Details for Patent: 10,729,739

Which drugs does patent 10,729,739 protect, and when does it expire?

Patent 10,729,739 protects FIRMAGON and is included in one NDA.

This patent has one hundred and eight patent family members in twenty-four countries.

Summary for Patent: 10,729,739

Title:	Methods of treating prostate cancer with GnRH antagonist
Abstract:	The invention provides methods and dosing regimens for safely and effectively treating androgen-dependent prostate cancer with a gonadotrophin releasing hormone (GnRH) antagonist without causing a testosterone spike and/or other side effect of GnRH agonist therapy such as a urinary tract infection, or an arthralgia-related or cardiovascular side effect.
Inventor(s):	Tine Kold OLESEN, Bo-Eric Persson, Per CANTOR, Egbert A van der Meulen, Jens-Kristian Slott JENSEN
Assignee:	Ferring BV
Application Number:	US15/405,552
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,729,739
Patent Claim Types: see list of patent claims	Use;

United States Patent 10,729,739: Degarelix Dosing Claims, Patent Scope, Expiration Risk, and Competitive Landscape

US Patent No. 10,729,739 covers a prostate-cancer treatment regimen using degarelix, marketed as Firmagon, with a 240 mg subcutaneous loading dose administered in two injections followed by an 80 mg subcutaneous maintenance dose every 28 days for approximately one year. The claims also cover broader dose, concentration, timing, biomarker, patient-selection, and comparative side-effect limitations.

The commercial core is claim 27 and its dependent claims 28-29. Those claims track the standard Firmagon regimen: 240 mg initially, delivered as two 120 mg subcutaneous injections, followed by 80 mg every 28 days as a single subcutaneous injection. The patent therefore targets the labeled dosing method rather than a new chemical entity or a narrowly experimental use.

What drug and treatment regimen does US Patent 10,729,739 protect?

US 10,729,739 protects methods of treating prostate cancer with degarelix, a gonadotropin-releasing hormone antagonist. Degarelix suppresses luteinizing hormone and follicle-stimulating hormone without the initial testosterone surge associated with GnRH agonists such as leuprolide.

The broad regimen requires:

Claim element	Claimed requirement
Disease	Prostate cancer
Active ingredient	Degarelix
Initial dose	160-320 mg
Initial route	Subcutaneous
Initial injection format	Two subcutaneous injections
Maintenance dose	60-160 mg
Maintenance interval	Every 20-36 days, or every 28 days in claims 14-26
Treatment duration	364 days
Testosterone outcome	Below 0.5 ng/mL
Comparative objective	Reduced likelihood of testosterone spike or other GnRH-agonist side effects

Claim 27 is narrower and commercially more important. It requires:

1. An initial 240 mg dose;
2. Two subcutaneous injections;
3. An 80 mg maintenance dose;
4. Administration every 28 days;
5. Testosterone suppression at or below 0.5 ng/mL from day 28 through day 364.

The claim set is directed to a method of use. It does not claim degarelix as a molecule, the general pharmaceutical composition, or every possible use of degarelix.

How many independent claims does US 10,729,739 have?

The patent has three independent claims: claims 1, 14, and 27.

Independent claim	Scope
Claim 1	Broad regimen with maintenance every 20-36 days and testosterone below 0.5 ng/mL through day 364
Claim 14	Regimen restricted to administration every 28 days, with testosterone at or below 0.5 ng/mL from day 28 through day 364
Claim 27	Specific 240 mg loading dose and 80 mg maintenance dose every 28 days

Claims 2-13 depend from claim 1. Claims 15-26 depend from claim 14. Claims 28-29 depend from claim 27.

The claim architecture gives the patent two layers of protection:

• Broad regimen protection covering a range of doses and intervals.
• Narrow commercial-regimen protection centered on the approved 240 mg/80 mg schedule.

What is the strongest claim in US Patent 10,729,739?

Claim 27 is the strongest commercial claim because it maps directly onto the standard Firmagon dosing schedule and contains fewer outcome variables than claims 1 and 14.

