US Patent 12,129,247: Opicapone Parkinson’s Disease Treatment Claims and Patent Landscape

US Patent 12,129,247 covers a specific administration method for opicapone, not the underlying discovery of opicapone itself. The independent claim requires four elements: Parkinson’s disease, oral administration, dosing without food or between food intakes, and concurrent treatment with levodopa. The dependent claims narrow the patent through food-timing windows, bedtime dosing, dose separation from levodopa, once-daily administration, 25 mg or 50 mg dosing, and solid oral dosage forms.

The patent therefore has meaningful value against products or prescribing instructions that intentionally use the claimed administration schedule. It is materially narrower than a composition-of-matter patent and does not, based on the supplied claims, block every opicapone product or every opicapone use.

What drug does US Patent 12,129,247 protect?

The claimed compound is opicapone, also known as BIA 9-1067. Opicapone is a selective catechol-O-methyltransferase inhibitor used as adjunctive therapy to levodopa/carbidopa or levodopa/benserazide in patients with Parkinson’s disease experiencing “off” episodes.[1]

The chemical name in claim 1 identifies the opicapone molecule:

5-[3-(2,5-dichloro-4,6-dimethyl-1-oxy-pyridin-3-yl)-[1,2,4]oxadiazol-5-yl]-3-nitrobenzene-1,2-diol.

The claimed active pharmaceutical ingredient is therefore not a new molecule for purposes of infringement analysis. The apparent inventive focus is the timing and conditions of administration.

Patent feature	Scope under claim 1
Active ingredient	Opicapone or a pharmaceutically acceptable salt
Disease	Parkinson’s disease
Patient	Human patient suffering from Parkinson’s disease
Route	Oral
Food condition	Without food and/or between intakes of food
Combination therapy	Therapeutically effective levodopa
Claim type	Method of treatment
Product form	Not limited in claim 1; claim 17 limits the method to oral solid form

What are the independent and dependent claims?

Claim 1 is the only independent claim in the supplied claim set. Claims 2 through 17 depend directly or indirectly on it.

Claim 1: core method claim

Claim 1 requires the following limitations to be satisfied in combination:

A human patient has Parkinson’s disease.
The patient receives opicapone or a pharmaceutically acceptable salt.
Administration is oral.
Administration occurs without food and/or between food intakes.
The dose is therapeutically effective.
The patient also receives a therapeutically effective amount of levodopa.

A method that omits levodopa would not satisfy the literal requirements of claim 1. A method that administers opicapone with food may also avoid the express food-timing limitation, depending on how the term “without food and/or between intakes of food” is construed and applied to the facts.

Dependent-claim structure

Claims	Limitation added
2	Administration 0.25 to 12 hours after food
3	Administration 0.25 to 2 hours before food
4	Administration less than one hour before sleep, before bedtime, or at bedtime
5	At least one hour after the prior meal and at least one hour before the next meal
6	Single daily dose
7	Administration before or after levodopa
8	Administration 30 to 150 minutes before or after levodopa
9	At least one hour before or after the last daily levodopa dose
10	Levodopa administered sequentially or concomitantly with an AADC inhibitor
11	AADC inhibitor is carbidopa or benserazide
12	0.5 to 6 hours after food
13	0.75 to 4 hours after food
14	0.5 to 1.5 hours before food
15	50 mg per dosing period
16	25 mg per dosing period
17	Oral solid form

Claims 12 and 13 narrow claim 2. Claim 14 narrows claim 3. Claims 10 and 11 narrow the levodopa regimen. Claims 15 and 16 provide alternative dose limitations rather than a combined 25 mg and 50 mg requirement.

How broad is the scope of US Patent 12,129,247?

The patent has a narrow-to-moderate scope. Its commercial relevance is greater than its molecular scope because it can apply to the administration instructions used with a marketed opicapone product.

The principal limitations are:

The treatment must concern Parkinson’s disease.
The patient must be human.
Opicapone must be administered orally.
Levodopa must also be administered.
The opicapone administration must occur without food or between meals.
Several dependent claims require precise spacing from food, sleep, bedtime, or levodopa.

