United States Patent 7,141,018: Thalidomide Risk-Management Patent Scope, Claims, Expiration, and Patent Landscape

U.S. Patent 7,141,018 is a Celgene patent directed to a computerized controlled-access program for thalidomide. Its central claim requires patient risk classification, collection of pregnancy-related information, a determination that the risk is acceptable, and generation of a prescription approval code before a pharmacy fills the prescription. The patent protects an operational risk-management workflow, not thalidomide itself, a particular dosage form, or a new therapeutic use.

The patent’s commercial importance was tied to Celgene’s controlled-distribution infrastructure for Thalomid and the FDA-mandated risk-management framework addressing thalidomide’s teratogenicity. The patent has expired based on the underlying U.S. patent term, so it does not currently create an enforceable barrier to generic thalidomide distribution. Its claim structure remains relevant to historical Paragraph IV litigation, freedom-to-operate analysis, and the design of drug-specific REMS programs.

What does U.S. Patent 7,141,018 cover?

Patent 7,141,018 covers a method for restricting access to thalidomide through a computer-based authorization process. The method is performed before prescription fulfillment and requires a pharmacy to receive or become aware of a prescription approval code generated after patient-risk screening.

The claim has five required operational elements:

The program defines multiple patient risk groups using predetermined thalidomide risk parameters.
The program collects patient information, including the patient’s ability to become pregnant and, optionally, whether the patient is pregnant.
The patient is assigned to one or more risk groups, and the information is entered into a computer-readable storage medium.
The program determines whether the risk of the adverse event is acceptable.
If the risk is acceptable, the program generates an approval code before the prescription is filled.

The claim is therefore narrower than a general requirement to counsel patients or register prescribers. It requires a sequence linking risk classification to a pre-dispensing approval code.

What is the protected technology?

The protected technology is a controlled-access database and authorization workflow. The claim does not require a particular programming language, database architecture, communications network, or proprietary software platform. A system may potentially fall within the claim if it performs the recited functions, even if it uses a modern web portal, cloud database, electronic health-record interface, call center, or other technical implementation.

The claim also does not expressly require:

A particular commercial brand of thalidomide;
A specific capsule strength;
A particular pregnancy test;
A particular pharmacy network;
A specific form of encryption;
A particular approval-code format;
A specific computer hardware configuration; or
A particular FDA REMS name.

The method is tied to thalidomide and to a disease or condition responsive to thalidomide. It is not drafted as a generic controlled-access method for every teratogenic drug.

How broad is claim 1 of Patent 7,141,018?

Claim 1 is broad in the identity of the disease, the architecture of the computer system, and the format of the approval code. It is narrower in the required sequence of patient classification, risk assessment, code generation, and pharmacy authorization.

Claim construction issues

The most commercially important limitations are the following:

Claim limitation	Practical meaning
“Disease or condition which is responsive to thalidomide”	The treatment indication is not limited to multiple myeloma, leprosy, or any named disease
“Restricting access”	The system must control whether the prescription can be filled
“Pharmacy only after”	Approval must precede pharmacy fulfillment
“Computer readable storage medium”	Patient, risk, and authorization information must be recorded in a computer-readable medium
“Plurality of patient risk groups”	At least two defined risk categories are required
“Ability ... to become pregnant”	Pregnancy potential is a required component of the information set
“Risk ... acceptable”	The system must make an acceptability determination before issuing the code
“Prescription approval code”	Some code or equivalent authorization must be generated and communicated before dispensing

The phrase “acceptable” is functional and potentially flexible. It does not specify a numerical risk threshold. A program operator can define the criteria, provided that the claim’s required risk-group and information-collection steps are performed.

The phrase “from a computer readable storage medium” also creates a potential construction issue. It may be interpreted as requiring code generation from stored patient and risk information rather than a purely manual approval process. A system relying only on paper forms, telephone approval without computerized record generation, or pharmacist judgment without an approval code would have a stronger non-infringement position.

What do dependent claims 2 through 9 add?

Claims 2 and 3: prescriber and pharmacy registration

Claim 2 requires registration of the prescribing physician in the computer-readable medium. Claim 3 requires registration of the pharmacy.

These claims capture the network-participant portion of a controlled distribution program. They are narrower than claim 1 because infringement requires the corresponding physician or pharmacy registration step. A system that registers patients but does not register prescribers or dispensing pharmacies would not meet these dependent limitations.

Claims 4 through 7: counseling and risk disclosure

Claim 4 adds patient counseling concerning drug risks and risk-avoidance measures. Claims 5 and 6 increase the requirement to full disclosure and require prescription fulfillment only after that disclosure.

Claim 7 requires the fact of full disclosure to be registered in the computer-readable storage medium before the approval code is generated.

