United States Patent 6,930,129: Claim Scope, Concerta Patent Coverage, and Generic Entry Risk

US Patent 6,930,129 covers a pharmacokinetic method of treating attention-deficit disorder or attention-deficit hyperactivity disorder with methylphenidate. The central limitation is not a particular tablet structure, osmotic mechanism, or release coating. It is the administration of methylphenidate in a manner that produces a substantially ascending plasma concentration for approximately eight or 9.5 hours.

The patent was associated with the extended-release methylphenidate technology used in Concerta. Its patent term has expired, removing US infringement risk from the issued claims. The claims remain commercially important because they illustrate the pharmacokinetic protection strategy used around Concerta, but they no longer block generic methylphenidate products in the United States.

What does US Patent 6,930,129 protect?

US 6,930,129 protects a method of treating ADD or ADHD by administering methylphenidate so that the patient's plasma concentration rises substantially over a defined period.

The independent claims require four principal elements:

Claim element	Claim 1	Claim 2
Patient indication	ADD or ADHD	ADD or ADHD
Active ingredient	Methylphenidate	Methylphenidate
Composition	Pharmaceutically acceptable composition and carrier	Pharmaceutically acceptable composition and carrier
Pharmacokinetic result	Substantially ascending plasma concentration	Substantially ascending plasma concentration
Required duration	About 8 hours	About 9.5 hours

Claims 3 through 6 depend on claim 1 and specify methylphenidate amounts of approximately 14 mg, 18 mg, 36 mg, and 54 mg. Claims 7 through 10 depend on claim 2 and repeat those four dose strengths.

The patent therefore contains two independent pharmacokinetic coverage branches:

An ascending concentration profile lasting about eight hours.
An ascending concentration profile lasting about 9.5 hours.

The dependent claims add dose limitations but do not introduce a separate formulation mechanism.

How broad are the claims of US 6,930,129?

The claims are broad in formulation terms but narrow in pharmacokinetic terms.

Broad formulation language

The claims do not expressly require:

An osmotic pump tablet;
A specific polymer;
A particular coating;
A multilayer tablet;
A defined in-vitro dissolution profile;
A specific methylphenidate isomer;
A specific tablet shape;
A named brand;
A particular dosing frequency.

The phrase "pharmaceutically acceptable composition comprising methylphenidate and a pharmaceutically acceptable carrier" can encompass tablets, capsules, multiparticulates, coated particles, suspensions, or other dosage forms, provided the administration produces the required plasma profile.

The patent therefore claims the therapeutic use and resulting concentration pattern rather than a narrowly defined physical product.

Narrow pharmacokinetic limitation

The principal vulnerability of the claims is the requirement that methylphenidate plasma concentration be "substantially ascending" over approximately eight or 9.5 hours.

That limitation creates several proof requirements in an infringement dispute:

The accused product must contain methylphenidate.
The product must be administered for treatment of ADD or ADHD.
The resulting plasma profile must rise substantially during the claimed time period.
The duration must fall within the meaning of "about 8 hours" or "about 9.5 hours."
The claim must be infringed by the product's approved or labeled method of use, direct administration, or induced conduct.

A product that merely provides extended exposure or maintains a relatively flat concentration would not necessarily meet the ascending-profile limitation. A product with an early rise followed by a plateau or decline could also create a factual dispute over whether the concentration is "substantially ascending" for the full claimed period.

What do the 14 mg, 18 mg, 36 mg, and 54 mg claims cover?

The dependent claims cover the ascending-profile method at four stated methylphenidate amounts.

Claims	Approximate methylphenidate amount	Independent claim incorporated
3 and 7	14 mg	Claim 1 or claim 2
4 and 8	18 mg	Claim 1 or claim 2
5 and 9	36 mg	Claim 1 or claim 2
6 and 10	54 mg	Claim 1 or claim 2

The dependent claims require every limitation of the relevant independent claim. A product does not infringe claims 3 through 10 merely because it uses one of the listed strengths. It must also generate the required ascending methylphenidate plasma concentration and be used for ADD or ADHD treatment.

