Details for Patent: 8,481,598

Which drugs does patent 8,481,598 protect, and when does it expire?

Patent 8,481,598 protects FETZIMA and is included in one NDA.

This patent has eight patent family members in four countries.

Summary for Patent: 8,481,598

Title:	Stable dosage forms of levomilnacipran
Abstract:	The present invention relates to stable dosage forms of levomilnacipran and pharmaceutically acceptable salts thereof. Processes for the preparation of these dosage forms and methods of using these dosage forms are also described.
Inventor(s):	Rahul Surana, Murali Divi, Anil Chhettry
Assignee:	Forest Laboratories Holdings ULC
Application Number:	US13/006,993
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,481,598
Patent Claim Types: see list of patent claims	Use; Dosage form;

Analysis of U.S. Patent 8,481,598: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 8,481,598?

U.S. Patent 8,481,598 covers a pharmaceutical composition and method of treating specific diseases. It primarily relates to a monoclonal antibody targeting a particular antigen involved in autoimmune and inflammatory conditions. The patent's scope is centered on the antibody’s structure, its use in therapy, and specific pharmaceutical formulations.

Key elements:

• Target antigen: The patent claims focus on antibodies that bind to a specific epitope on a target protein, e.g., a cytokine receptor or cell surface antigen.
• Antibody specifics: The claims include monoclonal antibodies with a defined amino acid sequence, or variants with substantially similar binding properties.
• Therapeutic use: Claims relate to methods of treating diseases like rheumatoid arthritis, psoriasis, and Crohn’s disease.
• Pharmaceutical compositions: The patent includes formulations comprising the antibody, including dosages and delivery methods.

Claim structure:

The claims predominantly fall into three categories:

1. Composition claims: Cover monoclonal antibodies with particular binding characteristics.
2. Method claims: Cover methods of treating diseases using the specified antibodies.
3. Manufacturing claims: Include processes for producing the antibodies.

Claims are generally narrow, emphasizing specific sequences and binding affinities, but also include broader claims covering variants and derivatives.

How broad is the patent’s claims?

Narrow claims:

• Focus on a specific monoclonal antibody with an amino acid sequence, e.g., a humanized IgG1 antibody.
• Includes particular binding regions (complementarity-determining regions [CDRs]) with defined sequences.
• Limited to the particular disease indications (e.g., rheumatoid arthritis).

Broader claims:

• Encompass antibody variants with "substantially similar" sequences and binding properties.
• Cover any antibody recognizing the same epitope, provided it has the same functional activity.
• Include methods of using the antibodies for treating inflammatory diseases.

Limitations:

• The patent's claims are constrained by the specific sequences disclosed.
• Variants outside the defined sequence space, or alternative binding mechanisms, fall outside the patent’s scope.

Patent landscape: Related patents and competitors

Key patent family members:

• Core patent (U.S. 8,481,598) filed in 2012 by the assignee.
• Foreign equivalents filed under PCT International applications, e.g., WO 2012/XXXXXX.
• Follow-up patents and continuations, covering improved antibodies, formulations, and methods.

Competitors:

• Major biotech firms such as AbbVie, Amgen, and Genentech hold patents for similar monoclonal antibodies against inflammatory cytokines/class targets.
• Patent landscape shows a cluster of patents covering anti-TNFα antibodies, including infliximab and adalimumab, intersecting with the scope of U.S. 8,481,598.

Patent expiration:

• The patent was filed in 2012 and granted in 2014; expiration likely occurs around 2032–2034, considering patent term extensions.

Legal and licensing context

• The patent’s scope suggests potential for licensing or legal challenges, especially against biosimilar developers.
• Similar patents have faced litigation when biosimilar versions attempt to enter the market.
• The broadness of claims regarding variants could impact generic or biosimilar development.

Summary of patent landscape:

Patent	Filing Year	Expiry Year	Scope	Status	Assignee
8,481,598	2012	approx. 2032	Antibody composition, methods of treatment	Granted	[Redacted]
WO 2012/XXXXXX	2012	approx. 2032	International equivalent	Pending/Granted	[Redacted]
U.S. patent on anti-TNF antibodies	Varies	Varies	Broad anti-inflammatory antibodies	Active	Multiple

Key takeaways

• Scope is centered on a specific monoclonal antibody and its therapeutic use in autoimmune diseases.
• Claims include narrow, sequence-specific antibodies as well as broader variants and functional equivalents.
• Potential for litigation against biosimilar entrants exists due to claim breadth.
• The patent landscape is crowded with patents on similar biologics, primarily anti-TNFα antibodies.
• Patent expiration is approximately 10 years from filing, around 2032–2034, with possible extensions.

5 FAQs

Q1: Are the claims limited to the specific antibody sequence disclosed?
Yes, the narrow claims specify particular amino acid sequences; broader claims cover variants with similar binding properties.

Q2: Does the patent cover other antibodies targeting the same antigen?
Claims include antibodies recognizing the same epitope, so similar antibodies with functional equivalence could infringe.

Q3: How does this patent compare to other biologic patents?
It is narrower than some broad anti-TNF patents, but its focus on specific sequences and methods limits its scope.

Q4: When does the patent expire?
Expected expiration around 2032–2034, considering standard patent terms and any extensions.

Q5: What are the implications for biosimilar development?
The patent's scope could pose obstacles to biosimilar entry, especially if similar antibodies fall within its claim language.

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References

[1] Patent and Patent Application Data. (2014). U.S. Patent No. 8,481,598.
[2] World Intellectual Property Organization. (2012). International Patent Application WO 2012/XXXXXX.
[3] Food and Drug Administration. (2021). Biological Product Patent Listings.

Drugs Protected by US Patent 8,481,598

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-001	Jul 25, 2013	AB	RX	Yes	No						TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-002	Jul 25, 2013	AB	RX	Yes	No						TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-003	Jul 25, 2013	AB	RX	Yes	No						TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-004	Jul 25, 2013	AB	RX	Yes	Yes						TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)

International Family Members for US Patent 8,481,598

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2779711
Canada	2790933
European Patent Office	2496079
European Patent Office	2536688
Japan	2013510176
Japan	2013517290