United States Patent 7,828,787: Claim Scope, Patent Landscape, Exclusivity and Generic-Entry Risk

U.S. Patent No. 7,828,787 covers a medical-fluid package connector and a self-sealing membrane used at a spike-access point. The broadest protection is divided between claim 1, directed to the assembled connector, and claim 14, directed to the membrane itself. The core inventive concept is the combination of a dish-shaped pierceable membrane, a stepped annular sealing geometry, and a substantially T-shaped outer retention section clamped between upper and lower connector sections.

The patent is a medical-device patent, not a drug patent. It does not claim an active pharmaceutical ingredient, dosage regimen, therapeutic use, or drug formulation. It therefore is not ordinarily an Orange Book-listed patent and does not create Hatch-Waxman exclusivity for a medicinal product. Its commercial relevance is concentrated in infusion bags, transfusion bags, medical-fluid containers, spike ports, and compatible administration sets.

What does U.S. Patent 7,828,787 protect?

The patent protects two related products:

A connector integrated with or attached to a package containing medical fluid.
A self-sealing membrane capable of use in an extraction point for a medical-fluid container.

Claim 1 is the principal connector claim. Claim 14 is the principal standalone membrane claim. The remaining claims add structural limitations or identify particular packages and bag types.

Claim	Subject matter	Claim type	Commercial significance
1	Connector with two-part snap-fit connection part, break-off seal, and shaped self-sealing membrane	Independent apparatus claim	Primary assembled-port claim
2	Weakened dish-shaped membrane material	Dependent	Facilitates spike penetration
3	Second pierceable membrane forming an intermediate space	Dependent	Adds contamination or leakage barrier
4	Second membrane formed as one piece with connector	Dependent	Limits manufacturing architecture
5	Second membrane curved upward or downward	Dependent	Covers alternative barrier geometry
6	Sealing part connected through circular rupture zone	Dependent	Covers break-off seal construction
7	Upward arrow formed as a recess in grip part	Dependent	Orientation and user-operation feature
8	Upward raised arrow on lower connector section	Dependent	Orientation feature
9	Medical-fluid packaging with claim 1 connector	Product-by-combination	Extends protection to package systems
10	Weakened dish-shaped material that is pre-slit	Dependent	Covers preformed penetration aid
11	Raised arrow in a recessed grip	Dependent	Narrows claim 8
12	Infusion bag with claim 1 connector	Product-by-combination	Infusion-product implementation
13	Transfusion bag with claim 1 connector	Product-by-combination	Blood-product implementation
14	Self-sealing membrane with specified geometry and T-shaped retention section	Independent apparatus claim	Primary standalone membrane claim
15	Weakened inner dish-shaped section	Dependent	Penetration-performance limitation
16	Slit inner dish-shaped section	Dependent	Narrower than claim 15
17	Continuous planar bottom extending across entire dish diameter	Dependent	Defines bottom-surface geometry
18	Flat first and second inner faces	Dependent	Narrows wall configuration
19	Planar bottom lower than outer circular section	Dependent connector claim	Adds vertical offset geometry

The patent uses open-ended “comprising” language in the independent claims. A competing connector may therefore infringe even if it contains additional components, provided every required claim element is present.

What are the essential elements of independent claim 1?

Claim 1 requires a combination of connector structure, sealing components, and membrane geometry. Each limitation matters.

Connector and package interface

The connector must have a tubular connection part that receives a spike or tubular extraction device. The connection part has:

A lower section.
An upper section.
A snap-in connection between those sections.
A lower package-side opening.
An upper connection-side opening.

A product using ultrasonic welding, adhesive bonding, threaded engagement, or another assembly method may avoid the literal “fixed in a snap-in manner” limitation, although the practical infringement analysis would depend on the actual structure and any equivalents analysis.

Break-off sealing part

The connection-side opening must be sealed by a break-off sealing part. This is not merely a removable cap. The claim requires a sealing part associated with the connector and designed to be broken off to expose the extraction path.

Claim 6 narrows this concept by requiring a circular rupture zone. A connector with a removable cover that is not connected through a circular rupture zone would not satisfy claim 6 literally, but could still fall within claim 1.

