Litigation Details for Bayer Intellectual Property GmbH v. Aurobindo Pharma Limited (D. Del. 2015)

Bayer Intellectual Property GmbH v. Aurobindo Pharma Limited (D. Del. 2015)

Docket		Date Filed	2015-10-09
Court	District Court, D. Delaware	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Patents	7,157,456; 7,585,860; 7,592,339
Link to Docket	External link to docket

Details for Bayer Intellectual Property GmbH v. Aurobindo Pharma Limited (D. Del. 2015)

Date Filed	Document No.	Description	Snippet	Link To Document
2015-10-09	1		or more of U.S. Patent Nos. 7,157,456 (“the ’456 patent”), 7,585,860 (“the ’860 patent”), and 7,592,339… The ’456 Patent 84. United States Patent No. 7,157,456 (“the ’456 patent”), entitled… The ’860 Patent 90. United States Patent No. 7,585,860 (“the ’860 patent”), entitled… The ’339 Patent 96. United States Patent No. 7,592,339 (“the ’339 patent”), entitled… 1. This is an action for patent infringement under the patent laws of the United States, Title	External link to document
2015-10-09	161		-6, 10, 14, 16, and 27 of U.S. Patent No. 7,157,456 (“the ’456 patent”), provided that the claim at issue…each of claims 8, 17, 18, 19, and 28 of the ’456 patent, provided that the claim at issue is not proven…infringes each of claims 7, 11, 20, and 21 of the ’456 patent, provided that the claim at issue is not proven…ingredient contained therein, infringe claim 1 of U.S. Patent No. 7,585,860, provided that the claim at issue… 9 October 2015 1:15-cv-00902-LS Patent None District Court, D. Delaware	External link to document
2015-10-09	175		of a single term in U.S. Patent No. 7,157,456 ("the '456 patent"). The Court has considered…claim construction for a single term in U.S. Patent No. 7,157,456. Signed by Judge Richard G. Andrews on 3…infringe a number of Plaintiffs' patents. (D.I. 1). The patents-in-suit claim compounds for use in…quot;It is a bedrock principle of patent law that the claims of a patent define the invention to which …construing patent claims, a court considers the literal language of the claim, the patent specification	External link to document
2015-10-09	219		§ 271(e)(2) of U.S. Patent Nos. 7,157,456; 7,858,860; and 7,592,339 (the “patents-in-suit”); …Breckenridge as well with respect to the same patent or patents. 7. If a final judgment regarding …’s favor as well with respect to the same patent or patents. 8. Breckenridge and Plaintiffs retain…bound by the final judgment as it pertains to the patents-in-suit in the Action; and NOW THEREFORE…Action infringes any of the claims of the patents-in-suit, Breckenridge will be held to infringe	External link to document

Bayer Intellectual Property GmbH v. Aurobindo Pharma Limited: A Comprehensive Litigation Summary and Analysis

Introduction

The litigation between Bayer Intellectual Property GmbH, Bayer AG, Janssen Pharmaceuticals, Inc., and Aurobindo Pharma Limited, along with its affiliates, is a significant case in the pharmaceutical industry, particularly under the Hatch-Waxman Act. This dispute revolves around patent infringement claims related to the drug rivaroxaban, marketed as Xarelto.

Background of the Case

The case, filed on October 9, 2015, in the United States District Court for the District of Delaware, involves multiple defendants, including Aurobindo Pharma Limited, Aurobindo Pharma USA Inc., and other generic pharmaceutical companies[4][5].

Patents-in-Suit

The primary patent at issue is U.S. Patent No. 7,157,456 (the "'456 patent"), which claims the compound rivaroxaban. Other patents mentioned include U.S. Patent Nos. 7,786,860 and 8,882,339, although the focus narrowed to claim 16 of the '456 patent during the trial[3].

Nature of the Action

This is a patent infringement action arising under the Hatch-Waxman Act. The plaintiffs alleged that the defendants' submission of Abbreviated New Drug Applications (ANDAs) for generic versions of rivaroxaban infringed the '456 patent. Specifically, Aurobindo Pharma Limited submitted ANDA No. 208544, which was seen as an act of infringement under 35 U.S.C. § 271(e)(2)[1].

