2:24-cv-08956
American Regent Inc v. Eugia Pharma Specialities Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: American Regent, Inc. (New York)
- Defendant: Eugia Pharma Specialities Ltd. (India); Eugia US LLC ( Delaware)
- Plaintiff’s Counsel: GIBBONS P.C.; Sterne, Kessler, Goldstein & Fox P.L.L.C.
- Case Identification: 2:24-cv-08956, D.N.J., 09/05/2024
- Venue Allegations: Venue is alleged to be proper based on Defendant Eugia US LLC having a regular and established place of business in New Jersey, and on Defendant Eugia Pharma Specialities Ltd. being a foreign corporation that may be sued in any judicial district.
- Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff's Selenious Acid injection product constitutes an act of patent infringement.
- Technical Context: The technology concerns stable injectable trace element compositions, specifically selenious acid, which are used as supplements for patients receiving intravenous parenteral nutrition.
- Key Procedural History: This is a Hatch-Waxman action initiated in response to a notice letter, dated August 5, 2024, in which Defendants informed Plaintiff of their ANDA filing containing a Paragraph IV Certification against the patent-in-suit. The patent-in-suit is listed in the FDA's "Orange Book" as covering Plaintiff's approved Selenious Acid drug products.
Case Timeline
| Date | Event |
|---|---|
| 2019-04-30 | Plaintiff's New Drug Application (NDA) No. 209379 for Selenious Acid approved by FDA |
| 2020-07-02 | ’565 Patent Priority Date |
| 2024-06-04 | ’565 Patent Issue Date |
| 2024-08-05 | Defendants' Paragraph IV Notice Letter sent to Plaintiff |
| 2024-09-05 | Complaint Filing Date |
| 2041-07-01 | ’565 Patent Expiration Date (as listed in Orange Book) |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,998,565 - "Trace element compositions, methods of making and use"
(Compl. ¶25).
The Invention Explained
- Problem Addressed: The patent's background section describes that when trace elements are added to parenteral nutrition (PN) solutions, the resulting admixture often has a short stability period of 24 to 48 hours. This necessitates frequent, costly, and time-consuming preparation of PN bags, increases waste, and makes it difficult to customize doses for individual patient needs. (’565 Patent, col. 1:10-56).
- The Patented Solution: The invention provides stable, injectable trace element compositions that, when added to PN solutions, allow the admixture to remain stable for a longer period of time, such as up to 14 days under refrigeration. The patent describes specific formulations of elements like zinc, copper, and selenium designed to achieve this extended stability, thereby reducing waste and logistical burdens for caregivers and healthcare facilities. (’565 Patent, Abstract; col. 2:31-44).
- Technical Importance: By enabling the pre-mixing of parenteral nutrition solutions in larger, more stable batches, the invention aims to improve the safety, efficiency, and cost-effectiveness of intravenous feeding for patients who cannot ingest food orally. (’565 Patent, col. 2:31-50).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" of the ’565 patent without specifying which claims. Independent claim 1 is representative. (Compl. ¶37).
- The essential elements of independent claim 1 include:
- An injectable composition comprising water
- 6 µg or 60 µg of selenium
- no chromium or chromium in an amount not to exceed 1 µg
- no aluminum or aluminum in an amount not to exceed 6 µg
- no iron or iron in an amount up to 10 µg
- and fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL of the injectable composition
- The complaint reserves the right to assert infringement of other claims of the ’565 patent, which may include dependent claims. (’565 Patent, col. 72:35-42).
III. The Accused Instrumentality
Product Identification
The accused instrumentality is Defendants' proposed generic drug product, identified as "selenious acid injection USP, 600 mcg base/10 mL (60 mcg selenium/mL) of selenium," for which Abbreviated New Drug Application (ANDA) No. 219756 was submitted to the FDA. (Compl. ¶¶1, 32).
Functionality and Market Context
The ANDA Product is a generic version of Plaintiff's Selenious Acid product and is intended to be used as a supplement for parenteral nutrition. (Compl. ¶31). The complaint alleges that the ANDA Product contains the "same or equivalent ingredients in the same or equivalent amounts" as Plaintiff's reference listed drug and will feature the "same or equivalent chemical and therapeutic properties." (Compl. ¶¶33-34).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
Claim Chart Summary
The complaint does not provide a claim chart. The infringement theory is based on the allegation that the product described in Defendants' ANDA, if commercially manufactured, would meet all limitations of at least one claim of the patent-in-suit. The following table summarizes the allegations for representative Claim 1 based on the information provided in the complaint.
