Patent: 5,176,912
Summary for Patent: 5,176,912
| Title: | Method of treating psoriasis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract: | A method of treating psoriasis which includes subcutaneously injecting into the tissue of a person a dose of cc of a mixture composed of 0.1 milligrams histamine phosphate, 9.25 milligrams bacteriologic peptadase, 110.00 milligrams diprophylline, 4.0 milligrams chlorophenamine, about 0.1 milligram methyl paraben and propylparaben, about 0.2 milligrams sodium chloride, water and then observing the site for between one and three days to observe when the tissue surface at the site is no longer inflamed and is normal and, then, successively injecting 1 cc again and again with a similar observation interval for a period of about two weeks to develop a tolerance to the mixture; and thereafter, repeating the process of injecting every twenty-four hours to seventy-two hours with a 2 cc injection until the symptoms of the psoriasis condition disappear. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inventor(s): | Cabezas; Orestes (Miami, FL) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Application Number: | 07/647,245 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Patent Claims: | see list of patent claims | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Patent landscape, scope, and claims summary: | United States Patent 5,176,912: Claims, Patent Scope, Expiration, and Psoriasis Treatment LandscapeUnited States Patent 5,176,912 covers a staged subcutaneous injection protocol for psoriasis using a specified multi-ingredient mixture. The patent issued on January 5, 1993, and its 17-year patent term likely expired on January 5, 2010, subject to any applicable term adjustment. The patent therefore no longer creates an enforceable exclusionary right in the United States. Its principal present-day importance is historical, freedom-to-operate analysis, and potential prior-art relevance. What does United States Patent 5,176,912 claim?The patent claims a method of treating psoriasis rather than a standalone composition, pharmaceutical product, or manufacturing process. Independent claim 1 requires all of the following:
The claimed mixture is stated as containing:
The claim text supplied uses “per millimeter.” That unit is chemically and pharmaceutically anomalous. The intended unit may have been “per milliliter,” but claim construction cannot automatically substitute a different unit without support in the issued patent specification, prosecution history, or correction record. The distinction is material because a concentration expressed per millimeter is facially defective, while a concentration expressed per milliliter is conventional. How broad is claim 1 of US 5,176,912?Claim 1 is narrow in its ingredient, dosage, route, sequencing, and treatment limitations. A potential practicing party would need to satisfy each limitation. The claim does not broadly cover:
The use of “comprising” makes the claim open-ended as to additional ingredients. A mixture containing the listed components plus other substances could still fall within the claim if every required limitation is met. The open transition does not eliminate the requirement to use the specified ingredients in the specified amounts. The claim is also limited by the functional treatment objective. The final step requires injections until the symptoms of psoriasis disappear. That language may create proof issues because the endpoint is patient-specific and potentially subjective. It does not necessarily make the claim unenforceable, but it complicates infringement evidence and raises questions about whether the specification supplies an objective standard for determining symptom disappearance. What are the dependent claims in US 5,176,912?The dependent claims narrow claim 1 as follows:
Claim 2 is narrower than claim 1 because it requires 2 cc rather than permitting any amount up to 2 cc. Claim 5 is the narrowest express claim because it requires both the inside forearm and a tolerance-development period of at least two weeks. What formulation is protected by US 5,176,912?The patent protects the claimed use of a formulation containing histamine phosphate, bacteriologic peptadase, diprophylline, chlorphenamine, preservatives, sodium chloride, and water in the stated quantities. The patent does not, based on the claims supplied, create a broad composition patent over the mixture itself. A composition claim would typically define the formulation independently of its use. These claims instead require administration to a person with psoriasis according to a specified protocol. The formulation limitations create several technical vulnerabilities: “Bacteriologic peptadase”“Bacteriologic peptadase” is not a standard modern generic drug name. It may refer to a particular enzyme preparation, bacterial digest, or historical product designation. The identity, source, purity, and assay of that ingredient would matter for claim construction. If the patent specification does not define the term adequately, a validity challenge could assert indefiniteness under 35 U.S.C. § 112(b). If the term identifies a recognized product in the historical record, the specification and prosecution history could supply an objective meaning. “Chlorphenamine”Chlorphenamine is commonly known in the United States as chlorpheniramine. The nomenclature difference does not necessarily create a substantive distinction, but the patent’s disclosure would control whether the terms are intended to identify the same active ingredient. Preservative amountThe claim recites “about 0.1 milligram methyl paraben and propylparaben.” It does not clearly state whether 0.1 mg is the combined amount or the amount of each preservative. The word “about” introduces ordinary formulation tolerance, but its scope would depend on the specification and technical context. Concentration unitThe “per millimeter” language is the most significant textual issue. If the issued claim actually contains that language, an accused party could argue that the claim does not define a workable concentration. If the source is a transcription error and the issued patent says “per milliliter,” the original patent record would control. When did US Patent 5,176,912 lose exclusivity?US Patent 5,176,912 issued on January 5, 1993. Because it was filed before the transition to the modern patent term measured generally from the earliest effective nonprovisional filing date, the governing term was generally 17 years from issuance under the pre-Uruguay Round regime. On that basis, the patent expired on January 5, 2010. The statutory framework is reflected in the former version of 35 U.S.C. § 154 and the transition rules enacted by the Uruguay Round Agreements Act.
