Details for Patent: 7,879,842

Which drugs does patent 7,879,842 protect, and when does it expire?

Patent 7,879,842 protects CORLANOR and is included in two NDAs.

Protection for CORLANOR has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has forty-nine patent family members in forty-two countries.

Summary for Patent: 7,879,842

Title:	Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Abstract:	β-Crystalline form of ivabradine of formula (I): characterised by its powder X-ray diffraction diagram. Medicinal products containing the same which are useful as bradycardics.
Inventor(s):	Stephane Horvath, Marie-Noelle Auguste, Gerard Damien
Assignee:	Les Laboratoires Servier SAS
Application Number:	US12/589,283
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,879,842
Patent Claim Types: see list of patent claims	Use; Composition;

U.S. Patent 7,879,842: Ivabradine Hydrochloride Beta-Crystalline Form, Claim Scope, Expiration, and Patent Landscape

U.S. Patent 7,879,842 protects a specific beta-crystalline polymorph of ivabradine hydrochloride, identified by powder X-ray diffraction peaks. Its direct scope covers the crystalline active pharmaceutical ingredient, solid pharmaceutical compositions containing that form, and treatment of angina pectoris, myocardial infarction, or heart failure using that form. It does not broadly cover all ivabradine, all ivabradine hydrochloride, or every crystalline form of the compound.

The patent was assigned to Les Laboratoires Servier and issued on February 1, 2011. Its ordinary U.S. patent term is expected to expire in 2025, subject to the controlling patent-term calculation and any applicable adjustment or extension. The patent is therefore primarily an end-of-life polymorph barrier rather than a long-duration composition-of-matter patent.

What does U.S. Patent 7,879,842 protect?

The patent protects a beta-crystalline form of ivabradine hydrochloride through XRPD-defined structural limitations. The core claim elements are:

Claim	Protected subject matter	Principal limitation
1	Beta-crystalline ivabradine hydrochloride	XRPD peaks at 9.2, 18.4, 19.7, 21.6, and 25.3 degrees 2-theta
2	Beta-crystalline ivabradine hydrochloride	XRPD peaks at 9.2, 9.7, 10.0, and 14.8 degrees 2-theta
3	Solid pharmaceutical composition	Claim 1 beta form plus pharmaceutically acceptable inert, non-toxic carrier
4	Treatment method	Administration of claim 1 beta form for angina pectoris, myocardial infarction, or heart failure
5	Solid pharmaceutical composition	Claim 2 beta form plus pharmaceutically acceptable inert, non-toxic carrier
6	Treatment method	Administration of claim 2 beta form for angina pectoris, myocardial infarction, or heart failure

Claims 1 and 2 are independent product claims. Claims 3 through 6 are not expressly dependent claims in the text supplied, but each incorporates the relevant beta form by reference.

The patent uses powder X-ray diffraction, or XRPD, as the principal fingerprint for identifying the solid form. The claims do not recite:

• A specific dosage strength
• A particular tablet excipient
• A manufacturing process
• A particle-size range
• A dissolution profile
• A purity threshold
• A specific crystalline habit
• A specific treatment dose or dosing schedule

The patent is therefore a product-form patent with composition and method-of-use extensions.

How should the XRPD limitations in claims 1 and 2 be interpreted?

A product seeking to avoid claim 1 must not contain the claimed beta form with the recited XRPD pattern, assuming the claim is construed to require the listed peaks as limitations. The same analysis applies to claim 2.

The two claims appear to identify the same general beta-crystalline form through different peak sets:

• Claim 1 recites five peaks.
• Claim 2 recites four peaks.
• Claim 1 emphasizes peaks at approximately 18.4, 19.7, 21.6, and 25.3 degrees 2-theta.
• Claim 2 emphasizes peaks at approximately 9.7, 10.0, and 14.8 degrees 2-theta.

Because XRPD peak positions can vary with instrument calibration, sample preparation, crystallinity, hydration, and measurement conditions, litigation would likely focus on whether the accused material produces the claimed pattern within an accepted analytical tolerance. A literal infringement analysis would normally require expert XRPD testing.

The absence of intensity ratios in the claims may broaden the identification test. The patent does not require a specific relative intensity, peak height, or complete diffractogram in the claim language supplied. That can make the claims easier to assert against a material exhibiting the required peak positions, but it may also create claim-construction and indefiniteness disputes if peak tolerances are not clearly defined.