These claims convert counseling from a separate clinical or regulatory activity into a recorded authorization condition. The important limitation is not merely that counseling occurs. The system must record the counseling event before generating the approval code.

Claim 8: facsimile and optical character recognition

Claim 8 requires transmission of the risk-group assignment and full-disclosure fact to the computer-readable storage medium by facsimile, with interpretation through optical character recognition software.

This is a highly specific implementation claim. It reflects the technology used by early controlled-distribution systems before fully electronic enrollment became standard. The claim is materially narrower than claim 1 and would not naturally cover an authorization process that uses only an electronic portal or application programming interface.

Claim 9: periodic follow-up information

Claim 9 requires:

A second set of information defined for each risk group;
Collection of that information at periodic intervals; and
Entry of the information into the computer-readable storage medium.

Claim 9 extends the patent from initial prescription authorization into longitudinal patient monitoring. It can cover recurring pregnancy-status checks, contraception compliance information, follow-up counseling, laboratory results, or other risk-specific data if those items are defined and recorded according to the claim.

What is the patent family and expiration status of U.S. 7,141,018?

Patent 7,141,018 is associated with Celgene’s controlled-access drug program patent family, including earlier patents directed to methods for controlling access to drugs. The family should be analyzed separately from Celgene’s patents covering thalidomide treatment methods, multiple myeloma, and pharmaceutical compositions.

Item	Patent 7,141,018
Patent type	U.S. utility patent
Technology	Computerized controlled access and prescription authorization
Patent holder associated with prosecution and commercialization	Celgene Corporation
Issue date	November 28, 2006
Core subject matter	Patient risk classification, database registration, approval-code generation, and pharmacy control
Underlying term	Based on the earliest effective nonprovisional filing in the family
Publicly reported expiration	June 7, 2019, subject to any applicable patent-term adjustment
Current enforceability	Expired

The patent’s expiration is distinct from FDA exclusivity. FDA approval of generic thalidomide is not blocked by an expired controlled-access patent. Nor does continued operation of a Thalomid REMS program revive patent rights.

Did Patent 7,141,018 have patent-term extension?

There is no established basis to treat Patent 7,141,018 as having pediatric exclusivity or Hatch-Waxman patent-term extension. Patent-term extension is generally associated with regulatory delay for an approved product and does not automatically apply to a software-enabled risk-management method. Any patent-term adjustment shown in USPTO records would affect the precise expiration date, but it would not change the patent’s expired status today. (USPTO, n.d.-a)

What was the Orange Book status of Patent 7,141,018?

The Orange Book records patents submitted by an NDA holder for an approved drug product when the patents claim the drug, a formulation, or an approved method of use. Thalidomide products were associated with a broader patent estate that included treatment-method and controlled-access patents.

For Orange Book analysis, the critical distinction is between:

A patent claiming thalidomide or a thalidomide formulation;
A patent claiming treatment of a specific disease;
A patent claiming a controlled-distribution or risk-management process; and
FDA regulatory requirements imposed through a REMS.

Patent 7,141,018 did not claim the thalidomide molecule. Its value depended on whether a generic applicant’s proposed distribution system practiced every limitation of the asserted claim. A Paragraph IV certification could therefore raise infringement questions concerning the proposed risk-management system without challenging the chemical identity or physical formulation of thalidomide.

The Orange Book must be checked by product and historical edition because patent listings can change, expire, or be delisted. The FDA’s current Orange Book database should control for present listing status. (FDA, n.d.-a)

What FDA regulatory program was connected to the patent?

Thalidomide was approved in the United States under NDA 020785 for erythema nodosum leprosum. Because of the drug’s severe teratogenic risk, FDA approval was linked to controlled distribution, prescriber and pharmacy controls, patient counseling, pregnancy testing, and contraception-related requirements.

The original Celgene program was known as the System for Thalidomide Education and Prescribing Safety, or S.T.E.P.S. The FDA later regulated thalidomide through a REMS framework. FDA materials identify Thalomid as a drug subject to risk-management controls because fetal exposure can cause severe birth defects. (FDA, n.d.-b)

The patent and the REMS are legally separate:

Issue	Patent 7,141,018	FDA REMS
Source of obligation	Patent statute	Federal Food, Drug, and Cosmetic Act
Owner or administrator	Patent holder	FDA-approved applicant or shared-system sponsor
Duration	Limited patent term	Continues while FDA requires it
Enforcement	Patent infringement action	FDA regulatory enforcement
Technical focus	Claimed authorization workflow	Safe-use requirements and monitoring
Effect after patent expiration	Claims become unenforceable	REMS obligations may continue

A generic sponsor can comply with the FDA REMS while using a technically different workflow that avoids the expired patent’s historical claim scope. Conversely, patent expiration does not eliminate the requirement to comply with an active FDA safety program.

Were there Paragraph IV challenges to the thalidomide patent estate?

