Litigation Details for AstraZeneca AB v. Zydus Pharmaceuticals (USA) Inc. (D. Del. 2018)

AstraZeneca AB v. Zydus Pharmaceuticals (USA) Inc. (D. Del. 2018)

Docket		Date Filed	2018-05-01
Court	District Court, D. Delaware	Date Terminated	2022-07-28
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Parties	ASTRAZENECA AB
Patents	10,232,003; 10,406,172; 6,414,126; 6,515,117; 7,851,502; 7,919,598; 7,943,582; 7,943,788; 8,221,786; 8,222,219; 8,361,972; 8,501,698; 8,513,202; 8,551,957; 8,685,934; 8,716,251; 8,785,403
Attorneys	Myoka Kim Goodin
Firms	Phillips, Goldman, McLaughlin & Hall, P.A.
Link to Docket	External link to docket

Details for AstraZeneca AB v. Zydus Pharmaceuticals (USA) Inc. (D. Del. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-05-01				External link to document
2018-05-01	11	Patent/Trademark Report to Commissioner of Patents	the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 7,851,502 ;7,919,598 ;8,221,786…2018 28 July 2022 1:18-cv-00664 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2018-05-01	102	Notice of Service	Invalidity of the Asserted Claims of U.S. Patent No. 6,515,117; (2) the Reply Expert Report of Garry Tobin…Invalidity of the Asserted Claims of U.S. Patent No. 6,515,117; and (3) the Expert Report of Radojka Savic…2018 28 July 2022 1:18-cv-00664 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2018-05-01	128	Redacted Document	ANDA Products”) infringes U.S. Patent No. 6,515,117 (“the ’117 patent”); WHEREAS, Zydus has …has asserted that the claims of the ‘117 patent are invalid and, therefore, not infringed; WHEREAS…2018 28 July 2022 1:18-cv-00664 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2018-05-01	139	Redacted Document	Objections United States Patent No. 10,406,172 - … U.S. Patent No. 6,774,112 (“the ’112 patent”) on August 10, 2004. 90. U.S. Patent Application… preclude patentability”). 17. When a patent challenger contends that a patent is obvious…Its NDA, and the ’117 Patent 1. This is a civil action for patent infringement, arising …AstraZeneca’s Orange Book-listed U.S. Patent No. 6,515,117 (“the ’117 patent”). One indication of FARXIGA®	External link to document
2018-05-01	145	Exhibit List	May 17 | “Vier | semen, | United States Patent No. 6,515,117 0004 May 17 |", | “"""…quot;"| Certified File History for U.S. Patent 6,515,117 0027 May 17 Gribble | Gribble |Confidential…0090 May 17 | Gribble | Gribble | United States Patent No. 7,863,327 - Gribble et al. 0091 May 17 IGribble…USA) Inc.'s Invalidity Contentions for U.S. Patent Nos. 7,943,788; 8,785,403 & 8,785,403 01 54…iemaay’ | Certified File History for United States Patent Application No. 16/014,479 0263 May 18 | Batchelor	External link to document
2018-05-01	170	Opinion	for infringement of U.S . Patent Nos. 6,414,126 ("the ' 126 patent") and 6,515,117 ("…the '117 Patent (PTX0242 at 183) Claims 14 and 16 of the ' 117 patent teach methods …quot;the ' 117 patent") under 35 U.S.C. § 271(e)(2)(A). (D.I. 1). I held a four-day bench trial…validity of claims 1-3, 14, and 16 of the ' 117 patent. (D.I. 135, ,rs ; Tr. at 2:22-3:1; see D.I. 66 … BACKGROUND The '117 patent is directed to compounds and methods for treatment	External link to document

AstraZeneca AB v. Zydus Pharmaceuticals (USA) Inc.: A Comprehensive Litigation Summary and Analysis

Case Overview

The case of AstraZeneca AB v. Zydus Pharmaceuticals (USA) Inc., filed as Civil Action No. 18-664-RGA in the U.S. District Court for the District of Delaware, revolves around a patent infringement dispute related to AstraZeneca's diabetes treatment drug, Farxiga (dapagliflozin)[1][3][5].

Background

AstraZeneca AB brought this action against Zydus Pharmaceuticals, Inc. on May 1, 2018, alleging infringement of U.S. Patent Nos. 6,414,126 and 6,515,117 under 35 U.S.C. § 271(e)(2)(A). The '117 patent is specifically directed to compounds and methods for treating diabetes and related diseases through the inhibition of sodium-dependent glucose transporters (SGLT2) found in the intestine and kidney[1][3][5].

