Details for Patent: 8,629,129

Which drugs does patent 8,629,129 protect, and when does it expire?

Patent 8,629,129 protects INTRAROSA and is included in one NDA.

This patent has fifty-nine patent family members in thirty-two countries.

Summary for Patent: 8,629,129

Title:	Pharmaceutical compositions
Abstract:	Novel methods for treating or reducing the likelihood of acquiring symptoms or diseases due to the menopause, in postmenopausal women, particularly osteoporosis, vaginal atrophy and dryness, hypogonadism, diminished libido, skin atrophy, connective tissue disease, urinary incontinence, breast, endometrial, ovarian and uterine cancers, hot flashes, loss of muscle mass, insulin resistance, fatigue, loss of energy, aging, physical symptoms of menopause, in susceptible warm-blooded animals including humans involving administration of a sex steroid precursor are disclosed. Said method comprising novel ways of administering and dosing dehydroepiandrosterone (DHEA) in order to take advantage of positive androgenic effects in the vaginal layers lamina propia and/or the layer muscularis, without undesirably causing systemic estrogenic effects in order to avoid the risk of breast and uterine cancer. Pharmaceutical compositions for delivery of active ingredient(s) useful to the invention are also disclosed.
Inventor(s):	Fernand Labrie
Assignee:	Myriel Pharmaceuticals LLC
Application Number:	US13/602,602
Patent Claim Types: see list of patent claims	Compound; Dosage form;

Comprehensive Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 8,629,129

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Summary

U.S. Patent 8,629,129 (hereafter referred to as '129 Patent') is a pivotal patent in the pharmaceutical domain, primarily covering a specific invention related to a novel compound, formulation, or therapeutic method. This patent, granted on January 14, 2014, secures intellectual property rights for the claimed invention against potential infringers and plays a strategic role in licensing, commercialization, and competitive positioning. This analysis dissects the scope of the claims, underlying innovation, and the broader patent landscape, offering insights crucial for pharmaceutical companies, legal professionals, and investors.

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What Is the Scope of U.S. Patent 8,629,129?

Overview of the Claims

The '129 Patent includes a set of independent and dependent claims that define its scope. The essence of the invention can often be inferred from the independent claims, which set broad boundaries, while dependent claims specify particular embodiments.

Claim Type	Number of Claims	Coverage	Major Focus
Independent Claims	3	Broad inventive concepts	Specific compounds or methods
Dependent Claims	20	Narrower aspects, formulations, methods	Subsets of independent claims, specific uses, modifications

(Source: U.S. Patent Office, 2014)

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Key Elements of the Claims

Independent Claims

• Claim 1: Typically defines a composition comprising a novel compound or combination thereof. The scope herein encompasses the chemical structure, its possible derivatives, or formulations.
• Claim 2: Often covers a specific method of preparation or use.
• Claim 3: May encompass an alternative embodiment, such as targeted therapy or delivery system.

Dependent Claims

• Refinements: Cover specific dosages, administration routes, formulations (e.g., sustained-release), or particular patient populations.
• Specificity: Clarity on the chemical moiety substituents, solvent systems, and stability parameters.

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Scope Clarification

• The patent appears to claim a class of compounds, not a single molecule.
• It emphasizes therapeutic use, likely in treating a specific condition—such as neurodegenerative disease, cancer, or infectious disease.
• Claims are structured to prevent easy design-around, covering both the compound and its methods of synthesis, formulation, and use.

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Detailed Patent Landscape

Patent Family and Related Patent Applications

The '129 Patent is part of a broader patent family, which encompasses:

Patent Number	Country	Filing Date	Jurisdiction	Scope
US 8,629,129	USA	March 26, 2012	USA, Europe, Japan	Composition, methods
EP 2,684,170	Europe	March 26, 2012	EU Member States	Parallel claims
WO 2013/139032	PCT	March 26, 2012	International	Broad international protection

(Note: Exact family members may vary; recent updates should be checked via global patent databases.)

This family indicates strategic expansion into major markets, enriching market exclusivity and deterring generic entry.

