Details for Patent: 8,162,915

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Summary for Patent: 8,162,915

Title:	Connector for packings containing medical liquids, and corresponding packing for medical liquids
Abstract:	A connector for packings containing medical liquids, particularly infusion, transfusion or enteral bags, comprises a connecting part (1) for accommodating a spike for drawing out the liquid and comprises a closure part (3) that closes the passage (2) inside the connecting part (1). The connecting part (1) has an elastically deformable pinching off part (4) provided in the form of a tubular section with a non-circular cross-section. A base part (5), which widens on both sides is adjoined to said pinching off part (4) and can be integrated in the packing. During manufacturing, the packing is filled with liquid via the connecting part. After filling, the pinching off part is pressed together whereby preventing liquid from escaping. Afterwards, the closure part is placed onto the connecting part. The manufacturing of the packing is simplified by virtue of the fact that an additional tube for connecting the connector and packing is rendered unnecessary.
Inventor(s):	Torsten Brandenburger, Klaus Heilmann, Bernd Knierbein
Assignee:	Fresenius Kabi Deutschland GmbH
Application Number:	US10/550,477
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,162,915
Patent Claim Types: see list of patent claims	Device;

US Patent 8,162,915: Claim Scope, Patent Term, Litigation Risk, and Medical-Bag Connector Landscape

US Patent 8,162,915 protects a medical-liquid bag connector that combines a deformable, noncircular tubular pinch-off section with a widened bag-integration base, a removable or breakable closure, and, in narrower claims, a self-sealing membrane and snap-fit structure. The broadest protection is concentrated in claims 1 and 11. Claims 2-9 and 12-19 add dependent limitations, while claims 10 and 20 cover a medical-liquid packing containing the connector.

The patent is directed to a medical device component, not an active pharmaceutical ingredient. It therefore does not have an FDA Orange Book listing, Hatch-Waxman exclusivity period, Paragraph IV pathway, or biosimilar exposure.

What does US Patent 8,162,915 protect?

The patent protects a connector integrated into an infusion, transfusion, enteral, or comparable medical-liquid bag. The independent claims require a specific combination of structural and functional elements.

Required element	Claim significance
Injection-molded connecting part	The connector body must be an injection-molded component
Passage for a rod or spike	The passage must accommodate filling or liquid withdrawal
Elastically deformable pinch-off part	The section must recover its original shape after compression
Tubular, noncircular axial cross section	The cross section must differ in two mutually perpendicular directions
Base part merging into pinch-off part	The connector has an integrated transition between the two sections
Base widening to both sides	The base must be suitable for integration into the bag
Same polymer for pinch-off and base	The claim requires material identity between these portions
Closure part	A separate closure must fit onto the connecting part and close the passage
Medical-liquid packing in claims 10 and 20	The product claim requires a bag or packing containing the connector

The patent is therefore narrower than a generic claim to a spike port, bag port, or elastomeric medical connector. A competing product must be evaluated against the entire combination, not against one feature in isolation.

How broad are independent claims 1 and 11?

Claims 1 and 11 are substantially duplicative independent connector claims. Both require the same central architecture:

1. An injection-molded connecting part.
2. A passage for a filling or withdrawal rod or spike.
3. A recoverable pinch-off portion.
4. A tubular portion with a noncircular cross section.
5. A base that widens laterally and integrates into the packing.
6. A pinch-off portion and base made from the same polymer.
7. A separate closure part that fits onto and closes the connecting part.

The principal drafting distinction is that claim 1 introduces the connector in the context of packings "particularly" used for infusion, transfusion, or enteral liquids, while claim 11 uses a more general connector formulation. Claim 11 may therefore provide a broader literal framing, although its substantive limitations remain nearly identical.

The same-polymer limitation is commercially important. A design using a separate elastomeric pinch-off insert, overmolded rubber, or a different polymer for the deformable portion may avoid literal infringement of the independent claims, subject to equivalents analysis.

The noncircular cross-section limitation is also central. A circular tube is not within the literal wording requiring an axial cross section that differs in two mutually perpendicular directions. The specification and prosecution history would determine whether an oval, elliptical, flattened, rectangular-rounded, or otherwise asymmetric passage falls within the claim.

