Details for Patent: 4,215,104

« Back to Dashboard

Summary for Patent: 4,215,104

Title:	Multi-fractionable tablet structure
Abstract:	The invention disclosed provides a multi-fractionable tablet structure initially configurated in a unitary dosage while having readily severable sub-dosage units as components thereof. Score markings are positioned variously about the tablet both along the top and bottom surfaces of an approximately rectangular configuration whereas in preferred embodiments thereof, score markings additionally appear along opposite vertical side surfaces of the tablet. Special placement of the score markings readily permit at least either an accurate bisectional fracture or accurate trisectional fracture of the tablet as may be desired for patient consumption.
Inventor(s):	Michael K. Ullman, Stephen T. David, Claude E. Gallian
Assignee:	Mead Johnson and Co LLC
Application Number:	US06/024,139
Patent Claim Types: see list of patent claims	Dosage form;

US Patent 4,215,104: Scope, Claim Construction, Expiration, and Tablet-Patent Landscape

US Patent 4,215,104 protects a physical tablet architecture designed to permit accurate fracture into halves and thirds. It does not claim a drug substance, active pharmaceutical ingredient, therapeutic indication, release profile, or manufacturing chemistry. The patent’s principal commercial relevance was therefore to scored-tablet design and tablet tooling.

Based on its 1980 grant date and the pre-1995 patent-term rules, the patent expired no later than July 29, 1997, assuming the grant date was July 29, 1980 and no unusual term adjustment or term extension applied. The claims do not create a current US exclusivity barrier for generic or branded products.

What does US Patent 4,215,104 protect?

The patent protects a unitary, approximately rectangular tablet with multiple score markings positioned to divide the tablet into approximately equal halves or thirds.

The core technical concept has four elements:

1. A rectangular tablet body.
2. Opposed planar surfaces joined by tablet walls.
3. Score markings arranged across the tablet’s surfaces and walls.
4. A geometry that permits fracture into bisectional or trisectional dosage units.

The patent is directed to tablet geometry rather than pharmacology. A product could potentially fall within the claims regardless of whether it contained an analgesic, cardiovascular drug, psychiatric drug, antibiotic, or other active ingredient, provided the physical structure met the relevant limitations.

How are the claims organized?

The claims contain two independent claim groups.

Claim group	Independent claim	Core structure	Dependent claims
Primary multidirectional-score structure	1	Two transverse scores on each planar surface plus vertical scores on front and rear walls	2-11
Alternative bisection/trisection structure	12	Two transverse scores on one planar surface and one longitudinal score on the opposite surface	13-15

Claims 1 and 12 are the principal infringement claims. The remaining claims narrow the structures by adding bevel angles, V-groove dimensions, groove depth, arcuate surfaces, and orientation requirements.

What is the scope of independent claim 1?

Claim 1 requires all of the following:

Limitation	Technical significance
Approximately rectangular unitary body	Excludes tablets lacking the claimed general rectangular form
First and second planar surfaces	Requires opposed substantially flat tablet surfaces
Vertical end walls relative to front and rear wall surfaces	Defines the tablet’s wall geometry and orientation
Two transverse score markings on each planar surface	Creates three approximately equal sections on both planar faces
One vertical score marking on each front and rear wall	Adds a second fracture direction through the tablet body
Vertical scores positioned between the transverse scores	Controls the intersection and location of the fracture lines
Ability to fracture into bisectional or trisectional units	States the intended functional result of the geometry

The broadest claim is not limited to any particular active ingredient, tablet weight, hardness, excipient, coating, compression process, or therapeutic use.

Claim 1 construction issues

The terms “approximately,” “approximately equal,” “approximately opposite,” and “at least” create claim-construction questions. They do not eliminate the need for objective structural correspondence. A court would likely evaluate the accused tablet’s dimensions, score placement, and fracture behavior in view of the specification and prosecution history.

The claim is also unusually dependent on orientation terms such as “front wall,” “rear wall,” “vertical end walls,” and “transverse.” Those terms may require a consistent reference orientation derived from the patent drawings and specification. The claim’s commercial reach could therefore depend on how the tablet is positioned for analysis.

A tablet with only one score line, irregular score placement, or no corresponding wall grooves would have a stronger noninfringement position against claim 1, although claim 12 could remain relevant if its separate arrangement were present.

What does claim 12 add to the patent landscape?

Claim 12 protects a different score arrangement:

• One planar surface has two transverse score markings.
• The opposite planar surface has one longitudinal score marking.
• The arrangement defines approximate thirds on one side and halves on the other.
• The tablet can be fractured into bisectional or trisectional dosage units.

Claim 12 is broader in one respect than claim 1 because it does not require vertical score markings on both front and rear walls. It is narrower in another respect because it requires a specific asymmetric arrangement between the two planar surfaces.

This claim could be relevant to tablets with a three-way scoring pattern on one face and a central dividing groove on the opposite face.

What do claims 2 through 11 protect?

The dependent claims add physical limitations that narrow the scope of claim 1.

