Details for Patent: 7,560,122

Summary for Patent: 7,560,122

Title:	Pharmaceutical dosage form bearing pregnancy-friendly indicia
Abstract:	A pharmaceutical dosage form comprising at least one active ingredient and destined for administration to pregnant women. The pharmaceutical dosage form bears pregnancy-friendly indicia apt to improve patient compliance with medically recommended dosage regimen resulting in improved product effectiveness. The pregnancy-friendly indicia is also apt to diminish the incidence of erroneous dispensing of or erroneous ingestion of pharmaceutical dosage forms not intended for pregnant women. Also disclosed is a method for achieving improved patient compliance resulting in improved product effectiveness. Also disclosed is a method for diminishing the incidence of erroneous dispensing of or erroneous ingestion of dosage forms not intended for pregnant women. Said methods comprising providing a pharmaceutical dosage form, intended for use by pregnant women, bearing pregnancy-friendly indicia apt to graphically distinguish dosage forms intended to be used during pregnancy from others.
Inventor(s):	Éric Gervais, Gordana Atanackovic, Raymond Hébert
Assignee:	Duchesnay Inc
Application Number:	US10/611,803
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,560,122
Patent Claim Types: see list of patent claims	Compound; Dosage form;

US Patent 7,560,122: Claim Scope, Validity Risks, and Doxylamine-Pyridoxine Patent Landscape

US Patent 7,560,122 protects a narrow pharmaceutical-tablet configuration rather than doxylamine succinate and pyridoxine hydrochloride as chemical entities. Its independent claim requires the simultaneous presence of four elements: a tablet, the doxylamine-pyridoxine combination, intended use by pregnant women for excessive nausea and vomiting, and a pregnant-woman graphic visibly applied to the tablet surface. A generic product that omits the graphic, uses a different dosage form, or separates the ingredients may avoid literal infringement of claim 1.

The claim has limited value as a primary pharmaceutical exclusivity right. Its commercial significance depends on whether it is listed for the relevant FDA product, whether the patent remains enforceable, and whether a competing manufacturer chooses a tablet design close enough to the claimed image limitation.

What does US Patent 7,560,122 protect?

Claim 1 protects a patient-compliance-oriented tablet containing doxylamine succinate and pyridoxine hydrochloride, with a visible pregnant-woman image applied directly to the tablet surface.

The claim can be divided into the following limitations:

Claim element	Scope
Pharmaceutical tablet	Requires a tablet rather than a capsule, liquid, powder, film, or separate tablet units
Intended for pregnant women	Ties the product to administration in pregnancy
Use against excessive nausea and vomiting	Connects the combination to treatment or prevention of pregnancy-related nausea and vomiting
Doxylamine succinate	Requires this specific salt of doxylamine
Pyridoxine hydrochloride	Requires this specific salt of vitamin B6
Therapeutically effective amounts	Requires quantities effective for the claimed therapeutic purpose
Graphical representation of a pregnant woman	Requires an image or pictorial depiction, not merely text or a pregnancy-related symbol
Applied to tablet surface	The graphic must be on the tablet, not only on packaging or labeling
Visible to the naked eye	Excludes microscopic, invisible, or machine-readable markings

The claim is therefore cumulative. Every limitation must be present for literal infringement.

How broad is the pregnant-woman graphic limitation?

The phrase “graphical representation of a pregnant woman” is potentially broad in visual form. It could cover:

• A realistic image;
• A stylized human figure with visible pregnancy characteristics;
• A line drawing;
• A silhouette;
• A profile view;
• A simplified pictogram.

The limitation does not appear, from the supplied text, to require a particular color, location, size, orientation, engraving method, or degree of realism. A manufacturer could face infringement risk if it used a recognizable pregnant-woman image even if the image differed materially from the branded product.

The claim does not expressly require the image to be legible under ordinary lighting, permanently bonded, embossed, printed with ink, or manufactured by a particular process. “Applied to the tablet surface” could include printing, coating, embossing, debossing, laser marking, or another surface-treatment method, subject to the patent’s specification and prosecution history.

What does US Patent 7,560,122 not protect?

The claim does not, on its face, provide broad protection for:

• Doxylamine as a molecule;
• Pyridoxine as a molecule;
• Any doxylamine-pyridoxine product without the claimed surface graphic;
• Any treatment of nausea in nonpregnant patients;
• Any capsule, liquid, powder, orally disintegrating film, or other non-tablet dosage form;
• Packaging that depicts a pregnant woman;
• A tablet containing only one of the two active ingredients;
• A tablet with a generic pregnancy symbol that is not a graphical representation of a pregnant woman;
• A method of manufacturing the active ingredients;
• A delayed-release or extended-release profile unless separately claimed;
• A particular strength, dissolution profile, excipient system, or coating unless included in another claim.

