API and IP Newsletter: 1.) DMF filings in March 2025 2.) Baxter Healthcare Corporation Vs Nevakar Injectables, Inc. – Norepinephrine composition
Contents
Recent DMF filings- March 2025
General information
- Gilead Sciences to pay $202 million in US settlement over HIV drug kickbacks
- Satsuma Pharmaceuticals Announces U.S. FDA Approval for Atzumi™ (Dihydroergotamine) Nasal Powder for the Acute Treatment of Migraine
Intellectual Property
Baxter Healthcare Corporation Vs Nevakar Injectables, Inc. – Norepinephrine composition
Recent DMF filings- March 2025
We track DMFs filed each month. The FDA publishes the list of DMF filings quarterly. The first quarter DMF filing list was released in the first week of April, and this week we are analysing DMFs filed in March 2025.
A total of 339 DMFs were filed in March 2025. The top DMF filers are listed below.
This number significantly exceeds the average monthly DMF filings. Some of our other observations are as follows.
General information
Gilead Sciences to pay $202 million in US settlement over HIV drug kickbacks
Gilead Sciences agreed to pay $202 million to settle a whistleblower lawsuit accusing the drugmaker of civil fraud for paying kickbacks to doctors who agreed to prescribe its HIV drugs.
The settlement announced on Tuesday by U.S. Attorney Jay Clayton in Manhattan resolved charges that Gilead violated the federal False Claims Act by defrauding Medicare, Medicaid and other programs into paying for drugs prescribed by doctors who spoke at and attended Gilead's promotional speaker programs.
News here
Satsuma Pharmaceuticals Announces U.S. FDA Approval for Atzumi™ (Dihydroergotamine) Nasal Powder for the Acute Treatment of Migraine
- Atzumi™ (dihydroergotamine(DHE)) nasal powder is the first and only DHE nasal powder for the acute treatment of migraine with or without aura in adults in an easy-to-use, easy-to-carry device.
- Atzumi is the first and only product utilizing the SMART (Simple MucoAdhesive Release Technology) platform which combines a proprietary advanced powder and device technology to simplify delivery of DHE.
- In clinical studies, Atzumi administration provided rapid and sustained DHE concentrations with low variability.
News here
Intellectual Property
Baxter Healthcare Corporation Vs Nevakar Injectables, Inc. – Norepinephrine composition
Overview
This write-up is related to Memorandum Opinion and Order from the United States District Court for the District of Delaware, concerning a patent infringement case between Baxter Healthcare Corporation and Nevakar Injectables, Inc.
The case involves patents related to ready-to-inject norepinephrine compositions.
The Orange Book lists two products. One is from Baxter: a premixed norepinephrine bitartrate in 5% dextrose injection.
Baxter claims this is the first and only FDA-approved, ready-to-use Premix Norepinephrine in Dextrose. Its consistent concentration helps minimise the risk of medication errors due to compounding. It also reduces the wait time for drug administration compared to compounding. Additionally, it can be stored at room temperature, making it available near the point of care.
This Baxter product was approved in January 2021.
Baxter listed one patent in the Orange Book.
The second product is from Long Grove Pharmaceuticals.
Long Grove Pharmaceuticals had in-licensed Norepinephrine in 0.9% Sodium Chloride premix formulation from Nevakar Injectables, Inc.
This manufactured, ready-to-use formulation is room-temperature stable and will be available in three commonly administered strengths: 4mg/250mL (16mcg/mL), 8mg/250mL (32mcg/mL), and 16mg/250mL (64mcg/mL)
Nevakar Or Long Grove’s product was approved in October 2022, and several patents are listed in the Orange Book.
In the US, in patent cases, a party may seek summary judgment to resolve issues such as patent validity, infringement, or enforceability before trial. If granted, it significantly simplifies the case by eliminating certain claims or defenses, potentially saving time and resources for both the court and the parties involved. However, the party seeking summary judgment must provide sufficient evidence to demonstrate that there is no credible basis for the opposing party's claims.
In this case, the court's decision granted the motion in part and denied it in part, specifically regarding literal direct infringement, direct infringement under the Doctrine of Equivalents (DOE), and indirect infringement.
The lawsuit concerns whether Baxter's Norepinephrine Bitartrate in 5% Dextrose Injection products infringe on Nevakar's patents related to ready-to-inject norepinephrine compositions.
