Details for Patent: 7,772,178

Which drugs does patent 7,772,178 protect, and when does it expire?

Patent 7,772,178 protects VICTRELIS and is included in one NDA.

This patent has nineteen patent family members in sixteen countries.

Summary for Patent: 7,772,178

Title:	Pharmaceutical formulations and methods of treatment using the same
Abstract:	Pharmaceutical formulations containing at least one compound of Formulae I-XXVI herein and at least one surfactant. Pharmaceutically acceptable carriers and excipients may also be included in the formulations. The formulations of the present invention are suited for use in single unit dosages.
Inventor(s):	Bruce A. Malcolm, Prudence K. Bradley, Anastasia Pavlovsky, Wing-Kee Philip Cho, Zhihui Qiu
Assignee:	Merck Sharp and Dohme LLC
Application Number:	US11/444,078
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Scope and Claims Analysis for US Patent 7,772,178: Surfactant-Defined Pharmaceutical Formulations Covering HCV and Cathepsin-Associated Disorders

US 7,772,178 is a US formulation-and-method patent built around a surfactant-defined drug delivery matrix plus a specified dose-range for an “at least one compound” (and salts). The independent claim 1 is structured as a two-part composition: (i) at least one surfactant selected from a closed list and present at 0.1% to 10% by weight, and (ii) the claimed “compound” present at 50 to 1000 mg (or salt). Dependent claims narrow to sodium lauryl sulfate, capsule dosage form, addition of lubricant (magnesium stearate), and the presence of typical excipients. Method claims cover treating HCV infection and treating a “cathepsin-associated disorder” by administering the claimed formulation.

Below is a claim-by-claim scope breakdown, what the claim language captures (and excludes), and what typically matters for freedom-to-operate (FTO), formulation design, and Paragraph IV-type risk analysis.

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What is the independent claim scope of US 7,772,178 (Claim 1) and what does it cover?

Claim 1 core elements (format: (a) surfactant + (b) compound/dose-range):

1. A pharmaceutical formulation comprising

   • (a) At least one surfactant present at about 0.1% to about 10% by weight, where the surfactant is selected from a listed group:
     • sodium lauryl sulfate
     • monoethanolamine
     • docusate sodium
     • poloxamer
     • lecithin
     • sorbitan fatty acid esters
     • polyoxyethylene sorbitan fatty acid esters
     • ethoxylated aliphatic alcohols
     • propylene glycol monocaprylate
     • glycerol monostearate
     • medium chain triglycerides
     • polyoxyethylene alkyl ethers
     • polyoxyethylene stearates
   • (b) At least one compound present at about 50 to about 1000 mg, where:
     • the compound is “or a pharmaceutically acceptable salt thereof”.

2. The claim is composition-based, not limited by specific manufacturing steps, particle size, polymorph, or whether the compound is a small molecule versus salt form beyond the “salt” wording.

How broad is it, practically?

• Surfactant breadth is high but the list is closed: infringing compositions must use at least one surfactant from that enumerated set.
• Surfactant amount is bounded: formulations outside 0.1% to 10% w/w avoid literal coverage for that element (subject to doctrine-of-equivalents risk depending on jurisdiction and prosecution history).
• Compound dose-range is bounded: the formulation must contain the “compound” at 50 to 1000 mg. This can be interpreted as per dosage unit (commonly mg per unit in caps/tablets) but the claim text does not explicitly state “per unit dose.” It still typically reads as an amount in the formulation, and in practice claim construction often treats such mg ranges as per dosage unit when paired with capsule/tablet language in dependent claims.

What does Claim 1 not say (important for design-around and litigation scope)?

Claim 1 does not require:

• A specific active ingredient identity in the claims you provided (the “compound” is unspecified in your excerpt).
• A specific route of administration in claim 1 (though method claims imply oral/administration generally via formulation).
• A specific pharmacological class, target, mechanism, or antiviral activity beyond the method claims’ disease labels.
• Specific excipient types in claim 1 (those appear in dependent claims).
• A specific solid state property (crystal form, amorphous content), which can matter in later formation patents.

