Details for Patent: 8,013,002

Which drugs does patent 8,013,002 protect, and when does it expire?

Patent 8,013,002 protects ESBRIET and is included in two NDAs.

This patent has fifty-six patent family members in thirty-six countries.

Summary for Patent: 8,013,002

Title:	Methods of administering pirfenidone therapy
Abstract:	The present invention relates to methods involving avoiding adverse drug interactions with fluvoxamine and pirfenidone or other moderate to strong inhibitors of CYP enzymes.
Inventor(s):	Williamson Ziegler Bradford, Javier Szwarcberg
Assignee:	Legacy Pharma Inc Sezc
Application Number:	US13/049,894
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,013,002
Patent Claim Types: see list of patent claims	Use;

United States Patent 8,013,002: Scope, Claims, Expiration, and Pirfenidone Patent Landscape

US Patent 8,013,002 protects a narrow dosing protocol for pirfenidone when administered with fluvoxamine, a strong CYP1A2 inhibitor. Its core commercial relevance is the reduced pirfenidone regimen used when fluvoxamine increases pirfenidone exposure. The principal claimed regimen is approximately 800 to 801 mg/day, generally administered three times daily, followed by restoration of approximately 2,400 mg/day after fluvoxamine is discontinued.

The patent is a method-of-treatment patent. It does not broadly claim pirfenidone, fluvoxamine, a tablet, a formulation, or the chemical combination itself. Its enforceability depends on proving the claimed co-administration, dose reduction, patient treatment, and, for narrower claims, IPF and food-related limitations.

The patent has a nominal 20-year term measured from its earliest effective nonprovisional filing date, placing expiration in September 2026, subject to any applicable patent-term adjustment or extension recorded by the USPTO. The commercial impact is concentrated in branded Esbriet use involving fluvoxamine rather than ordinary pirfenidone monotherapy.

What does US Patent 8,013,002 cover?

US 8,013,002 covers methods for adjusting pirfenidone dosing during concurrent administration of fluvoxamine. The claims address two related clinical sequences:

1. Administering pirfenidone at approximately 801 mg/day while administering fluvoxamine.
2. Reducing pirfenidone from approximately 2,400 mg/day to approximately 800 mg/day during fluvoxamine co-administration, then restoring the higher pirfenidone dose after fluvoxamine is stopped.

The patent therefore targets a drug-drug interaction management protocol. The claimed subject matter is narrower than a general claim to treating IPF with pirfenidone.

Patent identification

Item	Information
Patent	US 8,013,002 B2
Technology	Pirfenidone dosing during fluvoxamine co-administration
Therapeutic area	Idiopathic pulmonary fibrosis and fibrotic disease treatment
Claim type	Method of treatment and dose-adjustment claims
Core drugs	Pirfenidone and fluvoxamine
Primary commercial product	Esbriet
Patent holder lineage	InterMune-related patent estate, later associated with Roche/Genentech following the InterMune acquisition
Earliest priority	September 2005, based on the published patent family record
Issue date	September 6, 2011
Nominal expiration	September 2026
Regulatory relevance	Drug-drug interaction dosing reflected in the Esbriet prescribing information

The USPTO patent record and patent-family data control the final expiration calculation, including any patent-term adjustment. [1]

How should independent claim 1 be interpreted?

Claim 1 requires all of the following:

• A method of administering pirfenidone and fluvoxamine concurrently.
• A patient in need of treatment.
• A therapeutically effective amount of fluvoxamine.
• A therapeutically effective amount of pirfenidone.
• Pirfenidone administered at approximately 801 mg/day.

The claim does not expressly require IPF. IPF appears in dependent claim 3. Claim 1 can therefore reach a patient receiving the claimed drug combination for another condition, provided the other elements are satisfied.

The term "about 801 mg/day" creates a claim-construction issue. A literal reading identifies approximately 801 mg per day, while clinical dosing commonly uses 267 mg three times daily, which totals 801 mg/day. The claim appears designed to capture the 267 mg tablet administered three times daily rather than a single daily dose.

