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United States Patent 5,984,906 (US5984906): Insulin Pen System and “Thinner Than G-29” Needle Claims, Expiration, and US Patent Landscape

US Patent 5,984,906 covers an insulin injection pen system and needle assembly engineered around a “thinner than a G-29 needle” needle, with dependent claims narrowing to an insulin formulation with a maximum crystal size of 15 µm and to specific needle geometry/attachments. The claim set is broad on needle-thickness and cartridge freedom-to-flow, then narrows on particle size and on mechanical details of the hub, threads, sleeve geometry, and needle exposure/insertion depth.

What does US 5,984,906 claim and how broad is the scope?

Direct claim themes

Device system: a pen-shaped syringe (disposable or durable) with a cartridge of insulin that “may freely flow” through a needle thinner than a G-29 needle.
Formulation constraint (dependent): insulin crystals with a maximal crystal size of 15 µm.
Needle assembly: a hub compatible with a standard insulin pen needle fitting, but arranged to accept only cartridges whose insulin types flow through a thinner-than-G-29 needle.
Needle geometry (dependent): two opposite needle portions; hub features including a threaded interior in an annular sleeve; a central protrusion embedding one needle portion; exposed end projection length corresponding to patient injection depth; injection part length 8–12 mm.

Claim 1 is the key independent claim (scope driver)

Claim 1 covers “an insulin injection system comprising a pen shaped syringe” where:

the needle is thinner than a G-29 needle; and
the cartridge contains an insulin type that “may freely flow” through that thinner needle.

Why this matters legally

“Thinner than G-29” is a relative structural limitation. In practice, it typically maps to a gauge-based diameter range, but the claim text does not define an objective numeric diameter.
“May freely flow” is a functional/behavioral limitation. Courts usually treat these as definite if the spec and intrinsic record provide a measurable standard. Without the specification text, enforceability and infringement mapping hinge on how “freely” is supported.

Dependent claim 2 adds a formulation particle-size limit

Claim 2 narrows the insulin type to maximal crystals size of 15 µm.

Critical scope impact

This turns the infringement question into a product-by-product formulation attribute. If an accused insulin uses different crystal size distribution, it may avoid claim 2 even if it still flows through a fine needle.
If “freely flow” already captures flow properties, claim 2 tightens that with a specific particle criterion.

Claim 3–4 cover disposable vs reusable pen architectures

Claim 3: disposable prefilled pen.
Claim 4: durable pen that receives cartridges engineered for the thin needle.

This is commercially relevant because different manufacturers distribute insulin via:

prefilled disposable pens (prefilled cartridges),
or “refill” systems using replaceable cartridges.

Claim 5–10 cover mechanical needle attachment and needle injection part length

Claim 5–7: needle hub with thread attachment and a central protrusion covering part of the needle length.
Claim 8: injection part length 8–12 mm.
Claims 9–10 restate dependency from claim 2 and claim 4.

This layer reduces the number of designs that can plausibly “get around” by using thin needles alone; it also increases design-around pathways via different hub geometry or needle insertion length.

Claims 11–14 focus on the needle assembly as a separable infringement product

Claim 11 defines a needle assembly comprising:

a hub with a standard insulin needle fitting compatible with standard pen mounting, while accepting cartridges that flow freely through thinner-than-G-29 needles; and
a thinner-than-G-29 needle secured in the base with first and second needle portions extending in opposite directions.

Claim 12 adds an annular sleeve extending from the base, spaced concentrically around a first needle portion, with a threaded interior that screws onto a standard externally threaded hub-receiving pen part.

Claim 13–14 define the injection depth mechanics using:

a second needle portion length appropriate for injecting into a human patient; and
a central protrusion embedding the second needle portion for a predetermined distance, with an exposed end projecting axially to match desired insertion depth.

Practical IP implication

Even if an accused pen uses a different cartridge system, a target that sells/uses a needle assembly that matches the mechanical definition may still be exposed.

How strong is the patent estate: what would need to be true for infringement?

Infringement is primarily a two-part match: thin needle + insulin flow (and crystal size for claim 2)

For independent claim 1, an accused system likely needs:

a pen-shaped syringe system; and
a needle that is thinner than G-29; and
an insulin cartridge/insulin type that “may freely flow” through that thinner needle.

For dependent claim 2, the additional requirement is:

maximal insulin crystal size of 15 µm.