Claim 1’s structural consequence

Any accused product that (i) uses one of the listed surfactants in the claimed wt% range and (ii) contains the claimed “compound” at the claimed mg range is within the core of the patent’s claim coverage, regardless of other excipients unless the claim language or other dependent limitations exclude it.

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Which surfactants and dosage amounts define infringement risk under Claim 1?

Surfactant list is the main design constraint. The claim uses a “selected from the group consisting of” construct. That phrasing typically makes the list exhaustive, so substituting a different surfactant outside the enumerated group is a common design-around.

Allowed surfactants (Claim 1)

• Sodium lauryl sulfate
• Monoethanolamine
• Docusate sodium
• Poloxamer
• Lecithin
• Sorbitan fatty acid esters
• Polyoxyethylene sorbitan fatty acid esters
• Ethoxylated aliphatic alcohols
• Propylene glycol monocaprylate
• Glycerol monostearate
• Medium chain triglycerides
• Polyoxyethylene alkyl ethers
• Polyoxyethylene stearates

Surfactant concentration window

• About 0.1% to about 10% by weight.

Active “compound” amount window

• About 50 mg to about 1000 mg (or pharmaceutically acceptable salt).

Litigation relevance: In dispute, the parties typically battle whether a formulation’s surfactant concentration and mg amount fall within the “about” ranges, which depends on expert construction, measurement methods (on a dry basis vs as-filled), and the level of manufacturing variation.

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How do dependent claims narrow Claim 1’s coverage (Claims 2, 3, 6-10)?

Claim 2: Sodium lauryl sulfate specifically

• “The pharmaceutical formulation of claim 1 wherein said at least one surfactant comprises sodium lauryl sulfate.”

Effect: This creates a narrower sub-scope, but importantly it does not expand coverage beyond Claim 1. Any product with sodium lauryl sulfate as the surfactant (and at 0.1-10% w/w) sits in both Claim 1 and Claim 2.

Claim 3: Capsule form

• “The pharmaceutical formulation of claim 1 wherein said formulation is in capsule form.”

Effect: This matters for dosage form design-arounds. A tablet or solution might avoid literal coverage for Claim 3 while still potentially infringing Claim 1 if Claim 1 is not limited to capsules (it is not). Capsules are a separate dependent hook for product-specific infringement theories.

Claim 6-7: Lubricant addition (magnesium stearate)

• Claim 6 adds: “further comprising 0.1 to 15% by weight of a lubricant.”
• Claim 7 specifies: “wherein the lubricant is magnesium stearate.”

Effect:

• Claim 6 creates coverage for formulations that have the listed surfactant(s) plus magnesium stearate in 0.1% to 15% w/w (if magnesium stearate also satisfies the lubricant identity in Claim 7).
• A formulation that avoids magnesium stearate or keeps lubricant outside that window can avoid Claims 6 and 7, but can still fall under Claim 1.

Claim 8-9: Excipients carriers/binders/disintegrants

• Claim 8 adds “one or more carriers, binders or disintegrants.”
• Claim 9 adds the combination including “magnesium stearate” plus carriers/binders/disintegrants.

Effect: These are typical formulation limitations. Almost any solid oral dosage will satisfy them, so these dependent claims often serve to reinforce infringement coverage for real-world generic or marketed formulations.

Claim 10: Another independent-style restatement

• “A pharmaceutical formulation, comprising: (a) a surfactant which is sodium lauryl sulfate present in 0.1 to 10% by weight and (b) at least one compound present in 50 to 1000 mg…”

Effect: Claim 10 is essentially Claim 1 narrowed to sodium lauryl sulfate, but it reads like a separate claim that can be asserted independently. This increases the enforcement leverage against products that use sodium lauryl sulfate, even if other surfactants are not present.

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What treatment methods are claimed (Claims 4 and 5), and what is their practical reach?

Claim 4: Method of treating HCV infection

• “A method of treating HCV infection comprising administering an effective amount of the pharmaceutical formulation of claim 1…”

Effect:

• This creates a method-of-use infringement pathway. An accused product that is composition-infringing under Claim 1 but used to treat HCV can drive infringement of the method claim as well.
• Labeling and marketing matter. For method claims, evidence often includes prescribing patterns, instructions, promotional claims, and regulatory approvals.

