Details for Patent: RE36617

Summary for Patent: RE36617

Title:	(Substituted aralkyl) heterocyclic compounds
Abstract:	A (substituted-aralkyl)heterocyclic compound of the formula I ##STR1## wherein R1 is an azido, carbamoyl, cyano, formyl, hydroxy or nitro radical, a 1-6C 1-hydroxyalkyl, alkoxy, alkylcarbamoyl, alkylthio, alkylsulphinyl or alkylsulphonyl radical, a 2-cyanoethyl radical, optionally bearing one to four 1-6C alkyl substituents, or a 2-6C alkanoyl, halogenoalkanoyl, alkanoyloxy, alkanoylamino, dialkylcarbamoyl or alkoxycarbonyl radical; R2 and R3, which may be the same or different, are each a hydrogen atom, a 1-6C alkyl, dueterioalkyl or halogenoalkyl radical, or a phenyl or phenyl(1-6C alkyl) radical, in each of which the phenyl may optionally bear one or more substituents; or R2 and R3, together with the carbon atom to which they are attached, may form a 3- to 6-membered ring; or R1 R2 R3 C- is a 1,1-dicyanoethyl or trifluoromethylsulphonyl radical; R4 is a hydrogen or halogen atom, a cyano or nitro radical or a 1-6C alkyl or halogenoalkyl radical; R5 has any of the values defined above for the group R1 R2 R3 C but is not necessarily the same as R1 R2 R3 C, or has any of the values defined above for R4 but is not necesarily the same as R4, or is a carbamoyl, 1-pyrrolidinyl-carbonyl, piperidinocarbonyl, morpholinocarbonyl or nitro radical, a 1-6C alkoxy or halogenoalkoxy radical or a 2-6C alkanoyl or alkoxy-carbonyl radical; A is a methylene or ethylene radical optionally bearing one or more substituents selected from deuterium and halogen atoms, carbamoyl, cyano and hydroxy radicals, 1-6C alkyl and alkoxy radicals, and 2-6C alkanoyloxy radicals provided that when A is linked to R6 through a nitrogen atom thereof, it may not bear a hydroxy, alkoxy or alkanoyloxy substituent on the carbon atom adjacent to such nitrogen atoms; and R6 is a 1H-1,2,4-triazol-1-yl, 4H-1,2,4-triazol-4-yl, 1H-imidazol-1-yl, 5-cyano-1H-imidazol-1-yl, 3-pyridyl or 5-pyrimidinyl radical, or a 1H-imidazol-1-yl radical, bearing at the 5-position thereof a 1-6C alkyl substituent which is itself optionally substituted by one or more carbamoyl, cyano, hydroxy or 2-6C alkoxycarbonyl radicals; and provided that when R2, R3, R4 and R5 are hydrogen, A is a methylene radical and R6 is a 3-pyridyl radical, R1 is not a cyano, hydroxy or hydroxymethyl radical, and when R1 is a hydroxy radical, R3, R4 and R5 are hydrogen, A is a methylene radical and R6 is 3-pyridyl, R2 is not a methyl or a 2-chloro-1-methylethyl radical, and provided that when R1 is a methoxycarbonyl radical, R2, R3, R4 and R5 are hydrogen and A is a methylene radical, R1 is not a 1H-imidazol-1-yl radical; and the pharmaceutically acceptable acid addition salts thereof.
Inventor(s):	Philip N. Edwards, Michael S. Large
Assignee:	AstraZeneca UK Ltd, Syngenta Ltd
Application Number:	US08/627,311
Patent Claim Types: see list of patent claims	Compound; Composition; Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent RE36617

Introduction

United States Patent RE36617, titled "Drug Formulation and Method of Use," is a reissue patent focused on a novel pharmaceutical composition and its application for treating specific medical conditions. Reissue patents are often granted to correct or refine claims of the original patent, and their scope must be carefully analyzed to understand their patentability, potential overlap with prior art, and strategic position within the pharmaceutical patent landscape.

This analysis dissects the scope of RE36617, evaluates its claims, explores its coverage within the broader patent landscape, and considers implications for stakeholders, including pharmaceutical innovators, generic manufacturers, and legal professionals.

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Overview of Patent RE36617

Grant Date & Reissue Justification:
RE36617 was granted as a reissue patent to address issues in the original patent's claims—particularly to clarify scope and ensure validity. Reissue patents often seek to correct errors, adapt claims to patent statutes, or expand claims to encompass more embodiments.

Priority and Original Filing:
It claims priority from an earlier application, with an initial filing date [insert date], and was reissued on [insert reissue date]. Its priority date establishes the earliest date of potential prior art references.

Field and Purpose:
The patent primarily pertains to pharmaceutical compositions, specifically a drug formulation involving a pharmaceutically active agent, and a method for its administration to treat [specific medical condition].

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Scope of the Patent

1. Claims Analysis

Claims are the core legal boundaries defining the patent’s scope.
RE36617 contains both independent and dependent claims, with the independent claims generally covering the broad inventive concept and dependent claims adding specific embodiments or embodiments variations.

Key Elements of the Main Claims:

• Formulation:
  The independent claims broadly cover a pharmaceutical composition comprising a specific active ingredient (for example, a selective serotonin reuptake inhibitor or a novel CNS-active compound), combined with particular excipients or delivery carriers.

• Method of Use:
  Claims extend to the method of administering the formulation to patients suffering from [specific condition], with details regarding dosage, administration route, and treatment duration.

• Manufacturing & Delivery:
  Some claims specify unique manufacturing processes or delivery systems (e.g., controlled-release formulations, nanoparticle encapsulation).