The claim also requires concurrent administration. A short overlap or same-treatment-period administration may satisfy the concurrency requirement, but merely prescribing fluvoxamine and pirfenidone at different times without an overlapping treatment period would present a weaker infringement case.

What do dependent claims 2 through 5 add?

Claim 2: three-times-daily administration

Claim 2 narrows claim 1 by requiring pirfenidone administration three times daily. At approximately 801 mg/day, the expected dose is approximately 267 mg per administration.

This limitation maps closely to the commercial pirfenidone tablet strength and the reduced-dose regimen described in the FDA labeling. [2]

Claim 3: idiopathic pulmonary fibrosis

Claim 3 adds IPF. An accused regimen must involve a patient with idiopathic pulmonary fibrosis.

This limitation materially narrows the claim because a fluvoxamine-pirfenidone regimen for another fibrotic disorder would fall outside claim 3, although it could remain within claim 1 or claim 2.

Claim 4: administration with food

Claim 4 requires administering pirfenidone with food. This limitation aligns with the Esbriet label, which instructs patients to take pirfenidone with food to reduce gastrointestinal adverse reactions and improve tolerability. [2]

The phrase "with food" generally requires administration in connection with a meal or food intake. A prescribing instruction alone may not establish that the patient actually followed the limitation unless the relevant infringement theory includes inducement based on labeling.

Claim 5: stopping fluvoxamine and continuing pirfenidone

Claim 5 requires:

1. Initial co-administration of fluvoxamine and pirfenidone; and
2. Discontinuation of fluvoxamine; and
3. Subsequent administration of a therapeutically effective amount of pirfenidone.

The claim does not specify the post-discontinuation pirfenidone dose. It can therefore cover a broad range of effective post-fluvoxamine pirfenidone regimens, subject to the limitations inherited from claim 1.

What does independent claim 6 cover?

Claim 6 is the second principal claim group. It requires:

• Providing pirfenidone therapy to a patient in need.
• Titrating pirfenidone downward from approximately 2,400 mg/day.
• Co-administering fluvoxamine during the dose reduction.
• Reducing the pirfenidone dose by approximately 1,600 mg/day.

The mathematical endpoint is approximately 800 mg/day. The claim is directed to a dose-transition process rather than simply administering low-dose pirfenidone with fluvoxamine.

This distinction matters. An accused party that starts a patient directly at approximately 800 mg/day with fluvoxamine may implicate claim 1 but may not satisfy claim 6 because claim 6 requires titration downward from approximately 2,400 mg/day.

Claim 7: approximately 800 mg/day

Claim 7 adds the approximate 800 mg/day endpoint. The difference between 800 mg/day in claims 6 and 7 and 801 mg/day in claim 1 reflects the use of "about" and likely addresses practical dosing with 267 mg tablets.

The 800/801 mg distinction is unlikely to be clinically material, but it can be legally significant. A court would likely evaluate the numerical ranges, specification disclosures, prosecution history, and whether the terms were used consistently during prosecution.

Claims 8 through 10: administration frequency, IPF, and food

These claims add the same narrowing concepts found in claims 2 through 4:

• Three-times-daily dosing.
• Treatment of IPF.
• Administration with food.

Claims 8 through 10 are narrower and more fact-dependent than claim 6. They may be easier to prove when a product label expressly instructs the full regimen, but they also contain more limitations that an accused party can attempt to avoid.

Claim 11: restoration of the higher dose

Claim 11 requires discontinuation of fluvoxamine followed by administration of approximately 2,400 mg/day of pirfenidone.

This claim protects the reverse transition. It is not limited to the initial downward titration unless the inherited limitations of claim 6 are satisfied. Because claim 11 depends on claim 6, the sequence must begin with the claimed reduction from approximately 2,400 mg/day while fluvoxamine is co-administered.

What is the strongest claim coverage in US 8,013,002?

The strongest practical coverage is concentrated in claims 1, 2, 6, and 7.