Claim 5: Method of treating a cathepsin-associated disorder

• “A method of treating a capthesin-associated disorder” (spelling as provided) by administering the formulation.

Effect:

• This is broader in disease labeling than HCV because it is anchored to a mechanism/association (cathepsin involvement) rather than a specific virus.
• In practice, whether the disease term is construed broadly can depend on the specification. From the claims alone, the term “cathepsin-associated disorder” is potentially wide and could cover many inflammatory, fibrotic, oncologic, and neurodegenerative conditions where cathepsin activity is implicated.

Key litigation point: Method claims can be difficult when the active is the same across indications but the product is not prescribed for the claimed disorder. Conversely, if the product’s clinical development includes cathepsin-related indications, the evidentiary burden improves for enforcement.

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What is the patent “claim map” in plain terms (linking composition limits to method limits)?

Composition anchor (Claim 1 / 10)

• Surfactant from listed group in 0.1-10% w/w
• Plus active “compound” or salt at 50-1000 mg

Dosage form reinforcement

• Capsule (Claim 3)

Formulation reinforcement

• Lubricant 0.1-15% (Claim 6) and magnesium stearate (Claim 7)
• Carriers/binders/disintegrants (Claim 8)
• Combined with magnesium stearate (Claim 9)

Use anchor

• Administer to treat HCV (Claim 4)
• Administer to treat cathepsin-associated disorder (Claim 5)

This structure means enforcement can be pursued at multiple levels:

• Composition-only (Claim 1/2/10 depending on surfactant identity)
• Composition plus dosage form (Claim 3)
• Composition plus typical manufacturing excipients (Claims 6-9)
• Composition plus disease/labeling (Claims 4-5)

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How does “about” impact claim coverage and how do courts typically treat it for surfactant wt% and mg ranges?

Both the surfactant wt% and the compound mg range are qualified with “about.” That phrase expands literal boundaries beyond exact endpoints.

In practice, infringement analysis typically turns on:

• Analytical method (how wt% is measured; basis on dry vs total)
• Finished dosage unit weight and fill consistency (capsule fill may vary)
• Manufacturing tolerances (batch release specifications vs nominal targets)
• Expert testimony on formulation tolerances and whether measured values fall within the “about” band

Because the claims are ranges with “about,” the endpoints (0.1% and 10%; 50 mg and 1000 mg) are not hard cutoffs in litigation.

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What patent landscape issues usually matter around formulation patents like this (and where risk tends to cluster)?

Even without the full file history in your excerpt, the claim pattern signals typical landscape features:

1) Ester/salt and dose-range overlap risk

If the “compound” is an HCV antiviral or cathepsin-targeting agent, many follow-on patents often cover:

• salts
• polymorphs
• process changes
• dosing regimens
• alternative formulations (e.g., different surfactants or capsule shells)

This patent specifically anchors on a surfactant list and wt% window plus a compound mg window. If later products use the same active but switch to non-listed surfactants or different dosage amounts, they may reduce literal risk.

2) Excipients do not always provide safe harbor

Dependent claims 8-9 indicate common excipients. Many generic formulations use magnesium stearate and standard carriers/disintegrants. Those features can push an accused product into dependent-claim territory even if the formulation changes otherwise.

3) Method claims can extend exposure beyond what is tested in composition-only studies

For HCV and cathepsin-associated disorders, the method claims can be implicated by:

• FDA labeling language
• promotional materials
• prescriber communications
• clinical use

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What would be the core freedom-to-operate “design-around levers” for this patent?

From the claim text provided, the strongest levers are:

1. Avoid using the enumerated surfactants (closed list).
2. If using one, stay outside 0.1% to 10% by weight.
3. Keep the dosage/unit content such that the “compound” amount is outside 50-1000 mg as construed in the claimed dosage form context.
4. Use a non-capsule dosage form to avoid Claim 3, while recognizing Claim 1 may still apply.
5. Avoid magnesium stearate lubricant or keep lubricant outside 0.1-15% to avoid Claims 6-7.
6. For method claims, avoid marketing and clinical use for HCV and the specified cathepsin-associated indication, though composition infringement still remains a separate issue.

