DCT
2:17-cv-06114
NYU Winthrop Hospital v. Microbion Corp
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: NYU Winthrop Hospital (New York)
- Defendant: Microbion Corporation (Delaware)
- Plaintiff’s Counsel: Amster, Rothstein & Ebenstein LLP
- Case Identification: 2:17-cv-06114, E.D.N.Y., 10/20/2017
- Venue Allegations: Plaintiff alleges venue is proper in the Eastern District of New York because a substantial part of the events giving rise to the claim occurred in the district, including the alleged conception and reduction to practice of the inventions by the omitted inventor, Dr. Philip Domenico, during his employment with Plaintiff in Mineola, New York.
- Core Dispute: Plaintiff seeks correction of inventorship under 35 U.S.C. § 256 for three U.S. patents, alleging that its former employee, Dr. Philip Domenico, was a true and correct inventor who was improperly omitted from patents assigned to the Defendant.
- Technical Context: The technology involves Bismuth-Thiol (BT) compounds used as antimicrobial agents, particularly for treating infections and preventing the formation of bacterial biofilms, a significant challenge in clinical and industrial settings.
- Key Procedural History: The complaint alleges that in 2005, Defendant entered into a license agreement for Plaintiff's patents and know-how related to BTs developed by Dr. Domenico. In 2008, pursuant to that agreement, Defendant allegedly requested and received copies of Dr. Domenico's confidential lab notebooks. Plaintiff alleges these notebooks and other confidential information formed the basis for the patents-in-suit, on which Defendant named its own employee as the sole inventor.
Case Timeline
| Date | Event |
|---|---|
| 2005-03-14 | Dr. Domenico's full-time employment with Winthrop ends |
| 2005-09-22 | Microbion and Winthrop enter into a License Agreement |
| 2008-01-01 | Microbion requests and Winthrop provides Dr. Domenico's lab notebooks |
| 2009-02-03 | Priority Date for U.S. Patent No. 8,389,021 |
| 2010-02-03 | Filing Date for application leading to ’021 Patent |
| 2012-08-03 | Filing Date for application leading to U.S. Patent No. 9,028,878 |
| 2013-02-12 | Filing Date for application leading to U.S. Patent No. 9,408,393 |
| 2013-03-05 | Issue Date for U.S. Patent No. 8,389,021 |
| 2015-05-12 | Issue Date for U.S. Patent No. 9,028,878 |
| 2016-08-09 | Issue Date for U.S. Patent No. 9,408,393 |
| 2017-10-20 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,408,393 - "Bismuth-Thiols as Antiseptics for Agricultural, Industrial and Other Uses"
The Invention Explained
- Problem Addressed: The patent family addresses the challenge of treating microbial infections, particularly those involving bacterial biofilms, which are communities of bacteria that exhibit significantly increased resistance to antibiotics and disinfectants and complicate the healing of wounds ('021 Patent, col. 4:11-22).
- The Patented Solution: The invention is a method for treating plants for a bacterial pathogen using a bismuth-thiol (BT) composition. The solution involves applying a suspension of BT compound microparticles of a specific size range to inhibit bacterial growth and biofilm formation (’393 Patent, col. 62:45-56). The use of BT compounds is described as an effective antiseptic approach that can overcome antibiotic resistance ('021 Patent, col. 23:10-18).
- Technical Importance: Developing effective treatments against bacterial biofilms is a significant goal in medicine and industry, as biofilms are a primary cause of persistent and hard-to-treat infections ('021 Patent, col. 4:56-61).
Key Claims at a Glance
- The complaint identifies independent claim 1 as containing elements conceived by Dr. Domenico (Compl. ¶26).
- Essential elements of Claim 1 include:
- A method for treating a plant for a bacterial pathogen.
- Contacting the plant with an effective amount of a bismuth-thiol (BT) composition.
- The contacting is performed under conditions to treat the plant or inhibit bacterial cell growth or inhibit biofilm formation, viability or growth.
- The BT composition comprises a suspension of BT compound microparticles.
- The microparticles have a volumetric diameter of from about 0.4 µm to about 10 µm.
- The complaint does not explicitly reserve the right to assert other claims for inventorship purposes.
U.S. Patent No. 9,028,878 - "Bismuth-Thiols as Antiseptics for Biomedical Uses, Including Treatment of Bacterial Biofilms and Other Uses"
The Invention Explained
- Problem Addressed: This patent addresses the problem of bacterial infections in biomedical contexts, particularly the treatment of bacterial biofilms which are resistant to conventional antibiotics and can cause chronic, non-healing wounds ('021 Patent, col. 1:15-23, col. 3:19-24).
