DCT

2:10-cv-00235

Hollander v. Hospira Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:10-cv-00235, E.D. Pa., 01/19/2010
  • Venue Allegations: Venue is alleged to be proper in the Eastern District of Pennsylvania because Defendant Hospira conducts business and sells the products at issue to consumers within the judicial district.
  • Core Dispute: Plaintiff, acting as a relator for the United States, alleges that Defendant has engaged in false patent marking in violation of 35 U.S.C. § 292 by marking millions of its medical products with expired patents for the purpose of deceiving the public.
  • Technical Context: The technology relates to containers for medical fluids, such as flexible IV bags and vials, and associated closure and delivery systems designed for sterile use in healthcare settings.
  • Key Procedural History: The complaint notes that Defendant Hospira, Inc. was spun off from Abbott Laboratories on April 30, 2004, at which point it began operating as an independent company. The allegations of false marking concern conduct occurring after this spin-off.

Case Timeline

Date Event
1980-12-12 U.S. Patent No. 4,368,765 Priority Date
1981-04-13 U.S. Patent No. 4,344,472 Priority Date
1982-08-17 U.S. Patent No. 4,344,472 Issued
1983-01-18 U.S. Patent No. 4,368,765 Issued
1983-12-23 U.S. Patent No. 4,614,267 Priority Date
1985-11-21 U.S. Patent No. 4,614,515 Priority Date
1985-12-09 U.S. Patent No. 4,757,911 Priority Date
1986-09-30 U.S. Patent No. 4,614,267 Issued
1986-09-30 U.S. Patent No. 4,614,515 Issued
1988-07-19 U.S. Patent No. 4,757,911 Issued
2000-12-12 ’765 Patent Allegedly Expired
2001-08-17 ’472 Patent Allegedly Expired
2003-12-23 ’267 Patent Allegedly Expired
2004-04-30 Hospira spin-off from Abbott Laboratories
2005-11-21 ’515 Patent Allegedly Expired
2005-12-09 ’911 Patent Allegedly Expired
2010-01-19 Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 4,344,472 - "PULL TAB TEAR CAP FOR CONTAINER PORT," issued August 17, 1982

The Invention Explained

  • Problem Addressed: The patent's background section notes that removing closures from sterile solution containers, such as IV bags, sometimes requires a pulling force greater than what a nurse with normal physical abilities can apply, which is a concern in medical settings, especially during emergencies (’472 Patent, col. 1:11-26).
  • The Patented Solution: The invention is a tear-away cap for a container port featuring a pull tab and a "weakened tear path" in its base (’472 Patent, col. 2:48-49). The structure is designed to concentrate pulling forces at a specific point on the tear path, allowing the cap to be initiated and removed with a force not exceeding approximately 12 pounds, thereby ensuring easy access while maintaining sterility before use (’472 Patent, Abstract; col. 3:20-25).
  • Technical Importance: The design provided a way to ensure a sterile seal on medical fluid containers that could be reliably and easily opened by healthcare professionals without exceptional physical strength (’472 Patent, col. 1:27-33).

Key Claims at a Glance

  • The complaint does not assert specific claims but makes a general allegation that the marked products were never covered by the patent (Compl. ¶34). Independent claim 1 is representative of the technology.
  • Independent Claim 1 elements include:
    • A base portion with a skirt for securing to a port.
    • A means defining a weakened tear path for removing a section of the base.
    • A pull member extending away from the base portion.
    • A force directing means between the pull member and base portion to direct pulling force into the tear path.
    • A flexible removal section that can be pulled away before tearing.

U.S. Patent No. 4,368,765 - "FLEXIBLE BAG WITH RECESSED SCRAPLESS HANGER," issued January 18, 1983

The Invention Explained

  • Problem Addressed: The patent describes issues with prior art flexible medical fluid bags where the hanger portion is either adhesively attached and difficult to separate, or its use creates scrap plastic pieces. Further, some hanger designs do not accommodate a wide variety of support hooks (’765 Patent, col. 1:18-50).
  • The Patented Solution: The invention integrates a "scrapless" hanger directly into the body of the flexible bag within the confines of an end wall (’765 Patent, Abstract). The hanger is formed by "tear and hinge lines" which, when torn by the user, create tab portions that fold away to form an aperture for hanging, without generating any waste material (’765 Patent, col. 2:4-14). The hinge lines are designed to bias the tabs outward, preventing them from obstructing the hanger hole (’765 Patent, col. 4:5-14).
  • Technical Importance: This design streamlined manufacturing by integrating the hanger into the bag itself and improved clinical usability by eliminating scrap material and creating a versatile hanging aperture (’765 Patent, col. 1:51-54).

