DCT

1:18-cv-08410

Parviz Ghahramani v. Julie Hughes

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-08410, S.D.N.Y., 09/14/2018
  • Venue Allegations: Venue is alleged to be proper in the Southern District of New York as all individual Defendants are residents of New York, the corporate Defendant has its principal place of business in New York, and a substantial part of the events giving rise to the claims allegedly occurred in the district.
  • Core Dispute: Plaintiffs seek a declaratory judgment upholding agreements that allegedly assign ownership of patents related to "cholestosome" drug delivery technology to Plaintiff TheraHoldings, and seek to correct the inventorship of those patents by removing two of the Defendants.
  • Technical Context: The technology involves cholestosome vesicles—nanoparticles formed from cholesteryl esters—designed for the oral delivery of therapeutics, including large molecules like proteins and peptides that are typically injectable.
  • Key Procedural History: The complaint describes a joint venture formed in 2013 between the parties to commercialize the cholestosome technology, memorialized in a "Share Purchase Agreement" and a "Contribution Agreement." Plaintiffs allege these agreements transferred ownership of the relevant patent portfolio to TheraHoldings. The dispute arises from an October 2017 letter in which Defendants purported to rescind these agreements and reclaim ownership of the intellectual property.

Case Timeline

Date Event
2006-03-20 U.S. Provisional Patent Application No. 60/784,118 Priority Date ('782 Patent)
2013-03-14 U.S. Provisional Patent Application No. 61/783,003 Priority Date ('968 Patent)
2013-11-15 Share Purchase and Contribution Agreements signed
2015-09-01 U.S. Patent No. 9,119,782 issues
2017-07-04 U.S. Patent No. 9,693,968 issues
2018-09-14 Complaint filed

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

U.S. Patent No. 9,119,782, "Drug Delivery Means," issued September 1, 2015

The Invention Explained

  • Problem Addressed: The patent background describes the chemical properties of lipids, phospholipids, and cholesteryl esters, implicitly framing the technical challenge as creating novel vesicle structures for drug delivery beyond conventional liposomes (US 9,119,782 B2, col. 1:22–col. 2:67).
  • The Patented Solution: The invention is a "cholestosome," a vesicle with a hollow compartment for holding drugs, where the outer membrane is made of cholesteryl esters rather than the phospholipids used in traditional liposomes. The patent discloses that using cholesteryl esters of varying lengths can create a "pocketed membrane surface," and the vesicle can be formed as a single-layered or multi-layered sphere (US 9,119,782 B2, col. 2:55-67).
  • Technical Importance: This approach creates a drug delivery vehicle from cholesteryl esters, which are prevalent in animal body fluids, distinguishing it from conventional phospholipid-based liposomes and potentially offering different characteristics for drug encapsulation and interaction with cells (US 9,119,782 B2, col. 4:18-20).

Key Claims at a Glance

  • The complaint's inventorship challenge encompasses the entire patent. Independent claim 1 is representative of the core technology.
  • Independent Claim 1 Elements:
    • A chemical composition comprising a population of cholestosome vesicles
    • Each vesicle comprising a hollow aqueous capable of being loaded with a chemical compound
    • And an exterior layer enclosing said hollow compartment
    • The exterior layer consisting essentially of a plurality of non-ionic cholesteryl fatty acid ester molecules selected from the group consisting of cholesteryl myristate, cholesteryl laurate, and mixtures thereof
    • Wherein the vesicle ranges in diameter from 1 nm to 1 micron

U.S. Patent No. 9,693,968, "Cholestosome Vesicles for Incorporation of Molecules Into Chylomicrons," issued July 4, 2017

The Invention Explained

  • Problem Addressed: The patent's background addresses the significant challenge of oral drug delivery for macromolecules like proteins. Such molecules are typically degraded in the gastrointestinal tract and cannot effectively pass through the intestinal enterocyte membrane, necessitating parenteral (injected) administration (US 9,693,968 B2, col. 3:1-22).
  • The Patented Solution: The invention is a "cargo-loaded cholestosome" with a neutral surface charge that allows it to be absorbed by intestinal enterocytes "in the manner of orally absorbed nutrient lipids" (US 9,693,968 B2, Abstract). Once inside the enterocyte, the cholestosome and its cargo are incorporated into chylomicrons—the body's natural transport system for dietary fats—and delivered throughout the body via the lymphatic system, bypassing the liver and enabling intracellular delivery (US 9,693,968 B2, col. 1:15-34).
  • Technical Importance: This technology claims to provide a mechanism for the oral delivery of large, complex molecules by hijacking the body’s natural chylomicron-based lipid transport pathway, thereby solving the dual problems of GI degradation and poor membrane permeability (US 9,693,968 B2, col. 4:36-42).

