DCT
2:24-cv-07805
American Regent Inc v. RK Pharma Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: American Regent, Inc. (New York)
- Defendant: RK Pharma, Inc. (Delaware)
- Plaintiff’s Counsel: Gibbons P.C.; Sterne, Kessler, Goldstein & Fox P.L.L.C.
- Case Identification: 2:24-cv-07805, D.N.J., 07/16/2024
- Venue Allegations: Venue is alleged to be proper based on Defendant having a regular and established place of business in New Jersey and having committed acts of infringement there, including the submission of the subject Abbreviated New Drug Application (ANDA) from an affiliate's New Jersey location. The complaint also states Defendant consented to personal jurisdiction and venue in the district.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an ANDA to seek FDA approval for generic versions of Plaintiff's Selenious Acid injectable products constitutes an act of patent infringement.
- Technical Context: The technology relates to stable, injectable trace element compositions, specifically containing selenious acid, which are used as supplements in parenteral nutrition for patients who cannot receive nutrients orally.
- Key Procedural History: The lawsuit was initiated under the Hatch-Waxman Act following Plaintiff's receipt of a Paragraph IV Certification notice from Defendant. The notice asserted that Defendant's proposed generic products would not infringe the patent-in-suit or that the patent is invalid. The patent-in-suit is listed in the FDA's "Orange Book" for Plaintiff's Selenious Acid products. The complaint notes related, consolidated litigation in the same district where Plaintiff has also asserted the patent-in-suit against Defendant.
Case Timeline
| Date | Event |
|---|---|
| 2019-04-30 | FDA approves Plaintiff's New Drug Application for Selenious Acid |
| 2020-07-02 | Earliest Priority Date for '565 Patent |
| 2024-06-04 | U.S. Patent No. 11,998,565 Issues |
| 2024-06-10 | Defendant sends Paragraph IV Notice Letter to Plaintiff |
| 2024-07-09 | Defendant consents to jurisdiction and venue in D.N.J. |
| 2024-07-16 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
- Patent Identification: U.S. Patent No. 11,998,565, “Trace element compositions, methods of making and use,” issued June 4, 2024. (Compl. ¶17).
The Invention Explained
- Problem Addressed: The patent describes that when trace elements are added to parenteral nutrition (PN) solutions, the resulting admixture often has a short stability period of only 24 to 48 hours. This short shelf-life can lead to product waste, increased costs, and logistical challenges for patients and healthcare providers who must frequently prepare fresh admixtures. ('565 Patent, col. 1:56 - col. 2:30).
- The Patented Solution: The invention is a stable, injectable trace element composition that, when added to PN, allows the admixture to remain stable for a longer period. This extended stability reduces waste and the frequency of admixing. The patent discloses specific formulations, including compositions containing selenium with very low or non-existent levels of potential contaminants like chromium, aluminum, and iron, designed to be safe for parenteral administration. ('565 Patent, Abstract; col. 2:46-54).
- Technical Importance: By creating a more stable formulation, the invention aims to improve the quality of life for patients requiring long-term parenteral nutrition and reduce costs and logistical burdens for healthcare systems. ('565 Patent, col. 2:35-39).
Key Claims at a Glance
- The complaint asserts infringement of one or more unspecified claims of the '565 patent. (Compl. ¶29). Independent claim 1 is representative of the core composition claims.
- Independent Claim 1 recites:
- 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. ('565 Patent, col. 71:36-42).
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are Defendant RK Pharma, Inc.’s proposed generic Selenious Acid products, which are the subject of Abbreviated New Drug Application (ANDA) No. 218536. (Compl. ¶1).
Functionality and Market Context
- The ANDA Products are alleged to be generic versions of Plaintiff American Regent's commercial Selenious Acid products and are intended to be administered intravenously as a supplement for parenteral nutrition. (Compl. ¶23).
- The complaint, citing a Notice Letter from the Defendant, identifies three proposed concentrations for the ANDA Products: Selenious Acid equivalent to 6 mcg Selenium/mL, 60 mcg Selenium/mL, and another formulation also at 60 mcg Selenium/mL. (Compl. ¶24).
- It is alleged that the ANDA Products contain the "same or equivalent ingredients in the same or equivalent amounts" and will feature the "same or equivalent chemical and therapeutic properties" as the Plaintiff's reference listed drugs. (Compl. ¶25-26).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not contain a claim chart. The infringement theory is based on 35 U.S.C. § 271(e)(2), where the submission of an ANDA is itself an act of infringement if the product described therein would infringe the patent upon commercialization. The analysis below is constructed from the complaint's allegations of equivalence between the ANDA Products and the patent claims.
