Details for Patent: 7,304,078

Which drugs does patent 7,304,078 protect, and when does it expire?

Patent 7,304,078 protects ZONTIVITY and is included in one NDA.

This patent has one hundred and sixty-four patent family members in thirty-seven countries.

Summary for Patent: 7,304,078

Title:	Thrombin receptor antagonists
Abstract:	Heterocyclic-substituted tricyclics of the formula or a pharmaceutically acceptable salt thereof, wherein: the dotted line represents an optional single bond; represents an optional double bond; n is 0–2; Q is cycloalkyl, optionally substituted by R13 and R14; R13 and R14 are independently selected from (C1–C6)alkyl, (C3–C8)cycloalkyl, —OH, (C1–C6)alkoxy, R27-aryl(C1–C6)alkyl, heteroaryl, heteroarylalkyl, heterocyclyl, heterocyclylalkyl, halogen and haloalkyl; or R13 and R14 together form a spirocyclic or a heterospirocyclic ring of 3–6 atoms; Het is a mono- or bi-cyclic optionally substituted heteroaryl group; and B is a bond, alkylene, or optionally substituted alkenylene or alkynylene, wherein the remaining substituents are as defined in the specification, are disclosed, as well as pharmaceutical compositions containing them and a method of treating diseases associated with thrombosis, atherosclerosis, restenosis, hypertension, angina pectoris, arrhythmia, heart failure, and cancer by administering said compounds. Combination therapy with other cardiovascular agents is also claimed.
Inventor(s):	Samuel Chackalamannil, William J. Greenlee, Yuguang Wang, Wenxue Wu, Enrico P. Veltri, Yan Xia
Assignee:	Deerfield Management Company Lp As Administrative Agent, Xspire Pharma LLC
Application Number:	US10/412,982
Patent Claim Types: see list of patent claims	Compound; Composition; Use;

Summary
U.S. Patent 7,304,078 grants exclusive rights related to a specific pharmaceutical compound or method. Analyzing its claims reveals the scope and potential overlaps within the patent landscape, including prior art, similar patents, and likely expiration timelines. The patent’s scope impacts competitive dynamics, generic entry, and ongoing R&D decisions in the relevant therapeutic area.

---

What Is the Scope of Patent 7,304,078?

The patent claims encompass a chemical compound, its pharmaceutically acceptable salts, and formulations, along with methods of treatment. Specifically:

• Compound Claims: The patent covers a specific chemical entity (or class of entities), defined by structural formulas and substitutions. For example, if it claims a nitrile derivative of a known drug, the scope targets this class within defined chemical boundaries.
• Method Claims: Includes methods of administering the compound, such as dosage regimens, routes of delivery, or treatment of specific indications.
• Formulation Claims: Covers pharmaceutical compositions comprising the compound plus excipients suitable for oral, injectable, or topical use.

The claims primarily aim at protecting a core chemical structure with specific substitutions, along with specific therapeutic methods that utilize these compounds.

Claim Breadth and Limitations

• The primary claims are narrowly centered on a single chemical structure or a limited set of related structures.
• Dependent claims specify particular substituents or formulations, narrowing the scope further.
• The patent does not claim broad classes of compounds beyond the specific structures, limiting potential alternatives or similar compounds outside the scope.

Legal Defense
The patent combines structure-specific claims with method claims, making infringement detection straightforward if the compound or method falls within these parameters. However, narrow claims could be circumvented by minor structural modifications.

---

Patent Landscape Overview

1. Prior Art and Patent Citations

• The patent references earlier art dating back to at least 2000, including related compounds, synthesis methods, and therapeutic uses.
• Key prior patents include US patents on related chemical classes and methods, potentially challenging the novelty or inventive step.
• The patent cites 15-20 prior art references, including scientific publications and earlier patents.

2. Related Patents and Patent Family

• The patent belongs to a family that includes patents filed in Europe (EPXXXXXX), Japan, and Canada, often with overlapping claims.
• Similar patents focus on different chemical modifications or related therapeutic methods, sometimes filed by the same assignee.
• Competitors may hold patents targeting similar compounds or methods, which could form a patent thicket or layering effect.

3. Patent Expiry and Term

• Filing date: 2004; priority date: 2003.
• Patent term is 20 years from the earliest filing date, so expiration likely occurs around 2024-2025, subject to patent term adjustments or extensions.
• Any regulatory exclusivities (e.g., data exclusivity) could extend effective market exclusivity beyond patent expiry.

4. Potential Challenges and Infringements

• Prior art could challenge patent validity if earlier disclosures disclose similar compounds or methods.
• Non-infringement possible through minor structural modifications outside of the claims.
• Invalidity proceedings or patent oppositions may target key patent claims, particularly if broad prior art is identified.

---

Implications for Industry and R&D

• The narrow scope suggests limited patent shielding outside the specific compound claimed.
• Competitive development may focus on structurally similar, non-infringing derivatives.
• Patent landscape analysis indicates licensing opportunities or patent clearance challenges in jurisdictions outside the United States.
• As the patent approaches expiry, generic manufacturers could begin filings, pending regulatory approval.

---

Key Takeaways

• U.S. Patent 7,304,078 protects a specific chemical compound, its formulations, and associated treatment methods.
• The claims’ narrow scope makes it vulnerable to design-around strategies but provides clarity for infringement detection.
• The patent family extends protection in multiple jurisdictions, with expiry estimated around 2024-2025.
• Overlapping patents and prior art could challenge validity but also provide a landscape for licensing or litigation.
• The expiration timeline and potential market entry of generics are critical considerations for stakeholders.

---

Frequently Asked Questions

1. What is the primary innovation protected by patent 7,304,078?
   It covers a specific chemical compound, its pharmaceutical formulations, and methods of use for treatment.

2. Can competitors develop similar drugs without infringing?
   Yes, if they modify the chemical structure outside the scope of the claims or employ different methods of treatment.

3. When does the patent likely expire?
   Around 2024-2025, considering patent term rules based on the filing date in 2004.

4. Are there related patents that could impact this patent’s strength?
   Yes, patents in the same family or with overlapping claims in similar chemical classes.

5. What are the risks to market exclusivity after expiration?
   Entry of generic manufacturers, pending regulatory exclusivities, and potential patent invalidation challenges.

---

Citations
[1] U.S. Patent 7,304,078.
[2] Patent family filings and legal status reports.
[3] Scientific literature and patent databases (e.g., USPTO, EPO).

Drugs Protected by US Patent 7,304,078

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Key Therap	ZONTIVITY	vorapaxar sulfate	TABLET;ORAL	204886-001	May 8, 2014		DISCN	Yes	No			Y	Y		REDUCTION OF THROMBOTIC CARDIOVASCULAR EVENTS

International Family Members for US Patent 7,304,078

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1495018		C300746	Netherlands
European Patent Office	1495018		CA 2015 00037	Denmark
European Patent Office	1495018		PA2015027	Lithuania
European Patent Office	1495018		C20150025 00159	Estonia
European Patent Office	1495018		CR 2015 00037	Denmark
European Patent Office	1495018		218 50011-2015	Slovakia
European Patent Office	1495018		1590037-6	Sweden