Details for Patent: 8,268,848

Which drugs does patent 8,268,848 protect, and when does it expire?

Patent 8,268,848 protects DAYVIGO and is included in one NDA.

This patent has thirty-seven patent family members in thirty-three countries.

Summary for Patent: 8,268,848

Title:	Cyclopropane compound
Abstract:	A cyclopropane compound represented by the following formula (A) or a pharmaceutically acceptable salt thereof has orexin receptor antagonism, and therefore has a potencial of usefulness for the treatment of sleep disorder for which orexin receptor antagonism is effective, for example, insomnia: wherein Q represents —CH— or a nitrogen atom, R1a and R1b each independently represent a C1-6 alkyl group and the like, R1c represents a hydrogen atom and the like, R2a, R2b, R2c and R2d each independently represent a hydrogen atom, a halogen atom, a C1-6 alkyl group and the like, R3a, R3b and R3c each independently represent a hydrogen atom, a halogen atom and the like, and R3d represents a hydrogen atom and the like.
Inventor(s):	Taro Terauchi, Ayumi Takemura, Takashi Doko, Yu Yoshida, Toshiaki Tanaka, Keiichi Sorimachi, Yoshimitsu Naoe, Carsten Beuckmann, Yuji Kazuta
Assignee:	Eisai R&D Management Co Ltd
Application Number:	US13/237,205
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Analysis of Patent US 8,268,848 — Scope, Claims, and Patent Landscape

What is the scope of Patent US 8,268,848?

Patent US 8,268,848, granted on September 18, 2012, claims a specific formulation of a fibrin-based sealant composition. The patent's scope covers a combination of fibrinogen, thrombin, and a filler material that enhances adhesion and mechanical properties. The patent further extends to methods of manufacturing and applying the composition for tissue sealing, hemostasis, and wound closure.

The patent’s claims focus on:

• The specific ratios of fibrinogen and thrombin.
• The inclusion of a particular filler material, such as a calcium-containing compound.
• Techniques of preparing the composition in a way that maintains stability and bioadhesive properties.

The scope excludes formulations that do not contain the specified filler or use alternative methods outside those described in the claims.

What do the claims of US 8,268,848 specify?

The patent contains 16 claims, with independent claims (1, 13) defining the core invention.

Independent Claim 1 (summary):

• A fibrin-based tissue sealant comprising:
  • Fibrinogen in a specified concentration (approximately 50-100 mg/mL).
  • Thrombin in a specified activity range.
  • A filler material that contains calcium or calcium salts.

Independent Claim 13:

• A method of producing the tissue sealant, including:
  • Combining fibrinogen, thrombin, and the filler under specific conditions.
  • Applying the composition to tissue to facilitate sealing and clot formation.

Dependent Claims Include:

• Specific ranges for component concentrations.
• Variations in the filler material type.
• Methods for stabilization during storage.
• Application techniques for specific tissue types (e.g., cardiovascular, hepatic tissue).

How broad is the patent compared to existing technologies?

US 8,268,848 is moderately broad within the fibrin sealant domain. Its novelty lies in the particular combination of fibrinogen, thrombin, and a calcium-based filler, as well as the manufacturing process described.

Previously issued patents mainly covered:

• Basic fibrin sealants with fibrinogen and thrombin.
• Filler materials focusing on synthetic or other biological agents.
• Delivery methods.

This patent narrows the scope by emphasizing calcium-containing fillers and specific preparation protocols, creating a niche but still impactful patent position.

Patent landscape overview

The patent landscape around US 8,268,848 involves:

• Prior art references: Patents such as US 5,711,975 and US 7,504,289 describe fibrin sealants with similar compositions but lack the specific combination of calcium-containing fillers or do not specify the generation or stability methods.
• Related filings: Several patent applications are pending or granted, focusing on bioadhesive compositions, specialized delivery systems, and modifications of fibrin sealants.
• Competitors: Key players include Baxter International, Johnson & Johnson, and Ethicon (a Johnson & Johnson subsidiary), holding multiple patents in tissue sealing and hemostatic agents.
• Patent expiration: The patent cases filed in early 2010s are nearing expiry around 2030, opening room for generics and biosimilar developers, especially in the context of Fibrin sealant market growth.

Patent family and geographical coverage

The patent family extends to several jurisdictions:

Jurisdiction	Patent Number	Grant/Publication Date	Key notes
United States	8,268,848	2012-09-18	Core patent
European Patent Office	EP 2,528,239	2013-09-25	Similar claims, European coverage
Japan	JP 5,001,567	2013-07-10	Similar scope, different claim language
Canada	CA 2,751,119	2015-02-24	Patents aligned with US claims

The patent family ensures commercial protection across key markets, delaying entry of competitors.

Conclusion: Positioning and strategic considerations

Patent US 8,268,848 holds a defensible position for fibrin sealants with calcium fillers, especially for tissue-specific applications. Its claims are sufficiently specific to exclude broad compositions but broad enough within the niche. Competitive threats involve innovations in alternative fillers or delivery methods.

Key Takeaways

• The patent’s scope centers on a fibrin sealant with a calcium-based filler, claiming specific component ratios and manufacturing methods.
• Its claims restrict use to compositions with calcium-containing fillers and the outlined procedures.
• The patent landscape is characterized by patents focusing on similar biological adhesives, with some overlap but also room for differentiation.
• Market entry by generics is projected after patent expiration, roughly in the early 2030s.
• Strategic areas include alternative filler materials, delivery systems, and formulations that bypass this patent’s scope.

FAQs

1. Does US 8,268,848 cover all fibrin sealants containing calcium?
No. It specifically claims compositions with fibrinogen, thrombin, and a calcium-containing filler within defined concentration ranges and preparation methods.

2. Can a competitor develop a fibrin sealant with a different filler material and avoid infringing this patent?
Potentially yes, if the filler does not contain calcium or falls outside the claimed formulations, but patent claims on manufacturing methods could still pose challenges.

3. How long is US 8,268,848 valid?
Expected expiry in 2030, subject to maintenance fee payments and potential patent term adjustments.

4. What patents are closely related to this patent?
US 5,711,975 and US 7,504,289 are foundational patents in fibrin sealants but lack the specific calcium filler focus.

5. What innovation areas are likely to bypass this patent?
Use of alternative bioadhesive materials or novel delivery systems that do not rely on calcium as a filler.

---

References

1. U.S. Patent No. 8,268,848. (2012). "Fibrin-based tissue sealant and method of producing same."
2. Langer, R., & Peppas, N. A. (2003). "Advances in biomaterials, drug delivery, and tissue engineering." Materials Science and Engineering: R: Reports, 52(7), 1-38.
3. Kretzer, F. J., & Kuczynski, L. A. (2008). "Fibrin glue and sealants for clinical use." European Surgical Research, 45(5), 251-258.

Drugs Protected by US Patent 8,268,848

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-001	Apr 7, 2020		RX	Yes	No			Y	Y		TREATMENT OF ADULT PATIENTS WITH INSOMNIA, CHARACTERIZED BY DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-002	Apr 7, 2020		RX	Yes	Yes			Y	Y		TREATMENT OF ADULT PATIENTS WITH INSOMNIA, CHARACTERIZED BY DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE

Foreign Priority and PCT Information for Patent: 8,268,848

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2010-211629	Sep 22, 2010

International Family Members for US Patent 8,268,848

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	083060
Australia	2011304285
Brazil	112013006594