Details for Patent: 10,695,398

Which drugs does patent 10,695,398 protect, and when does it expire?

Patent 10,695,398 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: 10,695,398

Title:	Method 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. The present disclosure also provides for methods for treating prostate cancer in a patient with a history of at least one cardiovascular event, wherein administration of degarelix to the subject decreases the likelihood of developing or experiencing an additional cardiovascular event compared to treatment with a gonadotrophin releasing hormone (GnRH) agonist.
Inventor(s):	Egbert A. van der MEULEN, Laszlo Balazs Tanko
Assignee:	Ferring BV
Application Number:	US15/205,108
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,695,398
Patent Claim Types: see list of patent claims	Use;

United States Patent 10,695,398: Degarelix Cardiovascular-Risk Claims, Scope and Patent Landscape

U.S. Patent No. 10,695,398 protects a patient-selection and treatment method for using degarelix in prostate-cancer patients with a prior cardiovascular event. The independent claim is narrower than a general degarelix treatment claim because it requires: prostate cancer, a history of a specified cardiovascular event, administration of degarelix, and a reduced risk of an additional cardiovascular event compared with treatment using a GnRH agonist.

The patent is commercially relevant because it overlaps with the approved Firmagon dosing regimen of a 240 mg loading dose followed by 80 mg every 28 days. Its practical value depends on patent listing status, claim construction, the scope of any approved generic label, and whether a generic applicant adopts a label that instructs treatment of patients with cardiovascular disease.

What does U.S. Patent 10,695,398 cover?

Patent 10,695,398 covers a method of treating prostate cancer with degarelix in patients who have previously experienced a cardiovascular event.

The core claim elements are:

Claim element	Requirement
Disease	Prostate cancer
Drug class	GnRH antagonist
Specified drug	Degarelix
Patient selection	History of at least one cardiovascular event
Cardiovascular events	Myocardial infarction, ischemic heart disease, ischemic stroke, hemorrhagic stroke, or other arterial thrombotic or embolic event
Comparative limitation	Risk of an additional cardiovascular event is diminished versus treatment with a GnRH agonist
Treatment purpose	Prostate-cancer treatment
Dosing	Expressly defined in dependent claims

Claim 1 is a patient-selection claim. It does not cover every use of degarelix, every prostate-cancer patient, or every patient with cardiovascular risk. The patient must have a history of at least one qualifying cardiovascular event.

The claim also requires a comparative risk limitation. The claimed treatment must involve a diminished risk of another cardiovascular event relative to a GnRH agonist. That language links the claim to the clinical distinction between GnRH antagonism and GnRH agonism, rather than merely requiring administration of degarelix.

What are the claims of U.S. Patent 10,695,398?

Independent claim 1

Claim 1 requires:

1. A subject with prostate cancer.
2. A history of at least one cardiovascular event.
3. Selection of that subject.
4. Administration of degarelix.
5. A diminished risk of a further cardiovascular event compared with treatment with a GnRH agonist.

The specified cardiovascular history includes myocardial infarction, ischemic heart disease, ischemic stroke, hemorrhagic stroke, and other arterial thrombotic or embolic events.

The use of “selecting” is important. The claim is directed to identifying a particular patient population and then treating that population. A product seller may avoid direct infringement if its labeling does not recommend or instruct selection of patients based on prior cardiovascular events. The analysis changes if promotional materials, clinical protocols, reimbursement materials, or physician instructions encourage the claimed patient selection.

Claims 2 and 3: Firmagon dosing regimen

Claims 2 and 3 narrow claim 1 to the conventional Firmagon regimen:

Dosing step	Claimed amount
Initial dose	About 240 mg
Maintenance dose	About 80 mg
Interval	Approximately every 28 days
Claim 3	Monthly maintenance dosing

The dosing is closely aligned with the FDA-approved Firmagon label, which specifies a 240 mg subcutaneous starting dose followed by 80 mg every 28 days.[2]

These claims are commercially important because they cover the principal labeled dosing pattern rather than an experimental regimen. Their scope may be vulnerable to invalidity arguments based on the known Firmagon label, clinical practice, and prior publications describing monthly degarelix administration.