Claim	Added limitation	Commercial effect
2	Beveled planar edges; score depth extends to the bevel-edge line	Targets a tablet edge and score relationship
3	Bevel angle of about 25° to 50°	Narrows the edge geometry
4	Bevel angle of about 30° to 45°	Further narrows claim 3
5	Vertical V-groove angle of about 40° to 50%; depth about one-fourth to one-third tablet width	Adds dimensional limits to wall grooves
6	Planar surfaces are top and bottom surfaces	Fixes one orientation
7	Planar surfaces are front and rear surfaces	Provides an alternative orientation
8	Deep vertical V-grooves with specified angle and depth	Reinforces claim 5’s groove architecture
9	V-groove angle about 45°	Narrowest angle limitation for the vertical groove
10	Transverse grooves with a 55° to 65° V-angle and depth one-fourth to five-eighths tablet thickness	Covers deep surface scores
11	Opposite planar surface is arcuate; V-groove angle about 60°	Adds curvature and score-angle restrictions

Claim 11, as provided, depends on claim 9 while also referring to a planar surface containing deeply grooved indentations. The exact dependency and antecedent basis should be checked against the issued patent document because the supplied claim text may contain transcription or formatting inconsistencies.

What do claims 13 through 15 protect?

Claims 13 through 15 narrow claim 12 through bevel geometry:

Claim	Limitation
13	Beveled planar edges and score depth extending to the bevel-edge line
14	Bevel angle of about 25° to 50°
15	Bevel angle of about 30° to 45°

These claims are directed to a tablet having the claim 12 score arrangement plus a defined beveled-edge configuration. They would not cover every scored rectangular tablet.

Does the patent claim a drug or active ingredient?

No. The supplied claims contain no drug name, chemical structure, active ingredient, dosage strength, indication, pharmacokinetic property, release profile, or patient population.

The patent therefore does not protect:

• A pharmaceutical compound;
• A salt, ester, polymorph, or stereoisomer;
• A therapeutic method;
• A sustained-release matrix;
• An enteric coating;
• A capsule;
• A tablet manufacturing process;
• A drug-device combination;
• A particular dosage strength.

Its subject matter is a physical tablet structure. The same tablet architecture could theoretically be used for multiple drug products.

When did US Patent 4,215,104 lose exclusivity?

The patent was granted in 1980. Patents issued from applications filed before June 8, 1995 generally received the greater of the former 17-year term from grant or the 20-year term from the relevant filing date, subject to statutory exceptions. 35 U.S.C. § 154(c)(1).

On the stated grant date of July 29, 1980, the ordinary 17-year term would have ended on July 29, 1997. The patent is therefore long expired and cannot presently block manufacture, sale, or use of a tablet that would have met its claims during the patent term.

Event	Date or period
Patent grant	1980
Ordinary 17-year term from grant	1997
Current US enforceability	Expired
Patent-term extension under the Hatch-Waxman framework	Not applicable to this tablet-structure patent on the supplied record

The expiration analysis concerns the US patent only. Foreign counterparts, if any, would have had separate national terms.

What is the Orange Book status of US Patent 4,215,104?

US Patent 4,215,104 is not, by its claim language, an Orange Book drug patent.

FDA Orange Book patent listings generally identify patents submitted by an NDA holder that claim the approved drug substance, drug product, or approved method of use. A general tablet-structure patent does not inherently identify a particular NDA product or active ingredient. FDA’s Orange Book framework separately addresses patents and regulatory exclusivity periods. (FDA, 2024)

The patent’s claims do not establish:

• An Orange Book listing;
• A product-specific NDA;
• A paragraph IV certification;
• A pediatric exclusivity period;
• New chemical entity exclusivity;
• Three-year clinical investigation exclusivity;
• Orphan-drug exclusivity.

A product-specific Orange Book listing would require evidence connecting the patent to a particular approved drug application. The claim text alone does not establish that connection.

Could the patent support a Paragraph IV challenge?

Not as a current enforceable patent. A Paragraph IV certification addresses a listed patent that the applicant asserts is invalid, unenforceable, or not infringed. Under 21 U.S.C. § 355(j)(2)(A)(vii)(IV), the certification is relevant when a generic applicant addresses an unexpired listed patent.

Because US Patent 4,215,104 expired in the 1990s, it would not ordinarily create a current Paragraph IV launch delay. A generic applicant would not need to await this patent’s expiration because the term has already ended.

Historically, if the patent had been listed against an NDA product while unexpired, a generic applicant could have raised:

• Noninfringement based on a different score arrangement;
• Invalidity for anticipation;
• Obviousness based on known scored-tablet designs;
• Indefiniteness involving “approximately” and “about”;
• Lack of written description or enablement for the full dimensional ranges.

No settlement terms or litigation outcome are established by the supplied claim text.

How strong is the patent estate?

The estate is commercially weak today because the patent is expired and appears to consist of a single US tablet-structure patent rather than a layered drug-product portfolio.

