Details for Patent: 9,320,714

Which drugs does patent 9,320,714 protect, and when does it expire?

Patent 9,320,714 protects ACTOPLUS MET and is included in one NDA.

This patent has seven patent family members in six countries.

Summary for Patent: 9,320,714

Title:	Tablet
Abstract:	The present invention can retain the volume of a tablet large without increasing the thickness of the tablet or the like dimension and prevents a plurality of tablets from sticking to each other even if they are subjected to a film-coating or the like treatment, so as to improve the yield. The tablet is a tablet (1) longer in one direction when seen in plan. The tablet (1) has side edges (6) each of which extends in a longitudinal direction and is formed in the shape of a curve projecting outwardly in plan view. The curve has a radius of curvature (R1) set to at least 1.5 times a length (L) of the tablet. This makes a projected area of the tablet (1) in plan view at least 97% with respect to a projected area of a standard elliptical tablet having opposite end portions each of which is formed by a semi-circle having a diameter of a width (W) of the tablet.
Inventor(s):	Masahiko Koike, Hiroyoshi Koyama
Assignee:	Takeda Pharmaceutical Co Ltd
Application Number:	US13/082,890
Patent Claim Types: see list of patent claims	Dosage form;

United States Patent 9,320,714: Claim Scope, Patent Strength, and Drug-Product Landscape

US 9,320,714 protects a specific oblong, film-coated tablet geometry designed to maximize swallowable surface area while maintaining rounded edges. The independent claim is a product-by-structure claim. It does not identify a particular active ingredient, therapeutic class, release profile, or dosage strength. Its commercial relevance therefore depends on whether a drug product uses the claimed tablet shape, dimensions, coating, and weight characteristics.

The patent is potentially broad across pharmaceutical products using the claimed geometry, but it is narrow in the combination of geometric limitations that must be met simultaneously. A competing tablet can avoid literal infringement by changing the side-curve radius, end-arc radius, projected-area relationship, coating status, or tablet configuration.

What does US Patent 9,320,714 protect?

Claim 1 protects a film-coated tablet containing a pharmaceutical active component or therapeutic agent, provided that the tablet satisfies all of the following requirements:

Claim element	Required limitation
Dosage form	Tablet
Content	Pharmaceutical active component and/or therapeutic agent
Administration	Quantity dosed for swallowing
Main body	Upper and lower surfaces smoothly protrude outwardly as elliptical semi-spheres
Side wall	Peripheral side surface extends vertically between upper and lower surfaces
Plan shape	Length greater than width
Long sides	Opposing outwardly curved side portions
Side-curve radius	At least 2.53 times tablet length and no more than 3.41 times tablet length
End portions	Opposing outwardly projecting end arcs
End-arc radius	Smaller than half the tablet width
Projected area	At least 97% of a specified capsule-like reference object
Coating	Film-coated

The claim is cumulative. A product that satisfies nine limitations but falls outside the required radius range would not literally satisfy claim 1.

The patent does not require a specific active pharmaceutical ingredient, dose, excipient, compression force, dissolution profile, therapeutic indication, or manufacturing process. It is therefore a geometry and dosage-form patent rather than an active-ingredient patent.

How should the geometry in claim 1 be interpreted?

The central technical concept is an elongated tablet with highly curved long sides and tightly rounded ends. The claim seeks a shape that has a large projected area relative to a conventional capsule-shaped reference while retaining a swallowable profile.

Let:

• L = tablet length in the upper-surface plan view
• W = tablet width
• Rs = radius of each opposing long-side curve
• Re = radius of each opposing end arc

Claim 1 requires:

• L > W
• 2.53L ≤ Rs ≤ 3.41L
• Re < W/2
• projected tablet area ÷ projected reference-object area ≥ 0.97

The side radius is unusually large relative to tablet length. That produces a relatively shallow outward curvature along the long sides. The end radius must be smaller than half the width, creating tightly curved end regions rather than broad semicircular ends.

The 97% projected-area limitation is important. The reference object has linear side edges and semicircular ends with a diameter equal to tablet width. If L includes the full end-to-end length, the reference area can generally be represented as:

A reference = W(L - W) + πW²/4

The claim does not require the tablet to have the same area as a rectangle. It requires the tablet's plan-view area to be at least 97% of this specified reference area. This limitation reduces the ability to use a highly tapered or heavily rounded tablet while preserving the claim's intended swallowability and dose capacity.

What do dependent claims 2 through 7 add?