The “freely flow” limitation is the main technical litigation hinge

“May freely flow” can be attacked both ways:

Noninfringement: accused insulin may not be shown to meet a “free flow” performance threshold in the specified thin needle configuration.
Validity/indefiniteness: if “freely flow” is not objectively measurable by the claim alone, some challenges can be aimed at claim clarity, though definiteness disputes depend heavily on the intrinsic record.

Needle geometry and length limits support “partial” design-around strategies

Claim 8 and the needle-embedding/insertion-depth mechanics (claim 14) provide concrete physical constraints. Competitors can often reduce risk by:

altering the hub’s central protrusion geometry,
changing the effective needle exposure length,
changing the sleeve/thread engagement structure,
or using different needle portion arrangements.

When does US 5,984,906 lose exclusivity in the US?

US patent term for pre-URAA patents (filed before June 8, 1995) is typically 17 years from grant under the old regime, or 20 years from earliest non-provisional filing for later priority dates. For a full “expiration date” calculation, the filing and priority data are required. Those bibliographic details are not provided in the prompt; therefore an exact exclusivity/expiration timeline cannot be stated from the claim text alone.

Actionable takeaway: treat US 5,984,906 as a legacy device patent that is likely expired or near-expiration in 2026, but exclusivity for continuation claims or related patents depends on the family’s filing dates and any additional patents in the same publication set.

What is the Orange Book status of US 5,984,906?

US 5,984,906 is a device/needle/pen system patent. Orange Book listing is typically reserved for patents that claim:

a drug substance,
a drug product,
or a method of use for an FDA-approved drug.

Device patents are often not listed in the Orange Book, even if they relate to drug administration. No Orange Book listing data is included in the prompt; a definitive Orange Book status cannot be provided.

Which insulin pens and fine needles could fall inside the claim boundaries?

“Thinner than G-29” is the central technical constraint

G-29 is a specific needle gauge (thin). Any needle labeled “29G” is not “thinner than,” so infringement generally requires more than G-29 (e.g., 30G, 31G, or smaller diameter depending on the standard mapping used in the patent/spec).

Key risk patterns:

Flow compatibility: systems that pair ultra-fine needles with insulin formulations known to pass through without clogging.
Cartridge engineering: claims 3–4 target cartridge-driven systems. A pen that uses a thin needle but the cartridge insulin does not meet “may freely flow” may avoid claim 1 (and likely claim 2).

Crystal size limit (15 µm) is an insulin product differentiator

If an accused insulin is a formulation with controlled particle size above 15 µm, it is less likely to meet claim 2. If below or supported by a crystal size distribution test meeting the limit, claim 2 exposure increases.

How do dependent needle assembly claims shape design-around options?

Claim 11–14 provide multiple mechanical features that can be changed without changing needle gauge:

Needle portions extend in opposite directions from the base (dual-direction portion concept).
Annular sleeve surrounding one needle portion, with a threaded interior compatible with standard pen hub threads.
Central protrusion embedding part of the needle along a predetermined distance.
Exposed end projecting to match injection depth.

Design-around pathways for a competitor:

use a hub without the annular sleeve with threaded interior structure as claimed,
change the embedded/projection relationship of the second needle portion,
use different thread engagement geometry,
or use different injection depth mechanics even if the needle gauge is thin.

What does the patent likely cover in manufacturing and component sales?

Because the needle assembly is claimed as a standalone structure (claim 11–14), exposure is not limited to full pen systems:

selling needle assemblies compatible with standard pen fittings that accept only certain cartridges (claim 11),
or manufacturing needles with the hub/base geometry and embedded insertion portion.

This component-claim structure matters for supply chain licensing and litigation strategy.

What prior art and obviousness risks typically apply to “ultra-fine insulin needles”?

The claims combine:

a thin needle threshold (“thinner than G-29”),
with a cartridge insulin that can flow through it,
plus mechanical attachment and injection depth geometry.

In the needle art, typical prior art includes:

ultra-fine pen needles marketed for reduced pain and improved delivery,
formulations and suspension controls for insulin to prevent clogging,
pen-needle hub designs with standard thread compatibility.

The risk for US 5,984,906 would be whether prior art already disclosed:

pens using needles thinner than G-29 with insulin that flows,
and similar pen-fitting/hub attachment structures, leaving limited novelty only in “crystal size ≤15 µm” or in the specific hub embedding/injection exposure geometry.

Without the patent’s specification, prosecution history, and the actual cited references from the file wrapper, a definitive novelty/obviousness position cannot be stated from the prompt.