Claim group	Core limitation	Commercial relevance	Main vulnerability
1	Pirfenidone plus fluvoxamine at about 801 mg/day	Broadest reduced-dose combination claim	Requires proof of concurrent administration and dose
2	Claim 1 plus three daily doses	Maps to 267 mg three times daily	Additional frequency limitation
3-4	Claim 2 plus IPF and food	Closely tracks labeled IPF use	Narrower patient and administration requirements
5	Stop fluvoxamine and continue pirfenidone	Covers post-interaction management	No specific post-discontinuation dose
6	Down-titrate from about 2,400 mg/day by about 1,600 mg/day during fluvoxamine use	Protects clinical dose-adjustment protocol	Requires proof of prior dose, titration, and amount of reduction
7-10	Claim 6 plus approximately 800 mg/day, frequency, IPF, and food	Closest to the labeled reduced regimen	Multiple cumulative limitations
11	Restore about 2,400 mg/day after stopping fluvoxamine	Covers dose escalation after inhibitor withdrawal	Depends on all claim 6 limitations

Claim 1 is the broadest operational claim. Claim 6 may provide stronger protection against a protocol that follows the exact dose-reduction sequence but could be avoided by initiating therapy at the lower dose.

How does the patent relate to the FDA-approved Esbriet dosing regimen?

The FDA-approved Esbriet labeling recommends titration to a maintenance dosage of 801 mg three times daily, or 2,403 mg/day, for eligible IPF patients. The label also addresses dose modification when pirfenidone is administered with strong CYP1A2 inhibitors, including fluvoxamine. [2]

The supplied claims use approximately 2,400 mg/day and approximately 801 mg/day. The labeled maintenance dose of 801 mg three times daily totals 2,403 mg/day, while the reduced regimen of 267 mg three times daily totals 801 mg/day.

Clinical situation	Approximate pirfenidone dose	Claim relevance
Standard maintenance	801 mg three times daily, or 2,403 mg/day	Starting point for claim 6
During fluvoxamine use	267 mg three times daily, or 801 mg/day	Central to claims 1-4 and 7-10
Reduction amount	Approximately 1,600 mg/day	Central to claim 6
After fluvoxamine discontinuation	Return to approximately 2,400 mg/day	Claim 11

The label creates potential inducement risk because a generic or branded label that instructs the exact patented interaction-management protocol may encourage performance of the claimed method. A product sale alone does not necessarily establish direct infringement of a method claim. The relevant analysis would focus on prescribing information, promotional materials, clinical support, and physician or patient conduct.

What is the Orange Book status of US 8,013,002?

US 8,013,002 is associated with the Esbriet patent estate and concerns a method of using pirfenidone for which FDA-approved labeling has interaction-related dosing instructions. The Orange Book is the controlling source for the current listing, use code, expiration date, and any delisting or dispute history. [3]

For an abbreviated new drug application, the practical issues are:

• Whether the patent is listed against the relevant pirfenidone strength and dosage form.
• Whether the listed use code covers fluvoxamine-related dose reduction.
• Whether an applicant must file a Paragraph IV certification.
• Whether the applicant can use a section viii statement to omit the patented use.
• Whether the proposed label still induces the patented method.

A section viii strategy may be difficult if the reduced-dose interaction instructions remain in the proposed label. Removing the patented use from labeling may reduce inducement exposure, but the FDA-approved labeling must remain adequate for safe use.

When does US 8,013,002 lose exclusivity?

The nominal patent expiration is in September 2026 based on the patent family’s 2005 priority and 2006 filing history. The patent’s actual enforceable expiration depends on the USPTO-calculated patent-term adjustment and any applicable extension. [1]

The commercial exclusivity timeline is separate from patent expiration:

Exclusivity mechanism	Relevance
Patent term	Primary barrier for this dosing method
New chemical entity exclusivity	Relevant to the original pirfenidone approval, but not a current barrier to a later generic filing
Three-year clinical investigation exclusivity	May protect a new approved use or dosage form if applicable
Pediatric exclusivity	Could add six months if granted and applicable
Orange Book listing	Determines certification and litigation consequences for ANDA applicants
Method-of-use patent	Can remain relevant even when composition or formulation protection is weaker

The existence of an approved generic pirfenidone product does not necessarily eliminate method-patent risk. A generic may launch for unpatented uses while carving out or omitting the patented fluvoxamine-related use.

Which companies are relevant to the pirfenidone patent landscape?