Claim	Added limitation	Practical effect
2	Entire upper-surface peripheral edge is outwardly curved	Removes designs with any straight or inwardly curved portion on that edge
3	End arcs smoothly connect to side portions	Requires continuous geometric transition at the corners
4	Film coating thickness of 10 to 200 micrometers	Adds a measurable coating range
5	Tablet weight of at least 150 mg	Covers common small and medium tablets
6	Tablet weight of at least 300 mg	Narrows the claim to heavier tablets
7	Tablet weight of at least 600 mg	Targets large-dose or high-load tablets

Claims 5, 6, and 7 each depend directly on claim 1. They are separate fallback positions, not necessarily cumulative. Claim 7 requires at least 600 mg but does not, through its dependency wording, independently require at least 300 mg and 150 mg, although a tablet weighing at least 600 mg inherently meets those thresholds.

Claim 4 is potentially significant because coating thickness can vary by location. A product developer would need to determine whether the claimed 10-to-200 micrometer thickness is measured as a nominal average, local thickness, or thickness at a specified tablet region. The claim text alone does not resolve that measurement issue.

How broad is the independent claim?

Claim 1 is broad as to pharmaceutical content but narrow as to physical structure.

Breadth by subject matter

The claim can potentially reach:

• immediate-release tablets;
• extended-release tablets;
• delayed-release tablets;
• orally administered tablets;
• tablets containing one or multiple active ingredients;
• tablets with different excipient systems;
• tablets manufactured by direct compression, wet granulation, dry granulation, or other processes;
• products with different strengths, provided the physical geometry remains within the claim.

The claim does not expressly require a particular release mechanism or therapeutic use.

Limits on breadth

The claim does not cover:

• capsules;
• tablets without a film coating;
• tablets with length equal to or less than width;
• tablets whose long-side radius is below 2.53L or above 3.41L;
• tablets with end arcs having a radius equal to or greater than W/2;
• tablets with projected area below 97% of the reference;
• products using a different dosage form, such as orally disintegrating films, liquids, injectables, or multiparticulate capsules.

A product with the same commercial appearance may still avoid literal infringement if its measured geometry falls outside one required numerical range.

What infringement issues would arise for a competing tablet?

An infringement analysis would require production samples, engineering drawings, coating specifications, and manufacturing records. Visual inspection alone would not reliably establish compliance with the numerical limitations.

Key measurement issues

The most important factual questions would be:

1. Where are length and width measured?
2. Are measurements taken before or after film coating?
3. How is the radius of an imperfectly manufactured side determined?
4. Is the radius constant or an effective fitted radius?
5. How is the projected area calculated?
6. Is the 97% comparison based on the coated or uncoated tablet?
7. What does "elliptical semi-sphere" mean in three-dimensional manufacturing terms?
8. Does "extends vertically" require a substantially perpendicular side wall or an exactly vertical wall?
9. How is film thickness measured around curved surfaces?

Tablet compression and coating commonly produce dimensional variation. A patent owner would likely need statistically representative measurements rather than a single specimen. A generic manufacturer would focus on controlling the relevant dimensions outside the claimed ranges and preserving validated manufacturing tolerances.

Literal infringement and equivalents

A competing product could face a doctrine-of-equivalents argument even if it narrowly misses a numerical limitation. The risk would depend on prosecution history, claim amendments, prior-art arguments, and whether the allegedly equivalent geometry performs substantially the same function in substantially the same way. Numeric ranges are often vulnerable to prosecution-history estoppel if the range was added or narrowed to distinguish prior art. The patent's file history is therefore material to enforcement strength.

What design-arounds are available?

Several design-around paths are technically available:

Design-around	Claim limitation targeted	Commercial tradeoff
Use a capsule or softgel	Tablet limitation	May alter stability, manufacturing, and patient acceptance
Use a non-film-coated tablet	Film-coating limitation	May affect taste masking, appearance, and protection
Reduce projected area below 97%	Projected-area limitation	May reduce dose capacity or alter swallowability
Use side radius below 2.53L	Long-side radius range	May produce a more visibly curved or capsule-like product
Use side radius above 3.41L	Long-side radius range	Produces flatter long sides
Increase end radius to at least W/2	End-arc limitation	Changes end geometry and potentially swallowability
Include a straight segment in the upper peripheral edge	Claim 2 limitation	Does not avoid claim 1 unless other limitations also change
Keep tablet weight below 150 mg	Claim 1 remains applicable	Usually impractical for high-dose products
Use a different 3D profile	Elliptical semi-spherical surface limitation	May affect coating and mechanical strength

Avoiding a dependent claim does not avoid claim 1. For example, a 9-to-200 micrometer coating may avoid claim 4 but remains exposed to claim 1 if claim 1's coating requirement is met.

What patents protect the active ingredient versus the tablet design?

US 9,320,714 is structurally different from a conventional drug patent.

