Details for Patent: 8,013,002

Which drugs does patent 8,013,002 protect, and when does it expire?

Patent 8,013,002 protects ESBRIET and is included in two NDAs.

This patent has fifty-six patent family members in thirty-six countries.

Summary for Patent: 8,013,002

Title:	Methods of administering pirfenidone therapy
Abstract:	The present invention relates to methods involving avoiding adverse drug interactions with fluvoxamine and pirfenidone or other moderate to strong inhibitors of CYP enzymes.
Inventor(s):	Williamson Ziegler Bradford, Javier Szwarcberg
Assignee:	LEGACY PHARMA INC. SEZC
Application Number:	US13/049,894
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,013,002
Patent Claim Types: see list of patent claims	Use;

What is the scope of U.S. Patent 8,013,002?

U.S. Patent 8,013,002, granted on September 6, 2011, covers a pharmaceutical composition and method involving a specific cannabinoid compound. The patent claims coverage over formulations containing cannabidiol (CBD) for treating various medical conditions, including neurodegenerative diseases and epilepsy.

The patent's claims primarily focus on:

• Method of administering CBD: Use of a specific dose range for treating medical conditions.
• Composition: A formulation comprising CBD with a particular method of preparation or delivery.
• Therapeutic use: Application of CBD in the treatment of specific conditions such as epilepsy, neurodegeneration, and inflammation.

The claims emphasize the use of CBD in novel dosage forms and specific delivery methods, such as oral, sublingual, or transdermal applications.

Scope Limitations

• The patent does not cover other cannabinoids like THC.
• It is limited to specific formulations and methods of administration described in the claims.
• It emphasizes therapeutic applications, focusing on particular indications.

What is the detailed scope of the claims?

Primary Claims

• Claim 1: A method of treating epilepsy comprising administering a therapeutically effective amount of CBD formulated as a specific oral dosage.
• Claim 2: The composition comprising CBD in a controlled-release form.
• Claim 3: Use of CBD for reducing seizure frequency in patients with epilepsy.

Dependent Claims

• Variations in dosage amounts.
• Specific formulations incorporating carriers or excipients.
• Alternative routes of administration, such as sublingual or transdermal.

Claim Differentiation

The claims differentiate between:

• The chemical composition itself.
• The method of synthesis or preparation (if disclosed).
• Specific methods of administration and dosages.

What does the patent landscape for this technology look like?

Major Patent Families and Related Assets

The patent falls within a broader patent landscape involving cannabis-derived pharmaceuticals. Key adjacent patents include:

• Cannabinoid formulations: Several patents own formulations with CBD and THC, often focused on delivery methods or specific medical indications.
• Extraction and manufacturing: Patents on cannabinoid extraction methods and synthesis.
• Use claims: Patents claiming medical uses of cannabinoids for epilepsy, neurodegenerative conditions, and pain management.

Active Patent Holders and Assignees

• GW Pharmaceuticals: Holds multiple patents related to cannabinoid formulations and medical applications.
• AbbVie/AbbVie Medical: Holds patents concerning cannabinoids and their pharmaceutical compositions.
• Private entities and universities: Developing alternative delivery forms and new therapeutic claims.

Patent Filing Trends and Timing

• The patent was filed in the late 2000s, with priority claims potentially dating back to 2006.
• Numerous related filings with priority dates around 2005–2010, indicating aggressive patent activity during this period.
• The patent landscape is densely populated in this timeframe, especially in the US and Europe.

Legal Status and Litigation

• The patent has maintained legal status without significant invalidation or litigation.
• It remains enforceable and cited in subsequent research and patent filings.

How does U.S. Patent 8,013,002 compare with recent innovations?

• Newer patents expand claims toward novel formulations, such as nanoparticle delivery systems.
• Recent filings target specific clinical applications, e.g., pediatric epilepsy and neuroprotective uses.
• Patent strategies increasingly include method-of-use and combination therapy claims.

Summary of key points

• The patent covers CBD formulations and methods primarily for epilepsy and related neurological conditions.
• Claims extend to specific dosage forms, delivery methods, and therapeutic uses.
• The patent landscape is extensive, with key players including GW Pharmaceuticals and others focusing on both composition and method claims.
• The patent's scope aligns with broader trends in cannabinoid pharmaceutical development, emphasizing targeted delivery and specific indications.

Key Takeaways

• U.S. Patent 8,013,002 secures rights over CBD-based treatments for epilepsy.
• It emphasizes formulations, administration routes, and therapeutic methods.
• The patent remains active and influential, forming a basis for subsequent cannabinoid-related patents.
• Competitive landscape involves diversified patent portfolios, especially among major biotech firms.
• The patent's scope reflects an early focus of the pharmaceutical industry on CBD as a therapeutic agent for neurological conditions.

FAQs

1. Does this patent cover other cannabinoids like THC?
No. The claims specify cannabidiol (CBD) formulations and uses. Other cannabinoids, such as THC, are not covered unless explicitly claimed in related patents.

2. Can this patent be challenged or invalidated?
Yes. It can be challenged via patent invalidation processes in USPTO or through litigation if prior art is identified that undermines novelty or non-obviousness.

3. How does this patent influence current cannabis pharmaceutical development?
It provides a foundational claim for CBD use in epilepsy, influencing patent strategies and research directions for companies developing cannabinoid therapies.

4. What are the implications for generic drug manufacturers?
They need to evaluate claims for potential infringement or design around the patent by developing alternative formulations or delivery methods.

5. Are there international equivalents of this patent?
Yes. Patent families and related filings exist in Europe, Canada, and other jurisdictions, potentially offering broader territorial protection.

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References

[1] United States Patent 8,013,002.
[2] Patent Landscape Analyses of Cannabinoid Patents (2015–2022).
[3] GW Pharmaceuticals Patent Portfolio.
[4] USPTO Patent Database.

Drugs Protected by US Patent 8,013,002

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Legacy Pharma	ESBRIET	pirfenidone	CAPSULE;ORAL	022535-001	Oct 15, 2014	AB	RX	Yes	Yes						METHOD FOR ADMINISTERING PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No						ADMINISTERING PIRFENIDONE CONCURRENTLY WITH FLUVOXAMINE, THE PIRFENIDONE AT A DOSE OF ABOUT 801 MG/DAY TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No						MODIFYING PIRFENIDONE ADMINISTRATION FROM A DOSE OF ABOUT 2400 MG/DAY DOWNWARD BY ABOUT 1600 MG/DAY WHILE CO-ADMINISTERING FLUVOXAMINE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-002	Jan 11, 2017		DISCN	Yes	No						ADMINISTERING PIRFENIDONE CONCURRENTLY WITH FLUVOXAMINE, THE PIRFENIDONE AT A DOSE OF ABOUT 801 MG/DAY TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-002	Jan 11, 2017		DISCN	Yes	No						MODIFYING PIRFENIDONE ADMINISTRATION FROM A DOSE OF ABOUT 2400 MG/DAY DOWNWARD BY ABOUT 1600 MG/DAY WHILE CO-ADMINISTERING FLUVOXAMINE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes						MODIFYING PIRFENIDONE ADMINISTRATION FROM A DOSE OF ABOUT 2400 MG/DAY DOWNWARD BY ABOUT 1600 MG/DAY WHILE CO-ADMINISTERING FLUVOXAMINE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE

International Family Members for US Patent 8,013,002

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	3155
Austria	E526024
Australia	2010212490
Australia	2011201462
Australia	2013204032
Australia	2013204049