DCT
1:17-cv-00660
Mallinckrodt IP v. B Braun Medical Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Mallinckrodt IP (Ireland) and Mallinckrodt Hospital Products Inc. (Delaware)
- Defendant: B. Braun Medical Inc. (Pennsylvania)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
- Case Identification: 1:17-cv-00660, D. Del., 05/31/2017
- Venue Allegations: Plaintiff alleges venue is proper because the case arises under the Hatch-Waxman Act, where infringement is tied to the submission of a New Drug Application (NDA) seeking nationwide approval, which constitutes an act of infringement in Delaware. Plaintiff further alleges that Defendant has a regular and established place of business in Delaware.
- Core Dispute: Plaintiff alleges that Defendant's submission of a New Drug Application to the FDA for a generic intravenous acetaminophen product constitutes an act of infringement of two patents covering specific methods of administering reduced doses of the drug.
- Technical Context: The lawsuit concerns intravenous acetaminophen, a non-opioid analgesic used for managing pain and fever, particularly in postoperative clinical settings.
- Key Procedural History: This action was filed under the Hatch-Waxman Act following Defendant's submission of NDA No. 204957 seeking to market a generic version of Plaintiff's OFIRMEV® product. The complaint notes that the '012' patent was previously and is currently the subject of other litigation. Defendant provided a Paragraph IV certification for the '012 patent, alleging it is invalid, unenforceable, or will not be infringed.
Case Timeline
| Date | Event |
|---|---|
| 2007-11-13 | Priority Date for '012 and '265' Patents |
| 2010-11-02 | FDA Approval for OFIRMEV® (Plaintiff's branded product) |
| 2016-07-26 | U.S. Patent No. 9,399,012 ('012 Patent) Issued |
| 2017-02-23 | Plaintiff receives first letter from Defendant regarding NDA |
| 2017-04-04 | U.S. Patent No. 9,610,265 ('265 Patent) Issued |
| 2017-04-21 | Plaintiff receives second letter from Defendant with Paragraph IV notice for '012 Patent |
| 2017-05-04 | '265 Patent listed in FDA Orange Book (approximate date) |
| 2017-05-31 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,399,012 - "Reduced Dose Intravenous Acetaminophen"
The Invention Explained
- Problem Addressed: The patent's background describes the side effects of conventional postoperative pain treatments like opioids (e.g., respiratory depression) and NSAIDs (e.g., bleeding risk) ('012 Patent, col. 3:17-34). It further notes that the standard 1000 mg intravenous (IV) dose of acetaminophen is limited to administration every six hours to avoid toxicity, which can create a gap in pain relief as the drug's effect wanes before the next dose can be given ('012 Patent, col. 4:10-24).
- The Patented Solution: The invention proposes a method of administering a reduced IV dose of acetaminophen, specifically between 550 mg and 800 mg, at more frequent intervals of three to five hours. This dosing regimen is designed to provide more consistent pain and fever relief by avoiding the "trough" in efficacy associated with the standard 6-hour interval, without exceeding the maximum recommended daily dose ('012 Patent, Abstract; col. 4:35-47).
- Technical Importance: This method offered clinicians greater flexibility to customize pain management, potentially providing more stable analgesia and reducing reliance on opioids ('012 Patent, col. 4:38-42).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claim 39 (Compl. ¶¶ 19-20).
- Independent Claim 1 requires:
- A method for treating pain or fever in a human subject weighing at least 50 kg.
- Administering intravenously a pharmaceutical composition with about 550 mg to 800 mg of acetaminophen.
- Repeating the administration at least once at an interval of about 3 to 5 hours.
U.S. Patent No. 9,610,265 - "Reduced Dose Intravenous Acetaminophen"
The Invention Explained
- Problem Addressed: Similar to its parent patent, the '265 Patent addresses the need for effective postoperative pain management while mitigating the side effects associated with opioids and NSAIDs ('265 Patent, col. 3:15-41).
