DCT
2:24-cv-07531
Salix Pharma Inc v. Carnegie Pharma LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Salix Pharmaceuticals, Inc. (California), Salix Pharmaceuticals, Ltd. (Delaware), and Bausch Health Ireland Ltd. (Ireland)
- Defendant: Carnegie Pharmaceuticals, LLC (New Jersey)
- Plaintiff’s Counsel: Morgan, Lewis & Bockius LLP
- Case Identification: 3:24-cv-07531, D.N.J., 07/03/2024
- Venue Allegations: Venue is asserted based on Defendant having its principal place of business in New Jersey and engaging in business activities within the state, including seeking FDA approval to market and sell the accused product there.
- Core Dispute: Plaintiffs allege that Defendant’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of Colazal® constitutes an act of infringement of two patents covering methods of administering the drug with food.
- Technical Context: The technology concerns pharmaceutical methods for treating gastrointestinal disorders, such as ulcerative colitis, by optimizing the administration schedule of the prodrug balsalazide to increase its local effect in the colon and reduce systemic side effects.
- Key Procedural History: This lawsuit was filed under the Hatch-Waxman Act, triggered by Defendant’s Paragraph IV certification asserting that its generic product would not infringe Plaintiffs’ patents or that the patents are invalid. The action was filed within the 45-day window following receipt of Defendant’s notice letter, which triggers an automatic 30-month stay of FDA approval for the generic product.
Case Timeline
| Date | Event |
|---|---|
| 2000-07-18 | FDA approves NDA for Colazal® 750 mg capsules. |
| 2005-08-24 | Earliest Priority Date for '872 and '884 Patents. |
| 2008-11-18 | U.S. Patent No. 7,452,872 issues. |
| 2009-12-01 | U.S. Patent No. 7,625,884 issues. |
| 2024-05-02 | FDA sends Paragraph IV acceptance letter to Carnegie. |
| 2024-05-20 | Carnegie sends Paragraph IV Notice Letter to Salix. |
| 2024-07-03 | Complaint filed. |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,452,872 - “Formulations and Uses of 2-hydroxy-5-phenylazobenzoic Acid Derivatives”
Issued November 18, 2008
The Invention Explained
- Problem Addressed: The patent addresses the need for a dosing regimen for balsalazide (a treatment for ulcerative colitis) that can increase the drug's therapeutic effect within the colon while simultaneously decreasing the systemic absorption of its active metabolites, which are associated with side effects (’872 Patent, col. 1:40-55).
- The Patented Solution: The invention is a method centered on the "unexpected finding" that administering balsalazide with food achieves the dual goals of increasing local bioavailability and decreasing systemic absorption (’872 Patent, col. 2:3-9). The patent specification describes that this method delays the drug's transit through the gastrointestinal tract, allowing for greater conversion to its active form in the colon and increasing contact time with the colonic mucosa (’872 Patent, col. 24:29-34).
- Technical Importance: This approach provided a method to potentially improve both the efficacy and the side-effect profile of an existing drug simply by modifying its administration instructions relative to food intake (’872 Patent, col. 18:5-12).
Key Claims at a Glance
- The complaint alleges infringement of one or more claims, with specific allegations tracking the language of independent claim 1 (Compl. ¶32).
- Independent Claim 1 requires:
- A method of increasing the bioavailability of balsalazide and its metabolites (5-ASA and NASA).
- Comprising administering to a subject a therapeutically effective amount of a solid dosage form of balsalazide with food.
- Wherein "administering with food" comprises administering the solid dosage form within 15 minutes after eating a meal.
- Wherein the bioavailability of balsalazide, 5-ASA, or NASA is increased compared to administering without food.
- Wherein the method decreases systemic adsorption of the 5-ASA and NASA metabolites.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 7,625,884 - “Formulations and Uses of 2-hydroxy-5-phenylazobenzoic Acid Derivatives”
Issued December 1, 2009
The Invention Explained
- Problem Addressed: As a divisional of the application that led to the '872 patent, the '884 Patent addresses the same technical problem: how to optimize the administration of balsalazide to improve treatment outcomes for gastrointestinal disorders (’884 Patent, col. 1:49-55).
- The Patented Solution: The solution is identical to that of the '872 Patent: administering balsalazide with food. This method is claimed to increase the bioavailability of the drug and its metabolites to the colon, where it is therapeutically active (’884 Patent, col. 2:5-9, 25-30).
- Technical Importance: This patent further protects the core inventive concept of using food to modulate the pharmacokinetics of balsalazide for therapeutic benefit (’884 Patent, col. 2:60-65).
Key Claims at a Glance
- The complaint specifically alleges inducement of claim 1 (Compl. ¶45).
- Independent Claim 1 requires:
- A method of treating a gastrointestinal disorder.
- Comprising administering a therapeutically effective amount of balsalazide with food.
- Wherein "administering with food" comprises administering the balsalazide within 15 minutes after eating a meal.
- Wherein the administration results in an increase in the bioavailability of balsalazide and its metabolites to the colon as compared to administering balsalazide in a fasted state.
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
- Defendant’s ANDA Product, a generic version of Colazal® (balsalazide disodium) 750 mg capsules, for which Defendant seeks FDA approval via ANDA No. 219422 (Compl. ¶2).
Functionality and Market Context
- The ANDA product is a pharmaceutical formulation intended for the treatment of mildly to moderately active ulcerative colitis (Compl. ¶17). The infringement allegations do not focus on the product's composition but on its intended use. The complaint alleges that the product's proposed labeling will instruct and encourage physicians and patients to administer the capsules in a manner that directly infringes the patented methods (Compl. ¶¶30, 43).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not provide a claim chart exhibit. The infringement allegations for both patents are based on a theory of inducement, alleging that the defendant’s proposed product label will instruct users to perform the patented methods.