Key Claims at a Glance

  • The complaint does not assert specific claims but makes a general allegation that the marked products were never covered by the patent (Compl. ¶46). Independent claim 1 is representative of the technology.
  • Independent Claim 1 elements include:
    • A body section of flexible plastic.
    • A hanger section at one end with a planar surface defined by tear and hinge lines.
    • The tear line defines two tab portions that are displaced to create a hanger aperture.
    • The hinge line is constructed to provide an outward biasing of the tab portions so they do not interfere with the aperture.

U.S. Patent No. 4,614,267 - "DUAL COMPARTMENTED CONTAINER," issued September 30, 1986

  • Technology Synopsis: The patent describes a container system designed to keep a medicament (e.g., in a stoppered vial) separate from a diluent (in a flexible bag) until the point of use (’267 Patent, Abstract). A user can manually manipulate the container from the outside to remove the stopper from the vial, allowing the two substances to mix within the sterile environment of the bag (’267 Patent, col. 2:13-20).
  • Asserted Claims: No specific claims are asserted in the complaint (Compl. ¶57).
  • Accused Features: The complaint alleges that various "ADD-Vantage vials" containing drugs such as Tobramycin, Vancomycin HCl, and others were falsely marked with the ’267 Patent (Compl. ¶55).

U.S. Patent No. 4,614,515 - "DRUG DELIVERY SYSTEM," issued September 30, 1986

  • Technology Synopsis: This patent discloses a drug delivery system comprising a stoppered vial that can be connected to a diluent container. The system includes a removable, pierceable diaphragm over the vial's stopper to maintain sterility (’515 Patent, Abstract). Access to the drug can be achieved by piercing the diaphragm and stopper with a cannula or by removing the diaphragm and stopper to add the drug directly to a diluent container (’515 Patent, col. 2:15-33).
  • Asserted Claims: No specific claims are asserted in the complaint (Compl. ¶66).
  • Accused Features: The complaint alleges that various "ADD-Vantage vials" were falsely marked with the ’515 Patent (Compl. ¶64).

U.S. Patent No. 4,757,911 - "CONTAINER AND CLOSURE CONSTRUCTION," issued July 19, 1988

  • Technology Synopsis: This invention relates to a closure for a container port, particularly for diluent bags subject to heat sterilization. The closure includes a flexible cover with an outer flange for bonding to the port and a central diaphragm with convolutions that allow it to expand or contract, minimizing pressure differentials during sterilization and preventing rupture of the tear line used for removal (’911 Patent, Abstract).
  • Asserted Claims: No specific claims are asserted in the complaint (Compl. ¶75).
  • Accused Features: The complaint alleges that flexible bags containing dextrose and sodium chloride injections were falsely marked with the ’911 Patent (Compl. ¶73).

III. The Accused Instrumentality

  • Product Identification: The accused products are numerous medical fluid products manufactured and sold by Hospira, including various concentrations of sodium chloride, dextrose, Lactated Ringer's, and Normosol injections in flexible bags, as well as several "ADD-Vantage vials" containing specific drugs (Compl. ¶¶ 32, 44, 55, 64, 73).
  • Functionality and Market Context: The accused products are primarily sterile solutions for intravenous administration and drug delivery systems used in hospitals, clinics, and other healthcare settings (Compl. ¶¶ 13-14). The complaint alleges that Hospira is a "global specialty pharmaceutical and medication delivery company" with net global sales in 2008 of over $3.6 billion, and that millions of units of the accused products are sold in the United States annually (Compl. ¶¶ 12, 15, 16).

