DCT
2:19-cv-18565
Chiesi USA Inc v. Gland Pharma Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Chiesi USA Inc. (Delaware) and Chiesi Farmaceutici S.p.A. (Italy)
- Defendant: Gland Pharma Ltd. (India)
- Plaintiff’s Counsel: Gibbons P.C.; Haug Partners LLP
- Case Identification: 2:19-cv-18565, D.N.J., 09/30/2019
- Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey as Defendant is an alien corporation and subject to personal jurisdiction within the district. Personal jurisdiction is asserted based on Defendant's business activities in New Jersey, its submission of a Paragraph IV certification notice to an address in New Jersey, and its previous submission to the court's jurisdiction in prior litigations.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market a generic version of the antiplatelet drug Kengreal® constitutes an act of infringement of a patent covering specific methods for manufacturing a high-purity, low-impurity formulation of the drug.
- Technical Context: The technology concerns pharmaceutical compounding methods for cangrelor, an intravenous antiplatelet drug used to reduce the risk of blood clots during percutaneous coronary interventions (PCI), a common cardiac procedure.
- Key Procedural History: This action was triggered by Defendant's filing of ANDA No. 213551, which included a Paragraph IV certification for the patent-in-suit, asserting that the patent is invalid, unenforceable, or will not be infringed by the proposed generic product. Plaintiff received a formal Notice Letter from Defendant regarding this certification on August 19, 2019. The complaint notes that Defendant has not filed a Paragraph IV certification for seven other patents listed in the FDA's Orange Book for Kengreal®, which may suggest Defendant intends to wait for those patents to expire before launching its product.
Case Timeline
| Date | Event |
|---|---|
| 2015-01-14 | ’687 Patent Priority Date |
| 2015-06-22 | FDA approves Kengreal® New Drug Application |
| 2016-03-29 | ’687 Patent Issue Date |
| 2019-08-19 | Defendant sends Paragraph IV Notice Letter |
| 2019-09-30 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,295,687 - Pharmaceutical Formulations Comprising High Purity Cangrelor and Methods for Preparing and Using the Same
- Patent Identification: U.S. Patent No. 9,295,687, Pharmaceutical Formulations Comprising High Purity Cangrelor and Methods for Preparing and Using the Same, issued March 29, 2016.
The Invention Explained
- Problem Addressed: The patent’s background section states that while cangrelor can be synthesized, the subsequent compounding process—mixing the active ingredient with excipients to create a final drug product—can generate impurities. These degradation products may affect the formulation's stability, shelf-life, and the ability to control dosage, which is critical for injectable drugs used in clinical settings (’687 Patent, col. 2:4-16).
- The Patented Solution: The invention claims to solve this problem through a specific compounding method that consistently produces "high purity cangrelor" with low levels of impurities (’687 Patent, Abstract). A central feature of the method is dissolving cangrelor in a solvent and then carefully mixing it with a pH-adjusting agent to maintain the solution’s pH within a specific range of 7.0 to 9.5, followed by lyophilization (freeze-drying) to achieve a low moisture content (’687 Patent, col. 3:62-65; col. 4:8-10). This process results in a final product where the combined total of certain specified degradants does not exceed 1.5% by weight (’687 Patent, col. 2:35-42).
- Technical Importance: The described method provides a way to manufacture a stable, injectable antiplatelet drug with a consistent and controlled purity profile, which is crucial for patient safety and for meeting regulatory standards (’687 Patent, col. 2:11-14).
Key Claims at a Glance
- The complaint alleges infringement of one or more unspecified claims. The first independent claim, Claim 1, is representative of the patented technology.
- Essential elements of independent Claim 1, a product-by-process claim, include:
- A pharmaceutical formulation prepared by a method comprising:
- (a) dissolving cangrelor in a solvent;
- (b) mixing a pH-adjusting agent with the solution to form a second solution with a pH between about 7.0 and 9.5;
- (c) removing the solvent to produce the final product with a moisture level of less than about 2.0% by weight;
- Wherein one or more excipients are added during the process;
- Wherein the resulting "high purity cangrelor" has a combined total of specified degradants not exceeding about 1.5% by weight.
- The complaint does not specify assertion of any dependent claims but reserves the right to do so.
III. The Accused Instrumentality
Product Identification
- Defendant's proposed generic cangrelor product, which is the subject of Abbreviated New Drug Application (ANDA) No. 213551 (Compl. ¶9).
Functionality and Market Context
- The accused instrumentality is a lyophilized (freeze-dried) powder formulation containing 50 mg of cangrelor per vial, intended for injection after reconstitution (Compl. ¶22, 37). The complaint alleges that the proposed generic product will have the same indications, usage, dosage, and administration instructions as the branded reference drug, Kengreal® (Compl. ¶24-25). Cangrelor is a P2Y12 platelet inhibitor used as an adjunct to percutaneous coronary intervention (PCI) (Compl. ¶17). The complaint also characterizes Defendant as a "global player" in the generic drug market (Compl. ¶7). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint alleges that the future commercial manufacture of Defendant's ANDA Product will infringe the ’687 patent (Compl. ¶43-44). As is common in initial complaints filed before discovery, the pleading does not contain specific factual allegations mapping Defendant's confidential manufacturing process to the patent's claim limitations. The infringement theory appears to be that in order to produce a stable, bioequivalent generic version of Kengreal®, Defendant must necessarily practice a process that falls within the scope of the asserted claims.
