Ferring Pharma Inc v. Finch Therap Group Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Ferring Pharmaceuticals Inc. and Rebiotix Inc. (Delaware)
  • Defendant: Finch Therapeutics Group, Inc., Finch Therapeutics, Inc., and Finch Therapeutics Holdings, LLC (Delaware)
  • Plaintiff’s Counsel: Womble Bond Dickinson (US) LLP
• Case Identification: 1:21-cv-01694, D. Del., 12/01/2021
• Venue Allegations: Venue is alleged to be proper in the District of Delaware because all Defendant entities are incorporated in Delaware.
• Core Dispute: Plaintiffs seek a declaratory judgment that their fecal microbiota transplant product, RBX2660, does not infringe seven of Defendants' patents, and/or that the asserted patent claims are invalid.
• Technical Context: The technology is Fecal Microbiota Transplantation (FMT), a therapeutic approach for treating recurrent Clostridium difficile infection (rCDI) by restoring a healthy gut microbiome.
• Key Procedural History: The complaint alleges that Defendants' S-1 filing with the Securities and Exchange Commission signaled an intent to aggressively enforce a "large and diverse patent portfolio" against competitors, specifically naming Plaintiff Rebiotix. This action by Defendants is presented as the basis for the controversy that necessitates a declaratory judgment.

Case Timeline

Date	Event
2010-08-04	Earliest Priority Date for all Patents-in-Suit
2013-03-21	Plaintiffs submit Investigational New Drug (IND) Application for RBX2660
2016-04-12	U.S. Patent No. 9,308,226 Issues
2018-05-08	U.S. Patent No. 9,962,413 Issues
2018-07-17	U.S. Patent No. 10,022,406 Issues
2018-09-04	U.S. Patent No. 10,064,899 Issues
2019-06-25	U.S. Patent No. 10,328,107 Issues
2019-11-05	U.S. Patent No. 10,463,702 Issues
2020-06-09	U.S. Patent No. 10,675,309 Issues
2021-05-03	Plaintiffs initiate Biologics License Application (BLA) submission for RBX2660
2021-11-30	Plaintiffs complete BLA submission for RBX2660
2021-12-01	Complaint for Declaratory Judgment Filed

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

U.S. Patent No. 10,675,309 - "Compositions for fecal floral transplantation and methods for making and using them and devices for delivering them"

The Invention Explained

• Problem Addressed: The patent background describes how antibiotic therapy can suppress or eradicate beneficial gut bacteria, allowing infectious agents like Clostridium difficile to proliferate and cause disease (U.S. 10,675,309 Patent, col. 2:14-20). This creates a need for methods to restore a healthy gut microbiota.
• The Patented Solution: The invention provides standardized compositions and devices for FMT (U.S. 10,675,309 Patent, col. 2:26-30). The ’309 Patent specifically claims an enema delivery system, configured for transport, containing a sealed pharmaceutical composition of fecal bacteria from a human donor that is processed to be "free of rough particulate matter" and includes saline and a cryoprotectant (U.S. 10,675,309 Patent, col. 32:16-29).
• Technical Importance: The invention aims to provide a reliable, standardized method for producing and delivering fresh fecal flora with a long shelf life, moving the therapy beyond ad-hoc, unstandardized preparations (U.S. 10,675,309 Patent, col. 17:25-30).

Key Claims at a Glance

• The complaint identifies independent claim 1 as exemplary (Compl. ¶85).
• Claim 1 of the ’309 Patent recites the following essential elements:
  • An enema delivery system configured for transporting to a remote facility
  • The system comprises a container, flexible tubing, and a pharmaceutical composition within the container
  • The composition is formulated for enema delivery from the container via the flexible tubing
  • The composition comprises saline, a cryoprotectant, and a preparation of viable uncultured non-pathogenic fecal bacteria from a human donor stool
  • The container is sealed
  • The pharmaceutical composition is free of rough particulate matter
  • The pharmaceutical composition is in an amount effective for treating recurrence of C. difficile infection

U.S. Patent No. 10,463,702 - "Compositions for fecal floral transplantation and methods for making and using them and devices for delivering them"

The Invention Explained

• Problem Addressed: The patent addresses the same technical problem as the '309 Patent: the disruption of normal gut microbiota by antibiotics, leading to opportunistic infections like C. difficile (U.S. 10,463,702 Patent, col. 2:14-20).
• The Patented Solution: The ’702 Patent claims an enema product for transport that includes a container made of an "oxygen-resistant material" (U.S. 10,463,702 Patent, col. 15:37-38). This container holds a pharmaceutical composition that comprises the "substantially entire microbiota of a stool sample," is "free of rough particulate matter," and is effective for treating C. difficile infection (U.S. 10,463,702 Patent, col. 32:2-15).
• Technical Importance: This patented solution emphasizes the preservation of the microbiota, particularly anaerobic bacteria, through the use of oxygen-resistant packaging, aiming to improve the viability and efficacy of the transplant material (U.S. 10,463,702 Patent, col. 20:3-5).