What generic or biosimilar entry risks exist for US 5,984,906?

For generics/biosimilars, the main exposure channel is indirect:

claim 1–2 involve insulin type and whether it flows through the thin needle,
but generic entry in the Hatch-Waxman sense typically does not change the device unless a Paragraph IV challenger couples a generic drug with a claimed device.

However, for marketing of insulin products under substitution, the “needle-compatible flow” and crystal size constraints can matter. If a generic/biosimilar insulin is formulated to flow through ultra-fine pen needles (and meets the crystal size limit), it may create infringement risk with claim 2 when paired with a system matching the device claims.

For a full litigation-risk assessment, you need the specific insulin products and devices sold with them, plus the patent’s prosecution narrowing positions. That information is not present here.

What patent-litigation posture typically applies to legacy device patents like US 5,984,906?

Legacy device patents often face:

infringement theories targeting pen and needle assembly bundles,
validity challenges arguing obviousness over needle gauge/pen compatibility prior art,
and noninfringement arguments based on different injection length, hub geometry, or crystal size/flow characteristics.

A critical point: the dependent claims offer multiple physical and formulation constraints that allow narrow noninfringement arguments. That generally reduces the chance of a “blanket” infringement finding across different competitors unless their products are engineered extremely close to the claim language.

Key comparisons: where enforcement is most likely vs least likely

Most likely enforcement targets

Pens/needle assemblies explicitly marketed with ultra-fine needle sizes beyond G-29.
Cartridge insulin formulations designed with crystal size distributions and supported tests.
Needle hubs with standard pen threading and with the specific sleeve/protrusion/embedded-length architecture.

Least likely enforcement targets

Ultra-fine needles (thin enough) paired with insulin whose maximal crystals are above 15 µm.
Needle assemblies that meet thinness but do not match hub/sleeve/protrusion geometry.
Injection systems that change effective exposed needle length away from the claimed 8–12 mm insertion part or alter embedding/projection structure.

Key Takeaways

US 5,984,906 is a combined device + formulation-performance patent centered on needle thickness “thinner than G-29” and cartridge insulin that “freely flows” through that thin needle.
Claim 2’s maximal crystal size of 15 µm is the most discriminating limitation and likely the biggest basis for noninfringement versus alternative insulin formulations.
Claims 5–10 and 11–14 materially constrain mechanical structure, especially hub/threaded-sleeve and needle embedding/exposed length tied to injection depth.
The patent landscape impact for competitors hinges on whether they match both the needle gauge threshold and either the crystal size limit (claim 2) or the specific hub/insertion geometry (claims 8 and 12–14).
Exact expiration, Orange Book status, and the live litigation/Paragraph IV footprint cannot be determined from the prompt alone because the bibliographic and listing data are not included.

FAQs

1) Does “thinner than G-29” mean a specific gauge range or just any needle smaller than 29G?

The claim language is relative (“thinner than a G-29 needle”) rather than numeric. How it maps in litigation usually depends on how the patent/spec defines or correlates “G-29” to diameter and how “thinner” is measured.

2) If an insulin flows through a thin needle but has crystals larger than 15 µm, does it avoid claim 2?

Yes for claim 2, because it adds a maximal crystal size limitation of 15 µm. Flow alone is not sufficient to meet claim 2.

3) Can a company infringe US 5,984,906 by selling only the needle assembly?

Claim 11–14 are directed to a needle assembly structure with the hub and thinner-than-G-29 needle features. Selling a matching needle assembly can create infringement exposure independent of the full pen system.

4) Would a reusable pen that uses standard external pen threads automatically fall within the attachment claims?

Not automatically. The hub/sleeve/threaded-interior/central-protrusion/needle embedding and exposure-length mechanics all affect whether the attachment structure matches the claims.

5) How do generic/biosimilar insulin products typically create or avoid risk from device patents?

Risk is highest when the generic/biosimilar insulin is paired with a system that meets the patent’s device claims and, for claim 2, meets the crystal size constraint. Risk is reduced when device geometry differs or the formulation particle size does not meet the claim.

References (APA)

United States Patent and Trademark Office. (n.d.). U.S. Patent No. 5,984,906. USPTO Patent Full-Text and Image Database.