IV. Analysis of False Marking Allegations

The complaint does not allege patent infringement but rather false patent marking under 35 U.S.C. § 292. The central allegation is that Hospira marked products with patent numbers after those patents had expired, with the intent to deceive the public.

  • ’472 Patent False Marking Allegations
    The complaint alleges that the ’472 Patent expired on August 17, 2001, nearly three years before the Hospira spin-off (Compl. ¶¶ 26, 31). It further alleges that since the spin-off, Hospira has marked "several dozen different products" with the ’472 Patent number, listing over 50 specific products, including various dextrose and sodium chloride injections (Compl. ¶¶ 31-32). The complaint asserts that this marking was done "for the purpose of deceiving the public into believing that such products are covered by the '472 Patent" (Compl. ¶40). A secondary allegation is that none of the products marked with the ’472 Patent were ever covered by it in the first place (Compl. ¶34).

  • ’765 Patent False Marking Allegations
    The complaint alleges that the ’765 Patent expired on December 12, 2000, over three years before the Hospira spin-off (Compl. ¶¶ 27, 43). It alleges that since the spin-off, Hospira has marked "dozens of different products" with the ’765 Patent number, listing over 40 specific products including sterile water, dextrose, and sodium chloride irrigation solutions (Compl. ¶¶ 43-44). As with the ’472 patent, the complaint alleges this marking was done with deceptive intent and that none of the marked products were ever covered by the patent (Compl. ¶¶ 46, 51).

  • Identified Points of Contention:

    • Evidentiary Questions: A primary question for the court will be factual: did Hospira mark or cause to be marked the specific products listed in the complaint with the corresponding expired patent numbers? The plaintiff will bear the burden of proving that the marking occurred on an article-by-article basis.
    • Scienter and Intent: The central legal dispute will likely concern the statutory requirement of "intent to deceive." The case may explore whether Hospira's alleged continued marking post-expiration was a deliberate act to deter competitors or an administrative oversight inherited from Abbott Laboratories. The duration and scale of the alleged marking may be presented as circumstantial evidence of intent.
    • Scope Questions: The complaint's secondary allegation that the products were "never covered" by the patents (e.g., Compl. ¶34, ¶46) raises a technical question of claim scope. However, the primary allegation of marking with an expired patent renders an article "unpatented" under § 292, which may make a detailed analysis of original patent coverage a secondary issue.

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

The complaint's primary theory is that Hospira marked products with expired patents. A determination of whether a patent has expired does not typically require claim construction. The complaint also makes the secondary allegation that the accused products were "never covered" by the patents in question (e.g., Compl. ¶34), which could potentially implicate claim construction. However, the complaint does not provide sufficient detail for analysis of specific claim terms that might be in dispute. The focus of the case, as pleaded, appears to be on the fact of marking post-expiration and the defendant's alleged deceptive intent.

VI. Other Allegations

  • Deceptive Intent (Analogous to Willfulness): The complaint repeatedly alleges that Hospira marked its products with expired patents "for the purpose of deceiving the public" (Compl. ¶¶ 40, 51, 60, 69, 78). The basis for this allegation of intent appears to be circumstantial. The complaint alleges that Hospira is a "highly sophisticated business entity with extensive experience" in patents and "knows or reasonably should know" that patents have a limited duration (Compl. ¶¶ 18, 25). The plaintiff alleges that continuing to mark millions of products for years after the patents expired demonstrates knowledge and an intent to discourage or deter competition (Compl. ¶¶ 42, 53).

VII. Analyst’s Conclusion: Key Questions for the Case

The resolution of this false marking case will likely depend on the answers to two central questions:

  • A core issue will be one of evidentiary proof: Can the plaintiff demonstrate, on an article-by-article basis, that Hospira did in fact mark the extensive list of accused products with the specific expired patent numbers as alleged in the complaint?
  • A dispositive question will be one of scienter: Assuming the marking is proven, can the plaintiff establish that Hospira acted with the specific "purpose of deceiving the public" as required by 35 U.S.C. § 292? The court will have to weigh whether the alleged conduct constitutes a deliberate strategy to mislead competitors or the public, or whether it can be explained as an administrative oversight, particularly in the context of assets and processes inherited after the 2004 spin-off from Abbott Laboratories.