Litigation Details for IMPAX LABORATORIES, INC. v. ZYDUS PHARMACEUTICALS USA, INC. (D.N.J. 2017)

IMPAX LABORATORIES, INC. v. ZYDUS PHARMACEUTICALS USA, INC. (D.N.J. 2017)

Docket		Date Filed	2017-12-21
Court	District Court, D. New Jersey	Date Terminated	2020-05-19
Cause	15:1126 Patent Infringement	Assigned To	Stanley R. Chesler
Jury Demand	None	Referred To	Cathy L. Waldor
Patents	7,094,427; 8,377,474; 8,454,998; 8,557,283; 9,089,607; 9,089,608
Link to Docket	External link to docket

Details for IMPAX LABORATORIES, INC. v. ZYDUS PHARMACEUTICALS USA, INC. (D.N.J. 2017)

Date Filed	Document No.	Description	Snippet	Link To Document
2017-12-21				External link to document
2017-12-20	1		and legally issued United States Patent No. 9,089,608 (“the ’608 patent”) entitled “Controlled Release …prior to the expiration of United States Patent No. 9,089,608. … U.S. Patent No. 9,089,608 On June 28, 2015, the PTO…is an action for patent infringement arising under the Food and Drug Laws and Patent Laws of the United…term of the ’608 patent would further infringe at least claim 21 of the ’608 patent under 35 U.S.C.	External link to document
2017-12-20	103		of equivalents, any valid claim of U.S. Patent Nos. 7,094,427; 8,377,474; 8,454,998; 8,557,283; and 9,… 2017 19 May 2020 2:17-cv-13476 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2017-12-20	145		component” in various claims in U.S. Patent No. 8,377,474 (the “’474 patent”) and found that, during prosecution…collectively, “Zydus”). In this patent infringement suit involving a pharmaceutical patent, the parties seek construction…construction of a claim term in U.S. Patent No. 9,089,608 (“the ’608 patent”). The parties dispute … attaches to the patent and then spreads to every limb and leaf in the family patent tree. It is not …prosecution of the ‘474 patent, cannot, 1 Zydus claims that the claims in the ‘474 patent also contained	External link to document
2017-12-20	211	Order on Motion in Limine	from a patent infringement dispute involving a pharmaceutical patent, U.S. Patent No. 9,089,608 (“the …the ’608 patent”). Claim 21 of this patent is at issue. The preamble of claim 21 states: “A controlled… 1 contention that the patent is void for indefiniteness. The parties… 2017 19 May 2020 2:17-cv-13476 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

IMPAX LABORATORIES, INC. v. ZYDUS PHARMACEUTICALS USA, INC.: A Comprehensive Litigation Summary and Analysis

Case Overview

The case of Impax Laboratories, Inc. v. Zydus Pharmaceuticals USA, Inc., filed in the United States District Court for the District of New Jersey (Case No. 2:17-13476), involves a patent infringement dispute related to the drug product Rytary® (carbidopa/levodopa extended-release capsules).

Drug Product and Patents-in-Suit

The litigation centers around U.S. Patent No. 9,089,608 (“the ’608 patent”), one of the six Orange Book-listed patents for Rytary®. Impax Laboratories, the patent holder, accused Zydus Pharmaceuticals of infringing the ’608 patent through its Abbreviated New Drug Application (ANDA) for a generic version of Rytary®[1].

Nature of the Case and Key Issues

• Impax's Allegations: Impax sued Zydus for infringing the ’608 patent. Zydus, in response, filed an Amended Answer to the Complaint that included six counterclaims seeking declaratory judgments of non-infringement for each of the six Orange Book-listed patents[1].
• Zydus's Counterclaims: Zydus alleged that its proposed generic product would not infringe any valid claim of the patents, either literally or under the doctrine of equivalents. Impax admitted in its answer to the counterclaims that the current proposed products specified in Zydus's ANDA did not infringe the patents other than the ’608 patent[1].

Judgment on the Pleadings

• Zydus's Motion: Zydus moved for judgment on the pleadings, arguing that Impax's admissions in its answer to the counterclaims constituted concessions of non-infringement for the patents other than the ’608 patent.
• Court's Decision: The court agreed with Zydus, relying on precedent from the District of New Jersey, particularly the decision in Par Pharm., Inc. v. Luitpold Pharm.. The court rejected Impax's argument that Zydus might change its ANDA formulation in the future, finding this argument speculative and similar to the rejected argument in Par Pharm.[1].

Key Rulings and Implications

• Speculation vs. Current Formulation: The court emphasized that the relevant product for determining infringement was the one specified in the ANDA as of the relevant date (June 1, 2018), and not any hypothetical future formulation. This ruling underscored the importance of focusing on the actual product described in the ANDA rather than speculative changes[1].
• Concession of Non-Infringement: Impax's admissions in its answer to the counterclaims were deemed sufficient to establish non-infringement for the patents other than the ’608 patent. This highlights the critical nature of careful pleading and the potential consequences of concessions made during litigation[1].

Confidentiality and Sealing of Documents

• Motion to Seal: During the litigation, Zydus moved to seal certain confidential materials related to its proprietary commercial and business interests, including research and development information. The court granted this motion, finding that the information was highly confidential and that sealing it was necessary to prevent serious injury to Zydus's business interests[4].

Legal and Business Implications

• Patent Infringement Litigation: This case illustrates the complexities and nuances of patent infringement litigation, particularly in the pharmaceutical industry. It underscores the importance of precise pleadings and the potential risks of making concessions during litigation.
• ANDA Filings: The case highlights the significance of the specific formulations described in ANDA filings and how these formulations are used to determine infringement.
• Confidentiality: The ruling on sealing confidential documents emphasizes the need to protect proprietary information during litigation to prevent competitive disadvantage.

Key Takeaways

• Precision in Pleadings: Careful drafting of pleadings is crucial to avoid unintended concessions.
• Focus on Current Formulations: In determining infringement, courts focus on the product formulation as described in the ANDA at the relevant time, rather than speculative future changes.
• Protection of Confidential Information: Companies must take steps to protect their proprietary information during litigation to avoid competitive harm.

Frequently Asked Questions (FAQs)

Q1: What was the primary issue in the case of Impax Laboratories, Inc. v. Zydus Pharmaceuticals USA, Inc.? A1: The primary issue was whether Zydus's generic version of Rytary® infringed Impax's U.S. Patent No. 9,089,608.

Q2: How did Zydus respond to Impax's infringement allegations? A2: Zydus filed an Amended Answer to the Complaint, including counterclaims seeking declaratory judgments of non-infringement for each of the six Orange Book-listed patents.

Q3: Why did the court grant Zydus's motion for judgment on the pleadings? A3: The court granted the motion because Impax's admissions in its answer to the counterclaims constituted concessions of non-infringement for the patents other than the ’608 patent.

Q4: What was the significance of the court's ruling on speculative future formulations? A4: The court's ruling emphasized that only the current formulation specified in the ANDA is relevant for determining infringement, not speculative future changes.

Q5: Why was the motion to seal confidential documents granted? A5: The motion was granted to protect Zydus's proprietary commercial and business interests, including confidential research and development information, from being disclosed to competitors.

Sources:

1. Impax Labs. V. Zydus Pharms. USA, Inc. | Robins Kaplan LLP
2. Impax Laboratories, Inc., In the Matter of - Federal Trade Commission
3. Applying Actavis, the FTC Reverses Initial Decision and Finds that ... | California Lawyers for the Arts
4. Impax Labs., Inc. v. Zydus Pharms. (Usa) Inc. - Casetext