Details for Patent: 10,085,992

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Which drugs does patent 10,085,992 protect, and when does it expire?

Patent 10,085,992 protects COSELA and is included in one NDA.

This patent has fifty-six patent family members in eighteen countries.

Summary for Patent: 10,085,992

Title:	Transient protection of normal cells during chemotherapy
Abstract:	This invention is in the area of improved compounds, compositions and methods of transiently protecting healthy cells, and in particular hematopoietic stem and progenitor cells (HSPC) as well as renal cells, from damage associated with DNA damaging chemotherapeutic agents. In one aspect, improved protection of healthy cells is disclosed using disclosed compounds that act as highly selective and short, transiently-acting cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors when administered to subjects undergoing DNA damaging chemotherapeutic regimens for the treatment of proliferative disorders.
Inventor(s):	Jay Copeland Strum, John Emerson Bisi, Patrick Joseph Roberts, Francis Xavier Tavares
Assignee:	Pharmacosmos Holding AS , Pharmacosmos AS
Application Number:	US15/342,990
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,085,992
Patent Claim Types: see list of patent claims	Use;

United States Patent 10,085,992: Scope, Claim Construction, Expiration, and Trilaciclib Patent Landscape

U.S. Patent No. 10,085,992 protects a chemotherapy-protection regimen using a CDK4/6 inhibitor, most directly associated with trilaciclib, before and during carboplatin-etoposide treatment for specified small cell lung cancer. The strongest claim coverage is directed to a timed sequence in which the CDK4/6 inhibitor is administered before chemotherapy, including a 30-minute or less interval and a three-day regimen within a 21-day cycle. The patent is a method-of-use patent, not a composition-of-matter patent.

The patent’s commercial relevance is tied to Cosela, trilaciclib hydrochloride, marketed by G1 Therapeutics and approved by the FDA to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving chemotherapy for extensive-stage small cell lung cancer.[1][2]

What does U.S. Patent 10,085,992 protect?

U.S. Patent 10,085,992 claims methods for reducing chemotherapy damage to hematopoietic stem cells or hematopoietic progenitor cells in a human treated for a defined CDK4/6-related form of small cell lung cancer.

The claimed treatment requires three therapeutic components:

1. Carboplatin.
2. Etoposide.
3. A CDK4/6 inhibitor having the chemical structure identified in the patent claims, or a pharmaceutically acceptable salt.

The claim language supplied identifies the inhibitor by formula rather than by name. The patented commercial product most closely associated with this chemistry is trilaciclib, administered as trilaciclib hydrochloride.

The core protected concept is chemotherapy-induced temporary cell-cycle arrest in normal hematopoietic cells. The CDK4/6 inhibitor is given before chemotherapy so that healthy hematopoietic stem and progenitor cells are protected while tumor cells remain susceptible to cytotoxic treatment. The claims do not generally claim treatment of the tumor by the CDK4/6 inhibitor alone.

What are the independent claims in Patent 10,085,992?

Claims 1 and 4 are the principal independent claims.

Claim 1: broad combination and sequencing claim

Claim 1 covers a method that:

• Treats a human for the specified CDK4/6 replication-independent small cell lung cancer.
• Targets hematopoietic stem cells or hematopoietic progenitor cells.
• Administers carboplatin.
• Administers etoposide.
• Administers the claimed CDK4/6 inhibitor.

Claim 1 does not require a 21-day cycle. It also does not specify a maximum interval between administration of the CDK4/6 inhibitor and chemotherapy. The claim requires the agents to be administered but, as quoted, does not expressly require the CDK4/6 inhibitor to precede carboplatin and etoposide. That sequencing requirement appears in dependent claim 2.

Claim 4: three-day, 21-day-cycle regimen

Claim 4 is narrower but operationally more specific. It requires:

• Administration on day 1 of a 21-day chemotherapy cycle of carboplatin, etoposide, and the CDK4/6 inhibitor.
• Administration of the CDK4/6 inhibitor before carboplatin and etoposide on day 1.
• Administration on days 2 and 3 of etoposide and the CDK4/6 inhibitor.
• Administration of the CDK4/6 inhibitor before etoposide on days 2 and 3.

