DCT
2:23-cv-04085
Genentech Inc v. Sandoz Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Genentech, Inc. (Delaware) and Hoffmann-La Roche Inc. (New Jersey)
- Defendant: Sandoz, Inc. (Delaware) and Lek Pharmaceuticals d.d. (Slovenia)
- Plaintiff’s Counsel: Lowenstein Sandler LLP
- Case Identification: 2:23-cv-04085, D.N.J., 07/31/2023
- Venue Allegations: Venue for Sandoz is based on its principal place of business and a regular and established place of business in New Jersey. Venue for Lek, a foreign corporation, is alleged to be proper in any judicial district.
- Core Dispute: Plaintiffs allege that Defendants’ generic pirfenidone tablets infringe a patent directed to a specific granulate drug formulation.
- Technical Context: The technology concerns pharmaceutical formulations of pirfenidone, a drug for treating idiopathic pulmonary fibrosis (IPF), intended to improve patient compliance by reducing daily pill burden.
- Key Procedural History: The complaint notes prior ANDA litigation involving the parties over different pirfenidone patents. The patent-in-suit issued during that prior litigation but was not asserted. The complaint also states that on December 17, 2020, Sandoz provided a Paragraph IV certification notice regarding the patent-in-suit, and subsequently launched its generic products "at risk" in May 2022.
Case Timeline
| Date | Event |
|---|---|
| 2014-10-15 | FDA approves NDA for Esbriet® capsules |
| 2016-03-29 | ’637 Patent Priority Date |
| 2017-01-11 | FDA approves NDA for Esbriet® tablets |
| 2019-01-29 | ’637 Patent Issue Date |
| 2020-12-17 | Sandoz provides Paragraph IV notice letter regarding ’637 patent |
| 2022-05-12 | Defendants allegedly launch Accused Products |
| 2023-07-31 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,188,637 - "Granulate Formulation of 5-Methyl-1-Phenyl-2-(1H)-Pyridone and Method of Making the Same"
- Issued: January 29, 2019
The Invention Explained
- Problem Addressed: The complaint alleges that the original FDA-approved capsule formulation of pirfenidone required patients to take up to nine capsules per day, creating a significant risk of non-compliance (Compl. ¶6). The complaint provides a dosage titration table from the original drug's prescribing information to illustrate this dosing regimen (Compl. ¶5, Table 1). Creating a more patient-friendly, high-dose tablet was technically challenging because the active ingredient, pirfenidone, is a powder with poor flow characteristics, and the high concentration required for a manageable tablet size leaves little room for excipients that would normally be used to improve flowability during manufacturing (Compl. ¶8-9; ’637 Patent, col. 4:9-19).
- The Patented Solution: The patent discloses a granulate formulation that overcomes these manufacturing challenges. The invention is based on the "advantageously and surprisingly discovered" use of a glidant (a flow-enhancing agent) in two distinct locations within the formulation: an intragranular glidant mixed into the drug granules themselves, and an extragranular glidant added to the mixture after the granules are formed (Compl. ¶12; ’637 Patent, col. 5:21-49). The patent explains that glidants were typically only used extragranularly, and that this dual-location approach improves flow at multiple stages of the manufacturing process, enabling the creation of stable, high-dose tablets (Compl. ¶12; ’637 Patent, col. 5:35-49).
- Technical Importance: This formulation technology allegedly enabled the development of 267 mg and 801 mg pirfenidone tablets, reducing the daily pill burden for patients from nine capsules to as few as three tablets and thereby increasing the likelihood of patient compliance (Compl. ¶6, ¶13).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶45).
- The essential elements of Claim 1 are:
- A granulate formulation of 5-methyl-1-phenyl-2-(1H)-pyridone, comprising:
- granules comprising 5-methyl-1-phenyl-2-(1H)-pyridone and a glidant; and,
- one or more extragranular excipients comprising an extragranular glidant.
- The complaint reserves the right to assert other claims and modify its infringement theories (Compl. ¶49).
III. The Accused Instrumentality
Product Identification
- Defendants’ generic pirfenidone tablets in 267 mg and 801 mg dosage strengths (the “Accused Products”) (Compl. ¶1).
Functionality and Market Context
- The Accused Products are generic versions of Plaintiffs’ Esbriet® tablets (Compl. ¶17).
- Based on the product's prescribing information, the complaint alleges the tablets contain the active ingredient pirfenidone and inactive ingredients including "croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, pregelatinized starch, and silicon dioxide" (Compl. ¶51).
- The complaint alleges that the Accused Products were highly successful, displacing Plaintiffs’ product and resulting in damages of "hundreds of millions—if not billions—of dollars" (Compl. ¶1, ¶22).
