Details for Patent: 10,350,174

Which drugs does patent 10,350,174 protect, and when does it expire?

Patent 10,350,174 protects NEUPRO and is included in one NDA.

This patent has forty-five patent family members in twenty-six countries.

Summary for Patent: 10,350,174

Title:	Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine
Abstract:	The present invention relates to a method for stabilizing rotigotine, the method comprising providing a solid dispersion comprising polyvinylpyrrolidone and a non-crystalline form of rotigotine, wherein the weight ratio of rotigotine to polyvinylpyrrolidone is in a range from about 9:3.5 to about 9:6. The present invention also relates to a solid dispersion comprising a dispersing agent and a dispersed phase, said dispersed phase comprising rotigotine and polyvinylpyrrolidone, wherein the weight ratio of rotigotine to polyvinylpyrrolidone is in a range from about 9:3.5 to about 9:6, a pharmaceutical composition comprising such a solid dispersion, in particular a transdermal therapeutic system, as well as a method for the preparation thereof.
Inventor(s):	Hans-Michael Wolff, Christoph Arth, Luc Quere, Walter Müller
Assignee:	UCB Pharma GmbH , LTS Lohmann Therapie Systeme AG
Application Number:	US15/982,744
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,350,174
Patent Claim Types: see list of patent claims	Composition; Formulation;

# US Patent 10,350,174: Rotigotine Solid-Dispersion Claims, Scope, Expiration Risk and Patent Landscape

US Patent 10,350,174 protects a specific rotigotine transdermal formulation rather than rotigotine as a molecule. Its core requirement is a stable solid dispersion containing rotigotine free base and polyvinylpyrrolidone, dispersed in a two-part solution-based silicone system. The broadest independent claim is claim 1. Claims 5 and 6 extend the formulation protection to pharmaceutical compositions and transdermal therapeutic systems.

The patent has meaningful formulation and design-around value because infringement requires the accused product to satisfy multiple compositional and, in several dependent claims, rheological or adhesion limitations. The strongest commercial protection is concentrated in the combination of rotigotine, high-molecular-weight PVP, and the BIO-PSA Q7 4301/Q7 4201 adhesive system. The patent does not broadly cover every rotigotine patch, every silicone adhesive, or rotigotine free base generally.

What does US Patent 10,350,174 protect?

The patent protects a rotigotine-containing solid dispersion embedded in a silicone dispersing agent. The claim architecture has four principal technical layers:

Protection layer	Relevant claims	Required subject matter
Core solid dispersion	1-4	Rotigotine free base, PVP, two-part solution-based silicones, and defined weight ratio
Pharmaceutical product	5	Pharmaceutical composition containing the claim 1 dispersion
Transdermal system	6-7	Patch or other transdermal therapeutic system containing the dispersion
Adhesive and performance parameters	8-13	Adhesive viscosity, dispersion viscosity, peel adhesion, and static shear
Manufacturing and solid-state form	14-15	Rotigotine polymorphic form II and high-molecular-weight PVP
Named commercial adhesive system	16	BIO-PSA Q7 4301 and BIO-PSA Q7 4201

The claims are formulation claims. They do not claim the chemical structure of rotigotine, its therapeutic use in Parkinson's disease, or a generic transdermal delivery platform without the specified dispersion.

What are the required elements of independent claim 1?

Claim 1 requires all of the following:

1. A stable solid dispersion.
2. A silicone dispersing agent.
3. The silicone dispersing agent must be a two-part mixture of solution-based silicones.
4. A dispersed phase containing rotigotine free base and polyvinylpyrrolidone.
5. A rotigotine free base-to-PVP weight ratio of about 9:4 to about 9:6.

The claim can be represented as:

Stable solid dispersion + two-part solution-based silicone system + rotigotine free base + PVP + approximately 9:4 to 9:6 weight ratio

The ratio corresponds to a rotigotine-to-PVP range of approximately 2.25:1 to 1.5:1. Claim 7 narrows the ratio to 9:6, or 1.5:1.

A product that contains rotigotine but uses a different polymer, a different silicone system, or a materially different rotigotine-to-PVP ratio may avoid literal infringement of claim 1. The doctrine of equivalents could still be relevant, but the numerical range and named adhesive limitations may make an equivalents theory more difficult where the accused formulation is materially different.

