Litigation Details for Bayer Intellectual Property GMBH v. Taro Pharmaceutical Industries Ltd. (D. Del. 2017)

Bayer Intellectual Property GMBH v. Taro Pharmaceutical Industries Ltd. (D. Del. 2017)

Docket		Date Filed	2017-04-21
Court	District Court, D. Delaware	Date Terminated	2020-09-02
Cause	35:271 Patent Infringement	Assigned To	Timothy Belcher Dyk
Jury Demand	None	Referred To
Parties	ALEMBIC PHARMACEUTICALS LIMITED
Patents	6,168,016; 7,157,456; 7,585,860; 7,592,339; 9,415,053; 9,539,218
Attorneys	Daniel R. Evans
Firms	Abrams & Bayliss LLP
Link to Docket	External link to docket

Details for Bayer Intellectual Property GMBH v. Taro Pharmaceutical Industries Ltd. (D. Del. 2017)

Date Filed	Document No.	Description	Snippet	Link To Document
2017-04-21				External link to document
2017-04-21	102	Stipulation-General (See Motion List for Stipulation to Extend Time)	Proposed] Order Regarding Infringement of U.S. Patent No. 9,539,218 by Sigmapharm Laboratories, LLC. (Myer, … 2 September 2020 1:17-cv-00462 830 Patent None District Court, D. Delaware	External link to document
2017-04-21	108	Stipulation-General (See Motion List for Stipulation to Extend Time)	Proposed] Order Regarding Infringement of U.S. Patent No. 9,539,218 by InvaGen Pharmaceuticals, Inc.. (Myer,… 2 September 2020 1:17-cv-00462 830 Patent None District Court, D. Delaware	External link to document
2017-04-21	109	Order	1-4 of U.S. Patent No. 9,539,218 ("the Asserted Claims of the '218 Patent"), provided…and Order Regarding Infringement of U.S. Patent No. 9,539,218. Signed by Judge Richard G. Andrews on 7… INFRINGEMENT OF U.S. PATENT NO. 9,539,218 Plaintiff Bayer Intellectual Property…infringement of the Asserted Claims of the '218 Patent, provided the claim at issue is not proven invalid…infringement of the Asserted Claims of the '218 patent. 4. Nothing in this stipulation shall	External link to document
2017-04-21	150	Pretrial Order	assert all four claims of U.S. Patent No. 9,539,218 (“the ’218 patent”). 2. By letter dated…the ’218 patent. Plaintiffs timely filed complaints alleging infringement of the ’218 patent against …Legible, accurate copies of United States patents and foreign patents, as well as their corresponding prosecutions… 1. This is a consolidated action for patent infringement under the Hatch-Waxman Act. Plaintiffs…rivaroxaban tablets prior to the expiration of the ’218 patent. Mylan’s letter also notified BIP and Janssen	External link to document
2017-04-21	156		on U.S. Patent No. 7,157,456 (“the ’456 patent”), which is not prior art. The ’456 patent issued from…The patents covering Xarelto 10 mg, 15 mg, and 20 mg tablets are U.S. Patent Nos 7,157,456, 7,… 1/2/2007 Certified Copy of U.S. Patent No. 7,157,456 B2 Kubitza…JOINT_RIV0000346 – 1/2/2007 U.S. Patent No. 7,157,456 …reference to a U.S. patent or U.S. patent application publication, which patent or patent application publication	External link to document

Bayer Intellectual Property GMBH v. Taro Pharmaceutical Industries Ltd.: A Comprehensive Litigation Summary and Analysis

Introduction

The litigation between Bayer Intellectual Property GMBH and Taro Pharmaceutical Industries Ltd. is a significant case in the realm of patent law, particularly involving pharmaceuticals. This dispute revolves around the infringement of Bayer's patents related to the drug rivaroxaban, a key component in the medication Xarelto.

Background

Bayer Intellectual Property GMBH, along with other affiliated companies, holds several patents related to rivaroxaban, a compound used to treat thromboembolic disorders. Taro Pharmaceutical Industries Ltd., among other generic drug manufacturers, has been accused of infringing these patents through the submission of Abbreviated New Drug Applications (ANDAs) to the U.S. Food and Drug Administration (FDA)[4].

Procedural History

The case, filed on May 19, 2017, involves Bayer's allegations that Taro and other generic drug companies infringed claims 1-4 of the '218 patent. This patent pertains to the formulation and manufacture of rapid-release rivaroxaban tablets. The litigation is part of a broader series of cases under the Hatch-Waxman Act, which governs the approval of generic drugs in the United States[4].