Title:	Syringe system
Abstract:	An insulin injection system comprises a pen shaped syringe with a cartridge containing insulin, and an injection needle. The needle is a G30 needle and the insulin is a type which may freely flow through a G 30 needle. When the insulin is the type comprising suspended crystals the maximal dimension of any crystal is 15 .mu.m.
Inventor(s):	Bonnichsen; Frits Frydendal (Lynge, DK), J.o slashed.rgensen; Peter Nissen (Broenshoej, DK)
Assignee:	Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:	08/794,026
Patent Claims:	see list of patent claims
Patent landscape, scope, and claims summary:	United States Patent 5,984,906 (US5984906): Insulin Pen System and “Thinner Than G-29” Needle Claims, Expiration, and US Patent Landscape US Patent 5,984,906 covers an insulin injection pen system and needle assembly engineered around a “thinner than a G-29 needle” needle, with dependent claims narrowing to an insulin formulation with a maximum crystal size of 15 µm and to specific needle geometry/attachments. The claim set is broad on needle-thickness and cartridge freedom-to-flow, then narrows on particle size and on mechanical details of the hub, threads, sleeve geometry, and needle exposure/insertion depth. What does US 5,984,906 claim and how broad is the scope? Direct claim themes Device system: a pen-shaped syringe (disposable or durable) with a cartridge of insulin that “may freely flow” through a needle thinner than a G-29 needle. Formulation constraint (dependent): insulin crystals with a maximal crystal size of 15 µm. Needle assembly: a hub compatible with a standard insulin pen needle fitting, but arranged to accept only cartridges whose insulin types flow through a thinner-than-G-29 needle. Needle geometry (dependent): two opposite needle portions; hub features including a threaded interior in an annular sleeve; a central protrusion embedding one needle portion; exposed end projection length corresponding to patient injection depth; injection part length 8–12 mm. Claim 1 is the key independent claim (scope driver) Claim 1 covers “an insulin injection system comprising a pen shaped syringe” where: the needle is thinner than a G-29 needle; and the cartridge contains an insulin type that “may freely flow” through that thinner needle. Why this matters legally “Thinner than G-29” is a relative structural limitation. In practice, it typically maps to a gauge-based diameter range, but the claim text does not define an objective numeric diameter. “May freely flow” is a functional/behavioral limitation. Courts usually treat these as definite if the spec and intrinsic record provide a measurable standard. Without the specification text, enforceability and infringement mapping hinge on how “freely” is supported. Dependent claim 2 adds a formulation particle-size limit Claim 2 narrows the insulin type to maximal crystals size of 15 µm. Critical scope impact This turns the infringement question into a product-by-product formulation attribute. If an accused insulin uses different crystal size distribution, it may avoid claim 2 even if it still flows through a fine needle. If “freely flow” already captures flow properties, claim 2 tightens that with a specific particle criterion. Claim 3–4 cover disposable vs reusable pen architectures Claim 3: disposable prefilled pen. Claim 4: durable pen that receives cartridges engineered for the thin needle. This is commercially relevant because different manufacturers distribute insulin via: prefilled disposable pens (prefilled cartridges), or “refill” systems using replaceable cartridges. Claim 5–10 cover mechanical needle attachment and needle injection part length Claim 5–7: needle hub with thread attachment and a central protrusion covering part of the needle length. Claim 8: injection part length 8–12 mm. Claims 9–10 restate dependency from claim 2 and claim 4. This layer reduces the number of designs that can plausibly “get around” by using thin needles alone; it also increases design-around pathways via different hub geometry or needle insertion length. Claims 11–14 focus on the needle assembly as a separable infringement product Claim 11 defines a needle assembly comprising: a hub with a standard insulin needle fitting compatible with standard pen mounting, while accepting cartridges that flow freely through thinner-than-G-29 needles; and a thinner-than-G-29 needle secured in the base with first and second needle portions extending in opposite directions. Claim 12 adds an annular sleeve extending from the base, spaced concentrically around a first needle portion, with a threaded interior that screws onto a standard externally threaded hub-receiving pen part. Claim 13–14 define the injection depth mechanics using: a second needle portion length appropriate for injecting into a human patient; and a central protrusion embedding the second needle portion for a predetermined distance, with an exposed end projecting axially to match desired insertion depth. Practical IP implication Even if an accused pen uses a different cartridge system, a target that sells/uses a needle assembly that matches the mechanical definition may still be exposed. How strong is the patent estate: what would need to be true for infringement? Infringement is primarily a two-part match: thin needle + insulin flow (and crystal size for claim 2) For independent claim 1, an accused system likely needs: a pen-shaped syringe system; and a needle that is thinner than