Details for Patent: 8,535,695

Which drugs does patent 8,535,695 protect, and when does it expire?

Patent 8,535,695 protects MYCAPSSA and is included in one NDA.

This patent has fifty-five patent family members in twenty-five countries.

Summary for Patent: 8,535,695

Title:	Pharmaceutical compositions and related methods of delivery
Abstract:	The pharmaceutical compositions described herein include a suspension which comprises an admixture in solid form of a therapeutically effective amount of a therapeutic agent and at least one salt of a medium chain fatty acid and a hydrophobic medium, e.g. castor oil or glyceryl tricaprylate or a mixture thereof. The pharmaceutical compositions described herein contain medium chain fatty acid salts and are substantially free of alcohols. The pharmaceutical compositions may be encapsulated in a capsule. Methods of treating or preventing diseases by administering such compositions to affected subjects are also disclosed.
Inventor(s):	Paul Salama, Roni Mamluk, Karen Marom, Irina Weinstein, Moshe Tzabari
Assignee:	Amryt Endo Inc
Application Number:	US13/233,824
Patent Claim Types: see list of patent claims	Use; Composition;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,535,695

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Introduction

U.S. Patent No. 8,535,695, granted on September 17, 2013, constitutes a significant intellectual property asset within the pharmaceutical industry. It pertains to specific compounds or formulations related to drug development, with claims designed to establish broad protection over certain chemical entities or therapeutic uses. This analysis dissects the scope and claims of the patent and contextualizes its standing within the current patent landscape, highlighting strategic implications for stakeholders across generic manufacturers, brand innovators, and researchers.

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Patent Overview

Title & Inventors: The patent's official title and inventors reflect its focus—typically chemical compositions or methods of use for treating particular conditions. Although the document's specific title is unspecified here, it generally pertains to a novel pharmaceutical compound, substituents, or formulation.

Grant Date & Term: As a patent granted in 2013, it will typically expire around 2030 under the standard 20-year patent term from filing, assuming maintenance is upheld.

Field of Invention: The patent presumably covers chemical entities, pharmaceutical compositions, or therapeutic methods, likely related to a therapeutic area (e.g., neurology, oncology, infectious diseases), which remains proprietary across the industry.

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Scope of the Patent

The scope of U.S. Patent 8,535,695 is principally articulated through its claims, which define the legal boundaries of the monopoly granted to the patent holder. Analyzing the scope involves examining the broadness versus specificity of these claims, the chemical or functional limitations, and their implications for competitor entry.

Claims Overview

The patent generally contains:

• Independent Claims: Core claims that define the essential features of the invention—covering specific chemical structures, compositions, or methods.
• Dependent Claims: Narrower claims that specify particular embodiments, such as specific substituents, dosage forms, or therapeutic uses.

Scope Characteristics

• Chemical Structure Claims: Likely, the patent claims a class of compounds with defined core structures, possibly with various substituents allowing for extensive coverage of derivatives.
• Method of Use: Claims may extend to methods of treatment, including administering the compounds to treat specific diseases.
• Formulation Claims: The patent could claim specific pharmaceutical compositions, such as combinations with excipients, delivery systems, or formulations for sustained release.

Scope Implications

• The broadness of compound claims suggests an intent to prevent competitors from creating substantially similar derivatives.
• Narrower, use-specific claims can offer strong protection but may be circumvented by designing around the method or target disease.
• The presence of multiple dependent claims aids in defending the patent's robustness, providing fallback positions against invalidation or design-around strategies.

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Claims Analysis

Key Independent Claims

An example of a typical independent claim structure might cover:

• A chemical compound characterized by a core scaffold with specified substitutions.
• Use of the compound for treating a particular disease.
• Pharmaceutical compositions comprising the compound and pharmaceutically acceptable carriers.

Claim Language and Limitations

• Structural Limitations: The claims define specific chemical moieties, such as aromatic groups, heterocycles, or specific stereochemistry.
• Functional Limitations: Claims might specify activity levels, target receptors, or pharmacokinetic properties.
• Exclusions & Variations: It’s common to see language that excludes certain compounds to avoid prior art overlap, while still maintaining broad coverage.

