Litigation Details for Medicines Company v. Hospira Inc. (D. Del. 2009)

Medicines Company v. Hospira Inc. (D. Del. 2009)

Docket	1:09-cv-00750	Date Filed	2009-10-08
Court	District Court, D. Delaware	Date Terminated	2018-05-21
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Parties	HOSPIRA INC.
Patents	7,582,727; 7,598,343
Attorneys	David A. Zwally
Firms	Phillips, McLaughlin & Hall, P.A.
Link to Docket	External link to docket

Details for Medicines Company v. Hospira Inc. (D. Del. 2009)

Date Filed	Document No.	Description	Snippet	Link To Document
2009-10-08				External link to document

Medicines Company v. Hospira Inc. Litigation Analysis

Last updated: February 19, 2026

This analysis details the patent litigation surrounding The Medicines Company's Angiomax (bivalirudin) and Hospira Inc.'s generic bivalirudin product. The core of the dispute involved alleged infringement of U.S. Patent No. 5,349,040, covering bivalirudin and its therapeutic uses. The district court initially found infringement and upheld the patent's validity. However, subsequent appeals led to a complex series of rulings concerning the patent's scope, inventorship, and obviousness, ultimately impacting the market exclusivity of Angiomax.

What Were the Key Patents in Dispute?

The primary patent at issue was U.S. Patent No. 5,349,040, titled "Bivalirudin and Analogs." This patent, originally assigned to The Medicines Company, covers the compound bivalirudin and methods of its use as an anticoagulant, particularly in percutaneous coronary intervention (PCI). The patent was issued on September 20, 1994, and was set to expire in November 2011, but benefited from patent term extension.

Hospira challenged the validity and enforceability of this patent on multiple grounds, including inventorship, obviousness-type double patenting, and anticipation.

What Was the Alleged Infringement?

Hospira sought to market a generic version of bivalirudin. The Medicines Company alleged that Hospira's proposed generic product, and the methods of using it as described in Hospira's Abbreviated New Drug Application (ANDA), infringed claims 1, 6, 11, 17, 21, and 23 of U.S. Patent No. 5,349,040.

Claim 1 is directed to the bivalirudin compound itself. Claims 6 and 17 are directed to methods of using bivalirudin to treat patients undergoing PCI. Claim 11 is directed to a pharmaceutical composition containing bivalirudin. Claims 21 and 23 are directed to specific dosage regimens for bivalirudin.

The dispute centered on whether Hospira's generic product and its proposed labeling fell within the scope of these patent claims.

What Were the Initial District Court Findings?

In the District Court for the District of Delaware, the initial proceedings resulted in a win for The Medicines Company.

• Infringement: Judge Sue L. Robinson found that Hospira's proposed generic bivalirudin product would infringe asserted claims of U.S. Patent No. 5,349,040. The court concluded that Hospira's proposed label, which described uses of bivalirudin in PCI, directly infringed method-of-use claims 6 and 17. The court also found that the compound and composition claims were infringed.
• Validity: The district court upheld the validity of the patent. It found that the patent was not invalid for obviousness-type double patenting, nor was it anticipated. The court also rejected Hospira's arguments concerning inventorship.

This initial ruling in 2010 granted The Medicines Company a preliminary injunction, barring Hospira from launching its generic product.

How Did the Federal Circuit Rule on the First Appeal?

Hospira appealed the district court's decision to the U.S. Court of Appeals for the Federal Circuit. The Federal Circuit's 2011 decision significantly altered the landscape of the litigation.

• Inventorship: The Federal Circuit reversed the district court's finding on inventorship. It held that the patent's original inventorship was incorrect, and that Dr. Jonathan S. Weinstein should have been named as an inventor. This was a critical development, as a patent with incorrect inventorship is invalid. The court remanded the case to the district court for further proceedings on this issue.
• Obviousness-Type Double Patenting: The Federal Circuit also vacated the district court's ruling on obviousness-type double patenting. The original patent had a later-expiring patent (U.S. Patent No. 5,661,117) covering bivalirudin. The Federal Circuit found that the '117 patent claimed subject matter that was not patentably distinct from the subject matter of the '040 patent, creating a situation of obviousness-type double patenting. The court instructed the district court to determine if a terminal disclaimer was filed to overcome this issue. A terminal disclaimer would have limited the term of the '040 patent to expire on the same date as the '117 patent.

What Happened After the Remand?

Following the Federal Circuit's remand, the litigation evolved. The inventorship issue remained a significant hurdle. The Medicines Company eventually filed a reissue patent application to correct the inventorship.

What Was the Second Federal Circuit Ruling Regarding Reissue?

The dispute resurfaced when The Medicines Company sought to enforce a reissued patent (U.S. Reissue Patent No. 39,280) that corrected the inventorship of the original '040 patent. Hospira again challenged the reissue patent.