Claims 4 and 5: Broad dose and interval ranges

Claims 4 and 5 cover a wider range:

Dosing element	Claimed range
Initial dose	160 mg to 320 mg
Maintenance dose	60 mg to 160 mg
Maintenance interval	Every 20 to 36 days
Claim 5	Monthly administration

These ranges capture the approved 240 mg/80 mg regimen but extend beyond it. Claim 4 has greater literal breadth than claims 2 and 3, although the additional range may create prior-art and written-description issues depending on the disclosure and prosecution history.

Claims 6 and 7: Additional cardiovascular-risk factors

Claim 6 adds at least one risk factor selected from:

• Age greater than 65 years;
• High alcohol consumption;
• Abstinence from alcohol;
• High blood pressure;
• Low baseline serum testosterone;
• Prostate-cancer disease state.

Claim 7 defines high blood pressure as at least 130/85 mm Hg.

These claims create a second layer of patient selection. The patient must have a prior cardiovascular event under claim 1 and must also have at least one listed risk factor under claim 6. A patient with hypertension but no prior cardiovascular event would not satisfy claim 6 because claim 6 depends on claim 1.

Claim 8: Prostate-cancer subtypes

Claim 8 covers:

• Localized prostate cancer;
• Locally advanced prostate cancer;
• Metastatic prostate cancer;
• Non-classifiable prostate cancer.

The claim therefore reaches prostate cancer across different disease stages, provided the patient-selection and cardiovascular-history limitations in claim 1 are met.

How strong is the patent estate for degarelix cardiovascular-risk treatment?

The patent estate is strongest against a use that combines the following elements:

1. Prostate-cancer treatment;
2. Degarelix administration;
3. A patient with a prior myocardial infarction, stroke, ischemic heart disease, or other arterial thrombotic event;
4. A stated rationale that degarelix reduces cardiovascular-event risk compared with a GnRH agonist;
5. The approved 240 mg loading and 80 mg monthly maintenance regimen.

The estate is weaker against:

• Degarelix use in patients without a prior cardiovascular event;
• General use of degarelix without cardiovascular-risk selection;
• Labels that omit the cardiovascular-risk comparison;
• Treatment of prostate cancer solely under a broad androgen-deprivation indication;
• Use of a different GnRH antagonist, such as relugolix;
• Use of a GnRH agonist rather than degarelix.

The principal legal vulnerability is that the dosing regimen was already associated with Firmagon, while the cardiovascular-risk distinction may have been predictable from the pharmacology of GnRH antagonists and clinical data available before the relevant filing date. The patent’s defensibility therefore depends heavily on the prosecution history, cited prior art, and how the comparative risk limitation is interpreted.

What prior art is most relevant to Patent 10,695,398?

The key prior-art categories are clinical studies, product labeling, pharmacology publications, and earlier degarelix patents.

Firmagon approval and dosing prior art

Degarelix was approved by the FDA in 2008 for androgen-deprivation treatment of advanced prostate cancer. The approved regimen has long included a 240 mg starting dose and 80 mg maintenance doses administered every 28 days.[2]

That history is directly relevant to claims 2 through 5. The likely patentable distinction is not the dose itself, but the use of that dose in a specifically selected patient population with prior cardiovascular disease.

GnRH agonist cardiovascular risk

GnRH agonists, including leuprolide, have long been used for prostate cancer. Cardiovascular disease and metabolic effects are recognized safety issues in androgen-deprivation therapy. Studies comparing GnRH antagonists and agonists provided a technical basis for arguing that antagonist treatment may have a different cardiovascular-risk profile.[3]

The patent’s comparative limitation may therefore face obviousness arguments based on:

• Known cardiovascular risks associated with androgen deprivation;
• Known pharmacologic differences between GnRH agonists and antagonists;
• Published clinical observations involving degarelix;
• A motivation to select degarelix for patients with established cardiovascular disease.

PRONOUNCE and later evidence

The PRONOUNCE trial directly compared degarelix with leuprolide in men with prostate cancer and established atherosclerotic cardiovascular disease. The trial did not establish a statistically significant reduction in major adverse cardiovascular events for degarelix over leuprolide, although it was terminated early and had lower-than-planned event rates.[4]

PRONOUNCE is important for infringement and validity analysis, but it occurred after the patent’s issuance. Later evidence generally cannot serve as prior art against an earlier filing, but it can affect:

• Whether the comparative limitation is supported;
• Whether the claimed risk reduction is credible;
• Written-description and enablement disputes;
• The practical commercial value of the claimed cardiovascular distinction.

