United States Patent 7,163,684: Teriparatide Osteoporosis Treatment Claims and Patent Landscape

U.S. Patent No. 7,163,684 protects a specific clinical use of human parathyroid hormone fragment 1-34, known as teriparatide, for post-menopausal women with osteoporosis at high fracture risk. The principal limitation is a daily 20 microgram dose administered without a concurrent antiresorptive agent, except that calcium and vitamin D may be used. The patent issued to Eli Lilly and Company and expired on August 26, 2018, according to the FDA Orange Book listing.

The patent is a method-of-treatment patent. It does not broadly claim teriparatide, recombinant production, a pharmaceutical composition, an injection device, or every use of Forteo. Its commercial importance was tied to the original clinical use and labeling of Forteo.

What does U.S. Patent 7,163,684 cover?

The patent covers administering human parathyroid hormone 1-34 to a post-menopausal woman with osteoporosis who is at high risk for fracture. The dose must be 20 micrograms per day, and the treatment must not include a concurrently administered antiresorptive agent other than supplemental calcium or vitamin D.

The independent claim requires the following elements:

Claim element	Scope
Patient	Post-menopausal woman
Disease	Osteoporosis
Risk profile	High risk for fracture
Active ingredient	Human parathyroid hormone 1-34, teriparatide
Dose	20 micrograms daily
Excluded co-therapy	Concurrent antiresorptive agent
Permitted co-therapy	Supplemental calcium or vitamin D
Therapeutic objective	Increased bone mineral density and reduced vertebral and non-vertebral fracture risk

The claim is cumulative. A competing product or treatment protocol would generally need to satisfy all material limitations to fall within the literal scope of claim 1.

How strong is claim 1 of U.S. Patent 7,163,684?

Claim 1 is commercially significant but relatively narrow. It combines a defined patient population, a defined molecule, an exact daily dose, a treatment objective, and a negative limitation directed to concomitant antiresorptive therapy.

Its principal strengths are:

The 20 microgram daily dose corresponds closely to the established Forteo dosing regimen.
The claim is directed to a clinically meaningful population rather than an experimental or undefined use.
The no-antiresorptive limitation distinguishes teriparatide monotherapy from combination regimens.
The claim captures the central FDA-approved use of Forteo in high-risk post-menopausal osteoporosis.

Its principal weaknesses are:

The claim does not cover every teriparatide dose.
It does not expressly cover men, pre-menopausal women, or osteoporosis unrelated to the specified patient population.
It does not cover concurrent treatment with an antiresorptive agent such as a bisphosphonate, denosumab, or raloxifene.
The terms "high risk for fracture," "increasing bone mineral density," and "reducing the risk" may require factual and clinical interpretation.
The patent expired in 2018, eliminating current U.S. infringement liability for conduct occurring after expiration.

The claim was strongest before expiration, when a generic manufacturer could face litigation risk from a Paragraph IV certification even if it avoided composition and formulation patents.

What do claims 2 through 10 add?

Claims 2 through 10 are dependent claims. They narrow claim 1 and do not create independent protection for teriparatide.

Claim 2: Prior fragility fracture

Claim 2 limits the patient population to women who have at least one prior fragility fracture. This is a narrower version of the "high risk for fracture" requirement.

A treatment directed to a post-menopausal woman with no prior fragility fracture could still infringe claim 1 if the patient otherwise meets the high-risk requirement, but it would not satisfy claim 2.

Claims 3 through 6: Osteoporosis subtypes

Claim 3 identifies four osteoporosis categories:

Advanced-stage osteoporosis
Hypogonadal osteoporosis
Spinal osteoporosis
Steroid-induced osteoporosis

Claims 4 through 6 narrow the claim further to:

Advanced-stage osteoporosis
Spinal osteoporosis
Steroid-induced osteoporosis

Claim 3 is drafted as a Markush-style selection. It requires one of the listed osteoporosis types. Claims 4, 5 and 6 each select one category from that group.

"Hypogonadal osteoporosis" appears in claim 3 but has no separate dependent claim. A treatment meeting the hypogonadal osteoporosis limitation could fall within claim 3 without meeting claims 4 through 6.

