US Patent 9,987,285: Rucaparib Camsylate Tablet Claims, Patent Scope, and Generic Entry Risk

US Patent 9,987,285 protects high-load oral formulations of rucaparib camsylate, the active pharmaceutical ingredient in Rubraca. The patent is formulation-focused rather than compound-focused. Its core protection covers tablets and capsules containing 45% to 90% w/w rucaparib camsylate, with dependent claims directed to high-dose tablets, dry granulation, specific excipients, and rapid dissolution.

The principal commercial risk is to a generic rucaparib product using a high-drug-load immediate-release tablet, particularly one containing approximately 70% to 80% API with microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

What drug does US Patent 9,987,285 protect?

The claimed compound is rucaparib, administered as rucaparib camsylate.

Item	Description
Active ingredient	Rucaparib
Salt form	Rucaparib camsylate
Brand	Rubraca
Developer and original patent holder	Clovis Oncology, Inc.
Therapeutic class	PARP inhibitor
Primary indications	Ovarian, fallopian tube, primary peritoneal and prostate cancers, subject to the applicable FDA label
Patent type	Pharmaceutical formulation
US patent	9,987,285
Issue date	June 5, 2018
Claimed dosage forms	Tablets, dry-granulated tablets, dry-granulated compositions and capsules

Rucaparib camsylate is the salt form used in Rubraca. The claims refer to the amount of the active compound in some places and to the amount of rucaparib camsylate in others. That distinction matters when calculating compliance with the claimed percentage and dose thresholds.

What are the independent claims in US 9,987,285?

The patent has four principal independent claim groups.

Claim 1: High-load tablet

Claim 1 covers:

A tablet comprising 45% to 90% w/w of rucaparib camsylate.

This is the broadest tablet claim. It does not require:

A specific filler
A specific disintegrant
A specific lubricant
Dry granulation
A particular tablet weight
A particular dissolution profile
A particular manufacturing process

A tablet with 45% to 90% w/w rucaparib camsylate can therefore fall within claim 1 even if its excipient system differs substantially from the disclosed examples.

Claim 19: Dry-granulated tablet

Claim 19 narrows the formulation to a dry-granulated tablet containing:

45% to 90% w/w rucaparib camsylate; and
At least 200 mg of rucaparib, calculated as the active compound.

Claim 20 raises the active-compound threshold to at least 300 mg.

Claim 25: Dry-granulated composition

Claim 25 covers a dry-granulated composition, rather than expressly requiring a finished tablet. It requires:

45% to 90% w/w rucaparib camsylate; and
At least 200 mg of rucaparib.

Claim 26 raises the threshold to at least 300 mg.

This claim group may reach intermediate granules or a dry-granulated pharmaceutical composition before final compression, depending on claim construction and the accused product’s manufacturing process.

Claim 27: Capsule

Claim 27 covers a capsule containing 45% to 90% w/w rucaparib camsylate. The claim is broader in dosage-form terms than the dry-granulation claims because it does not require a tablet or a specified dry-granulation process.

How do the dependent claims narrow the patent scope?

The dependent claims create several nested formulation positions.

Claims	Limitation
2	API at 50% to 90% w/w
3	API at 55% to 90% w/w
4	API at 60% to 90% w/w
5	API at 65% to 85% w/w
6	API at 70% to 80% w/w
7	Filler, disintegrant and lubricant ranges
8	Narrower excipient ranges
9	API at 70% to 80% w/w within the claim 8 formulation
10	At least 200 mg rucaparib
11	At least 300 mg rucaparib
12	Microcrystalline cellulose filler
13	Magnesium stearate lubricant
14	Sodium starch glycolate disintegrant
15	Combination of the three specified excipients
16	At least 95% API release within 30 minutes
17	At least 95% API release within 15 minutes
18	At least 95% API release within 10 minutes
28	At least 250 mg rucaparib

Claims 2 through 6 are percentage-range claims. A product within 70% to 80% w/w will generally also fall within the broader ranges of claims 2 through 5, assuming the product satisfies the parent claim.

