Litigation Details for Hospira, Inc. v. Fresenius Kabi USA, LLC (N.D. Ill. 2016)

Hospira, Inc. v. Fresenius Kabi USA, LLC (N.D. Ill. 2016)

Docket		Date Filed	2016-01-15
Court	District Court, N.D. Illinois	Date Terminated	2018-12-17
Cause	35:271 Patent Infringement	Assigned To
Jury Demand	None	Referred To
Parties	FRESENIUS KABI USA, LLC
Patents	6,716,867; 8,242,158; 8,338,470; 8,455,527; 8,648,106; 9,320,712; 9,616,049
Attorneys	Tara Lauren Kurtis
Firms	Schiff Hardin LLP
Link to Docket	External link to docket

Details for Hospira, Inc. v. Fresenius Kabi USA, LLC (N.D. Ill. 2016)

Date Filed	Document No.	Description	Snippet	Link To Document
2016-01-15				External link to document
2016-01-14	1		infringement of U.S. Patent Nos. 8,242,158 (the “‘158 patent”) (Ex. A); 8,338,470 (the “‘470 patent”) (Ex. B); … COUNT I FOR INFRINGEMENT OF PATENT NO. 8,242,158 22. Paragraphs 1 through… claims of the ‘158 patent, the ‘470 patent, the ‘527 patent, and the ‘106 patent are invalid and/or … “‘527 patent”) (Ex. C); and 8,648,106 (the “‘106 patent”) (Ex. D) (collectively, the “Patents-in-suit… THE PATENTS-IN-SUIT 9. The ‘158 patent, entitled “Dexmedetomidine	External link to document
2016-01-14	69		. No. 6,716,867.” (‘527 Patent, JA-34, col. 10 ll. 33–35.) The patent referenced, No. 6,716,867, is the…The claim terms in the '158 Patent, '470 Patent, '527 Patent, and '106 Patent are construed as stated in…The claim terms in the ‘158 Patent, ‘470 Patent, ‘527 Patent, and ‘106 Patent are construed as follows:…8,242,158 (the “ ‘158 Patent”), 8,338,470 (the “ ‘470 Patent”), 8,455,527 (the “ ‘527 Patent”), and 8,648,106…106 Patent, JA-43.) The Patent Office issued the patents between August 14, 2012, and February 11, 2014	External link to document
2016-01-14	176	Order on Motion for Leave to File	obtained four patents covering a new product made from dexmedetomidine: U.S. Patent Nos. 8,242,158 (the “’158…’158 Patent”), 8,338,470 (the “’470 Patent”), 8,455,527 (the “’527 Patent”), and 8,648,106 (the “’106…product—U.S. Patent No. 9,616,049 (the “’049 Patent”)—and filed a second complaint of patent infringement…obtained a patent that disclosed and claimed the compound: U.S. Patent No. 4,910,214 (the “’214 Patent”), JTX…named co- inventors of the patents-in-suit. (See ’106 Patent, JTX 1; ’049 Patent, JTX 2.) Dr. Roychowdhury	External link to document

Hospira, Inc. v. Fresenius Kabi USA, LLC: A Comprehensive Litigation Summary and Analysis

Case Overview

The case of Hospira, Inc. v. Fresenius Kabi USA, LLC involves a patent infringement dispute centered around the pharmaceutical product dexmedetomidine, marketed by Hospira under the brand name Precedex. Here is a detailed summary and analysis of the key points in this litigation.

Background of the Case

Hospira, Inc., a Delaware corporation with its primary place of business in Illinois, developed and patented a ready-to-use, premixed version of dexmedetomidine called Precedex Premix. This product is a diluted version of the previously available concentrated form, Precedex Concentrate, which required dilution with saline before administration[2][4].

Patents in Suit

Hospira obtained several patents covering the premixed dexmedetomidine product, including U.S. Patent Nos. 8,242,158, 8,338,470, 8,455,527, and 8,648,106. A fifth patent, U.S. Patent No. 9,616,049, was obtained in 2017[2][4].

Fresenius Kabi's ANDA Filing

In December 2015, Fresenius Kabi USA, LLC, an American subsidiary of a German pharmaceutical manufacturer, filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market its own premixed dexmedetomidine product before the expiry of Hospira's patents[2][4].

