Patent: 10,351,615
Summary for Patent: 10,351,615
| Title: | Methods of treatment with long-acting growth hormone | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract: | Use of a growth hormone protein and polynucleotides encoding same comprising an amino-terminal carboxy-terminal peptide (CTP) of chorionic gonadotrophin and two carboxy-terminal chorionic gonadotrophin CTPs attached to the growth hormone in methods of inducing weight loss or body fat reduction, methods of increasing insulin-like growth factor (IGF-1) levels, and methods of reducing the dosing frequency of a growth hormone in a human subject are disclosed. Pharmaceutical compositions comprising the growth hormone and polynucleotides encoding the growth hormone of the invention and methods of using same are also disclosed. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inventor(s): | Fares; Fuad (Hourfish Village, IL), Fima; Udi Eyal (Dvira, IL) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Assignee: | OPKO Biologics Ltd. (Kiryat Gat, IL) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Application Number: | 14/236,509 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Patent Claims: | see list of patent claims | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Patent landscape, scope, and claims summary: | US Patent 10,351,615: Claims, Scope, Expiration, and Somatrogon Patent LandscapeUS Patent 10,351,615 protects a dosing regimen for treating growth hormone deficiency in adults with a specific CTP-modified human growth hormone, now associated with somatrogon and NGENLA. The patent is narrower than a product patent because its independent claim requires the exact three-CTP molecular architecture, an approximately 1.8 to 2 mg weekly dose, adult growth hormone deficiency, IGF-1 monitoring, and maintenance within a normal therapeutic range. The patent’s principal commercial importance is limited by NGENLA’s current U.S. labeling, which is directed to pediatric patients rather than adults. The patent is therefore relevant to adult development, off-label use, and potential future label expansion, but it is not a complete barrier to pediatric commercialization by itself. What does US Patent 10,351,615 cover?US Patent 10,351,615 covers a method of treating adult growth hormone deficiency using a CTP-modified human growth hormone with the following structure:
The claim is directed to method-of-treatment activity, not to the composition in the abstract. A party generally must practice the claimed method, induce its practice, or contribute to its practice to create an infringement risk. Core claim limitations
The independent claim uses both structural and clinical limitations. That combination strengthens validity against a generic structural anticipation argument but creates enforcement challenges because infringement depends on the administered dose, patient population, monitoring, and treatment outcome. What is the patent expiration date for US Patent 10,351,615?The patent has a reported expiration date of March 25, 2028, subject to any applicable patent-term adjustment or correction in the official USPTO record. The patent issued on July 16, 2019. Its effective term is tied to an earlier priority date in the underlying CTP-modified growth hormone family. [1]
The patent expiration date is materially earlier than NGENLA’s biologic exclusivity period. Patent expiry would not, by itself, permit a competing biologic to enter the U.S. market. A follow-on product would still require FDA approval through the biosimilar or interchangeable-biologic pathway. How strong are the claims in US Patent 10,351,615?The patent has meaningful but concentrated claim strength. Its strongest features are the exact molecular sequence and the defined CTP arrangement. Its weaker features are the adult-only limitation, dose approximation, IGF-1 result limitation, and the requirement to measure IGF-1. Structural claim strengthThe structure in claim 1 corresponds to the three-CTP growth hormone format used for somatrogon. The specified sequence and arrangement make it difficult to invalidate the claim with prior art directed only to:
The claim is more vulnerable if an earlier publication disclosed the same three-CTP architecture and sequence, even if it did not disclose the precise adult dosing regimen. Functional claim strengthThe claim requires maintaining IGF-1 levels within a normal therapeutic range. That limitation can support patentability if the cited clinical data demonstrated a dosing relationship that was not predictable from the structural disclosure alone. The same limitation can complicate enforcement. A product may have the same molecule and dose but avoid direct literal infringement if the supplier does not direct users to measure IGF-1 or if the treatment protocol does not require the claimed monitoring step. Weaknesses created by “approximately”The claims use “approximately 1.8 to 2 mg/week,” “approximately 2 mg/administration,” and “approximately 1.8 mg/administration.” Courts generally interpret “approximately” in light of the specification, prosecution history, clinical practice, and technical tolerances. The term does not create an unlimited dosing range. Potential disputes include:
The patent is stronger against an identical fixed-dose regimen than against a materially different titration or weight-adjusted protocol. Weaknesses created by “normal therapeutic range”“Normal therapeutic range” is potentially vulnerable to indefiniteness arguments if the specification does not establish an objective range. IGF-1 values vary by:
In clinical practice, IGF-1 is often interpreted using age-adjusted standard deviation scores rather than one universal numerical interval. A court would likely examine the patent’s specification and prosecution record to determine whether a skilled endocrinologist could identify the relevant range with reasonable certainty. What do the dependent claims add?Claims 2 through 9 add commercially relevant limitations but do not materially broaden claim 1.