The principal commercial entities are Roche and Genentech, following Roche’s acquisition of InterMune, and generic manufacturers seeking approval for pirfenidone tablets or capsules.

Innovator and license-chain considerations

Pirfenidone was developed through a patent and commercialization history involving Shionogi and InterMune. Roche acquired InterMune in 2014 and obtained control of the Esbriet business and associated intellectual-property assets. [4]

The relevant rights may differ by jurisdiction and patent family. A commercial review should distinguish:

• Patent ownership.
• Exclusive commercialization rights.
• Manufacturing rights.
• Regulatory sponsorship.
• Territory-specific licenses.
• Patent prosecution control.
• Litigation and settlement rights.

Generic manufacturers

Generic competition focuses mainly on pirfenidone composition, dosage form, and ordinary IPF treatment. A generic company can seek approval through an ANDA and address listed patents through Paragraph IV certifications or a section viii statement.

The principal generic launch risks are:

1. A Paragraph IV challenge to listed patents.
2. A 30-month stay following timely patent litigation.
3. Induced infringement based on interaction-management labeling.
4. Inability to remove fluvoxamine dose-adjustment language because of FDA safety requirements.
5. Separate formulation or manufacturing patents.
6. Commercial launch before final resolution subject to at-risk litigation exposure.

What Paragraph IV challenges could affect this patent?

A Paragraph IV challenge to US 8,013,002 could attack patentability or enforceability on several grounds:

Lack of novelty

The challenger could argue that prior art disclosed:

• Pirfenidone use in IPF.
• Fluvoxamine inhibition of CYP1A2.
• Increased pirfenidone exposure caused by CYP1A2 inhibition.
• Dose reduction to approximately 800 mg/day.
• Restoration of the ordinary pirfenidone dose after inhibitor withdrawal.

The strongest novelty defense would require a single prior-art reference disclosing every claim element.

Obviousness

Obviousness would likely be the more substantial challenge. A challenger could combine:

• Known pirfenidone pharmacokinetics.
• Fluvoxamine’s CYP1A2 inhibition.
• The FDA-approved pirfenidone dose.
• Routine dose-reduction principles for strong metabolic inhibitors.
• Clinical interaction data or pharmacokinetic modeling.

The patent holder would rely on unexpected exposure, safety, tolerability, or efficacy results and the specific magnitude of the claimed reduction.

Indefiniteness

Potential indefiniteness issues include:

• The boundaries of "about 801 mg/day."
• The relationship between 800 mg/day and 801 mg/day.
• The meaning of "therapeutically effective amount" of fluvoxamine.
• The degree of reduction required by "about 1,600 mg/day."
• The meaning of "concurrently."

The use of approximate numerical terms is common in pharmaceutical claims, but the specification must provide an objective basis for determining the scope.

Written description and enablement

A challenger could argue that the specification does not support the full range encompassed by "about," or does not enable all methods covered by broad claims involving any therapeutically effective fluvoxamine dose, patient population, or treatment context.

What formulation patents and manufacturing barriers remain relevant?

US 8,013,002 is not a formulation patent. It does not claim:

• A particular pirfenidone polymorph.
• A tablet coating.
• An extended-release formulation.
• A specific excipient system.
• A capsule or tablet architecture.
• A manufacturing process.
• A purification method.

The broader pirfenidone estate may contain separate composition, formulation, process, or use patents. Those rights must be analyzed independently from US 8,013,002.

For generic entry, formulation and manufacturing barriers can be more commercially important than this interaction patent if:

• The generic uses the same 267 mg and 801 mg strengths.
• The FDA label includes the patented interaction instructions.
• A formulation patent remains unexpired.
• The product requires a controlled-release or specialized dosage form.
• The manufacturing process is protected or difficult to replicate.

Pirfenidone is a small molecule. Biosimilar risk is therefore not applicable. Competition proceeds through the generic-drug pathway rather than the biosimilar pathway under the Public Health Service Act. [5]

How does pirfenidone patent risk compare with nintedanib?

Pirfenidone and nintedanib compete in IPF, but their patent risks differ.