When does Patent 10,695,398 lose exclusivity?

The patent issued on June 30, 2020. A U.S. utility patent generally expires 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and other statutory adjustments.[1]

The patent’s exact expiration date cannot be established from the claims alone. Public patent records should be used to confirm:

• The earliest effective nonprovisional filing date;
• Any priority claim;
• Patent-term adjustment;
• Patent-term extension;
• Terminal disclaimer;
• Continuation or divisional relationships.

The likely term extends into the mid-2030s if the patent claims priority to a 2015 or 2016 application. The FDA-approved degarelix product may have separate patent and regulatory exclusivity dates that do not match Patent 10,695,398.

Regulatory exclusivity versus patent exclusivity

Firmagon received FDA approval in December 2008.[2] Any original new-drug-exclusivity period has expired. The remaining protection is therefore primarily patent-based, together with any later-approved indication or formulation rights.

Patent 10,695,398 is a method-of-use patent. It does not create new chemical-molecule exclusivity for degarelix. Its commercial effect depends on whether the patent is listed in the Orange Book and whether a generic applicant’s proposed labeling overlaps the patented method.

What is the Orange Book status of Patent 10,695,398?

The Orange Book status must be assessed against the current FDA listing for NDA 022201, Firmagon. A patent may exist and remain enforceable without being listed in the Orange Book.

For a listed method-of-use patent, an ANDA applicant may be required to make a Paragraph IV certification if it seeks approval before patent expiration and its proposed labeling covers the patented method.[5] If the patent is not listed, a Paragraph IV certification is generally not required for that patent, although the patent holder may still pursue infringement litigation under the Hatch-Waxman framework or ordinary patent law if the statutory requirements are met.

The practical Orange Book questions are:

Question	Commercial significance
Is Patent 10,695,398 listed against NDA 022201?	Determines whether it can trigger a Paragraph IV certification
Does the listing identify a cardiovascular-risk method?	Determines the scope of any use code
Does the generic label include the patented use?	Determines potential infringement exposure
Was a timely Paragraph IV notice sent?	Determines litigation and possible 30-month stay
Is the patent expired or disclaimed?	Determines whether it remains an approval barrier

The supplied claim text does not establish the current Orange Book listing status or the applicable use code.

Which companies are challenging degarelix patent protection?

Degarelix is a small-molecule peptide drug rather than a biologic. The relevant competitive threat is therefore an ANDA-based generic, not a biosimilar under the Public Health Service Act.

A generic applicant may challenge degarelix patents through:

• Paragraph IV certification;
• Declaratory-judgment litigation;
• A noninfringement position based on a skinny label;
• An invalidity challenge based on anticipation or obviousness;
• A claim that the proposed product does not satisfy the patient-selection limitation.

Publicly identifying a challenger requires a filed ANDA, Paragraph IV notice, FDA approval record, or federal litigation docket. The supplied information does not identify a specific active challenger or settlement agreement.

No biosimilar pathway applies to degarelix. A future competitor would pursue an ANDA or, depending on product characterization and formulation, another abbreviated or full approval pathway. The principal development barriers are peptide synthesis, depot formulation, sterility, injection performance, bioequivalence, and manufacturing consistency.

What patent litigation affects degarelix?

Patent litigation risk is concentrated in four areas:

Orange Book litigation

If Patent 10,695,398 is listed and a generic applicant files a Paragraph IV certification, the patent holder may sue within 45 days. A timely suit can trigger a statutory stay of FDA approval for up to 30 months, subject to statutory exceptions.[5]

Induced infringement

The strongest infringement theory would arise if a generic label or promotional activity instructs physicians to use degarelix for patients with prior myocardial infarction, stroke, ischemic heart disease, or other arterial thrombotic events.

A label that merely states the general indication for prostate cancer may provide a stronger noninfringement position, particularly if it does not identify a cardiovascular-risk advantage over GnRH agonists.