Generic thalidomide applicants faced the need to address listed patents and controlled-distribution requirements in their ANDAs. Paragraph IV litigation risk depended on which patents were listed for the relevant reference product and whether the proposed generic distribution system practiced the asserted claims.

The main challenge categories were:

Chemical and composition patents. These concerned thalidomide itself or pharmaceutical compositions.
Treatment-method patents. These concerned uses such as multiple myeloma or other responsive diseases.
Risk-management patents. These concerned enrollment, counseling, risk classification, and dispensing authorization.
Regulatory access issues. These concerned whether a generic sponsor could participate in or replicate the FDA-approved controlled-access framework.

The existence of a Paragraph IV certification would not itself establish infringement. For Patent 7,141,018, the relevant question would have been whether the ANDA applicant’s proposed system generated an approval code after collecting and storing the specified patient-risk information and before pharmacy fulfillment.

Because the patent expired in 2019, it no longer presents a current Paragraph IV launch barrier. Historical litigation records should be reviewed through PACER, USPTO Patent Center, FDA ANDA records, and the Orange Book’s historical patent listings. (USPTO, n.d.-b)

What patent litigation affected Patent 7,141,018?

Patent 7,141,018 was part of Celgene’s broader enforcement environment surrounding thalidomide and related products. Litigation risk generally centered on generic entry, listed thalidomide patents, and the adequacy of proposed controlled-distribution programs.

The most important legal issues in a case involving this patent would have been:

Whether the generic sponsor’s program used a plurality of defined risk groups;
Whether pregnancy potential was actually determined;
Whether patient data and risk assignments were stored electronically;
Whether an approval code was generated before dispensing;
Whether the pharmacy had to become aware of the code;
Whether the generic sponsor performed every claimed step or induced another participant to perform it;
Whether different actors created divided-infringement problems;
Whether the claim was anticipated or rendered obvious by earlier restricted-distribution systems; and
Whether functional terms such as “acceptable risk” were definite.

A settlement involving a different thalidomide patent would not necessarily resolve liability under Patent 7,141,018. Settlement terms are often product-specific, patent-specific, and confidential. Public docket entries should be distinguished from final judgments, consent orders, and private commercial settlements.

How strong was the patent estate for controlled thalidomide access?

The estate had moderate historical strength but limited long-term durability.

Strengths

It addressed a commercially necessary dispensing process.
It linked patient screening to a mandatory pre-dispensing approval code.
It covered multiple program participants, including physicians and pharmacies.
It included both initial enrollment and periodic follow-up.
It was connected to a regulatory safety framework that made controlled distribution commercially relevant.

Weaknesses

The claims were process claims rather than molecule claims.
The workflow could be redesigned around claim-specific limitations.
Facsimile and optical-character-recognition limitations were technologically narrow.
The claims depended on functional concepts such as acceptable risk.
Divided performance by patients, physicians, pharmacies, and program operators could complicate infringement proof.
Prior restricted-distribution and patient-monitoring systems created potential obviousness defenses.
The patent term ended before the current generic market matured.

The patent was stronger as a historical negotiating asset than as a continuing barrier to generic entry.

How does Patent 7,141,018 compare with formulation and method-of-use patents?

Patent category	Protected subject matter	Generic-entry risk after expiration
Controlled-access patent	Enrollment, risk classification, approval code, pharmacy authorization	Low
Formulation patent	Capsule composition, excipients, release profile, stability	Depends on separate patent term
Method-of-use patent	Treatment of a specified disease or patient population	Depends on carve-out and claim scope
Compound patent	Thalidomide molecule or chemical form	Generally unavailable as a current barrier
REMS requirement	FDA-mandated safe-use system	May continue independently of patent expiration

A formulation patent can remain important even when a controlled-access patent expires. A generic sponsor may also avoid an approved method-of-use patent through a Section viii label carve-out, but it cannot avoid a patent that covers the product itself or a required manufacturing process.

What generic launch risks exist for thalidomide?

The main current risks are regulatory and commercial rather than Patent 7,141,018 infringement.

Regulatory risks

Compliance with the active thalidomide REMS or successor FDA requirements;
Pregnancy-testing and contraception controls;
Prescriber and pharmacy certification;
Patient enrollment and counseling;
Reporting and monitoring obligations;
Product labeling consistency with the reference listed drug.

Commercial risks

Limited market size compared with oncology blockbusters;
Manufacturing and quality-control requirements for a highly potent teratogenic compound;
Distribution costs associated with restricted dispensing;
Physician and pharmacy willingness to participate;
Competition from lenalidomide and pomalidomide in hematologic oncology;
Potential price erosion after multiple generic entrants.

Manufacturing and intellectual-property barriers

Patent 7,141,018 does not claim a thalidomide manufacturing process. A separate process patent, trade secret, impurity-control method, or facility qualification issue could still affect supply. The patent also does not prevent a generic manufacturer from using a different computerized safety architecture after expiration.

