United States Patent 7,351,414: Claim Scope, Expiration, Orange Book Status, and Teriparatide Patent Landscape

U.S. Patent No. 7,351,414 protected a specific osteoporosis treatment regimen using daily 20 μg human parathyroid hormone 1-34, also known as teriparatide. The claims were limited to fracture-risk reduction in women and men with osteoporosis and excluded concurrent treatment with antiresorptive agents other than calcium or vitamin D. The patent was assigned to Eli Lilly and Company and expired on August 24, 2021, based on the reported patent-term endpoint. It no longer presents a live U.S. patent barrier to generic teriparatide products.

The patent was important because it protected the clinical use of the Forteo regimen rather than the teriparatide molecule itself. Its commercial value depended on the relationship between the claimed dosing regimen, the Forteo prescribing information, and FDA approval of competing teriparatide products.

What does U.S. Patent 7,351,414 protect?

Patent 7,351,414 protects methods of treating osteoporosis with human parathyroid hormone 1-34 at a daily dose of 20 μg. The claimed treatment must be directed to a patient with osteoporosis who is at risk for bone fracture, and the treatment must reduce vertebral and nonvertebral fracture risk.

The independent claims divide the population by sex:

Claim	Patient population	Active agent	Dose	Concurrent therapy limitation	Claimed result
1	Woman with osteoporosis at risk for fracture	Human PTH 1-34	20 μg daily	No antiresorptive other than vitamin D or calcium	Reduced vertebral and nonvertebral fracture risk
2	Subset of claim 1	Same	Same	Same	Advanced-stage, spinal, or steroid-induced osteoporosis
3	Man with osteoporosis at risk for fracture	Human PTH 1-34	20 μg daily	No antiresorptive other than vitamin D or calcium	Reduced vertebral and nonvertebral fracture risk
4	Subset of claim 3	Same	Same	Same	Hypogonadal osteoporosis

The patent does not broadly claim every use of teriparatide. It does not cover all doses, all treatment durations, all osteoporosis patients, or all combination regimens.

How should the independent claims be interpreted?

Human parathyroid hormone 1-34

The claimed active ingredient is the N-terminal 34-amino-acid fragment of human parathyroid hormone. In commercial practice, this is teriparatide.

A product containing teriparatide would satisfy the active-agent limitation if it is administered in the claimed clinical regimen. The claims do not require a particular manufacturing process, formulation excipient, delivery device, or brand name.

The claims also do not extend to every PTH-related molecule. Abaloparatide, sold as Tymlos, is a different peptide and is outside the literal active-agent limitation. Romosozumab, denosumab, bisphosphonates, calcitonin, and selective estrogen receptor modulators are also outside the claimed molecule.

Daily dose of 20 μg

The 20 μg daily limitation is central. A competing regimen using 40 μg every other day, 10 μg daily, or another dosing schedule would not literally satisfy the stated daily-dose limitation.

The analysis becomes more complex if a product is labeled for 20 μg daily but physicians prescribe a different dose. Method-of-use infringement generally turns on the acts encouraged by the product labeling and the evidence of intended use. An ANDA label that directs use at 20 μg daily would create a stronger infringement risk than a label limited to a materially different regimen.

The claim does not state a total cumulative dose or a maximum treatment duration. A course of treatment can therefore fall within the claim if the 20 μg daily regimen and the other limitations are met.

Exclusion of concurrent antiresorptive therapy

The phrase "without concurrent administration of an antiresorptive agent other than vitamin D or calcium" narrows the claims substantially.

The regimen permits calcium and vitamin D. It excludes concurrent administration of antiresorptive drugs such as:

Alendronate
Risedronate
Ibandronate
Zoledronic acid
Denosumab
Calcitonin
Selective estrogen receptor modulators when used as antiresorptive therapy

The limitation raises factual questions concerning treatment overlap. A patient who previously received an antiresorptive drug but is no longer receiving it may fall within the claim, depending on the meaning of "concurrent." A patient receiving teriparatide together with denosumab or a bisphosphonate would present a strong noninfringement position because the claimed exclusion is not satisfied.