The patent does not appear, from the supplied claims, to cover:

Opicapone as a chemical compound in the abstract.
Every opicapone formulation.
Every opicapone dose.
Opicapone monotherapy.
Nonoral administration.
Parkinson’s disease treatment without levodopa.
Administration expressly taken with food.
Manufacturing processes for opicapone.
Opicapone intermediates or polymorphs unless separately claimed in other patents.

The “and/or” wording in claim 1 increases the potential reach of the food limitation. It may cover administration without food as well as administration between meals. The dependent claims impose more objective timing windows, which can make infringement easier to evaluate but also easier to design around.

What formulation patents are relevant to opicapone?

Claim 17 is a dosage-form limitation, not a conventional formulation claim. It requires that opicapone be administered orally as a solid form. It does not, by itself, require a specific excipient, particle size, dissolution profile, coating, capsule, tablet architecture, or manufacturing process.

This distinction matters:

Patent category	Covered by the supplied claims?
Opicapone molecule	No, not as a standalone composition claim
Pharmaceutically acceptable opicapone salt	Included in claims 1 and 17
Tablet or capsule as a solid oral form	Included by claim 17 when used in the claimed method
Specific excipient combination	Not expressly required
Controlled-release formulation	Not expressly required
Manufacturing process	No
Polymorph or crystalline form	Not expressly required
Bioavailability profile	Not expressly required

A generic or follow-on developer could therefore face separate patent risks from composition, salt, polymorph, formulation, process, or method-of-use patents even if it avoids US Patent 12,129,247.

What is the FDA and Orange Book significance?

Ongentys is the US brand for opicapone. The FDA approved Ongentys capsules in 2020 as adjunctive treatment to levodopa/carbidopa or levodopa/benserazide in adults with Parkinson’s disease experiencing “off” episodes.[1]

The FDA label identifies 50 mg as the recommended dose, taken once daily at bedtime. The label instructs patients to take opicapone without food, with the dose taken at least one hour before and one hour after food.[1] Those instructions closely correspond to the limitations in claims 5, 6, and 15, although the patent’s legal scope depends on the full claim language and the applicable patent record.

FDA label element	Relationship to the supplied claims
Once-daily administration	Claim 6
50 mg dose	Claim 15
Bedtime administration	Claim 4
Without food	Claim 1
At least one hour from food	Claim 5
Adjunct to levodopa	Claim 1
Levodopa/carbidopa or levodopa/benserazide	Claims 10 and 11

An Orange Book listing is legally important because an approved abbreviated new drug application may need to address listed patents through certifications, including a Paragraph IV certification. Patent listing cannot be determined from the claims alone. The relevant FDA Orange Book entry and patent-use-code records control whether a particular patent is listed against Ongentys.[2]

When does opicapone lose regulatory and patent exclusivity?

Regulatory exclusivity and patent exclusivity are separate.

Ongentys received FDA approval in 2020. The product’s five-year new chemical entity exclusivity period would ordinarily prevent submission of an ANDA for five years after approval, subject to statutory exceptions. That period is distinct from later patent protection.[1]

The expiry date for US Patent 12,129,247 depends on its earliest effective nonprovisional priority date, terminal disclaimers, patent-term adjustment, and any applicable patent-term extension. A reliable expiration date cannot be calculated from the claims supplied in the question. The grant number alone does not establish the enforceable expiry date.

For commercial planning, the relevant exclusivity dates are:

Exclusivity layer	Relevance
FDA NCE exclusivity	Delays certain ANDA submissions during the statutory period
Orange Book patent listing	Determines whether the patent must be addressed in an ANDA certification
Method-of-use patent	Can create a Paragraph IV or section viii labeling issue
Patent-term adjustment	May extend the listed patent term
Terminal disclaimer	May limit the term to another patent’s expiration
Patent-term extension	Potentially applies to qualifying regulatory delay, but not automatically

What Paragraph IV challenges could target this patent?

A generic applicant could challenge the patent through a Paragraph IV certification if the patent is listed in the Orange Book and the applicant asserts that the patent is invalid, unenforceable, or will not be infringed.