Claims 1 and 14 require proof of a pharmacodynamic result, specifically testosterone suppression below or at 0.5 ng/mL over a defined treatment period. Claim 27 also includes that result, but its dosing parameters are precise and easier to compare against a product label, prescribing information, medical records, and pharmacy claims.

Claim 27 requires all of the following:

• Prostate cancer treatment;
• Degarelix;
• 240 mg initial dose;
• Subcutaneous delivery;
• Two initial injections;
• 80 mg maintenance dose;
• Every-28-day administration;
• Testosterone at or below 0.5 ng/mL from day 28 through day 364.

A competing product that uses the same approved regimen would face a direct literal-infringement theory if the patent is enforceable and unexpired. A product with a different loading dose, maintenance dose, interval, injection format, or treatment objective would need to be analyzed element by element.

What formulations and injection concentrations are protected?

Claims 9-10, 12-13, 22-23, and 25-26 add concentration limitations.

The claimed concentration ranges are:

Dose	Claimed concentration
Initial dose	5-40 mg/mL
Initial dose preferred concentration	40 mg/mL
Maintenance dose	5-40 mg/mL
Maintenance dose preferred concentration	20 mg/mL

The patent therefore reaches formulation and presentation details associated with the dosing method. The concentration limitations do not independently protect a degarelix formulation outside the claimed treatment method. A product must be used in the claimed prostate-cancer regimen for these method claims to become relevant.

Claim 11 and claim 24 require the maintenance dose to be administered as a single injection. Claim 29 adds the same single-injection limitation to the specific 240 mg/80 mg regimen.

These limitations are commercially significant because the standard regimen uses two injections for the loading dose and one injection for the maintenance dose. A competing formulation that permits a different injection volume or administration pattern may avoid some dependent claims while remaining exposed to the independent claims.

What patient characteristics and treatment outcomes are claimed?

The dependent claims add patient-selection and clinical-response limitations.

Claim	Additional limitation
3	Reduced likelihood of undesirable side effects compared with leuprolide
4	At least approximately 30% PSA reduction by day 14
5	At least approximately 60% PSA reduction by day 28
6	At least approximately 80% likelihood of maintaining PSA below approximately 5 ng/mL
7	Locally advanced prostate cancer and at least approximately 40% PSA reduction by day 14
8	Body mass index below 30 kg/m²

These claims create narrower fallback positions, but they also increase proof burdens.

For infringement, a patentee would need to establish the claimed treatment method and the relevant patient or outcome limitation. Claims based on a physician’s intent, patient BMI, PSA response, or comparative side-effect profile can be more difficult to enforce than dose-and-schedule claims because the facts may vary between patients and may not be known before treatment.

The BMI limitation in claim 8 is particularly narrow. It does not cover patients with a BMI of 30 kg/m² or higher. The PSA limitations also require clinical evidence at specific time points.

How does US 10,729,739 compare with the FDA-labeled Firmagon regimen?

The patent’s claim 27 closely corresponds to the FDA-approved Firmagon regimen.

Attribute	Patent claim 27	FDA Firmagon labeling
Loading dose	240 mg	240 mg
Loading administration	Two subcutaneous injections	Two subcutaneous injections
Maintenance dose	80 mg	80 mg
Maintenance interval	Every 28 days	Every 28 days
Route	Subcutaneous	Subcutaneous
Indication	Prostate cancer	Advanced prostate cancer
Testosterone target	At or below 0.5 ng/mL from day 28 to day 364	Testosterone suppression is a labeled pharmacologic objective

The FDA label identifies Firmagon as a GnRH antagonist indicated for the treatment of advanced prostate cancer. It describes the 240 mg starting dose and 80 mg maintenance dose administered every 28 days. The label also distinguishes degarelix from GnRH agonists by avoiding the testosterone surge associated with agonist initiation. [1]

This overlap creates a conventional method-of-use patent risk for an authorized generic, follow-on injectable, or other product that relies on the same regimen.

When does US Patent 10,729,739 lose exclusivity?

