United States Patent 7,842,699: Scope, Claims, Expiration, and Tofacitinib Patent Landscape

US Patent 7,842,699 protects treatment methods using tofacitinib, also known as CP-690,550, for atopic dermatitis, ulcerative colitis, and Crohn's disease. The patent does not claim tofacitinib as a chemical entity, a composition, a tablet, a manufacturing process, or a particular dose. Its enforceable scope depends on proving that a defendant administered tofacitinib, or a covered salt, to treat one of the claimed diseases.

The patent is commercially important because its ulcerative-colitis claims correspond to an FDA-approved Xeljanz indication. The atopic-dermatitis and Crohn's-disease claims are broader from a disease-coverage perspective but do not correspond to the principal current U.S. Xeljanz indications.

What drug does US Patent 7,842,699 cover?

The claimed compound is tofacitinib:

Item	Description
Generic name	Tofacitinib
Development code	CP-690,550
Drug class	Janus kinase, or JAK, inhibitor
Principal molecular target	JAK1 and JAK3, with activity across JAK-family signaling
Brand	Xeljanz and Xeljanz XR
Key salt	Tofacitinib citrate
Patent claim format	Treatment method claims
Patent number	US 7,842,699 B2
Patent holder historically associated with development	Pfizer
Relevant dosage forms	Oral immediate-release and extended-release products, although the patent itself does not claim a specific formulation

The chemical name in the claims identifies the tofacitinib free base. The claims also cover pharmaceutically acceptable salts, including tofacitinib citrate by virtue of the broader salt language in claims 2, 3, 8, 9, 14, and 15. The claims do not expressly require the citrate salt. They cover the free base and the listed salt classes.

What are the independent claims in US 7,842,699?

The patent has three principal independent treatment claims.

Independent claim	Disease	Covered active ingredient	Route requirement	Patient requirement
Claim 1	Atopic dermatitis	Tofacitinib or pharmaceutically acceptable salt	None	Mammal
Claim 7	Ulcerative colitis	Tofacitinib or pharmaceutically acceptable salt	None	Mammal
Claim 13	Crohn's disease	Tofacitinib or pharmaceutically acceptable salt	None	Mammal

Each independent claim requires:

A mammal in need of treatment.
Administration of a therapeutically effective amount.
Tofacitinib or a pharmaceutically acceptable salt.
Treatment of the specifically named disease.

The claims are method-of-treatment claims. A claim is potentially infringed when a party practices the claimed treatment method, induces another party to practice it, or supplies the drug with instructions that encourage the claimed use.

How do the dependent claims narrow the patent scope?

The dependent claims add salt, route, patient, and combination-treatment limitations.

Claims	Limitation
2, 8, 14	Require a pharmaceutically acceptable salt
3, 9, 15	Limit the salt to the enumerated salt group
4, 10, 16	Require oral administration
5	Limit the mammal to a human
6, 12, 18	Require concomitant administration of an immune-modulating or anti-inflammatory agent
11, 17	Specify administration of tofacitinib itself rather than the broader "tofacitinib or salt" formulation

Claims 11 and 17 are unusually important from a claim-drafting perspective. They depend on claims 7 and 13 but remove the alternative salt language by expressly requiring administration of the named compound. They do not create new disease coverage. They narrow the active-ingredient formulation to the free base as written.

The patent therefore contains layered protection:

Broad disease claims for tofacitinib and its pharmaceutically acceptable salts.
Salt-specific claims.
Oral-use claims.
Human-treatment claims.
Combination-treatment claims.
Free-base claims for ulcerative colitis and Crohn's disease.

What does US 7,842,699 not claim?

The patent does not expressly claim:

Tofacitinib as a chemical compound.
Tofacitinib citrate as a crystalline form.
A specific dosage, such as 5 mg or 10 mg twice daily.
Tofacitinib extended-release tablets.
A tablet excipient system.
A particular pharmacokinetic profile.
A specific JAK inhibition level.
A manufacturing process.
A method of treating rheumatoid arthritis or psoriatic arthritis.
A method of treating alopecia areata.
A specific treatment duration.
A specific patient age, body weight, disease-severity score, or prior-treatment history.

These exclusions matter because a generic manufacturer can avoid infringement of this patent by avoiding the claimed disease indication in its label, subject to the separate risks presented by other listed patents and induced-infringement theories.

What is the legal scope of the atopic-dermatitis claims?

Claims 1 through 6 cover treatment of atopic dermatitis with tofacitinib or a covered salt. Claim 1 is the broadest atopic-dermatitis claim. Claim 5 narrows the claim to humans, while claim 4 narrows it to oral administration.