Claim 4 therefore maps closely to a conventional platinum-etoposide schedule in which etoposide is administered on three consecutive days and treatment cycles repeat every 21 days.

How do dependent claims 2 through 9 narrow the patent scope?

Claim	Limitation added	Practical effect
2	CDK4/6 inhibitor precedes carboplatin and etoposide	Establishes the protective pre-treatment sequence
3	CDK4/6 inhibitor administered about four hours or less before chemotherapy	Narrows timing
4	Day 1 through day 3 treatment in a 21-day cycle	Claims the recurring platinum-etoposide schedule
5	CDK4/6 inhibitor administered within about four hours before day 1 chemotherapy	Narrows day 1 timing
6	CDK4/6 inhibitor administered within about four hours before day 2 and day 3 etoposide	Extends the timing limitation across the cycle
7	CDK4/6 inhibitor administered 30 minutes or less before chemotherapy	Creates a tighter timing claim
8	30 minutes or less before day 1 carboplatin and etoposide	Tight day 1 schedule
9	30 minutes or less before day 2 and day 3 etoposide	Tight day 2 and day 3 schedule

Claims 7 through 9 are commercially important because they define a highly specific administration interval. A competing regimen that administers trilaciclib materially earlier than 30 minutes before chemotherapy may avoid literal infringement of those claims while remaining potentially relevant to claims 1 through 6.

What is the claim scope of the chemotherapy-protection method?

Covered patient population

The claims are limited to a human treated for the specified small cell lung cancer characterized in the claims by CDK4/6 replication-independent biology. The wording creates a potential claim-construction issue because the phrase must be interpreted in the context of the specification, prosecution history, and applicable case law.

The claims do not expressly cover every cancer patient receiving carboplatin and etoposide. A treatment protocol must satisfy the disease limitation and the claimed CDK4/6-related characterization.

Covered healthy cells

The protected normal-cell population is limited to:

• Hematopoietic stem cells.
• Hematopoietic progenitor cells.

The claims do not expressly cover all healthy tissues, organs, or cell types. The patent’s practical objective is reduction of myelosuppression, including preservation of bone marrow function, rather than protection of renal, neural, cardiac, or gastrointestinal tissues.

Covered chemotherapy

The required cytotoxic agents are carboplatin and etoposide. A regimen using cisplatin instead of carboplatin would not literally satisfy the quoted claims, even though cisplatin-etoposide is a clinically related regimen. A regimen using topotecan or another chemotherapy agent instead of etoposide also falls outside the literal combination requirement.

The patent does not require a particular carboplatin dose, etoposide dose, route of administration, infusion duration, or formulation in the claims quoted by the user.

Covered CDK4/6 inhibitor

The inhibitor must have the claimed chemical formula or be a pharmaceutically acceptable salt. This is narrower than a claim to every CDK4/6 inhibitor.

The claim should not be read as covering palbociclib, ribociclib, or abemaciclib merely because those products inhibit CDK4/6. Those compounds would need to satisfy the claimed formula, which they do not appear to do based on their distinct chemical structures. The practical product associated with this patent is trilaciclib hydrochloride.

When does U.S. Patent 10,085,992 expire?

U.S. Patent 10,085,992 issued on October 2, 2018.[3] Public patent records identify an April 15, 2013 priority date and an April 15, 2014 nonprovisional filing date for the relevant family. On that basis, the base patent term is generally calculated from the nonprovisional filing date, producing a nominal expiration date of April 15, 2034, subject to patent-term adjustment, terminal disclaimer, and any applicable statutory modification.[3][4]

Milestone	Date
Earliest reported priority date	April 15, 2013
Nonprovisional filing date	April 15, 2014
Patent issued	October 2, 2018
Nominal base expiration	April 15, 2034

The legally operative expiration date should be confirmed against the USPTO patent record because patent-term adjustment can extend the term beyond the base date. The expiration of this patent also does not determine the expiration of separate composition, formulation, manufacturing, or other method-of-use patents covering trilaciclib.

