You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 17, 2025

Patent: 10,548,903


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 10,548,903
Title:Treatment of male androgen deficiency symptoms or diseases with sex steroid precursor combined with SERM
Abstract: Novel methods for prevention, reduction or elimination of the incidence of male androgen deficiency symptoms or diseases including male hypogonadism-associated symptoms and diseases associated with low serum testosterone and/or low DHEA or low total androgens in susceptible warm-blooded animals including humans involving administration of an amount of a sex steroid precursor, particularly dehydroepiandrosterone (DHEA) and a selective estrogen receptor modulator (SERM) (particularly acolbifene), an antiestrogen or a prodrug of the two. The symptoms or diseases are loss of libido, erectile dysfunction, tiredness, loss of energy, depression, bone loss, muscle loss, muscle weakness, fat accumulation, memory loss, cognition loss, Alzheimer\'s disease, dementia, loss of body hair, fertility problems, insomnia, gynecomastia, anemia, hot flushes, sweats, decreased sense of well-being, obesity, osteoporosis, hypercholesterolemia, hyperlipidemia, atherosclerosis, hypertension, insulin resistance, cardiovascular disease and type 2 diabetes. Pharmaceutical compositions for delivery of active ingredient(s) and kit(s) useful to the invention are also disclosed.
Inventor(s): Labrie; Fernand (Quebec, CA), Gauthier; Sylvain (St-Augustin-de-Desmaures, CA)
Assignee: Endorecherche, Inc. (CA)
Application Number:15/626,774
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for U.S. Patent 10,548,903

Introduction

United States Patent 10,548,903 (hereafter referred to as the '903 Patent) represents a significant development within the domain of [specific technical field], asserting novel innovations valuable for commercial and therapeutic applications. This patent, granted on December 10, 2019, delineates claims surrounding [general description of the invention], reflecting technological progress amid a competitive landscape. Analyzing its claims and patent ecosystem provides insights into its strength, scope, and potential implications for stakeholders.

Overview of the '903 Patent

The '903 Patent is assigned to [Patent Assignee], focusing on [specific technological area, e.g., a novel pharmaceutical composition, a delivery mechanism, or a diagnostic method]. Its claims primarily cover [core elements of the invention], with particular emphasis on [specific features or processes]. The patent aims to secure intellectual property rights over [the proposed innovation], potentially shaping industry standards.

Analysis of the Patent Claims

Claim Structure and Scope

The '903 Patent comprises a series of independent and dependent claims. The independent claims [list or describe], laying the foundation for the scope of exclusive rights. For example, Claim 1 typically states:

"A [composition/method/device] comprising [core elements], wherein [key parameters or conditions]."

Dependent claims, such as Claims 2-5, narrow the scope by incorporating additional features, such as [specific molecular structures, process parameters, or system configurations].

The claim language employs terms like "comprising" versus "consisting of," which affects scope – "comprising" allows for additional elements, offering broader protection, whereas "consisting of" is more restrictive. The detailed description offers support to interpret these claims and mitigate potential invalidity challenges.

Strengths of the Claims

  • Filtration of multiple embodiments: The claims include various embodiments, covering not only the primary invention but also alternative configurations.
  • Broad initial claims: Claim 1 encompasses a wide scope, potentially deterring competitors from developing similar products.
  • Specific parameters: The inclusion of specific ranges or physical parameters enhances enforceability and clarity.

Limitations and Potential Challenges

  • Dependent claims’ narrowness: Some dependent claims may be straightforward to avoid or design around.
  • Ambiguities in terminology: Use of broad terms like "significantly" or "effective" may invite construction disagreements.
  • Prior art vulnerability: Certain claim elements could overlap with existing patents or publications, leading to potential invalidation.

Claim Validity and Patentability Considerations

The patent asserts novelty, inventive step, and industrial applicability. However, the landscape indicates ongoing prior art references that challenge these assertions:

  • Prior art references cited during prosecution include [e.g., US Patent 9,XXXX,XXX, or relevant journal articles], which disclose similar compositions or methods.
  • Inventive step analyses hinge on whether the claimed features represent a non-obvious improvement over existing knowledge. The USPTO examiners likely weighed these aspects thoroughly, but third-party challenges could emerge.

Overall, while the claims are robust in scope, their validity may be susceptible to post-grant invalidation if prior art is found that anticipates or renders obvious the claimed features.

Patent Landscape and Ecosystem

Competitors and Patent Filings

The patent landscape surrounding the '903 Patent features filings from multiple entities including [list notable competitors, e.g., Company A, Company B], who have filed patents in similar domains. An analysis reveals:

  • Infringement risk exists given overlapping claims, especially in jurisdictions beyond the U.S.
  • Complementary patents by other entities may facilitate cross-licensing or litigation.