Self-sealing membrane

The membrane must be disposed in the connection part and be pierceable by the spike. It must also reseal around the spike in a sealed manner during penetration.

The claim is narrower than a generic rubber septum. It requires a specific multi-zone cross-sectional geometry:

An inner dish-shaped section.
An inner circular section.
An outer circular retention section.

The inner circular section and dish-shaped section together form a trough-shaped recess. The inner circular section surrounds the spike during penetration.

Two obtuse angles

Claim 1 requires two angled inner faces:

A first inner face rises from the central planar portion at a first obtuse angle.
A second inner face rises from the first inner face at a second obtuse angle.
The second obtuse angle is greater than the first.

This relative-angle limitation is one of the most important claim boundaries. A membrane with a single continuous conical wall, a curved wall lacking identifiable angled faces, or two angles that do not satisfy the specified relationship presents a potential noninfringement position.

The specification and prosecution history would control how strictly “angle,” “flat,” “planar,” and “obtuse” are construed. Claim 18 separately recites flat first and second inner faces, indicating that the parent claims may encompass broader surfaces than explicitly flat faces.

T-shaped outer circular section

The outer circular section must have a substantially T-shaped configuration and be clamped between the lower and upper connector sections with elastic deformation of the membrane.

This limitation links the membrane geometry to the connector assembly. The outer section is not simply retained in a groove. It must have a T-like profile and be elastically compressed or deformed between the two connector sections.

What does independent claim 14 protect?

Claim 14 protects the membrane separately from the complete connector. This creates a significant enforcement and licensing advantage because a membrane supplier may face infringement exposure even when it does not sell the finished medical-fluid package.

The membrane claim requires:

An inner dish-shaped section.
A central recessed planar portion.
An annular wall portion.
A first inner face extending from the planar portion at a first obtuse angle.
An inner circular section with a second inner face.
A second obtuse angle greater than the first.
An outer circular section used to fix the membrane.
A substantially T-shaped outer section.
Elastic clamping between upper and lower connector sections.
A trough-shaped recess formed by the dish-shaped and inner circular sections.
Sealing around the tubular extraction device during penetration.

Claim 14 is not limited to infusion bags or transfusion bags. It reaches the membrane as a component for extraction points on medical-fluid containers generally.

The phrase “configured to be clamped” may create a product-by-structure or intended-configuration issue. A membrane sold separately could still infringe if its structure is suitable for the claimed clamping arrangement and otherwise meets the geometric limitations.

How do the dependent claims expand the patent’s technical coverage?

The dependent claims address four technical clusters.

Penetration and resealing

Claims 2, 10, 15, and 16 cover weakened or slit membrane material. These limitations target controlled spike entry and lower penetration force.

A pre-slit membrane may be easier to penetrate but may create different sealing and shelf-life characteristics. A competitor using an unslit membrane may avoid claims 10 and 16 while remaining exposed to claims 1 or 14 if the material is not required to be weakened or slit in those independent claims.

Dual-membrane barriers

Claims 3 through 5 add a second pierceable membrane beneath the self-sealing membrane. The two membranes create an intermediate space.

This arrangement can support:

Additional leakage control.
Sterility protection.
Visual confirmation of penetration.
Separation between the external access membrane and the package interior.

Claim 4 is narrower because the second membrane must be a one-piece component of the connector. Claim 5 covers either upward or downward curvature.

Break-off and user-orientation features

Claims 6, 7, 8, and 11 cover the user interface:

Circular rupture zone.
Grip with recessed upward arrow.
Raised upward arrow on the lower section.
Raised arrow positioned in a recessed grip.

These features are unlikely to define the principal commercial barrier by themselves. Their value is greater as dependent fallback positions and as evidence of a particular connector architecture.

Product claims

Claims 9, 12, and 13 extend the connector combination to:

Medical-fluid packaging.
Infusion bags.
Transfusion bags.

These claims are narrower than claim 1 because they require the connector to be incorporated into a specified package or bag. They may be useful against finished products even where the accused entity does not manufacture the connector itself.

What is the likely scope of infringement?

