Litigation Details for ASTRAZENECA AB v. APOTEX CORP. (D.N.J. 2015)

ASTRAZENECA AB v. APOTEX CORP. (D.N.J. 2015)

Docket		Date Filed	2015-05-15
Court	District Court, D. New Jersey	Date Terminated	2017-06-05
Cause	35:271 Patent Infringement	Assigned To	Freda L. Wolfson
Jury Demand	None	Referred To	Douglas Arpert
Parties	APOTEX INC.
Patents	8,536,206; 8,604,064; 8,618,142
Attorneys	MELISSA E. FLAX
Link to Docket	External link to docket

Details for ASTRAZENECA AB v. APOTEX CORP. (D.N.J. 2015)

Date Filed	Document No.	Description	Snippet	Link To Document
2015-05-15				External link to document
2015-05-15	1		expiration of U.S. Patent Nos. 8,536,206 (the “’206 patent”); 8,604,064 (the “’064 patent”); and 8,618,142…. This is an action for patent infringement arising under the patent laws of the United States, …8,618,142 (the “’142 patent”) (collectively, the “patents-in-suit”). … PATENTS-IN-SUIT 17. On September 17, 2013, the U.S. Patent and Trademark …copy of the ’206 patent is attached hereto as Exhibit A. The claims of the ’206 patent are valid and	External link to document

AstraZeneca AB v. Apotex Corp.: A Comprehensive Litigation Summary and Analysis

Introduction

The case of AstraZeneca AB v. Apotex Corp. is a significant patent infringement litigation that involved AstraZeneca AB (Astra) and Apotex Corp. (Apotex), among other defendants. This case revolves around the infringement of Astra's patents related to the drug omeprazole, a proton pump inhibitor used to treat gastroesophageal reflux disease (GERD) and other conditions.

Background

AstraZeneca held several patents for omeprazole, including those related to the drug's formulation and manufacturing process. Apotex, a generic drug manufacturer, entered the market with its own version of omeprazole, leading Astra to initiate litigation for patent infringement.

Initial Litigation and Infringement Finding

In the initial phase of the litigation, the district court found that Apotex had indeed infringed Astra's patents. This decision was affirmed by the United States Court of Appeals for the Federal Circuit in In re Omeprazole Patent Litig., 536 F.3d 1361 (Fed.Cir.2008)[4].

Damages Calculation

The subsequent phase of the litigation focused on determining the damages owed to Astra due to Apotex's infringement. The district court conducted a bench trial to calculate these damages based on a reasonable royalty theory.

Hypothetical Negotiation and Royalty Rate

The district court's analysis centered on a hypothetical negotiation between Astra and Apotex to determine a reasonable royalty rate. The court concluded that, in such a negotiation, Astra and Apotex would have agreed on a royalty rate of 50% of Apotex's profits from the sales of its infringing omeprazole product during the period of infringement (2003-2007)[1][3][4].

Apotex's Arguments

Apotex challenged the district court's damages award on several grounds:

• Market Genericization: Apotex argued that by November 2003, the market for omeprazole was already "well on its way to full genericization," suggesting that its entry caused minimal harm to Astra[1][3][4].
• Undue Emphasis on Astra's Market Control: Apotex contended that the court placed too much emphasis on Astra's ability to temporarily keep Apotex off the market by refusing to grant a license[1][3][4].
• Contemporaneous Licensing Agreements: Apotex argued that the court gave insufficient weight to contemporaneous licensing agreements that Astra had with other companies, which had lower royalty rates than 50%[1][3][4].

Federal Circuit's Decision

The Federal Circuit reviewed Apotex's arguments and upheld the district court's decision in part, while reversing and remanding in part. Here are the key points:

• Comparable Licenses and Settlements: The Federal Circuit found that the district court properly considered the similarities and differences between the hypothetical negotiation and other comparable licenses and settlements. For instance, Astra's settlements with Teva and Andrx were cited as evidence supporting the 50% royalty rate[1][3][4].
• Entire Market Value Rule: Apotex argued that the district court should have apportioned the damages based on the relative contribution of the patented feature (the sub-coating) to the overall value of the omeprazole product. However, the Federal Circuit did not find this argument persuasive, as the district court's approach was deemed appropriate given the circumstances[1][3][4].

Final Judgment and Appeal

The district court's final judgment awarded Astra $76,021,994.50 plus prejudgment interest. Apotex appealed this decision, leading to the Federal Circuit's review and partial affirmation of the district court's judgment[4].

Key Takeaways

• Reasonable Royalty Calculation: The case highlights the importance of a thorough analysis in determining reasonable royalty rates in patent infringement cases.
• Market and Licensing Considerations: The decision underscores the need to consider market conditions and contemporaneous licensing agreements when assessing damages.
• Federal Circuit's Role: The Federal Circuit's review ensures that district courts adhere to established legal principles in patent infringement cases.

FAQs

1. What was the main issue in the AstraZeneca AB v. Apotex Corp. case? The main issue was the calculation of damages due to Apotex's infringement of AstraZeneca's omeprazole patents.

2. What was the royalty rate determined by the district court? The district court determined a royalty rate of 50% of Apotex's profits from the sales of its infringing omeprazole product.

3. Why did Apotex challenge the district court's damages award? Apotex challenged the award because it believed the court overcompensated Astra, ignored market genericization, and gave undue emphasis on Astra's market control.

4. What was the Federal Circuit's decision regarding Apotex's arguments? The Federal Circuit upheld the district court's decision in part, affirming the use of comparable licenses and settlements to determine the royalty rate.

5. What was the final judgment awarded to AstraZeneca? The final judgment awarded AstraZeneca $76,021,994.50 plus prejudgment interest.

Cited Sources

1. JDSupra - AstraZeneca AB v. Apotex Corp.
2. Wiley - Federal Circuit Patent Bulletin: AstraZeneca AB v. Apotex Corp.
3. Casetext - AstraZeneca AB v. Apotex Corp., 782 F.3d 1324