The exact expiration date depends on the patent’s effective filing date, patent-term adjustment, patent-term extension, terminal disclaimers, and any applicable regulatory extension. A grant date alone does not establish the final expiration date.

The patent issued on July 31, 2020, according to the patent record. [2] Its enforceable life generally runs from the applicable US nonprovisional filing date for 20 years, subject to statutory adjustments under 35 U.S.C. §§ 154 and 156.

Exclusivity component	Relevance to US 10,729,739
Patent term	Governed principally by the 20-year term from the earliest effective nonprovisional filing date
Patent-term adjustment	May extend the ordinary term for qualifying USPTO delays
Patent-term extension	Could apply only if statutory requirements are satisfied
Terminal disclaimer	Could shorten the term if the patent is tied to an earlier patent
Regulatory exclusivity	Separate from patent term and depends on the approved product and application

The controlling expiration date should be taken from the USPTO patent file and the applicable Orange Book entry, not inferred from the issue date. [2, 3]

Is US 10,729,739 listed in the Orange Book?

Orange Book listing is a separate question from patent validity and enforceability.

The FDA Orange Book lists patents submitted by an NDA holder as covering the approved drug, its formulation, or an approved method of use. A method-of-use patent may be listed with a use code that identifies the approved indication or regimen. [3]

For a commercial freedom-to-operate analysis, the relevant questions are:

1. Whether US 10,729,739 is listed against the Firmagon NDA;
2. Whether the listing identifies a method of use corresponding to the 240 mg/80 mg regimen;
3. Whether the listing remains active;
4. Whether the patent is subject to a terminal disclaimer or later expiration;
5. Whether a later abbreviated new drug application would need a Paragraph IV certification.

The claims supplied here establish the patent scope but do not establish the patent’s current Orange Book listing status. An Orange Book listing also does not validate the claims. It affects the regulatory pathway and potential Hatch-Waxman litigation consequences.

What Paragraph IV challenges could target this patent?

A generic applicant seeking FDA approval before patent expiry could file a Paragraph IV certification asserting that the patent is invalid, unenforceable, or not infringed.

Potential challenge theories include:

Lack of written description or enablement

The claims cover broad ranges of loading doses, maintenance doses, dosing intervals, concentrations, and one-year testosterone outcomes. A challenger could argue that the specification does not adequately support the full breadth of every claimed combination.

This issue would be strongest against the broad ranges in claims 1 and 14 if the supporting clinical data centered primarily on 240 mg followed by 80 mg every 28 days.

Anticipation

Prior clinical studies, regulatory documents, or earlier patent publications may disclose degarelix dosing schedules, testosterone suppression, and prostate-cancer treatment. Anticipation requires one reference to disclose every claim element arranged as claimed.

The closer the prior disclosure is to the 240 mg/80 mg regimen, the greater the risk to claim 27.

Obviousness

A challenger could combine earlier degarelix dosing disclosures with known clinical objectives, including suppression below 0.5 ng/mL and avoidance of testosterone flare. The central issue would be whether a skilled person would have selected the claimed dose, interval, injection format, and treatment duration with a reasonable expectation of success.

The patent holder would likely rely on clinical data, rapid PSA declines, durable testosterone suppression, and differences from leuprolide as evidence of nonobviousness.

Indefiniteness

Terms such as “reduced likelihood,” “other GnRH agonist side-effect,” “about,” and “low PSA level” could be challenged if the specification does not provide objective boundaries. The word “about” is common in pharmaceutical claims, but its scope depends on the intrinsic record and technical context.

Ineligible subject matter

Because the claims recite treatment methods using a specified drug and dosing regimen, they are more defensible under 35 U.S.C. § 101 than claims directed only to a natural correlation. The patent still could face eligibility arguments if a challenger characterizes the claims as applying a natural pharmacologic relationship with conventional administration steps. [4]

Which companies are most likely to challenge the patent?

The principal potential challengers would be:

• Generic injectable manufacturers developing degarelix products;
• Contract manufacturers supplying a degarelix follow-on product;
• Specialty pharmaceutical companies seeking a prostate-cancer injectable platform;
• Firms pursuing an authorized generic or license-based product;
• Manufacturers developing a longer-acting GnRH antagonist with a competing administration schedule.