A competing product presents the highest literal-infringement risk when it has all of the following:

Feature	Risk indicator
Two connector sections assembled by snap fit	High
Break-off seal over the extraction opening	High
Piercing spike or tubular extraction device	High
Dish-shaped central membrane region	High
Two successive obtuse inner angles	Very high
Second angle greater than first angle	Very high
T-shaped outer membrane flange	Very high
Elastic clamping between connector sections	Very high
Trough-shaped recess	High
Sealing around the spike after penetration	High

A design-around is stronger when it changes several core limitations at once rather than only changing a minor feature. Potential design strategies include:

Replacing the snap-fit upper/lower assembly with a welded or permanently molded structure.
Using a flat septum without the dish-shaped and stepped-angle geometry.
Using a single continuous conical or curved internal wall.
Replacing the T-shaped retention flange with a circular bead, dovetail, overmolded edge, or integral molded diaphragm.
Positioning the membrane outside the claimed clamping interface.
Using a non-break-off closure.
Eliminating the claimed trough-shaped recess.

Changing only the arrow orientation, grip design, or presence of a second membrane would not necessarily avoid claim 1 or claim 14.

What patent landscape surrounds U.S. Patent 7,828,787?

The relevant landscape is a medical-device patent field rather than a pharmaceutical patent field. The principal technical categories are:

Landscape category	Typical protected subject matter	Relationship to U.S. 7,828,787
Spike ports and access connectors	Ports receiving administration spikes	Directly adjacent
Self-sealing septa	Elastomeric membranes resealing after puncture	Core overlap risk
Medical-fluid bag closures	Break-off caps, peelable seals, rupture zones	Adjacent
Dual-membrane ports	Two pierceable barriers and sterile intermediate spaces	Claims 3-5
Connector retention structures	Snap fits, beads, grooves, crimped or clamped membranes	Core structural issue
Infusion and transfusion bags	Bag assemblies incorporating access ports	Claims 9, 12, and 13
Needleless access systems	Valves and non-spike access mechanisms	Possible design-around field
Manufacturing methods	Molding, overmolding, membrane insertion, sterilization	Potential separate IP barriers
Material formulations	Elastomer composition, coatings, lubricity, resealing properties	Potential separate IP barriers

The patent’s strongest technical position is the intersection of membrane geometry and connector retention. Earlier patents may disclose individual elements such as a pierceable septum, a break-off cap, or a snap-fit housing. The claim’s enforceable distinction is the particular combination of the two obtuse angles, trough-shaped recess, and T-shaped outer section elastically clamped between connector sections.

A freedom-to-operate review should separate three questions:

Whether a product reads on claim 1 or claim 14.
Whether an earlier patent anticipates the claimed combination.
Whether separate patents cover the elastomer, molding process, bag film, sterilization method, or administration set.

Avoiding claim 7, 8, or 11 does not resolve exposure under the independent claims.

When does U.S. Patent 7,828,787 lose exclusivity?

The patent was granted on November 9, 2010. Its expected base patent term is generally calculated from the relevant U.S. filing or international filing date, not from the grant date, under 35 U.S.C. § 154. Based on the patent’s filing-era technology and the usual twenty-year term structure, the patent would be expected to expire around 2026, subject to any patent-term adjustment, terminal disclaimer, or other term event recorded by the USPTO.

Event	Date or period
U.S. patent grant	November 9, 2010
Expected statutory term	Approximately 20 years from the applicable earliest nonprovisional or international filing date
Expected expiration window	Approximately 2026
Regulatory exclusivity	None created by this device patent
Orange Book listing	Not expected for the connector or membrane claims
Generic drug approval barrier	None under Hatch-Waxman based solely on this patent

A precise expiration date requires the USPTO patent-term calculation, including any patent-term adjustment and terminal disclaimer. The claims themselves do not establish those events.

What is the Orange Book status of U.S. Patent 7,828,787?

U.S. Patent 7,828,787 is not a conventional Orange Book patent. Its claims cover a connector, membrane, medical-fluid package, infusion bag, and transfusion bag. They do not claim:

A drug substance.
A drug product formulation.
A method of using a drug to treat a disease.
A drug-delivery composition.
A pharmaceutical dosage form.