How do claims 2 through 4 narrow the invention?

Claim 2: Rotigotine solubility below 1 weight percent

Claim 2 requires rotigotine free base to have solubility below 1 wt-% in the dispersing agent. This limitation supports the patent's distinction between a true dispersed phase and a formulation in which rotigotine is substantially dissolved in the silicone adhesive.

A competing patch with rotigotine dissolved above the claimed threshold would not meet claim 2, although it could still fall within claim 1 if all claim 1 requirements are satisfied.

Claim 3: Complex viscosity of 5 to 15 MP

Claim 3 requires the solid dispersion to have a complex viscosity between 5 and 15 MP. The claim uses a rheological measurement rather than a chemical identity. This creates a potential enforcement issue because infringement depends on:

• The measurement method.
• Temperature.
• Frequency or oscillation conditions.
• Instrument configuration.
• Whether "MP" means the unit used in the patent's specification or a typographical representation of a defined rheology unit.

A product outside the range under a properly replicated test would avoid claim 3 but could remain within claim 1.

Claim 4: Microreservoir structure

Claim 4 requires rotigotine free base and PVP to be present in a multitude of microreservoirs. This is a structural limitation. It is narrower than simply requiring a dispersion and may require microscopic, spectroscopic, or manufacturing evidence to establish infringement.

The claim gives the patent a potential advantage against products that use substantially the same silicone matrix but organize the active and polymer phase into discrete microreservoirs.

What do claims 5 and 6 cover?

Claim 5 covers a pharmaceutical composition containing the claim 1 solid dispersion. Claim 6 covers a transdermal therapeutic system containing that dispersion.

These claims are product-level extensions. They can apply to a finished patch, but they do not eliminate the need to prove the underlying claim 1 formulation. A patch that contains rotigotine but does not contain the claimed two-part silicone dispersion should not infringe claims 5 or 6.

Claim 6 is commercially important because it connects the formulation to the marketed dosage form. It can be asserted against a patch manufacturer even where the accused party does not manufacture the underlying silicone dispersion separately.

What additional restrictions apply to claim 7?

Claim 7 requires:

• A transdermal therapeutic system.
• Rotigotine free base loading of 0.1 to approximately 3.15 mg/cm².
• A rotigotine-to-PVP ratio of 9:6.

The loading range is broad enough to cover multiple patch strengths when expressed per unit area. The exact application depends on the patch's active area and the method used to calculate drug loading.

Claim 7 is narrower than claim 6 but may be commercially significant because a generic patch can be designed around either the loading range or the 9:6 ratio. A product outside either limitation would not literally infringe claim 7.

What adhesive systems are covered by claims 8 through 13?

Claims 8 through 13 add performance limitations to the silicone dispersing agent.

Claim	Technical limitation
8	At least a first adhesive with complex viscosity of 40 to 250 MP
9	At least a second adhesive with complex viscosity of 1 to 10 MP
10	The dispersing agent has complex viscosity of 5 to 25 MP
11	First and second adhesives; solid dispersion viscosity of 5 to 15 MP
12	Defined peel adhesion ranges at 50 g/m² and/or 150 g/m² thickness
13	Static shear adhesion of 20 to 150 minutes

These claims describe a blended adhesive system. The likely formulation objective is to balance:

• Drug dispersion stability.
• Patch adhesion.
• Skin conformability.
• Cohesive strength.
• Processability.
• Controlled drug release.

Claims 8 and 9 separately characterize the two adhesive components. Claim 10 then characterizes the combined dispersing agent. Claims 11 through 13 add performance requirements to the combination.

The claims create several testing-sensitive infringement questions. Small differences in test protocol can change whether a formulation falls within a viscosity or adhesion range. A patent dispute would likely focus on the specification's defined test methods and whether those methods are incorporated into the claim interpretation.

What is the significance of claim 16 and the BIO-PSA products?

Claim 16 identifies BIO-PSA Q7 4301 and BIO-PSA Q7 4201 as the two-part silicone mixture.

This is the most commercially concrete claim in the patent because it identifies commercial adhesive products by name. It does not necessarily limit the patent only to material purchased under those trademarks if the claim is construed functionally or if the named products are examples of the claimed components. The precise scope depends on the claim language, specification, prosecution history, and the legal treatment of the product names.