The most likely legal theories would involve:

Invalidity

Potential issues include:

Lack of novelty if prior art disclosed opicapone administration without food with levodopa.
Obviousness if the prior art taught opicapone, bedtime dosing, fasting administration, and levodopa combination therapy.
Written-description or enablement issues concerning the full breadth of the food-timing language.
Indefiniteness challenges directed to terms such as “without food,” “between intakes of food,” “therapeutically effective,” or “dosing periodicity.”

The strength of these arguments depends on the patent specification, prosecution history, cited prior art, and examiner amendments. The claim text alone does not resolve them.

Noninfringement

A generic applicant could pursue a label that omits or carves out the patented method if FDA law permits a lawful section viii strategy. The practical difficulty is that claims 1 and 17 track the labeled use of opicapone closely. A label instructing patients to take 50 mg once daily at bedtime without food while receiving levodopa would create a substantial inducement risk if the patent is enforceable and listed.

Induced infringement

A generic product does not need to reproduce the patented method in its manufacturing process to face risk. Marketing materials, prescribing information, patient instructions, and dosage recommendations can support an induced-infringement theory if they encourage the claimed regimen.

What generic launch scenarios exist?

Launch scenario	Patent risk
Launch before patent expiry with a full label	High risk if the label directs the claimed fasting, bedtime, levodopa regimen
Paragraph IV challenge	Litigation risk and potential 30-month stay under Hatch-Waxman
Section viii carve-out	Potentially lower risk, but difficult if the patented regimen is central to the approved use
Launch with food instructions	May avoid some method limitations, but could conflict with FDA labeling and clinical performance
Launch after patent expiry	Lower patent risk, subject to other listed patents
At-risk launch after litigation	Exposure to damages, injunction risk, and launch disruption
Product with a different dose	May avoid claims 15 and 16, but not necessarily claim 1 or other claims

A 25 mg product could avoid claim 15, and a dose other than 25 mg or 50 mg could avoid both claims 15 and 16. That change would not necessarily avoid claim 1, which has no fixed dose limitation.

How strong is the patent estate?

The supplied patent has a focused but commercially relevant position.

Strengths

It tracks the FDA-approved use of opicapone.
It combines the active ingredient with levodopa, limiting easy label-based separation.
Claims 5, 6, 11, and 15 align closely with common clinical instructions.
The dependent claims provide multiple fallback positions for litigation.
The method can potentially reach label-driven infringement even when the generic product is chemically identical.

Vulnerabilities

The underlying molecule was known before this patent.
Food restriction and bedtime administration may be vulnerable to obviousness arguments if taught by prior art.
Claims 2, 3, 8, 12, 13, and 14 use timing ranges that may be susceptible to anticipation or obviousness attacks.
A method-of-use claim generally has less universal blocking power than a composition-of-matter claim.
A noninfringing label strategy may be available if the FDA-approved uses can be separated from the patented regimen.
The patent does not expressly claim a specific formulation technology or manufacturing barrier.

Overall, the patent is strongest against a generic label that copies the Ongentys dosing instructions. It is weaker as a barrier to alternative opicapone regimens, nonstandard doses, or products that rely on a legally effective indication carve-out.

Which companies are relevant to the opicapone competitive landscape?

BIAL developed opicapone and commercialized Ongentys. Neurocrine Biosciences became the US commercial partner for Ongentys.[3] The principal competitive products in adjunctive Parkinson’s disease therapy include entacapone, carbidopa/levodopa/entacapone combinations, and other treatments for motor fluctuations.

The key commercial distinction is dosing convenience. Opicapone is administered once daily, while entacapone is generally administered with each levodopa dose. That difference increases the commercial importance of claims 4, 6, 9, and 15 because they correspond to the product’s practical prescribing pattern.

What litigation and settlement issues matter?

The relevant litigation questions are:

Whether US Patent 12,129,247 is listed for Ongentys.
Whether an ANDA applicant has filed a Paragraph IV certification.
Whether the patent owner has sued within the statutory 45-day period.
Whether a settlement grants a licensed entry date.
Whether any agreement includes a launch license, supply arrangement, or authorized-generic provision.
Whether other opicapone patents remain enforceable after this patent is challenged.