The FDA Orange Book generally concerns approved drug products and patents that meet applicable listing categories for those products. A medical-device patent may affect commercial supply, packaging, or administration equipment without creating an Orange Book patent listing or a Paragraph IV filing obligation.

Are there Paragraph IV challenges to this patent?

A Paragraph IV certification is a Hatch-Waxman mechanism used in an abbreviated new drug application for a listed drug. It is not the normal challenge mechanism for a standalone connector or membrane patent.

Accordingly:

A generic drug applicant would not ordinarily file a Paragraph IV certification solely against this patent.
An ANDA applicant could face separate device-related issues if the approved drug product includes a patented delivery device, but the analysis would depend on the drug application, labeling, listing status, and product configuration.
A medical-device manufacturer would more likely challenge validity or enforceability through district-court litigation, an inter partes review, or another applicable USPTO proceeding.

The patent’s relevance to a drug product would arise through an integrated container-closure system or proprietary administration device, not through conventional active-ingredient exclusivity.

What litigation and settlement issues affect the patent?

The claim set creates several likely litigation issues.

Claim construction

The most consequential terms are:

“Substantially T-shape configuration.”
“First obtuse angle.”
“Second obtuse angle.”
“Second obtuse angle is greater than the first.”
“Trough-shaped recess.”
“Surrounds the spike in a sealed manner.”
“Fixed in a snap-in manner.”
“Clamped with elastic deformation.”

Microscopic cross-sectional measurements, finite-element analysis, and inspection of the molded membrane would likely be important evidence.

Anticipation and obviousness

Validity challenges would likely focus on combinations of prior art concerning:

Medical-fluid spike connectors.
Piercing septa.
Self-sealing elastomeric membranes.
Snap-fit housings.
Break-off caps.
T-shaped membrane flanges.
Dual-membrane sterile barriers.

For an anticipation challenge, one reference would need to disclose every limitation of the challenged claim. Obviousness arguments could combine references, but the geometric relationship between the two obtuse angles and the T-shaped clamping structure would likely receive substantial attention.

Enablement and written description

The independent claims are structural and relatively detailed. A challenge would examine whether the disclosure supports the full range of:

Membrane materials.
Angle relationships.
T-shaped retention profiles.
Spike diameters.
Connector dimensions.
Resealing behavior.

The more broadly “substantially T-shaped” and functionally defined portions are construed, the more important the written-description and enablement analysis becomes.

Settlement and licensing

Any settlement involving this patent would likely address:

Licensed connector configurations.
Approved infusion or transfusion bag products.
Geographic rights.
Supply obligations for membranes or molded ports.
Rights to future improvements.
Manufacturing-source restrictions.
Quality and sterilization controls.

A settlement would not automatically create drug-market exclusivity. Its commercial effect would depend on whether the licensed component is a bottleneck in a bag or administration-set supply chain.

How strong is the patent estate?

The disclosed claims indicate a focused estate rather than a broad pharmaceutical platform.

Strength factor	Assessment
Independent connector claim	Meaningful protection, but dependent on several structural limitations
Independent membrane claim	Stronger against component suppliers because it is not limited to a finished bag
Geometric specificity	Creates differentiation but also creates noninfringement opportunities
Product claims	Useful against finished infusion and transfusion bags
Manufacturing coverage	Not apparent from the supplied claims
Material coverage	Limited; the claims do not broadly claim elastomer chemistry
Method-of-use coverage	None apparent
Drug formulation coverage	None
Biosimilar relevance	None directly
Device supply-chain relevance	High
Design-around exposure	Moderate to high if competitors change membrane geometry and retention architecture

The estate’s principal strength is claim 14, which can reach the membrane separately from the package. Its principal weakness is that both independent claims recite a dense collection of structural limitations. A competitor may avoid literal infringement by changing the internal wall geometry, retention flange, or connector assembly method.

What generic launch risks exist?

There is no conventional generic-drug launch risk based on this patent alone. The relevant commercial risks are device and packaging risks:

A medical-fluid bag manufacturer could face infringement exposure if its port reproduces the claimed membrane geometry.
An infusion-set supplier could face exposure if it supplies a compatible connector with the claimed two-part snap-fit structure.
A drug manufacturer using infusion or transfusion packaging could face supply-chain disruption if the port is licensed or sourced from a restricted vendor.
A competing manufacturer could launch a redesigned port by changing the septum geometry, connector assembly, or retention profile.
A product may avoid claim 14 but still implicate other patents covering sterilization, molding, bag films, or administration-set interfaces.

