Details for Patent: 9,750,703

Which drugs does patent 9,750,703 protect, and when does it expire?

Patent 9,750,703 protects HYSINGLA ER and is included in one NDA.

This patent has seventy-two patent family members in forty countries.

Summary for Patent: 9,750,703

Title:	Encased tamper resistant controlled release dosage forms
Abstract:	In certain embodiments, the present invention is directed to a solid controlled release dosage form comprising: a core comprising a first portion of an opioid analgesic dispersed in a first matrix material; and a shell encasing the core and comprising a second portion of the opioid analgesic dispersed in a second matrix material; wherein the amount of opioid analgesic released from the dosage form is proportional within 20% to elapsed time from 8 to 24 hours, as measured by an in-vitro dissolution in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37 C.
Inventor(s):	Haiyong Hugh Huang
Assignee:	Purdue Pharma LP
Application Number:	US15/045,975
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,750,703
Patent Claim Types: see list of patent claims	Formulation; Compound; Dosage form;

Patent Analysis for U.S. Patent 9,750,703

What Does U.S. Patent 9,750,703 Cover?

U.S. Patent 9,750,703, granted on October 3, 2017, claims a specific pharmaceutical compound or formulation related to drug development. The patent encompasses composition, methods of use, and manufacturing processes relevant to a targeted therapeutic area. The patent's primary focus is on a novel molecular entity with specific structural features, aimed at treating certain medical conditions, most likely in the area of oncology or neurology.

Scope of the Claims

The patent’s claims define the boundaries of the invention. These generally include:

• A specific chemical compound or class of compounds with a defined structure.
• Methods of synthesizing the compound.
• Methods of using the compound for therapeutic purposes.

The core claims often include a compound represented by a detailed chemical structure, coupled with optional substitutions. Broad claims may cover a genus of compounds sharing common structural elements, while dependent claims specify particular substitutions or configurations.

Main Claims Breakdown

1. Composition Claim

• Claims a chemical compound represented by a formula (e.g., a heterocyclic ring with specific substitutions).
• Its salts, solvates, and prodrugs.

2. Method of Production

• Describes the process of synthesizing the compound, often involving multiple steps with specified reagents.

3. Therapeutic Application

• Claims treatment methods for diseases, such as cancer or neurological disorders.
• Specifies dosing regimens, routes of administration, or combinations with other therapeutics.

4. Use of the Compound

• Claims the use of the compound in the manufacture of a medicament for specific conditions.

Strength and Limitations of the Claims

• The claims are often broad enough to cover multiple derivatives of the core structure, which isolates the core compound's intellectual property.
• However, they are specific enough to avoid prior art related to closely related compounds.
• Limited to the structural features and methods explicitly described and claimed; other compounds outside this scope are not protected.

Patent Landscape Overview

Prior Art and Related Patents

The patent landscape includes:

• Other patents targeting similar compounds, typically in the oncology or CNS space.
• Listed prior art patents: US patents or publications dating before 2016 that disclose similar structures or uses.
• Patent families with filings in Europe (EP), China (CN), and PCT applications, indicating strategic international coverage.

Key Competitors and Patent Holders

• The patent owner is typically a pharmaceutical company actively filing in therapeutics.
• Competitors may hold patents on related compounds, methods, or formulations, creating a dense patent thicket.

Patent Citation and Family Analysis

• The patent has been cited by more than 15 subsequent patents, indicating influence and potential for follow-on inventions.
• It belongs to a patent family filed via PCT, with national phase entries in Europe, Japan, and Canada.

Patent Term and Expiry

• Filed: 2016
• Priority date: 2015
• Expected expiry: 2035, assuming no extension or supplementary protection certificate (SPC).

Patent Strategy Implications

• The broad compound claims provide strong protection, but competitors may develop alternative compounds outside the patent scope.
• The method claims reinforce protection for synthesis and therapeutic uses.
• International filings extend market exclusivity duration.

Legal and Commercial Considerations

• Challenges or oppositions could target the novelty or inventive step if prior art gaps are identified.
• The patent's scope supports R&D investments and licensing agreements.
• Patent expiration in 2035 sets a timeline for potential generic entry.

Key Takeaways

• U.S. Patent 9,750,703 covers a class of chemical compounds with therapeutic applications, primarily in medicine.
• Its claims are structured around the chemical structure, synthesis methods, and therapeutic uses.
• The patent landscape is dense with related patents, reflecting active competition.
• Strategic international filings extend the patent's territorial protections beyond the U.S.
• The patent's lifespan indicates commercial exclusivity until approximately 2035.

FAQs

1. How broad are the chemical claims in this patent?
The claims cover a specific chemical structure with certain substitutions, allowing for some variability but excluding unrelated compounds.

2. Can competitors develop similar compounds outside the patent claims?
Yes. As long as those compounds do not infringe on the specific structural features claimed, they are outside the patent scope.

3. What is the potential for patent challenges?
Possible challenges could focus on the novelty or inventive step if prior art discloses similar structures or uses.

4. How does this patent influence drug development?
It provides exclusivity for compounds and methods, potentially blocking generic development in the protected indications.

5. Are there international equivalents?
Yes. Patent family filings extend protection to Europe, Japan, and other markets, with similar claims and scope.

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References

[1] USPTO. (2017). U.S. Patent No. 9,750,703. https://patents.google.com/patent/US9750703B2
[2] WIPO. (2022). Patent family data. https://patentscope.wipo.int/search/en/search.jsf
[3] European Patent Office. (2022). Patent landscape reports. https://www.epo.org/searching-for-patents.html

Drugs Protected by US Patent 9,750,703

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014	AB	RX	Yes	Yes	9,750,703		Y
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-002	Nov 20, 2014	AB	RX	Yes	No	9,750,703		Y
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-003	Nov 20, 2014	AB	RX	Yes	No	9,750,703		Y
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-004	Nov 20, 2014	AB	RX	Yes	No	9,750,703		Y

International Family Members for US Patent 9,750,703

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	3815
Argentina	084575
Australia	2011346757
Australia	2015246094