The claim does not exclude every concomitant medicine. Calcium and vitamin D are expressly permitted, and non-antiresorptive drugs are not excluded by the text.

Fracture-risk reduction

The claims recite treatment "reducing the risk of vertebral and nonvertebral bone fracture." This language describes the therapeutic purpose and outcome of the method.

The limitation is commercially relevant because the Forteo label identifies reduction of the risk of vertebral and nonvertebral fractures in postmenopausal women with osteoporosis and in men with primary or hypogonadal osteoporosis at high risk for fracture. [2]

For infringement analysis, the relevant question is whether the accused regimen is directed to the claimed fracture-risk reduction, not whether every individual patient experiences a fracture-risk reduction. Clinical evidence, prescribing information, marketing materials, and treatment protocols would be relevant to proving the intended use.

What do the dependent claims add?

Claim 2: advanced-stage, spinal, and steroid-induced osteoporosis

Claim 2 narrows the female-patient claim to three osteoporosis categories:

Advanced-stage osteoporosis
Spinal osteoporosis
Steroid-induced osteoporosis

The claim does not require all three categories. "Selected from" ordinarily identifies alternative members of a group. A patient meeting one listed category may satisfy the disease limitation.

Steroid-induced osteoporosis is particularly relevant to glucocorticoid-treated patients. A teriparatide regimen directed to a woman with glucocorticoid-associated osteoporosis could fall within claim 2 if the 20 μg daily dose, lack of excluded antiresorptive therapy, and fracture-risk limitations are also present.

Claim 4: hypogonadal osteoporosis in men

Claim 4 narrows claim 3 to men with hypogonadal osteoporosis. The claim requires the underlying male-patient limitations in claim 3 and adds the hypogonadal condition.

This claim has a narrower patient population than claim 3. A male patient with osteoporosis caused by another condition would not satisfy claim 4, although the broader claim 3 could still be relevant.

What did the patent not cover?

Patent 7,351,414 did not directly claim:

The teriparatide molecule as a chemical entity
The manufacture of teriparatide
A teriparatide formulation
A prefilled injection pen
A cartridge or delivery device
Teriparatide at doses other than 20 μg daily
Combination treatment with an excluded antiresorptive agent
Abaloparatide or romosozumab
A generic product independent of the claimed method of use
Every osteoporosis indication

Its protection was therefore narrower than a compound patent or formulation patent. Its commercial leverage came from the overlap between the claims and the approved Forteo treatment instructions.

When did U.S. Patent 7,351,414 expire?

The reported expiration date for U.S. Patent 7,351,414 was August 24, 2021. The patent was issued on April 1, 2008, and its term was governed by the 20-year patent-term framework, subject to any applicable adjustments or extensions reflected in official patent records. [1]

The patent’s expiration has three consequences:

The claims are no longer enforceable as live patent rights.
A later generic product is not required to avoid the 20 μg daily teriparatide regimen based on this patent.
Historical Paragraph IV litigation involving the patent no longer creates a continuing injunction risk from this patent.

Patent expiration does not erase the historical importance of the patent. It remains relevant to understanding the timing of generic entry, prior ANDA disputes, settlement terms, and the commercial protection previously associated with Forteo.

What was the Orange Book status of Patent 7,351,414?

Patent 7,351,414 was listed in connection with Eli Lilly’s Forteo product, teriparatide injection, under NDA 021318. The listing related to a method of use rather than a compound or formulation claim. [3]

An Orange Book method-of-use listing can require an ANDA applicant to address the patent through:

A Paragraph III certification stating that the patent will not be infringed before expiration;
A Paragraph IV certification asserting that the patent is invalid, unenforceable, or not infringed; or
A section viii statement carving out the patented use from the proposed labeling.

For a method patent, the section viii route can be commercially important if the applicant’s label excludes the patented indication or patient population. That strategy is effective only if the remaining label does not encourage use that falls within the patent claims.