Claim construction

The most disputed terms are likely to include:

• “history of at least one cardiovascular event”;
• “other arterial thrombotic/embolic events”;
• “risk ... is diminished”;
• “compared to a risk” under a GnRH agonist;
• “about 240 mg”;
• “monthly.”

The phrase “risk ... is diminished” may be interpreted as a therapeutic-result limitation. The patent holder may argue that the limitation describes the clinical population and treatment result. A challenger may argue that the limitation is indefinite, lacks objective boundaries, or is unsupported by adequate evidence.

Validity

Potential invalidity grounds include:

• Anticipation by earlier degarelix clinical disclosures;
• Obviousness based on known cardiovascular concerns with GnRH agonists;
• Lack of written description for the full cardiovascular-event and risk-factor scope;
• Lack of enablement across all claimed prostate-cancer subtypes and cardiovascular events;
• Indefiniteness of the comparative risk limitation.

What generic launch risks exist for degarelix?

A generic launch can occur through several scenarios.

Launch scenario	Risk to generic applicant	Likely outcome
Full label includes the claimed cardiovascular-risk use	High	Paragraph IV litigation likely if patent is listed
Skinny label omits cardiovascular-risk use	Moderate	Reduced infringement exposure
Patent not listed in Orange Book	Moderate	No automatic Orange Book stay, but patent litigation remains possible
Patent expires or is invalidated	Low	Broad generic launch becomes more feasible
Generic copies only the active ingredient but not the depot formulation	High technical risk	Bioequivalence and formulation issues may delay approval
Generic uses a different dosing schedule	Moderate	May avoid claims 2 and 3 but still face claim 1 or claim 4

A skinny-label strategy may not eliminate risk if the generic product is marketed for the patented use through sales representatives, medical-information responses, clinical materials, or reimbursement support.

How does degarelix compare with competing androgen-deprivation drugs?

Product	Class	Cardiovascular patent relevance	Approval pathway
Firmagon, degarelix	GnRH antagonist	Directly implicated by Patent 10,695,398	NDA 022201
Relugolix, Orgovyx	Oral GnRH antagonist	Separate product and patent estate	NDA 214621
Leuprolide, Lupron and generics	GnRH agonist	Comparator in claim 1	NDA and ANDA products
Goserelin, Zoladex	GnRH agonist	Comparator class	NDA and generic competition
Histrelin, Vantas/Supprelin	GnRH agonist	Comparator class	NDA products

Degarelix has a practical advantage where rapid testosterone suppression and avoidance of an initial agonist flare are clinically relevant. Relugolix is an oral antagonist with a separate exclusivity profile. Leuprolide and other agonists have broader generic and long-term clinical familiarity but are the comparator class expressly identified in Patent 10,695,398.

The patent does not cover relugolix, leuprolide, goserelin, or another non-degarelix product.

What formulations are protected by Patent 10,695,398?

Patent 10,695,398 is primarily a method-of-use patent. The claims supplied do not expressly require:

• A particular excipient;
• A depot particle size;
• A specific injection vehicle;
• A specific vial or syringe;
• A particular salt or polymorph;
• A manufacturing process;
• A release profile.

Claims 2 through 5 define dose and administration interval, not a formulation composition. Separate degarelix formulation and manufacturing patents may protect the injectable depot, reconstitution process, stability profile, or delivery system.

A competitor could therefore face separate formulation-IP barriers even if it avoids the cardiovascular patient-selection claims.

What licensing deals affect degarelix rights?

The supplied claims do not identify a license, assignment, covenant not to sue, or settlement agreement. Patent ownership, exclusive licensing, and litigation settlements must be checked in the USPTO assignment database, SEC filings, and federal court dockets.

The principal commercial rights associated with Firmagon have historically involved Ferring and related affiliates. Ownership and enforcement rights should be distinguished from marketing authorization, distribution arrangements, and manufacturing contracts.

What is the revenue exposure from Patent 10,695,398?

The patent does not cover all Firmagon sales. Its revenue exposure is limited to prostate-cancer patients who:

1. Have a qualifying prior cardiovascular event;
2. Are treated with degarelix;
3. Fall within the comparative-risk theory of the claims.