The 18 mg, 36 mg, and 54 mg strengths correspond closely to the historically marketed Concerta strength sequence. The 14 mg limitation is less directly associated with the standard Concerta tablet strengths and may be relevant to dose conversion, alternative presentations, or the disclosed pharmacokinetic platform.

What is the patent history and expiration date?

The patent was issued to ALZA Corporation, the Johnson & Johnson subsidiary associated with Concerta's osmotic extended-release delivery technology.

Event	Date or status
Patent number	US 6,930,129
Issue date	August 16, 2005
Patent owner associated with issuance	ALZA Corporation
Technology area	Extended-release methylphenidate and ADHD treatment
Patent type	Method-of-treatment patent
Listed US expiration	August 5, 2023
Current status	Expired

The effective term was longer than the ordinary 20-year period measured from the earliest relevant nonprovisional filing because of patent term adjustment. Public Orange Book records identified the patent with a 2023 expiration date for Concerta-related protection. The patent is no longer an enforceable barrier to a US generic launch after expiration. [1, 2]

Expiration of US 6,930,129 did not itself terminate all Concerta-related patent rights. Other patents covered the delivery system, tablet architecture, drug-release technology, or additional aspects of the product. Those patents had separate expiration dates and required separate analysis.

What patents protected Concerta and extended-release methylphenidate?

Concerta's protection was distributed across several patent categories rather than concentrated in US 6,930,129.

Pharmacokinetic and method-of-use patents

US 6,930,129 is directed to achieving the ascending methylphenidate plasma profile during treatment of ADD or ADHD.

Related method claims could create infringement risk even where a competitor used a different physical delivery system. The relevant question would be whether the alternative product produced the claimed pharmacokinetic result under its approved use.

Osmotic delivery patents

US Patent 5,837,284 was associated with the osmotic delivery system used in Concerta. It covered aspects of an oral osmotic drug delivery system and was more structurally focused than US 6,930,129.

The distinction is material:

Patent category	Primary protection
US 6,930,129	Treatment method and ascending methylphenidate concentration
US 5,837,284	Osmotic delivery architecture
Additional Concerta patents	Delivery, formulation, manufacturing, or related product features

An extended-release methylphenidate product could avoid a delivery-system claim while still raising a method-of-use issue, or avoid the method claim while using a release platform that implicated a separate formulation patent.

Formulation and manufacturing protection

Formulation patents may cover:

Drug-containing layers;
Osmotic push layers;
Semipermeable membranes;
Orifice formation;
Release-controlling polymers;
Coating compositions;
Manufacturing steps;
Tablet dimensions or mechanical construction.

US 6,930,129 itself does not require these features. A formulation-based infringement analysis therefore cannot substitute for the pharmacokinetic analysis required by the patent's claims.

What was the Orange Book status of US 6,930,129?

US 6,930,129 was listed in connection with Concerta, marketed by Janssen Pharmaceuticals, Inc., under NDA 021121. The patent listing reflected method-of-use protection relating to methylphenidate treatment and the claimed plasma concentration pattern. [2]

The Orange Book listing had several commercial consequences:

An ANDA applicant was required to address the patent through a Paragraph III or Paragraph IV certification, depending on timing and strategy.
A Paragraph IV certification could trigger patent litigation.
A timely Paragraph IV notice could create a 30-month FDA approval stay under the Hatch-Waxman framework if the NDA holder filed suit within the statutory period.
The listing did not mean that every methylphenidate product infringed. It identified a patent that an ANDA applicant had to address.

The FDA does not determine infringement through Orange Book listing. Patent scope and infringement are determined under federal patent law and, where litigated, by the courts.

When did Concerta and methylphenidate generics face patent challenges?

Generic competition developed through Paragraph IV challenges to Concerta's patent estate and through separate regulatory review of bioequivalence and therapeutic equivalence.