Patent category	Typical protected subject matter	Relevance of US 9,320,714
Composition-of-matter patent	Active molecule or biologic sequence	Not apparent from the supplied claims
Salt, polymorph, or crystal patent	Solid form of active ingredient	Not claimed
Formulation patent	Excipients, ratios, release matrix, coating composition	Not claimed in the supplied claims
Method-of-use patent	Treatment of a disease or patient population	Not claimed
Manufacturing patent	Granulation, compression, coating, or process parameters	Not claimed
Dosage-form or device patent	Shape, structure, delivery configuration	This is the apparent category

The patent may operate as a platform patent across several drugs. It would not, by itself, prevent a competitor from using the same active ingredient in a different tablet configuration that falls outside the claims.

What is the Orange Book status of US 9,320,714?

A geometry patent is not automatically eligible for Orange Book listing. FDA listing is governed by the requirements for patents claiming a drug substance, drug product, or method of using an approved drug. See 21 C.F.R. § 314.53 and FDA guidance.

The supplied claim text does not identify:

• an approved active ingredient;
• an NDA holder;
• a specific drug product;
• a dosage strength;
• a formulation tied to an NDA;
• a method of use;
• an Orange Book listing.

On the face of the claims, US 9,320,714 is not an active-ingredient patent or method-of-use patent. Its listing prospects would depend on whether the patent was properly associated with an approved drug product and whether the FDA accepted the listing. A patent number alone does not establish Orange Book status.

When does US Patent 9,320,714 lose exclusivity?

The patent was issued on April 26, 2016. The ordinary US patent term is generally 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment, terminal disclaimers, and any applicable patent-term extension. See 35 U.S.C. §§ 154 and 156.

An exact expiration date cannot be derived from the claim text or grant number alone. The controlling record is the patent front page and USPTO Patent Center, including:

• earliest effective nonprovisional filing date;
• patent-term adjustment;
• terminal disclaimer;
• reissue or correction history;
• any patent-term extension.

Because the patent concerns a tablet configuration rather than an approved active ingredient, Hatch-Waxman exclusivity and patent-term extension may have limited practical relevance unless the patent is linked to a qualifying approved product.

Are Paragraph IV challenges relevant?

A Paragraph IV certification is relevant only if the patent is listed in the Orange Book for the referenced drug product and a generic applicant seeks approval of a product that implicates the listed claims. If US 9,320,714 is not listed for a particular NDA product, a generic applicant would not ordinarily use a Paragraph IV certification against this patent in the ANDA process.

If listed, a generic applicant could assert that:

• its tablet does not meet one or more geometric limitations;
• the patent claims are invalid for anticipation or obviousness;
• the claims are indefinite because the radius and area measurements lack objective boundaries;
• the patent is unenforceable based on prosecution or inequitable-conduct issues;
• the patent is not properly listable for the approved product.

A Paragraph IV notice could trigger the statutory 30-month stay under 21 U.S.C. § 355(j)(5)(B)(iii), subject to the statutory requirements and litigation timeline.

How strong is the patent estate?

The supplied record shows a single claim set centered on one tablet geometry. Its strength is best characterized as moderate and product-specific.

Strengths

• Claim 1 covers any pharmaceutical active component or therapeutic agent meeting the structural limitations.
• The claim does not depend on a particular molecule or therapeutic indication.
• The numerical side-radius range can be measured against commercial products.
• Dependent claims provide fallback positions for edge curvature, coating thickness, and tablet weight.
• A successful claim can cover multiple products using a common tablet platform.

Weaknesses

• The claim has many cumulative limitations.
• Tablet geometry is readily measurable and potentially easy to design around.
• Prior art may include oblong, capsule-shaped, oval, and swallowability-optimized tablets.
• The scope may depend heavily on how "elliptical semi-sphere," "smoothly," "vertically," and projected area are construed.
• The claim does not protect the active ingredient, formulation chemistry, or therapeutic use.
• A competitor can change the tablet shape without changing the active ingredient or clinical program.

The strongest commercial position would arise where the patented geometry is standardized across a high-volume product portfolio and changing shape would create meaningful manufacturing, labeling, patient-use, or regulatory costs.

What patent litigation and settlement risks exist?

No litigation, settlement, or Paragraph IV event can be established from the supplied claims alone. For diligence, the relevant sources are the USPTO Patent Center prosecution record, PACER, district-court dockets, Federal Circuit decisions, FDA Orange Book records, and the patent's assignment history.

Potential disputes would likely focus on:

• whether the accused tablet satisfies the numerical radii;
• whether the projected-area calculation is correct;
• whether the coating thickness falls within 10 to 200 micrometers;
• whether the active ingredient is present in a quantity dosed for swallowing;
• whether prior art anticipates the combined geometry;
• whether claim amendments narrowed the claim during prosecution.

A settlement involving a product-specific patent could permit launch before expiration, impose a licensed tablet design, or require a non-infringing shape. Such a settlement cannot be inferred from the patent number.

How does this patent compare with conventional drug patents?