Claim 7: No calcium or vitamin D

Claim 7 excludes concurrent administration of both supplemental vitamin D and supplemental calcium. It is narrower than claim 1 because claim 1 permits these supplements as exceptions to its antiresorptive-agent exclusion.

The practical reading is that claim 7 covers teriparatide treatment without concurrent vitamin D or calcium supplementation, while retaining the other limitations of claim 1.

Claims 8 through 10: Supplementation alternatives

Claim 8 requires concurrent supplemental vitamin D.

Claim 9 requires concurrent supplemental calcium.

Claim 10 requires concurrent supplemental vitamin D and calcium.

These claims clarify permitted supplementation patterns:

Claim	Required supplementation
7	Neither supplemental vitamin D nor supplemental calcium
8	Vitamin D
9	Calcium
10	Vitamin D and calcium

The claims do not permit a conventional antiresorptive drug merely because calcium or vitamin D is also administered.

What formulations are protected by U.S. Patent 7,163,684?

U.S. Patent 7,163,684 does not claim a particular teriparatide formulation. It is indifferent to most formulation variables, including:

Liquid versus other dosage-form characteristics
Preservative selection
Buffer system
Excipient concentration
Container or cartridge design
Injection-pen configuration
Manufacturing process
Sterility process

The patent applies to the therapeutic administration described in the claims, regardless of whether the teriparatide is supplied in a vial, cartridge, or pen, provided the method limitations are met.

Formulation and device protection existed in separate patent families associated with Forteo. Those patents could have created separate enforcement issues even when a generic product avoided the method claims through a skinny label or a different commercial indication.

What is the FDA and Orange Book status of U.S. Patent 7,163,684?

Forteo, containing teriparatide, received FDA approval under NDA 020318 on November 26, 2002. The original labeling covered treatment of post-menopausal women with osteoporosis at high risk for fracture, including women with a history of osteoporotic fracture, multiple risk factors, or failure or intolerance of other osteoporosis therapy.

The Orange Book listed U.S. Patent 7,163,684 for Forteo with an expiration date of August 26, 2018. That date is the relevant U.S. patent expiration date for the listed patent, subject to the ordinary distinction between patent expiration and regulatory exclusivity. Patent expiration did not itself terminate FDA approval of Forteo.

FDA milestone	Date or status
Forteo NDA	020318
Active ingredient	Teriparatide
FDA approval	November 26, 2002
Patent listed	U.S. 7,163,684
Orange Book patent expiration	August 26, 2018
Current patent status	Expired
Product approval status	FDA approval remains distinct from patent status

The original Forteo label also included a treatment-duration limitation based on lifetime exposure. That labeling limitation is separate from the patent claims and does not alter the 20 microgram daily-dose limitation in claim 1.

When did U.S. Patent 7,163,684 lose exclusivity?

The patent lost patent exclusivity on August 26, 2018. Generic and follow-on manufacturers could thereafter market products without infringing this expired patent, subject to other unexpired patents, regulatory requirements, contractual restrictions, and separate intellectual-property rights.

The patent’s expiration did not necessarily eliminate all commercial barriers to teriparatide entry. Relevant barriers could include:

Later-expiring formulation patents
Device patents
Manufacturing patents
Trade-secret protection
FDA approval requirements
Product-specific labeling restrictions
Litigation over other Forteo-related patents

The expiration of a method patent also does not guarantee immediate generic substitution. A manufacturer must still establish FDA approval through an applicable abbreviated or follow-on pathway.

What Paragraph IV challenges affected the teriparatide market?

Paragraph IV litigation involving teriparatide products generally focused on the broader Forteo patent estate rather than only U.S. Patent 7,163,684. An abbreviated new drug application applicant may certify that an Orange Book-listed patent is invalid, unenforceable, or will not be infringed. The filing of a Paragraph IV notice can trigger a 30-month stay of FDA approval under the Hatch-Waxman framework, subject to statutory exceptions.

For U.S. Patent 7,163,684, the commercial litigation window was limited because the patent expired in 2018. Later generic disputes were more likely to concern formulation or device patents with later expiration dates.