The claim language does not require:

Topical administration.
A particular severity of atopic dermatitis.
Failure of corticosteroid therapy.
Use in adults or children.
A particular JAK biomarker.
Combination therapy.

The oral-use dependent claim does not exclude other routes from claim 1. A non-oral administration may remain within claim 1 if the other claim elements are met.

The commercial significance of these claims is limited by regulatory status. Tofacitinib has not been the principal FDA-approved systemic treatment for atopic dermatitis. A company marketing tofacitinib for that indication would face method-of-use patent exposure even if the product had regulatory approval for another disease.

What is the legal scope of the ulcerative-colitis claims?

Claims 7 through 12 cover treatment of ulcerative colitis. This is the strongest commercial portion of the patent because Xeljanz received FDA approval for moderately to severely active ulcerative colitis in adults who had an inadequate response or intolerance to tumor necrosis factor blockers, subject to the approved labeling conditions.

The claim language is broader than the FDA indication in several respects. It does not expressly require:

Moderate-to-severe disease.
Adult patients.
Prior TNF-blocker failure.
Induction followed by maintenance treatment.
A particular dosage schedule.
Tofacitinib citrate rather than the free base.

A generic applicant may still avoid an infringement claim by pursuing a label that omits ulcerative-colitis use. The risk increases if the proposed label, promotional material, product information, or prescribing instructions encourage use for ulcerative colitis.

What is the legal scope of the Crohn's-disease claims?

Claims 13 through 18 cover treatment of Crohn's disease. The claims use the same structure as the ulcerative-colitis claims and cover tofacitinib, salts, oral administration, human treatment, and combination therapy.

Tofacitinib has not become a principal FDA-approved therapy for Crohn's disease in the same way it has for ulcerative colitis. The Crohn's claims therefore have greater pipeline and off-label-use relevance than direct current-label relevance.

These claims can still matter in several situations:

A clinical trial using tofacitinib for Crohn's disease.
An investigational product supplied for Crohn's disease.
A label or promotional campaign that encourages Crohn's-disease use.
A combination regimen in which tofacitinib is administered with another immunomodulator or anti-inflammatory.
A later regulatory submission seeking a Crohn's-disease indication.

What salts are protected by US 7,842,699?

The salt claims enumerate the following categories:

Hydrochloride
Hydrobromide
Hydroiodide
Nitrate
Sulfate
Bisulfate
Phosphate
Acid phosphate
Acetate
Lactate
Citrate
Acid citrate
Tartrate
Bitartrate
Succinate
Maleate
Fumarate
Gluconate
Saccharate
Benzoate
Methanesulfonate
Ethanesulfonate
Benzenesulfonate
p-Toluenesulfonate
Pamoate

Tofacitinib citrate is the principal commercial salt associated with Xeljanz. The patent's salt claims are not limited to citrate, so a developer cannot necessarily avoid the claims by selecting another listed pharmaceutically acceptable salt.

The claims do not expressly cover every possible salt without limitation. A salt must fall within the claim language and satisfy the pharmaceutical-acceptability and treatment requirements.

When does US Patent 7,842,699 lose exclusivity?

The patent issued on November 30, 2010. Its term is governed by the 20-year patent term measured from the applicable nonprovisional or international filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and other statutory adjustments.

Public patent records associate the patent with an August 31, 2007 filing date and an August 31, 2027 nominal expiration date. The controlling legal expiration date is the expiration date shown in the USPTO record after any patent-term adjustment. The patent's practical blocking effect can also differ from its nominal expiration because:

FDA-listed patents may have different relevance by indication.
A generic may use a section viii statement to carve out patented uses.
Patent litigation may resolve before expiration.
Settlement agreements may provide an agreed launch date earlier than the patent expiration.
Separate compound, formulation, or crystalline-form patents may expire on different dates.

Patent-term profile

Event	Date or status
Earliest associated priority period	2006 priority period
U.S. filing	August 31, 2007, as reflected in public patent records
Patent publication	2008 publication period
Patent grant	November 30, 2010
Nominal term endpoint	August 31, 2027
Practical generic-risk period	Dependent on Orange Book listings, ANDA challenges, and settlements

What is the Orange Book status of US 7,842,699?

US 7,842,699 has been associated with the Xeljanz patent estate and is relevant principally to the ulcerative-colitis indication. FDA Orange Book relevance depends on whether the patent is listed against the applicable approved product and whether the patent claims an approved method of use.

