Details for Patent: 9,463,160

Summary for Patent: 9,463,160

Title:	Dosage form exhibiting rapid disperse properties, methods of use and process for the manufacture of same
Abstract:	A rapidly dispersing dosage form is described. The dosage form releases its active ingredients within a period of less than about ninety seconds. These dosage forms exhibit a three-dimensional shape that is retained for adequate storage but is readily dispersed in the presence of excess moisture. Also disclosed are methods of administration of a medicament and a process for the preparation of rapidly dispersing dosage forms.
Inventor(s):	Jaedeok Yoo, Sandeep Kumar, Donald C. Monkhouse
Assignee:	Massachusetts Institute of Technology
Application Number:	US10/200,029
Patent Claim Types: see list of patent claims	Composition; Compound; Process; Delivery;

US Patent 9,463,160: Claim Scope, Expiration, Litigation Risk and 3D-Printed Drug Patent Landscape

US Patent 9,463,160 protects a rapid-dispersing, non-compressed pharmaceutical matrix manufactured by three-dimensional printing. Its core limitations are cumulative: a powder-based matrix, a water-soluble binder, patterned placement of an active ingredient or binder, solvent evaporation, rapid moisture-triggered dispersion, defined hardness, and defined porosity.

The patent is strategically relevant to orally disintegrating and rapidly dispersing dosage forms, particularly products manufactured through powder-bed or binder-jet three-dimensional printing. The broadest commercial risk is concentrated in claims 1-3. Claims 4-34 narrow the estate through compositional gradients, specific excipients, active ingredients, density, porosity, hardness, and dispersion-time limitations.

The patent appears to originate from the Aprecia/ZipDose technology platform. A commercial product using the same general platform, Spritam (levetiracetam), was approved by the FDA in 2015 as the first FDA-approved 3D-printed drug product (FDA, 2015).

What does US Patent 9,463,160 protect?

The patent claims a pharmaceutical article and manufacturing process rather than a particular therapeutic molecule alone. The protected subject matter is a three-dimensional printed dosage form with rapid dispersion and specified physical properties.

Claim element	Scope
Dosage-form structure	Non-compressed solid matrix
Manufacturing technology	Three-dimensional printing
Matrix components	Bulk powder material and water-soluble binder
Active ingredient placement	Predetermined printed pattern or compositional gradient
Manufacturing fluid	Pharmaceutically acceptable solvent, with active ingredient and/or binder
Manufacturing step	Layer deposition, patterned binding-fluid application, solvent evaporation
Performance	Dispersion in about 90 seconds or less upon moisture contact
Mechanical property	Hardness of about 1-20 kp
Porosity	10%-90%
Narrower preferred range	30%-70% porosity and 3-10 kp hardness
Narrower rapid-release range	Less than 30, 15, 10 or five seconds
Density	150-1,300 mg/mL, with narrower ranges of 400-1,000 mg/mL

The claims do not require a specific printer brand, nozzle architecture, layer thickness, tablet shape, solvent, or active ingredient in the independent claims. That breadth makes the patent more relevant to competing binder-jet and powder-bed systems than a claim limited to a particular formulation or machine.

How are claims 1 through 3 different?

Claims 1, 2 and 3 are independent claims with overlapping but distinct allocation of the active ingredient and binder.

Claim 1: active ingredient in the binding fluid

Claim 1 requires a matrix containing bulk powder, water-soluble binder and active ingredient. The process requires applying binding fluid to powder layers, with the binding fluid containing either:

1. solvent and active ingredient; or
2. solvent, active ingredient and water-soluble binder.

This claim is directed toward printing the drug through the liquid binding phase. A product may face claim 1 exposure if the active is delivered through the printhead fluid and becomes patterned within the powder bed.

Claim 2: active ingredient in the powder layer or binding fluid

Claim 2 covers a matrix in which the active ingredient is present in the powder layer, the binding fluid, or both. The process therefore accommodates two manufacturing configurations:

• active ingredient premixed with the bulk powder; or
• active ingredient included in the binding fluid.

Claim 2 is potentially broader from a formulation-design perspective because it captures products in which the drug is not printed exclusively through the liquid phase.

Claim 3: pharmaceutical composition with printed binder or active

Claim 3 is directed to a pharmaceutical composition and allows either the binder or active ingredient to be three-dimensionally printed according to a predetermined pattern. It expressly covers two alternative process routes:

• powder and binder layers with an active-containing binding fluid; or
• powder and active-containing layers with a binder-containing binding fluid.

The alternative-process structure gives claim 3 substantial coverage of formulation and manufacturing variations. A design-around that shifts the active ingredient from the binding fluid to the powder may avoid one claim formulation but remain exposed to another.

What technical limitations define infringement risk?

A competing product must satisfy all limitations of at least one asserted claim. The most important limitations are the following.

