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):	Koike; Masahiko (Osaka, JP), Koyama; Hiroyoshi (Osaka, JP)
Assignee:	TAKEDA PHARMACEUTICAL COMPANY LIMITED (Osaka-Shi, JP)
Application Number:	13/082,890
Patent Claim Types: see list of patent claims	Dosage form;

United States Patent 9,320,714: A Detailed Analysis

Overview of the Patent

United States Patent 9,320,714, titled "Tablet," is owned by Takeda Pharmaceuticals Usa Inc. and is associated with the drug Actoplus Met. This patent is one of the several that protect the intellectual property of Actoplus Met, a medication used to treat type 2 diabetes.

Patent Details

• Patent Number: US9320714
• Issue Date: August 11, 2015
• Expiration Date: February 2029[2].

Inventors and Assignees

The patent is assigned to Takeda Pharmaceuticals Usa Inc. The inventors and specific details about their contributions are not explicitly mentioned in the available sources, but the patent is part of Takeda's broader intellectual property portfolio.

Claims and Scope

Primary Claims

The patent primarily covers the formulation and composition of Actoplus Met tablets. Here are some key aspects of the claims:

• Tablet Composition: The patent describes the specific formulation of the tablet, including the active ingredients, excipients, and the method of preparation. This includes details on the film-coating layer, which may contain substances like hydroxypropylmethyl cellulose or hydroxypropyl cellulose[5].

• Dosage and Administration: The claims also cover the dosage form, which is typically an oral tablet. This includes specifications on the size, shape, and other physical characteristics of the tablet.

Scope Concepts

The scope of this patent can be analyzed using the concept of scope concepts, which categorize patents by their claims and overarching themes. For US9320714, the scope concepts would include:

• Drug Formulation: This patent is heavily focused on the formulation of Actoplus Met, including the specific combination of active ingredients and excipients.
• Dosage Forms: The patent covers the tablet form of the drug, including its physical and chemical properties.
• Manufacturing Process: The claims may also include methods for manufacturing the tablets, ensuring consistency and quality in the final product.

Patent Landscape

Family Patents

Actoplus Met is protected by a family of patents, each covering different aspects of the drug. Here is a brief overview of some of the other patents in this family:

• US9101660: This patent covers a solid preparation of Actoplus Met and is set to expire in January 2027[2].
• Expired Patents: Several other patents related to Actoplus Met have already expired, including those covering pharmaceutical compositions filed between 1996 and 2001[2].

Global Protection

While US9320714 provides protection within the United States, Actoplus Met is also protected by patents in multiple other countries. Understanding the global patent landscape is crucial for strategizing market entry and identifying potential generic entry points[2].

Exclusivity and Generic Launch

The patent exclusivity for Actoplus Met is set to expire in February 2029, which is when generic versions of the drug can be launched. The current active patents, including US9320714, play a critical role in delaying generic competition until their expiration dates[2].

Patent Analytics and Claim Coverage

To fully understand the protection offered by US9320714, patent analytics tools can be used. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps or opportunities in the patent coverage. For example, using a Claim Coverage Matrix, one can determine which claims are actively protecting the intellectual property and where there might be gaps in coverage[3].

Impact on Market Strategy

Understanding the scope and claims of US9320714 is vital for market strategy. Here are a few key points:

• Competitive Advantage: The patent provides Takeda Pharmaceuticals with a competitive advantage by preventing generic competition until its expiration.
• Market Entry Points: Analyzing the broader patent landscape can help identify markets with weaker patent protection, which could be ideal for generic entry points.
• Product Development: The patent details can guide the development of new products or formulations that do not infringe on the existing claims.

Legal and Regulatory Considerations

The patent is subject to various legal and regulatory requirements. For instance, the FDA's Orange Book provides detailed information on drug patents and exclusivities, which is crucial for understanding the regulatory environment[4].

Key Takeaways

• Patent Expiration: US9320714 expires in February 2029, marking the potential launch date for generic versions of Actoplus Met.
• Scope and Claims: The patent covers the formulation, composition, and dosage form of Actoplus Met tablets.
• Global Protection: Actoplus Met is protected by a family of patents across multiple countries.
• Market Strategy: Understanding the patent landscape is crucial for market strategy, including identifying competitive advantages and potential generic entry points.

FAQs

1. What is the primary focus of US9320714?

   • The primary focus of US9320714 is the formulation and composition of Actoplus Met tablets.

2. When does the patent expire?

   • The patent expires in February 2029.

3. Who owns the patent?

   • The patent is owned by Takeda Pharmaceuticals Usa Inc.

4. What other patents protect Actoplus Met?

   • Actoplus Met is protected by a family of patents, including US9101660 and several expired patents.

5. How does the patent impact market strategy?

   • The patent provides a competitive advantage by delaying generic competition and guides the development of new products to avoid infringement.

Cited Sources:

1. Actoplus Met patent expiration - Pharsight

   • https://pharsight.greyb.com/drug/actoplus-met-patent-expiration

2. United States Patent 9,320,714

   • https://patentimages.storage.googleapis.com/c6/75/b4/c364fcbb2aa8ef/US9320714.pdf

3. Patent Analytics | Intellectual Property Law

   • https://www.slwip.com/services/patent-analytics/

4. Approved Drug Products with Therapeutic Equivalence Evaluations

   • https://www.drugpatentwatch.com/p/fda-orange-book/supplements/orangebook-ed36-supp05-.pdf

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	9,320,714		Y
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-002	Aug 29, 2005	AB	RX	Yes	Yes	9,320,714		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
Japan	5022893
Japan	WO2006106815
Spain	2593469