Claims 12 through 15 create a commercially important excipient combination:

Microcrystalline cellulose
Sodium starch glycolate
Magnesium stearate

A generic manufacturer using this conventional direct-compression or granulation system could face multiple overlapping claims even if it avoids one narrower percentage range.

What formulation is most strongly protected?

The strongest practical overlap concerns a high-load immediate-release tablet with the following profile:

Formulation attribute	Claimed position
Rucaparib camsylate	45% to 90% w/w
Preferred API loading	70% to 80% w/w
Filler	Microcrystalline cellulose
Disintegrant	Sodium starch glycolate
Lubricant	Magnesium stearate
Manufacturing route	Dry granulation for claims 19-26
Rucaparib dose	At least 200 mg, 250 mg or 300 mg depending on claim
Dissolution	At least 95% release in 30, 15 or 10 minutes in 0.01N HCl using USP II paddles at 75 rpm

Claim 15 is particularly relevant because it combines the preferred API range with the three named excipients through its dependency on claim 9. Claim 24 provides a similar dry-granulated formulation position.

What dissolution characteristics are protected?

Claims 16 through 18 require rapid release in an acidic dissolution test:

USP II paddle apparatus
75 rpm
0.01N hydrochloric acid
At least 95% API release within 30 minutes, 15 minutes or 10 minutes

The 10-minute limitation in claim 18 is the narrowest and most technically demanding. A product that releases 95% of its API within 10 minutes will likely satisfy the broader 15-minute and 30-minute limitations as well, assuming the same test conditions.

These claims are performance-based. They may be difficult to assess from a public label alone because the relevant dissolution data may appear only in regulatory submissions, confidential ANDA materials or discovery records.

How should the percentage limitations be interpreted?

The claims use w/w percentages, but the claim language distinguishes between:

Rucaparib camsylate as the claimed API material; and
Rucaparib as the active compound for dose thresholds.

The rucaparib dose claims, including 200 mg, 250 mg and 300 mg, appear to refer to the rucaparib moiety rather than the full camsylate salt. A manufacturer could therefore not reliably assess infringement by comparing only the labeled amount of rucaparib camsylate with the claimed dose.

A formulation also may satisfy more than one claim simultaneously. For example, a tablet containing 75% w/w rucaparib camsylate, 300 mg rucaparib, microcrystalline cellulose, sodium starch glycolate and magnesium stearate could implicate:

Claim 1
Claims 2 through 6
Claims 7 through 9
Claims 10, 11 and 15
Potentially claims 16 through 18, depending on dissolution
Claim 28

When does US Patent 9,987,285 expire?

The patent issued on June 5, 2018. Its term is governed by the earliest effective nonprovisional or international filing date in the priority chain, subject to any patent-term adjustment or other statutory adjustment.

Public patent records associate the patent family with a 2014 international filing and an expected US patent term extending into 2034. The practical projected expiration is approximately May 2034, subject to the USPTO’s official term calculation and any applicable adjustment. The patent’s expiration should be confirmed against the current USPTO Patent Center record and the FDA Orange Book before relying on a specific launch date.

What is the Orange Book status of US 9,987,285?

US 9,987,285 is part of the Rubraca patent estate and has been associated with the FDA-listed rucaparib product. The Orange Book analysis should distinguish between:

Compound patents covering rucaparib or its salt;
Formulation patents covering tablets or capsules;
Method-of-use patents covering cancer treatment;
Regulatory exclusivity listed separately from patent exclusivity.

The patent at issue is a formulation patent. It does not independently establish protection for every use of rucaparib, every rucaparib salt, or every dosage form.

An Orange Book-listed formulation patent can be relevant to an ANDA applicant’s Paragraph IV certification. The applicant must assess whether its proposed product infringes the listed claims and whether those claims are valid and enforceable.

What Paragraph IV challenge risks exist?

A generic applicant seeking FDA approval for rucaparib tablets would likely evaluate a Paragraph IV certification against listed Rubraca patents. The principal design-around positions against US 9,987,285 would include:

Using less than 45% w/w rucaparib camsylate.
Using more than 90% w/w API, if technically feasible.
Using a different salt or free-base form.
Using a capsule rather than a tablet, although claim 27 separately covers capsules.
Avoiding dry granulation.
Using an alternative excipient system.
Avoiding the 200 mg, 250 mg and 300 mg rucaparib thresholds.
Demonstrating a dissolution profile outside the claimed release limitations.