- The Patented Solution: The invention is a method for treating bacterial biofilms by administering a BT composition in a synergistic combination with another antibiotic. This combination therapy is intended to overcome antibiotic resistance and effectively treat biofilm-associated infections (’878 Patent, col. 10:4-21). The patent specification details how certain BT compounds can enhance the efficacy of antibiotics against otherwise resistant bacteria ('021 Patent, col. 24:20-40).
- Technical Importance: The solution addresses the critical clinical need for new treatments that can overcome the challenge of antibiotic-resistant bacterial strains, particularly within the protective structure of a biofilm ('021 Patent, col. 4:11-22).
Key Claims at a Glance
- The complaint identifies independent claim 9 as containing elements conceived by Dr. Domenico (Compl. ¶25).
- Essential elements of Claim 9 include:
- A method for treating a bacterial biofilm in a subject.
- The method comprises identifying a biofilm associated with gram positive or gram negative bacteria, or both.
- Administering a bismuth thiol (BT) composition in a synergistic combination with another antibiotic.
- The other antibiotic is selected from a specific list (methicillin, vancomycin, etc.).
- The BT compound comprises bismuth or a bismuth salt and a thiol-containing compound.
- The complaint does not explicitly reserve the right to assert other claims for inventorship purposes.
U.S. Patent No. 8,389,021 - "Bismuth-Thiols as Antiseptics for Epithelial Tissues, Acute and Chronic Wounds, Bacterial Biofilms and Other Indications"
Technology Synopsis
The '021 Patent describes compositions and methods using BT compounds as antiseptics for epithelial tissues, such as in acute and chronic wounds. The patent highlights the unexpected synergy between certain BT compounds and antibiotics for treating bacterial infections, particularly those involving biofilms ('021 Patent, Abstract).
Asserted Claims
The complaint asserts that Dr. Domenico contributed to the conception and reduction to practice of at least the elements of independent claim 13 (Compl. ¶27).
Alleged Inventive Contribution
The subject matter allegedly invented by Dr. Domenico includes the method of protecting an epithelial tissue surface against a bacterial pathogen by contacting it with an effective amount of a BT composition (Compl. ¶27).
III. Analysis of Inventorship Allegations
The core of the complaint is not infringement but a dispute over inventorship. The Plaintiff alleges that Dr. Domenico conceived of key elements of the claimed inventions, and that this conception was documented in his confidential lab notebooks, which were provided to the Defendant in 2008 under a license agreement (Compl. ¶¶22, 24, 42).
U.S. Patent No. 9,408,393 Inventorship Allegations
| Claim Element (from Independent Claim 1) | Alleged Contribution by Dr. Domenico | Complaint Citation | Patent Citation |
|---|---|---|---|
| a method for treating a plant for a bacterial pathogen | Dr. Domenico allegedly pioneered the use of BTs as antimicrobial agents and conceived of their use for treating pathogens. | ¶¶15, 26 | col. 1:15-23 |
| contacting the plant with an effective amount of a bismuth-thiol (BT) composition under conditions to treat the plant or inhibit bacterial cell growth or inhibit biofilm formation | Dr. Domenico allegedly conceived of and reduced to practice the use of BT compositions to inhibit bacterial growth and biofilm. | ¶¶24, 26, 42 | col. 24:2-18 |
| wherein the BT composition comprises a suspension of BT compound microparticles comprising a volumetric diameter of from about 0.4 µm to about 10 µm | The complaint alleges that conceptions in the patents were drawn from data in Dr. Domenico's lab notebooks, which allegedly documented his work on BT formulations. | ¶¶24, 26, 42 | col. 10:27-46 |
U.S. Patent No. 9,028,878 Inventorship Allegations
| Claim Element (from Independent Claim 9) | Alleged Contribution by Dr. Domenico | Complaint Citation | Patent Citation |
|---|---|---|---|
| a method for treating a bacterial biofilm ... comprising ... identifying a biofilm associated with gram positive or gram negative bacteria, or both | Dr. Domenico allegedly conceived of treating bacterial biofilms and identifying their association with gram positive or gram negative bacteria. | ¶¶25, 42 | col. 3:19-24 |
| administering a bismuth thiol (BT) composition, in a synergistic combination, with another antibiotic, the other antibiotic being selected from [a specified list] | Dr. Domenico allegedly conceived of administering a BT composition in a synergistic combination with specific antibiotics. | ¶¶25, 42 | col. 24:19-40 |
| wherein the BT compound comprises bismuth or a bismuth salt and a thiol-containing compound | The complaint alleges Dr. Domenico was the "pioneer of BTs" and his work, documented in lab notebooks, formed the basis for the claimed formulations. | ¶¶15, 25, 42 | col. 17:1-11 |
- Identified Points of Contention:
- Conception vs. General Knowledge: A primary question will be whether Dr. Domenico's alleged contributions rise to the level of "conception" of the complete and operative invention as claimed, or if they represent general background knowledge or pioneering work in the field of BTs. The court will need to distinguish between conceiving the specific claimed methods and simply being the first to explore the general antiseptic properties of BTs.
