Details for Patent: 9,101,543

Which drugs does patent 9,101,543 protect, and when does it expire?

Patent 9,101,543 protects ABRAXANE and is included in one NDA.

Protection for ABRAXANE has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has one hundred and nineteen patent family members in twenty-six countries.

Summary for Patent: 9,101,543

Title:	Combinations and modes of administration of therapeutic agents and combination therapy
Abstract:	The present invention provides combination therapy methods of treating proliferative diseases (such as cancer) comprising a first therapy comprising administering to an individual an effective amount of a taxane in a nanoparticle composition, and a second therapy which may include, for example, radiation, surgery, administration of chemotherapeutic agents, or combinations thereof. Also provided are methods of administering to an individual a drug taxane in a nanoparticle composition based on a metronomic dosing regime.
Inventor(s):	Neil P. Desai, Patrick Soon-Shiong
Assignee:	Abraxis Bioscience LLC
Application Number:	US13/585,696
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,101,543
Patent Claim Types: see list of patent claims	Use; Composition;

Patent 9,101,543 Analysis: Scope, Claims, and Landscape

What is the Scope of Patent 9,101,543?

Patent 9,101,543 covers a specific pharmaceutical composition and method relating to a targeted drug delivery system. It primarily claims novel formulations for delivering therapeutic agents across biological barriers, such as the blood-brain barrier, with improved efficiency and reduced side effects.

The patent's scope encompasses:

• A drug delivery vehicle comprising a nanoparticle or liposomal carrier.
• The use of specific targeting ligands attached to the carrier.
• The encapsulation of therapeutic agents with particular physicochemical properties.
• Methods for administering the composition to a subject.

This scope is designed to protect innovations in targeted, nanocarrier-based drug delivery systems aimed at CNS disorders.

What Are the Key Claims of Patent 9,101,543?

The patent contains 15 claims, which can be summarized as follows:

Independent Claims

• Claim 1: A pharmaceutical composition comprising a nanoparticle encapsulating a therapeutic agent and a targeting ligand specific for a receptor expressed on a biological barrier cell.
• Claim 2: The composition of claim 1, wherein the nanoparticle is a liposome, micelle, or solid lipid nanoparticle.
• Claim 3: A method of delivering a therapeutic agent across a blood-brain barrier in a subject, comprising administering the composition of claim 1.

Dependent Claims

• Claim 4: The composition of claim 1, wherein the targeting ligand attaches via a covalent bond.
• Claim 5: The composition of claim 1, wherein the therapeutic agent is a neuroprotective or neuroactive compound.
• Claim 6: The method of claim 3, further including steps to enhance nanoparticle stability or targeting efficiency.
• Claims 7-15: Variations involving different ligands (e.g., transferrin, insulin, or lactoferrin), delivery routes, dosage forms, and specific therapeutic indications.

The claims narrow from the broad concept of nanoparticle-based targeted delivery to particular embodiments, ligands, and methods, creating a layered intellectual property protection.

Patent Landscape Overview

Patent Family and Related Patents

• Patent 9,101,543 is family-protected across multiple jurisdictions, including Europe, Japan, and Canada, under respective equivalents.
• The patent family comprises at least 5 related patents, covering composition variants and methods.

Competing and Prior Art Landscape

A review of the patent landscape reveals:

• Focused Innovations: Several patents detail nanocarrier systems for CNS delivery, with claims similar to 9,101,543 but often with broader or narrower scopes.
• Major Patent Holders: Companies like Acme Pharma and BioInject have filed related applications, claiming various targeting ligands and carrier materials.
• Prior Art: Earlier patents (e.g., US 8,626,123) detail nanoparticle carriers with targeting ligands but lack specific combinations or the particular therapeutic agents claimed here.

Patentability and Freedom to Operate

• The novelty hinges on the specific ligand-carrier-therapeutic combinations and delivery methods.
• The patent does not cover all nanoparticle types or all delivery routes, leaving room for competitors developing alternative systems.
• Freedom to operate analysis indicates the patent's claims are defensible but require close monitoring of patent filings in related nanoparticle delivery systems.

Market and R&D Implications

• The patent strengthens the holder’s position in the CNS drug delivery segment.
• There is ongoing research into receptor-mediated transport systems serving neurodegenerative and psychiatric conditions.
• Competitive landscape is active, with key players pursuing similar nanoparticle-based delivery platforms.

Key Takeaways

• Patent 9,101,543 claims a nanoparticle system for crossing biological barriers, including specific ligands and therapeutic agents.
• Its scope is focused on CNS delivery applications but leaves room for alternative approaches.
• The patent landscape includes multiple filings with overlapping concepts, emphasizing the importance of precise claim drafting.
• The patent provides strategic protection but faces competition from broad prior art and emerging innovations.

FAQs

1. Does Patent 9,101,543 cover all nanoparticle delivery systems? No. It specifically claims systems using certain ligands, carrier types, and therapeutic agents. Broad nanoparticle platforms without these features are not covered.

2. How vulnerable are the claims to prior art challenges? The claims are narrowed to specific ligand and carrier combinations, which can be challenged if prior art discloses similar features, but current novelty appears intact.

3. Can competitors develop similar delivery methods? Yes, by using different ligands, carrier materials, or targeting approaches that fall outside the patent claims.

4. What is the patent’s enforcement potential? The patent's claims are enforceable in the U.S., with equivalent patents in other jurisdictions, providing a strong IP position for targeted CNS delivery systems.

5. What are the key considerations for R&D? Focus on developing alternative ligands, delivery routes, or therapeutic targets to avoid infringement while building around the patent.

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References

1. United States Patent and Trademark Office. (2017). Patent 9,101,543. Retrieved from https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&TERM1=9,101,543&FIELD1=&co1=AND&TERM2=&FIELD2=&d=PTXT

Drugs Protected by US Patent 9,101,543

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes					Y

International Family Members for US Patent 9,101,543

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1853250		C300673	Netherlands
European Patent Office	1853250		CA 2014 00034	Denmark
European Patent Office	1853250		PA2014022	Lithuania
European Patent Office	1853250		300673	Netherlands
European Patent Office	1853250		37/2014	Austria