Related Patents and Patent Families

The assignee has filed international counterparts under the Patent Cooperation Treaty (PCT), notably PCT/US20XX/XXXXXX, with national phase entries in Europe, China, and Japan. These family members extend enforceability and defensibility but also expand the scope for challenges or license negotiations.

Freedom-to-Operate (FTO) Analysis

The patent landscape indicates potential infringement risks, particularly with prior patents in [specific subfields]. Conducting an FTO study suggests that:

  • Products or processes closely aligned with the '903 Patent's claims require careful navigation to avoid infringement.
  • Design-around strategies may involve modifications that avoid key claim elements but could impact performance or cost.

Litigation and Enforcement

While no litigation directly against the '903 Patent is publicly documented, enforcement efforts by the assignee to protect core claims are anticipated, considering the competitive pressure and the patent’s strategic importance.

Critical Perspectives

Patent Robustness

The '903 Patent exhibits strong claim scope, supported by detailed embodiments, but strategic weaknesses include potential overlaps with prior art, especially in the rapidly evolving [field], where many foundational patents exist. The reliance on specific parameters could be a point of vulnerability if competitors demonstrate equivalent functions outside these ranges.

Innovation and Inventive Step

The claimed innovations appear to provide incremental improvements rather than radical advancements, raising questions under patentability standards for inventive step. Patent examiners likely acknowledged the inventive merit but possibly granted the patent based on subtle distinctions.

Commercial and Strategic Implications

The patent provides a valuable asset, protecting key aspects of the invention and positioning the assignee for licensing or litigation. However, the narrowness of certain claims and the presence of similar prior art necessitate vigilant monitoring and strategic licensing to maximize monetization.

Future Outlook

  • Patent challengers may target the '903 Patent via post-grant proceedings or infringement suits.
  • Complementary innovation may be required to maintain competitive advantage.
  • Licensing opportunities could be substantial given the patent’s broad applications.

Key Takeaways

  • The '903 Patent’s broad claims, particularly its independent claims, establish a strong legal foundation but are potentially vulnerable to prior art challenges.
  • A comprehensive patent landscape indicates considerable competition and overlapping IP, emphasizing the importance of strategic patent management.
  • Ongoing international filings and patent family extensions bolster the patent’s enforceability but simultaneously expand the scope for infringement and validity challenges.
  • Innovators seeking to utilize similar technology should carefully evaluate claim scope and prior art to avoid infringement.
  • Continuous monitoring of legal developments, third-party filings, and market dynamics remains crucial to safeguarding and leveraging the patent’s value.

FAQs

1. What is the core innovation claimed in U.S. Patent 10,548,903?
The patent primarily claims a [specific composition, method, or device], characterized by [key features], designed to improve [e.g., efficacy, stability, delivery] within [application domain].

2. How robust are the claims against prior art?
While the claims are broad and supported by detailed embodiments, they face potential challenges from prior art disclosures that predate the filing date, particularly concerning [specific elements or ranges].

3. Can the patent landscape impact the enforceability of the '903 Patent?
Yes. Overlapping patents, especially in similar technological areas, can lead to invalidation arguments or licensing disputes, affecting the patent’s enforceability.

4. What strategies should companies employ to navigate this patent landscape?
Conduct thorough freedom-to-operate analyses, consider designing around key claims, and explore licensing opportunities where overlaps exist to mitigate infringement risks.

5. What future legal or market developments could influence the patent’s value?
Changes in patent laws, new intervening prior art, or shifts in industry standards may impact the patent’s validity and commercial utility, underscoring the need for ongoing IP management.


Sources Cited:

[1] USPTO Patent Full-Text and Image Database, Patent 10,548,903, December 10, 2019.
[2] Filed international applications and related patent families.
[3] Prior art references cited during prosecution.
[4] Market analysis reports on [specific application domain].

More… ↓

⤷  Get Started Free

Details for Patent 10,548,903

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 January 15, 1974 ⤷  Get Started Free 2037-06-19
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 December 27, 1984 ⤷  Get Started Free 2037-06-19
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 February 15, 1985 ⤷  Get Started Free 2037-06-19
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 February 16, 1990 ⤷  Get Started Free 2037-06-19
Bel-mar Laboratories, Inc. CHORIONIC GONADOTROPIN chorionic gonadotropin Injection 017054 March 26, 1974 ⤷  Get Started Free 2037-06-19
Ferring Pharmaceuticals Inc. A.P.L. chorionic gonadotropin For Injection 017055 December 13, 1974 ⤷  Get Started Free 2037-06-19
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.