US Patent 7,762,994: Claim Scope, Expiration, and Patent Landscape for Dual-Compatible Injection Pen Needle Mounts

US Patent 7,762,994 protects an injection-device needle mount that accepts two incompatible needle formats: a bayonet-mounted needle arrangement and a conventional screw-on pen needle. The patent is directed to the mechanical interface at the distal end of an injection pen, not to a drug, cartridge, formulation, or therapeutic method. Its commercial significance is concentrated in injection devices that support rapid, partial-turn attachment of one needle type while retaining compatibility with threaded pen needles.

The patent was assigned to Novo Nordisk A/S and issued on July 27, 2010. Based on the earliest disclosed priority date of August 20, 2004, the ordinary 20-year US patent term ran to August 20, 2025, subject to any applicable patent-term adjustment or terminal disclaimer recorded in the USPTO file history.[1][2]

What does US Patent 7,762,994 protect?

The patent protects a dual-interface needle mount having two separate coupling mechanisms located on the same end segment of an injection device.

The first mechanism is a bayonet coupling. It uses:

Longitudinal grooves in the outer cylindrical wall of the needle mount;
A first groove portion extending substantially parallel to the device axis;
A second groove portion angled relative to the first portion;
Radially inward protrusions on the mating needle hub; and
Axial insertion followed by rotation to lock the needle arrangement.

The second mechanism is a conventional male-threaded connection. It uses external threads at the distal end of the injection device that mate with internal threads in a conventional pen needle hub.

The central commercial concept is compatibility with both:

A double-point needle housed within a tubular member using inward-facing protrusions and a bayonet connection; and
A conventional screw-on pen needle having a threaded cylindrical hub.

The claims do not broadly cover every injection-device needle connector. They require the coexistence of the two coupling systems on the same end segment and require specific structural cooperation between the groove geometry and the bayonet needle hub.

How many independent claims does US 7,762,994 contain?

The supplied claims contain three independent claims: claims 1, 5, and 8.

Claim	Claim type	Principal subject matter	Key limitations
1	Apparatus	Dual-compatible needle mounting system	Cylindrical body, separate bayonet grooves, angled groove portions, distal male threads
5	Combination/system	Injection device with two needle arrangements	Cartridge-containing injection device, bayonet needle, conventional threaded pen needle
8	Functional apparatus/system	Two independent couplings on the same end segment	Axial and rotational bayonet engagement plus threaded hub engagement

Claims 2 through 4 depend from claim 1. Claims 6 and 7 depend from claim 5.

The claims are cumulative rather than redundant. Claim 1 emphasizes the physical mounting system. Claim 5 places the mounting system in the context of a medication injection device and specifies removal behavior. Claim 8 recites the coupling sequence and interaction between the needle-hub protrusions and the groove portions.

What are the key limitations in claim 1?

Claim 1 has several limitations that materially narrow infringement analysis.

Two separate coupling mechanisms

The first and second coupling mechanisms must be separate and located at the same end segment. A product using a bayonet connector at one end of the device and screw threads at a different end would not satisfy this limitation.

The claim also distinguishes the bayonet grooves from the threaded mechanism. A groove cannot simply be characterized as part of the threaded coupling unless the accused structure has the claimed independent coupling functions.

Bayonet grooves with an angled portion

The first coupling mechanism requires grooves in the cylindrical outer wall. At least one groove must have:

A first portion; and
A second portion oriented at an angle to the first portion.

The specification and dependent claims support an L-shaped or substantially L-shaped groove. The angled portion converts axial insertion into rotational locking. A purely helical thread, a straight axial slot, or a snap-fit without the claimed angled groove is less likely to satisfy this limitation.

Male threads at the distal end

The second coupling mechanism must have male threads at the distal end. The claim is directed to a female-threaded needle hub that screws onto the device. A device using internal threads, a smooth friction fit, or a proprietary nonthreaded connector would fall outside this limitation unless another claim construction captured the structure.

Interchangeable use of two needle arrangements

The system must allow either the threaded needle hub or the bayonet needle hub to be mounted and dismounted. A device that physically contains both structures but does not permit operative use of both needle types presents a potential noninfringement position.

How do claims 2 through 4 narrow the invention?

