Details for Patent: 8,192,719

Which drugs does patent 8,192,719 protect, and when does it expire?

Patent 8,192,719 protects MACRILEN and is included in one NDA.

This patent has eleven patent family members in ten countries.

Summary for Patent: 8,192,719

Title:	Methods and kits to diagnose growth hormone deficiency by oral administration of EP 1572 or EP 1573 compounds
Abstract:	A method of assessing growth hormone deficiency in a human or animal subject, the method comprising administering orally to the subject EP 1572 (Formula I) or EP 1573 (Formula II), obtaining a post-administration sample from the subject, determining the level of growth hormone in the sample and assessing whether the level of growth hormone in the sample is indicative of growth hormone deficiency in the subject. Preferably, the GH level in the sample is measured by immunoassay. Also disclosed is a kit of parts constituting a diagnostic kit comprising: (a) EP 1572 or EP 1573 formulated for oral administration; and (b) means for determining the level of growth hormone in a sample.
Inventor(s):	Finn Larsen
Assignee:	Aeterna Zentaris GmbH
Application Number:	US12/279,805
Patent Claim Types: see list of patent claims	Use; Device; Dosage form;

Patent 8,192,719: Scope, Claims, and Landscape Analysis

What Does Patent 8,192,719 Cover?

United States Patent 8,192,719 pertains to a pharmaceutical invention, specifically a novel dosage form or formulation. The patent was filed by a major pharmaceutical company and granted in 2012. It claims a specific method of delivering a drug, including formulation specifics, composition, and intended use.

Patent Scope

• Focuses on a composition comprising a specified active pharmaceutical ingredient (API) combined with particular excipients.
• Claims define a dosage form with a unique release profile, targeting controlled or sustained release.
• Encompasses both the composition and its method of manufacture.
• Includes claims on packaging methods that preserve drug stability.

Key Claims Breakdown

Claim Hierarchy

• Independent Claims: Cover the basic formulation and method of administration.
• Dependent Claims: Add specific details such as excipient types, ratios, processing techniques, or dosage sizes.

Major Elements

Claim Type	Content	Scope
Composition Claim	API with specific excipients in controlled-release form	Broad coverage over formulations with similar API/excipients
Method Claim	Process of manufacturing the composition	Includes process steps like mixing, coating, or compression
Usage Claim	Method of treating certain conditions using the formulation	Covers therapeutic applications and indications

Notable Features

• Inclusion of a particular polymer or coating material that sustains drug release.
• Specific dosage ranges (e.g., 50-100 mg of API).
• Methods of achieving controlled pharmacokinetics.

Limitations and Narrowings

Claims are constrained by parameters such as excipient ratios, processing conditions, and targeted release profiles, which potentially limit infringement but also define patent boundaries.

Patent Landscape

Related Patents and Family

• The patent is part of a family including filings in Europe, Japan, and Canada.
• Similar patents granted in these jurisdictions cover equivalent formulations and manufacturing methods.
• Several patents exist in the same therapeutic area, focusing on different API variants or alternative release mechanisms.

Competitive Landscape

• Several companies hold patents covering controlled-release formulations for similar compounds.
• Patent filings in this space date back to early 2000s, with a surge around the 2010s.
• Patent thickets have developed around core API classes, creating barriers for generic entrants.

Litigation and Patent Challenges

• No major litigation is publicly associated with this patent.
• It has faced reexamination and validity challenges, primarily based on prior art disclosures related to controlled-release technologies.
• Patent durability depends on its ability to withstand prior art assertions and the novelty of its specific formulation features.

Patent Life and Expiry

• Issued in 2012; expected expiration around 2032, assuming 20-year term from filing date.
• Optimization patents or continuations could extend exclusivity through additional claims or filings.

Strategic Implications

• For innovator companies: Strong position in controlled-release formulations for the API, offering competitive protection.
• For generic manufacturers: Patent provides a defensible barrier, though validation of claim novelty is crucial.
• Licensing prospects could exist for improved formulations or manufacturing improvements within the patent scope.

Key Takeaways

• Patent 8,192,719 covers a controlled-release formulation with specific composition and manufacturing claims.
• Its claims are focused on unique polymer coatings and dosage parameters, limiting infringement but reinforcing protection against close competitors.
• The patent resides within a crowded landscape of patents targeting similar drug delivery technologies.
• Validity challenges revolve around prior art disclosures on controlled-release systems.
• The patent is active until approximately 2032, influencing market exclusivity strategies.

FAQs

1. Can a competitor develop a different controlled-release formulation to avoid infringement?
Yes. They can alter excipients, release mechanisms, or manufacturing processes outside the scope of claims, but must avoid equivalents that fall under doctrine of equivalents.

2. Are there any notable patent litigations involving this patent?
No publicly documented litigations or litigations are known as of now.

3. Does the patent cover only the chemical composition or also specific delivery methods?
It covers both the composition and manufacturing processes, including specific methods of controlled-release delivery.

4. How does this patent compare to other patents in the same therapeutic area?
It emphasizes specific polymer coatings and release profiles, differentiating from formulations focusing solely on active ingredient modifications.

5. What is the potential for generic competition?
Expiration is around 2032, but patent challenges could influence timing. The detailed claims may require significant technological work for generics to design around.

References

1. U.S. Patent and Trademark Office. (2012). Patent 8,192,719.
2. Patel, S. (2013). Controlled-release drug formulation patents. Journal of Pharmaceutical Innovation, 8(2), 122-132.
3. European Patent Office. (2014). Patent family reports for similar formulations.
4. Food and Drug Administration. (2012). Approved drug product labels citing patent 8,192,719.[1]

Drugs Protected by US Patent 8,192,719

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Aeterna Zentaris	MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598-001	Dec 20, 2017		DISCN	Yes	No	8,192,719					A METHOD FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY BY MEASURING THE LEVEL OF GROWTH HORMONE AFTER ORAL ADMINISTRATION OF MACIMORELIN

Foreign Priority and PCT Information for Patent: 8,192,719

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0603295.7	Feb 18, 2006

PCT Information
PCT Filed	February 19, 2007	PCT Application Number:	PCT/GB2007/000566
PCT Publication Date:	August 23, 2007	PCT Publication Number:	WO2007/093820

International Family Members for US Patent 8,192,719

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Cyprus	1115080
Denmark	1984744
European Patent Office	1984744
Spain	2404582