What is the scope of claim 1 for ivabradine manufacturers?

Claim 1 is potentially infringed by an ivabradine hydrochloride API that has the claimed beta-crystalline XRPD pattern, regardless of whether the API is manufactured by Servier, a contract manufacturer, or a generic applicant.

The claim is not limited to:

• Ivabradine tablets
• Corlanor-branded products
• A particular supplier
• A particular synthesis route
• A particular indication
• A particular particle size
• A particular API grade

A generic company could therefore face product-claim exposure even if its tablets use different excipients, have different labeling, or are made by a different chemical process. The relevant question is the solid form of the ivabradine hydrochloride used in the commercial product.

A generic product using an amorphous form, a different polymorph, a solvate, a hydrate, or a non-infringing crystalline form could avoid literal infringement if the selected material does not meet the XRPD limitations. That strategy carries technical risk because processing, storage, milling, granulation, humidity, or compression can cause polymorphic conversion.

What formulations are protected by claims 3 and 5?

Claims 3 and 5 cover solid pharmaceutical compositions containing the claimed beta-crystalline form and one or more pharmaceutically acceptable carriers.

Potentially covered products include:

• Immediate-release tablets
• Film-coated tablets
• Capsules containing solid API
• Granulated oral dosage forms
• Powder blends
• Solid unit-dose products

The claims do not require a particular excipient. A composition could potentially fall within the claims even if it uses a different formulation platform from the reference product, provided that it contains the claimed beta form.

The formulation claims are narrower than the API claims because they require both:

1. The specified beta-crystalline ivabradine hydrochloride; and
2. A solid pharmaceutical composition containing that form.

A liquid solution would not ordinarily satisfy a solid-composition limitation, although the underlying API used to make the solution could raise separate issues under the product claims depending on the accused material.

What methods of treatment are protected by claims 4 and 6?

Claims 4 and 6 cover administration of the claimed beta-crystalline form to a human for treatment of:

• Angina pectoris
• Myocardial infarction
• Heart failure

The claims do not specify:

• Dose
• Frequency
• Route of administration
• Disease severity
• Patient age
• Concomitant therapy
• Heart-rate threshold
• Left-ventricular ejection fraction

The method claims are broad in the treatment variables but narrow in the required active form. They are most relevant to a product labeled for one of the listed conditions and containing the claimed beta form.

For an ANDA applicant, method claims can be addressed through a section viii statement or a permissible labeling carve-out if the patented indication is not necessary for the proposed product. The practical result depends on the Orange Book listing, the approved labeling, and the scope of the generic applicant's proposed label under the Hatch-Waxman framework. The Federal Food, Drug, and Cosmetic Act governs paragraph IV certifications and related approval timing. 21 U.S.C. § 355(j).

When does U.S. Patent 7,879,842 lose exclusivity?

The patent's ordinary term is expected to end in 2025. The controlling expiration date should be verified against the USPTO patent-term record and the FDA Orange Book listing for the relevant product. A patent's issue date does not determine expiration. The calculation generally begins from the earliest effective nonprovisional U.S. filing date, subject to terminal disclaimers, patent-term adjustment, and patent-term extension rules. 35 U.S.C. §§ 154 and 156.

Milestone	Date or status
Priority family	French priority claimed before the U.S. filing
U.S. patent application	Filed in the mid-2000s
U.S. patent publication	Published before issuance
Patent grant	February 1, 2011
Expected ordinary term end	2025
FDA product approval	Corlanor approved April 15, 2015
New-drug exclusivity	Separate FDA exclusivity from patent rights
Generic-entry risk	Material as the patent approaches expiration

The patent should not be confused with FDA marketing exclusivity. Corlanor's approval-based exclusivity and the patent term are separate rights. FDA regulatory exclusivity does not extend the patent, and patent expiration does not itself guarantee immediate generic approval if other listed patents or regulatory barriers remain.

What is the Orange Book status of ivabradine and Corlanor?

Corlanor is the U.S. brand for ivabradine tablets and oral solution marketed by Amgen under its U.S. relationship with Servier. FDA approved Corlanor tablets and oral solution under NDA 206143 on April 15, 2015. The approved heart-failure indication covers certain adult patients with stable symptomatic heart failure, sinus rhythm, and elevated resting heart rate, with the precise criteria defined in the FDA label. [2]

A patent listed in the Orange Book can create a certification obligation for an ANDA applicant. The applicant may need to submit one of four patent certifications:

• Paragraph I: No patent information has been submitted.
• Paragraph II: The listed patent has expired.
• Paragraph III: The applicant will wait until patent expiration.
• Paragraph IV: The listed patent is invalid, unenforceable, or will not be infringed.