Claims 2 through 4 add geometric restrictions to the bayonet groove.

Claim	Added limitation	Practical effect
2	Angle between groove portions is 90 degrees or less	Covers right-angle and acute-angle bayonet paths
3	First portion is widest at the top end and forms an entrance	Addresses insertion of the hub protrusions
4	First and second portions form a substantially L-shaped groove	Provides the clearest geometric definition of the bayonet path

Claim 4 is particularly relevant for design-around analysis. A competitor using a curved, helical, cammed, or non-L-shaped path may argue that the groove does not form a substantially L-shaped configuration. That argument would depend on the patent specification, prosecution history, and the actual geometry.

What additional limitations appear in claims 5 through 7?

Claim 5 requires an injection device containing a cartridge from which medication is injected into a patient. It also identifies the two needle arrangements in greater detail.

The first arrangement includes:

A double-point hollow needle;
A tubular member surrounding the needle; and
One or more protrusions extending radially inward from the tubular member's inner wall.

The second arrangement includes:

A hollow needle fixed in a conventional pen needle hub;
A generally cylindrical hub; and
Internal threads that screw onto the device's external male threads.

Claim 5 also requires that the bayonet needle be removable by less than a full rotation. Claims 6 and 7 sharpen the distinction:

Claim 6 requires removal of the first needle arrangement by rotating the tubular member less than one revolution.
Claim 7 requires removal of the second needle by rotating it multiple revolutions.

These limitations separate the fast bayonet connection from the conventional screw-on connection. A threaded system that locks in less than one revolution could create a claim-construction dispute, particularly if it also has angled grooves and a separate threaded interface.

What does claim 8 add to the patent scope?

Claim 8 emphasizes the operational sequence of the bayonet connection.

The cylindrical needle member is first displaced axially so that the inward-facing protrusions engage the first groove portions. The member is then rotated so that the protrusions enter the angled second portions. This produces a locked bayonet connection.

Claim 8 also requires a second coupling consisting of male threads at the distal end that engage the internal wall of a cylindrical pen needle hub. The claim therefore captures the same-end, dual-interface architecture from a functional perspective.

For infringement analysis, the most important claim 8 elements are:

A longitudinal groove in the outer cylindrical wall;
An angled second groove portion;
A cylindrical member surrounding a hollow needle;
Radially inward protrusions on that member;
Axial followed by rotational engagement;
Less-than-one-revolution removal for the first needle; and
Separate threaded engagement for the second needle.

What products and technologies are closest to the claimed invention?

The patent is most closely associated with injection pens capable of accepting a proprietary bayonet-mounted needle, such as Novo Nordisk's NovoTwist-type needle arrangement, while also accepting conventional threaded pen needles.

Technology category	Relationship to US 7,762,994
Conventional screw-on pen needles	Relevant to the second coupling mechanism
Bayonet-mounted pen needles	Relevant to the first coupling mechanism
Double-ended needles in tubular members	Specifically described in claims 5 and 8
Disposable insulin pens	Likely commercial application
Reusable cartridge injection pens	Covered when the claimed same-end interfaces are present
Auto-injectors with proprietary connectors	Potentially relevant, but only if the claimed groove and thread architecture is present
Needle safety systems	Adjacent technology, not inherently covered
Cartridge, formulation, or drug patents	Outside the claims

The patent does not require insulin, a particular cartridge volume, a specific injection force, a dose setting mechanism, or a particular needle gauge. Its scope is primarily mechanical.

How strong is the patent estate for the claimed needle-mount architecture?

The individual patent has moderate structural specificity and narrow functional focus.

Strengths

The claims combine several identifiable elements:

Same-end dual compatibility;
A dedicated bayonet groove path;
A separate male-threaded connector;
Distinct needle-hub structures;
Different attachment and removal motions; and
A specific axial-then-rotational bayonet operation.

This combination may have been more difficult to anticipate than a claim directed only to a bayonet mount or only to a threaded pen needle connector.

The claims also provide multiple infringement theories. A product may be assessed under the general mounting-system language of claim 1, the injection-device combination in claim 5, or the operational coupling language in claim 8.

