DCT
5:17-cv-02474
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: Stradley Ronon Stevens & Young, LLP; Latham & Watkins LLP (Of Counsel)
- Case Identification: 5:17-cv-02474, E.D. Pa., 06/01/2017
- Venue Allegations: Plaintiff alleges venue is proper because Defendant resides in the district with a principal place of business, has a regular and established place of business, and because its filing of a New Drug Application constitutes an act of infringement directed to the district under the Hatch-Waxman Act.
- Core Dispute: Plaintiff alleges that Defendant’s submission of a New Drug Application for a generic injectable acetaminophen product constitutes infringement of patents related to specific dosage regimens for intravenous acetaminophen.
- Technical Context: The technology concerns intravenous formulations of acetaminophen, a common non-opioid analgesic and antipyretic, used for managing pain and fever, particularly in postoperative clinical settings.
- Key Procedural History: This action arises under the Hatch-Waxman Act, triggered by Defendant’s filing of New Drug Application (NDA) No. 204957 seeking approval to market a generic version of Plaintiff’s OFIRMEV® product. Defendant provided a Paragraph IV certification for U.S. Patent No. 9,399,012, alleging the patent is invalid, unenforceable, and/or will not be infringed. The complaint also notes prior related litigation between the parties concerning the patents-in-suit in the District of Delaware.
Case Timeline
| Date | Event |
|---|---|
| 2007-11-13 | Earliest Priority Date for ’012 and ’265 Patents |
| 2010-11-02 | FDA Approval of OFIRMEV® |
| 2016-07-26 | U.S. Patent No. 9,399,012 Issues |
| 2017-02-23 | Plaintiff receives first letter from Defendant regarding NDA No. 204957 |
| 2017-04-04 | U.S. Patent No. 9,610,265 Issues |
| 2017-04-21 | Plaintiff receives second letter from Defendant regarding NDA No. 204957 |
| 2017-06-01 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,399,012 - "Reduced Dose Intravenous Acetaminophen"
- Patent Identification: U.S. Patent No. 9,399,012, titled "Reduced Dose Intravenous Acetaminophen", issued July 26, 2016.
The Invention Explained
- Problem Addressed: The patent’s background section identifies limitations with the standard 1000 mg intravenous (IV) dose of acetaminophen for postoperative pain relief ('012 Patent, col. 3:10-15). Due to hepatotoxicity concerns, this dose is limited to a maximum frequency of every six hours, which may not align with the drug's effective duration, potentially creating a "gap in coverage" for patients ('012 Patent, col. 3:25-30).
- The Patented Solution: The patent proposes using a "reduced dose" of IV acetaminophen (less than 1000 mg) to permit more frequent administration, such as every four hours. This approach is intended to provide better overall symptom relief by maintaining a more consistent plasma concentration of the drug, while still adhering to the established maximum daily safety limit ('012 Patent, col. 3:32-42).
- Technical Importance: This dosing strategy provides physicians with greater flexibility to customize pain and fever treatment, potentially improving patient outcomes by avoiding troughs in analgesic coverage associated with less frequent, higher-dose administrations ('012 Patent, col. 3:39-44).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claim 39 (Compl. ¶15-16).
- Independent Claim 1 of the ’012 Patent recites the following essential elements:
- A method for treating pain or fever in an adult or adolescent human subject weighing at least 50 kg.
- The method comprises administering a pharmaceutical composition via an intravenous route.
- The composition comprises "about 550 mg to about 800 mg of acetaminophen."
- The administration is repeated at least once at an "interval of about 3 to about 5 hours."
- The complaint does not explicitly reserve the right to assert other dependent claims.
U.S. Patent No. 9,610,265 - "Reduced Dose Intravenous Acetaminophen"
- Patent Identification: U.S. Patent No. 9,610,265, titled "Reduced Dose Intravenous Acetaminophen", issued April 4, 2017.
The Invention Explained
- Problem Addressed: The ’265 Patent, which is a continuation of the application that led to the ’012 Patent, addresses the same clinical problem of optimizing postoperative pain management while minimizing the side effects associated with opioids and NSAIDs ('265 Patent, col. 1:16-41).