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An injectable composition comprising water... | The ANDA Product is an injectable solution. | ¶32 | col. 72:35 |
| 6 µg or 60 µg of selenium... per 1 mL of the injectable composition | The ANDA Product is disclosed as "selenious acid injection USP, 600 mcg base/10 mL (60 mcg selenium/mL) of selenium," which corresponds to the 60 µg/mL limitation. | ¶32 | col. 72:36 |
| no chromium or chromium in an amount not to exceed 1 µg | The complaint alleges the ANDA Product contains the "same or equivalent ingredients" as Plaintiff’s patented product, which is alleged to meet this limitation. | ¶33 | col. 72:37-38 |
| no aluminum or aluminum in an amount not to exceed 6 µg | The complaint alleges the ANDA Product contains the "same or equivalent ingredients" as Plaintiff’s patented product, which is alleged to meet this limitation. | ¶33 | col. 72:38-39 |
| no iron or iron in an amount up to 10 µg | The complaint alleges the ANDA Product contains the "same or equivalent ingredients" as Plaintiff’s patented product, which is alleged to meet this limitation. | ¶33 | col. 72:39-40 |
| and fluoride in an amount of 0.0001 µg to 2.7 µg | The complaint alleges the ANDA Product contains the "same or equivalent ingredients" as Plaintiff’s patented product, which is alleged to meet this limitation. | ¶33 | col. 72:40-41 |
Identified Points of Contention
- Scope Questions: A potential dispute may arise over the scope of the negative limitations (e.g., "no chromium or chromium in an amount not to exceed 1 µg"). The primary question will be whether the product as specified in the ANDA will, upon manufacture, contain these elements as impurities in amounts that exceed the claimed upper limits.
- Technical Questions: Since the complaint does not include the ANDA itself, a key factual question for the court will be what the ANDA specification reveals about the presence and quantity of chromium, aluminum, iron, and fluoride in the final drug product. The infringement case for these elements currently rests on the assertion that the ANDA product is the "same or equivalent" as the patented product. (Compl. ¶33).
V. Key Claim Terms for Construction
The Term
"no chromium or chromium in an amount not to exceed 1 µg"
Context and Importance
This term is a negative limitation, meaning infringement occurs if the accused product does not contain more than the specified amount of chromium. Its construction is critical because the presence of trace impurities is common in pharmaceutical manufacturing. Practitioners may focus on this term because the dispute will likely center on whether the level of chromium specified or inherently present in the ANDA product falls outside this claimed range.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: A party may argue that the plain language "not to exceed 1 µg" sets a clear and unambiguous upper boundary. The specification supports this by listing, for an embodiment, "Chromium (Cr): Not more than 1.0 µg/mL" as a drug product release specification. (’565 Patent, Table 2, col. 14:1-12).
- Evidence for a Narrower Interpretation: A party could point to specification language stating that in some cases, the composition "does not contain any detectable chromium or no chromium at all" to argue that the "no chromium" clause should be given independent meaning, potentially tied to the limits of detection technology. (’565 Patent, col. 14:59-61). This could raise questions about how to interpret the disjunctive "or" connecting "no chromium" with the explicit numerical limit.
VI. Other Allegations
Indirect Infringement
The complaint alleges induced infringement, asserting that Defendants' proposed package insert will instruct medical professionals to administer the ANDA Product in a manner that directly infringes the ’565 patent. This is alleged to be done with knowledge and specific intent. (Compl. ¶37). The complaint also pleads contributory infringement, alleging the ANDA product is especially made for an infringing use and lacks substantial non-infringing uses. (Compl. ¶38).
Willful Infringement
The complaint alleges that Defendants have had knowledge of the ’565 patent since at least the date they submitted the ANDA and were aware that the submission constituted an act of infringement. (Compl. ¶40). It further alleges that the case is "exceptional," which is the basis for seeking an award of attorneys' fees under 35 U.S.C. § 285. (Compl. ¶41).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of compositional fact: what are the exact specifications for impurities, particularly chromium, aluminum, and iron, in the final drug product as defined by Defendants' ANDA? The outcome of the infringement analysis will depend heavily on the contents of that confidential regulatory filing.
- A key legal and evidentiary question will be one of proof under the Hatch-Waxman Act: given that the ANDA Product's disclosed selenium concentration appears to meet a central limitation of Claim 1, can the Plaintiff demonstrate that the hypothetical product, as described in the ANDA, will necessarily meet all of the claim's other limitations, especially the negative limitations on maximum impurity levels?