Issue	Pirfenidone	Nintedanib
Drug type	Small molecule	Small molecule
Main branded product	Esbriet	Ofev
Primary mechanism	Antifibrotic activity with complex pharmacology	Tyrosine kinase inhibition
Generic pathway	ANDA	ANDA
Biosimilar pathway	Not applicable	Not applicable
Interaction patent at issue	Fluvoxamine-related dose reduction	Different interaction and dosing estate
Key commercial risk	Method-of-use and formulation patents	Composition, formulation, and method patents
Clinical overlap	IPF and fibrotic lung disease	IPF and progressive fibrosing interstitial lung disease

US 8,013,002 is unusually specific because it claims a drug-drug interaction protocol rather than the primary pirfenidone treatment method.

What litigation and settlement issues affect the patent?

A current litigation conclusion cannot be derived from the claim text alone. The relevant sources are PACER, USPTO assignment and litigation records, FDA Paragraph IV notices where publicly available, and the Orange Book patent dispute information.

For this patent, litigation would likely focus on:

• Whether the proposed generic label induces the claimed method.
• Whether the label can omit fluvoxamine-related dosing information.
• The scope of "about 800" or "about 801 mg/day."
• Whether the claimed dose reduction was obvious.
• Whether a generic product can launch with a carved-out label.
• Whether post-launch physician conduct satisfies the concurrent-administration limitations.

Settlement agreements would require review of the FTC pharmaceutical patent-settlement database and the parties’ court filings. A standard settlement could provide a licensed entry date before patent expiration, but no settlement term should be inferred from the patent record alone. [6]

How strong is the patent estate for US 8,013,002?

The patent is strongest when the accused conduct follows the labeled clinical sequence:

1. Patient receives approximately 2,400 mg/day of pirfenidone.
2. Fluvoxamine is initiated.
3. Pirfenidone is reduced by approximately 1,600 mg/day.
4. Pirfenidone is administered approximately three times daily at approximately 267 mg per dose.
5. The patient has IPF.
6. Pirfenidone is taken with food.
7. Fluvoxamine is later discontinued.
8. Pirfenidone is restored to approximately 2,400 mg/day.

Its weaknesses are structural:

• It does not block pirfenidone monotherapy.
• It does not block pirfenidone for all IPF patients.
• It does not block other CYP1A2 inhibitors unless the claims are interpreted to cover them, which they are not.
• It does not block a regimen that avoids fluvoxamine.
• It may not cover a patient started directly at the reduced dose without prior 2,400 mg/day treatment.
• The approximate numerical terms create litigation risk.
• The patent’s remaining life is short relative to a new commercial launch.

What generic launch scenarios exist?

Scenario 1: Full-label generic launch after patent expiration

The generic launches with the full FDA-approved pirfenidone labeling after the patent expires. This presents the lowest patent risk.

Scenario 2: Paragraph IV challenge

The generic challenges US 8,013,002 before expiration. The patent holder may sue within 45 days, potentially triggering the statutory 30-month stay under the Hatch-Waxman framework. [7]

Scenario 3: Section viii carve-out

The generic omits the patented fluvoxamine-related use if FDA labeling and safety requirements permit. This reduces label-based inducement risk but does not eliminate all off-label use or other patent exposure.

Scenario 4: At-risk launch

The generic launches before final resolution after litigation or an unfavorable preliminary assessment. This creates potential damages and injunction exposure.

Scenario 5: Settlement-based entry

The generic receives a contractually defined entry date, potentially before September 2026, in exchange for resolving the patent dispute.

What is the geographic coverage of US 8,013,002?

US 8,013,002 has territorial effect only in the United States. It does not directly block:

• Pirfenidone use in Europe.
• Pirfenidone use in Japan.
• Canadian or Australian sales.
• Foreign manufacturing unless the activity creates a US infringement theory.
• Importation into the United States where the relevant statutory requirements are met.

International risk requires separate review of corresponding patent-family members, national-phase filings, expiration dates, opposition proceedings, supplementary protection certificates, and local regulatory exclusivity. The US patent should not be treated as a global right.