- The Patented Solution: The invention describes a method for multimodal pain management that involves co-administering a reduced IV dose of acetaminophen (about 500 mg to 750 mg) with an opioid analgesic. This combination therapy aims to achieve synergistic pain relief, which may allow for lower doses of opioids and thereby reduce their associated risks ('265 Patent, Abstract; col. 8:54-67). The patent specifies that co-administration can be simultaneous or sequential ('265 Patent, col. 5:35-46).
- Technical Importance: This approach aligns with the clinical strategy of multimodal analgesia, which combines different types of pain relievers to improve efficacy and minimize the side effects of any single agent ('265 Patent, col. 8:31-38).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claim 7 (Compl. ¶¶ 22-23).
- Independent Claim 1 requires:
- A method of treating pain in a human subject weighing at least 50 kg.
- Co-administering a first composition with about 500 mg to 750 mg of acetaminophen and a second composition with an opioid analgesic.
- The first composition (acetaminophen) is administered intravenously.
III. The Accused Instrumentality
Product Identification
The accused instrumentality is Defendant's proposed generic "Acetaminophen for Injection, 10 mg/ml," for which it submitted New Drug Application (NDA) No. 204957 to the FDA (Compl. ¶11).
Functionality and Market Context
The complaint alleges that Defendant's product is a generic version of Plaintiff's OFIRMEV® and that, upon approval, its labeling will be substantially identical to the OFIRMEV® label (Compl. ¶¶ 11, 31, 46). The infringement analysis is based on the instructions that will foreseeably be included in this label (Compl. ¶40). The complaint alleges the proposed label will instruct use for pain and fever, including administration of a 650 mg dose every 4 hours for adults and adolescents weighing over 50 kg (Compl. ¶¶ 32-34). The complaint also highlights that the OFIRMEV® label, which Defendant's label is expected to mirror, contains a table with recommended dosing information. Table 1 of the OFIRMEV® labeling provides recommended dosing information, including a 650 mg dose for adults and adolescents weighing 50 kg and over (Compl. ¶34, ¶50). It is also alleged that the label will indicate the product for managing moderate to severe pain with "adjunctive opioid analgesics" (Compl. ¶48).
IV. Analysis of Infringement Allegations
'012 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for the treatment of pain or fever in an adult human or an adolescent human subject weighing at least 50 kg, in need thereof... | The proposed label for Defendant's product will instruct its use for treating pain or fever in adult and adolescent subjects weighing at least 50 kg. | ¶¶32, 41-42 | col. 25:45-48 |
| comprising administering to the subject, by an intravenous route of administration, a therapeutically effective amount of a pharmaceutical composition comprising about 550 mg to about 800 mg of acetaminophen; | The proposed label will instruct administering a 650 mg dose of acetaminophen intravenously. This dosage falls within the claimed range. | ¶¶32-33, 41-42 | col. 25:49-53 |
| and repeating said administration at least once at an interval of about 3 to about 5 hours. | The proposed label will instruct repeating the 650 mg dose at a 4-hour interval. This interval falls within the claimed range. | ¶¶32-33, 41-42 | col. 25:54-56 |
'265 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating pain in a human subject weighing at least 50 kg | The proposed label for Defendant's product will instruct its use for treating pain in subjects weighing at least 50 kg. | ¶¶47, 49, 57-58 | col. 23:55-56 |
| comprising: co-administering to the subject a therapeutically effective amount of a first pharmaceutical composition comprising about 500 mg to about 750 mg of acetaminophen | The proposed label will instruct administering a 650 mg dose of acetaminophen, which is within the claimed range. | ¶¶47, 49-50, 57-58 | col. 23:57-60 |
| and a therapeutically effective amount a second pharmaceutical composition comprising an opioid analgesic; | The proposed label will indicate the product for the "Management of moderate to severe pain with adjunctive opioid analgesics," which the complaint alleges instructs and encourages co-administration with an opioid. | ¶¶47-48, 57-58 | col. 23:61-63 |
| wherein the first pharmaceutical composition is administered to the subject intravenously. | The product is an intravenous formulation, and its proposed label will instruct for intravenous administration. | ¶¶47, 51, 57-58 | col. 23:64-66 |
Identified Points of Contention:
- Scope Questions: A potential dispute may arise over the construction of the term "about" as it defines the claimed dosage and interval ranges. While the accused 650 mg dose and 4-hour interval appear to fall within the scope of "about 550 mg to about 800 mg" and "about 3 to about 5 hours," the precise breadth of "about" is a common subject of claim construction.