A competing manufacturer could reduce literal infringement risk by using:

• A non-BIO-PSA silicone system.
• A different two-part adhesive combination.
• A chemically distinct silicone adhesive.
• A formulation that does not satisfy the claim's dispersion and ratio requirements.

The existence of a non-infringing alternative does not by itself invalidate the patent. It affects design-around feasibility and commercial leverage.

What does claim 14 protect regarding rotigotine polymorph II?

Claim 14 requires the dispersed phase to be obtained by mixing rotigotine free base polymorphic form II and PVP in a solution.

This claim has both process and starting-material characteristics. It does not merely require that form II be present in the final product. It states that the dispersed phase is obtained by a specified preparation route using form II and PVP in solution.

The distinction matters:

• A final patch containing no detectable form II may still raise an infringement issue if the claimed process was used.
• A patch made from a different polymorph may avoid literal infringement of claim 14.
• Claims 1 and 6 could still remain relevant if the final formulation satisfies their composition limitations.

Solid-state characterization would be central to any dispute involving this claim. X-ray powder diffraction, thermal analysis, and process records may be relevant.

What does claim 15 protect regarding PVP molecular weight?

Claim 15 limits PVP to a molecular weight of 1,000,000 to 1,500,000 g/mol.

This is a narrow polymer limitation. It strengthens the claim against high-molecular-weight PVP formulations but provides a clear design-around route through:

• Lower-molecular-weight PVP.
• Higher-molecular-weight PVP.
• Another povidone grade outside the range.
• A different polymeric dispersing agent.

The patent holder would need reliable evidence establishing the molecular-weight measurement technique. Polymer molecular weight may vary depending on whether the specification uses viscosity-average, weight-average, number-average, or supplier-designated molecular weight.

How strong is the patent estate based on the supplied claims?

The individual claims have different strength profiles.

Claim group	Relative protection	Primary strength	Primary vulnerability
Claim 1	Broadest	Combines key formulation elements	Requires proof of every element, including silicone mixture and ratio
Claims 2-4	Moderate	Adds measurable solubility, viscosity, and microreservoir limitations	Testing and construction disputes
Claims 5-7	Commercially important	Reaches finished pharmaceutical products and patches	Product must contain the claim 1 dispersion
Claims 8-13	Narrow but technical	Captures adhesive performance and blended systems	Easy design-around if parameters are altered
Claim 14	Process-focused	Protects use of polymorphic form II in preparation	Process proof may be difficult
Claim 15	Narrow composition claim	Captures a defined PVP molecular-weight window	Straightforward polymer substitution
Claim 16	Product-specific	Directly identifies a commercial adhesive pair	Potential construction and equivalence disputes

The estate is strongest where a commercial patch uses the same rotigotine/PVP ratio, the same two-part silicone system, and the same viscosity profile. It is weaker against formulations that use a different polymer or a non-silicone matrix.

When does US Patent 10,350,174 lose exclusivity?

US Patent 10,350,174 issued on July 16, 2019. Its exact expiration date cannot be determined from the claims alone because US patent term depends on the earliest effective nonprovisional filing date, any priority claims, patent-term adjustment, terminal disclaimers, and possible patent-term extension under 35 U.S.C. §§ 154 and 156.

For commercial diligence, the controlling date is the patent's term calculation in the USPTO file and Patent Center records, not the issue date. The patent's claims do not establish a separate regulatory exclusivity period. Patent expiration and FDA exclusivity are distinct rights.

A later-issued formulation patent can remain enforceable after earlier rotigotine compound patents expire. That is the principal strategic relevance of this patent.

What is the Orange Book status of US Patent 10,350,174?

Orange Book listing must be evaluated against the approved rotigotine product and the patent's claimed subject matter. FDA regulations permit listing of patents that claim the drug substance, drug product, formulation, composition, or approved method of use, subject to FDA's patent-listing requirements.[2][3]

The patent claims are directed to a rotigotine solid dispersion and transdermal system. They are therefore the type of claims that could support a drug-product or formulation listing if the approved product practices the claimed invention. The patent number alone does not establish:

• Whether it is currently listed for a specific NDA.
• Which NDA or supplement is associated with it.
• Whether the listing is active.
• Whether a use code applies.
• Whether the listed patent has been delisted or corrected.