Claims 2 and 8 are likely the most commercially relevant dependent claims because they correspond to the stated dosing range. Claim 3 is likely readily met by a subcutaneous injectable product. Claim 4 may be useful in a sequence-based infringement analysis. Claims 5 and 7 provide additional fallback positions if claim 1 is challenged. Claim 9 has limited commercial value because it narrows treatment to male adults. It may have value in litigation if clinical evidence or prescribing information identifies a male-specific regimen. What FDA product is associated with the patent?The relevant commercial product is NGENLA, whose active ingredient is somatrogon-ghla. NGENLA is a long-acting recombinant human growth hormone containing three CTP domains. Pfizer markets the product in the United States following its acquisition and commercialization relationship involving OPKO’s CTP technology. [2] The FDA approved NGENLA for once-weekly treatment of pediatric patients aged 3 years and older with growth failure due to inadequate secretion of endogenous growth hormone. The approved pediatric indication does not correspond fully to claim 1 of US Patent 10,351,615, which requires an adult subject. [3] NGENLA and the patent claim
The product may satisfy the structural and dosing limitations while not satisfying the adult-subject limitation under the current label. This distinction is central to infringement analysis. Does the patent appear in the Orange Book?No. NGENLA is a biologic, not a conventional small-molecule drug listed through the standard Orange Book framework. Biologic patent and exclusivity information is addressed through FDA biologic approval records and the Purple Book framework rather than ordinary Orange Book patent certifications. [4] Accordingly:
When does NGENLA lose regulatory exclusivity?NGENLA received FDA approval in 2023. Reference biological products generally receive 12 years of data exclusivity under the BPCIA, subject to statutory limitations and any pediatric extension. The base exclusivity period would extend to approximately June 28, 2035. A six-month pediatric exclusivity period could extend that period to approximately December 28, 2035 if properly granted. [3,5] This regulatory exclusivity is separate from the March 2028 expiration date reported for US Patent 10,351,615. Generic versus biosimilar entryA conventional generic cannot rely on NGENLA through an ANDA because NGENLA is a biologic. The practical entry routes are:
A biosimilar applicant could potentially challenge the patent before 2028. Regulatory exclusivity could still delay approval or commercial launch after a successful patent challenge. Are there Paragraph IV challenges or patent litigation involving this patent?There is no conventional Paragraph IV pathway for this biologic patent. Publicly available FDA and patent records should therefore be distinguished from small-molecule litigation databases that report ANDA filings and Paragraph IV notices. The relevant litigation questions are:
The patent’s method-of-use structure makes induced-infringement allegations more important than direct composition infringement. A biosimilar sponsor could reduce risk by labeling the product for a non-infringing population or omitting adult-use instructions, although prescribing behavior and promotional conduct would remain relevant. No public Paragraph IV challenge should be inferred from the existence of a competing growth hormone product. Skytrofa, Genotropin, Omnitrope, Humatrope, Nutropin AQ, and other growth hormone products use different technologies or are not interchangeable with somatrogon. What other patents protect somatrogon and CTP technology?US Patent 10,351,615 is one part of a broader patent estate. Relevant protection may include: Composition patentsComposition claims can cover:
Composition claims are generally stronger than method claims because they do not depend on the patient population, dose, monitoring procedure, or treatment outcome. Formulation patentsFormulation patents may cover:
The supplied claim set does not contain a formulation limitation. A separate formulation patent could remain relevant after the method patent expires. Method-of-use patentsMethod claims may cover:
US Patent 10,351,615 is particularly focused on adult dosing and IGF-1 maintenance. That focus may provide protection beyond a basic composition patent, but it also creates more infringement elements to prove. Manufacturing and process patentsManufacturing barriers may involve:
For a biosimilar applicant, these manufacturing issues are regulatory barriers rather than necessarily infringement barriers. A process patent can still delay entry if the applicant’s manufacturing method practices a protected process. How does this patent compare with competing long-acting growth hormone products?
