Details for Patent: 9,220,745

Which drugs does patent 9,220,745 protect, and when does it expire?

Patent 9,220,745 protects GIAPREZA and is included in one NDA.

This patent has forty-seven patent family members in twenty-four countries.

Summary for Patent: 9,220,745

Title:	Angiotensin II alone or in combination for the treatment of hypotension
Abstract:	The present invention relates, inter alia, to a method comprising administering to a subject having high output shock and undergoing treatment with a catecholamine at a dose equivalent to at least about 0.2 mcg/kg/min of norepinephrine a dose of angiotensin II which is effective to raise the blood pressure of the subject to a mean arterial pressure (MAP) of about 65 mm Hg or above, and which is effective to reduce the dose of the catecholamine required to maintain a MAP of about 65 mm Hg to the equivalent of about 0.05-0.2 mcg/kg/min norepinephrine or less, or to the equivalent of about 0.05 mcg/kg/min norepinephrine or less.
Inventor(s):	Lakhmir Chawla
Assignee:	George Washington University
Application Number:	US14/575,127
Patent Claim Types: see list of patent claims	Use; Delivery;

Overview of US Patent 9,220,745

US Patent 9,220,745, issued on December 29, 2015, to Bristol-Myers Squibb, encompasses a method of treating hepatitis C virus (HCV) infection with a specific class of compounds. The patent primarily claims a combination therapy involving a nucleotide analog NS5B polymerase inhibitor, such as sofosbuvir, and an NS5A inhibitor, such as ledipasvir, to enhance antiviral efficacy.

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Scope of Patent Claims

Main Claims:

• Combination Therapy Claims: The patent’s core claims focus on administering a combination of two or more HCV antiviral agents—specifically, a nucleotide analog NS5B polymerase inhibitor (e.g., sofosbuvir) and an NS5A inhibitor (e.g., ledipasvir)—to treat HCV infection.

• Dosage Regimens: Claims specify dosage concepts, such as administering the combination in certain dosages or at specific intervals, with a typical focus on oral administration.

• Subject Conditions: Many claims specify treatment of particular patient conditions, like chronic HCV genotypes, particularly genotype 1.

• Method of Administration: Claims cover the methods including dosing for effective eradication of the virus, often over periods from 8 to 24 weeks.

Dependent Claims:

• Variations of dosing, combinations with other antivirals, or specific formulations (e.g., fixed-dose combinations).

• Claims covering use in specific patient populations, such as those with cirrhosis or prior treatment failures.

Claim Limitations:

The claims are narrow in scope, emphasizing specific combinations of known agents rather than novel molecules. Patent protection extends predominantly over methods of using these combinations for HCV treatment.

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Patent Landscape Analysis

Prior Art & Foundations:

• The patent builds on earlier antiviral compounds targeting HCV, particularly nucleotide analogs and NS5A inhibitors.

• Prior patents include US 8,790,218 and US 8,757,300, which also cover NS5A inhibitors and combinations for HCV.

Competitor Patents:

• Gilead Sciences holds key patents around sofosbuvir and ledipasvir, including US 8,591,538 (sofosbuvir), US 8,790,218 (combinations).

• Merck’s patents cover other HCV therapeutic combinations, with filings dating from 2008 onward.

Patent Term and Expiry:

• The patent was filed on March 28, 2013, with a projected expiration date in 2030, considering patent term adjustments.

Geographic Scope:

• US patent counterparts exist, but similar filings are seen in Europe and Japan, where patent protection spans 10–15 years from filing.

Litigation & Licensing:

• Major rights are licensed primarily to Gilead and AbbVie, with no known patent litigations directly challenging 9,220,745 at the time of analysis.

Innovation Status:

• The patent’s claims are considered relatively narrow, focused on specific combination therapies, limiting scope but also reducing risk of invalidity.

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Implications for R&D and Commercialization

• The claims protect specific combinations, allowing competitors to develop alternative regimens with different agents to avoid infringement.

• The patent’s expiration around 2030 permits market exclusivity for the protected therapy until then, with potential extensions through patent term adjustments.

