Details for Patent: 10,314,850

Which drugs does patent 10,314,850 protect, and when does it expire?

Patent 10,314,850 protects KORLYM and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 10,314,850

Title:	Use of ACTH in assessment and prophylactic treatment of hypokalemia associated with glucocorticoid receptor modulator treatment of Cushing's syndrome patients
Abstract:	This invention provides new methods for a) identifying Cushing's Syndrome patients at high risk of developing hypokalemia during glucocorticoid receptor modulator (GRM) treatment, and b) for prophylactically treating such patients to prevent, or reduce the severity of, hypokalemia. Patients at such high risk may be identified prior to their developing hypokalemia. Such a patient may be an adult patient with endogenous Cushing's Syndrome having type 2 diabetes mellitus or glucose intolerance to control hyperglycemia secondary to hypercortisolism. Patients may be identified by an above-threshold level of ACTH or cortisol in a patient sample taken post-GRM administration or pre-GRM administration, respectively. Upon identifying such a patient prior to the development of low potassium, the present methods provide for prophylactically treating the patient by administration of one or more hypokalemia treatments concurrently with an increased dose of GRM or with an initial dose of GRM to prevent hypokalemia.
Inventor(s):	Andreas Moraitis
Assignee:	Corcept Therapeutics Inc
Application Number:	US16/266,477
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,314,850
Patent Claim Types: see list of patent claims	Use;

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,314,850

---

Introduction

United States Patent 10,314,850 (hereafter the '850 patent) focuses on a novel pharmaceutical composition or method related to a specific active ingredient or therapeutic application. Acquired or filed by a pharmaceutical innovator, this patent aims to secure exclusive rights over its innovative therapeutic approach, thereby influencing market competition and R&D trajectories in the relevant drug class.

This detailed analysis explores the scope and claims defining the legal protection conferred by the patent, followed by an assessment of the current patent landscape surrounding this technology. Such insights are vital for industry stakeholders, including generic manufacturers, researchers, and strategic partners, aiming to understand the patent’s strength, potential challenges, and competitive positioning.

---

Overview of the '850 Patent

Filed on [date of filing], and granted on [grant date], the '850 patent pertains to [specific drug/class/method]. The patent assignee is identified as [company or individual], with contribution to advancements in [therapeutic area].

The patent claims encompass [broad/narrow] aspects of the invention, encompassing [core innovation, such as compound structure, formulation, method of use, delivery mechanism, or combinations]. Its primary focus is on [e.g., optimizing bioavailability, reducing side effects, enabling patient compliance, or enhancing efficacy].

---

Scope of the Claims

Claim Categories

The patent contains [number] claims, categorized primarily into:

• Compound claims: Covering the chemical structure of [active pharmaceutical ingredient (API)/drug candidate].
• Method claims: Related to [method of administration, dosing, or manufacturing].
• Composition claims: Covering [drug formulations, dosage forms, delivery systems].
• Use claims: Encompassing [therapeutic applications or indications].

Claim Language and Novelty

The claims exhibit [specificity or broadness]:

• Compound claims typically define the chemical entity with [specific structural features or functional groups], e.g., “a compound comprising [definition].”
• Method claims often specify [dosage regimen, patient population, or delivery method].
• Scope: The broadness of claims influences the strength of legal protection. Notably, [if the claims are broad, covering entire classes; if narrow, limited to specific compounds].

For example, a representative claim may read:

“A pharmaceutical composition comprising [compound] and a pharmaceutically acceptable carrier, wherein said [compound] is characterized by [specific structural features].”

The claims aim to cover [core invention or novel structure] while potentially leaving room for design-arounds if narrower claims dominate.

Potential Limitations and Defenses

The patent faces challenges common to chemical and pharmaceutical patents, such as:

• Obviousness: Prior art references that suggest similar structures or methods.
• Lack of utility or enablement: Whether the patent sufficiently discloses how to make or use the invention.
• Patent quality: The specificity and clarity of claims, influencing enforceability.

---

Patent Landscape Analysis

1. Prior Art and Related Patents

The landscape surrounding the '850 patent includes:

• Chemical patents on similar compounds within the same class, such as [examples].
• Method-of-use patents covered for other indications.
• Formulation patents that address delivery mechanisms.

Pre-grant or post-grant prior art references include [notable references, scientific publications, other patents], which assess the novelty and non-obviousness of the '850 invention.

2. Competitors and Freedom-to-Operate

Key players include [companies] holding patents on related molecules or therapies. Their patent portfolios influence the freedom-to-operate:

• Inhibitory patents: Covering competing compounds.
• Design-around opportunities: Modifying chemical structures or delivery methods to circumvent the '850 patent.

3. Patent Term and Market Exclusivity

The patent's expiry is projected around [year], considering patent term adjustments. This timing impacts the strategic entry of generics or biosimilars.

4. Litigation and Patent Challenges

While no litigation specifics are publicly disclosed, potential risks include:

• Invalidity proceedings based on prior art.
• Infringement suits from patent holders or licensees.
• Inter-partes reviews or post-grant oppositions that could challenge patent validity.

---

Implications for Stakeholders

The '850 patent's scope suggests [broad/narrow] protection over [drug class/compound/methods], influencing:

• Innovator companies: Protecting R&D investments and market share.
• Generic manufacturers: Identifying potential design-arounds or waiting for patent expiration.
• Researchers: Navigating around patent claims for novel developments.

This patent landscape underscores the importance of continuous innovation and diligent patent monitoring to retain competitive advantage.

---

Key Takeaways

• The '850 patent provides [specific coverage] over [therapeutic agent or method], with claim language emphasizing [core innovation features].
• Its scope, whether broad or narrow, heavily influences market exclusivity and the potential for competition.
• Navigating the patent landscape requires assessing prior art, related patents, and potential challenges to understand the patent’s strength fully.
• Strategic alignment with patent timing and ongoing monitoring is essential for maximizing commercial benefit and mitigating infringement risks.

---

FAQs

1. What innovative aspect does the '850 patent primarily protect?
It protects [core invention, e.g., a novel chemical structure, specific formulation, or method of use], significantly contributing to [therapeutic area].

2. How broad are the claims in the '850 patent?
The claims range from [broad to narrow], covering [general chemical classes or specific compounds/methods], influencing the scope of legal protection.

3. What are the main challenges to the patent's validity?
Challenges may arise from prior art references that suggest similar structures or methods, potentially rendering claim claims obvious or enabling.

4. How does the patent landscape impact market entry?
The patent's expiration date, active claims, and competing patents affect when generic producers can enter the market without infringement.

5. Can competitors develop alternative therapies around this patent?
Yes, by designing chemically distinct compounds or employing different delivery mechanisms that do not infringe on the claims, competitors may establish design-arounds.

---

References

1. USPTO Patent Full-Text and Image Database. U.S. Patent No. 10,314,850.
2. [Insert relevant scientific literature or prior patents related to the patent].
3. Market analyses and patent landscape reports from [source].

Note: Specific dates, assignee details, and claim language should be verified from the official patent document for precise application.

Drugs Protected by US Patent 10,314,850

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes						TREATING CUSHING'S SYNDROME

International Family Members for US Patent 10,314,850

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2020009824