This distinction is important. The claim is directed to a product configuration with a compliance-related visual identifier. It is not a conventional composition claim covering the pharmacological combination across all dosage forms.

How should claim 1 be construed for infringement analysis?

A likely infringement analysis would focus on six technical and commercial questions.

Is the competing product a tablet?

A product marketed as a capsule, softgel, oral solution, powder, or film would have a strong noninfringement position against the supplied claim. A bilayer or multilayer tablet would likely remain a “tablet” unless the patent specification or prosecution history narrows that term.

Does it contain both specified salts?

The claim requires doxylamine succinate and pyridoxine hydrochloride. A formulation using doxylamine in another salt form, or pyridoxine in another chemical form, could raise both literal-scope and doctrine-of-equivalents issues. Salt substitutions are highly fact-specific and depend on prosecution history, chemical equivalence, and whether the patentee surrendered alternatives.

Is the product intended for pregnancy-related nausea and vomiting?

A label directed to nausea and vomiting during pregnancy would strongly support this limitation. A product labeled only for general nausea, insomnia, or vitamin supplementation would present a different analysis, although evidence of actual intended use could matter.

Is the image on the tablet?

A pregnant-woman image on the carton, blister, bottle, package insert, or tablet imprint code is not necessarily enough. The supplied claim requires the graphical representation to be applied to the tablet surface.

Is the image visible to the naked eye?

A visible imprint, coating, engraving, or printed image would likely satisfy this limitation if the image is recognizable as a pregnant woman. A microscopic authentication mark or invisible ultraviolet code would not ordinarily meet the express visibility requirement.

Does “compliance improving” impose a separate limitation?

The phrase describes the tablet as a compliance-improving product. Courts often distinguish between a functional statement that limits an apparatus or composition and a statement that merely describes intended use. The result would depend on the claim language as a whole, the specification, and the prosecution history.

If “compliance improving” is treated as a capability limitation, the patentee may need to show that the tablet’s graphic has the claimed compliance-improving function. If treated as intended use or a preamble description, the core enforceable limitations may remain the tablet, drug combination, intended pregnancy use, and surface graphic.

What formulations are protected by US Patent 7,560,122?

Based on the supplied claim, the protected formulation must contain therapeutically effective amounts of both active ingredients. The claim does not identify a required release mechanism or excipient system.

Potentially covered formulations include:

• Immediate-release tablets;
• Delayed-release tablets;
• Extended-release tablets;
• Film-coated tablets;
• Uncoated tablets;
• Bilayer tablets;
• Tablets using different excipients or compression methods.

Coverage of those variants depends on whether they also satisfy the graphic, pregnancy-use, and active-ingredient limitations.

The claim does not independently require the formulation to reproduce the release characteristics of Diclegis or Bonjesta. If the patent contains separate dependent claims directed to delayed release, tablet strength, coating, or specific excipients, those claims could create a different infringement analysis. The supplied text is insufficient to attribute those limitations to claim 1.

How does US Patent 7,560,122 compare with core drug patents?

Patent category	Typical protected subject matter	Relevance to 7,560,122
Active-ingredient patent	Doxylamine, pyridoxine, or a new chemical entity	7,560,122 does not appear to claim the molecules broadly
Combination patent	Doxylamine plus pyridoxine for pregnancy-related nausea	Claim 1 includes the combination but adds restrictive tablet and graphic elements
Formulation patent	Release profile, coating, excipients, or dosage strength	May be covered only if separately claimed
Method-of-use patent	Treating nausea and vomiting in pregnancy	Claim 1 includes intended-use language but is drafted as a product claim
Design or compliance patent	Visual identifier intended to improve adherence	The principal distinctive feature of claim 1
Manufacturing patent	Synthesis, granulation, compression, coating, or marking process	Not apparent from the supplied claim

A competitor that designs around the graphic may still face separate patent claims directed to the formulation, release profile, method of use, or manufacturing process. Claim 1 should not be treated as the entire patent estate.

What is the FDA and Orange Book significance?

