DCT

5:10-cv-00836

Siler Khodr v. Bachem Bioscience Inc

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 5:10-cv-00836, W.D. Tex., 10/14/2010
  • Venue Allegations: Venue is alleged to be proper as Defendants are considered residents of the district and operate a website allowing direct purchases by Texas residents.
  • Core Dispute: Plaintiff, a researcher, alleges that Defendants are manufacturing and selling a synthetic hormone analog that infringes her patent on chemically-stabilized Gonadotropin-releasing hormone (GnRH) analogs.
  • Technical Context: The technology involves chemically modifying peptide hormones to increase their stability against enzymatic degradation in the body, thereby enhancing their therapeutic potential for regulating fertility.
  • Key Procedural History: The complaint alleges a prior business relationship in which the Plaintiff hired one of the Defendants, Peninsula Laboratories, to exclusively synthesize the patented analog for her research. The complaint further alleges that Defendants' current marketing materials for the accused product attribute the analog's development to the Plaintiff.

Case Timeline

Date Event
1999-10-15 U.S. Patent No. 6,323,179 Priority Date
2001-11-27 U.S. Patent No. 6,323,179 Issue Date
"as least as early as 2006" Alleged first sale of Accused Product by Defendants
2010-10-14 Complaint Filing Date

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

U.S. Patent No. 6,323,179 - "Chicken GnRH Analogs and Uses Thereof in Regulation of Fertility and Pregnancy"

  • Patent Identification: U.S. Patent No. 6,323,179, "Chicken GnRH Analogs and Uses Thereof in Regulation of Fertility and Pregnancy," issued November 27, 2001.

The Invention Explained

  • Problem Addressed: The patent's background section explains that naturally occurring Gonadotropin-releasing hormones (GnRH) are therapeutically limited because they are rapidly degraded by enzymes in the human body, particularly by a "post-proline peptidase" (also called "C-ase-1") found in placental tissue (Compl. ¶17; ’179 Patent, col. 7:41-47).
  • The Patented Solution: The invention claims to solve this problem by creating modified versions, or "analogs," of a non-mammalian GnRH (specifically, Chicken II GnRH). These analogs are engineered to be resistant to degradation by making specific chemical substitutions at key positions in the peptide chain: a "D-amino acid" at position 6 and an "ethylamide or aza-Gly-amide" at position 10. This structure is intended to bind with high affinity to specific GnRH receptors in chorionic, placental, or ovarian tissue while resisting enzymatic breakdown (’179 Patent, Abstract; col. 9:1-8).
  • Technical Importance: This approach provided a method for creating more stable and targeted hormone analogs for potential use in fertility regulation, such as post-coital contraception or pregnancy maintenance (’179 Patent, col. 9:12-21).

Key Claims at a Glance

  • The complaint asserts independent Claim 1 and dependent Claim 2 (’179 Patent, col. 23:35-49; Compl. ¶56).
  • Independent Claim 1 requires:
    • A Chicken II GnRH decapeptide analog with a specific base sequence (p-Glu-His-Trp-Ser-His-Xaa1-Trp-Tyr-Pro-Xaa2)
    • The analog must be "capable of binding to human chorionic, placental or ovarian GnRH receptors"
    • The analog must be "active in the presence of a post-proline peptidase or an endopeptidase"
    • The analog must comprise a D-amino acid substitution at position 6
    • The analog must comprise an ethylamide or aza-Gly-amide substitution at position 10

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendants' Product No. H-6038, marketed as a "(D-Arg⁶, Azagly¹⁰)-LHRH II (human, chicken)" analog (Compl. ¶32).

Functionality and Market Context

  • The complaint alleges the accused product is a synthetic peptide with the specific chemical sequence Pyr-His-Trp-Ser-His-D-Arg-Trp-Tyr-Pro-Azagly-NH₂ (Compl. ¶33). It is allegedly marketed as a "useful LHRH analog for the site-specific regulation of the ovarian function" (Compl. ¶34). The complaint includes a reference to Exhibit C, a product monograph, which allegedly discloses the product's infringing sequence (Compl. ¶33). Further, the complaint references a screenshot from the Defendants' website, described in Exhibit E, where typing "Khodr" into the site's search bar allegedly leads directly to the accused product's sales page (Compl. ¶38).