The authoritative source is the current FDA Orange Book patent and exclusivity data for the relevant rotigotine NDA.[2]

What Paragraph IV challenge risks exist?

A generic applicant seeking approval for a rotigotine transdermal system could address the patent through an ANDA certification.

Certification	Effect
Paragraph I	No patent information listed
Paragraph II	Listed patent has expired
Paragraph III	Applicant will wait until patent expiration
Paragraph IV	Patent is invalid, unenforceable, or will not be infringed

A Paragraph IV strategy against this patent could rely on non-infringement or invalidity.

Potential non-infringement positions

A generic applicant could argue that its product:

• Does not use a two-part solution-based silicone system.
• Uses rotigotine in a different physical state.
• Uses a rotigotine-to-PVP ratio outside approximately 9:4 to 9:6.
• Uses no PVP or a different polymer.
• Falls outside the claimed viscosity or adhesion ranges.
• Does not contain microreservoirs.
• Does not use polymorphic form II as required by claim 14.
• Uses PVP outside the 1,000,000 to 1,500,000 g/mol range.
• Does not use BIO-PSA Q7 4301 and Q7 4201.

Potential invalidity positions

Potential invalidity theories include:

• Anticipation by an earlier rotigotine transdermal dispersion.
• Obviousness based on silicone adhesive systems, PVP solid dispersions, and known rotigotine patches.
• Indefiniteness involving "stable," "about," "multitude," or rheological units.
• Lack of written description or enablement for the full viscosity, adhesion, and formulation ranges.
• Indefiniteness or construction disputes concerning molecular-weight measurement.
• Prosecution-history estoppel limiting the scope of amended numerical ranges.

The patent's technical limitations may help defend against broad obviousness attacks if the specification demonstrates an unexpected stability, adhesion, or release profile. Those advantages must be evaluated against the prior art and the prosecution record.

Which companies are challenging the patent?

The supplied claim text identifies no Paragraph IV filer, ANDA applicant, district-court action, Federal Circuit appeal, or settlement agreement involving US 10,350,174.

A reliable challenger analysis requires matching the patent against:

• FDA Orange Book listings.
• FDA Paragraph IV litigation records.
• PACER and district-court complaints.
• PTAB proceedings.
• Patent assignment and licensing records.
• Public generic launch announcements.

No challenge, license, or settlement should be attributed to a company solely because it markets a rotigotine product or has challenged another Neupro-related patent. Patent families often contain separate patents with different claim scope and expiration dates.

How does this patent compare with earlier rotigotine protection?

Rotigotine patent protection can be divided into four categories:

Category	Typical subject matter	Relationship to US 10,350,174
Compound patents	Rotigotine molecule and salts	Separate from the formulation claims
Therapeutic-use patents	Parkinson's disease, restless legs syndrome, dosing	Not covered by the supplied claims
Patch or delivery patents	Reservoirs, matrices, release control, patch construction	Technically adjacent
Solid-dispersion patents	Rotigotine, PVP, silicone adhesive, rheology	Directly relevant

US 10,350,174 is most important after basic compound protection has expired. It may delay a generic that otherwise could use rotigotine in a patch, but it should not prevent every rotigotine formulation from entering the market.

What manufacturing and intellectual-property barriers remain?

The main manufacturing barriers are process control and analytical reproducibility.

A manufacturer seeking to avoid the patent must control:

• Rotigotine polymorphic form.
• PVP grade and molecular weight.
• Active-to-polymer ratio.
• Silicone adhesive composition.
• Mixing and solvent-removal conditions.
• Particle or microreservoir morphology.
• Final viscosity.
• Peel adhesion.
• Static shear performance.
• Drug loading per unit area.

The formulation may also be protected by unasserted or separate know-how involving drying conditions, coating speed, liner selection, backing materials, crystal control, and release-rate optimization. Those matters are not established by the supplied claims and should not be treated as part of US 10,350,174 without documentary support.

What generic launch scenarios exist?

Scenario 1: Non-silicone design-around

A generic uses a different adhesive class or matrix. This is the clearest route around claim 1, but it may create new risks involving skin adhesion, irritation, drug flux, stability, and regulatory comparability.

Scenario 2: Silicone formulation outside the claimed ratio

A generic uses silicone adhesives but changes the rotigotine-to-PVP ratio outside the claimed range. The design must avoid falling within the "about" construction applied to the ratio.