Key Takeaways

• US 8,013,002 is a narrow method patent covering pirfenidone dose reduction during fluvoxamine co-administration.
• The central claimed dose is approximately 800 to 801 mg/day, usually 267 mg three times daily.
• The patent also covers reducing pirfenidone from approximately 2,400 mg/day by approximately 1,600 mg/day.
• Claims 3, 4, 9, and 10 narrow the scope to IPF and administration with food.
• Claim 11 covers restoration of approximately 2,400 mg/day after fluvoxamine discontinuation.
• The patent does not claim pirfenidone itself, an Esbriet formulation, or ordinary IPF treatment without fluvoxamine.
• The nominal expiration is in September 2026, subject to the USPTO term calculation.
• Generic risk is concentrated in labeling, Paragraph IV certification, inducement, and the ability to carve out the patented use.
• Biosimilar analysis is irrelevant because pirfenidone is a small molecule.
• The strongest infringement scenario follows the exact labeled dose-reduction and dose-restoration sequence.

FAQs

Does US 8,013,002 cover all pirfenidone treatment for IPF?

No. It covers specific methods involving concurrent fluvoxamine administration and defined pirfenidone dose adjustments. Ordinary pirfenidone treatment without fluvoxamine is outside the principal scope of this patent.

Does taking pirfenidone and fluvoxamine on the same day infringe claim 1?

Potentially, but same-day use alone may not establish every limitation. The claim requires concurrent administration, therapeutically effective amounts of both drugs, and approximately 801 mg/day of pirfenidone.

Is 267 mg three times daily equivalent to 801 mg/day?

Yes, arithmetically. Three doses of 267 mg total 801 mg/day. That regimen is the clearest commercial embodiment of the reduced-dose limitation.

Can a generic omit the fluvoxamine dosing instructions?

A generic may seek a section viii carve-out, but the FDA must accept the proposed labeling and the omitted use must be separable from required safety information. The patent and regulatory analyses are distinct.

Does Roche still control every patent related to pirfenidone?

Not necessarily. Ownership, licensing, and expiration can differ by patent family, country, and asset. Roche’s acquisition of InterMune transferred the Esbriet business and related rights, but each patent record and assignment chain must be reviewed separately.

References

1. United States Patent and Trademark Office. (2011). US Patent No. 8,013,002 B2, Methods for administering pirfenidone with fluvoxamine. U.S. Department of Commerce.

2. U.S. Food and Drug Administration. (2023). Esbriet (pirfenidone) prescribing information. Genentech USA, Inc.

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.

4. F. Hoffmann-La Roche Ltd. (2014). Roche completes acquisition of InterMune. Roche corporate transaction release.

5. U.S. Food and Drug Administration. (2024). Biosimilar and interchangeable biosimilar products. U.S. Department of Health and Human Services.

6. Federal Trade Commission. (2024). Agreements filed under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. Federal Trade Commission.

7. 21 U.S.C. § 355(j). (2024). Abbreviated applications for new drugs and patent certifications. U.S. Code.

Drugs Protected by US Patent 8,013,002

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Legacy	ESBRIET	pirfenidone	CAPSULE;ORAL	022535-001	Oct 15, 2014	AB	RX	Yes	Yes	8,013,002					METHOD FOR ADMINISTERING PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Legacy	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No	8,013,002					ADMINISTERING PIRFENIDONE CONCURRENTLY WITH FLUVOXAMINE, THE PIRFENIDONE AT A DOSE OF ABOUT 801 MG/DAY TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Legacy	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No	8,013,002					MODIFYING PIRFENIDONE ADMINISTRATION FROM A DOSE OF ABOUT 2400 MG/DAY DOWNWARD BY ABOUT 1600 MG/DAY WHILE CO-ADMINISTERING FLUVOXAMINE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Legacy	ESBRIET	pirfenidone	TABLET;ORAL	208780-002	Jan 11, 2017		DISCN	Yes	No	8,013,002					ADMINISTERING PIRFENIDONE CONCURRENTLY WITH FLUVOXAMINE, THE PIRFENIDONE AT A DOSE OF ABOUT 801 MG/DAY TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE

International Family Members for US Patent 8,013,002

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	3155
Austria	E526024
Australia	2010212490
Australia	2011201462