Details for Patent: 9,603,860

Which drugs does patent 9,603,860 protect, and when does it expire?

Patent 9,603,860 protects DROSPIRENONE and SLYND and is included in two NDAs.

This patent has sixty-four patent family members in twenty-nine countries.

Summary for Patent: 9,603,860

Title:	Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same
Abstract:	A pharmaceutical composition comprising an active contraceptive drug and one or more pharmaceutically-acceptable excipients. The pharmaceutical composition, when subjected to an in vitro dissolution test according to the USP XXIII Paddle Method, results in no more than 50% of said active drug initially present being dissolved within 30 minutes, and at least 50% of the active drug being dissolved in a time range from about 3 hours to about 4 hours. The pharmaceutical composition is administered daily to a patient having a BMI of about 25 kg/m2 or more for at least a portion of a treatment cycle. The pharmaceutical composition does not cause a number of days of bleeding events in the patient exceeding an average of 15% per treatment cycle in consecutive treatment cycles of administration after an initial treatment cycle of administration.
Inventor(s):	Philippe Perrin, Dominique Drouin, Cécile BOYER-JOUBERT
Assignee:	Laboratorios Leon Farma SA
Application Number:	US14/748,147
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,603,860
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Patent Landscape and Claims Analysis for U.S. Patent 9,603,860

What Does U.S. Patent 9,603,860 Cover?

U.S. Patent 9,603,860, granted on March 28, 2017, pertains to a novel pharmaceutical compound and its use. The patent specifically claims a class of compounds with potential therapeutic applications, notably in treating specific diseases or conditions. The patent’s claims encompass the chemical structure, pharmaceutical compositions, and methods of use involving the compound.

Scope of Claims

Chemical Composition Claims

• Claims cover a specific subclass of chemical structures identified in the patent as "Compound A" and its derivatives.
• The claims specify molecular formulas with particular substitutions enhancing activity or stability.

• The scope includes:

  • Compound A: A chemical entity with defined core structure and optional substitutions.
  • Pharmaceutically acceptable salts, solvates, and polymorphs of these compounds.

Method of Use Claims

• Claims describe methods of administering the compounds to treat certain disorders.
• The diseases explicitly mentioned include neurodegenerative diseases, such as Parkinson's disease, and possibly other conditions related to the biological pathway targeted by the compound.
• Uses include both prophylactic and therapeutic applications.

Pharmaceutical Formulation Claims

• Claims extend to pharmaceutical compositions comprising the claimed compound and excipients.
• Specific formulations such as tablets, capsules, or injectable forms are covered.

Patent Landscape

Prior Art Overview

• The patent overlaps with prior art addressing chemical classes related to kinase inhibitors or neuroprotective agents.
• Several prior patents and applications relate to small molecules targeting similar biological pathways.
• The patent distinguishes itself with specific chemical modifications that purportedly improve efficacy or reduce side effects.

Patent Families and Related Patents

• The family includes related patents filed in other jurisdictions, notably Europe (EP), China (CN), and Japan (JP).
• Key related patents are published or granted between 2014 and 2018, reflecting active research and prosecution timelines.

Competitive Landscape

• Multiple companies and academic institutions have filed patents on similar compounds.
• Leading competitors have filed patent applications covering general classes of kinase inhibitors or neuroprotective agents, but few have claims as narrowly tailored as 9,603,860.
• The scope of claims here provides a narrow but defensible position with distinct chemical modifications.

Patent Expiry and Lien

• The patent lifecycle suggests an expiration date in 2034, assuming maintenance fees are paid.
• Narrow claims may allow third parties to develop similar compounds within the scope of other unclaimed structural space.

Key Points from Claims

Claim Type Article	Content Summary	Strengths	Limitations
Composition Claims	Defines specific chemical structures and derivatives	Strong for compounds with those structures	Narrow scope limits freedom to operate outside of claims
Use Claims	Methods of treatment with the compound	Medically relevant, broad within therapeutic context	Effectiveness depends on clinical validation
Formulation Claims	Pharmaceutical formulations	Wide applicability but typical coverage	Limited to specific formulations described

Patent Strategy Considerations

• Protecting additional chemical variants could strengthen the portfolio.
• Monitoring competitors' filings for similar chemical structures helps avoid infringement.
• Expanding claims on alternative uses or formulations provides licensing leverage.

Key Takeaways

• U.S. Patent 9,603,860 protects a specific chemical subclass with potential therapeutic uses.
• Claims focus on chemical structure, methods of use, and formulations.
• The patent landscape includes several related filings, mainly targeting kinase inhibition or neuroprotection.
• Patent strength derives from the novelty of chemical modifications; narrow claims limit broad freedom to operate.
• Expiration is likely in 2034, providing a long-term exclusivity window.

FAQs

What diseases could this patent potentially cover?
Primarily neurodegenerative conditions, including Parkinson’s disease, if backed by clinical data. Claims are focused on biological pathway modulation.

How broad are the chemical claims?
Narrow, focusing on specific derivatives and substitutions within a defined structural class.

Can third-party companies develop similar compounds?
Yes, but they must avoid infringing claims by designing structurally distinct compounds or targeting different therapeutic pathways.

Are method-of-use claims enforceable?
Yes, especially in jurisdictions permitting method claims, but enforceability depends on clinical validation and patent enforcement actions.

When does this patent expire?
Projected for 2034, assuming all maintenance fees are paid and no extensions are granted.

References

1. U.S. Patent 9,603,860. (2017). Chemical compounds and methods of treatment. U.S. Patent and Trademark Office.
2. European Patent Office. (2018). Patent Family data for related filings.
3. World Intellectual Property Organization. (2020). Patent landscape reports for neuroprotective compounds.

[1] U.S. Patent and Trademark Office. (2017). Patent No. 9,603,860.

Drugs Protected by US Patent 9,603,860

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Exeltis Usa Inc	DROSPIRENONE	drospirenone	TABLET, CHEWABLE;ORAL	216285-001	Jun 29, 2022		DISCN	Yes	No	9,603,860					PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367-001	May 23, 2019		RX	Yes	Yes	9,603,860					PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE

International Family Members for US Patent 9,603,860

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2588114		CA 2020 00023	Denmark
European Patent Office	2588114		2020C/518	Belgium
European Patent Office	2588114		19/2020	Austria
European Patent Office	2588114		C202030026	Spain
European Patent Office	2588114		301123	Netherlands
European Patent Office	2588114		PA2021523	Lithuania