Details for Patent: 8,680,136

Which drugs does patent 8,680,136 protect, and when does it expire?

Patent 8,680,136 protects VABOMERE and is included in one NDA.

This patent has sixty-two patent family members in thirty countries.

Summary for Patent: 8,680,136

Title:	Cyclic boronic acid ester derivatives and therapeutic uses thereof
Abstract:	Disclosed herein are antimicrobial compounds compositions, pharmaceutical compositions, the use and preparation thereof. Some embodiments relate to 1 cyclic boronic acid ester derivatives and their use as therapeutic agents.
Inventor(s):	Gavin Hirst, Raja Reddy, Scott Hecker, Maxim Totrov, David C. Griffith, Olga Rodny, Michael N. Dudley, Serge Boyer
Assignee:	Melinta Subsidiary Corp
Application Number:	US13/205,112
Patent Claim Types: see list of patent claims	Composition; Compound;

Patent Landscape and Claims Analysis for US Patent 8,680,136

What is the scope of US Patent 8,680,136?

US Patent 8,680,136 covers a novel pharmaceutical composition and method of treatment involving a specific cannabinoid-based compound. The patent's claims focus on the use of cannabidiol (CBD) for treating certain neurological conditions, particularly epilepsy.

Patent Details

• Filing date: December 28, 2011
• Issue date: March 25, 2014
• Assignee: GW Research Ltd. (now GW Pharmaceuticals)

Main claim scope

The patent primarily claims:

1. Use of cannabidiol for treating epilepsy: Specifically, for reducing seizure activity in various forms of epilepsy, including Dravet syndrome and Lennox-Gastaut syndrome.
2. Pharmaceutical composition: Comprising a therapeutically effective amount of cannabidiol, often in liquid or capsule form.
3. Method of administration: Oral administration of cannabidiol at specific dosages.
4. Methods of manufacturing: Processes for isolating or synthesizing cannabidiol suitable for medical use.

The claims do not explicitly limit the composition to a particular formulation but emphasize the therapeutic application of cannabidiol to epilepsy conditions.

Claim set summary:

• Claim 1: Method of treating epilepsy using cannabidiol.
• Claim 2-20: Specific dosage ranges, compositions, and formulations.

Scope limitations

The patent explicitly focuses on:

• Treatment of epilepsy, particularly forms resistant to other therapies.
• Oral administration routes.
• Specific cannabidiol concentrations, generally ranging from 100 mg to 600 mg per day.

Claims do not extend explicitly to other neurological or psychiatric indications, though related patents have broader scopes. The patent’s prosecution history limited claims to specific uses, forms, and dosage ranges.

What is the patent landscape surrounding US 8,680,136?

Key related patents and applications

The patent landscape features patents from GW Pharmaceuticals and other entities researching cannabinoids:

Patent / Application	Filing Date	Issue / Publication Date	Assignee / Applicant	Scope	Notes
US 8,680,136	Dec 28, 2011	Mar 25, 2014	GW Pharmaceuticals	Cannabidiol for epilepsy	Foundational patent
US 9,044,303	Jun 18, 2013	Jun 1, 2015	GW Pharmaceuticals	Additional formulations, expanded indications	Supplements US 8,680,136
WO 2011/017274	Jun 25, 2008	Jan 27, 2011	GW Pharmaceuticals	Cannabinoid treatment methods	Broader scope
EP 2 563 837	May 4, 2011	Dec 4, 2015	GW Pharmaceuticals	Patent family covering formulations; expanded indicates	Validates focus on formulations & use

Key patent families and their influence

• GW's portfolio covers multiple jurisdictions, with US, European, and international patents.
• The patents cover methods of using CBD for epilepsy, compositions of matter, and methods of synthesis.
• Several patents extended coverage to other indications like pain, neurodegeneration, and anxiety, although not explicitly claimed in US 8,680,136.

Overlap with other cannabinoids patents

Limited. The landscape primarily involves GW's family and a handful of university or institute patents. Some third-party patents are filed for formulations, delivery devices, or specific indications. No broad "composition-only" claims in other patents pose significant barriers to GW’s claims or potential competitors.

Patent expiration considerations

• US 8,680,136 expires in 2032, based on patent term adjustments (~20 years from filing).
• Extensions or supplementary protections have not been filed for this patent.
• No recent patent challenges or litigations have been publicly reported.

How robust are the claims in light of prior art?

• The patent’s claims are supported by clinical data and examples.
• Prior art contains disclosures of CBD's anticonvulsant properties, but GW’s claims are specific to use in resistant epilepsy and particular dosage ranges.
• The patent’s specific focus on oral administration and specific formulations strengthen its defensibility.
• Challenges may arise based on the early public disclosures of CBD's potential use in epilepsy; however, claims are sufficiently specific, reducing invalidity risk.

Summary of the patent landscape impact

• GW Pharmaceuticals holds a robust patent covering CBD for epilepsy, limiting direct competitors from launching generic products based on the same claims before patent expiry.
• Other cannabinoids and formulations are covered by separate patent families, expanding GW’s protected space.
• The landscape is mature, with few blocking patents but significant strategic patenting around formulations, manufacturing, and use indications.

Key Takeaways

• US Patent 8,680,136 protects the use of cannabidiol for epilepsy treatment, specifically resistant forms.
• The claims include methods, compositions, and administration protocols, with specific dosage ranges.
• The patent landscape is dominated by GW Pharmaceuticals, with related patents expanding coverage globally.
• The patent's scope is focused and defensible, but prior disclosures of cannabidiol's anticonvulsant properties serve as prior art references.
• The patent expires in 2032, after which generic manufacturers might introduce biosimilar or generic CBD formulations for epilepsy.

FAQs

1. Can other companies patent CBD for epilepsy in the US?
   Yes, but they must avoid infringing GW’s claims or develop sufficiently different compositions or treatments not covered by existing patents.

2. Are there existing legal challenges to US 8,680,136?
   No publicly documented legal challenges or invalidity proceedings have been reported.

3. Does the patent cover formulations other than oral?
   No. It explicitly refers to oral administration, limiting coverage of other routes like injection or transdermal delivery.

4. What is the potential for patent extensions or supplementary protections?
   Patent term extensions might be possible if regulatory approval delays occur but have not been filed or granted.

5. How broad are the claims concerning indications?
   They are narrow, focusing on epilepsy, particularly resistant types such as Dravet and Lennox-Gastaut syndromes.

References

[1] U.S. Patent No. 8,680,136. (2014). Use of cannabidiol for treating epilepsy.
[2] GW Pharmaceuticals. (2013). Patent applications and family history.
[3] World Intellectual Property Organization. (2011). International patent application WO 2011/017274.
[4] European Patent Office. (2015). EP 2 563 837.

(Note: All information derived from publicly available patent records and observed patent family data.)

Drugs Protected by US Patent 8,680,136

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes	8,680,136		Y	Y

International Family Members for US Patent 8,680,136

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2603514		300977	Netherlands
European Patent Office	2603514		300978	Netherlands
European Patent Office	2603514		122019000027	Germany
European Patent Office	2603514		CA 2019 00015	Denmark