 15, 2014, and was granted Orphan Drug Exclusivity through October 15, 2021.

Case Timeline

Date Event
2001-01-29 ’217 Patent Priority Date
2005-09-22 ’150 Patent Priority Date
2010-01-01 FDA initially denies approval for Esbriet®
2013-02-26 ’150 Patent Issue Date
2014-10-15 FDA approves first NDA for Esbriet®
2017-02-07 ’217 Patent Issue Date
2018-12-10 Defendants send Paragraph IV Notice Letter
2019-01-23 Complaint Filing Date
2021-10-15 Esbriet® Orphan Drug Exclusivity expiration date

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

U.S. Patent No. 8,383,150 - "Granulate Formulation of Pirfenidone and Pharmaceutically Acceptable Excipients"

The Invention Explained

  • Problem Addressed: The patent describes a general need for pharmaceutical formulations of pirfenidone that can produce desirable and optimized pharmacokinetic (PK) responses in patients, such as controlling the rate and extent of drug absorption. (’150 Patent, col. 2:10-14).
  • The Patented Solution: The invention is a granulate formulation of pirfenidone for use in a capsule, which includes specific "pharmaceutically acceptable excipients" such as binders, fillers, and disintegrators. (’150 Patent, Abstract). The specification explains that including these excipients, particularly binders like microcrystalline cellulose, can prolong the drug's absorption phase, resulting in a significant increase in key PK parameters like Tmax (time to maximum concentration) and AUC (area under the curve, a measure of total drug exposure) compared to a formulation of pirfenidone alone. (’150 Patent, col. 7:35-65; FIG. 5).
  • Technical Importance: By modifying the drug's release profile to prolong absorption, the formulation aimed to optimize the therapeutic effect of pirfenidone for chronic conditions like IPF. (’150 Patent, col. 2:10-14).

Key Claims at a Glance

  • The complaint asserts independent claims 1 (a product claim) and 27 (a method claim) (Compl. ¶¶ 41-42).
  • Independent Claim 1 requires:
    • A granulate formulation of 5-methyl-1-phenyl-2-(1H)-pyridone (pirfenidone).
    • The formulation comprises pharmaceutically acceptable excipients, which include an "effective amount of binder."
    • This effective amount of binder increases the AUC of the pirfenidone by "at least 45% upon oral administration, as compared to pirfenidone without excipients orally administered in a capsule shell."
  • Claim 27 is a method claim for treating idiopathic pulmonary fibrosis by administering the formulation of claim 1.
  • The complaint reserves the right to assert additional claims.

U.S. Patent No. 9,561,217 - "Pharmaceutical Composition Containing as an Active Ingredient 5-Methyl-1-Phenyl-2-(1H)-Pyridone"

The Invention Explained

  • Problem Addressed: The patent addresses several challenges in creating a high-dose tablet of pirfenidone: its characteristic odor and bitterness, its low compressibility (making it difficult to form into a hard tablet), and its instability when exposed to light, all of which impact patient compliance and manufacturability. (’217 Patent, col. 2:1-5).
  • The Patented Solution: The invention is a tablet that consists of a compressed core containing pirfenidone and various excipients, which is then covered by a coating. (’217 Patent, Abstract). Critically, this outer coating includes a "light-shielding agent," such as titanium oxide, to improve the drug's stability. (’217 Patent, col. 2:5-11, col. 4:55-57). This combination allows for a compact, hard tablet that masks the unpleasant taste and protects the active ingredient from degradation.
  • Technical Importance: This formulation technology provided a solution for creating a stable, patient-friendly, and commercially viable solid oral dosage form for a high-dose drug with challenging physical properties. (’217 Patent, col. 2:40-54).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶¶ 50-51).
  • Independent Claim 1 requires:
    • A coated dosage form.
    • The dosage form comprises a compressed tablet containing pirfenidone as an active ingredient.
    • The dosage form also comprises a coating disposed on the tablet, with the coating itself comprising a "light shielding agent."
  • The complaint reserves the right to assert additional claims.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendants' proposed generic pirfenidone tablets in 267 mg and 801 mg dosage strengths, for which Defendants submitted Abbreviated New Drug Application (ANDA) No. 212078 (the "ScieGen ANDA Product") (Compl. ¶¶ 1, 8).

Functionality and Market Context

  • The ScieGen ANDA Product is a generic version of Plaintiffs' FDA-approved drug, Esbriet®, and is intended for treating Idiopathic Pulmonary Fibrosis (IPF) (Compl. ¶¶ 1, 30).
  • In filing the ANDA, Defendants have represented to the FDA that their product contains the same active ingredient (pirfenidone), dosage form (tablet), route of administration, and dosage strengths as Esbriet®, and that it is bioequivalent to Esbriet® (Compl. ¶35).
  • Defendants seek FDA approval to commercially manufacture and sell the ScieGen ANDA Product in the United States prior to the expiration of the Asserted Patents (Compl. ¶33).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

’150 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A granulate formulation of 5-methyl-1-phenyl-2-(1H)-pyridone... The ScieGen ANDA Product is a tablet formulation containing pirfenidone as its active ingredient. ¶35 col. 1:19-21
...comprising...pharmaceutically acceptable excipients, said excipients comprising an effective amount of binder... The complaint alleges on information and belief that the ScieGen ANDA Product "contains the same components recited in claim 1," but does not specify the product's excipients or binders. ¶42 col. 2:26-52
...to increase the AUC of the 5-methyl-1-phenyl-2-(1H)-pyridone at least 45% upon oral administration, as compared to pirfenidone without excipients orally administered in a capsule shell. The complaint does not contain specific allegations regarding the AUC of the ScieGen ANDA Product, but alleges that the product is bioequivalent to Plaintiffs' Esbriet® product, which is alleged to be covered by the claims. ¶35, ¶41 col. 12:1-4