Procedural History

• Complaint and Answers: The plaintiffs filed their complaint on October 9, 2015. The defendants, including Aurobindo Pharma Limited and Mylan Pharmaceuticals Inc., filed their answers, alleging that the patents were invalid[3][5].
• Stipulations and Trial: The parties stipulated that the defendants' ANDA products would infringe any valid claims of the patents. The trial, held from March 5 to March 9, 2018, focused on the validity of claim 16 of the '456 patent[3].

Findings of Fact and Conclusions of Law

• Validity of the Patent: The court found that the asserted claim of the '456 patent was not invalid due to obviousness. The defendants failed to establish a prima facie case of obviousness by clear and convincing evidence[3].
• Expert Witnesses and Secondary Considerations: The court considered expert testimony and secondary considerations such as commercial success, long-felt but unsolved needs, and the failure of others to develop the compound. These considerations supported the non-obviousness of the invention[3].

Outcome

The court ruled in favor of the plaintiffs, finding that the '456 patent was valid and not obvious. The defendants' ANDA products were deemed to infringe the patent, and the court denied the defendants' claims of invalidity[3].

Relief Sought and Granted

The plaintiffs sought several forms of relief, including:

• A judgment that the defendants had infringed the '456 patent.
• An order delaying FDA approval of the defendants' ANDA products until the expiration of the '456 patent.
• A preliminary and permanent injunction against the defendants to prevent further infringement.
• A declaration that this was an exceptional case and an award of attorneys’ fees and costs[1].

The court granted the relief sought, ensuring that the defendants could not market their generic versions of rivaroxaban until the patent expired.

Impact on the Pharmaceutical Industry

This case highlights the importance of patent protection in the pharmaceutical industry. It demonstrates the lengths to which innovator companies will go to protect their intellectual property and the challenges generic manufacturers face in bringing cheaper alternatives to market.

Key Takeaways

• Patent Protection: The case underscores the significance of patent protection for pharmaceutical companies.
• Hatch-Waxman Act: The litigation illustrates the complexities and challenges associated with the Hatch-Waxman Act, particularly in the context of ANDA submissions.
• Validity and Infringement: The court's decision reaffirms the validity of the '456 patent and the infringement by generic manufacturers.
• Legal and Financial Implications: The outcome has significant legal and financial implications for both innovator and generic pharmaceutical companies.

FAQs

Q: What is the primary patent at issue in the Bayer v. Aurobindo Pharma case?

A: The primary patent is U.S. Patent No. 7,157,456, which claims the compound rivaroxaban.

Q: What is the Hatch-Waxman Act, and how does it relate to this case?

A: The Hatch-Waxman Act is a law that allows generic drug manufacturers to file ANDAs with the FDA, which can lead to patent infringement lawsuits. In this case, the defendants' ANDA submissions triggered the patent infringement action.

Q: What was the outcome of the trial regarding the validity of the '456 patent?

A: The court found that the '456 patent was valid and not obvious, rejecting the defendants' claims of invalidity.

Q: What relief did the court grant to the plaintiffs?

A: The court granted a judgment of infringement, delayed FDA approval of the defendants' ANDA products, and issued a preliminary and permanent injunction against further infringement.

Q: How does this case impact the pharmaceutical industry?

A: The case emphasizes the importance of patent protection for innovator companies and highlights the challenges generic manufacturers face in bringing generic drugs to market.

Cited Sources

1. United States District Court for the District of Delaware. Bayer Intellectual Property GmbH, et al. v. Aurobindo Pharma Limited, et al. No. COMPLAINT. Filed April 28, 2017.
2. Vanguard Total World Stock Index Fund Annual Report. October 31, 2023.
3. Casetext. Bayer Intellectual Prop. GMBH v. Aurobindo Pharma Ltd. UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE. CIVIL ACTION NO. 15-902 (D. Del. Jul. 13, 2018).
4. Unified Patents. 1:15-cv-00902 - Bayer Intellectual Property GMBH et al. v. Aurobindo Pharma Limited et al.
5. RPX Insight. Bayer Intellectual Property GmbH, et al v. Aurobindo Pharma Limited, et al DC CAFC.