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Details for Patent: 9,220,747
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Summary for Patent: 9,220,747
| Title: | Methods using desmopressin acetate in orodispersible form |
| Abstract: | Described are orodispersible solid dosage forms of desmopressin or a pharmaceutically acceptable salt thereof useful for treating diseases or conditions such as incontinence, primary nocturnal enuresis (PNE), nocturia, and central diabetes insipidus. The dosage forms disintegrate in the mouth within 10 seconds and provide good desmopressin bioavailability. |
| Inventor(s): | Anders Nilsson, Hans Lindner, Jçrgen Wittendorff |
| Assignee: | Ferring BV |
| Application Number: | US14/326,939 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 9,220,747 |
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Patent Claim Types: see list of patent claims | Use; Composition; Dosage form; |
| Patent landscape, scope, and claims: | Patent 9,220,747 Scope and Claims: Desmopressin Orodispersible Solid Dosage Form and Bioavailability/Disintegration Limits for Incontinence, PNE, Nocturia, and Central Diabetes Insipidus Executive summary US Drug Patent 9,220,747 claims a method of treating selected water-balance/urinary conditions (including primary nocturnal enuresis (PNE) and nocturia) by administering desmopressin acetate in an orodispersible solid dosage form that (i) disintegrates in the mouth within 10 seconds and (ii) contains 0.5 to 75 μg desmopressin acetate (free base), producing desmopressin bioavailability >0.1% to ~0.38%, with dependent claims narrowing bioavailability windows, dosage ranges, open matrix networks (gelatin, including fish gelatin non-gelling), citric acid, tighter disintegration times (5 sec, 2 sec), and once- vs twice-daily dosing. How strong is US Patent 9,220,747 for blocking desmopressin orodispersible generics?Answer (claim-level strength): Strongest against products that match the claim’s combination of (a) orodispersible format with rapid disintegration and (b) specific desmopressin dose (free-base measured) and (c) achieved bioavailability window. The “bioavailability as a result” limit is the narrowest practical differentiator for design-around, because it ties infringement to pharmacokinetic performance, not only formulation structure. What exactly does Claim 1 require?Claim 1 is a tight product-by-performance method. It requires all of the following:
This means a challenger cannot avoid the claim by changing only one attribute. A non-infringing product must either:
How do dependent claims tighten infringement risk?Key dependent claims create additional “lock-in” parameters:
Practical impact: If a commercial product hits Claim 1 but misses one dependent limitation, it still can infringe Claim 1. Dependent claims matter for narrowing arguments, claim construction, and damages theories by showing the patentee’s preferred performance/formulation embodiments. What is the scope of “orodispersible solid dosage form” and “disintegrates in the mouth within 10 seconds”?Answer: The claim requires an orodispersible dosage form that measurably disintegrates in-mouth within 10 seconds. Dependent claims set shorter endpoints: 5 seconds and 2 seconds. Claim 1 disintegration limit (10 seconds)
Dependent claims narrow to faster products
Design-around vector: Slowing disintegration beyond the limit (for example, intentionally timing above 10 seconds) is a direct path around the disintegration element. A slower formulation still has to consider whether it remains “orodispersible” and whether it still achieves bioavailability in the same band. How do the dose limits work: “desmopressin acetate measured as the free base of from 0.5 μg to 75 μg”?Answer: The claimed content is measured as desmopressin free base equivalent, not as the acetate salt mass per se. That metric is a common litigation lever, because formulation analytics and labeling can cause disputes. Claim 1 dose window
Dependent claim dose window
Design-around vector: A product with an administered dose outside either window is non-infringing as to those dosing strengths. This is especially relevant if a competitor chooses a higher or lower tablet/orodispersible strength than the patentee’s range. How is “desmopressin bioavailability of greater than 0.1% to about 0.38%” used in claim scope?Answer: The bioavailability clause is an outcome limitation. It requires that the claimed method produce desmopressin bioavailability in the specified range after administration of the orodispersible dosage form. What the bioavailability subrange set implies
Infringement consequence: Even if a dosage form meets disintegration and dose content, a competitor can avoid Claim 1 by pushing bioavailability outside the band. The direction of movement matters:
Litigation consequence: Bioavailability becomes a central technical and statistical question, including assay variability, study design, and how “bioavailability” is defined (AUC-based vs other metric) in the patent’s description. Which disease indications are covered by US 9,220,747?Answer: The claim enumerates four: incontinence, PNE, nocturia, and central diabetes insipidus. Any product administration that satisfies the formulation/performance limits while treating any of these indications fits the claim. Indication-specific dependent claims
Practical implication: Indication labeling and real-world prescribing can matter for infringement arguments. If the product is used off-label for a listed indication, method-of-use infringement analysis will hinge on evidence of “administering to a subject in need thereof.” What formulation features are claimed beyond dose and disintegration?Answer: Dependent claims capture a specific formulation architecture: an open matrix network using water-soluble or water-dispersible inert carriers, including gelatin, specifically fish gelatin non-gelling, plus citric acid in some embodiments. Open matrix network limitation (Claim 5)Claim 5 requires:
Design-around vector: A competitor can avoid Claim 5-8 by using a different network concept (closed matrix, different carrier class not captured as inert water-soluble/dispersible open matrix, or different excipient structure). However, because Claim 5 is dependent, matching Claim 1 without Claim 5 still can infringe. Gelatin and fish gelatin non-gelling (Claims 6-8)
Infringement consequence: These limits narrow to a particular excipient embodiment. They are strong for narrowing validity and infringement scenarios when the competitor uses gelatin variants. Citric acid (Claim 9)
Design-around vector: If the product omits citric acid entirely or uses a different acid system, it may avoid Claim 9. Again, Claim 9 is dependent. How does dosing frequency (once vs twice daily) affect claim scope?Answer: Frequency is only in dependent limitations, but it matters for specific bottle labeling and method instructions.
Practical impact: A competitor whose product is dosed differently (for example, three times daily or as-needed regimens) may avoid those dependent claims, but still can infringe Claim 1 if the other elements are met. What claims are the main litigation battlegrounds for US 9,220,747?Answer: The dispute is most likely to cluster around four claim elements:
Dependent excipient limits (open matrix, gelatin/fish gelatin, citric acid) add technical specificity but are secondary if Claim 1 is met. What does the claim set imply about the patent’s likely commercial target?Answer: The tight bioavailability band plus rapid disintegration suggests the patentee targeted an oral platform intended to mimic exposure achieved by existing desmopressin products while improving usability. The inclusion of incontinence, PNE, and nocturia indicates broad urology/uropediatrics alignment; CDI coverage extends to endocrine use. Competitive inference: The most direct competitive threats are desmopressin oral solid products that claim “rapidly disintegrating,” “orodispersible,” and “consistent exposure,” particularly at low microgram free-base strengths. Patent landscape for US 9,220,747: what other patent claims likely surround this estate?Answer: The claim language structure indicates a landscape where adjacent patents commonly fall into four buckets:
Limitation: Only the claim text was provided. Without the patent publication record, specification disclosures, or an Orange Book-family map, a complete US patent-by-patent landscape cannot be stated accurately here. How do you evaluate generic entry risk against this patent?Answer: Generic risk is highest when a proposed ANDA/505(j) candidate:
Lower risk scenarios:
Secondary risk factors:
What generic entry scenarios are most plausible based on the claim structure?Answer: Competitors typically pursue one of two strategies: Scenario A: “Platform match” with performance tuning
Scenario B: Structural disconnection from claimed performance
Key Takeaways
FAQs1) What is the single most important limiter in US 9,220,747 Claim 1? 2) Do excipient details (gelatin, fish gelatin, citric acid) matter if Claim 1 is met? 3) Can a product avoid infringement by changing only the disintegration time? 4) Are dosing frequency limits required for Claim 1 infringement? 5) What claim element is most likely to require pharmacokinetic evidence in litigation? References
More… ↓ |
Drugs Protected by US Patent 9,220,747
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| >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: 9,220,747
| Foriegn Application Priority Data | ||
| Foreign Country | Foreign Patent Number | Foreign Patent Date |
| United Kingdom | 0210397.6 | May 7, 2002 |
| PCT/IB02/04036 | Sep 20, 2002 | |
International Family Members for US Patent 9,220,747
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Argentina | 039092 | ⤷ Start Trial | |||
| Argentina | 039794 | ⤷ Start Trial | |||
| Argentina | 107948 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