Three-dimensional printed architecture

The claims require more than a conventional porous tablet or a tablet manufactured by ordinary granulation. The matrix must have a three-dimensionally printed architecture, with patterned placement of active ingredient or binder.

A conventional lyophilized orally disintegrating tablet, spray-dried particle, molded wafer, or compressed tablet would not ordinarily satisfy this limitation without evidence that the claimed three-dimensional printing process or architecture is present.

Non-compressed matrix

The claims repeatedly require a non-compressed solid matrix. This limitation distinguishes the claimed article from conventional direct-compression tablets.

A product made by powder deposition followed by compression presents a potential non-infringement position if compression materially creates the final matrix. The position becomes less secure if compression is used only for handling or post-processing and the claimed printed matrix remains the principal structure.

Patterned placement

The patent requires active ingredient or binder placement according to predetermined patterns. This limitation may reach:

• spatial drug concentration gradients;
• multiple active-ingredient zones;
• printed binder grids;
• shell-core architectures;
• localized taste-masking regions; and
• programmed disintegration channels.

A random or uniform application process may present a stronger non-infringement position, although the meaning of "predetermined pattern" will depend on the intrinsic evidence and prosecution history.

Rapid dispersion

The principal performance threshold is dispersion in about 90 seconds or less on contact with moisture. Claims 18-22 narrow the period to less than 60, 30, 15, 10 or five seconds.

The claim language uses both "disperses" and "disrupts." Those terms may create claim-construction issues. Dispersion can imply breakup into particles or a dispersed suspension, while disruption can imply physical disintegration without requiring complete dissolution. Testing methodology, moisture conditions, agitation, sample geometry and endpoint definition are likely to affect infringement and validity disputes.

Hardness and porosity

The independent claims require hardness of approximately 1-20 kp and porosity of 10%-90%. These numerical limitations are important because they can be tested against commercial samples.

Claims 23-29 narrow porosity to approximately 30%-70%, while claims 30-34 narrow hardness to approximately 3-10 kp. Claims 25-29 combine rapid dispersion, intermediate porosity and density, creating narrower but commercially plausible fallbacks.

What formulations are protected by US 9,463,160?

The patent is formulation-flexible. Claim 11 identifies bulk powder materials including:

• spray-dried lactose;
• fructose;
• sucrose;
• dextrose;
• sorbitol;
• mannitol;
• xylitol; and
• microcrystalline cellulose.

Claim 12 identifies water-soluble binders including:

• arabinogalactan;
• polyvinylpyrrolidone, or PVP;
• sorbitol;
• mannitol; and
• xylitol.

Claim 7 narrows the matrix to lactose and PVP and identifies a taste-masking agent as the active ingredient. Claims 13 and 17 expand the commercial application to over-the-counter and oral-care ingredients, including:

• chlorpheniramine maleate;
• pseudoephedrine hydrochloride;
• diphenhydramine hydrochloride;
• doxylamine succinate;
• dextromethorphan hydrobromide;
• acetaminophen;
• taste-masking agents;
• salivary-gland stimulants;
• breath fresheners; and
• nasal decongestants.

Claim 9 covers compositions with two different active ingredients. This is important for combination cold, allergy, analgesic and oral-care products.

The claims do not require levetiracetam. Spritam is therefore commercially relevant to the patent family, but the claim set is not limited to Spritam or to central nervous system drugs.

How strong is the patent estate for rapid-release 3D-printed drugs?

The estate is strongest where a product combines all of the following:

1. powder-bed or binder-jet three-dimensional printing;
2. a non-compressed matrix;
3. patterned active or binder deposition;
4. water-soluble excipients;
5. rapid moisture-triggered dispersion; and
6. porosity and hardness within the claimed ranges.

It is weaker against products using a different manufacturing principle, such as:

• compression-based orally disintegrating tablets;
• freeze-dried wafers;
• hot-melt extrusion;
• fused-deposition modeling;
• semisolid extrusion;
• conventional inkjet deposition onto a preformed substrate; or
• nonprinted porous granules.

Validity pressure points

The principal validity issues are likely to involve anticipation and obviousness based on earlier rapid-dissolve dosage forms, porous matrices and three-dimensional printing references.

The most important prior-art categories include:

• early three-dimensional printing patents;
• orally disintegrating and fast-dissolving tablets;
• binder-jet pharmaceutical manufacturing;
• porous powder compacts;
• patterned drug loading;
• taste-masking matrices; and
• rapid-release excipient systems.

The foundational three-dimensional printing work associated with Sachs and colleagues established powder-layer deposition and selective binder application before the asserted patent family (Sachs et al., 1993). The patent’s defensibility therefore depends less on the general concept of printing a porous object and more on the combination of printed pharmaceutical architecture, specified dispersion performance, hardness, porosity and formulation process.

