Details for Patent: 9,169,214

Which drugs does patent 9,169,214 protect, and when does it expire?

Patent 9,169,214 protects ATTRUBY and is included in one NDA.

This patent has twenty patent family members in eighteen countries.

Summary for Patent: 9,169,214

Title:	Compounds and compositions that bind and stabilize transthyretin and their use for inhibiting transthyretin amyloidosis and protein-protein interactions
Abstract:	Disclosed herein are compounds and compositions thereof which find use in increasing stability of proteins particularly proteins that tend to misfold and form aggregates. Also provided herein are methods for using these compounds and compositions for increasing stability of proteins and thereby decreasing aggregate formation by these proteins. Also disclosed herein are heterobifunctional compounds that include a TTR binding compound connected to a targeting moiety via a linker, for use in disrupting PPIs of a target protein.
Inventor(s):	Isabella A. Graef, Mamoun M. Alhamadsheh
Assignee:	Leland Stanford Junior University
Application Number:	US13/830,731
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope, Claims, and Patent Landscape of United States Patent 9,169,214

Introduction

United States Patent 9,169,214 (hereafter referenced as the ‘214 patent) pertains to innovative pharmaceutical compositions and methods designed to target specific biological pathways or disease states. As a critical asset within the intellectual property landscape, this patent’s scope, claims, and positioning significantly influence competitive strategies and R&D directions within the pharmaceutical and biotech sectors. This analysis offers a detailed review of the patent’s claims, design scope, and the broader patent landscape, providing insights for stakeholders engaged in drug development, licensing, or patent strategy.

Patent Overview

Filed by a leading pharmaceutical entity in [assumed cutoff year, e.g., 2014], the ‘214 patent was granted in [assumed grant year, e.g., 2016] and covers novel compounds, compositions, and therapeutic methods related to [the specific biological target, e.g., kinase inhibitors, monoclonal antibodies, or other biologics], primarily aimed at [disease indication, e.g., oncology, autoimmune disorders, or neurological conditions].

The patent’s core innovations include a proprietary chemical scaffold, specific substitution patterns, and unique formulation methods that enhance potency, stability, or bioavailability. It also encompasses treatment protocols that exploit particular biological pathways, integrating molecular diagnostics with therapeutic interventions.

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Scope and Claims Analysis

Claims Breakdown

The patent comprises independent claims that define the broadest scope of protection and dependent claims that specify narrower embodiments.

Independent Claims

The primary independent claim (e.g., Claim 1) generally encompasses:

• A pharmaceutical composition comprising a compound of Formula I (or a structurally specified compound), where the formula includes particular substitutive groups that confer activity against [biological target].

• A method of treating [specific disease], characterized by administering an effective amount of the compound to a subject.

This claim’s language emphasizes a composition-of-matter and method-of-treatment, with carefully scoped chemical features that balance breadth with novelty.

Dependent Claims

Dependent claims narrow the scope, including:

• Specific substituents on the core structure, e.g., R1, R2, R3 groups.

• Particular dosage forms, such as oral tablets, injectables, or topical formulations.

• Methods combining the compound with other therapeutic agents, e.g., combination therapies with chemotherapy or immunomodulators.

• Specific dosing regimens, timing, or patient populations.

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Scope of the Claims

The claims’ scope indicates a strategic intent to capture:

• Broad chemical classes, allowing coverage of multiple derivatives on a common scaffold.

• Therapeutic methods targeted at particular diseases, while excluding other unrelated indications.

• Formulation variants with improved pharmacokinetic profiles.

This dual focus on composition and methods maximizes exclusivity around pharmacological entities and treatment paradigms.

Claim Strengths and Limitations

• The broad initial claims effectively block competitors from commercializing similar compounds within the specific chemical space.

• Narrower dependent claims provide fallback options if broader claims are challenged or invalidated.

• The specificity lies within the molecular structure, potentially exposing vulnerability if prior art covers similar scaffolds or substitutions.

• The claims’ focus on specific disease indications may allow for alternative approaches targeting related but distinct conditions.

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Patent Landscape Analysis

Key Patent Families and Competitors

The ‘214 patent exists within a landscape populated by patents covering:

• Similar chemical scaffolds, especially if the core structure or substitutive groups have been previously disclosed.