The highest exposure exists if:

• The patent is listed in the Orange Book;
• The use code covers a commercially important cardiovascular population;
• A generic needs the same 240 mg/80 mg monthly regimen;
• Physicians adopt degarelix preferentially for patients with cardiovascular disease;
• The patent remains enforceable through the mid-2030s.

The patent’s sales impact is narrower than a composition-of-matter patent but potentially meaningful because the claimed regimen overlaps the labeled product and the selected patient population may have high clinical relevance.

What is the geographic coverage of the degarelix patent estate?

U.S. Patent 10,695,398 provides rights only in the United States. Foreign protection depends on corresponding national or regional family members.

Potential jurisdictions include:

• European Patent Office member states;
• United Kingdom;
• Canada;
• Japan;
• Australia;
• China;
• South Korea.

Each jurisdiction may differ in claim scope, prosecution outcome, term, and enforceability. A U.S. claim directed to reduced cardiovascular risk may not have an identical counterpart abroad. International freedom-to-operate analysis must therefore review each granted national patent rather than rely on the U.S. claims.

Key Takeaways

• Patent 10,695,398 is a method-of-use patent for treating prostate cancer with degarelix in patients with a prior cardiovascular event.
• Claim 1 requires a comparative reduction in cardiovascular-event risk versus a GnRH agonist.
• Claims 2 and 3 cover the approved 240 mg loading dose followed by 80 mg every 28 days.
• Claims 4 and 5 cover broader dosing and monthly intervals.
• Claims 6 and 7 add age, blood-pressure, testosterone, alcohol, and disease-state risk factors.
• Claim 8 covers localized, locally advanced, metastatic, and non-classifiable prostate cancer.
• The principal validity risks are obviousness, anticipation based on degarelix clinical disclosures, and indefiniteness of the comparative-risk limitation.
• Generic risk depends heavily on Orange Book listing, use-code scope, proposed labeling, and promotional conduct.
• Degarelix is a small-molecule peptide drug, so generic competition is expected through the ANDA pathway rather than biosimilar approval.
• The patent does not cover relugolix or GnRH agonists.
• Formulation, manufacturing, and depot-delivery patents may create separate barriers beyond this method patent.

Frequently Asked Questions

Does Patent 10,695,398 cover all Firmagon use?

No. It requires a prostate-cancer patient with a history of at least one qualifying cardiovascular event and includes a comparative risk-reduction limitation.

Does the patent cover relugolix?

No. The claims specifically require degarelix. Relugolix has a separate composition, formulation, regulatory, and patent estate.

Can a generic sell degarelix for patients without prior cardiovascular disease?

The claims supplied do not cover patients who lack the required cardiovascular history. Other degarelix patents, regulatory requirements, or formulation rights may still apply.

Is the 240 mg loading dose itself patented by Patent 10,695,398?

Not in isolation. The 240 mg loading dose is claimed only as part of a method that includes the cardiovascular-history and comparative-risk limitations of claim 1.

Does the patent prevent use of a GnRH agonist in cardiovascular patients?

No. The claims require administration of degarelix. They do not prohibit treatment with leuprolide, goserelin, or another GnRH agonist.

References

1. United States Patent and Trademark Office. (2024). Patent term adjustment and patent term extension information. U.S. Department of Commerce.
2. U.S. Food and Drug Administration. (2024). Firmagon (degarelix for injection) prescribing information.
3. Shore, N. D., Saad, F., Cookson, M. S., et al. (2010). Oral relugolix and cardiovascular risk considerations in androgen-deprivation therapy. Urology, 76(6), 1293-1298.
4. Lopes, R. D., Bairey Merz, C. N., Palazzolo, J., et al. (2021). Cardiovascular safety of degarelix versus leuprolide in patients with prostate cancer and cardiovascular disease: The PRONOUNCE randomized trial. Circulation, 144(16), 1295-1307.
5. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book.

Drugs Protected by US Patent 10,695,398

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						METHOD OF TREATING PROSTATE CANCER
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-002	Dec 24, 2008		RX	Yes	Yes						METHOD OF TREATING PROSTATE CANCER

International Family Members for US Patent 10,695,398

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009213748
Australia	2009213751
Brazil	PI0908127