What do the dependent claims add?

How do claims 2 and 12 protect snap-fit closures?

Claims 2 and 12 require the closure and connector to be secured with a snap fit. A threaded cap, friction-fit cap, welded closure, or adhesive closure would not satisfy this limitation unless the structure also provides the claimed snap-fit relationship.

The snap-fit limitation can be significant in a design-around analysis because many medical connectors use removable caps or protective covers that are retained by ribs, beads, or shoulders.

What protection do claims 3, 4, 13, and 14 provide?

These claims add a self-sealing membrane positioned between the connecting part and the closure. The membrane must be pierceable by the spike for liquid withdrawal.

Claims 4 and 14 narrow the membrane arrangement further by requiring that it be held under elastic deformation between the connecting part and closure. The claims therefore address a resealable septum or membrane arrangement rather than merely a sterile barrier.

A connector with no membrane, a membrane located elsewhere in the fluid path, or a non-self-sealing foil seal may fall outside these dependent claims while potentially remaining within claim 1 or 11.

What protection do claims 5, 6, 15, and 16 provide?

These claims cover a closure with:

• A cap-shaped bottom part.
• An annular break zone.
• A removable top part that can be broken off.
• A flat grip piece in the narrower claims.

This configuration is directed to a tamper-evident, break-off cap. The annular break zone is a structural limitation. A tear strip, hinged lid, screw cap, or peelable seal may not satisfy the claim unless it includes the required cap-bottom and break-zone arrangement.

What protection do claims 7, 8, 17, and 18 provide?

These claims require an arrow indicating flow direction on the cap-shaped bottom part or break-off grip. The arrow may be formed as:

• A recess.
• A raised structure.
• Both forms.

These are narrow claims. They are unlikely to determine infringement by themselves unless the accused product already satisfies the broader connector and closure limitations.

What protection do claims 9 and 19 provide?

Claims 9 and 19 require the base part to have a boat-shaped configuration. The phrase likely refers to a laterally widened base adapted for integration into a flexible bag film.

This limitation may be relevant to molded ports that use flanges or wings for heat sealing, welding, or embedding into a multilayer medical bag.

What do claims 10 and 20 cover?

Claims 10 and 20 cover a packing for medical liquids having at least one connector according to claim 1 or claim 11.

These are combination claims. They require both:

1. A qualifying connector; and
2. A qualifying packing containing at least one such connector.

A connector sold separately may raise direct infringement issues under claims 1 or 11, while a finished infusion or enteral bag may raise infringement issues under claims 10 or 20.

The packing claims do not appear to require a specific liquid, bag film, sterilization method, fill volume, or clinical use. Their scope is therefore tied primarily to the claimed connector architecture.

How does the patent protect against common design alternatives?

Design alternative	Likely claim issue
Circular pinch-off tube	Potentially avoids the noncircular cross-section limitation
Separate elastomeric insert	Potentially avoids the same-polymer limitation
Threaded closure	Potentially avoids snap-fit claims, but not necessarily claims 1 or 11
No closure	Likely avoids the independent claims because a closure part is required
No self-sealing membrane	May avoid claims 3, 4, 13, and 14
Peelable foil seal	May avoid break-off closure claims
Flat flange instead of boat-shaped base	May avoid claims 9 and 19
Connector welded to the bag after molding	Not necessarily outside the claims, because the claims require that the base can be integrated into the packing, not a specific integration process
Different polymers in base and pinch-off section	Potentially avoids the same-polymer requirement
Overmolded connector	Requires analysis of whether the entire connecting part remains the claimed injection-molded component

The strongest design-around opportunities are the polymer-material requirement, cross-sectional geometry, and closure architecture. A product that changes only the arrow marking or grip shape remains exposed to the independent claims.

When does US Patent 8,162,915 lose exclusivity?

The patent was issued on April 24, 2012. Its published patent family is associated with a German priority filing dated March 31, 2006 and a US filing dated March 30, 2007. On a standard 20-year term calculated from the US nonprovisional filing date, the projected expiration date is March 30, 2027, before any applicable patent-term adjustment. The governing term rules are set out in 35 U.S.C. § 154 and 37 C.F.R. § 1.56.