For a small-molecule product, an ANDA applicant generally must address listed patents through one of four mechanisms:

Paragraph I certification: no patent information is listed.
Paragraph II certification: the patent has expired.
Paragraph III certification: the applicant will wait until patent expiration.
Paragraph IV certification: the listed patent is invalid, unenforceable, or will not be infringed.

A generic company may also use a section viii statement to omit a patented method of use from its label where the FDA-approved product has other non-patented uses.

The patent does not automatically block every tofacitinib generic. Its practical impact depends on the combination of:

The ANDA's proposed label.
The FDA-listed use code.
Other Xeljanz patents.
The applicant's paragraph IV position.
Induced-infringement evidence.
Any settlement or launch agreement.

Which other patents are important in the tofacitinib landscape?

US 7,842,699 is one component of a broader tofacitinib estate.

Patent category	Typical protection	Strategic relevance
Compound patents	Tofacitinib and related JAK inhibitors	Core molecule protection
Salt patents	Tofacitinib citrate and other salts	Protect commercial active form
Formulation patents	Immediate-release or extended-release dosage forms	Can delay or complicate generic substitution
Method patents	Rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and other diseases	Indication-specific barriers
Dosing patents	Dose selection, induction, maintenance, or risk-management regimens	May create narrower but commercially relevant barriers
Manufacturing patents	Intermediates, synthesis, purification, and crystallization	Can raise supply-chain and development costs
Regulatory exclusivity	New chemical entity, pediatric, or indication exclusivity	Separate from patent rights

The basic tofacitinib compound estate, including patents associated with US 7,713,942 and US 7,820,666, has historically been more important for broad product exclusivity than US 7,842,699. The method patent becomes more important as compound-patent protection expires because an applicant may still face indication-specific litigation.

How does US 7,842,699 compare with competing JAK patent estates?

Drug	Company associated with originator product	Main U.S. use areas	Patent-risk profile
Tofacitinib	Pfizer	Rheumatoid arthritis, psoriatic arthritis, ulcerative colitis	Mature estate; multiple compound, use, formulation and regulatory layers
Upadacitinib	AbbVie	Rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn's disease	Later-generation estate with significant formulation and method-of-use protection
Abrocitinib	Pfizer	Atopic dermatitis	Smaller commercial footprint than Xeljanz but relevant atopic-dermatitis patent coverage
Baricitinib	Eli Lilly and Incyte	Rheumatoid arthritis, alopecia areata, COVID-19	Distinct compound and method estate
Deucravacitinib	Bristol Myers Squibb	Psoriasis	TYK2-focused estate rather than a direct tofacitinib substitute
Ozanimod	Bristol Myers Squibb	Ulcerative colitis and multiple sclerosis	S1P-modulator estate, not chemically overlapping with tofacitinib

US 7,842,699 does not create direct chemical overlap with these competing products. Its risk is indication-specific. A competitor launching a different JAK inhibitor generally does not infringe the patent merely by treating the same disease. Infringement would require practice of the claimed tofacitinib treatment method.

What generic launch scenarios exist for tofacitinib?

Scenario 1: Full-label generic launch after patent expiry

A generic applicant waits until expiration of the relevant listed patents and launches with the approved indications. This is the lowest litigation-risk route but delays commercial entry.

Scenario 2: Paragraph IV challenge

The applicant certifies that US 7,842,699 is invalid, unenforceable, or not infringed. The certification can trigger patent litigation and a potential 30-month FDA approval stay under the Hatch-Waxman framework.

Scenario 3: Section viii carve-out

The applicant removes ulcerative-colitis language or another patented indication from its label. This approach can avoid direct label overlap but does not eliminate all induced-infringement risk.

Scenario 4: Settlement-based launch

The applicant agrees to a delayed launch date, potentially before the nominal patent expiration. The commercial value of the settlement depends on the remaining term of the compound and formulation patents.

Scenario 5: Narrow indication launch

The applicant launches only for non-patented indications, if permitted by the relevant Orange Book use codes and other patent claims.

What litigation and settlement issues affect the patent?

The key litigation questions are claim-specific:

Whether the proposed generic label encourages ulcerative-colitis treatment.
Whether the product is tofacitinib or a covered salt.
Whether the use is treatment of the claimed disease.
Whether the patent is valid under written-description, enablement, anticipation, or obviousness standards.
Whether the asserted claims are enforceable.
Whether the patent is properly listed for the relevant product and use.
Whether the proposed label creates induced infringement.

The patent's disease-specific claims may be attacked on traditional validity grounds. The most relevant technical issues include whether the specification adequately supports treatment of each claimed disease and whether the claimed therapeutic result was enabled across the full scope of the disease claims. The claims use broad "therapeutically effective amount" language and do not identify a fixed dose, which can increase both flexibility and litigation exposure.