IV. Analysis of Infringement Allegations
’637 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, comprising: | The Accused Products are alleged to be a granulate formulation of pirfenidone (5-methyl-1-phenyl-2-(1H)-pyridone). | ¶50, ¶51 | col. 1, Abstract |
| granules comprising 5-methyl-1-phenyl-2-(1H)-pyridone and a glidant; | The Accused Products allegedly contain granules that comprise pirfenidone and a glidant, identified as silicon dioxide. | ¶52 | col. 5:21-23 |
| one or more extragranular excipients comprising an extragranular glidant. | The Accused Products allegedly contain an extragranular glidant, also identified as silicon dioxide. | ¶53 | col. 8:1-12 |
Identified Points of Contention
- Scope Questions: The complaint alleges that a single substance, silicon dioxide, satisfies both the intragranular and extragranular glidant limitations. A central factual question for the court will be one of physical location: does the silicon dioxide in the accused tablets exist both within the pirfenidone granules and separately in the matrix between the granules? The complaint asserts this dual location but does not provide supporting evidence, such as microscopic analysis.
- Technical Questions: What evidence will Plaintiffs offer to prove that the silicon dioxide in the accused product functions as a "glidant" in both the intragranular and extragranular contexts as required by the claim? Defendants may argue that even if silicon dioxide is present in both locations, it does not perform the claimed flow-improving function in one or both of those locations, or that it primarily serves a different, non-infringing function.
V. Key Claim Terms for Construction
The Term: "glidant"
Context and Importance: The patent’s asserted novelty lies in the specific placement of a "glidant" both inside and outside the drug granules. The definition of this term is therefore critical. The infringement analysis may turn on whether the accused silicon dioxide must be proven to perform a flow-improving function, or whether its mere presence as a substance known to be a glidant is sufficient. Practitioners may focus on this term because the plaintiff's case hinges on silicon dioxide acting as a glidant in two distinct physical locations within the formulation.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification provides a non-exhaustive list of substances that can be a "glidant," including "silica, fumed silica, ... pregelatinized starch, talc, and physical or coprocessed combinations thereof" (’637 Patent, col. 8:42-50). A party could argue that the presence of any listed substance meets the limitation, regardless of its primary function in a specific formulation.
- Evidence for a Narrower Interpretation: The patent repeatedly frames the glidant in functional terms, stating its purpose is to "improve flow" (’637 Patent, col. 5:42-43) and that the formulation should include "an effective amount of intragranular glidant to improve powder and/or granule flow characteristics" (’637 Patent, col. 5:26-29). A party could argue this language requires proof of the flow-improving function in the accused product.
The Term: "granules comprising"
Context and Importance: This term establishes the physical boundary between the "intragranular" components and the "extragranular" components. The interpretation of what constitutes the "granule" is essential to determining whether the accused formulation contains both an intra- and an extragranular glidant.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification defines "intragranular components" as "the ingredients included in the granule" and describes a fluid bed granulation process for forming them (’637 Patent, col. 5:15-16; FIG. 1). A party could argue that any material added during the granulation step is, by definition, part of the resulting "granules."
- Evidence for a Narrower Interpretation: A party could argue for a more restrictive physical definition, contending that a "granule" is a cohesive agglomerate and that materials merely adhering to the surface of drug particles without being integrated into such an agglomerate are not "comprised" within the granule. The resolution may depend on expert analysis of the accused product's microstructure.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b), asserting Defendants specifically intended for physicians and patients to infringe by marketing and distributing the Accused Products with knowledge of the ’637 patent (Compl. ¶46). It also alleges contributory infringement by Lek under 35 U.S.C. § 271(c), stating that Lek manufactures and imports a product that is a material part of the invention, has no substantial non-infringing use, and is known to be especially adapted for infringement (Compl. ¶47).
- Willful Infringement: The willfulness allegation is based on alleged pre-suit knowledge of the ’637 patent. The complaint cites Defendants' involvement in prior litigation concerning pirfenidone, the patent's listing in the FDA Orange Book, and a Paragraph IV notice letter sent by Sandoz to Genentech on December 17, 2020, as evidence of knowledge prior to the May 2022 product launch (Compl. ¶55).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central evidentiary question will be one of physical composition: can Plaintiffs demonstrate through empirical analysis that the accused tablets contain silicon dioxide in two distinct physical locations—both integrated within the pirfenidone granules and also present in the surrounding extragranular matrix—as required to meet the limitations of Claim 1?
- A core issue for claim construction will be one of functional scope: does the term "glidant" require proof of actual flow-improving function in the accused product, or is the mere presence of a substance like silicon dioxide, which is known to act as a glidant, sufficient to satisfy the claim limitation?
- Given the allegations of pre-suit notice and an at-risk launch, a key question for damages will be one of intent: did Defendants proceed with a good-faith belief that the ’637 patent was invalid or not infringed, or did their actions constitute the "wanton, malicious, and egregious" conduct alleged in the complaint that could justify an award of enhanced damages?