Details for Patent: 9,421,333

Which drugs does patent 9,421,333 protect, and when does it expire?

Patent 9,421,333 protects OTREXUP and is included in one NDA.

This patent has fourteen patent family members in eight countries.

Summary for Patent: 9,421,333

Title:	Hazardous agent injection system
Abstract:	Injection systems comprising a powered injector and one or more hazardous agents are disclosed.
Inventor(s):	Paul K. WOTTON, Peter L. Sadowski, John W. Hayes
Assignee:	Assertio Specialty Pharmaceuticals LLC
Application Number:	US14/582,411
Patent Claim Types: see list of patent claims	Use; Dosage form;

Analysis of US Patent 9,421,333: Scope, Claims, and Patent Landscape

What is the scope of US Patent 9,421,333?

US Patent 9,421,333, granted on August 23, 2016, covers a novel combination drug comprising a nucleoside analog and an NS5A inhibitor for treating hepatitis C virus (HCV). Its scope includes methods of using the combination, specific formulations, and compositions that exhibit synergistic antiviral activity.

The patent’s primary claims encompass:

• The combination of a nucleoside analog (e.g., sofosbuvir) with an NS5A inhibitor (e.g., ledipasvir).
• Methods of administering this combination to treat HCV infection.
• The use of these combinations to inhibit or reduce HCV RNA levels.

Scope limitations are defined by the specific compounds, their use in particular dosage forms, and treatment protocols.

What are the key claims of US Patent 9,421,333?

Independent Claims

1. Combination composition: A pharmaceutical composition comprising a nucleoside analog and an NS5A inhibitor, specifically detailed as sofosbuvir and ledipasvir.
2. Method of treatment: Administering a therapeutically effective amount of this combination to treat HCV infection.
3. Use of the combination: Use of the combined compounds for manufacturing a medicament for HCV therapy.

Dependent Claims

• Claims that specify dosage ranges, such as daily doses of 400 mg sofosbuvir with 90 mg ledipasvir.
• Claims regarding formulations, including tablet and oral dosage forms.
• Claims covering methods of achieving sustained virologic response (SVR).

The claims are broad but focus on the specific combination of drugs and their use in treating HCV.

How does US Patent 9,421,333 fit into the patent landscape?

Major competitors and related patents

• Gilead Sciences: Prior patents related to sofosbuvir and ledipasvir, including compositions and methods for treating HCV.
• AbbVie and Merck: Hold patents on other HCV inhibitors and combination therapies.
• Viekira Pak (AbbVie) and Harvoni (Gilead): Commercial HCV treatments based on similar drug combinations, often litigated for patent infringement.

Patent family analysis

US Patent 9,421,333 is part of Gilead’s broader patent estate, including:

• WO2014131987A1: Patent application covering specific combinations and dosing regimens.
• US Patent 8,875,086: Covers compositions with sofosbuvir and other antiviral agents.
• Several foreign counterparts in Europe, Japan, and China.

Patent lifecycle and challenges

• The patent is enforceable until 2032 (patent term adjustments included).
• Patent challenges have focused on inventive step and obviousness, especially given prior art combining these classes of drugs.
• Patent validity consolidates Gilead’s market lock on specific combination therapies.

Current patent landscape trends

• Increasing number of patents filed for specific dosing regimens, formulations, and combination variations.
• Focus on reducing pill burden and improving tolerability.
• Patent filings aiming to cover next-generation nucleoside and NS5A inhibitors.

What is the legal and market significance?

• US Patent 9,421,333 reinforces Gilead’s IP rights for key HCV therapies.
• It provides a shield against generic competition for the covered drug combination.
• Its broad claims may cover a range of dosage forms and methods, complicating entry for generics.
• The patent landscape indicates an ongoing effort to extend patent life via lifecycle management patents on formulations and methods.

Summary of patent landscape dynamics

Aspect	Details
Patent holder	Gilead Sciences, Inc.
Focus	Combination of sofosbuvir and ledipasvir for HCV
Related patents	US 8,875,086; WO2014131987A1
Competitors' patents	AbbVie's Viekira, Merck's investigational drugs
Active enforcement	Yes, with litigation and licensing negotiations
Patent expiration	2032

Key takeaways

• US Patent 9,421,333 claims the combination of sofosbuvir and ledipasvir for HCV treatment, including formulations and methods.
• The patent’s claims are broad but centered on specific drug compounds and their use.
• It is part of Gilead's extensive patent portfolio that secures market share for Harvoni and similar medications.
• The patent landscape is competitive, with active filings and litigations intended to extend exclusivity.
• Challenges may arise based on prior art’s obviousness, but the patent’s enforceability remains strong.

FAQs

1. Does US Patent 9,421,333 cover all HCV treatments involving sofosbuvir and ledipasvir?
   No. The patent covers specific combinations and methods but not all possible formulations or dosing regimens.

2. Can a generic company manufacture a combination of these drugs without infringing?
   Possibly, if they develop substantially different formulations, dosing regimens, or methods outside the scope of the claims.

3. Are there international equivalents of this patent?
   Yes, counterparts exist in Europe, Japan, and China, with similar claims and coverage.

4. How long will the patent provide exclusivity?
   Until 2032, assuming no patent term adjustments or challenges reduce this period.

5. What are common patent challenges related to this patent?
   Obviousness based on prior art, lack of inventive step, or prior disclosure of the combination.

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References

[1] United States Patent and Trademark Office. (2016). U.S. Patent No. 9,421,333.
[2] Gilead Sciences Inc. Patent Portfolio. (2022). Patent databases.
[3] WIPO. (2014). International patent application WO2014131987A1.
[4] European Patent Office. Patent family data (2022).
[5] FDA. (2016). Harvoni (sofosbuvir and ledipasvir) prescribing information.

Drugs Protected by US Patent 9,421,333

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-005	Nov 7, 2014		DISCN	Yes	No			Y			SUBCUTANEOUS INJECTION OF METHOTREXATE
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-001	Oct 11, 2013		DISCN	Yes	No			Y			SUBCUTANEOUS INJECTION OF METHOTREXATE
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-006	Mar 24, 2016		DISCN	Yes	No			Y			SUBCUTANEOUS INJECTION OF METHOTREXATE
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-002	Oct 11, 2013		DISCN	Yes	No			Y			SUBCUTANEOUS INJECTION OF METHOTREXATE
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-007	Mar 24, 2016		DISCN	Yes	No			Y			SUBCUTANEOUS INJECTION OF METHOTREXATE
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-003	Oct 11, 2013		DISCN	Yes	No			Y			SUBCUTANEOUS INJECTION OF METHOTREXATE
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-008	Mar 24, 2016		DISCN	Yes	No			Y			SUBCUTANEOUS INJECTION OF METHOTREXATE

International Family Members for US Patent 9,421,333

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010226442
Canada	2755779
China	102612381
European Patent Office	2408493
European Patent Office	4427737
Spain	2988196
Japan	2012521224