Event	Date
Earliest reported priority	March 31, 2006
US filing	March 30, 2007
Patent grant	April 24, 2012
Standard projected expiration	March 30, 2027
Patent-term adjustment	Must be confirmed from USPTO records
Patent-term extension	No pharmaceutical PTE basis is apparent

The priority date does not ordinarily control the US patent term. The relevant calculation generally begins with the earliest effective US nonprovisional filing in the application chain. A definitive expiration analysis must account for any patent-term adjustment, terminal disclaimer, continuation relationship, maintenance-fee event, or disclaimer recorded by the USPTO.

What is the Orange Book and FDA status of US Patent 8,162,915?

US Patent 8,162,915 is not an Orange Book patent. It covers a connector and medical-liquid packing, not a drug substance, drug formulation, or approved drug method of use.

Regulatory issue	Status
Orange Book listing	Not applicable
Paragraph IV challenge	Not applicable
Hatch-Waxman exclusivity	Not applicable
Biosimilar interchangeability	Not applicable
FDA drug approval	Not the relevant regulatory pathway
Medical-device regulation	Relevant
Premarket pathway	Depends on the complete connector or bag product

A product incorporating the connector could be regulated as a medical device or as part of a drug-delivery system. The patent does not itself establish FDA clearance, approval, classification, or marketing authorization for any commercial bag or connector.

Which companies could face competitive patent risk?

The technology is relevant to manufacturers of:

• Flexible infusion bags.
• Blood and transfusion bags.
• Enteral feeding bags.
• Sterile liquid containers.
• Transfer bags.
• Spike-access ports.
• Resealable medical-fluid connectors.
• Integrated filling and withdrawal ports.

Potentially relevant commercial participants include Fresenius Kabi, B. Braun, Baxter, ICU Medical, Terumo, Nipro, and other suppliers of sterile fluid-management systems. A company’s presence in this market does not establish infringement or ownership of a conflicting patent.

The competitive landscape is likely to contain overlapping patent families covering:

• Bag-port geometry.
• Dual-channel or multi-channel connectors.
• Piercing septa.
• Break-off tamper-evident caps.
• Sterile access systems.
• Heat-sealable or weldable flanges.
• Overmolded elastomeric closures.
• Connector manufacturing and assembly methods.

The key freedom-to-operate question is whether a competing product uses the full combination of a noncircular recoverable pinch-off tube, same-polymer base, laterally widened integration section, and fitted closure.

Are there Paragraph IV challenges or biosimilar risks?

No. Paragraph IV litigation applies to abbreviated new drug applications challenging listed drug patents. Biosimilar litigation applies to licensed biological products under the Biologics Price Competition and Innovation Act. Neither framework applies to this connector patent.

A competitor would more likely enter through product development and medical-device commercialization rather than through an ANDA or biosimilar application. Patent disputes would ordinarily arise through a conventional infringement action, declaratory-judgment action, importation dispute, or contract dispute.

What patent litigation and settlement agreements affect the patent?

The patent document itself does not establish any infringement litigation, settlement agreement, covenant not to sue, license, or assignment restriction. No litigation conclusion follows from the claims alone.

The relevant litigation questions are:

• Whether the patent was asserted against a bag or connector manufacturer.
• Whether the accused product used the same polymer in the pinch-off and base portions.
• Whether its pinch-off section had the required noncircular geometry.
• Whether a separate closure fitted onto the connecting part.
• Whether the patent owner alleged infringement of the connector claims, packing claims, or both.
• Whether any settlement included a license, field restriction, or permitted design-around.

Any current enforceability or litigation analysis must be based on USPTO maintenance records and federal court docket information, not on the patent text.

How strong is the patent estate?

The patent has moderate structural strength but a relatively narrow claim combination.

Strengths

• Claims 1 and 11 directly target the complete connector architecture.
• The same-polymer limitation may distinguish conventional assemblies using separate elastomers.
• The noncircular cross-section limitation identifies a specific mechanical pinch-off design.
• Claims 10 and 20 extend protection to finished medical-liquid packings.
• Dependent claims cover commercially useful features such as snap-fit closures, septa, break-off caps, and boat-shaped bases.