Because the patent expired in 2021, it is no longer a prospective Orange Book barrier to approval or launch. The current Orange Book status must be evaluated against the applicable FDA edition and the NDA’s remaining listed patents, not against the expired 7,351,414 patent alone.

Which Paragraph IV challenges affected Forteo?

Eli Lilly faced ANDA-based challenges to Forteo-related patents as generic manufacturers sought approval for teriparatide injection. The public litigation landscape included disputes involving Teva and other generic applicants concerning patents covering the clinical use of teriparatide and related product protections.

The critical legal issue in a method-patent case is whether the proposed generic labeling directs physicians to administer teriparatide:

To the claimed patient population;
At 20 μg daily;
Without a concurrently administered excluded antiresorptive agent; and
For fracture-risk reduction.

A generic applicant could challenge the patent through invalidity arguments, noninfringement arguments, or a label carve-out. Typical invalidity theories would include obviousness based on prior clinical studies, anticipation, written description, enablement, and indefiniteness.

The patent’s clinical subject matter created a substantial obviousness question because teriparatide’s anabolic effect, osteoporosis use, and 20 μg daily dosing were supported by clinical development and FDA labeling. Lilly’s counterargument would focus on the claimed combination of patient selection, dosing, absence of concurrent antiresorptive therapy, and demonstrated reduction in both vertebral and nonvertebral fractures.

What litigation and settlement issues affected the patent?

Forteo-related litigation involved ANDA applicants seeking approval before or around the expiration of Lilly’s patent estate. Settlement agreements in pharmaceutical patent cases can establish an agreed generic launch date, but the precise commercial effect depends on the patents covered, the applicants’ products, and any licenses or launch conditions.

For Patent 7,351,414, the expiration date was the decisive endpoint. Once the patent expired, a settlement restriction tied solely to that patent could no longer provide a continuing exclusionary right unless the agreement contained an independent contractual restriction.

Patent 7,351,414 should therefore be separated from later or parallel Forteo patents covering:

Teriparatide formulations
Injection devices
Manufacturing methods
Stability characteristics
Product presentation
Other method-of-use claims

A generic manufacturer could face residual risk from those rights even after the expiration of the 7,351,414 claims.

How strong was the patent estate for Forteo?

The 7,351,414 patent was commercially meaningful but technically narrow.

Strength factor	Assessment
Active agent	Strong identification of teriparatide
Dose	Narrow, exact 20 μg daily limitation
Patient population	Limited to men and women with osteoporosis at fracture risk
Treatment context	Narrowed by exclusion of concurrent antiresorptive therapy
Result limitation	Tied to vertebral and nonvertebral fracture-risk reduction
Formulation coverage	None apparent from the quoted claims
Manufacturing coverage	None apparent from the quoted claims
Device coverage	None apparent from the quoted claims
Current enforceability	Expired
Generic exposure	High after expiration

The patent was more vulnerable to label design-around than a broad composition patent. A competitor could seek to avoid the claims by using a different dose, omitting the claimed fracture-reduction indication, carving out certain populations, or labeling concurrent use with another therapy. Those strategies had to comply with FDA labeling rules and could not be used if the remaining label still encouraged the patented use.

How does teriparatide compare with competing osteoporosis products?

Product	Active ingredient	Principal mechanism	Relationship to Patent 7,351,414
Forteo	Teriparatide	PTH receptor agonist with anabolic bone effect	Directly aligned with claimed regimen
Generic teriparatide	Teriparatide	Same active ingredient	Patent expired; no continuing barrier from 7,351,414
Tymlos	Abaloparatide	PTH1 receptor agonist	Different peptide; outside literal active-agent limitation
Prolia	Denosumab	RANKL inhibition	Antiresorptive; excluded if administered concurrently
Evenity	Romosozumab	Sclerostin inhibition	Different biologic and mechanism
Fosamax and other bisphosphonates	Various bisphosphonates	Antiresorptive	Excluded from the claimed concurrent regimen

Teriparatide is a peptide drug administered by injection. It is not a conventional small-molecule generic in the chemistry sense, but FDA approval of follow-on teriparatide products proceeds through the applicable abbreviated pathway for the reference product. Forteo was approved under an NDA, and teriparatide competitors are generally evaluated as generic or follow-on products rather than as biosimilars under section 351(k). [2][4]

What generic entry risks remained after expiration?