’687 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical formulation... prepared by a method comprising: (a) dissolving cangrelor or a salt thereof in a solvent to form a first solution | The complaint alleges Defendant's ANDA Product is "cangrelor for injection," which would require dissolving cangrelor in a solvent as part of its manufacturing process. | ¶37, ¶44 | col. 16:45-47 |
| (b) mixing a pH-adjusting agent with the first solution... wherein the pH of the second solution is between about 7.0 and 9.5 | The complaint does not provide specific details on Defendant’s pH control methods but generally alleges that the manufacture of the ANDA Product will infringe. | ¶44 | col. 18:60-62 |
| (c) removing the solvent from the second solution to produce high purity cangrelor... under conditions wherein a level of moisture of less than about 2.0% by weight is achieved | The complaint identifies the ANDA product as a "lyophilized formulation," a process that removes solvent, but provides no data regarding the moisture level of Defendant's product. It generally alleges the resulting product will infringe. | ¶22, ¶44 | col. 23:59-65 |
| wherein the high purity cangrelor... has a combined total of selected... degradants of cangrelor not exceeding about 1.5% by weight | The complaint does not provide data on the impurity profile of Defendant's product but generally alleges that the manufacture of the ANDA Product, based on the Kengreal® reference drug, will result in a product that meets this limitation. | ¶36, ¶44 | col. 2:35-42 |
- Identified Points of Contention:
- Evidentiary Question: A central question for discovery will be to determine the specifics of Defendant's confidential manufacturing process. What evidence will show that Defendant's process for its ANDA product includes the specific step of controlling the pH of the cangrelor solution to within the claimed 7.0-9.5 range during compounding?
- Technical Question: A key factual dispute will likely be whether Defendant's final drug product, as described in its ANDA, meets the patent's definition of "high purity cangrelor," which is defined by a specific quantitative limit on five named impurities (<1.5% combined total).
V. Key Claim Terms for Construction
- The Term: "high purity cangrelor"
- Context and Importance: This term appears in the claims and is quantitatively defined in the specification. Infringement will likely depend on whether Defendant's ANDA product meets this specific purity profile. Practitioners may focus on this term because it is a product-by-process limitation that defines the boundary between the patented formulation and other cangrelor formulations.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The parties may not dispute the meaning of this term, as it is explicitly defined. A broader argument is not readily apparent from the specification.
- Evidence for a Narrower Interpretation: The patent provides a precise, limiting definition: "cangrelor having a combined total of selected hydrolysis and oxidation degradants of cangrelor not exceeding about 1.5% by weight" (’687 Patent, col. 3:12-16). This definition is tied to five specific impurities (Impurities A, B, C, D, and E). A court may construe this term narrowly to only include formulations that meet this exact quantitative and qualitative impurity profile.
- The Term: "wherein the pH of the second solution is between about 7.0 and 9.5"
- Context and Importance: This limitation describes the core process step of the invention. The infringement analysis will turn on whether Defendant's process includes this step. Its interpretation could be critical if Defendant's process involves pH levels that fluctuate during mixing.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language could be interpreted as requiring only that the final pH of the "second solution," before solvent removal, falls within the 7.0-9.5 range, potentially tolerating temporary fluctuations during the mixing process.
- Evidence for a Narrower Interpretation: The specification warns against "locally different pH or 'hot spots'" and emphasizes that "the pH range must be maintained throughout the process" (’687 Patent, col. 19:6-12). This language may support a narrower construction requiring that the pH of the solution remains within the 7.0-9.5 range for the duration of the mixing step.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that upon receiving FDA approval, Defendant's commercial sale of its ANDA Product will induce and/or contribute to infringement by third parties (Compl. ¶45). The factual basis for this appears to be that Defendant's product labeling will instruct end-users (e.g., healthcare professionals) on reconstitution and administration, which, combined with Defendant's direct infringement in manufacturing the product, would lead to infringement by others (Compl. ¶44-45).
- Willful Infringement: The complaint does not use the term "willful," but it requests a finding that the case is "exceptional" under 35 U.S.C. § 285 and seeks enhanced damages under § 284 (Compl. Prayer ¶I, J). The alleged basis for this is Defendant's pre-suit knowledge of the ’687 patent, as evidenced by its filing of a Paragraph IV certification and its transmission of a Notice Letter to Plaintiff (Compl. ¶21, 23, 40-41).
VII. Analyst’s Conclusion: Key Questions for the Case
- A primary issue in this case will be one of evidentiary proof: What are the specific details of the manufacturing process and final product specifications contained within Defendant's confidential ANDA filing? The case will likely turn on whether discovery reveals that this process and product align with the specific pH, moisture, and impurity limitations recited in the asserted claims of the ’687 patent.
- A secondary, and potentially dispositive, question will be one of claim construction: Can the process limitation requiring a pH "between about 7.0 and 9.5" be met if the pH of the solution temporarily deviates outside this range during the mixing process, or must the pH be continuously maintained within the claimed range to infringe? The answer may determine whether Defendant's process, once revealed, falls inside or outside the scope of the patent.