- The Patented Solution: This patent claims methods of multimodal pain management, specifically by co-administering a reduced dose of intravenous acetaminophen with an opioid analgesic. This combination therapy aims to achieve effective pain relief while potentially allowing for a lower required dose of the opioid, thereby reducing its associated risks and side effects ('265 Patent, col. 2:10-14).
- Technical Importance: The claimed solution formalizes a method for adjunctive pain therapy, a common clinical practice, by specifying particular dosage ranges for IV acetaminophen when used in conjunction with opioids.
Key Claims at a Glance
- The complaint asserts dependent claim 7, which relies on independent claim 1 (Compl. ¶18-19).
- Independent Claim 1 of the ’265 Patent recites the following essential elements:
- A method of treating pain in a human subject weighing at least 50 kg.
- The method comprises "co-administering" a first and second pharmaceutical composition.
- The first composition comprises "about 500 mg to about 750 mg of acetaminophen" and is administered intravenously.
- The second composition comprises an "opioid analgesic."
- The complaint does not explicitly reserve the right to assert other dependent claims.
III. The Accused Instrumentality
Product Identification
- Defendant's proposed generic "acetaminophen for injection 10 mg/ml," for which it submitted NDA No. 204957 to the FDA (Compl. ¶10, ¶23).
Functionality and Market Context
- The accused product is a generic version of Plaintiff's OFIRMEV® brand injectable acetaminophen (Compl. ¶10). The complaint’s infringement theory is not based on the composition of the product itself, but on the method of use that will allegedly be instructed by its FDA-mandated labeling (Compl. ¶27). Plaintiff alleges that the label for Defendant’s Generic Product will be substantially identical to the OFIRMEV® label and will instruct and recommend administration in a manner that infringes the patents-in-suit (Compl. ¶37, ¶53). The complaint specifies that the OFIRMEV® label, for adults and adolescents weighing 50 kg and over, recommends a dosage of "1000 mg every 6 hours or 650 mg every 4 hours," and is indicated for the "Management of moderate to severe pain with adjunctive opioid analgesics" (Compl. ¶29, ¶44).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
U.S. Patent No. 9,399,012 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, | Defendant's proposed label will allegedly instruct administration for treating pain or fever in this patient population, based on the approved labeling for OFIRMEV®. | ¶37 | col. 3:12-15 |
| comprising administering to the subject, by an intravenous route of administration, | Defendant's product is an injectable formulation intended for intravenous administration. | ¶10 | col. 3:10-12 |
| a therapeutically effective amount of a pharmaceutical composition comprising about 550 mg to about 800 mg of acetaminophen; | The proposed label will allegedly recommend a dose of 650 mg, which falls within the claimed range of "about 550 mg to about 800 mg." | ¶29, ¶37 | col. 6:27-28 |
| and repeating said administration at least once at an interval of about 3 to about 5 hours. | The proposed label will allegedly recommend a dosing interval of 4 hours, which falls within the claimed range of "about 3 to about 5 hours." | ¶29, ¶37 | col. 2:20-22 |
Identified Points of Contention
- Scope Questions: The complaint's allegations place the accused dosage (650 mg) and interval (4 hours) squarely within the patent's claimed numerical ranges. A potential point of contention may revolve around the construction of the term "about" as it defines the outer boundaries of the claims, which could become relevant if alternative, non-accused dosing instructions are considered.
- Technical Questions: The primary question is one of induced infringement: does the language of Defendant's proposed product label, which is expected to mirror the OFIRMEV® label, actively encourage or instruct medical professionals to perform all steps of the claimed method, thereby establishing the requisite intent for inducement under 35 U.S.C. § 271(b)?
U.S. Patent No. 9,610,265 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 comprising: | Defendant's proposed label will allegedly instruct administration for treating pain in this patient population. | ¶53 | col. 1:16-18 |
| 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 allegedly will recommend a 650 mg dose of acetaminophen, which is within the claimed range, and indicate the product for use with adjunctive opioids. | ¶43-46, ¶53 | col. 1:49-50 |
| and a therapeutically effective amount a second pharmaceutical composition comprising an opioid analgesic; | The OFIRMEV® label, which the accused label will allegedly mirror, is explicitly indicated for the "Management of moderate to severe pain with adjunctive opioid analgesics." | ¶44 | col. 2:11-12 |
| wherein the first pharmaceutical composition is administered to the subject intravenously. | Defendant's product is an injectable formulation intended for intravenous administration. | ¶10 | col. 1:21-23 |
Identified Points of Contention
- Scope Questions: A central question will concern the scope of "co-administering." The dispute may focus on whether the label's indication for use with "adjunctive opioid analgesics" is sufficient to meet this limitation, or if a more explicit instruction for simultaneous or temporally-proximate administration is required.
