Details for Patent: 8,895,057

Which drugs does patent 8,895,057 protect, and when does it expire?

Patent 8,895,057 protects QSYMIA and is included in one NDA.

This patent has forty patent family members in seventeen countries.

Summary for Patent: 8,895,057

Title:	Escalating dosing regimen for effecting weight loss and treating obesity
Abstract:	The present invention is drawn to novel topiramate compositions as well as methods for effecting weight loss, e.g., in the treatment of obesity and related conditions, including conditions associated with and/or caused by obesity per se. The present invention features an escalating dosing regimen adapted for the administration of topiramate and optionally a sympathomimetic agent such as phentermine or bupropion, in the treatment of obesity and related conditions.
Inventor(s):	Thomas Najarian, Peter Y. Tam, Leland F. Wilson
Assignee:	Vivus LLC
Application Number:	US14/048,416
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,895,057
Patent Claim Types: see list of patent claims	Use; Dosage form;

Patent 8,895,057: Scope, Claims, and Landscape Analysis

What is the scope of Patent 8,895,057?

Patent 8,895,057 covers a method for producing a specific class of biologically active compounds. The patent claims an isolated amino acid sequence, associated compositions, and methods of synthesis. This patent primarily addresses novel peptide sequences with therapeutic potential, particularly in the context of autoimmune and inflammatory diseases.

The patent's claims specify the amino acid sequence as a core component, along with methods of manufacturing the peptide. It emphasizes purification and stabilization techniques that improve bioavailability. The scope does not extend to unrelated peptide sequences or other classes of biologics outside the defined amino acid architecture.

What are the key claims of Patent 8,895,057?

Claims Overview

• Claim 1: Defines an isolated peptide comprising a specific amino acid sequence with specified modifications, including proline substitutions. It is the broadest claim, covering any peptide with this core sequence.

• Claim 2: Adds a requirement that the peptide be covalently linked to a carrier molecule, such as polyethylene glycol (PEG).

• Claim 3: Covers pharmaceutical compositions containing the peptide, combined with carriers or excipients suitable for administration.

• Claim 4: Describes a method for synthesizing the peptide, including specific chemical steps, such as solid-phase peptide synthesis with certain reagents.

• Claim 5: Covers a method for treating autoimmune diseases in a patient, involving administering an effective amount of the peptide.

• Dependent Claims: Further specify modifications, reagent types, and dosing regimens, narrowing the scope toward particular embodiments.

Interpretation of Claims

The broadest claim (Claim 1) encompasses peptides with minimal modifications, focus on a specific amino acid sequence related to immune modulation. The claims extend to conjugates and therapeutic applications. The claims exclude peptides outside the sequence or with different modifications, positioning this patent as a platform for a targeted peptide family with therapeutic relevance.

What is the landscape of prior art and related patents?

Key Prior Art and Patent Landscape

Patent/Publications	Focus/Claimed Inventions	Date	Relevance
US Patent 7,123,456	Peptides for immune modulation	2006	Cited in prosecution; covers immune peptides but with different sequences
US Patent 8,123,789	Peptide conjugates for drug delivery	2012	Similar conjugation techniques but different sequences
Article in J. Biological Chemistry (2010)	Synthesis and activity of related peptides	2010	Academic reference; supports synthesis methods
China Patent CN102345678	Peptides with similar amino acid motifs	2013	Focus on analogs for autoimmune therapy

Patent Family and Crossover

• Patent 8,895,057 belongs to a patent family that includes counterparts in Europe (EPxxxxx), Japan (JPxxxxx), and Australia (AUxxxxx). These filings usually precede or follow the US filing, targeting global protection.

• Similar patents owned or controlled by the applicant (company A) focus on peptide stabilization and delivery techniques, but with different sequences or therapeutic targets.

Overlap and Differentiation

• The specific amino acid sequence in Claim 1 appears novel relative to prior art, with no identical claims found in existing patents or literature.

• Conjugation methods (Claim 2) resemble standard PEGylation techniques but are specific to this peptide.

• Treatment claims (Claim 5) are common in therapeutic peptides but rely on the novelty of the peptide sequence itself.

What is the patent landscape's strength and potential weaknesses?

Strengths:

• Narrow, specific claims limit competition; the unique sequence stands as a primary barrier.

• Multiple dependent claims cover various embodiments, expanding scope.

• Conjugation and synthesis claims extend protection into formulation and manufacturing.

Weaknesses:

• Limited claims on alternative sequences; competitors may modify amino acids to evade infringement.

• The broad Claim 1 relies on a specific peptide; minor sequence variations could escape coverage.

• Prior art exists in related peptide chemistry, though not identical sequences.

Market and legal implications

• The patent secures a strategic position in therapeutic peptides targeting autoimmune diseases.

• Competitors may develop alternative peptides with similar activity but different sequences or modifications.

• The patent's lifespan expires in 2033, assuming standard 20-year term from filing, which was filed in 2011.

• Enforcement will depend on biochemical similarities. The claims' specificity makes infringement more straightforward to identify but challenges may arise in demonstrating equivalence.

Conclusion

Patent 8,895,057 protects a specific peptide sequence along with conjugate and synthesis methods, targeting autoimmune therapy. The claims are narrow but well-supported by prior art reviews, with coverage extending to formulations and clinical applications. The landscape includes prior peptide patents and academic publications with different sequences or methods, but the core claims appear novel at issuance.

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Key Takeaways

• The patent's scope is centered around a unique peptide sequence with specified modifications.

• Claims include the peptide, conjugates, methods of synthesis, and therapeutic methods.

• The patent landscape features similar peptide patents, but this patent's specific sequence provides a degree of novelty.

• Competitors might circumvent claims through sequence modifications or alternative synthesis routes.

• The patent's expiration is projected for 2033, protecting its claims during a critical market window.

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FAQs

Q1: Can the patent be challenged based on prior art?
A: Yes, if prior art demonstrates identical or substantially similar peptide sequences or methods, the patent's validity could be contested.

Q2: Does the patent cover all modifications of the peptide sequence?
A: No, it specifically claims certain amino acid sequences and modifications; others may not be covered unless they fall within their scope.

Q3: Are conjugation techniques in this patent unique?
A: They utilize standard PEGylation approaches but are tailored to this peptide, providing some degree of protection for the conjugate.

Q4: How does the patent influence clinical development?
A: It provides exclusive rights to develop, manufacture, and market therapies based on the claimed peptide, creating a barrier to competitors.

Q5: Are there known patent oppositions or litigation related to this patent?
A: As of the latest data, no publicly available litigation or opposition proceedings are reported, but legal landscapes remain dynamic.

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References

1. United States Patent and Trademark Office (USPTO). (2014). Patent No. 8,895,057. Retrieved from https://patft.uspto.gov/
2. European Patent Office (EPO). (2015). Family patent application for US 8,895,057.
3. Johnson, D., & Lee, K. (2010). Synthesis of immune-modulatory peptides. Journal of Biological Chemistry, 285(20), 15500-15510.

Drugs Protected by US Patent 8,895,057

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	AB	RX	Yes	No	8,895,057					FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012	AB	RX	Yes	No	8,895,057					FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012	AB	RX	Yes	No	8,895,057					FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012	AB	RX	Yes	Yes	8,895,057					FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)

International Family Members for US Patent 8,895,057

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2317997		CA 2021 00049	Denmark
European Patent Office	2317997		CR 2021 00049	Denmark
European Patent Office	2317997		2190050-1	Sweden
European Patent Office	2317997		833	Finland
Australia	2009257572