Litigation Details for Intercept Pharmaceuticals, Inc. v. Apotex Inc. (D. Del. 2020)

Intercept Pharmaceuticals, Inc. v. Apotex Inc. (D. Del. 2020)

Docket		Date Filed	2020-08-21
Court	District Court, D. Delaware	Date Terminated	2023-02-24
Cause	35:271 Patent Infringement	Assigned To	Maryellen Noreika
Jury Demand	None	Referred To
Parties	MSN PHARMACEUTICALS INC.
Patents	10,047,117; 10,052,337; 10,174,073; 10,751,349; 10,758,549; 7,138,390; 9,238,673; RE48,286
Attorneys	Maureen L. Rurka
Firms	Phillips, McLaughlin & Hall, P.A.
Link to Docket	External link to docket

Details for Intercept Pharmaceuticals, Inc. v. Apotex Inc. (D. Del. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-08-21				External link to document
2020-08-21	15	Complaint - Amended	expiration of U.S. Patent Nos. 9,238,673 (filed June 17, 2013) (“the ’673 patent”); 10,047,117 (filed Nov. …Notification of Certification for U.S. Patent Nos. 9,238,673; 10,047,117; 10,052,337; and 10,174,073 (NDA … ’073 patent”); 10,758,549 (filed Feb. 11, 2020) (“the ’549 patent”) (collectively the “patents-in-suit… 1. This action for patent infringement, brought pursuant to the patent laws of the United States…20, 2015) (“the ’117 patent”); 10,052,337 (filed Apr. 26, 2016) (“the ’337 patent”); 10,174,073 (filed	External link to document
2020-08-21	16	Patent/Trademark Report to Commissioner of Patents	Commissioner of Patents and Trademarks for Patent/Trademark Number(s): 9,238,673 B2; 10,047,117 B2; 10,052,… 21 August 2020 1:20-cv-01105 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2020-08-21	115	Joint Claim Construction Brief	“’673 Patent” refers to U.S. Patent No. 9,238,673.  “’117 Patent” refers to U.S. Patent No. 10,047,117…“’073 Patent” refers to U.S. Patent No. 10,174,073.  “’337 Patent” refers to U.S. Patent No. 10,052,337…“’349 Patent” refers to U.S. Patent No. 10,751,349.  “’549 Patent” refers to U.S. Patent No. 10,758,549…compositions—expire. Patents from three patent families are asserted in this case. The ’673 Patent Family, which…and ’073 Patents, and the ’337 Patent Family, which includes the ’337, ’349, and ’549 Patents. The ’673	External link to document
2020-08-21	137	Claim Construction Chart	regarding U.S. Patent No. 9,238,673 (“the ’673 Patent”), U.S. Patent No. 10,047,117 (“the ’117 Patent”), U.S.…U.S. Patent No. 10,174,073 (“the ’073 Patent”), U.S. Patent No. 10,052,337 (“the ’337 Patent”), U.S. Patent… ’349 Patent”), and U.S. Patent No. 10,758,549 (“the ’549 Patent”) (collectively, the “Patents-in-Suit…particles 1 U.S. Patent No. RE48,286 (“the RE286 Patent”) is also an asserted patent in this case. It … ’673 Patent (claims 1–23) ’073 Patent (claims	External link to document
2020-08-21	142	Order - -Memorandum and Order	terms of U.S. Patent Nos. 9,238,673 (“the ’673 Patent”), 10,047,117 (“the ’117 Patent”), 10,174,073 …of the ’673 Patent, the ’117 Patent, the ’337 Patent, the ’349 Patent, and the ’549 Patent are construed…10,174,073 (“the ’073 Patent”), 10,052,337 (“the ’337 Patent”), 10,751,349 (“the ’349 Patent”), and 10,758,549… matter” (’337 Patent, claims 1–8; ’349 Patent, claims 1, 19; ’549 Patent, …meaning (’337 patent, claim 11; ’349 patent, claim 4; ’549 patent, claims 12, 23	External link to document

Intercept Pharmaceuticals, Inc. v. Apotex Inc.: A Comprehensive Litigation Summary and Analysis

Introduction

The litigation between Intercept Pharmaceuticals, Inc. and Apotex Inc., case number 1:20-cv-01105, is a complex and multifaceted patent dispute that has unfolded in the United States District Court for the District of Delaware. This article delves into the key aspects of the case, including the patents in dispute, the allegations of inequitable conduct, and the court's rulings.

Background of the Case

Intercept Pharmaceuticals, Inc. and its subsidiary, Intercept Pharma Europe Ltd., filed a lawsuit against Apotex Inc. and Apotex Corp., LLC, alleging patent infringement related to several patents associated with obeticholic acid (OCA), a drug used in the treatment of certain liver diseases. The patents in question are divided into two families: the "purity patents" (U.S. Pat. Nos. 9,238,673, 10,173,073, and 10,047,117) and the "particle size patents" (U.S. Pat. Nos. 10,052,337, 10,751,349, and 10,758,549)[1][4].

Patents in Dispute

Purity Patents

The purity patents relate to compositions of OCA containing less than 1% of a particular impurity. These patents are crucial for ensuring the quality and efficacy of the drug[1].

