American Regent Inc v. Cipla USA Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: American Regent, Inc. (New York)
  • Defendant: Cipla USA, Inc. (Delaware) and Cipla Limited (India)
  • Plaintiff’s Counsel: GIBBONS P.C.; Sterne, Kessler, Goldstein & Fox P.L.L.C.
• Case Identification: 2:24-cv-11112, D.N.J., 12/13/2024
• Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Cipla USA, Inc. is organized under the laws of New Jersey, maintains its principal place of business there, and has thus committed acts of infringement in the district.
• Core Dispute: Plaintiff alleges that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to market generic versions of Plaintiff's Selenious Acid injection products constitutes an act of patent infringement.
• Technical Context: The technology relates to stable, injectable trace element compositions, specifically those containing selenium, which are used as supplements in parenteral nutrition for patients who cannot receive nutrition orally.
• Key Procedural History: The complaint notes that this case involves the same ANDA as a related action, American Regent Inc v. Cipla USA Inc et al., C.A. No. 24-7796 (D.N.J.), which asserts a different patent. Plaintiff also alleges providing pre-suit notice to Defendants of the patent-in-suit’s impending issuance.

Case Timeline

II. Technology and Patent(s)-in-Suit Analysis

• Patent Identification: U.S. Patent No. 12,150,957, "Trace element compositions, methods of making and use," issued November 26, 2024.

The Invention Explained

• Problem Addressed: The patent describes a problem in parenteral nutrition (PN) where admixing trace elements into a PN solution results in a short period of stability, often just 24 to 48 hours. This necessitates frequent, costly, and time-consuming preparation of PN bags, burdens patients and caregivers, and can lead to waste and drug shortages if admixed solutions are not used promptly (’957 Patent, col. 1:46 - col. 2:39).
• The Patented Solution: The invention is a stable injectable composition containing specific concentrations of trace elements like selenium, zinc, copper, and manganese. This composition, when added to parenteral nutrition, allows the final mixture to remain stable for a longer period, reducing the frequency of admixing and enabling preparation in larger, more efficient batches (’957 Patent, Abstract; col. 2:46-59). The patent also discloses compositions with specific, low levels of certain impurities.
• Technical Importance: This technology aims to improve the quality of life for patients on long-term parenteral nutrition and reduce healthcare costs by creating more stable, longer-lasting nutritional formulations (’957 Patent, col. 2:31-39).

Key Claims at a Glance

• The complaint alleges infringement of "one or more claims" without specifying them (Compl. ¶38). Independent claim 19 is a representative method of use claim.
• Independent Claim 19 includes the following essential elements:
  • A method of providing a composition to a patient in need thereof, comprising administering the composition to the patient.
  • The composition comprises water.
  • The composition comprises selenium at a concentration of 6 µg, 40 µg, or 60 µg per 1 mL.
  • The composition has no chromium, or chromium in an amount not to exceed 1 µg per 1 mL.
  • The composition has no aluminum, or aluminum in an amount not to exceed 6 µg per 1 mL.
  • The composition has no iron, or iron in an amount not to exceed 10 µg per 1 mL.
  • The composition comprises iodine in an amount of 0.0001 µg to 0.2 µg per 1 mL.

III. The Accused Instrumentality

Product Identification

• The accused instrumentalities are Cipla’s proposed generic Selenious Acid products ("the ANDA Products") described in ANDA No. 218661 (Compl. ¶1).

Functionality and Market Context

• The complaint alleges that the ANDA Products are generic versions of American Regent's Selenious Acid injection products, intended for use as a supplement to intravenous solutions for parenteral nutrition (Compl. ¶¶1, 32).
• The accused products are identified as "selenious acid injection USP" and are formulated at two concentrations: equivalent to 12 mcg selenium/2 mL (6 mcg selenium/mL) and equivalent to 600 mcg selenium/10 mL (60 mcg selenium/mL) (Compl. ¶33).
• The complaint alleges 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 American Regent's branded products (Compl. ¶¶32, 34-35).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint. The complaint alleges that Cipla’s filing of its ANDA constitutes infringement under 35 U.S.C. § 271(e)(2)(A) and that commercialization of the ANDA Products post-approval will constitute direct and indirect infringement (Compl. ¶¶37-39). The infringement theory for the impurity limitations appears to be based on the allegation that the generic is equivalent to the branded product (Compl. ¶35).

’957 Patent Infringement Allegations

• Identified Points of Contention:
  • Evidentiary Questions: The complaint does not provide specific factual allegations regarding the impurity levels (chromium, aluminum, iron) or the iodine content of Cipla's ANDA Products. A central question will be what evidence supports the allegation that the accused products meet these specific, quantitative claim limitations.
  • Scope Questions: The interpretation of the "no [impurity]" limitations will be critical. The dispute may center on whether this requires an absolute absence of the element or an amount below a certain detection threshold.

V. Key Claim Terms for Construction

• The Term: "no chromium," "no aluminum," "no iron"
• Context and Importance: These negative limitations are central to defining the scope of the invention. Whether Cipla's product infringes will depend heavily on how these terms are construed, as achieving an absolute zero concentration of any element is technically impossible. Practitioners may focus on these terms because the infringement case for these elements rests on an "information and belief" pleading based on bioequivalence, which may be challenged.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation (i.e., allowing for trace amounts): The claims themselves provide an alternative to "no," stating "or [impurity] in an amount not to exceed [X] µg" (’957 Patent, col. 74:5-8). This suggests that "no" is not absolute and could be interpreted as a level below the specified upper limit or a de minimis amount. The specification also states it is "desirable to have no or little chromium" (’957 Patent, col. 13:60-61), reinforcing that a small or trace amount may be permissible within the claim scope.
  • Evidence for a Narrower Interpretation (i.e., closer to absolute zero): A party could argue that "no" should be given its plain and ordinary meaning of "zero" or "none," and that the alternative numerical limit is a distinct option, not a definition of "no." The patent emphasizes the importance of limiting impurities, stating the compositions "contain little or no impurities" (’957 Patent, col. 13:46).

VI. Other Allegations

• Indirect Infringement: The complaint alleges that Cipla will induce infringement because its proposed package insert will instruct and encourage medical practitioners and patients to administer the ANDA Product in a manner that infringes the ’957 patent’s method claims (Compl. ¶38). It further alleges contributory infringement, stating the product is especially made for infringing use and not suitable for substantial non-infringing use (Compl. ¶39).
• Willful Infringement: The complaint alleges Cipla had knowledge of the ’957 patent since at least October 11, 2024, when American Regent's counsel sent an email notifying Cipla of the patent's impending issuance, more than two months before the complaint was filed (Compl. ¶41).

VII. Analyst’s Conclusion: Key Questions for the Case

• A core issue will be one of claim construction and proof: How will the court interpret the "no [impurity]" limitations in Claim 19, and what factual evidence will American Regent present to demonstrate that Cipla's proposed generic product meets these negative limitations as well as the positive limitation for iodine content?
• A key question of infringement under § 271(e)(2) will be whether Cipla's proposed product label, once revealed, will instruct users to perform all steps of the asserted method claims, thereby supporting the allegations of induced infringement.