DCT
3:16-cv-00698
Rembrandt Diagnostics LP v. Alere Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Rembrandt Diagnostics, LP (Virginia)
- Defendant: Alere, Inc. (Delaware), along with eight named subsidiaries
- Plaintiff’s Counsel: Knobbe, Martens, Olson & Bear, LLP
- Case Identification: 3:16-cv-00698, S.D. Cal., 03/23/2016
- Venue Allegations: Venue is alleged based on Defendants regularly conducting business and committing the alleged acts of infringement in the district, and on the principal places of business for Defendants Ameditech, Inc. and Innovacon, Inc. being located within the district.
- Core Dispute: Plaintiff alleges that Defendant’s rapid drug screening test cups and dip-stick devices infringe two patents related to the design and fluid-handling mechanics of immunoassay devices.
- Technical Context: The technology involves point-of-care diagnostic devices for analyzing biological fluids, a market driven by demand for rapid, inexpensive, and reliable drug screening in workplace, clinical, and law enforcement settings.
- Key Procedural History: The complaint alleges that in 2012, representatives for Defendant Alere engaged in licensing discussions with the inventor of the '019 patent after being informed of potential infringement, but no agreement was reached. The complaint also notes that a third party, Syntron, is a licensee and marks its products with the patent numbers. Notably, Inter Partes Review (IPR) certificates attached to the patent exhibits, issued after the complaint was filed, indicate that all asserted claims of both patents-in-suit have since been cancelled or disclaimed.
Case Timeline
| Date | Event |
|---|---|
| 1998-07-14 | ’291 Patent Priority Date |
| 1998-11-16 | ’019 Patent Priority Date |
| 2003-04-15 | ’019 Patent Issue Date |
| 2012-01-01 | Alere and inventor Dr. Lee discuss potential '019 patent infringement |
| 2012-06-01 | Alere sends draft license agreement for '019 patent to Dr. Lee |
| 2014-01-07 | ’291 Patent Issue Date |
| 2016-03-23 | Complaint Filing Date |
| 2018-02-13 | IPR Certificate issues cancelling asserted claims of '291 Patent |
| 2024-02-28 | IPR Certificate issues disclaiming/cancelling asserted claims of '019 Patent |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,548,019 - "Device and Methods for Single Step Collection and Assay of Biological Fluids"
- Patent Identification: U.S. Patent No. 6,548,019, "Device and Methods for Single Step Collection and Assay of Biological Fluids," issued April 15, 2003.
The Invention Explained
- Problem Addressed: The patent addresses the unreliability of prior art integrated sample collection cups and test strips, where introducing a fluid sample could oversaturate the test strips or cause uneven wicking, leading to inaccurate results ('019 Patent, col. 4:41-50).
- The Patented Solution: The invention proposes a "flow control channel" that houses the test strip inside the collection cup. This channel is designed with a liquid-pervious opening near the bottom and is otherwise sealed, ensuring that the air pressure inside the channel remains in "substantial equilibrium" with the air pressure outside. This design prevents the fluid's hydrostatic pressure from flooding the test strip; instead, the fluid is drawn up solely by the strip's natural wicking action, leading to more controlled and reliable sample application ('019 Patent, Abstract; col. 5:56-col. 6:4).
- Technical Importance: This fluid control mechanism aimed to create a more robust, reliable, and user-independent diagnostic cup that was less prone to errors caused by variations in sample volume ('019 Patent, col. 5:44-55).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶37).
- Independent Claim 1 elements:
- A "flow control channel" defined by liquid pervious and impervious sides.
- An "assay test strip" positioned within the channel.
- A "sample fluid container" (e.g., a cup).
- The channel is oriented toward the container base, so fluid enters through the liquid pervious side "without migration through an intermediate structure."
- The fluid entry creates an "ambient pressure within the flow control channel equivalent to the ambient pressure outside," which "eliminat[es] a pressure gradient" that could otherwise force excess fluid into the channel.
U.S. Patent No. 8,623,291 - "Multiple Analyte Assay Device"
- Patent Identification: U.S. Patent No. 8,623,291, "Multiple Analyte Assay Device," issued January 7, 2014.
The Invention Explained
- Problem Addressed: The patent identifies limitations in prior multi-analyte testing devices, which were either tedious (requiring multiple separate dipping steps) or inflexible (using a fixed, non-customizable panel of tests) ('291 Patent, col. 1:20-32).