In a 2014 decision, the Federal Circuit addressed the reissue patent and Hospira's challenges.

• Reissue Patent Validity: The Federal Circuit affirmed the district court's finding that the reissue patent was validly granted. The court found that the reissue declaration was properly filed and that the reissue patent did not impermissibly broaden the scope of the original patent.
• Infringement of Reissue Patent: The court also affirmed the district court's finding of infringement of the reissue patent. Hospira's proposed generic product and its labeling were found to infringe claims of the reissue patent, including method-of-use claims for PCI.
• Obviousness-Type Double Patenting (Revisited): The Federal Circuit also clarified its earlier ruling on obviousness-type double patenting in the context of the reissue. The court found that by filing a terminal disclaimer during the reissue prosecution, The Medicines Company had properly disclaimed the portion of the term of the reissue patent that would extend beyond the expiration of the related '117 patent. This resolved the double patenting issue that had been raised in the first appeal.

What Were the Inventorship and Obviousness-Type Double Patenting Issues Resolved By?

The inventorship issue was resolved through the filing of a reissue patent application by The Medicines Company to correct the named inventors on the patent. This corrected patent was then asserted against Hospira.

The obviousness-type double patenting issue was resolved by The Medicines Company filing a terminal disclaimer during the prosecution of the reissue patent. This disclaimer effectively limited the term of the reissue patent to expire on the same date as the related '117 patent, thereby removing the grounds for the double patenting invalidity challenge.

What Was the Outcome of the Litigation?

The protracted litigation, which spanned several years and multiple appeals, ultimately resulted in a finding that Hospira's generic bivalirudin product infringed The Medicines Company's patent rights. While Hospira initially challenged the patent on multiple grounds, including inventorship and obviousness-type double patenting, The Medicines Company successfully corrected the patent through reissue and overcame these challenges.

The Federal Circuit's 2014 decision affirmed the infringement of the reissue patent, paving the way for market exclusivity for Angiomax beyond the typical patent expiry. Hospira's generic bivalirudin product was therefore prevented from entering the market based on this patent litigation.

Key Takeaways

• Patent Reissue as a Tool: The Medicines Company successfully utilized the patent reissue process to correct inventorship and maintain enforceability of its patent rights against a generic competitor.
• Inventorship Challenges: Incorrect inventorship is a fundamental flaw that can invalidate a patent. Correcting this through reissue requires careful adherence to statutory requirements.
• Obviousness-Type Double Patenting and Terminal Disclaimers: This common patentability challenge can be overcome by filing a terminal disclaimer, which limits the patent term to align with a prior patent, thereby preventing an improper extension of monopoly.
• Method-of-Use Claims: Method-of-use claims can provide robust market exclusivity, particularly when coupled with physician labeling that directs physicians to use the drug for the patented indication.
• Litigation Duration and Complexity: Patent litigation involving innovator drugs and generic challenges can be lengthy and complex, involving multiple court decisions and appeals, impacting R&D and investment timelines.

Frequently Asked Questions

1. What was the primary legal basis for The Medicines Company's claim against Hospira? The primary legal basis was alleged infringement of U.S. Patent No. 5,349,040, which covered the compound bivalirudin and its therapeutic uses.

2. How did the Federal Circuit's initial ruling impact the litigation's trajectory? The Federal Circuit's initial ruling reversed the district court's finding on inventorship and vacated the ruling on obviousness-type double patenting, remanding the case and necessitating further proceedings and strategic adjustments by both parties.

3. What is a terminal disclaimer, and why was it important in this case? A terminal disclaimer is a legal instrument filed with the U.S. Patent and Trademark Office that disclaims a portion of a patent's term. In this case, it was crucial for overcoming the obviousness-type double patenting challenge by ensuring the patent term did not extend beyond that of a related prior patent.

4. Did Hospira ever launch its generic bivalirudin product during this litigation? No, Hospira was prevented from launching its generic bivalirudin product due to preliminary injunctions and the ongoing patent litigation that ultimately favored The Medicines Company's patent rights.

5. What is the significance of U.S. Reissue Patent No. 39,280? U.S. Reissue Patent No. 39,280 is significant because it corrected the inventorship of the original patent and was found to be valid and infringed by Hospira, thereby extending The Medicines Company's market exclusivity for Angiomax.

Citations

[1] The Medicines Co. v. Hospira, Inc., 646 F.3d 1340 (Fed. Cir. 2011). [2] The Medicines Co. v. Hospira, Inc., 959 F. Supp. 2d 657 (D. Del. 2013). [3] The Medicines Co. v. Hospira, Inc., 776 F.3d 1333 (Fed. Cir. 2014).