Weaknesses

The same structural detail creates design-around opportunities. A competitor could consider:

Moving the two coupling systems to different axial locations;
Replacing the L-shaped groove with a cam track or helical path;
Using an internal rather than external thread;
Eliminating inward radial protrusions from the needle hub;
Using a quarter-turn or snap-lock geometry that does not require the claimed axial and rotational sequence;
Integrating a proprietary needle connector that cannot accept a conventional threaded hub; or
Placing the threaded interface on a removable adapter rather than the injection device's distal end.

The strongest validity challenge would likely focus on prior art combining a bayonet needle mount with a conventional threaded pen needle connector on the same injection device. Prior art showing each feature separately would be less compelling than art disclosing their integration in the claimed arrangement.

When did US Patent 7,762,994 lose exclusivity?

The ordinary US patent term expired on August 20, 2025, calculated from the earliest priority date identified for the family.[1][2] The controlling date should be confirmed against the USPTO Patent Center record for any patent-term adjustment, terminal disclaimer, reexamination certificate, or other term event.

Because the patent is a mechanical device patent, it does not receive the Hatch-Waxman five-year patent-term extension available to certain drug patents. It also does not create FDA regulatory exclusivity for an active pharmaceutical ingredient.

The expiration analysis is therefore separate from any exclusivity associated with insulin, GLP-1 products, or other medicines used in injection pens.

What is the Orange Book status of US Patent 7,762,994?

US Patent 7,762,994 is not an Orange Book drug patent. The FDA Orange Book lists patents submitted for approved drug products, including patents directed to active ingredients, formulations, compositions, and methods of use.[3]

A needle-mount patent generally does not appear as an Orange Book-listed patent unless it is properly submitted in connection with an approved drug product and meets applicable FDA listing requirements. The claims supplied here are directed to a mounting system and injection-device architecture. They do not claim a drug, formulation, or method of treating a disease.

Accordingly:

It does not create a Paragraph IV pathway by itself.
A generic drug applicant would not ordinarily certify against it solely because the applicant uses a pen injector.
A device manufacturer could still face ordinary patent infringement exposure if the patent were unexpired and the accused device practiced all claim limitations.

Are there Paragraph IV challenges or biosimilar risks?

No direct Paragraph IV or biosimilar challenge follows from this patent.

Paragraph IV certifications apply to patents listed in the Orange Book for an approved drug. Biosimilar applicants address patents under the Biologics Price Competition and Innovation Act, generally through the patent-exchange and litigation framework associated with the reference biologic. A mechanical needle-mount patent does not itself create a biologic exclusivity barrier.

The relevant competitive risks were device-side rather than drug-side:

A competing pen manufacturer using the same dual-compatible mount;
A needle supplier selling a compatible bayonet needle arrangement;
A generic or follow-on injector incorporating the same connector geometry; or
A combination-product applicant using an unexpired patented device interface.

Those risks materially declined when the US patent term expired.

What patent litigation and licensing issues affect this patent?

The patent record should be reviewed for assignments, maintenance fees, terminal disclaimers, reexamination, inter partes review, and litigation history. The supplied claims alone do not establish a licensing agreement, settlement, covenant not to sue, or court construction.

The likely commercial licensing issue was compatibility between:

The injection-pen manufacturer;
The proprietary bayonet needle supplier;
Conventional pen needle manufacturers; and
Device manufacturers seeking to support both formats.

A license covering the injection pen would not necessarily authorize manufacture of the needle arrangement, and a needle-supplier license would not necessarily authorize use of the patented injection-device mount. These rights should be analyzed separately.

No Orange Book patent litigation or Paragraph IV settlement is inherent in this patent. Any litigation would more likely have been a conventional patent infringement dispute involving an injection-device manufacturer or needle supplier.

How does this patent compare with conventional threaded pen-needle patents?

Issue	US 7,762,994	Conventional threaded pen-needle patent
Primary focus	Dual compatibility	Screw-on needle attachment
Connector types	Bayonet plus external male thread	Usually threaded connector only
Needle removal	Bayonet removal in less than one revolution	Multiple revolutions
Claim dependency on groove geometry	High	Often low or absent
Drug-specific limitations	None apparent	Usually none unless combination-product claims are used
Main design-around path	Change groove, location, or connector architecture	Change thread or hub structure
Orange Book relevance	Generally none	Generally none
Biosimilar relevance	None directly	None directly

The patent's differentiator is not the existence of a bayonet connector alone. It is the integration of the bayonet connector and conventional screw threads at the same distal end of an injection device.

