Litigation Details for ASTRAZENECA AB v. HEC PHARM CO., LTD. (D.N.J. 2015)

ASTRAZENECA AB v. HEC PHARM CO., LTD. (D.N.J. 2015)

Docket		Date Filed	2015-08-05
Court	District Court, D. New Jersey	Date Terminated	2017-02-28
Cause	35:271 Patent Infringement	Assigned To	Mary Little Cooper
Jury Demand	None	Referred To	Tonianne J. Bongiovanni
Patents	6,369,085; 7,411,070; 8,466,175
Link to Docket	External link to docket

Details for ASTRAZENECA AB v. HEC PHARM CO., LTD. (D.N.J. 2015)

Date Filed	Document No.	Description	Snippet	Link To Document
2015-08-05				External link to document
2015-08-05	1		The Patents-in-Suit 14. United States Patent No. 6,369,085 (“the ’085 patent”), entitled… sell products covered by United States Patent Nos. 6,369,085; 7,411,070; and 8,466,175. 6. … This is a civil action for patent infringement arising under the patent laws of the United States, …been and still is the owner of the ’085 patent. The ’085 patent will expire on May 25, 2018, and pediatric…relating to the ’085 patent expires on November 25, 2018. 16. United States Patent No. 7,411,070	External link to document
2015-08-05	4		TRADEMARK NO. OR TRADEMARK 1 US 6,369,085 B1 4/9/2002 … PATENT OR DATE OF PATENT HOLDER OF PATENT OR TRADEMARK…Pleading PATENT OR DATE OF PATENT HOLDER OF PATENT OR TRADEMARK… ____ Trademarks or X Patents. ( ____ the patent action involves 35 U.S.C. § 292.) DOCKET… AO120 Patent Form filed. (km) (Entered: 08/06/2015) 5 August 2015 PACER Document	External link to document

Litigation Summary and Analysis for ASTRazeneca AB v. HEC Pharm Co., Ltd.

Introduction

The litigation between AstraZeneca AB and HEC Pharm Co., Ltd. is a complex patent infringement case that involves multiple patents and legal jurisdictions. Here, we will summarize the key points and analyze the significant aspects of this litigation.

Background

AstraZeneca AB, along with its subsidiaries, initiated litigation against HEC Pharm Co., Ltd. and its affiliates in response to HEC's filing of an Abbreviated New Drug Application (ANDA) for generic versions of AstraZeneca's Ticagrelor tablets. This litigation was filed in the United States District Courts for the District of Delaware and the District of New Jersey[5].

Patents in Dispute

The litigation centered around several patents held by AstraZeneca, including but not limited to, U.S. Patent Nos. 10,300,065 (the '065 patent) and RE46,276 (the '276 patent). HEC Pharm Co., Ltd. had submitted paragraph IV certifications stating that these patents were invalid, unenforceable, or would not be infringed by their generic versions of Ticagrelor tablets[5].

Initiation of Litigation

AstraZeneca initiated litigation within the statutory 45-day period following HEC's ANDA filing. The cases were filed in two different jurisdictions: the United States District Court for the District of Delaware (Civil Action No. 15-01041) and the United States District Court for the District of New Jersey (Civil Action No. 15-08082)[5].

Claims and Defenses

AstraZeneca alleged that HEC's generic Ticagrelor tablets infringed their patents. HEC, in turn, argued that the patents were invalid, unenforceable, or would not be infringed by their products. This is a common strategy in ANDA litigation, where the generic manufacturer challenges the validity and enforceability of the innovator's patents[5].

Court Proceedings

The litigation involved various legal proceedings, including claim construction hearings and bench trials. However, the specific details of these proceedings in the AstraZeneca v. HEC Pharm case are not as extensively documented in the provided sources as in other similar cases.

Outcome

The cases filed against HEC Pharm Co., Ltd. were eventually dismissed. The exact reasons for the dismissal are not detailed in the available sources, but it is common for such cases to be resolved through settlement, stipulation, or judicial decision[5].

Similar Cases and Precedents

In similar patent infringement cases involving AstraZeneca, such as AstraZeneca AB v. Mutual Pharmaceutical Co. and AstraZeneca AB v. Mylan Pharmaceuticals Inc., the courts have carefully examined claim constructions and the validity of the patents in question. For instance, in AstraZeneca AB v. Mutual Pharmaceutical Co., the court found that the defendant's products infringed AstraZeneca's patents based on a detailed comparison of the product components with the patent claims[1].

In AstraZeneca AB v. Mylan Pharmaceuticals Inc., the court's claim construction and the stipulated judgment of infringement were later vacated and remanded by the appellate court due to disagreements over the claim construction of specific patent elements[4].

Key Takeaways

• Patent Infringement Litigation: The case highlights the complexities and legal challenges involved in patent infringement litigation, particularly in the pharmaceutical industry.
• Claim Construction: The construction of patent claims is a critical aspect of such litigation, as seen in other AstraZeneca cases.
• ANDA Filings: Generic manufacturers often challenge the validity and enforceability of patents through ANDA filings, leading to extensive legal battles.
• Jurisdiction and Venue: The case was filed in multiple jurisdictions, which is common in patent litigation to ensure comprehensive legal coverage.

FAQs

1. What was the basis for AstraZeneca's litigation against HEC Pharm Co., Ltd.?

   • AstraZeneca initiated litigation in response to HEC Pharm Co., Ltd.'s filing of an ANDA for generic versions of Ticagrelor tablets, alleging patent infringement.

2. Which patents were involved in the litigation?

   • The litigation involved several patents, including U.S. Patent Nos. 10,300,065 and RE46,276.

3. In which courts were the cases filed?

   • The cases were filed in the United States District Courts for the District of Delaware and the District of New Jersey.

4. What was the outcome of the litigation?

   • The cases filed against HEC Pharm Co., Ltd. were eventually dismissed.

5. How common is it for patent infringement cases to be dismissed?

   • It is not uncommon for patent infringement cases to be resolved through dismissal, often due to settlement or stipulation.

Cited Sources:

1. ASTRAZENECA AB v. MUTUAL PHARMACEUTICAL CO., INC. - Casetext.
2. Case 3:03-cv-06025-FLW-TJB Document 640 Filed 06/05/09 - GovInfo.
3. Case 3:03-cv-06025-FLW-TJB Document 625 Filed 03/25/09 - GovInfo.
4. ASTRAZENECA AB v. MYLAN PHARMACEUTICALS INC. - CAFC.
5. Ticagrelor Tablets - accessdata.fda.gov - FDA.