DCT

1:21-cv-00732

Janssen Pharma Inc v. DR Reddys Laboratories

I. Executive Summary and Procedural Information

Parties & Counsel:
- Plaintiff: Bayer Pharma AG (Germany), Bayer AG (Germany), and Janssen Pharmaceuticals, Inc. (Pennsylvania)
- Defendant: Dr. Reddy's Laboratories, Inc. (New Jersey) and Dr. Reddy's Laboratories, Ltd. (India)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP; Williams & Connolly LLP; Sidley Austin LLP
Case Identification: 1:21-cv-00732, D. Del., 05/24/2021
Venue Allegations: Venue is alleged to be proper for the U.S. defendant based on its personal jurisdiction and prior consent to venue in the district, and for the foreign defendant based on its subjection to personal jurisdiction.
Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff’s 2.5 mg XARELTO® product constitutes an act of infringement of a patent covering a method of use for the drug.
Technical Context: The technology involves a specific combination drug therapy—low-dose rivaroxaban (an anticoagulant) and low-dose aspirin—used to reduce the risk of major cardiovascular events in patients with coronary or peripheral artery disease.
Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s submission of an ANDA with a Paragraph IV certification, asserting that its generic product would not infringe the patent-in-suit or that the patent is invalid. The patent-in-suit is listed in the FDA’s “Orange Book” for XARELTO®. A Supplemental Examination Certificate for the patent was issued on February 10, 2021, which concluded that no substantial new question of patentability was raised in the request.

Case Timeline

Date	Event
2018-02-02	’310 Patent Priority Date
2020-11-10	’310 Patent Issue Date
2021-02-10	’310 Patent Supplemental Examination Certificate Issued
2021-04-14	Dr. Reddy’s Notifies Plaintiffs of ANDA Filing
2021-05-24	Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 10,828,310 - "Reducing the Risk of Cardiovascular Events," issued November 10, 2020

The Invention Explained

Problem Addressed: The patent describes the high risk of major adverse cardiovascular events (e.g., heart attack, stroke) faced by patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD). It notes that prior antithrombotic treatment regimens were often limited by either insufficient efficacy compared to standard antiplatelet therapy or an unacceptably high risk of major bleeding. (’310 Patent, col. 2:1-29).
The Patented Solution: The invention is based on the discovery from a large-scale clinical trial (the COMPASS trial) that a specific combination therapy—a low dose of the anticoagulant rivaroxaban (2.5 mg twice daily) with a low dose of aspirin (75-100 mg daily)—can effectively reduce the risk of cardiovascular death, stroke, and myocardial infarction in this patient population, while maintaining an acceptable safety profile regarding bleeding events. (’310 Patent, Abstract; col. 3:51-55).
Technical Importance: This specific dosing regimen provided a method of treatment that successfully balanced the competing goals of therapeutic efficacy and patient safety, addressing a long-standing challenge in the long-term management of patients with stable atherosclerotic vascular disease. (’310 Patent, col. 17:41-52).

Key Claims at a Glance

The complaint asserts independent claim 1. (Compl. ¶35).
The essential elements of independent claim 1 are:
- A method of reducing the risk of myocardial infarction, stroke or cardiovascular death in a human patient with coronary artery disease and/or peripheral artery disease,
- comprising administering to the human patient rivaroxaban and aspirin in amounts that are clinically proven effective in reducing the risk of myocardial infarction, stroke or cardiovascular death in a human patient with coronary artery disease and/or peripheral arterial disease,
- wherein rivaroxaban is administered in an amount of 2.5 mg twice daily,
- and aspirin is administered in an amount of 75-100 mg daily.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the filing of the ANDA itself, which seeks FDA approval to market a generic version of Plaintiffs' 2.5 mg XARELTO® product. (Compl. ¶1). The complaint alleges that the proposed labeling for the Defendant's ANDA product will direct medical providers and patients to use it in a manner that practices the patented method—specifically, by instructing the administration of 2.5 mg rivaroxaban twice daily in combination with 75-100 mg of aspirin daily to reduce the risk of major cardiovascular events in patients with CAD or PAD. (Compl. ¶32).