G-29; and an insulin cartridge/insulin type that “may freely flow” through that thinner needle. For dependent claim 2, the additional requirement is: maximal insulin crystal size of 15 µm. The “freely flow” limitation is the main technical litigation hinge “May freely flow” can be attacked both ways: Noninfringement: accused insulin may not be shown to meet a “free flow” performance threshold in the specified thin needle configuration. Validity/indefiniteness: if “freely flow” is not objectively measurable by the claim alone, some challenges can be aimed at claim clarity, though definiteness disputes depend heavily on the intrinsic record. Needle geometry and length limits support “partial” design-around strategies Claim 8 and the needle-embedding/insertion-depth mechanics (claim 14) provide concrete physical constraints. Competitors can often reduce risk by: altering the hub’s central protrusion geometry, changing the effective needle exposure length, changing the sleeve/thread engagement structure, or using different needle portion arrangements. When does US 5,984,906 lose exclusivity in the US? US patent term for pre-URAA patents (filed before June 8, 1995) is typically 17 years from grant under the old regime, or 20 years from earliest non-provisional filing for later priority dates. For a full “expiration date” calculation, the filing and priority data are required. Those bibliographic details are not provided in the prompt; therefore an exact exclusivity/expiration timeline cannot be stated from the claim text alone. Actionable takeaway: treat US 5,984,906 as a legacy device patent that is likely expired or near-expiration in 2026, but exclusivity for continuation claims or related patents depends on the family’s filing dates and any additional patents in the same publication set. What is the Orange Book status of US 5,984,906? US 5,984,906 is a device/needle/pen system patent. Orange Book listing is typically reserved for patents that claim: a drug substance, a drug product, or a method of use for an FDA-approved drug. Device patents are often not listed in the Orange Book, even if they relate to drug administration. No Orange Book listing data is included in the prompt; a definitive Orange Book status cannot be provided. Which insulin pens and fine needles could fall inside the claim boundaries? “Thinner than G-29” is the central technical constraint G-29 is a specific needle gauge (thin). Any needle labeled “29G” is not “thinner than,” so infringement generally requires more than G-29 (e.g., 30G, 31G, or smaller diameter depending on the standard mapping used in the patent/spec). Key risk patterns: Flow compatibility: systems that pair ultra-fine needles with insulin formulations known to pass through without clogging. Cartridge engineering: claims 3–4 target cartridge-driven systems. A pen that uses a thin needle but the cartridge insulin does not meet “may freely flow” may avoid claim 1 (and likely claim 2). Crystal size limit (15 µm) is an insulin product differentiator If an accused insulin is a formulation with controlled particle size above 15 µm, it is less likely to meet claim 2. If below or supported by a crystal size distribution test meeting the limit, claim 2 exposure increases. How do dependent needle assembly claims shape design-around options? Claim 11–14 provide multiple mechanical features that can be changed without changing needle gauge: Needle portions extend in opposite directions from the base (dual-direction portion concept). Annular sleeve surrounding one needle portion, with a threaded interior compatible with standard pen hub threads. Central protrusion embedding part of the needle along a predetermined distance. Exposed end projecting to match injection depth. Design-around pathways for a competitor: use a hub without the annular sleeve with threaded interior structure as claimed, change the embedded/projection relationship of the second needle portion, use different thread engagement geometry, or use different injection depth mechanics even if the needle gauge is thin. What does the patent likely cover in manufacturing and component sales? Because the needle assembly is claimed as a standalone structure (claim 11–14), exposure is not limited to full pen systems: selling needle assemblies compatible with standard pen fittings that accept only certain cartridges (claim 11), or manufacturing needles with the hub/base geometry and embedded insertion portion. This component-claim structure matters for supply chain licensing and litigation strategy. What prior art and obviousness risks typically apply to “ultra-fine insulin needles”? The claims combine: a thin needle threshold (“thinner than G-29”), with a cartridge insulin that can flow through it, plus mechanical attachment and injection depth geometry. In the needle art, typical prior art includes: ultra-fine pen needles marketed for reduced pain and improved delivery, formulations and suspension controls for insulin to prevent clogging, pen-needle hub designs with standard thread compatibility. The risk for US 5,984,906 would be whether prior art already disclosed: pens using needles thinner than G-29 with insulin that flows, and similar pen-fitting/hub attachment structures, leaving limited novelty only in “crystal size ≤15 µm” or in the specific hub embedding/injection exposure geometry. Without the patent’s specification, prosecution history, and the actual cited references from the file wrapper, a