The most difficult design-around is likely a conventional high-dose immediate-release tablet. Rucaparib products may require a high API load because the clinical dose can be substantial. Moving below the 45% threshold could materially increase tablet size, while changing the salt or dosage form could create bioavailability, stability or regulatory comparability issues.

What generic launch scenarios are most plausible?

Scenario	Patent exposure	Commercial assessment
High-load tablet, 70%-80% API, conventional excipients	High	Direct overlap with core and dependent claims
High-load dry-granulated tablet	Very high	Potential overlap with claims 19-24
High-load capsule	High	Claim 27 remains relevant
Tablet below 45% API	Lower under literal claim scope	May create tablet-size and manufacturing disadvantages
Tablet above 90% API	Potentially outside percentage claims	Likely difficult to formulate and compress
Alternative salt	Potentially outside claims directed to camsylate	Requires separate regulatory and pharmaceutical evaluation
Low-dose or pediatric formulation	Potentially outside dose claims	Still may implicate percentage-based claims
Modified-release formulation	Depends on API loading and dosage form	May avoid rapid-release claims but not necessarily claims 1 or 27
Non-dry-granulated tablet	May avoid dry-granulation claims	Claim 1 and related tablet claims remain relevant

A non-dry-granulated formulation does not automatically avoid the patent. Claim 1 is directed to a tablet and does not require dry granulation. Likewise, changing excipients does not avoid the broad 45% to 90% API-loading limitation.

How strong is the patent estate for rucaparib?

The estate has different strength levels by subject matter.

Strongest area: high-load oral formulation

The claims cover the commercial problem of placing a large amount of rucaparib camsylate into an administrable solid dosage form. The broad 45% to 90% range gives the patent meaningful reach against conventional high-load tablets and capsules.

Moderate area: specified excipient combinations

Microcrystalline cellulose, sodium starch glycolate and magnesium stearate are common pharmaceutical excipients. Their common use may create prior-art and obviousness issues, but the combination is tied to the high API loading and performance limitations in several dependent claims.

Moderate-to-strong area: dry granulation

Dry granulation is specifically claimed in claims 19 through 26. A manufacturer that uses roller compaction or slugging to produce the rucaparib granulate may face a more direct infringement theory than a manufacturer using a different process.

Narrower area: rapid dissolution

The release claims are narrower because they require a specific test medium, apparatus, rotation speed and release threshold. They can strengthen the patent against products with the same performance profile but are more vulnerable to non-infringement if the generic product uses a different dissolution behavior.

What other patents cover rucaparib?

The broader rucaparib patent landscape includes several categories:

Patent category	Subject matter
Compound patents	Rucaparib and structurally related PARP inhibitors
Salt and solid-form patents	Camsylate salts, crystalline forms and solid-state properties
Formulation patents	Tablets, capsules, high API loading and dissolution
Method-of-use patents	Treatment of ovarian, prostate and other cancers
Combination patents	Rucaparib with chemotherapy, hormonal agents or other anticancer agents
Manufacturing patents	Preparation of rucaparib, intermediates and pharmaceutical compositions

US 9,987,285 should not be treated as the entire Rubraca estate. A generic applicant may avoid this formulation patent and still face compound, use, solid-form or manufacturing patents. Conversely, expiration of a compound patent does not automatically eliminate formulation-patent risk.

Which companies are challenging the Rubraca patent estate?

The provided patent claims do not identify an ANDA filer, Paragraph IV notice, district-court action or settlement agreement. No party should be identified as a challenger solely from US 9,987,285.

For transaction, launch or litigation analysis, the relevant records are:

FDA Paragraph IV notice information;
District court docket filings;
Federal Circuit opinions;
Orange Book patent listings;
ANDA litigation settlements;
FDA approval letters and exclusivity records.

A patent grant alone does not establish that litigation has been filed or that a settlement exists.

Does biosimilar risk apply to rucaparib?