IV. Analysis of Infringement Allegations

’179 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A Chicken II GnRH decapeptide analog, having the sequence p-Glu-His-Trp-Ser-His-Xaa1-Trp-Tyr-Pro-Xaa2... The accused product is alleged to be a GnRH II decapeptide analog with the sequence Pyr-His-Trp-Ser-His-D-Arg-Trp-Tyr-Pro-Azagly-NH₂, which maps directly onto the claimed sequence structure. ¶40-50 col. 23:35-43
...comprising a D-amino acid substitution at position 6... The accused product is alleged to have D-Arginine, a D-amino acid, at the sixth amino acid position. ¶46 col. 23:41-42
...and an ethylamide or aza-Gly-amide substitution at position 10. The accused product is alleged to have an aza-Gly-amide substitution at the tenth amino acid position. ¶50 col. 23:42-43
...capable of binding to human chorionic, placental or ovarian GnRH receptors... The complaint asserts that the accused product is capable of binding to these specific receptors. ¶51 col. 5:29-37
...and active in the presence of a post-proline peptidase or an endopeptidase... The complaint asserts that the accused product is active in the presence of these specific enzymes. ¶52 col. 7:41-47
  • Identified Points of Contention:
    • Technical Questions: The complaint makes direct allegations matching the accused product's chemical structure to the patent's claims. However, for the functional limitations—"capable of binding" and "active in the presence"—the complaint offers conclusory statements (Compl. ¶¶51-52). A central technical question for the court will be what evidence the Plaintiff presents to prove that the accused product actually performs these specific biological functions as required by the claims. The defense may argue that while the chemical structure is similar, the product does not meet these functional requirements.

V. Key Claim Terms for Construction

  • The Term: "capable of binding to human chorionic, placental or ovarian GnRH receptors"
  • Context and Importance: This term is critical because it defines a required functional property of the claimed analog, not just its chemical structure. Infringement hinges on whether the accused product exhibits this specific biological activity. Practitioners may focus on this term because the dispute could center on the degree and type of binding required to meet the claim limitation.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language uses "or," which may support an interpretation that binding to any one of the three listed receptor types is sufficient to infringe (Compl. ¶51). The specification also discusses these receptors in general terms, potentially supporting a broad reading of the term "capable" (’179 Patent, col. 6:7-14).
    • Evidence for a Narrower Interpretation: The patent’s abstract and detailed description repeatedly emphasize the invention's preferential binding to chorionic/placental receptors over other types, such as pituitary receptors (’179 Patent, Abstract). A party could argue that "capable of binding" should be construed to require this demonstrated preference. The patent’s examples also provide specific binding affinity data (Ka values), which could be used to argue that the term implies a quantitative threshold of binding strength that must be met (’179 Patent, col. 14:57-64).

VI. Other Allegations

  • Indirect Infringement: The complaint includes a claim for induced infringement (Compl. ¶67). However, the specific factual allegations focus on Defendants' own acts of making, offering for sale, and selling the accused product, which are acts of direct infringement. The complaint does not detail specific actions by Defendants that would cause a third party to infringe.
  • Willful Infringement: The complaint alleges Defendants' infringement is "deliberate and willful" (Compl. ¶68). The factual basis for this allegation appears to stem from two key assertions: (1) Plaintiff solicited Defendant Peninsula Laboratories in the late 1990s to produce the GnRH II analog for her exclusive use (Compl. ¶21); and (2) Defendants' own product monograph and website allegedly acknowledge the Plaintiff's role in developing the analog (Compl. ¶¶35, 38). These allegations, if proven, could support a finding of pre-suit knowledge of the patent and the technology's origin.

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

The litigation will likely center on two primary questions:

  1. A key evidentiary issue will be one of biological function: While the chemical structure of the accused product appears to align with the patent claims, a central question for the court will be whether the Plaintiff can produce sufficient technical evidence to prove the product also meets the claims' functional requirements, namely being "capable of binding" to specific receptors and remaining "active" in the presence of specific enzymes.

  2. A core question of fact will concern the parties' prior relationship: The allegation that a Defendant was originally hired by the Plaintiff to synthesize the now-accused product, and subsequently sold it while allegedly attributing it to her, creates a powerful narrative. The resolution of these facts will be critical for the determination of willful infringement.