Estate characteristic	Assessment
Active ingredient protection	None in the supplied claims
Method-of-use protection	None
Formulation protection	No chemical or release-formulation protection
Tablet-geometry protection	Yes
Manufacturing-process protection	None apparent
Orange Book relevance	No product-specific relevance shown
Current enforceability	None after expiration
Generic entry barrier	None from this patent
Biosimilar relevance	None
Geographic scope	United States only
Licensing value today	Limited unless tied to historical know-how or a separate active patent family

The claims were more valuable as an engineering constraint than as a pharmaceutical exclusivity asset. Their commercial leverage would have depended on whether a marketed tablet used the specified multidirectional scoring geometry and whether competing designs could avoid the claim limitations.

What formulation and manufacturing barriers did the claims create?

The patent does not claim a formulation composition, but its structure would have affected tablet manufacture.

Potential technical constraints include:

• Die and punch tooling capable of creating scores on multiple surfaces;
• Control of score depth and V-groove angle;
• Tablet mechanical strength sufficient to survive packaging and handling;
• Predictable fracture along the intended score lines;
• Avoidance of excessive friability;
• Consistent subdivision into approximate halves and thirds;
• Compatibility between bevel geometry and compression tooling;
• Uniformity of dose in each fractured unit.

These are manufacturing and design-around issues, not continuing patent barriers. A manufacturer could seek to avoid the claims through different score placement, a nonrectangular profile, different groove angles, one-sided scoring, nonintersecting score lines, or a tablet that is not capable of the claimed fracture pattern.

How does this patent compare with drug, formulation, and method-of-use patents?

Patent category	Typical protected subject matter	Present in US 4,215,104?
Drug-substance patent	Molecular structure, salts, stereochemistry	No
Formulation patent	Excipients, release matrix, coating, dissolution profile	No
Method-of-use patent	Treating a disease or patient group	No
Manufacturing patent	Synthesis, granulation, compression, coating process	No apparent
Tablet-design patent	Shape, scoring, subdivision, physical geometry	Yes
Device patent	Delivery mechanism or drug-device system	No apparent

This distinction matters in diligence. A company assessing generic entry must separately review active compound, formulation, process, method-of-use, and device patents. Clearance of US Patent 4,215,104 would not establish freedom to operate for the underlying drug.

What geographic coverage does the patent provide?

The patent covers the United States only. Patent rights are territorial. The existence of this US patent does not establish protection in Europe, Canada, Japan, China, or other jurisdictions.

Any international patent family would require separate review of:

• Priority filings;
• National-phase applications;
• Grant and expiration dates;
• Maintenance-fee status;
• Claim amendments;
• Terminal disclaimers;
• Continuations and divisionals;
• Foreign litigation or opposition records.

The US claims supplied here cannot establish foreign rights.

What generic launch risks exist?

The patent presents no current US generic launch risk because it is expired.

During its term, the principal risk would have been design infringement by a generic tablet using substantially the same score arrangement. A generic manufacturer could have reduced risk by adopting:

1. A single central score;
2. A nonrectangular tablet;
3. Scores on only one planar surface;
4. A different half-and-third subdivision pattern;
5. Score lines that do not extend into the walls;
6. Different groove dimensions outside the claimed ranges;
7. A tablet that is not intended or configured for subdivision.

Those design changes could affect tablet usability, dose flexibility, regulatory labeling, and compliance with FDA expectations for scored tablets. They would not, however, revive the expired patent.

Key Takeaways

• US Patent 4,215,104 is a tablet-structure patent, not a drug patent.
• Claims 1 and 12 are the principal independent claims.
• The claims cover rectangular tablets with specific surface, wall, score, bevel, and groove arrangements.
• No active ingredient, formulation, method of use, or manufacturing chemistry is claimed.
• The patent’s ordinary US term ended in the 1990s, based on its 1980 grant and applicable pre-1995 term rules.
• It presents no current US exclusivity, Orange Book, Paragraph IV, biosimilar, or generic-launch barrier.
• Any remaining diligence should distinguish this expired tablet-design patent from separate patents covering the drug substance, formulation, process, indication, or delivery system.

FAQs About US Patent 4,215,104

Is US Patent 4,215,104 still enforceable?

No. Its ordinary US patent term expired in the 1990s, approximately 17 years after its 1980 grant.

Does US Patent 4,215,104 cover pill splitting?

It covers a specific scored-tablet architecture designed to permit fracture into approximate halves and thirds. It does not cover all pill-splitting methods or every scored tablet.

Does the patent protect a particular pharmaceutical product?

No. The supplied claims do not identify an active ingredient, drug product, dosage strength, or therapeutic indication.

Can a generic manufacturer use the claimed tablet shape today?

Yes, from the standpoint of this expired US patent. The manufacturer would still need to assess other active patents, FDA requirements, trademark issues, and product-specific regulatory obligations.

Does this patent create biosimilar risk?

No. Biosimilar regulation concerns biologic products. US Patent 4,215,104 claims a physical tablet structure and has no apparent relevance to biologic exclusivity.

References

1. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. U.S. Department of Health and Human Services.

2. United States Code. (2024). 21 U.S.C. § 355: New drugs.

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

4. United States Patent and Trademark Office. (1980). United States Patent No. 4,215,104: Tablet structure.

Drugs Protected by US Patent 4,215,104

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

International Family Members for US Patent 4,215,104

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	372853
Austria	A160880
Australia	533115
Australia	5647480