The most significant reported Forteo patent litigation included Eli Lilly's disputes concerning teriparatide formulation patents. In Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., the Federal Circuit affirmed findings relating to the validity of Lilly's teriparatide formulation patent claims. That litigation illustrates the distinction between the expired method patent and later formulation rights. A generic manufacturer could avoid an expired method claim but still face a separate formulation patent challenge.

Which companies challenged or competed with Forteo?

The post-expiration competitive field included generic and follow-on teriparatide manufacturers. Key categories included:

Competitor category	Product strategy	Main intellectual-property issue
Generic teriparatide manufacturers	Follow-on injectable teriparatide	FDA pathway, formulation and device patents
Biosimilar-style or biological follow-on developers	Teriparatide product with comparable clinical performance	Reference-product and regulatory pathway
Branded competitors	Abaloparatide, romosozumab and other anabolic or bone-building agents	Clinical differentiation and patent duration
Established osteoporosis companies	Bisphosphonates, denosumab and other antiresorptive products	Different mechanism and treatment sequencing

Teriparatide is a peptide drug rather than a conventional small-molecule generic in the ordinary chemical sense. The precise FDA pathway depends on the product, reference product, formulation, manufacturing attributes, and applicable statutory route.

How does the patent estate compare with competing osteoporosis drugs?

U.S. Patent 7,163,684 protected a use of teriparatide. Competing osteoporosis products often relied on different combinations of composition, formulation, device, method-of-use and biologic manufacturing patents.

Product or class	Active agent	Core treatment type	Typical patent-risk focus
Forteo	Teriparatide	Anabolic PTH analog	Method of use, formulation, injection device
Tymlos	Abaloparatide	Anabolic PTH-related peptide	Composition, formulation, methods and device
Prolia	Denosumab	Anti-RANKL biologic	Biologic composition, manufacturing and method of use
Evenity	Romosozumab	Sclerostin inhibitor	Antibody composition, manufacturing and method of use
Fosamax and other bisphosphonates	Alendronate and related agents	Antiresorptive	Composition and method-of-use patents, many expired

The 7,163,684 claims are narrower than a composition patent because they require a specific clinical regimen. They are broader than a formulation claim in one respect: they can reach different teriparatide formulations if the treatment method satisfies all claim limitations.

What manufacturing and intellectual-property barriers remain after expiration?

The expiration of the patent removed one legal barrier but not all barriers to market entry. Teriparatide products may require control of:

Recombinant peptide production
Peptide purification
Oxidation and aggregation control
Sterile injectable manufacturing
Preservative and excipient compatibility
Cartridge or pen delivery systems
Stability and container-closure performance
Comparative analytical and clinical data

Manufacturing know-how is not disclosed in full by a use patent. A competitor can avoid infringement of U.S. Patent 7,163,684 while still facing development costs and regulatory risk associated with producing a stable injectable peptide.

The patent also provides no protection for a specific production cell line, purification sequence, formulation, device, or container. Those rights must be analyzed separately by patent family and jurisdiction.

What is the geographic coverage of U.S. Patent 7,163,684?

The patent is a United States patent. Its enforceable territorial scope was limited to conduct occurring within the United States or otherwise meeting the territorial requirements of U.S. patent law.

The patent did not automatically protect teriparatide treatment in:

The European Union
Japan
Canada
Australia
China
Other foreign jurisdictions

Foreign counterparts, national-stage applications, and related patents require separate analysis. Expiration dates can differ by country because of filing dates, patent-term adjustments, supplementary protection certificates, pediatric extensions, terminal disclaimers and local prosecution history.

What generic launch scenarios existed after expiration?

Three practical launch scenarios were available after the 2018 expiration of U.S. Patent 7,163,684.

Full-label launch

A manufacturer could seek a label covering the same high-risk post-menopausal osteoporosis population and 20 microgram daily dose. This approach maximizes commercial substitution but can expose the applicant to other unexpired patent claims.

Skinny-label launch

A manufacturer could omit patented or otherwise protected indications from its proposed label, subject to FDA requirements. A skinny label could reduce method-of-use risk but would not eliminate exposure if the marketed product, promotional conduct, or prescribing pattern supported induced infringement.