Key Claims at a Glance

  • The complaint's inventorship challenge encompasses the entire patent. Independent claim 1 is representative of the core technology.
  • Independent Claim 1 Elements:
    • A pharmaceutical composition adapted for oral administration to the duodenum
    • Comprising a population of cargo-loaded vesicles with an encapsulated pharmaceutically active agent
    • The vesicles have a surface layer consisting essentially of one or more cholesteryl esters
    • The vesicles are stable to stomach acid and are not broken by cholesteryl ester transporters
    • The cargo-loaded vesicles enter duodenal enterocytes intact
    • The enterocytes add the intact vesicles into chylomicrons to produce transformed chylomicrons for transport to body cells

III. Key Legal and Factual Allegations

  • Dispute Over Ownership and Contract Validity: Plaintiffs allege that a 2013 "Contribution Agreement" and "Share Purchase Agreement" contractually obligated the inventor Defendants to assign all intellectual property rights for the cholestosome technology, including the patent families of the '782 and '968 Patents, to Plaintiff TheraHoldings (Compl. ¶¶26-30). The core of the dispute is a letter dated October 3, 2017, in which Defendant Schentag, on behalf of other Defendants, purports to rescind these agreements, claiming "TheraHoldings has no rights to these patents and intellectual property" (Compl. p. 14). Plaintiffs seek a declaratory judgment that the 2013 agreements are valid and that TheraHoldings is the rightful owner of the technology (Compl. ¶¶60-62). Plaintiffs further allege that Defendants executed a new, "Purported Assignment" of the application leading to the '782 Patent to Defendant TheraSyn in 2018, an act alleged to be inconsistent with the 2013 agreements (Compl. ¶53).

  • Allegations of Incorrect Inventorship: A central patent-law claim in the complaint is for correction of inventorship under 35 U.S.C. § 256 (Compl. ¶¶79-81). Plaintiffs allege that Defendants Jerome J. Schentag and Julie Hughes "contributed nothing to any of the inventions comprising the cholestosome technology that would qualify them as inventors" (Compl. ¶¶22-23, 80). The complaint requests a court order directing the USPTO to remove Schentag and Hughes as co-inventors from the patents-in-suit and related applications (Compl. ¶81).

  • Allegations Regarding Commercialization Failures: The complaint presents evidence, including an email from Defendant Schentag to a representative from Eli Lilly, to support its contention that the joint venture's lack of commercial success was due to Defendants' technical failures, not any breach by Plaintiffs (Compl. ¶¶45, 55). The email discusses a "problem is making a stable solution of vancomycin that is concentrated" and states, "vancomycin is refusing to cooperate" (Compl. p. 20). This visual evidence is used to allege that Defendants were "unable to produce the vancomycin cholestosome formulation required for the Lilly test," thereby undermining Defendants' justification for rescinding the 2013 agreements (Compl. ¶45).

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

  • A central issue will be one of contractual validity: are the 2013 Contribution and Share Purchase Agreements valid and enforceable, as alleged by Plaintiffs, or were they validly rescinded by Defendants, thereby reverting ownership of the patent portfolio?
  • A key factual question will be one of inventive contribution: did Defendants Schentag and Hughes make contributions that qualify them as inventors under 35 U.S.C. § 100, or should they be removed from the patents-in-suit as Plaintiffs allege?
  • A related evidentiary question will be one of breach and performance: did the commercialization failures stem from Plaintiffs' alleged non-performance, as suggested in Defendants' rescission letter, or from Defendants' alleged technical inability to produce stable and reproducible formulations of the cholestosome technology, as Plaintiffs contend?