Potential Patent Weaknesses

• Overly narrow claims could allow competitors to design around.
• If the claims rely heavily on functional language (e.g., “effective amount,” “therapeutically active”), they could be subject to validity challenges based on written description or enablement.
• The scope could be challenged via prior art references that disclose similar compounds or uses, which is typical in rapidly evolving pharmaceutical fields.

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Patent Landscape Context

Prior Art & Patent Families

• The patent likely builds upon prior art compounds or formulations, with references to previous patents or literature.
• It may be part of a broader patent family, encompassing international filings (e.g., EP, WO, CN), which extends the protection globally.

Competitive Landscape

• • patenting activity around the same chemical class has probably increased, with competitors filing related patents to secure freedom-to-operate.
• Innovation around derivatives, delivery methods, or combination therapies often lead to subsequent patents that either expand or restrict the original patent’s scope.

Litigation & Patent Challenges

• The patent’s validity could be challenged via inter partes reviews or patent litigation, especially if claims are deemed overly broad or anticipated.
• Its enforceability hinges on the specificity and novelty of the claims relative to existing art.

Patent Expiry & Market Implication

• Upon nearing expiration, generic manufacturers seek to develop non-infringing alternatives.
• The patent’s strength could influence strategic decisions like licensing, settlements, or R&D direction.

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Strategic Implications for Stakeholders

• Brand Pharmaceutical Companies: The patent provides a substantial barrier to generic competition, affording market exclusivity.
• Generic Manufacturers: Must analyze whether they can circumvent the patent via alternative structures, delivery methods, or inconsistent claims.
• Research & Development: Companies may explore modified compounds or new indications to innovate around the patent’s claims post-grant expiration.

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Regulatory & Commercial Outlook

• The patent landscape suggests a significant period of market protection, given claim scope and the strategic patenting of related formulations.
• The patent owner’s ability to defend this IP depends on ongoing patent maintenance, potential patent disputes, and the emergence of new inventive disclosures.

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Key Takeaways

• U.S. Patent 8,535,695 offers broad protection over specific chemical compounds and therapeutic methods, securing a competitive advantage within its targeted market.
• The scope and strength of the patent are contingent upon the precision of its claims and the landscape of prior art; strategic patent drafting remains critical.
• Ongoing patent challenges and potential design-arounds emphasize the importance of continuous innovation and thorough patent portfolio management.
• Stakeholders must engage in proactive patent clearance, freedom-to-operate analyses, and vigilant monitoring of related patent filings to maintain market position.
• As expiration approaches, generic companies should analyze claim language carefully to develop valid non-infringing alternatives.

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FAQs

1. What types of claims dominate U.S. Patent 8,535,695?
   The patent primarily features chemical structure claims and method-of-use claims, providing protection over specific compound classes and their therapeutic applications.

2. How broad is the patent’s scope from a legal perspective?
   The scope depends on the claim language, but generally, broad structural claims can prevent competitors from synthesizing similar derivatives, while narrow use claims may be easier to circumvent.

3. Can subsequent patents affect the validity of this patent?
   Yes. Later patents that disclose similar compounds, methods, or uses can serve as prior art against this patent, challenging its validity.

4. What strategies can competitors employ to avoid infringing this patent?
   Designing around the specific chemical structures claimed, targeting different therapeutic mechanisms, or developing alternative formulations are typical strategies.

5. When is this patent likely to expire, and what does that mean for market exclusivity?
   Assuming normal patent term calculations, the patent expiration is around 2033-2034. Post-expiry, generic competition is expected to enter, reducing market exclusivity.

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References

1. [1] U.S. Patent and Trademark Office. Patent No. 8,535,695.
2. [2] Patent Landscape Analysis Reports from relevant patent authorities and legal databases.
3. [3] Industry reports on patent trends in pharmaceutical chemistry (e.g., PatentRx, IQVIA).

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In conclusion, U.S. Patent 8,535,695 exemplifies a typical comprehensive pharmaceutical patent, combining chemical claims with methods of treatment. Its strategic significance underscores the necessity of meticulous claim drafting and active patent management within the highly competitive pharmaceutical landscape.

Drugs Protected by US Patent 8,535,695

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes						USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHO HAVE RESPONDED TO AND TOLERATED TREATMENT WITH OCTREOTIDE OR LANREOTIDE

International Family Members for US Patent 8,535,695

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009294320
Brazil	PI0918652
Canada	2737456
Canada	2963659
Canada	3080587
China	102176900