- Technical Questions: For the '265 Patent, a key question is whether the label's indication for use "with adjunctive opioid analgesics" (Compl. ¶48) constitutes an instruction to perform the claimed "co-administering" step. The analysis will focus on whether this language actively encourages or teaches the combination therapy required by the claim.
V. Key Claim Terms for Construction
The Term: "about"
- Context and Importance: This term appears in the dosage and interval limitations of the asserted independent claims in both patents (e.g., "about 550 mg to about 800 mg," "about 3 to about 5 hours"). The infringement case hinges on the accused 650 mg dose and 4-hour interval falling within these ranges. Practitioners may focus on this term because its construction determines the literal boundaries of the claims.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification uses "about" frequently when describing various dosages and formulation characteristics, which may suggest that the inventors did not intend the numerical values to be strict, absolute limits ('012 Patent, col. 5:25-40).
- Evidence for a Narrower Interpretation: The patent explicitly claims a specific dose of "650 mg" in dependent claims (e.g., '012 Patent, Claim 39), which could be used to argue that "about" should not be interpreted so broadly as to render such dependent claims redundant or that the inventors knew how to be precise when they intended to be.
The Term: "co-administering"
- Context and Importance: This term from Claim 1 of the '265 Patent is central to the infringement allegation for that patent. The case will turn on whether Defendant's product label is found to induce infringement by instructing or encouraging the "co-administering" of its acetaminophen product and an opioid.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification provides an explicit definition, stating that "concurrent administration" and similar phrases mean the components "may be administered at the same time or sequentially in any order at different points in time" ('265 Patent, col. 5:35-43). Plaintiff may argue that the label's instruction to use the product with "adjunctive opioid analgesics" (Compl. ¶48) directly encourages a practice that falls within this broad definition.
- Evidence for a Narrower Interpretation: A defendant may argue that the term, in the context of the full claim, requires a more affirmative instruction to combine the drugs as part of an integrated treatment protocol, and that a general indication for adjunctive use does not meet this threshold.
VI. Other Allegations
- Indirect Infringement: The complaint's primary theory is induced infringement under 35 U.S.C. § 271(b). It alleges that Defendant, by seeking approval for a product with a label that instructs medical professionals on its use, will knowingly and intentionally encourage infringement of the patented methods (Compl. ¶¶ 42, 58, 67-68, 80-81).
- Willful Infringement: The complaint alleges that Defendant was aware of the '012 Patent prior to filing its NDA, as evidenced by its Paragraph IV certification letter (Compl. ¶¶ 60, 69). It further alleges Defendant was aware of the application that issued as the '265 patent while continuing to seek approval of its NDA (Compl. ¶61). Based on this alleged pre-suit knowledge, Plaintiff asserts the case is "exceptional" and seeks enhanced damages and attorneys' fees (Compl. Prayer ¶E).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of label-based infringement: as this is a Hatch-Waxman action preceding commercial launch, the dispute centers on a future event. The case will largely depend on whether the final, FDA-approved label for Defendant's product contains explicit instructions that fall squarely within the dosage, timing, and co-administration elements of the asserted claims.
- A central legal question will be one of inducement: does the anticipated product label's language, such as indicating the drug for use "with adjunctive opioid analgesics," meet the legal standard for actively encouraging or instructing the "co-administering" step required by the '265 patent?
- A key question of claim scope may turn on the construction of the term "about." The court's interpretation will determine whether the 4-hour dosing interval and 650 mg dose taught by the label are definitively captured by the claim language "about 3 to about 5 hours" and "about 550 mg to about 800 mg," or if this creates a potential avenue for a non-infringement defense.