The patent is not a general weekly growth hormone patent. It does not, on its face, cover all long-acting growth hormone products. It targets a particular CTP fusion molecule and a defined regimen. What generic or biosimilar launch risks exist?The principal risks are timing, claim construction, and product labeling. Before March 2028A biosimilar sponsor would face the reported patent term, any additional patents in the family, and potential BPCIA litigation. The sponsor could challenge validity, noninfringement, or enforceability. The most credible noninfringement theories would focus on:
After March 2028The specific patent would no longer block a qualifying method that practices its claims, assuming no term adjustment or related patent extends protection. Regulatory exclusivity would remain a separate issue until approximately 2035. The commercial launch date would therefore depend more heavily on the reference-product exclusivity period and any surviving composition, formulation, manufacturing, or use patents. Revenue exposureNGENLA’s revenue exposure is not determined by this patent alone. The product’s commercial protection depends on:
The 2028 expiration of US Patent 10,351,615 should not be treated as a full loss-of-exclusivity date for NGENLA. What is the overall patent strength?US Patent 10,351,615 is a moderately strong but narrow method patent. Its strengths are:
Its weaknesses are:
The patent is valuable as a targeted adult-treatment patent and as a component of a broader portfolio. It is not sufficient by itself to establish full exclusivity for somatrogon or NGENLA. Key Takeaways
FAQsCan a pediatric NGENLA treatment infringe US Patent 10,351,615?Not necessarily. Claim 1 requires treatment of a human adult subject. Pediatric use would not literally satisfy that limitation, although other patents in the NGENLA portfolio could still apply. Does the patent cover Skytrofa or Sogroya?The supplied claims do not appear to cover Skytrofa or Sogroya because those products use different long-acting technologies and do not have the claimed one-CTP N-terminal and two-CTP C-terminal structure. Is somatrogon a biosimilar to somatropin?No. Somatrogon is a distinct engineered growth hormone molecule. It is not a biosimilar version of unmodified somatropin. Can a biosimilar applicant avoid the patent by omitting IGF-1 monitoring from its label?Potentially, but omission from labeling does not automatically eliminate infringement risk. Actual promotion, instructions, treatment protocols, and prescribing behavior would remain relevant to induced or contributory infringement theories. Does expiration of US Patent 10,351,615 permit immediate NGENLA competition?No. Patent expiration and biologic regulatory exclusivity are separate. A competing sponsor would still need FDA approval and could face other composition, formulation, manufacturing, device, or use patents. References
More… ↓ |
Details for Patent 10,351,615
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Approval Date | Patent No. | Expiredate |
|---|---|---|---|---|---|---|---|
| Ferring Pharmaceuticals Inc. | NOVAREL | chorionic gonadotropin | For Injection | 017016 | January 15, 1974 | 10,351,615 | 2032-08-02 |
| Ferring Pharmaceuticals Inc. | NOVAREL | chorionic gonadotropin | For Injection | 017016 | December 27, 1984 | 10,351,615 | 2032-08-02 |
| Ferring Pharmaceuticals Inc. | NOVAREL | chorionic gonadotropin | For Injection | 017016 | February 15, 1985 | 10,351,615 | 2032-08-02 |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Approval Date | >Patent No. | >Expiredate |