definitive novelty/obviousness position cannot be stated from the prompt. What generic or biosimilar entry risks exist for US 5,984,906? For generics/biosimilars, the main exposure channel is indirect: claim 1–2 involve insulin type and whether it flows through the thin needle, but generic entry in the Hatch-Waxman sense typically does not change the device unless a Paragraph IV challenger couples a generic drug with a claimed device. However, for marketing of insulin products under substitution, the “needle-compatible flow” and crystal size constraints can matter. If a generic/biosimilar insulin is formulated to flow through ultra-fine pen needles (and meets the crystal size limit), it may create infringement risk with claim 2 when paired with a system matching the device claims. For a full litigation-risk assessment, you need the specific insulin products and devices sold with them, plus the patent’s prosecution narrowing positions. That information is not present here. What patent-litigation posture typically applies to legacy device patents like US 5,984,906? Legacy device patents often face: infringement theories targeting pen and needle assembly bundles, validity challenges arguing obviousness over needle gauge/pen compatibility prior art, and noninfringement arguments based on different injection length, hub geometry, or crystal size/flow characteristics. A critical point: the dependent claims offer multiple physical and formulation constraints that allow narrow noninfringement arguments. That generally reduces the chance of a “blanket” infringement finding across different competitors unless their products are engineered extremely close to the claim language. Key comparisons: where enforcement is most likely vs least likely Most likely enforcement targets Pens/needle assemblies explicitly marketed with ultra-fine needle sizes beyond G-29. Cartridge insulin formulations designed with crystal size distributions and supported tests. Needle hubs with standard pen threading and with the specific sleeve/protrusion/embedded-length architecture. Least likely enforcement targets Ultra-fine needles (thin enough) paired with insulin whose maximal crystals are above 15 µm. Needle assemblies that meet thinness but do not match hub/sleeve/protrusion geometry. Injection systems that change effective exposed needle length away from the claimed 8–12 mm insertion part or alter embedding/projection structure. Key Takeaways US 5,984,906 is a combined device + formulation-performance patent centered on needle thickness “thinner than G-29” and cartridge insulin that “freely flows” through that thin needle. Claim 2’s maximal crystal size of 15 µm is the most discriminating limitation and likely the biggest basis for noninfringement versus alternative insulin formulations. Claims 5–10 and 11–14 materially constrain mechanical structure, especially hub/threaded-sleeve and needle embedding/exposed length tied to injection depth. The patent landscape impact for competitors hinges on whether they match both the needle gauge threshold and either the crystal size limit (claim 2) or the specific hub/insertion geometry (claims 8 and 12–14). Exact expiration, Orange Book status, and the live litigation/Paragraph IV footprint cannot be determined from the prompt alone because the bibliographic and listing data are not included. FAQs 1) Does “thinner than G-29” mean a specific gauge range or just any needle smaller than 29G? The claim language is relative (“thinner than a G-29 needle”) rather than numeric. How it maps in litigation usually depends on how the patent/spec defines or correlates “G-29” to diameter and how “thinner” is measured. 2) If an insulin flows through a thin needle but has crystals larger than 15 µm, does it avoid claim 2? Yes for claim 2, because it adds a maximal crystal size limitation of 15 µm. Flow alone is not sufficient to meet claim 2. 3) Can a company infringe US 5,984,906 by selling only the needle assembly? Claim 11–14 are directed to a needle assembly structure with the hub and thinner-than-G-29 needle features. Selling a matching needle assembly can create infringement exposure independent of the full pen system. 4) Would a reusable pen that uses standard external pen threads automatically fall within the attachment claims? Not automatically. The hub/sleeve/threaded-interior/central-protrusion/needle embedding and exposure-length mechanics all affect whether the attachment structure matches the claims. 5) How do generic/biosimilar insulin products typically create or avoid risk from device patents? Risk is highest when the generic/biosimilar insulin is paired with a system that meets the patent’s device claims and, for claim 2, meets the crystal size constraint. Risk is reduced when device geometry differs or the formulation particle size does not meet the claim. References (APA) United States Patent and Trademark Office. (n.d.). U.S. Patent No. 5,984,906. USPTO Patent Full-Text and Image Database. More… ↓ ⤷ Start Trial

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	October 28, 1982	5,984,906	2017-02-03
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	December 29, 2015	5,984,906	2017-02-03
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	August 06, 1998	5,984,906	2017-02-03
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	March 31, 1994	5,984,906	2017-02-03
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

Patent: 5,984,906

Summary for Patent: 5,984,906