Litigation Details for ASTRAZENECA AB v. PERRIGO COMPANY PLC (D.N.J. 2015)

ASTRAZENECA AB v. PERRIGO COMPANY PLC (D.N.J. 2015)

Docket		Date Filed	2015-02-04
Court	District Court, D. New Jersey	Date Terminated	2017-06-09
Cause	35:271 Patent Infringement	Assigned To	Mary Little Cooper
Jury Demand	None	Referred To	Tonianne J. Bongiovanni
Patents	6,369,085; 6,428,810; 7,411,070
Link to Docket	External link to docket

Details for ASTRAZENECA AB v. PERRIGO COMPANY PLC (D.N.J. 2015)

Date Filed	Document No.	Description	Snippet	Link To Document
2015-02-04				External link to document
2015-02-03	1		The Patents-in-Suit 16. United States Patent No. 6,369,085 (“the ’085 patent”), entitled… sell products covered by United States Patent Nos. 6,369,085 and 7,411,070. 6. On information… 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… 18. United States Patent No. 7,411,070 (“the ’070 patent”), entitled “Form of S- omeprazole	External link to document
2015-02-03	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/Trademark Form filed. (jjc) (Entered: 02/09/2015) 9 February 2015 PACER Document	External link to document
2015-02-03	22		mg and The Patent-in-Suit 22. Plaintiffs admit United States Patent No. 6,369,085 (“the ’085… Plaintiffs admit United States Patent No. 7,411,070 (“the ’070 patent”), entitled “Form of S-Omeprazole…085 patent”), entitled “Form of S-Omeprazole,” was duly and legally issued by the United States Patent…certification with respect to the ’085 and ’070 patents. Plaintiffs deny the remaining allegations of … (Declaration of Non-Infringement of ’085 Patent) 34. Plaintiffs repeat and reassert	External link to document
2015-02-03	53		eight patents listed for NEXIUM 24HR® in the FDA’s Orange Book: U.S. Patent No. 6,369,085 (the “‘…“‘085 patent”) and U.S. Patent No. 7,411,070 (the “‘070 patent”). AstraZeneca did not assert any claims…infringement and invalidity as to U.S. Patent No. 6,428,810 (the “‘810 patent”). [Docket Entry No. 41]. Plaintiffs…Perrigo on the other patents listed in the Orange Book, including the ‘810 patent even though Perrigo…with infringement of the ‘810 patent, then discovery regarding this patent and a Markman hearing will	External link to document

Litigation Summary and Analysis for AstraZeneca AB v. Perrigo Company PLC (3:15-cv-01057)

Case Overview

The litigation between AstraZeneca AB and Perrigo Company PLC, filed as 3:15-cv-01057, is a complex patent dispute involving pharmaceutical products. Here is a detailed summary and analysis of the key points in this case.

Background

This case is part of a broader set of Hatch-Waxman litigation, which involves disputes over generic versions of patented pharmaceuticals. AstraZeneca AB, along with its subsidiaries, filed a lawsuit against Perrigo Company PLC and other defendants related to the generic version of AstraZeneca's drug Nexium® (esomeprazole magnesium delayed-release capsules)[2].

Patents in Dispute

The litigation centers around two patents: the '085 Patent and the '070 Patent, both related to the form of S-omeprazole. The '085 Patent was issued in 2002, and the '070 Patent, a divisional application of the '085 Patent, was issued in 2008. Both patents are set to expire on May 25, 2018[2].

Claim Construction

A critical aspect of this case is the claim construction hearing, which aimed to define key terms in the patents. The court had to construe the term "the magnesium salt of S-omeprazole trihydrate," which is central to both patents. The court reviewed intrinsic evidence, including the written description, prosecution history, and related prior art, as well as extrinsic evidence such as expert testimony[2].

Court Findings

The court's findings were crucial in determining the scope of the patents. The court concluded that the term "the magnesium salt of S-omeprazole trihydrate" should be interpreted based on its plain meaning and not limited by specific types of sterilization or other processes mentioned in the prosecution history. This interpretation was significant as it affected how the claims were to be understood and applied[2].

Appeals and Further Proceedings

The case involved appeals to the United States Court of Appeals for the Federal Circuit. In one related appeal, the Federal Circuit reversed and remanded a district court decision due to an incorrect claim construction. The appellate court affirmed other aspects of the district court's decision, including findings of obviousness and the dismissal of certain claims[3].

Antitrust Implications

While the primary focus was on patent infringement, the broader context of pharmaceutical litigation often involves antitrust considerations. In similar cases, companies have been accused of using patent litigation and settlement agreements to delay generic competition, which can have significant antitrust implications. For example, the FTC has taken action against pharmaceutical companies for engaging in anticompetitive practices to maintain monopoly power over branded drugs[4].

Expert Testimony and Evidence

The case relied heavily on expert testimony from both sides. Perrigo's experts, as well as those from AstraZeneca, presented arguments and evidence to support their respective positions on claim construction and patent validity. The court's decision was influenced by the weight and credibility of this expert testimony[2].

Impact on Generic Competition

The outcome of this litigation has significant implications for generic competition in the pharmaceutical market. AstraZeneca's efforts to protect its patents aim to delay the entry of generic versions of Nexium®, which could maintain higher prices for the branded drug. Conversely, Perrigo's success in challenging these patents could expedite the availability of lower-cost generic alternatives, benefiting consumers[2].

Key Takeaways

• Patent Claim Construction: The case highlights the importance of precise claim construction in patent litigation, which can significantly impact the scope and validity of patents.
• Antitrust Considerations: Pharmaceutical patent disputes often intersect with antitrust law, as companies may use litigation and settlements to delay generic competition.
• Expert Testimony: The credibility and weight of expert testimony are crucial in determining the outcome of complex patent disputes.
• Consumer Impact: The resolution of such cases can have a direct impact on the availability and pricing of essential medications.

FAQs

Q: What were the main patents involved in the AstraZeneca v. Perrigo litigation? A: The main patents involved were the '085 Patent and the '070 Patent, both related to the form of S-omeprazole.

Q: What was the central issue in the claim construction hearing? A: The central issue was the interpretation of the term "the magnesium salt of S-omeprazole trihydrate."

Q: How did the court's claim construction affect the case? A: The court's interpretation of the key term influenced how the claims were understood and applied, impacting the validity and scope of the patents.

Q: Were there any antitrust implications in this case? A: While not directly addressed in this specific case, similar pharmaceutical patent disputes often involve antitrust considerations related to delaying generic competition.

Q: What was the significance of expert testimony in this case? A: Expert testimony was crucial in supporting or challenging the claim constructions and patent validity, influencing the court's decision.

Sources

1. United States District Court District of New Jersey: AstraZeneca AB, Akeiebolaget v. Perrigo Company PLC, Civil Action No. 15-1057 (MLC)(DEA)[2].
2. United States Court of Appeals for the Federal Circuit: AstraZeneca LP v. Breath Ltd., No. 08-1512[3].
3. Federal Trade Commission: Overview of FTC Actions in Pharmaceutical Products[4].