'565 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An injectable composition comprising water, | The ANDA Products are alleged to be injectable solutions containing the same or equivalent ingredients as Plaintiff's approved Selenious Acid products. | ¶23, ¶25 | col. 71:36 |
| 6 µg or 60 µg of selenium, | Defendant's Notice Letter allegedly disclosed that its ANDA Products include formulations with concentrations of 6 mcg/mL and 60 mcg/mL of selenium. | ¶24 | col. 71:37 |
| no chromium or chromium in an amount not to exceed 1 µg, | The ANDA Products are alleged to have the same or equivalent chemical properties as Plaintiff's products, which are asserted to be covered by the patent's limitations, including the near-zero chromium level. | ¶26, ¶28 | col. 71:38-39 |
| no aluminum or aluminum in an amount not to exceed 6 µg, | The ANDA Products are alleged to have the same or equivalent chemical properties as Plaintiff's products, which are asserted to be covered by the patent's limitations, including the near-zero aluminum level. | ¶26, ¶28 | col. 71:39-40 |
| no iron or iron in an amount up to 10 µg, and | The ANDA Products are alleged to have the same or equivalent chemical properties as Plaintiff's products, which are asserted to be covered by the patent's limitations, including the low iron level. | ¶26, ¶28 | col. 71:40-41 |
| fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL of the injectable composition. | The complaint does not provide sufficient detail for analysis of this specific element. | col. 71:41-42 |
- Identified Points of Contention:
- Factual Questions: The central factual dispute will concern the exact formulation specified in RK Pharma's confidential ANDA filing. The complaint's allegations of equivalence (Compl. ¶25-26) are a proxy for the direct evidence that will be produced during discovery. The question is whether the ANDA specification describes a product that meets every limitation of the asserted claims.
- Scope Questions: The case may turn on the interpretation of the negative limitations, such as "no chromium." A question for the court will be whether this term means absolutely zero, which may be technically unachievable, or "below a certain level of detection." The resolution of this question will determine the scope of the claim and whether the accused product infringes.
V. Key Claim Terms for Construction
- The Term: "no chromium or chromium in an amount not to exceed 1 µg"
- Context and Importance: This limitation appears central to the patent's novelty, as it distinguishes the invention from prior art and addresses safety concerns related to contaminants. Infringement will depend entirely on whether the accused ANDA product falls within this stringent purity requirement. Practitioners may focus on this term because its construction will likely be dispositive of infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party arguing for broader scope (e.g., that "no chromium" covers any commercially pure formulation) may point to specification language stating that "the injectable composition of this disclosure does not contain any detectable chromium or no chromium at all." ('565 Patent, col. 16:60-61). This suggests an intent to claim compositions that are effectively chromium-free for practical purposes.
- Evidence for a Narrower Interpretation: A party seeking a narrower scope may argue that the term "no chromium" is indefinite or not enabled, as trace amounts of contaminants are always present. They might argue that the alternative phrase "not to exceed 1 µg" defines the only enforceable boundary of the claim. The specification’s characterization of chromium as a "potential manufacturing process contaminant" could be used to argue that some amount is always anticipated. ('565 Patent, col. 16:59-60).
VI. Other Allegations
- Indirect Infringement: The complaint alleges that upon FDA approval, RK Pharma will induce infringement by providing a product with a package insert that instructs medical professionals on how to administer the product in an infringing manner. (Compl. ¶29). It further alleges contributory infringement, stating the ANDA Products are "especially made or adapted for use in infringing" and are "not suitable for substantial non-infringing use." (Compl. ¶30).
- Willful Infringement: The complaint does not contain a formal count for willful infringement. However, it alleges that RK Pharma has had "knowledge of the '565 patent" since at least the date it submitted its ANDA. (Compl. ¶32). It also requests a finding that the case is "exceptional" under 35 U.S.C. § 285, which is the basis for an award of attorneys' fees and can be related to a finding of litigation misconduct or willful infringement. (Compl. ¶33).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of evidentiary proof: What are the exact specifications of the accused product as detailed in RK Pharma’s confidential ANDA submission? The case will depend on whether discovery reveals a formulation that meets every positive and negative limitation of the asserted claims.
- A key legal and technical question will be one of claim construction and measurement: How will the court interpret the limitation "no chromium," and what level of the element, if any, constitutes infringement? The case will likely involve disputes over the limits of detection for analytical testing equipment and whether any amount found in the accused product is sufficient to avoid infringement.
- A central defense will likely be one of invalidity: Are the claimed compositions, particularly the negative limitations requiring near-zero levels of contaminants like chromium, non-obvious over the prior art? RK Pharma may argue that achieving such purity levels was a known goal and obvious to try for one of ordinary skill in the art of pharmaceutical formulation.