Key Claims at a Glance

• The complaint identifies independent claim 1 as exemplary (Compl. ¶98).
• Claim 1 of the ’702 Patent recites the following essential elements:
  • An enema product configured for transporting to a remote facility
  • The product comprises a container and a pharmaceutical composition within the container
  • The composition is formulated for enema delivery directly from the container
  • The container comprises an oxygen-resistant material
  • The composition comprises saline, a cryoprotectant, and the substantially entire microbiota of a stool sample
  • The composition is free of rough particulate matter of the stool sample
  • The substantially entire microbiota is in an amount effective for treating a C. difficile infection

U.S. Patent No. 10,328,107

• Patent Identification: U.S. Patent No. 10,328,107, issued June 25, 2019.
• Technology Synopsis: This patent claims a method for preparing a composition of viable bacteria. The method involves receiving a non-frozen stool sample at a central location, testing it for pathogens, mixing it with a cryoprotectant, and homogenizing it (Compl. ¶111).
• Asserted Claims: Independent claim 1 is identified as exemplary (Compl. ¶111).
• Accused Features: Plaintiffs argue their RBX2660 product is not manufactured by "receiving at a central location a non-frozen stool sample from a donor" (Compl. ¶118).

U.S. Patent No. 10,064,899

• Patent Identification: U.S. Patent No. 10,064,899, issued September 4, 2018.
• Technology Synopsis: This patent claims a method for producing a composition of bacteria from the phylum Firmicutes. The method includes receiving a stool sample, mixing it with a liquid containing a buffer, homogenizing and filtering it to produce a filtrate, and then selectively removing bacteria from that filtrate (Compl. ¶124).
• Asserted Claims: Independent claim 1 is identified as exemplary (Compl. ¶124).
• Accused Features: Plaintiffs assert that their RBX2660 suspension does not contain a buffer, as required by the claim (Compl. ¶131).

U.S. Patent No. 10,022,406

• Patent Identification: U.S. Patent No. 10,022,406, issued July 17, 2018.
• Technology Synopsis: This patent claims a pharmaceutical composition comprising an added cryoprotectant and "extracted stool bacterial material without fiber" (Compl. ¶137).
• Asserted Claims: Independent claim 1 is identified as exemplary (Compl. ¶137).
• Accused Features: Plaintiffs allege their RBX2660 suspension does not contain "extracted stool bacterial material without fiber" and is not "free of rough particulate matter" as required by the claims (Compl. ¶144).

U.S. Patent No. 9,962,413

• Patent Identification: U.S. Patent No. 9,962,413, issued May 8, 2018.
• Technology Synopsis: The patent claims a method for preparing a microbiota filtrate. The process includes receiving a prescreened stool sample, mixing it with a liquid containing both a buffer and a cryoprotectant, and then homogenizing and filtering the mixture (Compl. ¶150).
• Asserted Claims: Independent claim 1 is identified as exemplary (Compl. ¶150).
• Accused Features: Plaintiffs allege their RBX2660 suspension does not contain a buffer as required by the claims (Compl. ¶157).

U.S. Patent No. 9,308,226

• Patent Identification: U.S. Patent No. 9,308,226, issued April 12, 2016.
• Technology Synopsis: This patent claims an "oxygen-free or substantially oxygen-free pharmaceutical preparation." The preparation must comprise a specific formulation of anaerobic microorganisms, an oxygen scavenging material, and an air-tight or anaerobic container (Compl. ¶163).
• Asserted Claims: Independent claim 1 is identified as exemplary (Compl. ¶163).
• Accused Features: Plaintiffs allege their RBX2660 suspension does not contain an oxygen scavenging material as required by the claims (Compl. ¶170).