Functionality and Market Context

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

’310 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A method of reducing the risk of myocardial infarction, stroke or cardiovascular death in a human patient with coronary artery disease and/or peripheral artery disease,	The proposed labeling for Defendant’s ANDA Product allegedly directs a method for this exact purpose in this specific patient population.	¶32	col. 3:51-60
comprising administering to the human patient rivaroxaban and aspirin in amounts that are clinically proven effective in reducing the risk of myocardial infarction, stroke or cardiovascular death in a human patient with coronary artery disease and/or peripheral arterial disease,	The complaint alleges Defendant's proposed labeling directs administration of rivaroxaban and aspirin in amounts that are "clinically proven effective" for the claimed purpose.	¶32	col. 4:5-9
wherein rivaroxaban is administered in an amount of 2.5 mg twice daily	Defendant's ANDA is for a 2.5 mg rivaroxaban tablet, and its proposed labeling allegedly instructs twice-daily administration.	¶¶29, 32	col. 4:9-10
and aspirin is administered in an amount of 75-100 mg daily.	Defendant’s proposed labeling allegedly directs co-administration with aspirin in the claimed dosage range.	¶32	col. 4:10-11

Identified Points of Contention:
- Legal Question: The primary issue in an ANDA case is whether the proposed product label will induce infringement. The complaint alleges that in its notice letter, Defendant "did not contest that the use of Dr. Reddy's ANDA Product in accordance with its proposed labeling would infringe the '310 patent." (Compl. ¶36). If this allegation is accurate, it raises the question of whether the infringement analysis is largely resolved, leaving patent validity as the central dispute.
- Scope Questions: A potential point of contention may arise from the claim phrase "clinically proven effective." A court will need to determine the scope of this term. A question for the court is whether this phrase is limited to the specific clinical trial data disclosed in the patent or if it has a broader meaning, and whether the term is sufficiently definite to satisfy the requirements of 35 U.S.C. § 112.

V. Key Claim Terms for Construction

The Term: "clinically proven effective"
Context and Importance: This term is a functional limitation that defines the required outcome of the administration step. Its construction is critical because it sets the evidentiary standard for both infringement and validity. Practitioners may focus on this term because defendants in pharmaceutical cases frequently challenge such functional, results-oriented language as being indefinite under 35 U.S.C. § 112.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself is not explicitly tied to a specific clinical trial. A party could argue that this phrase should be given its plain and ordinary meaning, covering any administration of the specified doses that is supported by competent and reliable clinical evidence of efficacy, regardless of whether that evidence is the specific trial cited in the patent.
- Evidence for a Narrower Interpretation: The patent specification is anchored in the results of the "phase III COMPASS trial." (’310 Patent, col. 3:26-28). The patent states that the "findings presented herein were obtained from" this trial. (Id.). A party could argue that "clinically proven effective" must be construed in light of this defining disclosure, meaning effectiveness as demonstrated by the COMPASS trial or a trial with a substantially similar design and outcome.

VI. Other Allegations

Indirect Infringement: The complaint alleges active inducement of infringement under 35 U.S.C. § 271(b). The factual basis is the allegation that Defendant, with knowledge of the '310 patent, created a proposed product label that instructs and encourages physicians and patients to perform the patented method. (Compl. ¶¶ 32, 38). The complaint also pleads contributory infringement, alleging the product is especially adapted for infringing use and is not suitable for a substantial non-infringing use. (Compl. ¶39).
Willful Infringement: The complaint alleges that Defendant has knowledge of the '310 patent, yet has "continued to assert its intent to engage in the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation" of its infringing product. (Compl. ¶37). This knowledge is allegedly based on the patent's listing in the FDA Orange Book and the statutory ANDA notification process.

VII. Analyst’s Conclusion: Key Questions for the Case

A central issue will be one of claim scope and validity: Is the term "clinically proven effective," as used in Claim 1, sufficiently definite under 35 U.S.C. § 112? The court's construction of this term—specifically, how it is defined by the clinical trial data disclosed in the patent—will likely determine the patent's ability to withstand a validity challenge.
A key legal question will be the consequence of pre-suit admissions: If, as alleged, the Defendant's Paragraph IV notice letter did not contest that its proposed label would result in infringement of the '310 patent, will that admission streamline the infringement portion of the case and shift the judicial focus almost exclusively to the patent's validity?