No. Rucaparib is a synthetic small-molecule drug, not a biologic. The relevant competitive pathway is an ANDA for a generic equivalent, not a biosimilar application under the Biologics Price Competition and Innovation Act.

The principal regulatory and patent risks are therefore:

Paragraph IV certification;
Hatch-Waxman litigation;
formulation design-around;
bioequivalence;
solid-state and salt-form selection;
commercial launch timing.

What regulatory exclusivity applies to Rubraca?

Rubraca received FDA approval through the NDA pathway. Patent protection and FDA regulatory exclusivity are separate rights.

The relevant FDA exclusivity categories may include:

New chemical entity exclusivity, if applicable at the time of approval;
Orphan-drug exclusivity for qualifying indications;
Pediatric exclusivity, if granted;
Any indication-specific exclusivity reflected in FDA records.

Regulatory exclusivity may prevent approval of a competing application for a defined period even when no patent blocks approval. It may also expire before formulation patents covering high-load rucaparib products.

Key Takeaways

US 9,987,285 is a rucaparib camsylate formulation patent, not the primary compound patent.
The broadest claim covers tablets containing 45% to 90% w/w rucaparib camsylate.
The most commercially important preferred range is 70% to 80% w/w API.
Claims separately cover dry-granulated tablets, dry-granulated compositions and capsules.
Microcrystalline cellulose, sodium starch glycolate and magnesium stearate are expressly claimed in dependent combinations.
The patent also covers tablets containing at least 200 mg, 250 mg or 300 mg of rucaparib.
Rapid dissolution claims require at least 95% release in 30, 15 or 10 minutes under specified acidic USP II conditions.
A generic using a high-load immediate-release tablet is exposed even if it avoids dry granulation or uses different excipients.
Rucaparib is a small molecule, so generic ANDA and Paragraph IV issues apply rather than biosimilar regulation.
The patent family is associated with protection extending into approximately 2034, subject to the official USPTO term calculation.
A complete launch opinion requires review of the entire Rubraca compound, formulation, solid-form, method-of-use and manufacturing estate.

FAQs

Can a generic avoid US 9,987,285 by using a different filler?

Possibly for claims requiring microcrystalline cellulose, but not necessarily for claim 1. A tablet containing 45% to 90% w/w rucaparib camsylate can still fall within the broad tablet claim regardless of filler selection.

Does avoiding dry granulation eliminate infringement risk?

No. Claims 1 through 18 cover tablets without requiring dry granulation. Avoiding dry granulation primarily targets claims 19 through 26.

Is a rucaparib free-base product outside the patent?

The claims expressly recite rucaparib camsylate. A free-base product may present a non-infringement position, but it would require separate analysis of claim construction, salt conversion in the finished product and the broader Rubraca patent estate.

Does a 300 mg rucaparib dose automatically infringe?

No. The dose threshold alone is insufficient. The product must also satisfy the parent formulation limitations, including the applicable dosage form and API percentage range.

Can a modified-release rucaparib formulation avoid the patent?

It may avoid the rapid-release claims, but a modified-release tablet or capsule could still fall within the broad API-loading and dosage-form claims if it contains 45% to 90% w/w rucaparib camsylate.

References

Clovis Oncology, Inc. (2018). Pharmaceutical compositions comprising rucaparib camsylate, U.S. Patent No. 9,987,285. United States Patent and Trademark Office.
U.S. Food and Drug Administration. (2016). Rubraca (rucaparib camsylate) prescribing information. FDA.
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.
United States Patent and Trademark Office. (n.d.). Patent Center: U.S. Patent No. 9,987,285. USPTO.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-001	Dec 19, 2016		RX	Yes	No	⤷ Start Trial	⤷ Start Trial	Y				⤷ Start Trial
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017		RX	Yes	No	⤷ Start Trial	⤷ Start Trial	Y				⤷ Start Trial
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015305696	⤷ Start Trial
Australia	2019272064	⤷ Start Trial
Brazil	112017000865	⤷ Start Trial
Canada	2955495	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 9,987,285

Which drugs does patent 9,987,285 protect, and when does it expire?

Summary for Patent: 9,987,285