A biosimilar pathway is not the normal route for degarelix because degarelix is a chemically synthesized peptide rather than a conventional FDA-licensed biological product. A follow-on applicant would more likely use an abbreviated new drug application or another drug-specific pathway rather than a biosimilar application under the Public Health Service Act.

What patent litigation affects degarelix and Firmagon?

The key litigation risk is not limited to US 10,729,739. A degarelix entrant would need to review the full patent estate covering:

• The degarelix compound and peptide sequence;
• Pharmaceutical salts and counterions;
• Depot or sustained-release formulations;
• Solvent and excipient systems;
• Reconstitution procedures;
• Injection concentration and volume;
• Manufacturing and purification methods;
• Prostate-cancer treatment methods;
• Dosing intervals and testosterone suppression;
• Pediatric, combination, or additional oncology uses.

A Paragraph IV notice concerning an Orange Book-listed patent could trigger a 45-day period for the NDA holder to file an infringement action. A timely action generally creates a 30-month stay of FDA approval, subject to statutory exceptions and court decisions. [5]

No settlement terms should be assumed from the existence of the patent. A settlement could provide a future generic entry date, a license, a manufacturing arrangement, or a covenant not to sue. Those terms would materially change the commercial value of the patent and must be verified from court filings, FDA records, or transaction disclosures.

How strong is the patent estate for degarelix?

US 10,729,739 has high commercial relevance but an uneven legal profile.

Factor	Assessment
Product alignment	Strong. Claim 27 tracks the standard labeled regimen
Claim breadth	Moderate to broad in claims 1 and 14
Clinical limitation burden	Significant. Testosterone and PSA outcomes may require patient-level proof
Formulation coverage	Narrow and dependent on the treatment method
Design-around potential	Moderate. Altering dose, interval, injection format, or formulation may avoid dependent claims
Prior-art exposure	Potentially meaningful because degarelix clinical dosing was publicly studied before issuance
Generic litigation leverage	Stronger if listed in the Orange Book and tied to the approved regimen
Biosimilar relevance	Low. Degarelix is not normally challenged through a biosimilar pathway

The strongest commercial protection is the combination of claim 27 with any separate compound, formulation, or manufacturing patents that remain enforceable. If US 10,729,739 is the only relevant unexpired patent, a competitor could explore a modified interval, alternate dose, different concentration, or nonidentical injection format.

What generic launch scenarios exist for degarelix?

Launch after patent expiry

This is the lowest-risk pathway. The entrant waits until all blocking patents and applicable regulatory exclusivities expire.

Paragraph IV launch

The applicant certifies that the patent is invalid, unenforceable, or not infringed. The NDA holder may sue within 45 days, triggering a potential 30-month stay.

Carve-out or section viii strategy

If the patent covers only a method of use that can be omitted from the generic labeling, an applicant may attempt a section viii statement. This approach is difficult where the patented regimen is the principal or only approved use reflected in the product label.

Design-around launch

A competitor could seek a regimen that does not meet one or more limitations, such as:

• A maintenance interval outside 20-36 days;
• A different loading dose;
• A different maintenance dose;
• A single initial injection;
• A different concentration;
• A formulation that changes administration volume;
• A treatment schedule that does not maintain the claimed testosterone threshold.

A design-around must also avoid other patents and remain clinically and regulatorily acceptable.

What licensing and transaction issues matter?

A license to US 10,729,739 would need to address more than patent rights. Key provisions would include:

• Field of use;
• Approved and unapproved indications;
• Authorized generic rights;
• Territory;
• Manufacturing rights;
• Supply obligations;
• Sublicensing;
• Patent-prosecution control;
• Enforcement control;
• Royalty structure;
• Milestone payments;
• Entry date and settlement restrictions;
• Allocation of Paragraph IV litigation costs.

The commercial value of a license depends on the remaining life of the patent, Orange Book status, the scope of related patents, and whether the license includes the underlying degarelix formulation and manufacturing rights.