Diclegis is the principal U.S. commercial product associated with the doxylamine succinate and pyridoxine hydrochloride combination for nausea and vomiting of pregnancy. Bonjesta is another prescription product using the same active ingredients with a different dosage regimen and release presentation. FDA product labeling identifies the active ingredients, indication, dosage form, and administration schedule.[2][3]

The Orange Book analysis requires product-specific confirmation. A patent may be relevant to a marketed product without being listed for every product containing the same ingredients. Orange Book listing also depends on whether the patent claims:

• The drug substance;
• The drug product or formulation;
• A method of use approved in the labeling.

A tablet-marking or graphic claim may face listing questions if it does not clearly claim the drug product as approved or a labeled method of use. The FDA Orange Book does not determine patent validity or infringement, and omission from the Orange Book does not eliminate ordinary patent enforcement rights.[1]

When does US Patent 7,560,122 lose exclusivity?

A patent’s enforceable term is generally measured from the applicable U.S. nonprovisional filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and other statutory rules.[4] The grant date alone does not establish the expiration date.

The relevant public-record fields are:

Term issue	Effect
Earliest effective nonprovisional filing date	Establishes the basic 20-year term
Patent-term adjustment	Can extend the term for qualifying USPTO delay
Patent-term extension	May extend certain FDA-regulated product patents under 35 U.S.C. § 156
Terminal disclaimer	Can shorten the term to the expiration of another patent
Maintenance fees	Nonpayment can cause lapse, subject to reinstatement rules
Litigation judgment	Can affect enforceability or claim scope without changing the nominal expiration date

For a commercial launch decision, the operative date should be taken from the USPTO patent record and any applicable Orange Book entry, not inferred from the patent number or grant date.[1][4]

What generic entry risks exist for doxylamine-pyridoxine tablets?

The graphic limitation creates a clear design-around pathway. A competing manufacturer could reduce claim-1 risk by using:

1. A tablet without any graphic;
2. A nonpregnant-woman symbol;
3. Text-only identification;
4. A tablet imprint consisting of letters or numbers;
5. A package-only image;
6. A capsule or alternative dosage form;
7. A product containing a different salt or formulation, if technically and regulatorily appropriate;
8. A separate two-tablet regimen rather than one combination tablet.

The strongest design-around is likely a tablet with no image at all. The commercial drawback is that the brand’s visual compliance strategy may be lost, but the patent limitation would be removed.

What Paragraph IV challenges could target this patent?

An ANDA applicant could submit a Paragraph IV certification if it believes the patent is invalid, unenforceable, or not infringed.[5] The likely theories against claim 1 would include:

• Anticipation by an earlier tablet containing the two active ingredients and a pregnancy-related graphic;
• Obviousness based on combining known doxylamine-pyridoxine therapy with a known tablet-identification or adherence graphic;
• Indefiniteness concerning “compliance improving,” “graphical representation,” or “excessive nausea and vomiting”;
• Lack of written description or enablement for the full range of graphical representations;
• Noninfringement because the proposed product lacks the surface graphic;
• Lack of statutory patent-listing relevance to the proposed ANDA product.

A Paragraph IV challenge is not necessary for a product that certifies the patent is not applicable or that uses a legally available noninfringing design, depending on the patent’s Orange Book status and the ANDA strategy.

How strong is the patent estate for the doxylamine-pyridoxine combination?

The strength of the overall estate cannot be judged from claim 1 alone. Claim 1 is narrow in product configuration but potentially easy to design around. Its main enforcement value would arise if:

• The patent remains unexpired;
• It is properly listed against the relevant FDA product;
• The commercial product uses the claimed image;
• The patentee has additional claims covering release characteristics or dosage strengths;
• The patent survived prior validity challenges;
• Competitors adopt a similar pregnancy graphic on the tablet itself.

The claim is weaker as a barrier to entry for a generic tablet that uses the same active ingredients but removes the image. It is stronger against a copycat product reproducing the branded tablet’s pregnancy graphic while retaining the same active ingredients and pregnancy indication.

Which companies are relevant to the competitive landscape?

The principal entities associated with this market include:

Company or product	Competitive relevance
Duchesnay	Originator associated with Diclegis and Bonjesta
Diclegis	Delayed-release doxylamine succinate/pyridoxine hydrochloride tablet
Bonjesta	Extended-release doxylamine succinate/pyridoxine hydrochloride tablet
ANDA applicants	Potential generic entrants subject to Orange Book certifications and patent litigation
FDA	Approves the product and administers the ANDA and Orange Book framework
USPTO	Maintains the patent record and administers patent prosecution and term adjustments

The core commercial issue is not whether doxylamine and pyridoxine are broadly available. Both ingredients have long histories of use. The issue is whether an entrant can reproduce the approved product’s dosage form, release profile, labeling, and commercial presentation without infringing surviving formulation or method-of-use claims.