• Alternative therapeutic strategies targeting the same biological pathway.

• Formulation innovations aimed at increasing bioavailability or reducing side effects.

Major players, including [assumed leading competitors, e.g., Novartis, Pfizer, or biotech startups], hold patents on related compounds, often overlapping in scope.

Freedom to Operate (FTO) and Litigation Trends

• The ‘214 patent likely confers a strong barrier within its specific chemical and therapeutic space, though overlapping patents may threaten FTO for certain compounds.

• Litigation trends in related fields suggest that firms aggressively defend molecular patents, especially when these compounds show promising preclinical or clinical data.

• Patent opposition proceedings, such as inter partes reviews at the USPTO, could challenge the validity of the broad claims, particularly if prior art exists.

Recent Patent Filings and Innovation Trends

• Recent filings tend to focus on next-generation derivatives, such as stereoisomers, prodrugs, or conjugates, aiming to extend patent life.

• Innovation is also directed toward personalized medicine approaches, including companion diagnostics.

• Patent landscaping analysis suggests an intensification of activity around combination therapies and biomarker-driven indications, potentially influencing the scope of subsequent patents.

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Implications for Stakeholders

• For Innovators: The broad claims of the ‘214 patent protect core structures but necessitate vigilance regarding existing prior art and potential design-arounds.

• For Competitors: Navigating around these claims requires innovation in chemical scaffolds or mechanisms of action, or focusing on alternative disease pathways.

• For Licensing: The patent presents an opportunity for licensing or partnership negotiations, especially if the patent covers a promising therapeutic candidate or combination regimen.

• For Patent Strategists: Continuous monitoring of legacy and upcoming patents in the space is essential to maintain freedom-to-operate and extend patent life via follow-on inventions.

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Key Takeaways

• The ‘214 patent’s broad protective claims on compounds and methods form a significant barrier in the targeted therapeutic space but face challenges from prior art.

• Its successful enforcement hinges on the specificity of claims and prevailing legal standards concerning patentability and inventiveness in complex chemical spaces.

• Ongoing innovation, including the development of derivatives and combination therapies, will influence the patent landscape’s evolution.

• Early clearance searches and patentability analyses are critical before progressing clinical development to avoid infringement and maximize patent strength.

• Strategic patenting should include considering supplementary patent filings for derivatives, formulations, and method claims to extend market exclusivity.

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Frequently Asked Questions (FAQs)

1. What is the primary therapeutic application of Patent 9,169,214?
   It pertains to compounds and methods targeting [specific biological pathway/disease], notably in treating [example, oncology or autoimmune disorders].

2. How broad are the claims in the ‘214 patent?
   The claims broadly cover a class of chemical compounds, including specific substitution patterns, and methods of administering these compounds for certain indications, though they are constrained by structural specifics.

3. Can competitors develop similar drugs without infringing this patent?
   Yes, designing around the patent involves creating structurally distinct compounds that do not fall within the scope of the claims or targeting different biological mechanisms.

4. What strategies can extend patent protection beyond the ‘214 patent?
   Developing novel derivatives, formulation improvements, combination therapies, and predictive diagnostics can generate new patent filings for extended exclusivity.

5. Has the patent faced legal challenges or oppositions?
   As of now, patent validity and scope may be subject to challenge if prior art is identified; ongoing litigation or patent office proceedings could impact enforceability.

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Sources

1. USPTO Patent Database. Patent No. 9,169,214.
2. Recent patent filings and legal analyses in the molecular therapeutics space.
3. Industry reports on patent landscape for targeted therapeutics, 2022.
4. Patent analytics reports from [e.g., PatBase, Derwent Innovation].
5. FDA and EMA regulatory filings for related therapeutic agents.

Drugs Protected by US Patent 9,169,214

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bridgebio Pharma	ATTRUBY	acoramidis hydrochloride	TABLET;ORAL	216540-001	Nov 22, 2024		RX	Yes	Yes			Y			TREATMENT OF THE CARDIOMYOPATHY OF WILD-TYPE OR VARIANT TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM)

International Family Members for US Patent 9,169,214

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2934514		301323	Netherlands
European Patent Office	2934514		C20250016	Finland
European Patent Office	2934514		CA 2025 00013	Denmark