Scenario 3: Polymer substitution

A generic replaces PVP with another polymer. This may avoid the core claim but could alter crystallization control, drug release, and patch manufacture.

Scenario 4: Paragraph III launch

If the patent remains listed and enforceable, an applicant may accept a delayed launch until the relevant patent term ends.

Scenario 5: Paragraph IV litigation

An applicant challenges validity, enforceability, or infringement. The commercial result depends on the patent's Orange Book listing, certification timing, litigation filing, and any 30-month stay.

What is the geographic coverage?

US Patent 10,350,174 provides rights only in the United States. Parallel protection must be assessed country by country through the related international and national-stage family.

The relevant diligence points are:

• Whether corresponding European, Canadian, Japanese, and other national patents issued.
• Whether the claims differ materially by jurisdiction.
• Whether national patents remain in force.
• Whether supplementary protection certificates or other extensions exist.
• Whether the same formulation is marketed outside the United States.

A US non-infringement position does not establish freedom to operate in Europe or other markets.

Key Takeaways

• Claim 1 is the central protection and requires a rotigotine/PVP solid dispersion in a two-part solution-based silicone system.
• The claimed rotigotine-to-PVP ratio is approximately 9:4 to 9:6.
• Claims 5 and 6 extend the core formulation to pharmaceutical compositions and transdermal systems.
• Claims 8 through 13 add viscosity, peel adhesion, and static shear limitations.
• Claim 14 focuses on preparation using rotigotine polymorphic form II.
• Claim 15 covers PVP with a molecular weight of 1,000,000 to 1,500,000 g/mol.
• Claim 16 identifies BIO-PSA Q7 4301 and Q7 4201.
• The patent does not broadly cover rotigotine, every rotigotine patch, or every silicone adhesive.
• The principal generic design-around routes are polymer substitution, silicone-system substitution, ratio modification, and rheology modification.
• Exact expiration and current Orange Book status require the official USPTO and FDA records because those facts are not established by the claim text.
• No Paragraph IV challenge, licensing deal, settlement, or litigation party is established by the supplied material.

FAQs

Does US 10,350,174 cover Neupro itself?

It may be relevant to a Neupro-type rotigotine patch if the marketed product practices the claimed solid dispersion, silicone system, PVP ratio, and other limitations. The patent number alone does not establish product coverage.

Can a rotigotine patch avoid this patent by eliminating PVP?

Potentially. Eliminating PVP would avoid a literal requirement of claim 1, but the formulation would need to be assessed against other rotigotine, patch, delivery, and method-of-use patents.

Is BIO-PSA Q7 4301 alone covered by claim 16?

Claim 16 requires the two-part mixture identified as BIO-PSA Q7 4301 and BIO-PSA Q7 4201. Use of Q7 4301 alone would not satisfy the literal limitation as quoted.

Does claim 14 cover every product made from rotigotine polymorphic form II?

No. Claim 14 also requires that the dispersed phase be obtained by mixing form II and PVP in a solution. Claims 1 and 6 may apply independently if their separate requirements are met.

Can a generic launch before patent expiration after receiving FDA approval?

FDA approval and patent clearance are separate issues. A generic may receive approval subject to a Paragraph III or Paragraph IV certification, but launch rights depend on patent listing, certification, litigation, settlement terms, and the enforceability of the asserted claims.

References

1. United States Patent and Trademark Office. (2019). U.S. Patent No. 10,350,174, stable solid dispersions comprising rotigotine.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. U.S. Food and Drug Administration. (2024). Patent listing requirements and patent certification procedures for approved drug products.
4. 35 U.S.C. §§ 154, 156. Patent term and patent term extension provisions.

Drugs Protected by US Patent 10,350,174

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-004	Apr 2, 2012		RX	Yes	No			Y
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-001	May 9, 2007		RX	Yes	Yes			Y
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-005	Apr 2, 2012		RX	Yes	No			Y
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-002	May 9, 2007		RX	Yes	No			Y
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-003	May 9, 2007		RX	Yes	No			Y
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-006	Apr 2, 2012		RX	Yes	No			Y

International Family Members for US Patent 10,350,174

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010334805
Brazil	112012017737
Canada	2767068
China	102665699
China	104189912
China	105997952