- Evidentiary Questions: The case may turn on the contents of Dr. Domenico's lab notebooks. A key question will be whether those notebooks provide corroborated evidence that Dr. Domenico conceived of the specific elements of the asserted claims, such as the particular microparticle size range in the '393 Patent or the "synergistic combination" with specific antibiotics in the '878 Patent, prior to the involvement of the named inventor.
No probative visual evidence provided in complaint.
IV. Key Claim Terms for Construction
While this is not an infringement action, the meaning of certain claim terms will be central to determining the scope of the invention that Dr. Domenico allegedly conceived.
- The Term: "microparticles comprising a volumetric diameter of from about 0.4 µm to about 10 µm" (’393 Patent, Claim 1)
- Context and Importance: Practitioners may focus on this term because the specific size range of the BT particles may be a critical element of the patented invention's novelty and efficacy. Whether Dr. Domenico conceived of this particular size range, as opposed to just BT compositions generally, could be a dispositive issue for the inventorship of this claim.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the microparticles more broadly as having a volumetric mean diameter (VMD) of "from about 0.4 µm to about 5 µm" in several embodiments, suggesting the upper limit of 10 µm may not be a strict requirement for operability ('021 Patent, col. 10:56-61).
- Evidence for a Narrower Interpretation: The patent provides a detailed method for preparing BT compositions that result in a "substantially monodisperse suspension of microparticles" within a specific size range, suggesting that achieving this particular VMD is a key feature of the described process ('021 Patent, col. 18:48-56, col. 19:1-6).
- The Term: "synergistic combination" (’878 Patent, Claim 9)
- Context and Importance: The concept of "synergy"—an effect greater than the sum of the individual components—is a key limitation. The inventorship question may hinge on whether Dr. Domenico conceived of this synergistic effect with the claimed classes of antibiotics, or merely the general idea of combination therapy.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent notes that "synergy in the antibacterial effects...is not readily predictable" but "surprisingly may result from selection of particular BT-antibiotic combinations," which could suggest that the term covers any empirically discovered synergistic effect ('021 Patent, col. 24:19-27).
- Evidence for a Narrower Interpretation: The specification defines synergy with reference to specific quantitative measures, such as a fractional inhibitory concentration index (FICI) of ≤0.5, and provides extensive data tables showing synergistic effects for specific BT compounds and antibiotics ('021 Patent, col. 15:35-50, Tables 2-17). This could support a narrower definition tied to a quantitatively demonstrable level of synergy.
V. Other Allegations
- Intentional Omission: The complaint alleges that "Microbion's omission of Dr. Domenico as an inventor was intentional" (Compl. ¶42(iv)). This allegation may be relevant to the Plaintiff's request for the court to declare the case "exceptional under 35 U.S.C. § 285" and award attorney fees (Prayer for Relief ¶D). Under 35 U.S.C. § 256, a court can order correction of inventorship if an inventor was omitted through "error," which can include an omission made without deceptive intent on the part of the omitted inventor.
VI. Analyst’s Conclusion: Key Questions for the Case
The resolution of this dispute will likely depend on the evidence presented to answer two central questions regarding the legal standard for inventorship.
- A core issue will be one of contribution to conception: What evidence exists to corroborate the allegation that Dr. Domenico contributed to the "definite and permanent idea" of the complete inventions as recited in the specific patent claims? This will require distinguishing his alleged foundational research on BTs from a contribution to the particular methods claimed, including limitations such as specific microparticle sizes and synergistic effects with enumerated antibiotics.
- A key evidentiary question will be one of derivation and disclosure: To what extent do the contents of Dr. Domenico's confidential lab notebooks, allegedly provided to Defendant in 2008, disclose the conceived and operative inventions claimed in the patents-in-suit? The case will likely involve a detailed comparison of the documentary evidence of Dr. Domenico's work against the specific limitations present in the asserted patent claims.