DCT
1:18-cv-01991
Ocular Therapeutix Inc v. Mati Therap Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Ocular Therapeutix, Inc. (Delaware)
- Defendant: Mati Therapeutics, Inc. (Delaware)
- Plaintiff’s Counsel: McCarter & English LLP
- Case Identification: 1:18-cv-01991, D. Del., 12/14/2018
- Venue Allegations: Venue is alleged to be proper because the Defendant, Mati Therapeutics, Inc., is incorporated in Delaware and thus resides in the district.
- Core Dispute: Plaintiff Ocular Therapeutix seeks a declaratory judgment that its DEXTENZA® product does not infringe U.S. Patent No. 7,922,702, owned by Defendant Mati Therapeutics.
- Technical Context: The technology involves drug-eluting intracanalicular inserts, which are small devices placed in the eye’s tear duct to provide localized, sustained release of medication for ophthalmic conditions.
- Key Procedural History: The complaint was filed following pre-suit correspondence in which Mati accused Ocular’s DEXTENZA product of infringement. Ocular’s non-infringement position relies significantly on arguments made during the patent’s prosecution, specifically an alleged disclaimer of “unitary, one-piece structures” to overcome a prior art rejection, which may give rise to prosecution history estoppel.
Case Timeline
| Date | Event |
|---|---|
| 2004-07-02 | ’702 Patent Priority Date |
| 2005-07-01 | ’702 Patent Application Filing Date |
| 2011-04-12 | ’702 Patent Issue Date |
| 2018-10-18 | Mati sends letter to Ocular alleging infringement of ’702 Patent |
| 2018-10-25 | Ocular sends letter to Mati denying infringement |
| 2018-11-30 | Ocular receives FDA approval to market DEXTENZA |
| 2018-12-04 | Mati sends letter reiterating infringement and willfulness claims |
| 2018-12-14 | Complaint for Declaratory Judgment of Non-Infringement Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,922,702 - “Treatment Medium Delivery Device and Methods for Delivery of Such Treatment Mediums to the Eye Using Such a Delivery Device,” issued April 12, 2011
The Invention Explained
- Problem Addressed: The patent describes drawbacks of conventional methods for delivering drugs to the eye, such as topical eye drops. These methods can be ineffective due to rapid drainage through the nasolacrimal duct, which reduces the drug’s contact time with the eye and can lead to unwanted systemic side effects (’702 Patent, col. 2:7-24). Existing topical inserts were also described as prone to causing eye irritation and inadvertent loss (’702 Patent, col. 2:32-36).
- The Patented Solution: The invention is a drug delivery device designed to be inserted and retained within the punctum (the opening of the tear duct). It is described as comprising a "first portion" for anchoring the device and a "second portion" that carries and controllably releases a treatment medium directly to the eye over a predetermined period (’702 Patent, Abstract; col. 3:3-13). Figure 2A, for example, illustrates an embodiment where the first portion is a tube (110) and the second portion is a cap (120) containing the therapeutic agent (’702 Patent, col. 7:39-47).
- Technical Importance: This design aims to provide a more effective pathway for controlled, direct drug delivery, increasing the local concentration and retention time of the medication while minimizing systemic absorption and the need for frequent patient administration (’702 Patent, col. 2:46-55).
Key Claims at a Glance
- The complaint identifies independent claims 1, 15, and 28 as being at issue (Compl. ¶19, ¶27).
- Independent Claim 15, which the complaint quotes as exemplary, recites the following essential elements (Compl. ¶18):
- A device comprising: a first portion configured for insertion into a punctum of a mammalian eye and retention by a single lacrimal canaliculus of the eye;
- a second portion retained on or in the first portion, the second portion including an at least partially encapsulating jacket or a coating; and
- a treatment medium carried by the second portion, wherein the second portion releases the treatment medium to the eye.
- The complaint notes that its non-infringement arguments apply to all claims of the ’702 Patent, including dependent claims (Compl. ¶24).
III. The Accused Instrumentality
- Product Identification: The accused product is the DEXTENZA® (dexamethasone ophthalmic insert) 0.4mg (Compl. ¶1).
- Functionality and Market Context:
- DEXTENZA is an FDA-approved, drug-eluting intracanalicular insert used for treating post-surgical ocular pain (Compl. ¶1, ¶11).
- From a technical standpoint, the complaint describes DEXTENZA not as a multi-part device, but as a "single structure consisting of a hydrogel insert with the anti-inflammatory medication dexamethasone dispersed throughout" (Compl. ¶24). The complaint provides a photograph of the DEXTENZA insert, depicting it as a small, yellow, cylindrical rod of uniform composition (Compl. ¶24). Ocular alleges that the entire insert is placed into the canaliculus (Compl. ¶27).
IV. Analysis of Infringement Allegations
The complaint seeks a declaratory judgment of non-infringement. The central non-infringement theory is that the accused DEXTENZA insert is a unitary, one-piece structure that lacks the claimed "second portion."