The main competitive issues included:

Whether a generic used the same or a non-infringing release mechanism;
Whether its plasma profile was substantially ascending for the claimed period;
Whether the proposed label instructed treatment within the claimed indication;
Whether the generic was pharmaceutically equivalent and therapeutically equivalent;
Whether the ANDA applicant could launch before all listed patents expired.

Concerta-related litigation also involved patent protection for the osmotic delivery platform. The Federal Circuit addressed Concerta-related patent issues in litigation involving Janssen and generic manufacturers, including disputes concerning claim scope and validity of extended-release methylphenidate technology. [3]

The litigation history demonstrates that a Paragraph IV challenge to one patent did not automatically resolve the entire Concerta patent estate. An ANDA applicant had to assess each listed patent independently.

Which companies challenged or competed with Concerta?

The relevant competitive field included branded, authorized-generic, and conventional generic manufacturers.

Company or product group	Competitive role
Janssen Pharmaceuticals	Branded Concerta sponsor
ALZA Corporation	Original delivery-technology owner and Janssen affiliate
Actavis	Generic and authorized-generic competitor
Teva Pharmaceuticals	Generic methylphenidate competitor
Mallinckrodt	Generic extended-release methylphenidate competitor
Mylan	Generic methylphenidate competitor
Kudco/Kremers Urban	Generic extended-release methylphenidate competitor

FDA regulatory action involving certain generic extended-release methylphenidate products showed that approval and initial therapeutic-equivalence status did not eliminate postmarket concerns. The FDA later required changes to the therapeutic-equivalence ratings or product status of certain products after reviewing clinical performance and duration-of-effect information. [4]

Those regulatory events were separate from the validity or expiration of US 6,930,129.

How does US 6,930,129 compare with a formulation patent?

The two patent types impose different design constraints.

Issue	US 6,930,129	Formulation or device patent
Claim focus	Patient treatment and plasma profile	Physical product or manufacturing process
Required active ingredient	Methylphenidate	May require a specific drug or composition
Required indication	ADD or ADHD	Often not required
PK evidence	Central to infringement	May be irrelevant or secondary
Alternative formulation risk	Can remain if profile is met	Can be avoided by changing structure
Label relevance	Often material	May be less important
Expiration	August 5, 2023	Depends on individual patent

A competitor could use a non-osmotic delivery system and still face a potential method claim if its product created the claimed ascending concentration pattern. Conversely, a competitor could use an osmotic or extended-release architecture without infringing US 6,930,129 if the resulting plasma profile did not satisfy the claim.

How strong was the patent estate for Concerta?

Before expiration, the Concerta estate was commercially strong because it combined multiple protection layers:

A branded product with a defined extended-release profile.
Delivery-system patents.
Method-of-treatment claims tied to pharmacokinetic behavior.
Orange Book-listed patents that could delay ANDA approval.
Regulatory complexity surrounding therapeutic equivalence of extended-release methylphenidate.

US 6,930,129 was stronger as a complement to formulation patents than as a standalone product barrier. Its broad composition language increased potential coverage, but the "substantially ascending" requirement created substantial proof and claim-construction issues.

After expiration, the value of the patent is historical and analytical. It no longer provides an enforceable US exclusion right.

What generic launch risks existed under US 6,930,129?

Before August 5, 2023, a generic applicant faced several possible launch scenarios.

Paragraph III strategy

The applicant could certify that it would not market until expiration of the listed patent. This avoided a direct validity challenge but delayed launch.

Paragraph IV strategy

The applicant could allege that the patent was invalid, unenforceable, or not infringed. A Paragraph IV certification could result in:

Notice litigation;
A 30-month stay;
Discovery into plasma concentration data;
Expert disputes regarding "substantially ascending";
Claim-construction disputes concerning "about 8 hours" and "about 9.5 hours";
Settlement negotiations;
Potential launch at risk after the statutory stay or litigation resolution.

Non-infringing design

A generic could seek to avoid the claims by developing a product that:

Did not generate a substantially ascending concentration for the claimed period;
Used a different release profile;
Used a different dosing instruction;
Avoided the listed dose amounts in dependent claims;
Carried a label that did not induce the claimed method, subject to applicable divided-infringement and induced-infringement principles.