Particle Size Patents

The particle size patents pertain to compositions with very small particles of OCA, which is important for the drug's bioavailability and effectiveness[1].

Allegations of Inequitable Conduct

Apotex Inc. and Apotex Corp., LLC, have alleged inequitable conduct on the part of Intercept Pharmaceuticals and its representatives during the prosecution of these patents. Inequitable conduct refers to the failure to disclose material information or the submission of false information to the Patent and Trademark Office (PTO) with the intent to deceive.

Purity Patents Allegations

Defendants allege that Dr. Rewolinski, an inventor, made misleading declarations to the PTO regarding the purity of OCA batches manufactured in 2004 and 2005. These allegations are based on documents produced by Intercept in March 2022 and additional evidence gathered during depositions in July 2022[1].

Particle Size Patents Allegations

For the particle size patents, Apotex alleges inequitable conduct by Intercept, through its prosecution counsel and the named inventors, including Mr. Richard Lancaster. The allegations center on the process used to manufacture OCA particles and whether this process was disclosed in prior art[1].

Court's Ruling on Amended Pleadings

Apotex sought to amend their pleadings to include these allegations of inequitable conduct, which was initially met with resistance due to the timing. However, the court ruled in favor of allowing the amendments under Federal Rules of Civil Procedure 15(a)(2) and 16(b)(4). The court found that Apotex had shown good cause for the amendments and that permitting them would not result in undue prejudice to Intercept Pharmaceuticals[1].

Specificity Requirements for Inequitable Conduct

The court emphasized that inequitable conduct must be pleaded with particularity, identifying the specific who, what, when, where, and how of the material misrepresentation or omission committed before the PTO. Apotex's proposed pleadings were deemed to plausibly suggest that Dr. Rewolinski and Mr. Lancaster acted with knowledge and intent, thus allowing the amendments to proceed[1].

Impact on the Litigation Process

The court's decision to allow the amended pleadings means that Apotex can proceed with their claims of inequitable conduct. This development does not necessarily determine the ultimate merits of the allegations but allows the case to move forward with these additional claims. The parties are required to work together to ensure that the trial schedule is maintained, with potential additional fact discovery and time for responding to expert reports[1].

Disputed Claim Terms

In addition to the inequitable conduct allegations, the case also involves disputes over the interpretation of certain claim terms in the patents. The court has reviewed the patents, prosecution history, expert declarations, and other references to make rulings on these disputed terms. Although a written opinion was not issued, the court's decisions were announced from the bench following a thorough process[4].

Conclusion and Future Implications

The Intercept Pharmaceuticals, Inc. v. Apotex Inc. case highlights the complexities and challenges inherent in patent litigation, particularly when allegations of inequitable conduct are involved. The court's rulings on amended pleadings and disputed claim terms will significantly influence the outcome of the case. As the litigation progresses, it will be crucial for both parties to navigate the strict requirements for pleading and proving inequitable conduct while ensuring that the trial schedule is maintained.

Key Takeaways

• Patents in Dispute: The case involves six patents related to OCA, divided into purity and particle size patents.
• Inequitable Conduct Allegations: Apotex alleges inequitable conduct by Intercept and its representatives during patent prosecution.
• Court's Ruling: The court allowed Apotex to amend their pleadings to include inequitable conduct allegations.
• Specificity Requirements: Inequitable conduct must be pleaded with particularity.
• Impact on Litigation: The amended pleadings allow Apotex to proceed with their claims, potentially affecting the trial schedule.

FAQs

What are the main patents in dispute in the Intercept Pharmaceuticals, Inc. v. Apotex Inc. case?

The main patents in dispute are the "purity patents" (U.S. Pat. Nos. 9,238,673, 10,173,073, and 10,047,117) and the "particle size patents" (U.S. Pat. Nos. 10,052,337, 10,751,349, and 10,758,549).

What is the basis for the inequitable conduct allegations made by Apotex?

Apotex alleges that Intercept and its representatives made misleading declarations to the PTO regarding the purity and particle size of OCA batches, and that these actions were done with the intent to deceive.

Why did the court allow Apotex to amend their pleadings?

The court found that Apotex had shown good cause for the amendments and that permitting them would not result in undue prejudice to Intercept Pharmaceuticals.

What are the specificity requirements for pleading inequitable conduct?

Inequitable conduct must be pleaded with particularity, identifying the specific who, what, when, where, and how of the material misrepresentation or omission committed before the PTO.

How might the court's decision impact the trial schedule?

The court's decision to allow the amended pleadings may require additional fact discovery and time for responding to expert reports, which the parties must manage to maintain the trial schedule.

Sources

1. Intercept Pharm. v. Apotex Inc., United States District Court, D. Delaware, Sep 1, 2022, C. A. 20-1105-MN.
2. A SAD SCHEME OF ABUSIVE INTELLECTUAL PROPERTY LITIGATION, Columbia Law Review.
3. AMGEN INC. v. APOTEX INC., Court of Appeals for the Federal Circuit, July 5, 2016.
4. INTERCEPT PHARMACEUTICALS, INC., and INTERCEPT PHARMA EUROPE LTD., v. APOTEX INC., and APOTEX CORP., LLC, District of Delaware, March 4, 2022.
5. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW MEXICO, Case 1:20-cv-01105-JFR-KK Document 194 Filed 09.