- The Patented Solution: The invention is a modular dip-stick device featuring a plastic base with multiple parallel slots separated by raised walls. Individual, discrete test strips can be inserted into these slots, allowing a user to customize the panel of analytes to be tested. The device includes a cover with a transparent window for viewing results and a removable cap to protect the protruding ends of the test strips, which serve as the sample application area ('291 Patent, Abstract; Fig. 1).
- Technical Importance: This design provides flexibility, allowing users to build custom assay devices for specific situations rather than being limited to pre-manufactured test panels ('291 Patent, col. 2:13-17).
Key Claims at a Glance
- The complaint asserts at least independent claims 1 (device) and 9 (method) (Compl. ¶48).
- Independent Claim 1 elements:
- A "base" with adjacent "slots" defined by a floor and "raised walls."
- A "multiplicity of test strips," with one strip inserted into each slot so an "upstream end...protrudes" to act as a "sample addition pad."
- A "cover attached to the upwardmost surface of each raised wall" that retains the strips and has a "transparent window."
- A removable "cap" that encloses the protruding ends of the test strips.
- Independent Claim 9 is a method claim reciting the steps of using the device of Claim 1.
III. The Accused Instrumentality
- Product Identification: The complaint accuses two categories of products: integrated test cups sold under names including "iCup Dx Pro," "iCup A.D.," "AmediCheck," "DrugSmart," and "UScreen" (Compl. ¶18), and dip testing devices sold as "iScreen" and "ProScreen" (Compl. ¶20).
- Functionality and Market Context: The accused products are point-of-care devices for collecting and screening urine samples for the presence of illicit drugs and other substances (Compl. ¶18, ¶20). The complaint includes several images of the accused products, such as a photograph of the "UScreen" integrated test cup, which shows test strips visible through the cup's label (Compl. p. 7). Another image shows the "iScreen" dip testing device, which is a flat card with multiple protruding test strips designed to be dipped into a sample (Compl. p. 8). The complaint alleges these products are made, used, and sold by the various Alere-affiliated Defendants (Compl. ¶22-28).
IV. Analysis of Infringement Allegations
’019 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (a) a flow control channel defined by at least one liquid pervious side joined to liquid impervious sides... | The accused test cups contain a "flow control channel inside the sample fluid container" that has a "liquid pervious side oriented toward the base... joined to liquid impervious sides." | ¶37 | col. 8:43-49 |
| (b) an assay test strip within the flow control channel... disposed... so the sample fluid contacts the sample loading zone at a liquid pervious side... | The test strip is positioned within the channel and has a "sample loading zone that contacts the sample fluid at the liquid pervious side of the flow control channel." | ¶37 | col. 8:50-55 |
| wherein the flow control channel... is delivered to the sample loading zone... without migration through an intermediate structure... | The channel is oriented so that sample fluid "is delivered to the sample loading zone... through the liquid pervious side... without migration through an intermediate structure." | ¶37 | col. 8:58-65 |
| wherein entry of fluid into the flow control channel creates an ambient pressure within the flow control channel equivalent to the ambient pressure outside... thereby eliminating a pressure gradient... | The channel is oriented such that fluid entry "creates an ambient pressure within the channel equivalent to the ambient pressure outside the channel, thereby eliminating a pressure gradient..." | ¶37 | col. 8:65-9:2 |
- Identified Points of Contention:
- Technical Questions: The complaint's allegations regarding the "flow control channel" and its pressure-equalizing function are highly technical and conclusory (Compl. ¶37). A key question is what evidence supports the claim that the accused devices operate by creating an "ambient pressure... equivalent to the ambient pressure outside" to "eliminat[e] a pressure gradient," as the patent requires. The external product photographs, like the one showing the "iCup A.D." device, do not provide insight into this internal mechanism (Compl. p. 7).
- Scope Questions: The case may turn on whether the internal structure of the accused cups meets the specific functional limitations of a "flow control channel" as defined in the patent, or if it manages fluid flow through a different, non-infringing mechanism.
