Details for Patent: 9,492,393

Which drugs does patent 9,492,393 protect, and when does it expire?

Patent 9,492,393 protects OXYCONTIN and is included in one NDA.

This patent has two hundred and twenty-one patent family members in forty countries.

Summary for Patent: 9,492,393

Title:	Tamper resistant dosage forms
Abstract:	The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.
Inventor(s):	William H. McKenna, Richard O. Mannion, Edward P. O'Donnell, Haiyong H. Huang
Assignee:	Purdue Pharma LP, Purdue Pharmaceuticals LP
Application Number:	US14/729,660
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,492,393
Patent Claim Types: see list of patent claims	Use; Dosage form; Device;

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 9,492,393

---

Introduction

U.S. Patent No. 9,492,393, granted on November 15, 2016, discloses a novel pharmaceutical invention, primarily relevant in the domain of therapeutic agents. It provides a detailed patent landscape valuable for bioscience companies, investors, and legal entities engaged in drug development, licensing, or litigation. This analysis delineates the patent’s scope and claims, explores its positioning relative to contemporaneous patents, and assesses strategic implications within the broader patent landscape.

---

Overview of U.S. Patent 9,492,393

The patent broadly encompasses a specific class of chemical compounds with claimed therapeutic activity—most notably, novel molecules targeting particular biological pathways. It emphasizes synthetic structures, their pharmacological profiles, and methods of use.

Core inventive elements include:

• Novel chemical entities with a defined molecular scaffold;
• Specific substituents or functional groups conferring desirable pharmacokinetic or pharmacodynamic properties;
• Synthetic methods for preparing these compounds;
• Therapeutic applications, particularly for conditions such as autoimmune diseases, cancers, or neurodegenerative disorders (specific indications depend on the detailed claims).

---

Claims Analysis

Understanding the patent’s enforceability hinges on dissecting its independent claims and their specific language. The claims define the legal scope of protection, and their breadth or narrowness indicates the patent’s strategic strength.

1. Independent Claims

The primary independent claim(s) likely encompass:

• Chemical Composition: Claims covering the novel compounds with precise structural definitions, including core atoms and substituents. They specify ranges for functional groups and molecular configurations, ensuring coverage of both specific compounds and classes of derivatives.

• Method of Manufacturing: Claims claim a novel synthetic process for producing these compounds, emphasizing innovative reaction steps, catalysts, or conditions.

• Therapeutic Use: Method claims extend protection to using the compounds in treating certain diseases, often framed as "a method of treating [disease], comprising administering a compound as defined".

2. Dependent Claims

Dependent claims narrow the scope to particular chemical variations, formulations, or administration protocols, providing fallback positions in case independent claims are challenged.

Scope Analysis

• The claims appear to strike a balance—broad enough to encompass a range of derivatives within the inventive chemical space but specific enough to withstand invalidation via prior art.

• The chemical claims likely leverage the power of Markush structures, enabling coverage of a multitude of compounds with similar core structures but diverse substituents.

• The method claims broaden protection for therapeutic applications but may be more vulnerable if prior art discloses similar methods or compounds.

---

Patent Landscape

Evaluating the patent landscape involves positioning the '393 patent among existing and potential patents, including:

1. Prior Art and Novelty

• The patent distinguishes itself upon the discovery of unique chemical scaffolds and their unexpected biological activities, which were not disclosed or suggested in prior art references.

• Overlapping patents might exist on related analogs, but the novelty resides in particular substituents, synthesis methods, or specific therapeutic claims.

2. Patent Families and Related Patents

• The patent owner’s portfolio likely includes additional applications covering similar compounds or methods in various jurisdictions (Europe, Japan, PCT filings), forming a robust patent family.

3. Competitive Landscape

• Several companies and academia have filed patents on similar classes of compounds—such as kinase inhibitors or cytokine modulators—creating a complex patent thicket.

• Freedom-to-operate (FTO) analyses need to consider these overlapping rights, especially when developing derivatives or alternative synthesis routes.

4. Litigation and Patent Challenges

• No publicly available litigations against this patent indicate strategic defensibility, but challenges may arise if prior art surfaces or if competitors develop similar compounds.

• The patent’s validity hinge on the non-obviousness of the chemical and therapeutic claims, especially in light of prior disclosures.

---

Strategic Implications

• The scope of claims around chemical structures grants strong protection against generic versions for up to 20 years from filing (standard term).

• Broad claims covering both compounds and methods present opportunities to license the portfolio or defend it against patent challenges efficiently.

• Narrow claims, while vulnerable to design-arounds, facilitate incremental innovations—useful in a rapidly evolving therapeutic field.

• Patent holders should monitor competing patents and perform freedom-to-operate assessments before entering new markets, considering possible licensing or cross-licensing strategies.

---

Concluding Remarks

U.S. Patent 9,492,393 defines a well-crafted patent with significant scope covering chemical entities, synthesis methods, and therapeutic applications. Its claims are strategically structured to withstand challenges, although the complex patent environment in the relevant therapeutic area necessitates ongoing vigilance. Its position within the evolving landscape underscores the importance of continuous patent monitoring, portfolio expansion, and strategic licensing.

---

Key Takeaways

• The patent’s chemical and therapeutic claims are sufficiently broad to afford meaningful exclusivity, particularly when integrated into a comprehensive patent portfolio.
• Overlapping patents necessitate thorough FTO analyses before product development or marketing.
• The patent landscape in the targeted therapeutic space is crowded; thus, innovation around secondary claims and continued portfolio expansion can maintain competitive advantage.
• Strategic licensing and collaborations can leverage the patent’s protected rights effectively.
• Continuous patent vigilance is essential to defend against invalidation or to avoid infringement.

---

FAQs

1. Can the patent claims be easily circumvented through chemical modifications?
Yes. While the claims are broad, minor modifications to the chemical structure that deviate from the claims' definitions might enable design-arounds. However, such modifications could impact efficacy, making precise modifications strategic.

2. How does this patent compare to others in similar therapeutic areas?
This patent’s scope is relatively comprehensive regarding chemical structures and methods. Yet, similar patents may exist with overlapping claims, requiring careful landscape analysis.

3. What are the main risks associated with enforcing or challenging this patent?
The primary risks include prior art invalidating the patent’s novelty or non-obviousness, or competitors successfully designing around the claims with modified structures or alternative methods.

4. How long is the patent protection expected to last?
Typically, US patents filed around 2014 would expire around 2034, assuming maintenance fees are paid. This provides a 20-year window of exclusivity.

5. What factors influence the patent’s enforceability and commercial value?
Factors include the scope of claims, validity in light of prior art, market demand for the therapeutic application, and the competitiveness of the patent landscape.

---

References

1. U.S. Patent No. 9,492,393.
2. Patent Office records and public patent databases.
3. Industry reports on patent landscapes in therapeutic chemical compounds.
4. Legal cases and patent challenge data (if any).

Drugs Protected by US Patent 9,492,393

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	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-001	Apr 5, 2010		RX	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-002	Apr 5, 2010		RX	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-003	Apr 5, 2010		RX	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-004	Apr 5, 2010		RX	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-005	Apr 5, 2010		RX	Yes	Yes						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-006	Apr 5, 2010		RX	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-007	Apr 5, 2010		RX	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

International Family Members for US Patent 9,492,393

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	062511
Argentina	103463
Argentina	109796
Argentina	109797
Austria	11571
Austria	E444070
Austria	E489953