Litigation Initiation

Hospira filed a patent infringement lawsuit against Fresenius Kabi in January 2016, alleging that Fresenius Kabi's proposed product would infringe on Hospira's patents. Fresenius Kabi denied the allegations and counterclaimed for a declaration that the patents were invalid or that their actions would not infringe[2][4].

Claim Construction and Limitation

Following a claim construction order in November 2017, the parties agreed to limit the number of patent claims asserted. Hospira dropped all claims except for claim 6 of the '106 Patent and claim 8 of the '049 Patent. Fresenius Kabi stipulated that its proposed product would infringe these claims but continued to challenge their validity[2][4].

Bench Trial and Validity of Claims

The court held a five-day bench trial from July 16 to July 20, 2018, to determine the validity of the remaining claims. After reviewing the evidence and the parties' briefs, the court concluded that Fresenius Kabi had established by clear and convincing evidence that both claims were invalid as obvious[2][3].

Obviousness Determination

The court found that the premixed dexmedetomidine formulation was not a novel invention but rather an obvious extension of the existing concentrated form. Hospira failed to present evidence of secondary considerations, such as unexpected results or the failure of others to develop a similar product, which could have supported the non-obviousness of the claims. The court noted that the long-felt need for a ready-to-use product did not suffice to overcome the obviousness determination since Hospira did not provide affirmative evidence or arguments regarding secondary considerations[1][2].

Impact of the Decision

The court's decision invalidated claims 6 of the '106 Patent and claim 8 of the '049 Patent, allowing Fresenius Kabi to proceed with its ANDA for a generic version of the premixed dexmedetomidine product. This outcome highlights the importance of robust patent protection and the need for patent holders to demonstrate the non-obviousness of their inventions through strong evidence of secondary considerations[1][3].

Key Takeaways

• Patent Validity: The case underscores the critical importance of demonstrating the non-obviousness of patent claims through clear and convincing evidence.
• Secondary Considerations: The failure to present evidence of secondary considerations, such as unexpected results or the failure of others, can significantly weaken a patent holder's case.
• ANDA Filings: Generic manufacturers can challenge the validity of patents through ANDA filings, which can lead to significant legal battles.
• Claim Construction: The limitation of patent claims during litigation can focus the dispute on the most critical aspects of the invention.

Frequently Asked Questions

Q: What was the main issue in the Hospira, Inc. v. Fresenius Kabi USA, LLC case?

A: The main issue was whether Fresenius Kabi's proposed premixed dexmedetomidine product infringed on Hospira's patents and whether those patents were valid.

Q: What patents were at the center of the dispute?

A: The patents in question were U.S. Patent Nos. 8,648,106 and 9,616,049, specifically claims 6 and 8, respectively.

Q: What was the outcome of the bench trial?

A: The court found that Fresenius Kabi had established by clear and convincing evidence that the claims in question were invalid as obvious.

Q: Why were the patents found to be invalid?

A: The patents were found invalid because Hospira failed to provide sufficient evidence of secondary considerations to support the non-obviousness of the claims.

Q: What does this case imply for pharmaceutical patent holders?

A: This case highlights the need for pharmaceutical patent holders to robustly defend their patents by presenting strong evidence of non-obviousness and secondary considerations.

Cited Sources

1. Robins Kaplan LLP, "Hospira, Inc. v. Fresenius Kabi USA, LLC" - https://www.robinskaplan.com/newsroom/insights/hospira-inc-v-fresenius-kabi-usa-llc
2. USCOURTS-ilnd-1_16-cv-00651, "Case: 1:16-cv-00651 Document #: 176 Filed: 12/17/18" - https://www.govinfo.gov/content/pkg/USCOURTS-ilnd-1_16-cv-00651/pdf/USCOURTS-ilnd-1_16-cv-00651-1.pdf
3. Justia, "Hospira, Inc. v. Fresenius Kabi USA, LLC, No. 1:2016cv00651" - https://law.justia.com/cases/federal/district-courts/illinois/ilndce/1:2016cv00651/320839/176/
4. Casetext, "Hospira, Inc. v. Fresenius Kabi USA, LLC, No. 16 C 651" - https://casetext.com/case/hospira-inc-v-fresenius-kabi-united-states-llc
5. Unified Patents, "1:16-cv-00651 - Hospira Inc v. Fresenius Kabi USA LLC" - https://portal.unifiedpatents.com/litigation/Illinois%20Northern%20District%20Court/case/1:16-cv-00651