What is the FDA regulatory status of trilaciclib?

The FDA approved Cosela, trilaciclib hydrochloride, on February 12, 2021, under NDA 214837.[1] The approved indication is to decrease the frequency of chemotherapy-induced bone marrow suppression in adult patients when administered before a platinum/etoposide-containing regimen, a topotecan-containing regimen, or a platinum/etoposide-containing regimen with topotecan and cyclophosphamide, doxorubicin, and etoposide in extensive-stage small cell lung cancer.

The FDA-approved label identifies Cosela as an intravenous product administered before chemotherapy. The label includes a dosing schedule based on the chemotherapy regimen and reflects the product’s intended use as a myelopreservation agent rather than as the principal antitumor drug.[2]

FDA approval does not by itself establish infringement of every claim in Patent 10,085,992. Infringement depends on the approved indication, the actual treatment protocol, the administered product, and the construction of the claim terms.

What is the Orange Book status of Patent 10,085,992?

The Orange Book is the relevant FDA listing for patents associated with approved small-molecule drug products. Cosela is a small-molecule drug product, so its listed patents, if any, are evaluated under the Orange Book framework rather than the biologics patent listing system.[5]

Patent 10,085,992 is relevant to Orange Book analysis because it claims a method of using the active ingredient in a specific chemotherapy setting. A method-of-use patent can support an FDA use code and can create a Paragraph IV challenge issue for a generic applicant seeking approval for a listed indication.

The commercial consequence depends on:

• Whether the patent is listed against Cosela.
• The use code assigned to the patent.
• Whether the generic applicant seeks the protected indication.
• Whether the applicant uses a Paragraph IV certification, a section viii statement, or a label carve-out.
• Whether the patent remains unexpired when the abbreviated new drug application is approved.

A generic applicant seeking only a nonprotected indication may attempt a section viii statement or skinny-label strategy. That approach would not eliminate risk if the proposed label, product marketing, physician instructions, or ordinary use would induce performance of the patented regimen.

How strong is the patent estate for Cosela and trilaciclib?

Patent 10,085,992 is strategically meaningful but does not, by itself, provide full product exclusivity.

Strengths

The patent has several commercially useful limitations:

• It covers the product’s intended supportive-care function.
• It links trilaciclib use to the established carboplatin-etoposide regimen.
• It claims pre-chemotherapy administration, which is central to the mechanism.
• Claims 4 through 9 cover repeated treatment-cycle protocols.
• The claims identify hematopoietic stem and progenitor cells, aligning with the product’s myelopreservation indication.
• The patent extends to pharmaceutically acceptable salts, supporting the marketed hydrochloride form.

Weaknesses

The patent also has material limitations:

• It is not a composition-of-matter claim.
• It does not cover every CDK4/6 inhibitor.
• It is limited to carboplatin and etoposide in the quoted claims.
• It does not cover every tumor type.
• The disease-language requirement may create a claim-construction dispute.
• Timing limitations in claims 3 and 5 through 9 can be avoided by changing administration intervals.
• Method claims require proof that the claimed regimen was performed or induced.

The estate is stronger against a generic that copies the approved Cosela indication and dosing sequence than against an entrant that seeks a narrow alternative label or develops a different CDK4/6 inhibitor.

What other patents may protect trilaciclib?

The relevant patent landscape should be divided into four categories.

Composition-of-matter patents

These protect the trilaciclib chemical entity, stereochemistry, salts, or related CDK4/6 inhibitor compounds. Composition claims are generally more powerful than the claims in Patent 10,085,992 because they can reach use of the compound across multiple indications.

Pharmaceutical composition and formulation patents

These may cover:

• Trilaciclib hydrochloride.
• Lyophilized injectable formulations.
• Reconstitution systems.
• Stability-enhancing excipients.
• Concentration ranges.
• Container or administration formats.

Formulation patents can remain relevant after a method-of-use patent expires, particularly where an injectable product has manufacturing or stability constraints.