A patent settlement can delay generic entry beyond the challenged patent’s ordinary expiration if it contains a commercially structured launch date. Conversely, a settlement may authorize earlier entry without invalidating the patent. The existence and terms of any settlement must be established from court filings, FDA records, or required regulatory disclosures.

What are the main infringement risks for a generic opicapone product?

The highest-risk conduct would include:

A label directing 50 mg once daily at bedtime.
Instructions to take the dose without food.
Instructions to separate opicapone from meals by at least one hour.
Instructions to administer opicapone with levodopa/carbidopa or levodopa/benserazide.
Promotional materials repeating those instructions.
Patient-support materials that encourage the claimed timing regimen.

A product that merely contains opicapone does not automatically infringe the supplied method claims. The risk arises from the intended use, labeling, instructions, and evidence showing that physicians and patients will perform the claimed method.

Key Takeaways

US Patent 12,129,247 is a method-of-treatment patent directed to opicapone use in Parkinson’s disease.
Claim 1 requires oral opicapone, administration without food or between meals, and combination treatment with levodopa.
The dependent claims protect specific food intervals, bedtime dosing, once-daily use, levodopa separation, 25 mg and 50 mg doses, and solid oral administration.
The claims closely track the FDA-approved Ongentys regimen.
The patent does not, on the supplied claims, cover opicapone as a standalone chemical composition or manufacturing process.
Generic risk is highest for a label that copies the 50 mg, once-daily, bedtime, fasting regimen.
A different dose or dosing schedule may avoid certain dependent claims but may not avoid claim 1.
Orange Book listing, Paragraph IV activity, litigation, settlement terms, and the enforceable expiry date require review of the official FDA, USPTO, and court records.

FAQs

Does US Patent 12,129,247 cover Ongentys itself?

No. The supplied claims cover a method of using opicapone with levodopa under specified food and dosing conditions. They are not product-by-process or standalone composition claims.

Can a generic avoid the patent by selling 25 mg opicapone?

Not necessarily. A 25 mg product may fall within claim 16 and could still fall within claim 1. Dose changes alone do not eliminate the core method limitations.

Does taking opicapone with levodopa automatically infringe?

No. The method must also satisfy the oral, Parkinson’s disease, food-timing, and therapeutically effective-dose limitations. Infringement depends on the complete regimen and evidence of intended use.

Are claims 2 and 12 separately important?

Yes. Claim 12 narrows claim 2 to administration 0.5 to 6 hours after food. If claim 2 is invalidated or avoided, claim 12 may remain relevant as a narrower fallback claim if its limitations are satisfied.

Does claim 17 protect a special opicapone tablet formulation?

No. Claim 17 requires administration as an oral solid form. It does not specify particular excipients, release characteristics, particle size, coating, or manufacturing steps.

References

U.S. Food and Drug Administration. (2020). Ongentys (opicapone) prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212489s000lbl.pdf
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/
Neurocrine Biosciences, Inc. (2020). Neurocrine Biosciences announces FDA approval of Ongentys (opicapone) capsules for Parkinson’s disease. https://ir.neurocrine.com
U.S. Patent and Trademark Office. (2024). Patent Center. https://patentcenter.uspto.gov
U.S. Patent and Trademark Office. (2024). Manual of Patent Examining Procedure, patent term and patent litigation provisions. https://www.uspto.gov/web/offices/pac/mpep/index.htm

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-001	Apr 24, 2020		RX	Yes	No	12,129,247	⤷ Start Trial				ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON’S DISEASE EXPERIENCING OFF EPISODES BY ADMINISTERING WITHOUT FOOD	⤷ Start Trial
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-002	Apr 24, 2020		RX	Yes	Yes	12,129,247	⤷ Start Trial				ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON’S DISEASE EXPERIENCING OFF EPISODES BY ADMINISTERING WITHOUT FOOD	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011358842	⤷ Start Trial
Brazil	112013007380	⤷ Start Trial
Brazil	112013020424	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 12,129,247

Which drugs does patent 12,129,247 protect, and when does it expire?

Summary for Patent: 12,129,247