Identified Points of Contention

  • Evidentiary Question: The complaint does not provide factual details about the composition or pharmacokinetic profile of the ScieGen ANDA Product. A central issue will be whether discovery reveals that the accused product contains an "effective amount of binder" that achieves the functionally-defined "at least 45%" increase in AUC relative to the specific baseline defined in the claim.
  • Scope Question: A potential dispute may arise over what constitutes an "effective amount of binder" and how the AUC comparison to the excipient-free baseline should be measured and proven for the accused product.

’217 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A coated dosage form, comprising: a compressed tablet comprising 5-methyl-1-phenyl-2-(1H)-pyridone as an active ingredient; The ScieGen ANDA Product is described as a pirfenidone tablet. The complaint alleges it contains the components of claim 1. ¶8, ¶51 col. 4:9-11
and a coating comprising a light shielding agent disposed on the compressed tablet. The complaint alleges on information and belief that the ScieGen ANDA Product contains the recited components, but provides no specific facts about whether the tablet is coated or contains a light shielding agent. ¶51 col. 4:55-57

Identified Points of Contention

  • Factual Question: The primary point of contention will be factual: is the ScieGen ANDA Product a "coated" tablet, and if so, does that coating contain a "light shielding agent"? The complaint's allegations are made on "information and belief" without supporting detail.
  • Technical Question: Assuming the accused product is coated, a technical question will be whether any of its components perform the function of a "light shielding agent" as required by the claim, or if the components serve other purposes.

V. Key Claim Terms for Construction

"an effective amount of binder to increase the AUC...at least 45%" (’150 Patent, Claim 1)

Context and Importance: This is a functional limitation that lies at the heart of the ’150 patent’s infringement theory. Proving infringement requires demonstrating that the accused product's formulation meets this specific, quantitative pharmacokinetic requirement. The construction of "effective amount" and the methodology for the "as compared to" baseline will be critical.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The specification provides a long, non-exclusive list of potential binders, suggesting that the term is not limited to a specific chemical class but rather to the function it performs. (’150 Patent, col. 4:32-34). Plaintiffs may argue that any substance acting as a binder that achieves the claimed AUC increase falls within the claim's scope.
  • Evidence for a Narrower Interpretation: The detailed description and figures emphasize specific embodiments using microcrystalline cellulose and povidone and show specific PK data. (’150 Patent, col. 7:59-65; FIG. 5). A defendant could argue that "effective amount" should be interpreted in light of these specific examples, potentially narrowing the scope to similar compositions or requiring a specific mechanism of action.

"light shielding agent" (’217 Patent, Claim 1)

Context and Importance: The presence of this agent in the coating is a mandatory element of the claim. Infringement hinges on whether the accused tablet has a coating and whether a component of that coating meets the definition of a "light shielding agent."

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The patent does not provide a formal definition but lists "titanium oxide and ferric oxide" as examples, followed by "and the like are more preferable," suggesting the term is not limited to only those two compounds. (’217 Patent, col. 5:63-65). Plaintiffs may argue the term encompasses any component that functionally blocks light to a sufficient degree to improve stability.
  • Evidence for a Narrower Interpretation: A defendant may argue that the term should be limited to agents added for the primary purpose of shielding light, as described in the patent's solution to the light-stability problem. (’217 Patent, col. 2:5, col. 2:48-54). They might contend that a substance with incidental or minor light-blocking properties, added for another purpose (e.g., as a colorant), does not qualify as a "light shielding agent."

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants will induce and contribute to infringement of both the ’150 and ’217 patents. The inducement allegation is based on the assertion that Defendants' promotional activities and product labeling will instruct medical professionals and patients to use the ScieGen ANDA Product in an infringing manner (Compl. ¶¶ 46, 55). The contributory infringement allegation is based on the assertion that the ScieGen ANDA Product is not a staple article of commerce and is especially made for use in an infringing way (Compl. ¶¶ 44, 53).
  • Willful Infringement: The complaint alleges that Defendants' infringement is willful, stating that their actions were undertaken with knowledge of the Asserted Patents and without a good faith belief of non-infringement (Compl. ¶58). This allegation is predicated on Defendants' Paragraph IV certification and notice letter, which establish pre-suit knowledge of the patents.

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

  • A key evidentiary question will be one of composition and function: Will discovery reveal that the ScieGen ANDA product's formulation, which is currently unknown, factually meets the specific compositional and functional limitations of the asserted claims? This includes whether it contains a "light shielding agent" (’217 patent) and a binder in an "effective amount" to increase AUC by at least 45% (’150 patent).
  • A core issue will be one of inferential proof: Can Plaintiffs substantiate their infringement allegations, which are currently based on "information and belief" and an assumption that bioequivalence to Esbriet® implies infringement of these specific formulation patents? The case will test whether the facts of the accused product's design, once known, align with the narrow technical requirements of the patent claims.
  • A central legal question will be one of claim construction: How will the court construe the key terms "effective amount of binder to increase the AUC...at least 45%" and "light shielding agent"? The breadth or narrowness of these definitions will likely determine the outcome of the infringement analysis.