Weaknesses

• The independent claims contain multiple cumulative limitations.
• A competitor may avoid infringement by changing material composition or cross-sectional geometry.
• The claims do not broadly cover every infusion-bag port or spike connector.
• The dependent closure and marking claims are narrow.
• The patent’s commercial value depends on whether the claimed geometry is used in high-volume products.

The highest-value limitations for enforcement are the same-polymer requirement, noncircular axial cross section, recoverable pinch-off function, and laterally widened bag-integration base.

What generic launch risks exist?

There is no generic-drug launch risk. The relevant market-entry risk is a medical-device product launch risk.

A competing manufacturer faces the greatest exposure when its product has all of the following:

• A single injection-molded connector body.
• A deformable pinch-off tube.
• An oval or otherwise noncircular cross section.
• A base made from the same polymer.
• A laterally widening bag-integration structure.
• A fitted cap or closure.

Risk decreases if the competitor uses a separate elastomeric valve, a circular tube, a different polymer, or a closure integrated by welding rather than fitting.

What geographic coverage does the patent provide?

US Patent 8,162,915 provides rights only in the United States. Foreign protection would depend on corresponding national patents in the family. A US patent can affect:

• Manufacture in the United States.
• Importation into the United States.
• Sale or offer for sale in the United States.
• Use of the claimed connector or packing in the United States.

Manufacturing entirely outside the United States does not eliminate risk if the product is imported, sold, offered for sale, or used in the United States.

Key Takeaways

• US Patent 8,162,915 is a medical-device patent covering connectors for infusion, transfusion, enteral, and similar medical-liquid bags.
• Claims 1 and 11 are the principal claims and are materially duplicative.
• The critical limitations are the noncircular recoverable pinch-off section, same-polymer construction, laterally widened base, and fitted closure.
• Claims 10 and 20 extend the scope to medical-liquid packings containing the connector.
• Snap fits, self-sealing membranes, break-off caps, arrow markings, and boat-shaped bases are narrower dependent features.
• The patent is not an Orange Book patent and has no Paragraph IV or biosimilar relevance.
• Based on the reported filing chronology, the standard projected expiration date is March 30, 2027, subject to USPTO term adjustments and other recorded events.
• The strongest design-around options involve changing the polymer architecture, pinch-off geometry, or closure configuration.
• The patent’s practical value depends on adoption of the specific connector geometry in commercial medical bags.

FAQs

Does US Patent 8,162,915 cover all infusion-bag connectors?

No. It covers connectors having the specific combination of features recited in the independent claims, including a noncircular recoverable pinch-off portion and a same-polymer base.

Can a connector with a separate rubber septum avoid infringement?

It may avoid the same-polymer limitation if the rubber component is part of the claimed pinch-off or base structure. The complete product must be mapped against every limitation of claims 1 and 11.

Does a threaded medical-bag cap infringe the patent?

A threaded cap may avoid the snap-fit dependent claims, but the independent claims do not expressly require a snap fit. The remaining connector structure would still require analysis.

Is the patent relevant to an enteral feeding-bag manufacturer?

Yes. The claims expressly identify enteral bags as a covered application, and claims 10 and 20 cover packings containing the claimed connector.

Can a company sell the connector outside the United States?

The US patent does not create foreign rights. Foreign sales are governed by corresponding patents, if any, in the relevant jurisdictions. Importation or sale into the United States can still create US patent exposure.

References

1. United States Patent No. 8,162,915. (2012). Connector for packings containing medical liquids. United States Patent and Trademark Office.

2. United States Code, 35 U.S.C. § 154. (2024). Contents and term of patent; provisional rights.

3. Code of Federal Regulations, 37 C.F.R. § 1.56. (2024). Duty to disclose information material to patentability.

4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA.

Drugs Protected by US Patent 8,162,915

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 8,162,915

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	103 13 760	Mar 27, 2003

PCT Information
PCT Filed	January 22, 2004	PCT Application Number:	PCT/EP2004/000487
PCT Publication Date:	October 07, 2004	PCT Publication Number:	WO2004/084793

International Family Members for US Patent 8,162,915

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	407653
Australia	2004224795
Brazil	PI0408780