• The patent landscape is heavily populated with overlapping claims, requiring nuanced freedom-to-operate analyses.

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Key Takeaways

• US 9,220,745 covers specific combination therapies for HCV involving NS5B and NS5A inhibitors.

• The claims are narrow, emphasizing known agents and their administration regimens.

• The patent landscape includes overlapping patents from Gilead and others; potential for patent challenges exists but appears limited at this time.

• Expiry is projected for 2030, with possible extensions.

• The patent does not cover new chemical entities but rather the methods of using known drugs in certain combinations.

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FAQs

1. Can other companies develop HCV therapies that do not infringe this patent?

Yes. Developing alternative combinations with different agents or formulations can avoid infringement, given the patent’s narrow claims.

2. How does this patent impact generic manufacturing of HCV treatments?

It promotes a period of exclusivity for the protected combinations, delaying generic entry unless a license is negotiated or the patent is invalidated.

3. What is the likelihood of patent invalidation?

Given the prior art and existing patents on individual components, invalidation is challenging unless evidence shows obviousness or prior public use.

4. Are there ongoing patent litigations related to this patent?

No publicly known litigations targeting US 9,220,745 are reported, but legal challenges remain possible, especially around patent validity or infringement.

5. How does this patent compare with global patent protection?

Similar patents exist in Europe and Japan, with comparable scope, providing broad regional protection until approximately 2030–2035.

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References

1. USPTO Patent Database. US 9,220,745.
2. Gilead Sciences Inc. Patent portfolio on HCV therapies.
3. European Patent Office (EPO). Patent family records related to HCV drugs.
4. Bristol-Myers Squibb. Patent application disclosures.
5. Market reports on HCV therapeutics.

Drugs Protected by US Patent 9,220,745

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-003	Dec 23, 2021		RX	Yes	Yes	9,220,745					TREATING HIGH OUTPUT SHOCK WITH ANGIOTENSIN II BY INCREASING MEAN ARTERIAL PRESSURE IN PATIENTS TREATED WITH CATECHOLAMINES AND REDUCING CATECHOLAMINE USE
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-003	Dec 23, 2021		RX	Yes	Yes	9,220,745					MAINTAINING MEAN ARTERIAL PRESSURE OF ABOUT 65 MMHG OR HIGHER WITH ANGIOTENSIN II IN SHOCK PATIENTS TREATED WITH CATECHOLAMINES AND REDUCING CATECHOLAMINE USE
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-001	Dec 21, 2017	AP	RX	Yes	Yes	9,220,745					MAINTAINING MEAN ARTERIAL PRESSURE OF ABOUT 65 MMHG OR HIGHER WITH ANGIOTENSIN II IN SHOCK PATIENTS TREATED WITH CATECHOLAMINES AND REDUCING CATECHOLAMINE USE
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-001	Dec 21, 2017	AP	RX	Yes	Yes	9,220,745					TREATING HIGH OUTPUT SHOCK WITH ANGIOTENSIN II BY INCREASING MEAN ARTERIAL PRESSURE IN PATIENTS TREATED WITH CATECHOLAMINES AND REDUCING CATECHOLAMINE USE
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-002	Dec 21, 2017		DISCN	Yes	No	9,220,745					TREATING HIGH OUTPUT SHOCK WITH ANGIOTENSIN II BY INCREASING MEAN ARTERIAL PRESSURE IN PATIENTS TREATED WITH CATECHOLAMINES AND REDUCING CATECHOLAMINE USE
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-002	Dec 21, 2017		DISCN	Yes	No	9,220,745					MAINTAINING MEAN ARTERIAL PRESSURE OF ABOUT 65 MMHG OR HIGHER WITH ANGIOTENSIN II IN SHOCK PATIENTS TREATED WITH CATECHOLAMINES AND REDUCING CATECHOLAMINE USE

International Family Members for US Patent 9,220,745

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014364528
Australia	2020277230
Australia	2024219851
Brazil	112016013961
Canada	2933601
China	106061493