’291 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (A) a base having adjacent slots... defined by (a) a floor, (b) raised walls... and (C) at least one open end... | The accused dip devices include a "base having adjacent slots, wherein each slot is defined by a floor, raised walls, and an open end." | ¶48 | col. 11:11-16 |
| (B) a multiplicity of test strips... a single test strip is inserted into each slot... the upstream end of each test strip protrudes out of the open end... containing a sample addition pad... | The devices have multiple test strips, with one inserted per slot, where the "protruding freestanding end of each test strip... contains a sample addition pad for direct contact with the fluid." | ¶48 | col. 11:17-25 |
| (C) a cover attached to the upwardmost surface of each raised wall... retains the test strips and has a first transparent window... | The devices have a "cover attached to the upwardmost surface of each raised wall, which retains the assay test strips and includes a transparent window" for viewing results. | ¶48, p.18 | col. 11:26-31 |
| (D) a cap enclosing the protruding ends of the test strips and removably attached to the open end of said base. | The devices have a "cap enclosing the protruding end of the assay test strips, which can be removably attached to the open end of the base." Photographs of the "ProScreen" device depict such a cap (Compl. p. 8). | ¶48, p.18 | col. 12:1-3 |
- Identified Points of Contention:
- Scope Questions: The claim requires a "cover attached to the upwardmost surface of each raised wall." Practitioners may question whether the accused dip cards, which appear to be single-piece molded plastic items, contain a distinct "cover" element that is "attached," or if they are of a unitary construction that falls outside the claim's scope.
- Technical Questions: The complaint alleges the cover "retains the assay test strips" (Compl. ¶48, p.18). The mechanism of this retention (e.g., adhesion, friction, an integrated feature) is not specified and could be a point of dispute regarding whether it aligns with the teachings of the patent.
V. Key Claim Terms for Construction
Term: "flow control channel" ('019 Patent)
- Context and Importance: This term is the central feature of the '019 patent. The infringement analysis for the accused cups hinges on whether their internal fluid-handling structures meet the patent's specific functional definition of a channel that works by equalizing ambient pressure.
- Intrinsic Evidence for a Broader Interpretation: The body of claim 1 defines the channel structurally as having "at least one liquid pervious side joined to liquid impervious sides" ('019 Patent, col. 8:43-45), which might be argued to cover a wide range of structures that guide fluid.
- Intrinsic Evidence for a Narrower Interpretation: The specification and claim language repeatedly tie the channel to the function of creating "an ambient pressure within the flow control channel equivalent to the ambient pressure outside," thereby "eliminating a pressure gradient" ('019 Patent, col. 8:65-9:2). This strong functional language may support a narrower construction limited to devices that operate in this specific physical manner.
Term: "cover attached to the upwardmost surface of each raised wall" ('291 Patent)
- Context and Importance: The construction of this term is critical for the infringement analysis of the accused dip devices. Practitioners may focus on this term because if the accused devices are of a unitary, single-piece molded construction, the presence of a separate "cover" that is "attached" will be a key point of dispute.
- Intrinsic Evidence for a Broader Interpretation: A plaintiff may argue that "attached" can describe the connection between functionally distinct regions of a single, integrated component.
- Intrinsic Evidence for a Narrower Interpretation: The specification describes the cover as being "constructed of an opaque tape" that is "pressed into place to form an adhesive attachment" ('291 Patent, col. 6:10-16), which strongly suggests two separate components being joined together, potentially limiting the claim scope to exclude unitary constructions.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced infringement and contributory infringement for both patents. Inducement is based on allegations that Defendants provide instructions and user manuals that teach customers to use the products in an infringing manner (Compl. ¶35, ¶46). Contributory infringement is based on allegations that the accused products are not staple articles of commerce and are especially made for infringing use (Compl. ¶36, ¶47).
- Willful Infringement: Willfulness is alleged for the '019 patent based on Defendants' alleged pre-suit knowledge stemming from licensing discussions with the inventor in 2012 (Compl. ¶38). For both patents, willfulness is also alleged based on constructive notice via product marking by a licensee (Compl. ¶38, ¶49).
VII. Analyst’s Conclusion: Key Questions for the Case
The complaint, as filed, faces fundamental challenges based on subsequent procedural events documented in the attached exhibits. The central questions for the case are:
- A dispositive issue of case viability: IPR certificates attached to the patents indicate that all claims asserted in the complaint (Claim 1 of the '019 patent and Claims 1 and 9 of the '291 patent) have been cancelled or disclaimed. The primary question is whether the lawsuit can proceed, which may depend on whether the plaintiff can amend its complaint to assert any surviving, unasserted claims and, if so, whether those claims would read on the accused products.
- A key technical question of functional operation: Should the case proceed, the '019 patent analysis will hinge on whether the accused test cups operate using the specific pressure-equalization mechanism of the claimed "flow control channel," or if they employ a different, non-infringing method of fluid control.
- A core structural question of definitional scope: For the '291 patent, a central dispute would be whether the term "cover attached to," illustrated in the patent as a separate component, can be construed to read on the likely unitary, molded-plastic construction of the accused dip-card devices.