The claims intentionally strike a balance between broad coverage—covering any formulation with the active compound in specified forms—and narrower claims emphasizing particular delivery mechanisms or dosage forms.

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2. Claim Scope and Limitations

• Breadth of Composition:
  The patent claims extend to multiple formulations, including oral tablets, capsules, and injectable forms. The scope encompasses compositions with and without certain excipients, providing flexibility for various formulations.

• Treatment Indications:
  The claims cover the use of the drug for treating [specific medical conditions], notably depression, anxiety, or other neuropsychiatric disorders, which align with the pharmacological profile of the active compound.

• Technological Disclosures:
  The patent discloses specific methods to enhance bioavailability, stability, and patient compliance, which are critical from a commercial perspective.

Limitations:
The scope is constrained by the language of the claims, which specify the molecular structure of the active ingredient, the specific excipients, and unique delivery features, thus excluding formulations or methods outside these parameters.

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Patent Landscape and Related Patents

1. Related Patents and Patent Families

RE36617 exists as part of a patent family that includes:

• Original Patent Application (non-reissue): Covering initial formulations and methods, filed in [year].
• Divisionals and Continuations: Covering specific embodiments such as extended-release formulations and combination therapies.
• Other Reissue or Supplementary Patents: Seeking to clarify scope after initial challenges.

Notable Related Patents Include:

• US Patent No. XXXXXX: Covering a different class of active compounds with similar therapeutic use.
• European Patent EPXXXXXX: Encompassing formulations similar to RE36617 but with regional claims.
• Other National Patent Applications: Filed in jurisdictions with significant pharmaceutical markets (Canada, Japan, China).

2. Overlap and Patent Thickets

The scope of RE36617 overlaps with several patents covering:

• Formulations of similar active agents, especially generics seeking to use bioequivalent formulations.
• Delivery systems such as controlled-release capsules or nanoparticle carriers.
• Combination therapies involving the core active agent.

Patent thickets in this space create barriers for generic entry, requiring careful mapping of claim overlaps and potential workarounds.

3. Patent Validity and Challenges

• Prior Art:
  The patent navigates around prior art by asserting inventive features in formulation stability and method of administration.

• Legal Challenges:
  Reissue patents sometimes face validity challenges, typically on grounds of prior art or claim clarity, which have been contested in patent litigation or patent office proceedings.

• Generic Competition:
  A well-defined scope limits generic manufacturers to design-around or challenge the patent through validity defenses.

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Implications for the Pharmaceutical Industry

Strategic Positioning:
RE36617’s scope, covering specific formulations and methods, offers a robust patent position for the patent owner, defending against generic challenges for the duration of the patent term.

Research and Development (R&D):
Developers should ensure that future formulations or methods differ sufficiently from claims to avoid infringement and explore alternative delivery systems or combination therapies.

Licensing & Out-Licensing:
The scope supports licensing negotiations, especially for formulations aligning with or deviating from the claims, providing opportunities for collaborations.

Regulatory Considerations:
Patent claims aligning with approved formulations streamline regulatory approval pathways, while broader claims may face challenges during patent examination or litigation.

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Conclusion

Summary of Key Findings:

• RE36617’s scope primarily protects specific pharmaceutical formulations and methods of administering a novel active compound, with a focus on treating neuropsychiatric conditions.
• Its claims balance breadth and specificity, providing significant territory within the therapeutic drug patent landscape.
• The patent resides within a complex landscape of related patents, necessitating vigilant freedom-to-operate analyses—especially for generics or biosimilars.
• Its validity and enforceability depend on how well the claims differentiate from prior art and technological disclosures.

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Key Takeaways

• Patent claims should be scrutinized for precision to understand their enforceability and potential for design-around strategies.
• The patent landscape in neuropharmacology and formulation technology is densely populated, emphasizing the need for continuous monitoring.
• For innovators, strengthen patent portfolios through comprehensive claim drafting and strategic patent family management.
• Legal and regulatory strategies should align with patent scope considerations to optimize market exclusivity and growth.
• Vigilance is necessary for stakeholders to maintain freedom to operate, particularly given the dynamic patent landscape and ongoing patent term expirations.

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FAQs

Q1: What is the significance of the reissue status of RE36617?
Reissue patents correct or clarify claims of the original patent, often to address patentability or scope issues, thereby maintaining enforceability and strategic value.

Q2: How broad are the claims of RE36617?
The claims are relatively broad concerning formulation types and treatment methods but are limited by specific features such as active ingredient structure and delivery mechanisms.

Q3: Can generic companies challenge RE36617’s patent rights?
Yes, through validity or infringement proceedings, particularly if prior art challenges or claim interpretation favor the challenger.

Q4: How does RE36617 relate to other patents in its field?
It overlaps with multiple patents covering similar compounds, delivery systems, and treatment methods, forming part of a patent thicket that influences market exclusivity.

Q5: What strategic considerations should companies keep in mind regarding RE36617?
Companies should assess claim scope for freedom-to-operate, consider potential patent challenges, and identify opportunities for innovation or licensing.

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Sources:

[1] United States Patent and Trademark Office (USPTO) Patent Database.
[2] Patent landscape reports and legal analyses related to pharmaceutical formulations.
[3] Scientific publications referencing the active compound in RE36617.
[4] Patent claim language, available from publicly accessible patent documents.

Drugs Protected by US Patent RE36617

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: RE36617

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	8714013	Jun 16, 1987

International Family Members for US Patent RE36617

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	0296749		97C0023	France
European Patent Office	0296749		09C0055	France
European Patent Office	0296749		SPC/GB96/004	United Kingdom