How does degarelix compare with leuprolide patent risk?

Issue	Degarelix	Leuprolide
Pharmacology	GnRH antagonist	GnRH agonist
Initial testosterone surge	Generally avoided	Associated with treatment initiation
Administration	Subcutaneous injection for Firmagon	Depot formulations and multiple delivery systems
Patent focus	Dosing regimen, formulation, and use	Depot technology, formulations, devices, and use
Main clinical distinction	Rapid suppression without flare	Testosterone flare followed by suppression
Patent challenge profile	Regimen and formulation overlap	Multiple formulation and delivery patents

Claim 3’s comparison with leuprolide is clinically relevant but may be legally narrower than the core dosing claims. It requires a decreased likelihood of an undesirable side effect compared with leuprolide. A challenger could argue that this limitation lacks a sufficiently objective boundary or that the evidence does not establish the comparison across the full claim scope.

Key Takeaways

• US 10,729,739 is a method-of-treatment patent covering degarelix dosing for prostate cancer.
• Claim 27 is the commercial center of gravity because it recites 240 mg initially and 80 mg every 28 days.
• The patent also claims broader dose ranges, 20-36-day intervals, injection concentrations, PSA responses, BMI, and comparison with leuprolide.
• The claims closely track the FDA-labeled Firmagon regimen.
• The patent does not independently claim the degarelix molecule.
• A generic or follow-on entrant must review the full degarelix estate, including formulation, manufacturing, compound, and use patents.
• Paragraph IV risk depends heavily on whether the patent is currently listed in the Orange Book and whether its use code covers the proposed product’s labeling.
• Biosimilar risk is limited because degarelix is a synthetic peptide drug rather than a conventional biologic.
• The principal invalidity risks are anticipation, obviousness, written description, enablement, and indefiniteness.
• The principal design-around options involve dose, interval, injection format, concentration, and formulation changes.

FAQs

Does US 10,729,739 cover all degarelix products?

No. It covers specified methods of treating prostate cancer with specified degarelix regimens and outcomes. It does not, by itself, cover every formulation, manufacturing process, dose, or indication.

Can a generic degarelix product avoid claim 27 by changing the injection concentration?

Possibly, but only if the changed concentration causes the product or use to fall outside the claim and does not infringe another claim or related patent. Claims 27-29 do not expressly require the 40 mg/mL initial or 20 mg/mL maintenance concentrations.

Does the patent protect monthly degarelix treatment?

Yes. Claims 2, 15, and 28 recite monthly administration, while claims 14 and 27 expressly require administration every 28 days. The term “monthly” may require claim-construction analysis because calendar-month administration and 28-day administration are not always identical.

Is a testosterone result below 0.5 ng/mL required for infringement?

For the independent claims, yes. Claims 1, 14, and 27 include testosterone-suppression limitations. The relevant threshold and treatment period differ slightly between claim groups, so clinical records and pharmacodynamic data may be material.

Does this patent create biosimilar exclusivity for Firmagon?

No. Patent protection and biologic regulatory exclusivity are separate concepts. Degarelix is generally handled as a drug product rather than through the standard biosimilar pathway.

References

1. U.S. Food and Drug Administration. (2024). Firmagon (degarelix for injection) prescribing information. FDA.

2. United States Patent and Trademark Office. (2020). U.S. Patent No. 10,729,739, Methods of treating prostate cancer. USPTO Patent Center.

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

4. 35 U.S.C. §§ 101, 102, 103, 112, 154, 156.

5. 21 U.S.C. § 355; 35 U.S.C. § 271(e).

Drugs Protected by US Patent 10,729,739

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-001	Dec 24, 2008		RX	Yes	No	10,729,739					TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-002	Dec 24, 2008		RX	Yes	Yes	10,729,739					TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT

International Family Members for US Patent 10,729,739

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009213748
Australia	2009213751
Brazil	PI0908127
Brazil	PI0908129
Canada	2714444
Canada	2714445
Canada	3235099