III. The Accused Instrumentality

• Product Identification: Plaintiffs' RBX2660 product (Compl. ¶8).
• Functionality and Market Context: RBX2660 is described as an enema preparation containing a liquid suspension of a "diverse consortium of fecal microorganisms" sourced from screened, healthy donors (Compl. ¶8). The manufacturing process involves blending fecal samples with a solution of saline and polyethylene glycol ("PEG") to form a slurry, which is then filtered to remove some, but not all, of the insoluble particulate matter (Compl. ¶8). RBX2660 is intended to be the first FDA-approved FMT drug for treating recurrent C. difficile infection and represents the culmination of extensive clinical trials (Compl. ¶¶29, 39).
  No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

U.S. 10,675,309 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Non-Infringing Functionality	Complaint Citation	Patent Citation
...wherein the pharmaceutical composition is free of rough particulate matter...	Plaintiffs’ RBX2660 product is not "free of rough particulate matter" because a significant amount of particulate matter remains in the suspension after processing and when it is delivered to a patient.	¶92	col. 32:26-27

U.S. 10,463,702 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Non-Infringing Functionality	Complaint Citation	Patent Citation
...wherein the pharmaceutical composition is free of rough particulate matter of the stool sample...	Plaintiffs’ RBX2660 product is not "free of rough particulate matter" because a significant amount of particulate matter from the stool sample remains in the suspension after processing.	¶105	col. 32:11-12

• Identified Points of Contention:
  • Scope Questions: The central point of contention for both the ’309 and ’702 Patents is the scope of the term "free of rough particulate matter." Plaintiffs' manufacturing process for RBX2660 is described as filtering to remove "some of the insoluble particulate matter" (Compl. ¶8), while their non-infringement argument relies on the assertion that a "significant amount of particulate matter remains" (Compl. ¶92). This raises the question of whether "free of" constitutes an absolute standard (i.e., total removal) or a relative standard (i.e., removal of particles above a certain size or type), and whether Plaintiffs' filtering process meets the standard required by the claims.
  • Technical Questions: For the ’702 Patent, the complaint alleges that the specification fails to define, describe, or enable a composition that comprises "the substantially entire microbiota of a stool sample" (Compl. ¶100). This suggests a potential indefiniteness or lack of enablement challenge, raising the evidentiary question of what technical characteristics define the "substantially entire microbiota" and whether the RBX2660 product, after filtration, retains those characteristics.

V. Key Claim Terms for Construction

• The Term: "free of rough particulate matter"
• Context and Importance: This term appears in the independent claims of both the '309 and '702 patents and forms the basis of Plaintiffs' primary non-infringement argument. Its construction will be critical in determining whether a product like RBX2660, which undergoes filtration but is alleged to retain significant particulate matter, falls within the scope of the claims. Practitioners may focus on this term because the patents do not appear to provide an explicit definition for what constitutes "rough" or how "free" of it a composition must be.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification of the ’702 Patent mentions a process of being "homogenized and filtered to remove large particles of matter" (U.S. 10,463,702 Patent, col. 19:29-30). A party could argue this suggests the term is relative and is met by standard filtering intended to remove large particles, not all particulates.
  • Evidence for a Narrower Interpretation: The complaint alleges that the specifications of the asserted patents fail to describe or enable a composition that is "free of rough particulate matter" (Compl. ¶¶87, 100). A party could argue that the absence of a clear definition or standard implies a plain and ordinary meaning of complete or near-complete removal, a standard that a simple filtration process might not achieve.

VI. Other Allegations

The complaint does not provide sufficient detail for analysis of indirect or willful infringement.

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

• A core issue will be one of definitional scope: can the claim limitation "free of rough particulate matter" be construed to cover a composition that, as Plaintiffs allege, is filtered but retains a "significant amount" of particulate matter? The resolution will depend on whether the court interprets "free of" as an absolute or relative standard, an issue for which the patent specifications may provide limited guidance.
• A key validity question will be one of enablement and definiteness: do the patent specifications, as Plaintiffs contend, fail to adequately describe and enable key technical features such as a composition "free of rough particulate matter" or one containing the "substantially entire microbiota of a stool sample"? The court's determination on these issues could impact the validity of the asserted claims.
• The case also presents a fundamental evidentiary challenge: Plaintiffs' non-infringement positions for several patents rest on the absence of specific components in their product (e.g., no "buffer", no "oxygen scavenging material"). The case will therefore turn on factual evidence regarding the precise composition and manufacturing process of RBX2660 and whether those facts align with the court's construction of the asserted claims.