Zydus's ANDA and Paragraph IV Certification

Zydus filed an Abbreviated New Drug Application (ANDA) No. 211582 with the FDA, seeking approval to manufacture, use, and sell a generic version of dapagliflozin. As part of this process, Zydus sent a Paragraph IV certification to AstraZeneca, asserting that the '117 patent was either invalid or not infringed by Zydus's ANDA product[1][3][5].

Trial and Dispute Narrowing

The case proceeded to a four-day bench trial before Judge Richard G. Andrews. By the time of the trial, the dispute had narrowed to the validity of claims 1-3, 14, and 16 of the '117 patent. Zydus argued that these claims were invalid due to obviousness[1][3][5].

Obviousness Argument

Zydus's argument for obviousness was based on three prior art references: WO '128, Hongu, and Kees. Zydus claimed that the patented compound was a minor modification of compounds disclosed in these references. However, the court found that WO '128 did not disclose comparative biological activity for any listed compound, and neither Hongu nor Kees provided a lead compound for further development. Moreover, both Hongu and Kees taught away from the patented modification, as they showed decreased biological activity resulting from such modifications[1][5].

Court's Decision

The court ruled that Zydus failed to prove by clear and convincing evidence that a person of ordinary skill in the art (POSA) would have had an affirmative reason to make the necessary modifications to render dapagliflozin obvious. The court emphasized that it was not sufficient for Zydus to show that the prior art references did not teach away from the modification; rather, Zydus needed to demonstrate a positive reason for making the change. Since Zydus did not meet this burden, the court found that claims 1-3, 14, and 16 of the '117 patent were not obvious[1][3][5].

Secondary Considerations

The court also addressed secondary considerations of non-obviousness, such as unexpected results, but found that these considerations were irrelevant since Zydus had not established obviousness in the first place[1][5].

Conclusion and Implications

The court concluded that Zydus had failed to prove any of the asserted claims were obvious and, as a result, found each of the asserted claims infringed. This decision was a complete win for AstraZeneca, securing over seven years of patent protection for Farxiga, a drug crucial for treating type 2 diabetes and related conditions[1][3][5].

Industry Impact

This case highlights the ongoing battles in the pharmaceutical industry to protect intellectual property rights. It underscores the importance of robust patent protection for innovative drugs and the challenges generic manufacturers face when attempting to enter the market with similar products. The decision reinforces the high bar set for proving obviousness and the necessity of clear and convincing evidence in such cases[2][4].

Key Takeaways

• Patent Protection: The case emphasizes the importance of strong patent protection for innovative pharmaceuticals.
• Obviousness Standard: The court's decision reiterates the high standard for proving obviousness, requiring clear and convincing evidence that a POSA would have had an affirmative reason to make the necessary modifications.
• Generic Entry Barriers: The ruling highlights the barriers generic manufacturers face when trying to enter the market with products that infringe on existing patents.
• Litigation Strategy: The case demonstrates the strategic importance of thorough analysis of prior art and the need to address secondary considerations of non-obviousness.

Frequently Asked Questions

Q: What was the main issue in the AstraZeneca AB v. Zydus Pharmaceuticals (USA) Inc. case?

A: The main issue was whether Zydus's proposed generic version of Farxiga (dapagliflozin) infringed AstraZeneca's '117 patent and whether the claims of the '117 patent were obvious.

Q: What were the key prior art references cited by Zydus?

A: Zydus cited WO '128, Hongu, and Kees as prior art references to argue for obviousness.

Q: Why did the court reject Zydus's obviousness argument?

A: The court rejected Zydus's argument because Zydus failed to show by clear and convincing evidence that a POSA would have had an affirmative reason to make the necessary modifications to render dapagliflozin obvious.

Q: What was the outcome of the case?

A: The court found that Zydus had failed to prove any of the asserted claims were obvious and, therefore, found each of the asserted claims infringed.

Q: What are the implications of this decision for the pharmaceutical industry?

A: The decision reinforces the importance of strong patent protection for innovative drugs and sets a high bar for generic manufacturers attempting to enter the market with similar products.

Cited Sources

1. U.S. District Court for the District of Delaware, Civil Action No. 18-664-RGA ZYDUS PH, May 1, 2018.
2. Law.com, AstraZeneca Files Flurry of Lawsuits to Protect Cancer Treatment Drug, January 10, 2025.
3. Justia, AstraZeneca AB v. Zydus Pharmaceuticals (USA) Inc., No. 1:18-cv-00664, October 15, 2021.
4. Finnegan, Protecting a blockbuster diabetes treatment for AstraZeneca, 2021.
5. Robins Kaplan LLP, AstraZeneca AB v. Zydus Pharms. (USA) Inc., February 7, 2022.