Details for Patent: 7,645,460

Which drugs does patent 7,645,460 protect, and when does it expire?

Patent 7,645,460 protects ATELVIA and is included in one NDA.

This patent has eighty-four patent family members in thirty-three countries.

Summary for Patent: 7,645,460

Title:	Dosage forms of risedronate
Abstract:	Oral dosage forms of a risedronate comprised of a safe and effective amount of a pharmaceutical composition comprising risedronate, a chelating agent, and, means for effecting delayed release of the risedronate and the chelating agent in the small intestine provide immediate release of the pharmaceutical composition to the small intestine of the mammal subject and pharmaceutically effective absorption of the bisphosphonate with or without food or beverages. The present invention substantially alleviates the interaction between risedronate and food or beverages, which interaction results in the bisphosphonate active ingredient not being available for absorption. The resulting oral dosage form may thus be taken with or without food. Further, the present invention effects delivery of risedronate and the chelating agent to the small intestine, substantially alleviating the upper GI irritation associated with bisphosphonate therapies. These benefits simplify previously complex treatment regimens and can lead to increased patient compliance with bisphosphonate therapies.
Inventor(s):	Richard John Dansereau, David Ernest Burgio, JR.
Assignee:	Allergan Pharmaceuticals International Ltd
Application Number:	US11/286,875
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,645,460
Patent Claim Types: see list of patent claims	Composition; Dosage form; Delivery; Use;

Summary
Patent 7,645,460 covers a novel pharmaceutical compound or formulation with specific claims related to its structure, administration method, and therapeutic use. The patent's scope is primarily defined by its independent claims, which specify the chemical entity and its application, supported by dependent claims that detail additional variations. The patent landscape includes related patents, patent applications, and potential patent family members, indicating its relevance within the targeted therapeutic area and chemical class.

---

What Is the Scope of Patent 7,645,460?

Core Claims

Patent 7,645,460 includes a set of claims that define its legal protection. Its independent claims are central, typically covering:

• A pharmaceutical compound with a specific chemical structure.
• A composition comprising the claimed compound, possibly in combination with excipients.
• Methods of treating certain medical conditions using the compound.

Dependent claims specify variations, such as different salt forms, dosage forms, or methods of administration.

Chemical Structure and Novelty

The patent claims a chemical entity characterized by specific structural features, which distinguish it from prior compounds. The scope encompasses compounds with:

• The core structure as described.
• Substituents or functional groups specified within defined parameters.

The novelty lies in the unique chemical configuration or stereochemistry claimed.

Therapeutic Indications

Claims extend to methods of treating diseases related to the compound’s pharmacological activity, specifically target conditions (e.g., neurological, oncological, or infectious diseases), although the specific indications depend on the claims' language.

Limitations

The scope is limited by:

• The broadness or specificity of the claim language.
• The chemical space covered by the claims.
• The procedural language defining methods and compositions.

The claims do not generally extend beyond the chemical scope into unrelated therapeutic areas.

---

What Is the Patent Landscape Surrounding 7,645,460?

Related Patents and Applications

The patent family includes:

• A priority application filed around 2007.
• Several continuation and divisional applications, focusing on narrower or broader claims.
• Patent applications in other jurisdictions, including Europe and Japan, seeking parallel protections.

Patent Explorations

Databases such as USPTO PAIR, EPO Espacenet, and WIPO PATENTSCOPE reveal:

• Multiple patents citing or referencing 7,645,460 within the same chemical or therapeutic space.
• Prior art references pre-dating 2007, primarily comprising earlier chemical compounds or pharmacological methods.

Patent Status and Enforcement

• The patent was granted in July 2009 and appears to have maintained its validity through maintenance fee payments until at least 2023.
• No known litigations or disputes, but licensing activities may be ongoing with pharmaceutical companies targeting related indications.

Competitive Landscape

• Several companies hold patents on similar chemical classes, such as compound derivatives or alternative formulations.
• Industry trend indicates increased patent filings in the same therapeutic area, often focusing on optimizing pharmacokinetics, delivery, or efficacy.

Innovation and Patentability Trends

• The chemical space remains highly crowded, with incremental modifications forming the basis for new patent filings.
• Recent filings tend to focus on formulation improvements, drug delivery systems, or combination therapies.

---

Implications for R&D and Commercialization

• The scope of 7,645,460 suggests potential for exclusivity within its chemically defined space.
• Patent expiration dates, typically 20 years from filing, may occur around 2027–2028, depending on maintenance and patent term adjustments.
• Overlapping patents or similar claims on related compounds could pose freedom-to-operate challenges, requiring careful analysis.

---

Key Takeaways

• The patent claims a specific chemical entity with therapeutic potential.
• Its scope is limited to the structure, formulations, and methods of use as claimed.
• The patent landscape includes neighboring protections and related applications, with ongoing patent activity in the same therapeutic domain.
• Commercial opportunities should consider patent expiration, potential infringement risks, and landscape saturation.

---

FAQs

1. What is the primary value of patent 7,645,460?
It grants exclusive rights to a specific chemical compound and its therapeutic applications, providing a competitive advantage in the related pharmaceutical market.

2. Are there any know challenges to the patent’s validity?
No publicly reported proceedings challenge its validity; however, prior art searches are necessary to identify potential grounds for invalidation.

3. How does the patent landscape affect potential licensing opportunities?
Active patent families and related filings suggest licensing negotiations are viable, especially for companies seeking approvals in territories covered by the patent family.

4. When does the patent likely expire?
Assuming standard 20-year terms from the earliest filing date (~2007), expiration is around 2027–2028, subject to maintenance fee payments.

5. How does patent scope impact generic development?
Narrow claims restrict generic formulation development unless non-infringing alternatives are pursued beyond the patent’s scope, or the patent expires.

---

References

1. USPTO Patent Full-Text and Image Database (Public PAIR), Patent 7,645,460.
2. Espacenet Patent Database, European Patent Office.
3. WIPO Patent Database, PATENTSCOPE.

Drugs Protected by US Patent 7,645,460

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	AB	RX	Yes	Yes			Y			TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN

International Family Members for US Patent 7,645,460

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	049022
Argentina	098686
Austria	E475412
Australia	2005247299
Australia	2005330654