'872 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of increasing the bioavailability of balsalazide and metabolites... said method comprising administering a therapeutically effective amount of a solid dosage form of balsalazide with food... | The ANDA Product is a solid capsule form of balsalazide, and its proposed labeling will allegedly direct administration with food to increase bioavailability. | ¶32 | col. 2:10-13 |
| wherein the solid dosage form is a tablet or capsule... | The ANDA Product is a capsule. | ¶2, ¶32 | col. 2:42-45 |
| wherein administering with food comprises administering the solid dosage form within 15 minutes after eating a meal... | The proposed labeling will allegedly instruct users to take the ANDA product within 15 minutes of a meal. | ¶32 | col. 2:52-55 |
| wherein the bioavailability of balsalazide, 5-ASA or NASA is increased compared to administering balsalazide without food... | The alleged administration with food, as directed by the label, is asserted to increase bioavailability. | ¶32 | col. 2:6-9 |
| and wherein the method decreases the systemic adsorption of the 5-ASA and NASA metabolites. | The alleged administration with food is asserted to decrease systemic absorption of the drug's metabolites. | ¶32 | col. 2:3-6 |
'884 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating a gastrointestinal disorder, said method comprising administering a therapeutically effective amount of balsalazide with food... | The ANDA Product is for treating a gastrointestinal disorder, and its proposed label will allegedly instruct administration with food. | ¶17, ¶45 | col. 2:60-62 |
| wherein administering with food comprises administering the balsalazide within 15 minutes after eating a meal... | The proposed labeling will allegedly instruct users to take the ANDA product within 15 minutes of a meal. | ¶45 | col. 2:54-56 |
| and wherein the administration results in an increase in the bioavailability of balsalazide and its metabolites...to the colon as compared to administering balsalazide in a fasted state. | The alleged administration with food, as directed by the label, is asserted to result in increased bioavailability to the colon. | ¶45 | col. 2:23-30 |
- Identified Points of Contention:
- Evidentiary Questions: The central issue is factual: what will Defendant's proposed product labeling actually say? The complaint's allegations are made "on information and belief" (Compl. ¶¶32, 45). The case will depend heavily on the specific language of the label submitted to the FDA.
- Scope Questions: Does the general concept of taking a drug "with food," if present on the label, satisfy the specific claim limitation of "administering the solid dosage form within 15 minutes after eating a meal"? The precision of the label's language will be critical.
V. Key Claim Terms for Construction
The Term: "with food"
Context and Importance: This term is the foundation of the patented methods. The infringement case hinges on whether the defendant's product label will instruct administration "with food" in a manner that meets the claims' requirements. Practitioners may focus on this term because its definition dictates whether a generic label creates liability for inducement.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent frequently uses the general phrase "administered with food" in its summary and description, suggesting a general association with food consumption could be sufficient (’872 Patent, col. 2:10-13).
- Evidence for a Narrower Interpretation: The asserted independent claims in both patents explicitly define the term, stating "wherein administering with food comprises administering the [balsalazide] within 15 minutes after eating a meal" (’872 Patent, col. 17:45-47; ’884 Patent, col. 25:5-8). This language provides a strong basis for a narrow construction that requires a specific temporal link to a meal, not just general co-administration.
The Term: "increase in the bioavailability... to the colon"
Context and Importance: This term describes the result of the claimed method and is a key therapeutic benefit. A dispute may arise over whether the defendant's product, when used as instructed, actually achieves this result or whether the label must explicitly promise it for inducement to occur.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the increased bioavailability qualitatively as an increase in contact time with the colonic mucosa and a greater conversion of the prodrug to its active form (’872 Patent, col. 1:50-55).
- Evidence for a Narrower Interpretation: The patent provides detailed pharmacokinetic data in tables and figures that quantify the effects of administration with food, including specific changes to Cmax and Tmax values (’872 Patent, Table 1, col. 24). A party could argue that the "increase" must correspond to the specific pharmacokinetic profile disclosed in the patent's examples.
VI. Other Allegations
- Indirect Infringement: The complaint is primarily based on indirect infringement. It alleges induced infringement on the grounds that Defendant's proposed product labeling will actively encourage and instruct physicians and patients to take the generic product with food, thereby performing the steps of the patented methods (Compl. ¶¶32, 45). The complaint also alleges contributory infringement, stating the ANDA Product is not a staple article of commerce and is especially made for an infringing use (Compl. ¶¶33, 46).
- Willful Infringement: The complaint does not contain a specific count for "willful infringement." However, it alleges that Defendant was aware of the patents-in-suit due to their listing in the FDA's Orange Book and its submission of a Paragraph IV certification against them (Compl. ¶¶37, 50). Based on this alleged knowledge, it seeks a declaration that the case is "exceptional" and an award of attorneys' fees under 35 U.S.C. § 285 (Compl. p. 11, ¶vi).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of inducement and evidence: Will the final, FDA-approved label for Carnegie's generic product contain specific instructions that encourage or direct users to take the drug "within 15 minutes after eating a meal"? As the complaint's allegations are based on "information and belief," the content of the proposed label is the central question of fact that will be developed during discovery.
- A key legal and factual question will be one of infringing use: Assuming the label contains some instruction regarding administration with food, is that instruction specific enough to meet all limitations of the asserted method claims? This will require the court to first construe the claims and then compare that construction to the specific directions for use on the defendant's product label.