Method-of-use patents

These include claims directed to:

• Reduction of chemotherapy-induced myelosuppression.
• Preservation of hematopoietic stem and progenitor cells.
• Use before platinum-based chemotherapy.
• Use before topotecan or other cytotoxic regimens.
• Treatment of extensive-stage small cell lung cancer.
• Reduction of transfusions, dose reductions, or growth-factor use.

Patent 10,085,992 is within this category.

Manufacturing and process patents

Manufacturing protection may cover:

• Chemical synthesis of trilaciclib.
• Salt formation.
• Crystallization.
• Purification.
• Impurity control.
• Preparation of sterile injectable drug product.

These patents can impose practical barriers even when the active ingredient is no longer composition-protected.

Does Patent 10,085,992 create biosimilar risk?

No conventional biosimilar pathway applies to trilaciclib because Cosela is a chemically synthesized small-molecule drug, not a biologic licensed under the Public Health Service Act. The relevant competitive pathway is an abbreviated new drug application under section 505(j) of the Federal Food, Drug, and Cosmetic Act.[5]

The principal risk is therefore generic entry, not biosimilar substitution. A generic applicant would need to address listed patents through Paragraph III, Paragraph IV, or section viii certifications, depending on the Orange Book listing and proposed labeling.

Which companies are challenging the Cosela patent estate?

The available claim information does not establish a filed Paragraph IV certification, ANDA litigation case, settlement agreement, or named challenger involving U.S. Patent 10,085,992. No challenger should be treated as confirmed without a complaint, FDA filing disclosure, court docket, or settlement record.

The absence of a confirmed challenge does not eliminate future risk. The most likely challenge pathway would involve a generic applicant asserting one or more of the following:

• Anticipation or obviousness based on earlier CDK4/6 inhibitor and chemotherapy-protection disclosures.
• Lack of written description for the claimed disease characterization.
• Indefiniteness of terms such as “effective amount,” “reducing the effect,” or “about 4 hours or less.”
• Noninfringement based on a different chemotherapy schedule or label.
• Invalidity based on the timing and treatment-cycle limitations.

What generic launch scenarios exist?

Scenario	Entry profile	Risk to originator
Paragraph III certification	Generic waits until patent expiry	Low pre-expiration litigation risk
Paragraph IV certification	Generic challenges validity or enforceability	High litigation risk
Section viii statement	Generic omits the protected method	Moderate risk, depending on label and conduct
Skinny label with platinum-only or nonprotected use	Limits approved use	Risk depends on induced infringement evidence
Alternative CDK4/6 inhibitor	Avoids the claimed formula	Lower direct infringement risk
Non-carboplatin regimen	Avoids a required claim element	Lower direct infringement risk
Different timing protocol	May avoid narrow timing claims	Depends on broader claims 1 and 2

A generic copying Cosela’s labeled use before carboplatin-etoposide and administering the same active ingredient shortly before chemotherapy would face the highest exposure.

What litigation and settlement issues matter?

For this patent, litigation risk centers on four issues.

First, the parties would likely dispute whether the accused product’s chemical ingredient satisfies the claimed formula or salt limitation.

Second, the parties would examine whether the clinical use satisfies the disease limitation and whether the defendant’s label encourages administration before carboplatin and etoposide.

Third, the timing language would matter. “About 4 hours or less” and “30 minutes or less” require interpretation in view of the specification and prosecution history. A regimen administered 45 minutes before chemotherapy could avoid the 30-minute claims but still implicate broader claims.

Fourth, a generic may seek a settlement with a delayed entry date. Any settlement involving a Paragraph IV challenge would require analysis under the Hatch-Waxman framework and applicable antitrust standards. No settlement agreement is established by the claim text supplied.

How does Patent 10,085,992 compare with competing CDK4/6 products?

