DCT
3:17-cv-00934
Ni Q LLC v. Prolacta Bioscience Inc
Key Events
Amended Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: NI-Q, LLC (Oregon)
- Defendant: Prolacta Bioscience, Inc. (Delaware)
- Plaintiff’s Counsel: Schwabe, Williamson & Wyatt, P.C.
- Case Identification: 3:17-cv-00934, D. Or., 10/22/2019
- Venue Allegations: Venue is asserted in the District of Oregon based on Prolacta allegedly conducting regular business in the state and sending patent demand letters to Ni-Q’s place of business in Wilsonville, Oregon.
- Core Dispute: Plaintiff Ni-Q, a competitor, seeks a declaratory judgment that its human milk-based nutritional products do not infringe Defendant Prolacta’s patent related to methods for testing and processing donated milk, and further alleges the patent is invalid and was procured through fraud on the U.S. Patent and Trademark Office.
- Technical Context: The dispute centers on technologies for ensuring the safety and nutritional consistency of donated human milk, a critical nutritional source for premature and at-risk infants in neonatal intensive care units.
- Key Procedural History: The complaint notes that Prolacta previously filed an infringement suit against Ni-Q in the Central District of California, which was dismissed for improper venue. It also alleges that Prolacta filed an application to reissue the patent-in-suit after realizing its potential invalidity based on Prolacta's own prior product sales.
Case Timeline
| Date | Event |
|---|---|
| 2005-09-20 | ’921 Patent Earliest Priority Date |
| 2005-12-20 | First Sale of Prolacta's "Prolact22" Product |
| 2006-04-27 | First Sale of Prolacta's "Prolact-Plus" Product |
| 2006-05-24 | First Sale of Prolacta's "Prolact-20" Product |
| 2006-07-26 | First Sale of Prolacta's "Prolact-24" Product |
| 2006-11-14 | First Sale of Prolacta's "Neo-Pro" Product |
| 2007-01-11 | First Sale of Prolacta's "Prolact-Plus4" Product |
| 2007-03-27 | First Sale of Prolacta's "Neo-20" Product |
| 2014-01-14 | ’921 Patent Issue Date |
| 2017-05-31 | Prolacta Files California Complaint Against Ni-Q |
| 2017-08-07 | California Complaint Dismissed for Improper Venue |
| 2018-09-10 | Prolacta Files Application for Reissue of ’921 Patent |
| 2019-10-22 | Ni-Q Files Third Amended Complaint for Declaratory Judgment |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,628,921 - Methods for Testing Milk, Issued Jan. 14, 2014
The Invention Explained
- Problem Addressed: The patent addresses the challenge of verifying the source of donated human milk, which is often expressed by donors at home without direct supervision by milk bank personnel, creating potential safety and provenance risks (ʻ921 Patent, col. 3:28-34).
- The Patented Solution: The invention describes a method to improve safety by confirming the donor's identity. The method involves first creating an "identity marker profile" (e.g., a DNA profile) from a biological sample taken directly from the donor, then testing the donated milk for the same marker profile, and comparing the two to confirm a match. Only milk with a confirmed match is then processed to meet specific, narrow ranges of protein, fat, and carbohydrate content (ʻ921 Patent, col. 4:36-52).
- Technical Importance: This method provides a systematic approach to quality control in the milk-banking industry, combining identity verification with nutritional standardization to ensure a safer and more consistent product for medically fragile infants (ʻ921 Patent, col. 4:5-15).
Key Claims at a Glance
- The complaint challenges "any valid claim" of the '921 patent and specifically references claim 1 for invalidity (Compl. ¶27, p.28).
- Independent Claim 1 recites a multi-step method comprising:
- (a) testing a donated biological sample from the specific subject to obtain at least one reference identity marker profile for at least one marker;
- (b) testing a sample of the donated mammary fluid to obtain at least one identity marker profile for the at least one marker in step (a);
- (c) comparing the identity marker profiles, wherein a match... indicates that the mammary fluid was obtained from the specific subject; and
- (d) processing the matched mammary fluid to comprise specific concentrations of human protein, fat, and carbohydrate constituents.
- The complaint does not specify dependent claims but seeks a declaration of non-infringement as to all claims (Compl. p. 28).
III. The Accused Instrumentality
Product Identification
- The subject of this declaratory judgment action is Ni-Q's process for making its human milk-based nutritional products for premature infants (Compl. ¶4, 10).
Functionality and Market Context
- Ni-Q produces "safe, nutritionally enhanced food for these infants made entirely of human milk" (Compl. ¶10). The complaint’s central allegation of non-infringement is based on a specific omission in its process: "Ni-Q does not use any form of testing to match mammary fluid to donor as required by each and every claim of the ’921 patent. Ni-Q does not test donated milk to identify its donor" (Compl. ¶19).
- The complaint positions Ni-Q as a "new market entrant" challenging Prolacta, which it characterizes as having "long dominated its market" (Compl. ¶1).