Potential Section 112 issues include:

• the boundary between "disperses" and "disrupts";
• the meaning of "about" for time, hardness, porosity and density;
• whether the specification enables the full range of active ingredients and excipient combinations;
• whether all claimed printed patterns achieve the required dispersion time; and
• whether the claims adequately support both active-in-fluid and active-in-powder manufacturing routes.

When does US Patent 9,463,160 lose exclusivity?

US Patent 9,463,160 issued on October 11, 2016. Its effective expiration depends on the earliest effective nonprovisional priority date, patent-term adjustment, terminal disclaimers and any patent-term extension. The statutory baseline for a post-June 8, 1995 utility patent is generally 20 years from the earliest effective U.S. nonprovisional filing date, subject to adjustment under 35 U.S.C. § 154.

Public patent records associate the patent with the Aprecia rapid-release and ZipDose platform and indicate a late-2020s base term. The practical expiration analysis must therefore distinguish:

Exclusivity category	Relevance
Patent term	Controls claim-based exclusion from practicing the patented technology
FDA new-drug exclusivity	Product-specific and separate from the patent term
Orange Book listing	Relevant only if the patent is listed against an approved drug product
Pediatric exclusivity	Can add six months to qualifying FDA exclusivity and patent periods
Patent-term adjustment	May extend the listed patent expiration date
Patent-term extension	May apply only to qualifying regulatory review delay

The issue date alone does not establish the expiration date. Patent Center and the USPTO patent term calculation control the final term analysis (USPTO, n.d.-a).

What is the Orange Book status of US 9,463,160?

A patent number does not automatically appear in the FDA Orange Book. Orange Book listing is tied to an approved drug product and requires the listed patent to claim the drug substance, drug product, or an approved method of use under FDA listing rules (FDA, n.d.-a).

For a product such as Spritam, the relevant analysis requires review of the product’s current FDA Orange Book entry, patent-listing submissions and any delisting or expiration updates. A platform patent may be commercially important without being listed against every product manufactured with the platform.

The patent claims a drug-delivery system and pharmaceutical composition. They are not classic drug-substance claims. Their Orange Book relevance therefore turns on whether a listed claim reads on the approved drug product as a drug product or method-of-use patent, rather than merely on the existence of the patent.

Which companies could challenge or design around the patent?

The principal competitive threat comes from companies commercializing 3D-printed or rapidly dispersing oral dosage forms, rather than from ordinary generic-tablet manufacturers.

Company or group	Relevant capability or risk
Aprecia Pharmaceuticals	Originator and principal commercial user of ZipDose technology
Generic drug manufacturers	Potential challengers if they market a rapidly dispersing product using a competing process
FabRx	Pharmaceutical 3D-printing platform and personalized dosage-form research
Triastek	3D-printed drug-delivery and structured dosage-form technology
Conventional ODT manufacturers	More likely to design around through compression, molding or lyophilization
CDMOs and specialty formulation companies	Potential licensees or process competitors

The record provided does not identify a particular Paragraph IV notice, ANDA litigation case or settlement involving US 9,463,160. A Paragraph IV challenge would require an ANDA applicant to certify that the patent is invalid, unenforceable or not infringed. The practical litigation risk depends on whether the proposed generic uses the patented architecture and process, not simply whether it contains the same active ingredient.

What generic launch scenarios exist?

Scenario 1: conventional nonprinted ODT

A generic using compression, freeze-drying or conventional molding may avoid the three-dimensional printing limitation. This is the clearest design-around path, although other ODT patents may apply.

Scenario 2: printed product with active in powder

A competitor may move the active ingredient from the binding fluid into the powder layer. This may avoid a narrow claim interpretation of claim 1 but remains exposed to claim 2 or claim 3.

Scenario 3: printed product outside the numerical ranges

A product with porosity below 10% or above 90%, hardness outside 1-20 kp, or dispersion above 90 seconds could challenge literal infringement. The commercial value of such a design depends on whether it still meets regulatory and patient-use requirements.

Scenario 4: printed matrix without patterned deposition

A uniform binder application or a process that does not create predetermined active or binder placement may avoid the pattern limitation. The prosecution history would be important in assessing whether the limitation was added to distinguish prior art.

Scenario 5: licensed platform

A manufacturer may obtain a license to the Aprecia platform instead of adopting a technically inferior design-around. Licensing is particularly relevant where the product requires rapid dispersion, high drug loading, taste masking and multi-active printing.

What patent litigation and settlement issues matter?

The most material litigation questions are:

• whether the accused product is truly non-compressed;
• whether the manufacturing process uses a three-dimensional printed architecture;
• whether the active or binder is applied in a predetermined pattern;
• whether the matrix meets the porosity and hardness ranges;
• whether dispersion occurs within the claimed time under the specified moisture conditions;
• whether claims 1-3 are invalid over earlier 3D-printing and fast-dissolving formulations; and
• whether a process claim can be enforced against a manufacturer when some steps occur at different facilities.

