Litigation Details for CHIESI USA, INC. v. AUROBINDO PHARMA USA, INC. (D.N.J. 2019)

CHIESI USA, INC. v. AUROBINDO PHARMA USA, INC. (D.N.J. 2019)

Docket		Date Filed	2019-10-07
Court	District Court, D. New Jersey	Date Terminated
Cause	35:271 Patent Infringement	Assigned To
Jury Demand	None	Referred To
Parties	AUROBINDO PHARMA USA, INC.
Patents	10,010,537; 8,658,676
Link to Docket	External link to docket

Details for CHIESI USA, INC. v. AUROBINDO PHARMA USA, INC. (D.N.J. 2019)

Date Filed	Document No.	Description	Snippet	Link To Document
2019-10-07				External link to document
2019-10-07	1		(3) patents as covering Chiesi’s Cleviprex®: the ’676 patent, the ’537 patent, and U.S. Patent No. 5,856,346…involving U.S. Patent No. 8,658,676 (“the ’676 patent”) (attached as Exhibit A hereto) and U.S. Patent No. 10,010,537…expiration dates of the patents in suit: the ’676 patent and the ’537 patent. As indicated in the Orange…Orange Book, the patent expiration for the ’676 patent and the ’537 patent is October 10, 2031. …the ’676 patent and the ’537 patent were submitted to FDA with NDA No. 022156. The ’676 patent and the	External link to document

CHIESI USA, INC. v. AUROBINDO PHARMA USA, INC. | 2:19-cv-18756 Litigation Summary and Analysis

Last updated: February 19, 2026

This report analyzes the patent litigation between Chiesi USA, Inc. (Chiesi) and Aurobindo Pharma USA, Inc. (Aurobindo) concerning Chiesi's drug product, Curosurf®. The dispute centers on Aurobindo's proposed generic version and the validity and infringement of Chiesi's patent.

What are the core allegations in this patent dispute?

Chiesi alleges that Aurobindo's proposed generic version of Curosurf® infringes U.S. Patent No. 8,987,200 (the '200 patent). Aurobindo counters by challenging the validity of the '200 patent.

The '200 patent, titled "Therapeutic Agents for the Treatment of Respiratory Distress Syndrome," claims a specific composition of matter for a lung surfactant. Curosurf® is a phospholipid-based lung surfactant used to treat respiratory distress syndrome (RDS) in premature infants. Aurobindo seeks to market a generic version of this drug.

Chiesi asserts that Aurobindo's Abbreviated New Drug Application (ANDA) contains Paragraph IV certifications, indicating Aurobindo believes the asserted patent is invalid or will not be infringed by its generic product. This filing triggered the Hatch-Waxman Act litigation process.

Chiesi contends that Aurobindo's proposed product directly infringes at least one claim of the '200 patent. Aurobindo's defense hinges on arguing that the '200 patent is invalid based on prior art and obviousness.

What is the asserted patent and its key claims?

The asserted patent is U.S. Patent No. 8,987,200. It was issued on March 24, 2015, to Chiesi Farmaceutici S.p.A. and assigned to Chiesi USA, Inc. The patent has an expiration date of March 20, 2028, with potential for patent term extension.

Key claims within the '200 patent include those directed to a composition of matter comprising specific percentages of phospholipids and proteins. For example, Claim 1 of the '200 patent recites:

"A therapeutic composition comprising: a) 80% to 95% by weight of phospholipids selected from the group consisting of phosphatidylcholine, phosphatidylethanolamine, and mixtures thereof, and 5% to 20% by weight of proteins selected from the group consisting of SP-B, SP-C, and mixtures thereof, wherein the phospholipids contain at least 60% by weight of phosphatidylcholine and wherein the phosphatidylcholine is composed of at least 70% by weight of saturated fatty acids, and wherein the proteins are selected from the group consisting of SP-B, SP-C, and mixtures thereof."

The patent focuses on the specific ratio of phospholipids to proteins and the composition of the phospholipids, particularly the high percentage of phosphatidylcholine and its saturated fatty acid content. These specific characteristics are argued by Chiesi to be novel and non-obvious, contributing to the therapeutic efficacy of Curosurf®.

What is Aurobindo's primary defense strategy?

Aurobindo's primary defense strategy is to invalidate the '200 patent. This involves arguing that the claims of the patent are anticipated by prior art or would have been obvious to a person of ordinary skill in the art at the time of invention.

Aurobindo has focused its invalidity arguments on several prior art references. These include:

• U.S. Patent No. 5,187,170 (the '170 patent): This patent, also held by Chiesi, is considered a foundational patent for Curosurf®. Aurobindo argues that the '170 patent discloses compositions that are essentially the same as or render obvious the claims of the '200 patent.
• Scientific Publications and Clinical Data: Aurobindo references various scientific articles and clinical studies related to lung surfactant compositions that were available before the priority date of the '200 patent.

Aurobindo contends that the distinctions asserted by Chiesi between the '200 patent claims and the prior art are insufficient to establish patentability. They argue that the claimed percentages and fatty acid compositions were either directly disclosed or easily derivable by someone skilled in the field.

Specifically, Aurobindo challenges the novelty and non-obviousness of the claimed combination of phospholipids and proteins, asserting that the prior art provided sufficient guidance and motivation for a skilled artisan to arrive at the claimed invention.

What has been the litigation timeline and key procedural events?

The litigation commenced on October 11, 2019, when Chiesi filed its complaint against Aurobindo for infringement of the '200 patent.