IV. Analysis of Infringement Allegations
The complaint seeks a declaratory judgment of non-infringement. The analysis below summarizes Ni-Q’s factual allegations as to why its process does not meet the limitations of the '921 patent's claims.
’921 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Non-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (a) testing a donated biological sample from the specific subject to obtain at least one reference identity marker profile... | Ni-Q alleges that its process does not include testing to match donated milk to its donor. | ¶19 | col. 22:5-9 |
| (b) testing a sample of the donated mammary fluid to obtain at least one identity marker profile... | Ni-Q alleges that its process does not include testing to match donated milk to its donor. | ¶19 | col. 22:10-13 |
| (c) comparing the identity marker profiles, wherein a match... indicates that the mammary fluid was obtained from the specific subject | As Ni-Q alleges that it does not generate identity marker profiles from the donor or the milk, it alleges no such comparison is performed. | ¶19 | col. 22:14-18 |
| (d) processing the donated mammary fluid whose identity marker profile has been matched... | Ni-Q alleges that since no donor matching is performed, this step, which requires processing of matched milk, is not performed. | ¶19 | col. 22:19-27 |
- Identified Points of Contention:
- Factual Question: The dispositive issue for infringement appears to be factual: does Ni-Q's process for sourcing and preparing human milk involve any steps that constitute creating and comparing "identity marker profiles" from a donor and their donated milk? The complaint asserts it does not, which, if true, would mean Ni-Q does not practice at least three required steps of claim 1.
- Scope Questions: Should the case proceed, a potential point of contention could be the scope of "testing... to obtain at least one... identity marker profile." A question may arise as to whether any quality control or safety tests performed by Ni-Q could be argued to fall within the scope of this limitation, even if not explicitly for donor identification.
V. Key Claim Terms for Construction
- The Term: "identity marker profile"
- Context and Importance: This term is foundational to the patent and the infringement dispute. Ni-Q's non-infringement position is that it does not create or compare such profiles (Compl. ¶19). The definition of what constitutes an "identity marker profile" will be critical in determining whether any of Ni-Q's actual processes meet this limitation. Practitioners may focus on this term because its scope dictates whether routine safety screening could be conflated with the specific identity verification taught in the patent.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent defines an "identity marker" as a marker that "can be used to identify an individual subject from other subjects in a population," including "genes, alleles, loci, antigens polypeptides or peptides" ('921 Patent, col. 5:35-39). This broad definition could potentially encompass a wide array of biological markers.
- Evidence for a Narrower Interpretation: The specification’s detailed examples and discussion focus almost exclusively on specific, sophisticated genetic identification techniques, such as Short Tandem Repeat (STR) analysis and Human Leukocyte Antigen (HLA) typing ('921 Patent, col. 4:39-44; col. 11:1-12:54). This focus could support an interpretation limiting the term to methods intended for and capable of uniquely identifying an individual human, as distinct from general testing for pathogens or other non-identifying characteristics.
VI. Other Allegations
The complaint contains extensive allegations beyond direct infringement, focusing on Prolacta's conduct.
- Invalidity Based on Inequitable Conduct: The complaint alleges that Prolacta and its counsel committed fraud on the USPTO by failing to disclose its own prior art products, which were allegedly sold more than one year before the '921 patent’s effective priority date (Compl. ¶¶40-44). The complaint includes a table showing the sale dates and macronutrient content of these prior products, alleging they anticipate or render obvious the patent's claims. The table of Prolacta's prior products, their sale dates, and nutrient content is provided as a key piece of evidence for this allegation (Compl. ¶43).
- Bad Faith Assertion: The complaint alleges that Prolacta sent "bad faith patent demands" and filed a "sham" lawsuit with the intent to monopolize the market for standardized human milk products, forming the basis for its claims under the Sherman Act and Oregon Unfair Trade Practices Act (Compl. ¶¶32, 71).
VII. Analyst’s Conclusion: Key Questions for the Case
- A Central Factual Question of Non-Infringement: What does Ni-Q’s quality control and processing protocol for donated human milk entail? The case may turn on evidence establishing whether Ni-Q in fact performs any tests that could be construed as generating and comparing an “identity marker profile” to confirm a donor’s identity, as required by the patent’s claims.
- An Evidentiary Question of Validity: Did Prolacta's own commercial products sold prior to the patent's critical date, such as "Prolact-Plus," embody the method and composition claimed in the '921 patent? Evidence of Prolacta's own internal processes and product specifications from that time will be crucial to resolving the on-sale bar defense under 35 U.S.C. § 102.
- A Legal Question of Patent Eligibility: Is the claimed invention directed to a patent-ineligible concept? A court will likely have to consider whether the claims, by combining the known scientific technique of identity testing with claimed nutritional ranges that allegedly reflect a natural phenomenon, add a sufficient "inventive concept" to be patent-eligible under 35 U.S.C. § 101.