What generic launch and commercial exposure risks existed?

Before expiration, a competitor entering the same pen-needle interface market faced several risks:

Product redesign risk. A competing pen might need to abandon compatibility with standard threaded pen needles.
Needle ecosystem risk. A proprietary bayonet system could require a dedicated needle supply chain.
Freedom-to-operate risk. Even if a competitor avoided this patent, separate patents could cover needle shields, safety mechanisms, hub manufacturing, or pen architecture.
Compatibility risk. A design that supported both needle formats could be commercially attractive but more likely to encounter patent overlap.
Geographic risk. US expiration did not automatically terminate corresponding rights in Europe, Japan, China, or other jurisdictions.

After US expiration, the claims no longer provide an ordinary US exclusion right, but foreign family members may have had different expiration dates, claim scopes, maintenance status, or prosecution outcomes.

What manufacturing and IP barriers remain after expiration?

Expiration of US 7,762,994 removes the patent barrier created by these claims. It does not eliminate other barriers, including:

Manufacturing tolerances for the groove and protrusion geometry;
Needle sterility and packaging requirements;
ISO 11608 requirements for needle-based injection systems;
FDA combination-product review;
Compatibility testing across pen and needle formats;
Trademark and trade-dress issues involving branded needle systems;
Separate patents covering safety shields or needle protection;
Foreign patents in the same family; and
Know-how relating to tooling, assembly, and quality control.

The expired patent may still have technical value as prior art against later patent applications claiming the same dual-interface concept.

Key Takeaways

US 7,762,994 covers a same-end injection-pen mount compatible with both bayonet and threaded needle arrangements.
The critical structural limitations are the angled bayonet grooves, inward hub protrusions, and separate distal male threads.
Claims 1, 5, and 8 are independent; claims 2 through 4 and 6 through 7 add geometry and removal-motion limitations.
The patent is a device patent, not a drug, formulation, Orange Book, Paragraph IV, or biosimilar patent.
Its ordinary US patent term ran to August 20, 2025, subject to the official USPTO term record.
The principal pre-expiration design-around strategies involved changing the groove path, connector location, thread orientation, or needle-hub engagement.
Expiration in the US does not establish expiration of corresponding foreign rights or freedom from other device patents.
Commercial exposure was concentrated in injection pens and compatible needle systems rather than pharmaceutical ingredients.

FAQs About US Patent 7,762,994

Does US Patent 7,762,994 cover NovoTwist needles?

It may read on an injection-device mount and needle arrangement having the claimed bayonet grooves, inward hub protrusions, and separate male-threaded interface. Product coverage depends on the exact commercial geometry and claim construction.

Can a conventional screw-on pen needle infringe this patent by itself?

Ordinarily, no. The claims require a dual-compatible mounting system with both the bayonet and threaded coupling mechanisms. A conventional threaded pen needle without the claimed injection-device mount would not satisfy the full combination.

Does patent expiration permit use of the same needle connector worldwide?

No. US expiration affects US patent rights only. Foreign family members and unrelated national patents require separate analysis.

Can a company obtain FDA approval for a dual-compatible pen without addressing this patent?

FDA clearance or approval and patent freedom to operate are separate issues. Regulatory authorization does not immunize a product from patent infringement claims.

Is the patent relevant to insulin pen competition?

Yes, at the device-interface level. It may be relevant to insulin pens and other cartridge injection devices that accept proprietary bayonet needles and conventional threaded pen needles, but it does not claim insulin or another active pharmaceutical ingredient.

References

United States Patent and Trademark Office. (2010). US Patent No. 7,762,994, Needle mount for an injection device. USPTO Patent Center.
Google Patents. (n.d.). US7762994B2, Needle mount for an injection device. Google Patents. https://patents.google.com/patent/US7762994B2/en
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA, Center for Drug Evaluation and Research. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Denmark	2002 01169	Aug 1, 2002

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	344076	⤷ Start Trial
Austria	439883	⤷ Start Trial
Australia	2003243922	⤷ Start Trial
Canada	2491356	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 7,762,994

Summary for Patent: 7,762,994