How does thalidomide compare with lenalidomide and pomalidomide patent estates?

Thalidomide has the oldest and least commercially durable estate of the three immunomodulatory drugs.

Product	Active ingredient	Main commercial patent issues	Biosimilar relevance
Thalomid	Thalidomide	Expired compound, use, and controlled-access patents; REMS compliance	None, because it is a small molecule
Revlimid	Lenalidomide	Formulation, method-of-use, and settlement-based generic-entry restrictions	None
Pomalyst	Pomalidomide	Method-of-use and formulation protection, plus REMS controls	None

Biosimilar risk does not apply to thalidomide, lenalidomide, or pomalidomide because these are small-molecule drugs approved through the ANDA pathway rather than biologics approved under the Public Health Service Act. The relevant competitors are generic manufacturers, not biosimilar developers.

What is the current commercial relevance of Patent 7,141,018?

The direct revenue exposure from this patent is effectively zero after expiration. Its historical value was linked to Celgene’s control over thalidomide distribution and the ability to make generic entry more operationally difficult.

The remaining commercial value lies in:

Historical analysis of Celgene’s controlled-distribution strategy;
Design of new restricted-access programs for teratogenic drugs;
Due diligence on patent-family prosecution;
Analysis of past generic settlements;
Benchmarking of FDA REMS implementation; and
Comparison of administrative-process patents with product and method-of-use patents.

The FDA safety framework remains commercially relevant even though the patent has expired. A generic manufacturer must still satisfy the applicable FDA requirements, but it is not required to use the exact patented workflow if that workflow is no longer enforceable.

Key Takeaways

Patent 7,141,018 covers a computerized thalidomide authorization method, not thalidomide itself.
Claim 1 requires risk-group classification, pregnancy-related information, electronic recordation, an acceptable-risk determination, and an approval code before dispensing.
Claims 2 and 3 add physician and pharmacy registration.
Claims 4 through 8 cover counseling, full disclosure, electronic recording, facsimile transmission, and optical character recognition.
Claim 9 covers periodic collection and storage of risk-specific follow-up information.
The patent was associated with Celgene’s S.T.E.P.S. controlled-distribution program and the broader FDA thalidomide risk-management framework.
The patent expired in 2019 and is no longer a current enforceable barrier to generic thalidomide entry.
FDA REMS obligations are separate from patent rights and may continue after patent expiration.
Thalidomide faces generic, not biosimilar, competition.
Current market barriers are more likely to arise from FDA safety controls, manufacturing quality, distribution infrastructure, and commercial demand than from Patent 7,141,018.

FAQs About U.S. Patent 7,141,018

Can a generic thalidomide manufacturer use a different REMS computer system?

Yes. Patent expiration removes the enforceable patent barrier, and a generic sponsor may use a different technical workflow. The system must still satisfy applicable FDA safety and REMS requirements.

Did Patent 7,141,018 claim thalidomide pregnancy testing itself?

No. The principal claim required collection of information concerning the patient’s ability to become pregnant and allowed collection of current pregnancy status. The patent claimed the broader authorization workflow linking that information to risk classification and approval-code generation.

Does Patent 7,141,018 cover every restricted-distribution drug program?

No. Claim 1 is expressly directed to thalidomide treatment and its risk profile. Other drugs may require separate claim analysis, particularly where the program does not use the same risk groups, pregnancy-related data, or approval-code process.

Can a pharmacy infringe the patent by filling thalidomide without an approval code?

Historically, possible infringement would have depended on whether all claim limitations were satisfied and on the pharmacy’s role in performing or participating in the claimed method. The patent’s expiration eliminates current infringement exposure under this patent.

Are thalidomide generics subject to biosimilar substitution rules?

No. Thalidomide is a small-molecule drug. Generic thalidomide products are evaluated under the ANDA framework, not the biosimilar pathway.

References

Food and Drug Administration. (n.d.-a). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services. https://www.accessdata.fda.gov/scripts/cder/ob/

Food and Drug Administration. (n.d.-b). Thalomid REMS. U.S. Department of Health and Human Services. https://www.accessdata.fda.gov/

United States Patent and Trademark Office. (n.d.-a). Patent term adjustment and patent term extension. U.S. Department of Commerce. https://www.uspto.gov/patents/laws/patent-term-adjustment

United States Patent and Trademark Office. (n.d.-b). Patent Center. U.S. Department of Commerce. https://patentcenter.uspto.gov/

U.S. Patent No. 7,141,018. (2006). Methods for controlling access to drugs. United States Patent and Trademark Office.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	1437201	⤷ Start Trial
Australia	2005201675	⤷ Start Trial
Australia	780486	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 7,141,018

Summary for Patent: 7,141,018