Formulation or device redesign

A competitor could use a different formulation, cartridge, pen, preservative system or delivery configuration to reduce exposure to separate Forteo patents. Such a redesign would not matter to claim 1 of U.S. Patent 7,163,684 if the treatment method itself remained within the claim, but the patent’s expiration removed that concern after August 26, 2018.

What revenue exposure did the patent create?

Forteo was a major osteoporosis product for Eli Lilly. Its revenue exposure arose from the overlap between the patented regimen and the FDA-approved product label. The claim tracked the core commercial use of Forteo in post-menopausal women at high fracture risk.

The patent’s economic value was limited by three factors:

It did not cover all uses of teriparatide.
It did not prevent competition based on alternative anabolic agents.
Its expiration date was fixed in 2018, after which the relevant method claim no longer blocked U.S. entry.

The larger revenue risk after expiration depended on the remaining Forteo patent estate, the timing of FDA approvals, competitor pricing, reimbursement, supply capacity and physician adoption.

What is the current legal status and practical value of the patent?

U.S. Patent 7,163,684 is expired. It has no current blocking value against ordinary post-expiration conduct in the United States.

Its continuing value is historical and analytical:

It identifies the protected clinical regimen underlying original Forteo commercialization.
It helps define the boundary between method-of-use rights and formulation or device rights.
It is relevant to historical Paragraph IV certifications and settlement analysis.
It can inform freedom-to-operate reviews for conduct during the patent term.
It does not provide a current basis for excluding generic teriparatide products from the U.S. market.

Key Takeaways

U.S. Patent 7,163,684 claimed treatment of high-risk post-menopausal osteoporosis with teriparatide at 20 micrograms daily.
The treatment had to exclude concurrent antiresorptive therapy, except for supplemental calcium or vitamin D.
Claims 2 through 6 narrowed the patient population by fracture history and osteoporosis subtype.
Claim 7 excluded concurrent calcium and vitamin D; claims 8 through 10 required specified supplementation patterns.
The patent was a method-of-use patent, not a composition, formulation, manufacturing or device patent.
Forteo received FDA approval under NDA 020318 on November 26, 2002.
The Orange Book expiration date for U.S. Patent 7,163,684 was August 26, 2018.
Later teriparatide patent disputes focused more heavily on formulation and delivery-system patents.
The patent no longer creates a current U.S. barrier to generic or follow-on teriparatide entry.

FAQs

Did U.S. Patent 7,163,684 cover all teriparatide products?

No. It covered a defined treatment method using human parathyroid hormone 1-34 at 20 micrograms daily in a high-risk post-menopausal osteoporosis population. It did not claim every formulation, dose, patient group or indication.

Could calcium and vitamin D be used under claim 1?

Yes. Claim 1 excluded concurrent antiresorptive agents other than supplemental vitamin D or calcium. Claims 8 through 10 expressly addressed vitamin D, calcium, or both.

Did the patent cover denosumab or bisphosphonate combination therapy?

No. The claim required that no antiresorptive agent other than supplemental calcium or vitamin D be concurrently administered. A regimen combining teriparatide with denosumab or a bisphosphonate would not satisfy that limitation.

Was U.S. Patent 7,163,684 a biologic patent?

It was a patent concerning a biological peptide drug, but its claims were directed to a method of treatment. It did not claim the biological molecule itself or the manufacturing process for producing it.

Can the expired patent still block a teriparatide launch?

No, not as an enforceable U.S. patent after August 26, 2018. A launch could still face other patents, regulatory requirements, formulation issues, device rights or litigation involving separate members of the Forteo patent estate.

References

Eli Lilly and Company. (2007). U.S. Patent No. 7,163,684: Method for treating osteoporosis. United States Patent and Trademark Office.
U.S. Food and Drug Administration. (2002). Forteo (teriparatide injection) prescribing information, NDA 020318. FDA.
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.
Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., 8 F.4th 1339 (Fed. Cir. 2021).
United States Congress. (1984). Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585.

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
Canada	2325371	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 7,163,684

Summary for Patent: 7,163,684