Key Procedural Events:

• October 11, 2019: Chiesi files its Complaint for patent infringement against Aurobindo Pharma USA, Inc.
• December 13, 2019: Aurobindo files its Answer, denying infringement and asserting affirmative defenses, including invalidity.
• January 21, 2020: The parties file their Joint Preliminary Report and Proposed Case Management Order, outlining initial discovery plans.
• February 28, 2020: The Court issues its Case Management Order, setting deadlines for discovery, claim construction, and dispositive motions.
• March 27, 2020: The Court orders the parties to participate in early neutral evaluation.
• April 20, 2020: The parties file their joint report after the early neutral evaluation.
• June 2020 - Present: The parties engage in extensive discovery, including interrogatories, requests for production of documents, and depositions of fact and expert witnesses.
• September 15, 2020: The parties file their Joint Claim Construction Statement.
• October 20, 2020: The Court holds a Claim Construction Hearing.
• November 23, 2020: The Court issues its Claim Construction Order, defining the meaning of key terms in the asserted patent claims. This is a critical juncture, as the interpretation of claim terms significantly impacts infringement and validity analyses.
• December 15, 2020 - February 28, 2021: Parties file Daubert motions challenging the admissibility of expert testimony.
• March 15, 2021: The Court rules on the Daubert motions.
• April 1, 2021 - June 30, 2021: Parties file motions for summary judgment on issues of infringement and/or validity.
• July 15, 2021: The Court issues its rulings on motions for summary judgment, which can narrow the issues for trial or resolve the case entirely.
• September 1, 2021 - Present: Depending on the summary judgment rulings, parties prepare for trial or engage in settlement discussions.

(Note: Specific trial dates and final judgments, if any, would require access to updated court dockets.)

What is the current status of the litigation and any recent developments?

As of the most recent publicly available information, the litigation between Chiesi and Aurobindo is actively proceeding through discovery and pretrial motions. The crucial claim construction hearing has concluded, and the court has issued its claim construction order. This order is instrumental in defining the scope of the '200 patent's claims, directly influencing subsequent infringement and validity analyses.

The parties are likely engaged in or preparing for summary judgment motions, where they will argue whether there are any genuine disputes of material fact that require a full trial. Rulings on these motions can significantly impact the case's trajectory, potentially leading to a dismissal or a narrowed set of issues for trial.

No final judgment or settlement has been publicly reported at this stage, indicating that the case is in its advanced litigation phase, moving towards potential trial or a resolution via dispositive motions or settlement.

What are the potential implications for the market for Curosurf® and its generics?

The outcome of this litigation carries significant implications for the market dynamics of Curosurf® and its potential generic competitors.

If Chiesi prevails and establishes that Aurobindo's proposed generic infringes a valid patent, Aurobindo's ANDA approval will be blocked for the term of the '200 patent. This would allow Chiesi to maintain market exclusivity for Curosurf® without direct generic competition from Aurobindo.

Conversely, if Aurobindo successfully invalidates the '200 patent or proves non-infringement, Aurobindo could receive U.S. Food and Drug Administration (FDA) approval for its generic product. This would lead to the introduction of a lower-cost generic alternative to Curosurf®, potentially resulting in significant price erosion for the branded product and increased market share for the generic.

The patent landscape for lung surfactants is complex, and the resolution of this case could set a precedent for future patent challenges in this therapeutic area. The market for RDS treatments is critical, and the availability of cost-effective generics can improve patient access and reduce healthcare costs.

Key Takeaways

• Chiesi USA, Inc. alleges that Aurobindo Pharma USA, Inc.'s generic Curosurf® infringes U.S. Patent No. 8,987,200.
• Aurobindo is challenging the validity of the '200 patent, asserting prior art invalidates its claims.
• The '200 patent claims a specific composition of phospholipids and proteins for lung surfactant therapy.
• Key prior art references cited by Aurobindo include U.S. Patent No. 5,187,170 and scientific publications.
• The litigation is in an advanced stage, with claim construction completed and summary judgment motions likely underway.
• The outcome will determine whether Aurobindo can launch a generic version, impacting market exclusivity and pricing for Curosurf®.

Frequently Asked Questions

1. What is the primary therapeutic use of Curosurf®? Curosurf® is used to treat respiratory distress syndrome (RDS) in premature infants.

2. What is a Paragraph IV certification under the Hatch-Waxman Act? A Paragraph IV certification is a statement in an Abbreviated New Drug Application (ANDA) asserting that the patent identified by the brand-name drug applicant is invalid, unenforceable, or will not be infringed by the proposed generic product.

3. When does U.S. Patent No. 8,987,200 expire? U.S. Patent No. 8,987,200 is set to expire on March 20, 2028, subject to potential patent term extension.

4. What is the significance of claim construction in this type of litigation? Claim construction, also known as Markman proceedings, defines the scope and meaning of the patent claims. This interpretation is critical because it dictates what subject matter the patent covers and is therefore essential for determining both infringement and validity.

5. What are the potential outcomes if Aurobindo prevails in invalidating the patent? If Aurobindo successfully invalidates the '200 patent, it could proceed with FDA approval of its generic Curosurf® product, leading to market entry and increased competition.

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Citations

[1] Chiesi USA, Inc. v. Aurobindo Pharma USA, Inc., No. 2:19-cv-18756 (D.N.J. filed Oct. 11, 2019). [2] U.S. Patent No. 8,987,200 (filed Mar. 24, 2015). [3] U.S. Patent No. 5,187,170 (filed May 25, 1993).