Any patent-term adjustment would need to be confirmed in the official USPTO record. A term adjustment is unlikely to alter the commercial conclusion because the patent has been expired for more than a decade. Is US 5,176,912 listed in the FDA Orange Book?The patent is not an active Orange Book barrier today. Orange Book listings identify patents submitted by sponsors for approved drug products under the Hatch-Waxman framework. A historical method-of-treatment patent may have been eligible for listing only if associated with an approved drug product and properly submitted by the relevant sponsor. The claims supplied do not identify an FDA-approved product, NDA holder, or branded formulation. The patent therefore should not be treated as an Orange Book-listed asset without a separate historical Orange Book record establishing such a listing. Even if it had once been listed, expiration removes its ability to block an ANDA applicant through a current Paragraph IV certification. FDA approval of a generic product would not infringe an expired patent. Are there Paragraph IV challenges to US 5,176,912?No current Paragraph IV challenge should be expected because the patent expired in 2010. Paragraph IV certifications address unexpired patents listed for approved drug products. An ANDA applicant has no commercial reason to challenge an expired patent as a barrier to approval. The patent also does not appear, from the supplied claims, to function as a conventional drug-product patent. It claims a treatment method involving a compounded or otherwise specified injectable mixture. That structure is less likely to have generated a standard Hatch-Waxman dispute than an active-ingredient, formulation, or approved-use patent covering a commercial NDA product. What patent litigation affects US 5,176,912?The supplied information does not establish any infringement action, declaratory judgment action, inter partes review, reexamination, or settlement involving US 5,176,912. Because the patent expired in 2010, any current litigation would generally be limited to historical damages, ownership, inventorship, or collateral issues rather than prospective injunctive relief. A patent-expiration analysis also changes the litigation posture:
How strong is the patent estate for this psoriasis therapy?The estate appears weak as a current commercial exclusion right because the sole identified patent is expired and the claims are highly protocol-specific.
The patent may have had practical value during its term if a competitor used the identical mixture and staged injection protocol. It would have been less effective against a competitor that changed the concentration, route, injection site, dosing sequence, or treatment endpoint. Does the patent create biosimilar or generic risk?The patent does not create a biosimilar issue. Biosimilar regulation concerns biological products licensed under the Public Health Service Act. The claimed therapy is a small-molecule and excipient mixture, not a biologic. Generic-drug risk is also no longer constrained by this patent. A generic or compounded alternative using a different formulation or regimen would face no live patent claim from US 5,176,912. FDA, state pharmacy, compounding, sterility, labeling, and clinical-safety requirements remain separate from patent status. What geographic coverage does the patent provide?US 5,176,912 provides United States patent rights only. It does not establish protection in Canada, Europe, Japan, or other jurisdictions. Foreign counterparts would require separate patent numbers, filing dates, national-stage records, and expiration analysis. Because the US patent has expired, geographic analysis is now relevant only to historical enforcement, foreign counterpart searches, or prior-art and licensing review. What are the likely generic launch scenarios?Three commercial scenarios are relevant:
The patent does not appear to protect a durable commercial platform. It lacks live composition, manufacturing, delivery-device, or biologic claims in the claim set provided. Key Takeaways
FAQsCould a physician still use the treatment described in US 5,176,912?Yes. Patent expiration removes the patent restriction. Clinical use remains subject to medical-practice standards, FDA requirements, pharmacy law, sterility controls, and patient-safety obligations. Does claim 1 cover every injection treatment for psoriasis?No. It covers only a method containing the required ingredients, amounts, subcutaneous route, injection sequence, tolerance period, and treatment objective. Can a new patent be obtained on the same psoriasis mixture?A new patent cannot normally revive the expired claims. Patentability would require a novel and nonobvious improvement, such as a distinct formulation, delivery system, manufacturing process, or clinically supported regimen. Does “about two weeks” mean exactly 14 days?Not necessarily. The term would be construed in light of the specification and ordinary technical meaning. Claim 4 separately requires a period of at least two weeks. Is a compounded formulation automatically covered by the patent?No. Compounding a similar mixture would not alone satisfy the method claims. The administration must also meet the route, dosing, sequence, site, tolerance, and psoriasis-treatment limitations. References
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Details for Patent 5,176,912
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Approval Date | Patent No. | Expiredate |
|---|---|---|---|---|---|---|---|
| Alk-abello, Inc. | HISTATROL | positive skin test control-histamine | Injection | 103754 | September 29, 1950 | 5,176,912 | 2011-01-29 |
| Jubilant Hollisterstier Llc | N/A | positive skin test control-histamine | Injection | 103891 | March 13, 1924 | 5,176,912 | 2011-01-29 |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Approval Date | >Patent No. | >Expiredate |