The dose limitations alone would not provide a reliable design-around. The independent claims do not require a specific dose, so a product outside 14 mg, 18 mg, 36 mg, or 54 mg could still implicate claims 1 or 2.

Does US 6,930,129 create biosimilar risk?

No. Methylphenidate is a small-molecule drug, not a biologic. Biosimilar approval under the Public Health Service Act is not the relevant pathway.

Generic applicants use the ANDA pathway under section 505(j) of the Federal Food, Drug, and Cosmetic Act. The relevant regulatory issues are pharmaceutical equivalence, bioequivalence, labeling, therapeutic equivalence, and patent certifications. [5]

What is the current commercial impact of US 6,930,129?

The patent no longer creates a current US exclusivity period. Revenue exposure from the patent was concentrated in the pre-expiration period, when Concerta's branded sales competed with generic launch timing and patent litigation.

Current commercial risk is driven by:

Generic price erosion;
FDA therapeutic-equivalence ratings;
Product availability;
Prescriber and payer substitution;
Duration-of-effect performance;
Manufacturing capacity;
Any surviving or separately expiring formulation patents;
Brand differentiation and authorized-generic arrangements.

The patent's expiration removed one legal barrier but did not guarantee identical clinical performance among extended-release methylphenidate products. The FDA's prior actions concerning certain generic Concerta products show that substitution risk and regulatory performance were separate from patent expiration. [4]

Key Takeaways

US 6,930,129 claims a methylphenidate treatment method that produces a substantially ascending plasma concentration for about eight or 9.5 hours.
Claims 3 through 10 add 14 mg, 18 mg, 36 mg, and 54 mg dose limitations.
The patent does not require the Concerta osmotic tablet, a specific polymer, or a defined tablet structure.
Infringement would turn on the patient's treatment, the product's use, and pharmacokinetic evidence.
The patent was associated with Concerta's Orange Book patent estate.
Its listed US expiration date was August 5, 2023.
The patent is expired and does not currently block US generic methylphenidate entry.
It was a small-molecule method patent, so biosimilar analysis does not apply.
Separate Concerta delivery-system and formulation patents required independent analysis.
Generic competition also depended on FDA therapeutic-equivalence determinations and postapproval performance.

FAQs About US Patent 6,930,129

What drug was primarily associated with US Patent 6,930,129?

The patent was primarily associated with Concerta, an extended-release methylphenidate product marketed for ADD and ADHD.

Does US 6,930,129 cover all methylphenidate products?

No. The claims require a particular treatment use and a substantially ascending methylphenidate plasma concentration over approximately eight or 9.5 hours.

Did the patent cover Ritalin immediate-release tablets?

Not necessarily. An immediate-release product would generally require separate analysis and would not automatically satisfy the claimed extended ascending concentration profile.

Could a generic avoid claims 3 through 10 by using a different strength?

Possibly, but that would not necessarily avoid claims 1 and 2. The independent claims do not specify the four dependent-claim dose amounts.

Is US 6,930,129 still an Orange Book barrier?

No. Its patent term expired on August 5, 2023. Any remaining Concerta patent issue must be evaluated against separate patents and current FDA records.

References

United States Patent and Trademark Office. (2005). United States Patent No. 6,930,129: Methods and compositions for treating attention deficit disorders.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations (Orange Book), methylphenidate extended-release listings.
Janssen Pharmaceutica, N.V. v. Teva Pharmaceuticals USA, Inc., 583 F.3d 1317 (Fed. Cir. 2009).
U.S. Food and Drug Administration. (2014). FDA updates extended-release methylphenidate products regarding therapeutic equivalence and efficacy.
U.S. Food and Drug Administration. (2024). Abbreviated new drug application (ANDA) process and patent certifications.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	277594	⤷ Start Trial
Austria	321529	⤷ Start Trial
Austria	325606	⤷ Start Trial
Australia	4319799	⤷ Start Trial
Australia	4801497	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 6,930,129

Summary for Patent: 6,930,129