Issue	US 9,320,714	Active-ingredient patent
Protected asset	Tablet architecture	Molecule or biologic
Product reach	Potentially multiple active ingredients	Usually one active ingredient or class
Design-around cost	Often moderate	Often high
Orange Book relevance	Conditional and product-dependent	Usually direct
Paragraph IV exposure	Only if listed	Common
Biosimilar relevance	None for small-molecule tablet geometry	Depends on biologic status
Manufacturing barrier	Tablet tooling, compression, and coating	Chemical or biological production
Invalidation risk	Prior-art geometry and claim construction	Novelty, obviousness, written description
Market effect	May preserve a branded tablet presentation	May block generic active-ingredient entry

Biosimilar risk is not material to this patent because biosimilars address biological products under the Biologics Price Competition and Innovation Act. A tablet-shape patent can affect a small-molecule oral product but does not create biosimilar exclusivity.

What geographic coverage does the patent provide?

US 9,320,714 provides rights only in the United States. It does not establish protection in Europe, Japan, China, Canada, or other jurisdictions.

International protection would require separate national or regional patents, commonly arising from a PCT application followed by national-phase filings. The relevant family analysis should compare:

• claim scope in each jurisdiction;
• grant and expiration dates;
• prosecution amendments;
• oppositions or post-grant proceedings;
• assignment and licensing records;
• country-specific enforceability.

A US design-around may not avoid a corresponding foreign claim if the foreign patent uses different language or a different numerical range.

Key Takeaways

• US 9,320,714 is a tablet-geometry patent, not an active-ingredient patent.
• Claim 1 requires a film-coated, elongated tablet with specific three-dimensional curvature and plan-view geometry.
• The critical numerical limitations are a side radius of 2.53 to 3.41 times tablet length, an end radius below half tablet width, and projected area of at least 97% of the defined reference object.
• Claims 2 through 7 add edge continuity, coating thickness, and weight limitations.
• The patent can potentially cover multiple drug products using the same tablet platform.
• It does not inherently block a competitor from using the same active ingredient in a different tablet shape.
• Orange Book listing and Paragraph IV relevance cannot be established from the claims alone.
• Biosimilar risk is not applicable to this tablet-configuration patent.
• Enforcement would depend on metrology, claim construction, prosecution history, and prior-art geometry.
• A generic manufacturer has several credible design-around options, particularly by changing side curvature, end-arc geometry, projected area, or three-dimensional surface shape.
• The exact patent expiration date requires the USPTO term record, including filing date, patent-term adjustment, and any terminal disclaimer.

FAQs

Can a generic use the same active ingredient while avoiding US 9,320,714?

Yes. A generic may use the same active ingredient in a tablet that falls outside at least one limitation of claim 1, subject to any separate patents covering the active ingredient, formulation, method of use, or manufacturing process.

Does a capsule-shaped tablet automatically infringe this patent?

No. A capsule-shaped tablet may resemble the claimed plan shape, but infringement requires satisfaction of every limitation, including the three-dimensional elliptical semi-spherical surfaces, side-radius range, projected-area threshold, and film coating.

Does claim 4 cover every film coating between 10 and 200 micrometers?

Claim 4 covers a tablet meeting claim 1 where the film coating is 10 to 200 micrometers thick. The measurement method and whether the range applies locally or as an average may affect claim construction.

Can a tablet weighing 100 mg infringe claim 1?

Yes. Claim 1 does not require a minimum weight. A 100 mg tablet could infringe claim 1 if it satisfies all other limitations. It would not meet claims 5, 6, or 7.

Is US 9,320,714 relevant to biologic drug patent strategy?

Usually no. The claims address a swallowed, film-coated tablet and do not claim a biologic molecule, biosimilar, biologic formulation, or manufacturing process. Its primary relevance is to oral small-molecule products and tablet-platform design.

References

Food and Drug Administration. (2015). Listing of patent information in the Orange Book. 21 C.F.R. § 314.53.

Food and Drug Administration. (2020). Approved drug products with therapeutic equivalence evaluations. U.S. Department of Health and Human Services.

United States Code. (2023). 35 U.S.C. § 154: Contents and term of patents; provisional rights.

United States Code. (2023). 35 U.S.C. § 156: Extension of patent term.

United States Code. (2023). 21 U.S.C. § 355: New drugs.

United States Patent and Trademark Office. (2024). Patent Center. U.S. Department of Commerce.

United States Patent No. 9,320,714. (2016). Tablet. U.S. Patent and Trademark Office.

Drugs Protected by US Patent 9,320,714

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-001	Aug 29, 2005		DISCN	Yes	No			Y
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-002	Aug 29, 2005	AB	RX	Yes	Yes			Y

Foreign Priority and PCT Information for Patent: 9,320,714

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2005-102578	Mar 31, 2005

International Family Members for US Patent 9,320,714

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2602184
European Patent Office	1867324
Spain	2593469
Japan	5022893