Patents-in-Suit: The motion concerns United States Patent Nos. 10,420,735 (the ""735 patent"), 10,471,026 (the "026 patent”), 10,568,850 (the '850 patent”), 10,646,458 (the “'458 patent”) and 11,602,508 (the '508 patent,” and collectively, the “patents-in-suit").
Some of these patents are OB listed patents.
Procedural History:
- The respective actions commenced on August 18, 2021.
- A Markman hearing (claim construction hearing) was held on November 15, 2022.
- The Court issued its Claim Construction Memorandum Order on June 26, 2023.
- Baxter filed a motion for summary judgment of non-infringement, which was fully briefed as of January 16, 2024.
- Oral arguments on the motion were heard on February 7, 2024.
Key Issues and Court's Analysis
1. Literal Direct Infringement:
- Definition: Literal infringement requires that every limitation recited in the patent claim is found in the accused product.
- "Chelating Agent" Construction: The Court had previously construed "chelating agent" to mean "a separate chemical compound, added to the composition."
- Nevakar's Argument: Nevakar argued that the chelating agent in Baxter's products is the norepinephrine itself, specifically the bitartrate anions that dissociate in solution.
- Court's Ruling: The Court found that Nevakar's theory was foreclosed by the claim construction of "chelating agent." The Court granted summary judgment of non-infringement on Nevakar's claims of literal direct infringement because Baxter's products do not contain a separate, added chelating agent.
2. Direct Infringement under the Doctrine of Equivalents (DOE):
- Definition: DOE allows a finding of infringement even if the accused product does not literally infringe the patent claims, provided that the differences between the claimed invention and the accused product are insubstantial.
- Legal Standards for DOE: The Court outlined the standards for DOE, including the function-way-result (FWR) test and the "insubstantial differences" test. The Court also addressed the limitations on DOE, specifically the "all-elements" rule and the "specific exclusion" rule.
- Baxter's Arguments:
- All-Elements Rule: Baxter argued that Nevakar's DOE argument would vitiate the "chelating agent" claim limitation.
- Specific Exclusion Rule: Baxter contended that the patent specification disclaims coverage of a chelating agent that is not separately added.
- Nevakar's Response: Nevakar presented expert testimony (Dr. Anderson) arguing that the dissociated bitartrate anions in Baxter's products are equivalent to a separately-added chelating agent, performing substantially the same function in substantially the same way.
- Court's Analysis and Ruling:
- The Court found that Baxter's vitiation argument did not warrant summary judgment. In jurisprudence, a "vitiation argument" generally refers to the argument that a legal action, contract, or decision is invalid due to a defect or flaw that renders it unenforceable.
- The Court cited Federal Circuit precedent (e.g., Cadence Pharms. Inc. SCR v. Exela Pharmsci Inc.) stating that a vitiation argument does not end the DOE inquiry; the court must still assess the substantiality of the differences.
- The Court also found that the specification excerpt cited by Baxter was not a clear and unmistakable disclaimer of coverage.
- The Court concluded that there was a genuine dispute of material fact as to whether the bitartrate anions in Baxter's products are equivalent to the claimed chelating agent. Therefore, the Court denied summary judgment on Nevakar's DOE-related direct infringement claims.
3. Indirect Infringement:
- Definition: Indirect infringement occurs when a party induces or contributes to the direct infringement of a patent.
- Court's Ruling: The Court stated that the indirect infringement claims rise and fall with the direct infringement claims. Since summary judgment was not warranted on Nevakar's claim for direct infringement under the DOE, Nevakar's indirect infringement claims can stand to the extent they are premised on DOE-related direct infringement allegations.
Conclusion and Order
- The Court ordered that Baxter's Motion for Summary Judgment be GRANTED IN PART and DENIED IN PART.
- Specifically, the Motion was:
- Granted as to Nevakar's literal direct infringement claims.
- Denied as to Nevakar's DOE direct infringement claims.
- Granted-in-part and denied-in-part as to Nevakar's indirect infringement claims (granted only to the extent those claims are premised on literal direct infringement allegations, and otherwise denied).
- Key Points
- The case hinges on interpreting the term "chelating agent" and whether the bitartrate anions in Baxter's product can be considered equivalent to a separately-added chelating agent under the DOE.
- The Court's decision reflects a careful application of Federal Circuit precedent regarding claim construction, the Doctrine of Equivalents, and summary judgment standards.
- The denial of summary judgment on the DOE claims means that this aspect of the case will proceed to trial, where a fact-finder will determine whether Baxter's products infringe Nevakar's patents under the Doctrine of Equivalents.
