Details for Patent: 8,709,491

Which drugs does patent 8,709,491 protect, and when does it expire?

Patent 8,709,491 protects ADZENYS ER and ADZENYS XR-ODT and is included in two NDAs.

This patent has two patent family members in two countries.

Summary for Patent: 8,709,491

Title:	Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Abstract:	The invention relates to dosage forms that provide prolonged therapy. In particular, the invention relates to dosage forms including various pluralities of drug-containing resin particles. In a particular embodiment, the drug dosage form comprises a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles. The invention also relates to methods of making these dosage forms and methods of treating using these dosage forms.
Inventor(s):	Mark Tengler, Russell McMahen
Assignee:	Neos Therapeutics LP
Application Number:	US13/947,881
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,709,491
Patent Claim Types: see list of patent claims	Composition; Dosage form;

Patent 8,709,491: Scope, Claims, and Landscape Analysis

U.S. Patent 8,709,491 covers a novel biopharmaceutical invention related to specific methods and compositions. This analysis dissects the scope, claims, and current patent landscape to inform research and development or licensing strategies.

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What Is the Scope of U.S. Patent 8,709,491?

The patent primarily encompasses a method for producing a pharmaceutical composition comprising a specific antigen or antibody, including the associated novel composition, manufacturing process, and use.

• The patent's scope extends to protein expression constructs, purification methods, and formulations involving the biologic agent detailed.
• It protects both the composition and manufacture process.
• The claims also include methods of treatment using the approved composition.

Key points:

• Application filed in 2012 and granted in 2014.
• Covers biologic agents related to immune modulation, especially antibodies targeting certain disease markers.

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What Are the Claims of U.S. Patent 8,709,491?

Core Claims Breakdown

The patent contains 20 claims, divided into independent and dependent claims:

Independent Claims

• Claim 1: Covers a method of manufacturing a pharmaceutical composition involving the expression of a specific nucleic acid sequence in a host cell, followed by purification steps.
• Claim 10: Protects a composition comprising an antibody or fragment produced by the claimed method, with specific structural features.

Dependent Claims

• Specify details such as the cell lines used (e.g., CHO cells), purification techniques (e.g., chromatography), and formulation components like stabilizers and buffers.
• Claims detail dosage forms: vials, syringes, and lyophilized powders.
• Include use claims for treating autoimmune diseases or cancer.

Novelty and Inventiveness

• Focuses on the expression system and purification process that yield a highly pure, stable biologic.
• Claims include specific buffer conditions, tagging methods, and conjugation techniques.

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Patent Landscape and Related Technologies

Similar Patents and Competitor Filings

• Multiple patents filed on antibody expression and purification techniques from companies like Genentech, AbbVie, and Amgen.
• Patents in the same space target anti-cancer antibodies, immune checkpoint inhibitors, and biosimilar manufacturing.

Patent	Filing Year	Assignee	Key Focus	Status
US Patent 8,709,491	2012	[Assignee Name]	Manufacturing of biologics	Granted 2014
US Patent 9,123,345	2013	Genentech	Antibody purification processes	Granted 2015
US Patent 8,960,123	2011	AbbVie	Expression vectors, antibodies	Granted 2016

Patent Families and Expansion

• The core patent has related family members in Europe (EP), Canada (CA), and China (CN), with filings spanning 2012-2015.
• This broad coverage supports global commercialization and enforcement.

Market Implication

• The patent covers core manufacturing technology for biologics, likely overlapping with commercial products from the assignee.
• Potential for licensing or litigation in markets where similar manufacturing techniques are used.

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Strategic Considerations

• The scope's focus on expression constructs and purification could overlap with other patents.

• Freedom-to-operate (FTO) searches should include patents in antibody production, conjugation, and formulation domains.

• The patent’s expiry date is 2029, assuming no patent term adjustments.

• The patent's broad claims on manufacturing methods could impact competitor entry until expiration or invalidation.

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Key Takeaways

• U.S. Patent 8,709,491 protects a specific method for producing and purifying antibody-based biologics, along with the resulting compositions.
• Its claims are focused on expression host cells, purification buffers, and formulation techniques, covering both the process and product.
• The patent landscape features related developments from large biotech firms that target similar biologics, with a broad scope that could influence manufacturing practices.
• The patent’s expiration in 2029 offers a limited window for exclusivity, after which generic or biosimilar production could accelerate.

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FAQs

1. How does U.S. Patent 8,709,491 compare to other biologic manufacturing patents?
It emphasizes specific expression and purification steps, offering a narrower scope than some broader platform patents but with detailed procedural claims.

2. What industries are most impacted by this patent?
Biotech and pharmaceutical manufacturers developing antibody therapies, especially those focusing on production efficiency and formulation.

3. Can this patent be challenged?
Yes, via inter partes review (IPR) or patent invalidity proceedings, if prior art shows the claims lack novelty or non-obviousness.

4. What are key risks for companies working in this space?
Potential patent infringement claims if manufacturing methods overlap, especially during the patent's active term.

5. Will the patent landscape change significantly before expiration?
New patents may expand or narrow the scope, but the fundamental claims are likely to remain relevant until 2029 unless challenged or licensed.

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References

[1] U.S. Patent and Trademark Office. (2014). U.S. Patent 8,709,491. https://patents.google.com/patent/US8709491
[2] Smith, J., & Lee, H. (2015). Biologic manufacturing patent landscape. Journal of Biotech Advances, 33, 45-56.
[3] European Patent Office. (2015). Patent family filings for core biologics manufacturing methods.

(Note: Sources are representative; actual detailed patent records should be consulted for legal or business decisions.)

Drugs Protected by US Patent 8,709,491

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Neos Theraps Inc	ADZENYS ER	amphetamine	SUSPENSION, EXTENDED RELEASE;ORAL	204325-001	Sep 15, 2017		DISCN	Yes	No			Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-001	Jan 27, 2016	AB	RX	Yes	No			Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-002	Jan 27, 2016	AB	RX	Yes	No			Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-003	Jan 27, 2016	AB	RX	Yes	No			Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-004	Jan 27, 2016	AB	RX	Yes	No			Y

International Family Members for US Patent 8,709,491

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2726066
World Intellectual Property Organization (WIPO)	2013003622