- Technical Questions: Similar to the ’012 Patent, the key question is one of inducement. Does the product label's description of use with adjunctive opioids merely inform physicians of a possible use, or does it rise to the level of affirmative instruction or encouragement to combine the accused product with an opioid in an infringing manner?
V. Key Claim Terms for Construction
The Term: "co-administering" ('265 Patent, Claim 1)
Context and Importance: This term is the central action of the claimed method. Its construction will determine whether the label's instruction for use with "adjunctive opioid analgesics" constitutes inducement of the claimed method. A broad definition would favor the Plaintiff's theory, while a narrow one requiring, for example, simultaneous administration from a combined formulation, could support a non-infringement argument.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The '265 patent is a continuation of the '012 patent, which defines a related term, "concurrent administration," as meaning components "may be administered at the same time or sequentially in any order at different points in time" ('012 Patent, col. 5:35-41). This definition suggests "co-administering" does not require simultaneous delivery.
- Evidence for a Narrower Interpretation: A defendant may argue that the term should be interpreted in the specific context of treating acute postoperative pain, where adjunctive therapies are typically administered within a close therapeutic window. The specification’s general discussion of combination therapies could be argued to provide context that limits the otherwise broad temporal scope ('265 Patent, col. 11:36-50).
The Term: "about" ('012 Patent, Claim 1; '265 Patent, Claim 1)
Context and Importance: This term modifies all numerical dosage and time limitations in the asserted independent claims. Its construction defines the literal scope of the patent's exclusivity. Practitioners may focus on this term because while the primary accused regimen of "650 mg every 4 hours" falls within the ranges, the scope of "about" is critical for determining infringement by any other potential dosage regimens that may be slightly outside the stated numerical values.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the invention in terms of a general principle—using a "reduced dose" to enable more frequent administration—which may support a construction of "about" that is not strictly limited to the precise numbers recited ('012 Patent, col. 3:32-38).
- Evidence for a Narrower Interpretation: The patent provides specific exemplary dosage ranges, such as "about 550 mg to about 800 mg" and "about 600 mg to about 700 mg" ('012 Patent, col. 6:27-34). A party could argue these specific disclosures provide the context for "about" and limit it to minor variations that preserve the functionality described in those embodiments.
VI. Other Allegations
- Indirect Infringement: The complaint is premised on a theory of induced infringement under 35 U.S.C. § 271(b). It alleges that Defendant, by seeking approval for its product with a label that will be substantially identical to the OFIRMEV® label, will intentionally encourage and instruct medical professionals to perform the patented methods (Compl. ¶38, ¶54, ¶63, ¶76). Knowledge is alleged based on Defendant’s Paragraph IV certification against the ’012 patent and its awareness of the patents listed in the FDA’s Orange Book (Compl. ¶25, ¶64, ¶77).
- Willful Infringement: The complaint alleges Defendant was aware of the ’012 patent and the application that led to the ’265 patent before and during its efforts to seek NDA approval (Compl. ¶56-57). It seeks a declaration that the case is "exceptional" under 35 U.S.C. § 285, which is the statutory basis for awarding attorney's fees (Compl., Prayer for Relief ¶F).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of inducement by labeling: does the proposed product label, by recommending a "650 mg every 4 hours" dosage and indicating the product for use as an "adjunctive opioid analgesic," provide the affirmative instruction and show the specific intent required to hold the Defendant liable for inducing infringement by medical professionals?
- A central legal question will be one of claim construction: how broadly will the court define "co-administering" in the context of adjunctive therapy, and what scope will be given to the term "about," which modifies every numerical limitation in the asserted claims and defines the ultimate boundaries of the patents' coverage?
- A key issue underlying the litigation, as signaled by the Defendant’s Paragraph IV certification mentioned in the complaint, will be validity: will the specific dosage and timing parameters recited in the claims be deemed a non-obvious and patentable invention over prior methods of administering intravenous acetaminophen for pain and fever?