No conclusion about a particular paragraph IV defendant, settlement date, or pending case should be drawn from the patent number alone. Those facts depend on current USPTO, FDA, PACER, and settlement records.

How strong is the patent estate around US 7,842,699?

The patent has moderate-to-strong indication coverage but limited standalone product coverage.

Strength factor	Assessment
Chemical coverage	Weak as a standalone patent because the compound is not claimed as such
Disease coverage	Strong for the three named diseases
Salt coverage	Broad, subject to the listed salt categories
Route coverage	Broad independent claims, with separate oral-use claims
Dose coverage	No specific dose requirement
Human-use coverage	Expressly protected in claim 5 and analogous dependent structures
Combination coverage	Broad but dependent on an additional agent being administered
Regulatory relevance	Highest for ulcerative colitis
Generic-carve-out exposure	Material
Manufacturing barrier	None in this patent
Biosimilar relevance	None

The patent is most valuable as an indication patent supporting Xeljanz's ulcerative-colitis exclusivity. It is less effective against a generic that can lawfully omit the patented indication. It does not independently prevent manufacture of tofacitinib or sale for every disease.

Does biosimilar risk apply to tofacitinib?

No. Tofacitinib is a chemically synthesized small molecule, not a biologic. The relevant competitive threat is an ANDA generic, not a biosimilar under the Biologics Price Competition and Innovation Act.

Generic risk centers on:

Paragraph IV certifications.
Section viii label carve-outs.
Orange Book patent listings.
Product and formulation patents.
Induced-infringement theories.
Authorized-generic or settlement arrangements.

Key Takeaways

US 7,842,699 is a method-of-treatment patent covering tofacitinib for atopic dermatitis, ulcerative colitis, and Crohn's disease.
Claims 1, 7, and 13 are the core independent claims.
The patent covers tofacitinib and specified pharmaceutically acceptable salts, including citrate.
It does not claim the chemical compound, a formulation, a specific dose, or a manufacturing process.
The ulcerative-colitis claims have the strongest commercial relevance because they align with an FDA-approved Xeljanz indication.
The nominal patent expiration is associated with August 31, 2027, subject to the controlling USPTO term calculation.
Generic applicants may challenge the patent under paragraph IV or attempt a section viii indication carve-out.
Tofacitinib faces generic, not biosimilar, competition.
The patent's standalone strength is moderate because its protection is indication-specific and does not independently block all tofacitinib products.
The broader tofacitinib estate includes separate compound, salt, formulation, dosing, and regulatory protections.

FAQs

Can a generic sell tofacitinib for rheumatoid arthritis without infringing US 7,842,699?

Potentially. Rheumatoid arthritis is not recited in the asserted claims provided. The generic must still evaluate other tofacitinib patents, FDA use codes, label language, and induced-infringement risk.

Does tofacitinib citrate fall within US 7,842,699?

Yes, the claims cover pharmaceutically acceptable salts and expressly include citrate among the enumerated salt categories.

Does the patent cover topical tofacitinib for atopic dermatitis?

Claim 1 does not specify an administration route. Claims 4, 10, and 16 specifically address oral administration but do not necessarily exclude other routes from the broader independent claims. The actual infringement analysis would depend on claim construction and the product's use.

Is US 7,842,699 a formulation patent for Xeljanz XR?

No. The supplied claims do not recite an extended-release matrix, excipient, dissolution profile, tablet structure, or other formulation limitation.

Can a company develop a different JAK inhibitor without infringing this patent?

Yes. The patent claims treatment using the specifically identified tofacitinib molecule or its covered salts. A different JAK inhibitor does not meet that active-ingredient limitation.

References

United States Patent and Trademark Office. (2010). US Patent No. 7,842,699 B2: Methods of treating diseases using a JAK inhibitor. U.S. Department of Commerce.
U.S. Food and Drug Administration. (2024). Xeljanz (tofacitinib) prescribing information. Pfizer Laboratories.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.
U.S. Food and Drug Administration. (2024). Approved drug product labeling and patent information for Xeljanz and Xeljanz XR. U.S. Department of Health and Human Services.
United States Code, 35 U.S.C. §§ 154, 271, 281, and 355.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1235830	⤷ Start Trial	C01235830/01	Switzerland	⤷ Start Trial
African Regional IP Organization (ARIPO)	1905	⤷ Start Trial
Argentina	026534	⤷ Start Trial
Austria	257157	⤷ Start Trial
Austria	380031	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 7,842,699

Summary for Patent: 7,842,699