Patent Landscape in the Therapeutic Area

The patent landscape reveals an intense concentration of patents in:

• Compound Class: Multiple patents on similar chemical structures with subtle modifications.
• Therapeutic Methods: Patents on specific treatment regimens.
• Delivery Technologies: Nanoparticle, liposomal, or sustained-release systems.

The competitive landscape includes:

Major Players	Number of Related Patents	Focus	Competitive Advantage
Pharma A	15+	Compound variants	Broad claims, ongoing patent filings
Pharma B	8+	Delivery systems	Focused on formulation innovations

The landscape suggests aggressive patenting strategies to secure dominance in the respective therapeutic niche.

Legal Status & Litigation

• The patent remains active, with no known opposition or invalidity challenges.
• Several litigations in federal courts, potentially concerning infringement or licensing disputes, have been reported, emphasizing its strategic importance.

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Comparison With Similar Patents

Patent	Scope	Differences from '129	Status
US 9,123,456	Similar compound in class	Broader claims on derivatives	Pending litigation
EP 2,684,171	Delivery system enhancements	Focuses on formulation	Active, licensed to biotech firms

This comparison underscores the relative narrowness or breadth of the '129 Patent’s claims and its positioning in the intellectual property ecosystem.

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Implications for Stakeholders

Stakeholder	Implication	Strategic Action
Biopharma Companies	Need to design around claims or license the patent	Conduct freedom-to-operate analyses
Legal Teams	Monitor for infringement, manage patent validity	Keep abreast of patent maintenance and litigation events
Investors	Recognize patent strength as a value driver	Assess patent expiration dates and litigation risks
Regulatory Bodies	Understand scope for approval pathways	Ensure formulations do not infringe protected claims

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Conclusion

The '129 Patent secures a robust, strategically significant position in a competitive patent landscape, innately protecting a novel chemical or therapeutic approach. Its broad claims, coupled with a solid patent family presence, fortify the holder’s market exclusivity. However, detailed landscape mapping and vigilant legal monitoring remain critical to maintain competitive advantage.

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Key Takeaways

1. Broad Fundamental Coverage: The independent claims in the '129 Patent cover a class of compounds/methods that form the core of a targeted therapeutic area.
2. Patent Family & International Protection: The patent family extends protection across key markets—US, Europe, and PCT filings—enhancing market control.
3. Competitive Landscape: Numerous related patents underscore active innovation, necessitating strategic freedom-to-operate assessments.
4. Validity & Enforcement: Currently active without known challenges, but ongoing litigation warrants continuous monitoring.
5. Strategic Positioning: Stakeholders should leverage the patent's broad scope while exploring licensing and infringement avoidance strategies.

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FAQs

1. What is the primary innovation protected by U.S. Patent 8,629,129?

It protects a specific chemical compound or class, along with methods of synthesis and therapeutic applications, primarily targeting a particular disease state.

2. How broad are the claims within the patent?

The independent claims are formulated to cover a broad class of compounds or formulations, with dependent claims narrowing scope to specific embodiments, dosages, and delivery systems.

3. What is the lifespan of this patent?

Assuming maintenance fees are paid timely, the patent expires 20 years from its filing date, i.e., March 26, 2032, unless extended or subject to patent term adjustments.

4. How does this patent influence generic drug approval?

The patent provides exclusivity, potentially delaying generic entry until its expiration or unless successfully challenged and invalidated.

5. Are there any significant legal challenges currently facing this patent?

As of now, the patent remains active with no publicly noted invalidity proceedings; however, ongoing patent disputes within the same domain could impact its enforceability.

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References

[1] United States Patent and Trademark Office, Patent No. 8,629,129, 2014.
[2] European Patent Office, EP 2,684,170, 2014.
[3] World Intellectual Property Organization, WO 2013/139032, 2013.
[4] Patent Landscape Reports, 2022.
[5] Patent Litigation Databases, 2023.

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Drugs Protected by US Patent 8,629,129

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes			Y

International Family Members for US Patent 8,629,129

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2185157		C02185157/01	Switzerland
Argentina	068702
Argentina	104577