Key Issues in Dispute

Claim Construction

A central issue in the case is the construction of the term "rapid-release tablet." Bayer argued that this term should be defined as "a tablet which, according to the USP release method using apparatus 2 (paddle), has a Q value (30 minutes) of 75%." In contrast, Taro and other defendants suggested a broader definition: "a tablet that is not a modified- (e.g., sustained- or retarded-) release tablet"[4].

Court Ruling on Claim Construction

On July 3, 2018, the court adopted Bayer's proposed construction in a Markman order, defining "rapid-release tablet" in line with Bayer's argument. This ruling was crucial as it determined whether the defendants' tablets would be considered infringing based on the specific release characteristics[4].

Infringement Stipulation

Following the claim construction ruling, the parties stipulated that if the court's construction of "rapid-release tablet" was upheld, Taro's proposed rivaroxaban tablets would literally infringe each of claims 1-4 of the '218 patent. This stipulation streamlined the litigation process by acknowledging infringement if Bayer's claim construction was validated[4].

Expert Testimony and Supplemental Briefs

In March 2019, the court ordered the parties to submit supplemental claim construction briefs and expert testimony on whether the court's construction of "rapid-release tablet" covers tablets that release more than 75% of the active ingredient within 30 minutes. Both parties agreed that no evidentiary hearing was necessary, and the court ultimately supported Bayer's construction based on the referenced patent application PCT/04/012897[4].

Patent Validity Challenges

While the primary focus was on claim construction and infringement, the defendants also challenged the validity of the '218 patent. However, the court's findings and the stipulations made by the parties did not delve deeply into the validity issues in this specific case, as the main contention was centered around the claim construction and its implications for infringement[4].

Similar Cases and Context

This case is part of a larger landscape of patent litigation involving rivaroxaban. Similar cases, such as Bayer Intellectual Property GMBH v. Aurobindo Pharma Ltd., have also involved challenges to the validity and infringement of Bayer's patents related to rivaroxaban. In these cases, courts have often grappled with issues of obviousness and the inventive step required for patentability[3].

Impact and Implications

The outcome of this case has significant implications for both Bayer and generic drug manufacturers. The court's ruling on claim construction sets a precedent for how similar patents will be interpreted in future cases. For Bayer, a favorable ruling helps maintain its exclusive rights to manufacture and market rivaroxaban tablets, protecting its intellectual property. For generic manufacturers, the ruling may delay or prevent the entry of generic versions of the drug into the market, affecting competition and pricing[4].

Key Takeaways

• Claim Construction: The court's definition of "rapid-release tablet" is critical in determining infringement.
• Infringement Stipulation: Taro acknowledged infringement based on the court's claim construction.
• Patent Validity: While challenged, the validity of the '218 patent was not the primary focus in this case.
• Broader Context: This case is part of ongoing patent litigation involving rivaroxaban.
• Impact: The ruling affects the market entry of generic rivaroxaban tablets and protects Bayer's intellectual property.

FAQs

What is the main issue in the Bayer v. Taro Pharmaceutical case?

The main issue is the construction of the term "rapid-release tablet" and whether Taro's proposed rivaroxaban tablets infringe Bayer's '218 patent.

What is the significance of the Markman order in this case?

The Markman order defined "rapid-release tablet" in line with Bayer's argument, which was crucial for determining infringement.

Did the court find Taro's tablets to be infringing?

Yes, based on the stipulation, if the court's construction of "rapid-release tablet" was upheld, Taro's tablets would be considered infringing.

What is the broader context of this litigation?

This case is part of a series of patent litigations involving rivaroxaban, with similar cases challenging the validity and infringement of Bayer's patents.

How does this ruling impact the pharmaceutical market?

The ruling delays or prevents the entry of generic versions of rivaroxaban into the market, affecting competition and pricing.

Cited Sources

1. Bayer Intellectual Property GMBH and Others v Dr Reddy's Laboratories (Pty) Ltd - SAFLII
2. Bayer Intellectual Property GMBH et al v. Taro Pharmaceutical Industries Ltd. - Justia
3. Bayer Intellectual Prop. GMBH v. Aurobindo Pharma Ltd. - Casetext
4. Bayer Intellectual Prop. GMBH v. Taro Pharm. Indus. Ltd. - Casetext
5. Bayer Intellectual Property GMBH et al v. Taro Pharmaceutical Industries Ltd. - Law360