After August 24, 2021, Patent 7,351,414 no longer blocked generic entry. Residual commercial risks could still arise from:

Other unexpired Orange Book patents
Device patents
Formulation or stability patents
Manufacturing-process patents
Regulatory exclusivity
FDA labeling disputes
Product-specific litigation
Patent rights in countries where corresponding family members remained in force

For U.S. launch planning, the relevant question became whether the applicant’s product and label were clear of the remaining Forteo patent estate, not whether the product practiced the 7,351,414 regimen.

The patent also did not create biosimilar-style interchangeability rights. Pharmacy substitution depends on FDA product status, state substitution law, and whether the competing product has the relevant generic or interchangeable designation.

What geographic coverage did the patent provide?

U.S. Patent 7,351,414 provided rights only in the United States. Corresponding foreign applications may have produced patents in Europe, Canada, Japan, Australia, or other jurisdictions, but each patent would have had separate claims, prosecution history, term, and expiration date.

A U.S. generic launch could proceed after the U.S. patent expired even if related foreign patents remained active. Conversely, a foreign launch could remain restricted by a corresponding local patent after U.S. freedom to operate was established.

Key Takeaways

Patent 7,351,414 claimed a method of treating osteoporosis with teriparatide at 20 μg daily.
The claims applied separately to women and men at risk for fracture.
The regimen could include calcium or vitamin D but excluded concurrent antiresorptive therapy.
Claim 2 covered advanced-stage, spinal, and steroid-induced osteoporosis in women.
Claim 4 covered hypogonadal osteoporosis in men.
The patent did not claim teriparatide as a molecule, a formulation, a device, or a manufacturing process.
The reported U.S. expiration date was August 24, 2021.
The patent was historically listed for Forteo under NDA 021318.
It is no longer a live U.S. patent barrier to generic teriparatide.
Remaining generic-entry risks must be assessed against other Forteo patents, FDA labeling, device rights, and manufacturing protections.
Tymlos, Prolia, Evenity, and bisphosphonates are not literally covered by the quoted claims because they use different active ingredients or treatment mechanisms.

FAQs

Is Patent 7,351,414 a compound patent for teriparatide?

No. It is a method-of-treatment patent. It claims administration of human PTH 1-34 at 20 μg daily for specified osteoporosis patients.

Does concurrent denosumab use fall within the claims?

Generally, no. Denosumab is an antiresorptive agent, and the claims exclude concurrent administration of an antiresorptive agent other than calcium or vitamin D.

Does the patent cover abaloparatide?

No. Abaloparatide is a different peptide. The quoted claims specifically require human parathyroid hormone 1-34.

Could a product using 10 μg of teriparatide infringe the quoted claims?

It would not literally satisfy the express 20 μg daily dose limitation. The patent’s expiration also eliminates current U.S. infringement risk from these claims.

Are the claims limited to postmenopausal women?

No. Claim 1 refers to a woman with osteoporosis and does not expressly limit the patient to postmenopausal women. Claim 3 covers men, and claim 4 narrows the male population to men with hypogonadal osteoporosis.

References

U.S. Patent and Trademark Office. (2008). U.S. Patent No. 7,351,414, Methods of treating osteoporosis.
U.S. Food and Drug Administration. (2024). Forteo (teriparatide injection) prescribing information. Eli Lilly and Company.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book.
U.S. Food and Drug Administration. (2024). Approved drug products and abbreviated new drug application pathway information for teriparatide injection.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	033639	⤷ Start Trial
Austria	231000	⤷ Start Trial
Australia	5575099	⤷ Start Trial
Australia	746277	⤷ Start Trial
Brazil	9909445	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 7,351,414

Summary for Patent: 7,351,414