The economic exposure is therefore linked to sales of medical-fluid containers and access systems, not to sales of the active pharmaceutical ingredient.

What geographic coverage does the patent provide?

U.S. Patent 7,828,787 provides enforceable rights in the United States only. Foreign protection would require separate national or regional family members. A European, German, or other foreign counterpart would have independent prosecution histories, claim scope, expiration calculations, and enforceability rules.

For international commercialization, the relevant review must distinguish:

U.S. patent rights.
European Patent Convention rights.
National rights in Germany, France, Italy, the United Kingdom, and other manufacturing or sales jurisdictions.
Patent rights in countries where infusion bags or connectors are manufactured.
Importation exposure for products made abroad and sold in the United States.

The U.S. patent cannot, by itself, block manufacture and sale outside the United States.

Key Takeaways

U.S. Patent 7,828,787 is a medical-device patent covering a medical-fluid connector and self-sealing membrane.
Claim 1 requires the complete connector architecture, including snap-fit upper and lower sections, a break-off seal, and a specifically shaped self-sealing membrane.
Claim 14 independently protects the membrane and is the most important claim for component-supplier exposure.
The critical geometry includes two obtuse inner angles, with the second greater than the first, a trough-shaped recess, and a substantially T-shaped outer section.
Claims 9, 12, and 13 extend the connector protection to medical-fluid packages, infusion bags, and transfusion bags.
The patent does not claim a drug, drug formulation, therapeutic method, or biosimilar product.
It is not a conventional Orange Book or Paragraph IV patent.
The expected base term runs approximately to 2026, subject to USPTO term adjustments and other recorded events.
The principal design-around opportunities involve replacing the snap-fit structure, changing the membrane geometry, or eliminating the T-shaped clamped retention profile.
The patent’s commercial value is concentrated in infusion and transfusion packaging supply chains.

Frequently Asked Questions

Does U.S. Patent 7,828,787 cover a standard rubber septum?

Not necessarily. The claims require more than a generic pierceable rubber septum. They specify a dish-shaped region, two successive inner faces with a defined angle relationship, a trough-shaped recess, and a T-shaped outer retention section.

Can a connector avoid infringement by using a welded housing instead of a snap-fit housing?

Potentially. Claim 1 expressly requires the upper and lower sections to be fixed in a snap-in manner. A welded or permanently molded connector may avoid literal infringement of that limitation, although the membrane claim and other patents would require separate analysis.

Is a pre-slit membrane required by the independent claims?

No. Pre-slitting is required by claim 10, and slitting is required by claim 16. Claims 1 and 14 do not expressly require a slit, although the broader claim language and prosecution history would control any construction of the membrane’s penetration characteristics.

Does the patent cover the infusion drug inside the bag?

No. Claims 12 and 13 cover an infusion bag or transfusion bag with the claimed connector. They do not claim the drug, biologic, blood product, or medical fluid placed inside the bag.

Can a membrane supplier be liable without selling a complete infusion bag?

Potentially. Claim 14 is directed to the membrane itself. A supplier whose membrane has the claimed structural features and is made or sold for the claimed use could face direct or contributory infringement issues, depending on the transaction and the product’s actual configuration.

References

United States Patent No. 7,828,787, claims 1-19 (2010).
United States Patent and Trademark Office. (2024). Manual of Patent Examining Procedure, § 2710: Term of patent.
United States Code, 35 U.S.C. § 154. Patent term.
United States Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. [Orange Book].

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	102 23 560	May 27, 2002

PCT Information
PCT Filed	February 24, 2003	PCT Application Number:	PCT/EP03/01847
PCT Publication Date:	December 04, 2003	PCT Publication Number:	WO03/099191

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	469630	⤷ Start Trial
Australia	2003208752	⤷ Start Trial
Brazil	0311342	⤷ Start Trial
Brazil	PI0311342	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Summary for Patent: 7,828,787