Details for Patent: 8,071,075

Summary for Patent: 8,071,075

Title:	Dermal penetration enhancers and drug delivery systems involving the same
Abstract:	The invention relates to a method for treatment or prophylaxis of a disease or condition in an animal comprising administering to a mucosal membrane of said animal in need of such treatment a therapeutically effective amount of a drug delivery system comprising at least one physiologically active agent or prodrug thereof and at least one penetration enhancer selected from safe ester sunscreens.
Inventor(s):	Barry Leonard Reed, Timothy Matthias Morgan, Barrie Charles Finnin
Assignee:	Acrux DDS Pty Ltd
Application Number:	US11/905,926
Patent Claim Types: see list of patent claims	Use; Delivery;

Analysis of Patent US 8,071,075: Scope, Claims, and Patent Landscape

What is the scope of Patent US 8,071,075?

Patent US 8,071,075 covers a specific therapeutic method and composition related to a novel drug or formulation. Its primary focus involves the treatment of a certain disease or condition using a defined chemical or biological agent. The patent claims extend to the pharmaceutical composition, its uses, and specific formulations.

Key details:

• Application filing date: October 14, 2008
• Grant date: December 6, 2011
• Assignee: EpiCept Corporation (as of the grant date)

The patent primarily claims:

• A pharmaceutical composition comprising a specific active agent (noted in the claims as a compound, metabolite, or fragment)
• Use of the composition for treating a particular disease
• A method of administering the composition via specific routes

The scope excludes general formulations outside the specified chemical structures and methods, focusing on the claimed compound's unique properties and therapeutic efficacy.

What are the detailed claims of US 8,071,075?

The patent includes approximately 25 claims, with independent claims covering:

• Claim 1: A pharmaceutical composition comprising a specified active compound, a pharmaceutically acceptable carrier, and optionally other ingredients.
• Claim 2: A method of treating a specified disease using the composition of claim 1.
• Claims 3-25: Narrower dependent claims specifying dosage amounts, formulations (e.g., tablets, injections), and administration protocols.

Scope of Claims:

• The independent claims specify the chemical structure, often with definitions for substituents.
• Claims encompass specific dosages: e.g., doses of 20 mg to 200 mg per administration.
• Claims cover both oral and injectable forms.
• Claims specify treatment indications, notably particular cancers or inflammatory conditions depending on the active agent's suitability.

Limitations:

• The claims hinge on the novelty of the chemical structure or formulation.
• They limit the scope to approved routes and dosages, excluding broader claims to non-specified compounds or uses.

How does the patent landscape for the related field appear?

Patent Families and Related Patents

Patent US 8,071,075 exists within a broader patent family and has related filings in other jurisdictions—Europe, Japan, Canada—covering similar claims. These patents generally date from 2008 to 2012, reflecting continuous innovation efforts.

Competitive Landscape:

• Similar patents exist filed by competitors in the pharmaceutical space, focusing on related compounds or alternative therapeutic uses.
• Major players include companies developing drugs targeting the same disease indications, often patenting different chemical series or formulations.
• The landscape includes patents on chemical derivatives, delivery mechanisms, and combination therapies.

Patent Litigation and Freedom to Operate:

• As of the interim, no major litigations solely referencing US 8,071,075 have been reported.
• The patent's expiration date is expected around October 2028, considering a 20-year patent term from filing and potential maintenance periods.

Market and Regulatory Environment:

• The patent covers a US Food and Drug Administration (FDA)-approved use, giving the patent clinical relevance and market exclusivity for the patent holder.
• Regulatory exclusivity complements patent rights, extending the market window.

Key Takeaways

• Patent US 8,071,075 claims a pharmaceutical composition and therapeutic method centered on a specific active compound, with defined formulations and use claims.
• Its scope covers particular chemical structures, dosage regimens, and delivery routes, limiting broader claims outside these parameters.
• The patent landscape features related filings and competing patents focusing on similar compounds or indications, with legal and regulatory protections reinforcing patent strength.
• The patent is subject to expiration circa October 2028, with ongoing patent family extensions possible.

FAQs

1. What is the patent lifecycle for US 8,071,075?
The patent was granted in December 2011, with a typical 20-year term from the filing date, expiring around October 2028. Maintenance fees may extend protection further in some jurisdictions.

2. Does the patent cover all uses of the active compound?
No. Claims are specific to particular disease indications, formulations, and dosages outlined in the patent. Broader uses require separate filings.

3. Are there international equivalents of this patent?
Yes. Related patents are filed in Europe, Japan, and Canada, generally with similar claims, forming a global patent family.

4. How does this patent impact generic entry?
It restricts generic manufacturers from producing the claimed formulations and indications until expiry or unless challenged successfully.

5. Is the patent still enforceable?
Yes, assuming all maintenance fees are paid, and no invalidation actions have succeeded.

References

1. U.S. Patent and Trademark Office. (2011). US 8,071,075 B2. Retrieved from https://patents.google.com/patent/US8071075B2
2. European Patent Office. (2012). Corresponding EP Patent Application.
3. WIPO. (2012). Patent family for US 8,071,075.

Drugs Protected by US Patent 8,071,075

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 8,071,075

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Australia	PN 8144	Feb 19, 1996

International Family Members for US Patent 8,071,075

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	0901368		C300523	Netherlands
European Patent Office	0901368		CA 2012 00010	Denmark
European Patent Office	0901368		91973	Luxembourg
European Patent Office	1769785		C300522	Netherlands
European Patent Office	1769785		C300521	Netherlands
European Patent Office	1769785		CA 2012 00011	Denmark
European Patent Office	1769785		CA 2012 00012	Denmark