The provided information does not establish a reported infringement action, Paragraph IV case or settlement specifically involving US 9,463,160. Any assertion of an active litigation or settlement would require a current PACER, PTAB and USPTO record review.

How does US 9,463,160 compare with earlier 3D-printing patents?

Earlier three-dimensional printing patents generally addressed the printing process itself, including selective deposition of binder onto powder layers. US 9,463,160 applies that technology to a defined pharmaceutical matrix with rapid moisture-triggered dispersion.

Feature	Foundational 3D-printing patents	US 9,463,160
Primary subject	General printed articles and powder-bed processes	Pharmaceutical rapid-release matrix
Active ingredient	Generally not central	Required in the independent pharmaceutical claims
Patterning	Structural or geometric patterning	Predetermined active or binder placement
Performance metric	Usually not a rapid oral-dispersion threshold	About 90 seconds or less
Physical parameters	General process and material limitations	Hardness and porosity ranges
Commercial focus	Broad additive manufacturing	Orally dispersing pharmaceutical compositions

The patent is therefore an application-specific improvement and commercialization patent, while earlier patents may represent the foundational process layer. Freedom-to-operate analysis must examine both levels.

Key Takeaways

• US 9,463,160 is centered on rapid-release, non-compressed pharmaceutical matrices made by three-dimensional printing.
• Claims 1-3 are the principal risk claims and cover alternative locations for the active ingredient and binder.
• The most important limitations are patterned printing, solvent evaporation, rapid dispersion, hardness and porosity.
• Claims 7, 11-13 and 17 are commercially relevant to lactose/PVP formulations, taste masking, cold medicines and oral-care products.
• A conventional compressed, molded or lyophilized ODT is the clearest technical design-around.
• A printed product can remain exposed even if the active ingredient is moved from the binding fluid to the powder layer.
• Spritam establishes the regulatory and commercial relevance of the underlying ZipDose platform, but the claims are not limited to levetiracetam.
• Orange Book relevance must be assessed by approved product and listing status; patent ownership alone does not create Orange Book protection.
• The patent’s likely exclusivity period extends into the late 2020s, subject to the official USPTO term calculation.
• The principal invalidity risks involve obviousness, enablement, claim construction of "about," and the scope of "disperses," "disrupts" and "predetermined pattern."

FAQs About US Patent 9,463,160

Does US 9,463,160 cover Spritam?

It may cover technology used in the same Aprecia rapid-release platform, but the claims are not limited to Spritam or levetiracetam. Product-specific patent coverage requires comparison with Spritam’s formulation, manufacturing process and current Orange Book listings.

Can a company avoid US 9,463,160 by compressing the tablet?

Compression may avoid the express non-compressed-matrix limitation. The analysis depends on whether compression creates the final dosage form or is merely a secondary handling step applied to a printed matrix.

Does the patent cover all 3D-printed medicines?

No. The claims require a particular combination of printed pharmaceutical architecture, bulk powder, water-soluble binder, rapid moisture-triggered dispersion, porosity and hardness. Other 3D-printed dosage forms may fall outside those limitations.

Are taste-masked active ingredients protected?

Yes, claim 7 specifically addresses a lactose/PVP matrix containing a taste-masking agent, and claim 17 identifies taste masking as a covered active-ingredient function.

Is a Paragraph IV certification against US 9,463,160 publicly established?

The supplied record does not establish a specific Paragraph IV certification or related litigation involving this patent. Such a certification would be applicant- and product-specific.

References

1. Aprecia Pharmaceuticals Company. (2016). Rapid release drug delivery system (U.S. Patent No. 9,463,160). United States Patent and Trademark Office.

2. Food and Drug Administration. (2015). FDA approves first 3D-printed drug. U.S. Department of Health and Human Services.

3. Food and Drug Administration. (n.d.-a). Approved drug products with therapeutic equivalence evaluations. U.S. Department of Health and Human Services.

4. Sachs, E. M., Haggerty, J. S., Cima, M. J., & Williams, P. A. (1993). Three-dimensional printing techniques. U.S. Patent No. 5,204,055. United States Patent and Trademark Office.

5. United States Patent and Trademark Office. (n.d.-a). Patent term adjustment and patent term calculation. U.S. Department of Commerce.

6. U.S. Code. (2024). 35 U.S.C. § 154, contents and term of patent; provisional rights. Cornell Law School Legal Information Institute.

Drugs Protected by US Patent 9,463,160

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 9,463,160

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	421318
Australia	6331498
Australia	7368701
Australia	736912
Canada	2281473
Germany	69840495
European Patent Office	0973507