Product	Active ingredient	Primary role	Relevance to Patent 10,085,992
Cosela	Trilaciclib hydrochloride	Myelopreservation before chemotherapy	Direct commercial relevance
Ibrance	Palbociclib	Antitumor CDK4/6 inhibitor	Different compound and principal indication
Kisqali	Ribociclib	Antitumor CDK4/6 inhibitor	Different compound and principal indication
Verzenio	Abemaciclib	Antitumor CDK4/6 inhibitor	Different compound and principal indication

Patent 10,085,992 should not be treated as a blocking patent against all CDK4/6 inhibitors. Its practical reach depends on the claimed formula, the required chemotherapy combination, the specified disease, and the protective-treatment sequence.

Key Takeaways

• U.S. Patent 10,085,992 is a method-of-use patent associated with trilaciclib-based protection of hematopoietic stem and progenitor cells during carboplatin-etoposide treatment.
• Claim 1 is the broadest quoted claim; claim 4 adds the day 1 to day 3, 21-day-cycle regimen.
• Claims 7 through 9 create the narrowest timing protection by requiring administration 30 minutes or less before chemotherapy.
• The patent does not claim every CDK4/6 inhibitor, every chemotherapy regimen, or every cancer indication.
• The nominal base expiration is April 15, 2034, subject to USPTO-confirmed patent-term adjustment and other term calculations.
• Cosela was FDA-approved in 2021 for reducing chemotherapy-induced bone marrow suppression in extensive-stage small cell lung cancer.
• Generic, rather than biosimilar, entry is the relevant competitive threat.
• The principal enforcement issues are the claimed chemical formula, disease definition, pre-chemotherapy timing, label scope, and induced infringement.
• Composition, formulation, manufacturing, and separate method-of-use patents may extend commercial protection beyond this patent’s expiration.

FAQs

Can a generic avoid Patent 10,085,992 by using palbociclib or ribociclib?

Potentially, because the claims require a CDK4/6 inhibitor having the claimed formula or a pharmaceutically acceptable salt. Palbociclib and ribociclib are structurally distinct compounds and would not ordinarily satisfy a trilaciclib-specific formula limitation.

Does Patent 10,085,992 cover cisplatin and etoposide?

The quoted claims require carboplatin and etoposide. A cisplatin-etoposide regimen would not literally satisfy the carboplatin limitation, although separate patents could cover related regimens.

Can administration of trilaciclib one hour before chemotherapy avoid infringement?

It may avoid claims requiring administration 30 minutes or less before chemotherapy. It would not necessarily avoid broader claims requiring administration before chemotherapy or within about four hours, depending on the specific claim and claim construction.

Is Cosela protected by a biologic exclusivity period?

No. Cosela is a small-molecule drug product. The relevant pathway for competitors is an ANDA, not a biosimilar application.

Does FDA approval prove that every Cosela use infringes Patent 10,085,992?

No. FDA approval establishes the authorized regulatory use, not infringement. Infringement depends on whether the actual product, patient population, chemotherapy combination, chemical form, timing, and treatment cycle satisfy the asserted claims.

References

1. U.S. Food and Drug Administration. (2021). FDA approves trilaciclib to reduce the frequency of chemotherapy-induced bone marrow suppression in adult patients with extensive-stage small cell lung cancer. https://www.fda.gov

2. U.S. Food and Drug Administration. (2021). Cosela (trilaciclib) prescribing information. G1 Therapeutics, Inc. https://www.accessdata.fda.gov

3. United States Patent and Trademark Office. (2018). U.S. Patent No. 10,085,992, methods of reducing the effect of chemotherapy on healthy cells. https://patents.google.com/patent/US10085992B2

4. United States Patent and Trademark Office. (n.d.). Patent term adjustment and patent term calculation. https://www.uspto.gov/patents/laws/patent-term-adjustment

5. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm

Drugs Protected by US Patent 10,085,992

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes	10,085,992					A METHOD TO DECREASE THE INCIDENCE OF CHEMOTHERAPY-INDUCED MYELOSUPPRESSION IN ADULT PATIENTS WHEN ADMINISTERED PRIOR TO A CARBOPLATIN AND ETOPOSIDE-CONTAINING REGIMEN FOR EXTENSIVE-STAGE SMALL CELL LUNG CANCER

International Family Members for US Patent 10,085,992

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2906156
Canada	2906157
Canada	2906166
Canada	3152117