Whether U.S. Patent 7,879,842 remains listed for a particular ivabradine product must be checked in the current FDA Orange Book entry. Orange Book listing status can change through patent delisting, expiration, correction, or product-specific regulatory action. [3]

What paragraph IV challenges and generic-entry risks exist?

A paragraph IV challenge to the patent could rely on one or more of the following positions:

1. The accused API is not the claimed beta form.
2. The XRPD peaks are absent or outside the accepted tolerance.
3. The claims are anticipated by an earlier disclosure of the same crystalline form.
4. The beta form would have been obvious in view of known ivabradine hydrochloride solid forms and routine crystallization techniques.
5. The claim language does not provide an objective boundary for peak position or peak identification.
6. The specification does not adequately enable the full scope of the claimed form.
7. The method claims are not infringed because the proposed label omits the patented use.

Polymorph patents often face a fact-intensive validity analysis. The patentee would typically rely on reproducible XRPD data, crystallization examples, comparative stability, purity, hygroscopicity, filtration, drying, or manufacturing advantages. An ANDA applicant would likely focus on prior-art disclosures, routine polymorph screening, and differences between the reference beta form and the proposed generic API.

A non-infringing polymorph strategy is technically possible but commercially difficult. The applicant must show that the selected form remains stable through API manufacture, formulation, packaging, transport, and shelf life. A form that converts into the patented beta form during processing could create infringement exposure even if the starting API was different.

What is the patent landscape around ivabradine?

The ivabradine estate has several distinct layers:

Patent layer	Typical subject matter	Relevance to generic entry
Original compound patents	Ivabradine and pharmaceutically acceptable salts	Generally expired or near-expired earlier than the polymorph patent
Polymorph patents	Beta-crystalline ivabradine hydrochloride	Directly relevant to API selection
Formulation patents	Tablets, excipients, release characteristics, dosage forms	Relevant to finished-product design
Method-of-use patents	Heart failure, angina, myocardial infarction, or patient subsets	Relevant to labeling and patent certification
Manufacturing patents	Crystallization, purification, seeding, or isolation	Relevant to API process design
Regulatory rights	NDA exclusivity and Orange Book listings	Affect approval timing independently of patent validity

U.S. Patent 7,879,842 is narrower than the original ivabradine compound estate but potentially more important for a modern generic because it targets the solid form normally selected for commercial manufacture.

How strong is the patent estate for this beta-crystalline form?

The patent has meaningful commercial strength in three areas:

• It claims the API form directly.
• It uses analytical characteristics that can be tested in an accused product.
• It extends to both compositions and treatment methods.

Its weaknesses are equally specific:

• It does not cover all ivabradine hydrochloride.
• It does not claim a manufacturing process.
• It lacks explicit XRPD tolerances in the supplied claims.
• It may be vulnerable to prior-art or obviousness attacks directed to polymorph discovery.
• The patent term is short relative to the development cycle for an alternative solid form.

The direct product claims are stronger than the treatment claims from a market-control perspective because they can reach the API regardless of the generic label's indication. The formulation and method claims provide fallback positions but may be easier to design around.

What licensing deals and companies are relevant?

Servier developed ivabradine and retained the underlying intellectual-property position. Amgen obtained U.S. rights to develop and commercialize ivabradine for heart failure and related cardiovascular uses. Corlanor's U.S. regulatory and commercial position therefore reflects a Servier-Amgen collaboration rather than ownership by an independent generic manufacturer. [4]

Generic competition is likely to involve companies that can:

• Qualify a non-infringing ivabradine solid form
• Challenge the listed polymorph patent
• Obtain API supply from a qualified manufacturer
• Address any remaining Orange Book patents
• Submit a complete ANDA with appropriate patent certifications
• Manage potential litigation under Hatch-Waxman

No conclusion about a particular company's paragraph IV position should be drawn solely from the existence of Patent 7,879,842. Litigation status requires a current PACER and FDA record review.

What patent litigation affects U.S. Patent 7,879,842?