What patent litigation and settlement issues matter?

A complete litigation assessment requires the current PACER docket, district-court complaints, Federal Circuit decisions, ANDA notices, and settlement terms. The principal litigation questions for this patent would be:

• Whether an ANDA applicant copied the tablet graphic;
• Whether the patent was listed for the relevant reference-listed drug;
• Whether the applicant made a Paragraph IV certification;
• Whether the patentee sued within the statutory window;
• Whether a 30-month stay applied;
• Whether the parties entered a licensed or delayed-entry settlement;
• Whether the settlement restricted the applicant’s formulation, tablet appearance, or launch date.

A settlement involving a different Diclegis or Bonjesta patent would not automatically establish the status of US 7,560,122. Each listed patent must be analyzed separately, including claim coverage, certification, litigation outcome, and any covenant not to sue.

What manufacturing and intellectual-property barriers remain?

The active ingredients are not the principal manufacturing barrier. More relevant barriers include:

• Achieving the reference product’s dissolution profile;
• Producing a stable combination tablet;
• Controlling doxylamine and pyridoxine content uniformity;
• Matching delayed-release or extended-release performance;
• Demonstrating bioequivalence under FDA requirements;
• Reproducing tablet hardness, coating, and stability;
• Avoiding patents covering release-control technology;
• Establishing a noninfringing tablet imprint or surface design.

A manufacturer can generally avoid claim 1 by omitting the pregnant-woman graphic. That choice does not resolve other formulation, method-of-use, regulatory exclusivity, or trade-dress issues.

Key Takeaways

• US Patent 7,560,122, based on the supplied claim, is a narrow product patent.
• Claim 1 requires a tablet containing doxylamine succinate and pyridoxine hydrochloride, intended for pregnancy-related nausea and vomiting, with a naked-eye-visible pregnant-woman graphic applied to the tablet surface.
• The patent does not broadly monopolize doxylamine, pyridoxine, or their combination.
• A generic manufacturer can likely reduce claim-1 risk by removing the graphic or using a different dosage form.
• The most important unresolved commercial questions are patent expiration, Orange Book listing, additional claims, prosecution history, and current litigation.
• Formulation, release-profile, method-of-use, and regulatory exclusivity rights may create greater entry barriers than the supplied claim.
• The patent’s value is highest against a copycat tablet that reproduces the branded visual identifier and lowest against a redesigned generic product.

Frequently Asked Questions

Does a pregnancy symbol on the tablet infringe US Patent 7,560,122?

It may, if the symbol is a graphical representation of a pregnant woman, is applied to the tablet surface, is visible to the naked eye, and the tablet contains the specified drug combination for the claimed use.

Does a pregnant woman on the package infringe the claim?

Not necessarily. The supplied claim requires the graphic to be applied to the tablet surface. Packaging-only artwork would not satisfy that limitation literally.

Can a generic use the same doxylamine-pyridoxine ingredients without infringing this claim?

Potentially yes. A product that lacks the claimed tablet graphic may avoid literal infringement, subject to other claims in the patent or related patents.

Does FDA approval invalidate or enforce US Patent 7,560,122?

No. FDA approval addresses safety, efficacy, quality, and regulatory requirements. Patent validity and infringement are determined under U.S. patent law and, where litigated, by the courts.

Is the patent relevant to Bonjesta as well as Diclegis?

Potentially, but relevance depends on the exact dosage form, tablet design, approved labeling, Orange Book listing, and the patent’s complete claim set. Claim 1 alone does not establish coverage of every doxylamine-pyridoxine product.

References

1. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book
2. U.S. Food and Drug Administration. (2023). Diclegis prescribing information.
3. U.S. Food and Drug Administration. (2023). Bonjesta prescribing information.
4. United States Patent and Trademark Office. (2024). Patent term adjustment and patent term extension resources. https://www.uspto.gov/patents/laws/patent-term-calculator
5. U.S. Food and Drug Administration. (2024). Guidance for industry: 180-day exclusivity when multiple ANDA applicants are eligible for shared exclusivity. https://www.fda.gov/regulatory-information/search-fda-guidance-documents

Drugs Protected by US Patent 7,560,122

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 7,560,122

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Canada	2392486	Jul 05, 2002

International Family Members for US Patent 7,560,122

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2003245774
Belgium	1016043
Canada	2392486
France	2841783
Greece	1004641