’702 Patent Infringement Allegations (as framed by Plaintiff’s non-infringement theory for Claim 15)
| Claim Element (from Independent Claim 15) | Alleged (Non)-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a first portion configured for insertion into a punctum of a mammalian eye and retention by a single lacrimal canaliculus of the eye | The DEXTENZA insert is a hydrogel structure inserted into the canaliculus (Compl. ¶24). Plaintiff alleges this unitary structure does not have a distinct "first portion" and "second portion" as contemplated by the patent (Compl. ¶25). | ¶24, ¶25, ¶27 | col. 15:15-19 |
| a second portion retained on or in the first portion, the second portion including an at least partially encapsulating jacket or a coating | Plaintiff alleges DEXTENZA is a "single structure" and therefore has no "second portion that is 'retained on or in'" the structure (Compl. ¶25). It is described as a hydrogel with medication "dispersed throughout, rather than in a separate structure or coating" (Compl. ¶24). | ¶24, ¶25 | col. 15:20-23 |
| a treatment medium carried by the second portion, wherein the second portion releases the treatment medium to the eye | Plaintiff alleges that since there is no "second portion," this limitation is not met. The treatment medium (dexamethasone) is contained within the "one and only structure—namely, the hydrogel insert" (Compl. ¶25, ¶26). | ¶25, ¶26 | col. 15:23-25 |
- Identified Points of Contention:
- Scope Questions: The primary dispute concerns the scope of the claim term "second portion." A key question is whether a unitary hydrogel with a dispersed drug can be considered to have a "first portion" (the structural body) and a "second portion" (the drug-carrying matrix, jacket, or coating), or if the claim requires two physically distinct and separate components. The complaint illustrates this by contrasting a photo of the unitary DEXTENZA insert (Compl. ¶24) with patent Figure 2A, which shows a device with a distinct cap (120) on a tube (110) (Compl. ¶20).
- Technical Questions: A factual question is whether the operational characteristics of the DEXTENZA hydrogel could be argued to meet the "jacket or a coating" limitation. For example, does the outer surface of the hydrogel from which the drug elutes function as a "coating" in a patentable sense, even if it is integral with the inner core?
- Legal Questions: The complaint raises a significant legal question of prosecution history estoppel by alleging the inventors disclaimed "single integral piece" devices during prosecution to distinguish the Freeman prior art (Compl. ¶23). The court will have to determine if this disclaimer limits the scope of the claims to exclude unitary structures like DEXTENZA.
V. Key Claim Terms for Construction
The Term: "a second portion retained on or in the first portion, the second portion including an at least partially encapsulating jacket or a coating" (from Claim 15)
- Context and Importance: The definition of this term is dispositive. Ocular’s entire non-infringement case, as pleaded, rests on the argument that its unitary DEXTENZA product does not have this required "second portion." Practitioners may focus on this term because its construction, particularly in light of the prosecution history, will likely resolve the question of infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (potentially favored by Defendant Mati): The patent states the second body portion (120) can be a "member, device... or coating that is applied, secured, attached or bonded" to the first portion (’702 Patent, col. 8:65-67). One could argue that a drug-infused hydrogel matrix that is formed onto a structural core constitutes a "coating" that is "bonded" to it, even if formed monolithically. The specification also states the second portion "can comprise a medium or material, for example a polymer, that is formed, cured or otherwise appropriately processed such that it is bonded to the first body portion" (’702 Patent, col. 9:12-16), which could be argued to describe the formation of the DEXTENZA insert.
- Evidence for a Narrower Interpretation (favored by Plaintiff Ocular): The complaint points to language from the prosecution history where the inventor allegedly distinguished the prior art Freeman patent because it was a "single integral piece," thereby disclaiming such structures (Compl. ¶23). Furthermore, all illustrated embodiments, such as the cap (120) on the tube (110) in Figure 2A, depict two structurally distinct components joined together, suggesting the "first portion" and "second portion" are separate parts (’702 Patent, Fig. 2A; Compl. ¶21). The claim language "retained on or in the first portion" may also suggest the assembly of two separate pieces rather than a single, integrated whole.
VI. Other Allegations
- Indirect Infringement: The complaint seeks a declaratory judgment that it has not induced or contributed to infringement by others, but does not plead specific facts related to this allegation (Compl. ¶30).
- Willful Infringement: The complaint states that Mati, in a letter dated December 4, 2018, alleged that any "post-approval conduct, namely any making, using, selling, offering to sell, or importing of Dextenza, willfully infringes Mati's patents" (Compl. ¶12). This allegation of pre-suit knowledge forms the basis for a potential willfulness claim by Mati, which Ocular's declaratory judgment action seeks to preempt.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of prosecution history estoppel: Did the patentee, by arguing that the Freeman prior art was a "single integral piece," unequivocally disclaim coverage for all unitary drug-delivery devices, thereby preventing the '702 patent claims from reading on the allegedly unitary DEXTENZA insert?
- A second central issue will be one of claim construction and technical characterization: Can the term "second portion ... including an at least partially encapsulating jacket or a coating" be construed to read on a single hydrogel structure where the drug is dispersed throughout? This raises the factual question of whether the drug-infused hydrogel of DEXTENZA can be technically and legally characterized as a device with a distinct "first portion" and "second portion."