The patent itself does not establish whether a current infringement action, ANDA lawsuit, settlement, or license exists. A complete litigation determination requires docket-level review of federal cases and FDA submission records.

The principal litigation trigger would be a paragraph IV notice alleging that Patent 7,879,842 is invalid, unenforceable, or not infringed. Servier, Amgen, or another listed patent owner could then bring an action within the statutory 45-day period, potentially triggering a 30-month stay of ANDA approval under 21 U.S.C. § 355(j)(5)(B)(iii), subject to statutory exceptions.

A settlement could provide a generic launch date before the nominal patent expiration date. Such agreements may contain license terms, launch dates, supply arrangements, or restrictions on the challenged product. A settlement cannot be inferred from patent expiration or from the absence of a public product launch.

How does Patent 7,879,842 compare with the original ivabradine patent?

The comparison is direct:

Issue	Original ivabradine patent	U.S. 7,879,842
Protected subject	Core chemical compound	Specific beta-crystalline hydrochloride form
Breadth	Broad across the claimed molecule and salts	Narrower, form-specific
Technical proof	Chemical identity and structure	XRPD pattern and crystalline form
Design-around path	Difficult before expiration	Alternative polymorph, amorphous form, or other solid form
Commercial role	Original molecule exclusivity	Lifecycle and formulation-stage barrier
Likely generic defense	Compound prior art and claim validity	XRPD comparison, polymorph prior art, obviousness, enablement

Key Takeaways

• U.S. Patent 7,879,842 is a polymorph patent for beta-crystalline ivabradine hydrochloride.
• Claims 1 and 2 are the principal commercial claims because they cover the API form itself.
• Claims 3 and 5 cover solid pharmaceutical compositions containing the claimed form.
• Claims 4 and 6 cover treatment of angina pectoris, myocardial infarction, and heart failure using the claimed form.
• The patent does not cover all ivabradine or all ivabradine hydrochloride.
• XRPD testing is central to infringement and validity analysis.
• The expected ordinary patent term ends in 2025, subject to the official USPTO and Orange Book records.
• A generic applicant may pursue a paragraph IV challenge, a non-infringing polymorph, a label carve-out, or a combination of these strategies.
• Remaining Orange Book patents, regulatory exclusivity, litigation, and settlement terms must be assessed separately from this patent.
• The main manufacturing barrier is maintaining a stable, reproducible alternative solid form that does not convert into the patented beta form.

FAQs About U.S. Patent 7,879,842 and Ivabradine

Does Patent 7,879,842 cover Corlanor by brand name?

No. It covers a beta-crystalline form of ivabradine hydrochloride and products containing that form. Corlanor is the branded product name.

Can a generic use ivabradine hydrochloride after the patent expires?

Yes, subject to FDA approval and any other unexpired Orange Book patents, regulatory exclusivity, applicable litigation outcomes, and manufacturing requirements.

Can a different ivabradine polymorph avoid this patent?

Potentially. The alternative form must not meet the claimed XRPD limitations and must remain stable during API manufacture and finished-product processing.

Are the treatment claims limited to heart failure?

No. Claims 4 and 6 list angina pectoris, myocardial infarction, and heart failure.

Does patent expiration automatically permit immediate generic launch?

No. FDA approval, remaining patents, regulatory exclusivity, court orders, settlements, and any applicable launch restrictions must also be considered.

References

1. United States Patent and Trademark Office. (2011). U.S. Patent No. 7,879,842, beta-crystalline form of ivabradine hydrochloride.
2. U.S. Food and Drug Administration. (2015). Corlanor (ivabradine) prescribing information, NDA 206143.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book.
4. Amgen Inc. (2015). Amgen announces FDA approval of Corlanor for certain patients with heart failure.
5. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j).
6. Patent Act, 35 U.S.C. §§ 154, 156.

Drugs Protected by US Patent 7,879,842

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Amgen Inc	CORLANOR	ivabradine	SOLUTION;ORAL	209964-001	Apr 22, 2019		DISCN	Yes	No	7,879,842		Y	Y		A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-001	Apr 15, 2015		DISCN	Yes	No	7,879,842*PED				Y
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-002	Apr 15, 2015		DISCN	Yes	No	7,879,842*PED				Y

Foreign Priority and PCT Information for Patent: 7,879,842

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
France	05 01985	Feb 28, 2005

International Family Members for US Patent 7,879,842

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	1907
Argentina	053147
Austria	E407926
Australia	2006200856