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What is the enforcement posture implied by Claim 10 (sodium lauryl sulfate-specific “independent-style” coverage)?

Claim 10 repeats the core elements but specifically requires sodium lauryl sulfate at 0.1-10% w/w plus the compound mg range.

Implication: If a product uses sodium lauryl sulfate, it faces an increased probability of falling into at least two independent hooks (Claim 1 plus Claim 10, depending on claim construction and whether sodium lauryl sulfate is among the “at least one surfactant” under Claim 1). That redundancy increases litigation leverage even if one claim is challenged.

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How many distinct claim “coverage buckets” exist based on the provided claim set?

Based on Claims 1-10, the coverage buckets are:

1. General surfactant from the enumerated list + compound mg range (Claim 1)
2. Same but sodium lauryl sulfate is present (Claim 2 and Claim 10)
3. Same but capsule dosage form (Claim 3)
4. Same plus lubricant at 0.1-15% (Claim 6)
5. Same plus magnesium stearate lubricant (Claim 7)
6. Same plus carriers/binders/disintegrants (Claim 8)
7. Same plus magnesium stearate + carriers/binders/disintegrants (Claim 9)
8. Same administered for HCV (Claim 4)
9. Same administered for cathepsin-associated disorder (Claim 5)

These buckets overlap heavily in typical capsule formulations using standard lubricants, so in practice many real commercial generics would test multiple buckets at once.

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Key Takeaways

• US 7,772,178 is a surfactant-defined formulation patent with a closed surfactant list and tight wt% and mg-range anchors.
• Independent coverage is Claim 1, with Claim 10 providing a sodium lauryl sulfate-specific, independent-style hook.
• Capsule form and standard excipients are covered in dependent claims, creating high overlap with typical solid oral manufacturing.
• Method claims expand exposure to administration for HCV infection and cathepsin-associated disorders, making labeling and actual use relevant.
• Design-around is primarily about surfactant selection and concentration, followed by dosage-unit mg content and lubricant identity/concentration.

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FAQs

1. Can changing the surfactant to one not listed in the claim avoid infringement of US 7,772,178?
   The claim uses “selected from the group consisting of,” so switching to a non-enumerated surfactant is the primary literal avoidance route.

2. If a generic uses sodium lauryl sulfate, does it automatically fall under US 7,772,178?
   Not automatically. It still must meet the wt% surfactant range (0.1-10%) and the compound mg range (50-1000 mg), plus any asserted dependent limitations.

3. Do method claims require that a product be FDA-labeled for HCV to infringe US 7,772,178?
   Method claims typically rely on evidence of administration to treat the claimed disorder, which can include labeling, promotion, and prescribing, not just label text.

4. Does avoiding magnesium stearate eliminate risk under the patent?
   It reduces risk for the dependent lubricant claims (6-7) but does not eliminate risk for the base formulation claims (1/10) if the core surfactant and compound amounts are still met.

5. Is “capsule form” a necessary requirement to infringe US 7,772,178?
   No. Capsule form is a limitation in dependent Claim 3. Claim 1 itself is not explicitly limited to capsules in the excerpt you provided.

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References (APA)

1. US Patent 7,772,178, claims 1-10 (as provided in the prompt).

Drugs Protected by US Patent 7,772,178

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Merck Sharp Dohme	VICTRELIS	boceprevir	CAPSULE;ORAL	202258-001	May 13, 2011		DISCN	No	No			Y			TREATMENT OF CHRONIC HEPATITIS C (CHC) GENOTYPE 1 INFECTION IN COMBINATION WITH PEGINTERFERON ALFA AND RIBAVIRIN IN ADULT PATIENTS (>=18 YEARS OF AGE) WITH COMPENSATED LIVER DISEASE

International Family Members for US Patent 7,772,178

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	055198
Australia	2006252553
Brazil	PI0610737