Details for Patent: 5,030,456
Summary for Patent: 5,030,456
| Title: | Dosage form for treating cardiovascular diseases | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract: | An osmotic device is disclosed comprising a first composition, and a second composition with the beneficial drug isradipine in the first composition. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inventor(s): | Atul D. Ayer, David R. Swanson, Anthony L. Kuczynski | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Assignee: | Alza Corp | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Application Number: | US07/516,582 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Patent Claim Types: see list of patent claims | Composition; Delivery; Device; | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Patent landscape, scope, and claims: | United States Patent 5,030,456: Claim Scope, Expiration, and Osmotic Drug-Delivery Patent LandscapeU.S. Patent No. 5,030,456 covers a composition used in an osmotic drug-delivery device. Its central limitation is polyethylene oxide with a molecular weight of approximately 7,000,000 to 7,800,000, combined with an osmotically effective compound. The claim is directed to the osmotic push or expansion composition rather than to a particular drug, dosage strength, membrane, tablet shape, or commercial product. The patent was assigned to ALZA Corporation and issued in 1991. Because it predates the 1995 change to the U.S. patent-term system, its ordinary term ran 17 years from issuance. The patent is therefore expired and does not create a current U.S. blocking right. Its historical importance is greater than its present enforcement value. What does U.S. Patent 5,030,456 claim?Claim 1 recites:
The claim has four principal elements:
The claim does not expressly require the composition to contain the drug. It also does not identify a specific osmagent, membrane material, dosage form, drug molecule, delivery rate, or treatment indication. What is the technical subject matter of the patent?The patent concerns the expandable driving composition used in an osmotic pump. In a typical osmotic device, water crosses a semipermeable membrane, the osmotic composition hydrates and expands, and that expansion displaces or pushes a drug formulation through an exit passage. High-molecular-weight PEO can function as a swellable polymer. The claimed molecular-weight range is directed to a PEO grade with sufficient hydration, expansion, and mechanical performance for prolonged drug delivery. The osmotically effective compound helps create the osmotic driving force. The claimed composition is distinct from the semipermeable membrane and the drug-containing compartment. A commercial osmotic product may contain several separate patent-relevant components:
Patent 5,030,456 addresses principally the composition used for the expansion or driving function. How should the molecular-weight limitation be interpreted?The molecular-weight limitation is the principal chemical boundary of claim 1. The claim identifies PEO at approximately 7,000,000 to 7,800,000 molecular weight. The phrase “about” creates a tolerance around the stated range. It does not normally authorize unlimited variation. The permitted range would depend on the patent specification, examples, testing methods, industry measurement practices, and the degree to which a nearby material performs substantially the same function. A product using PEO with a nominal molecular weight of 7,500,000 would fall squarely within the stated range. A product using 5,000,000 or 10,000,000 molecular-weight PEO would present a stronger non-infringement position, although literal infringement and equivalents would depend on the full record. Molecular-weight analysis would require attention to:
The patent specification is important because it may define the relevant molecular-weight measurement and identify acceptable commercial grades. Does claim 1 require a drug in the composition?No. The claim requires a composition that, when used in an osmotic device, delivers a drug. It does not expressly require the drug to be physically mixed with the claimed PEO and osmagent. That distinction matters. A push composition may be separate from the drug layer. A composition manufacturer could therefore face a different infringement analysis from a finished-dose manufacturer. Liability would depend on whether the supplied composition itself meets the claim and whether the relevant conduct occurred while the patent was enforceable. The phrase “for use in an osmotic device” may also affect the analysis of an intermediate composition sold without a complete device. The claim is not drafted as a pure composition-of-matter claim. Its intended use and functional language are part of the claim construction and infringement analysis. What limitations are absent from the claim?Claim 1 does not expressly require:
These omissions make the claim potentially broad within its technical field. The molecular-weight range remains the central narrowing feature. What patents formed the surrounding osmotic-delivery landscape?Patent 5,030,456 sits within the ALZA osmotic-delivery patent family and a broader group of patents covering osmotic pumps, membrane systems, expandable layers, and controlled-release dosage forms.
Representative earlier ALZA osmotic patents include U.S. Patent Nos. 3,845,770, 3,916,899, 4,111,202, 4,327,725, 4,612,008, 4,765,989, and 4,783,337. Those patents should not be treated as interchangeable with Patent 5,030,456. Their claim scope varies materially and may cover device architecture rather than the specific high-molecular-weight PEO composition. The relevant landscape must be analyzed at the product level. A product can avoid Patent 5,030,456 while infringing a separate patent covering its membrane, orifice, drug layer, coating, or manufacturing process. When did U.S. Patent 5,030,456 lose exclusivity?Patent 5,030,456 issued on July 16, 1991. For a pre-June 8, 1995 application, the ordinary term was generally 17 years from issuance under the transitional patent-term rules. The ordinary expiration date was therefore July 16, 2008, subject to any terminal disclaimer, patent-term adjustment, or other recorded event. The patent is now expired. It cannot support a current U.S. patent infringement action for conduct occurring after expiration. Historical activities before expiration would require a separate analysis of claim construction, infringement, validity, damages, and any applicable procedural defenses.
The patent’s expiration does not eliminate the commercial relevance of later patents covering specific osmotic products or later-developed compositions. What is the Orange Book status of Patent 5,030,456?Patent 5,030,456 should not be treated as a current Orange Book barrier. The Orange Book concerns patents and exclusivity associated with approved drug products and relies on patent information submitted for listed products under FDA procedures. A broad platform patent covering an osmotic-device composition is not automatically an Orange Book-listed patent. Even where a related patent was historically listed against an approved product, expiration removes the patent from its role as a current patent-based barrier to abbreviated new drug approval. Orange Book status must be evaluated by product and listing history, not by patent number alone.[1] Patent 5,030,456 also predates modern product-specific listing practices. Its claim is directed to a delivery composition rather than to a named active ingredient or a particular approved product. Were Paragraph IV challenges relevant?A Paragraph IV certification is relevant when an ANDA applicant asserts that a listed patent is invalid, unenforceable, or not infringed. Patent 5,030,456 could have been relevant to an ANDA only if it was listed for the reference product and remained unexpired when the ANDA certification was made. Because the patent expired in 2008, it does not create a present Paragraph IV launch risk. A generic applicant today would not ordinarily need to challenge this patent to obtain approval. The commercial dispute would instead focus on:
No current generic-entry assessment should rely on Patent 5,030,456 alone. What formulation patents may still matter for osmotic products?Later formulation patents can protect the drug layer independently from the PEO push composition. Common claim categories include: Drug-layer formulationsThese claims may cover a specific active ingredient with binders, osmაგენტs, lubricants, solubilizers, or suspending agents. A product could avoid Patent 5,030,456 but infringe a drug-layer patent. Membrane and coating systemsA membrane patent may claim cellulose derivatives, plasticizers, pore formers, thickness ranges, or coating processes. Such claims can control water influx and release rate. Delivery-orifice designsPatents may cover laser-drilled openings, asymmetric orifices, passage dimensions, or protective coatings. Manufacturing methodsProcess patents may cover bilayer compression, membrane coating, drilling, curing, and assembly. Manufacturing rights can remain relevant even when an older composition patent has expired. Method-of-use patentsA patent may claim administration of an osmotic dosage form for a specific indication, dosing interval, patient group, or clinical outcome. Those patents are separate from the composition claim in Patent 5,030,456. How strong is the patent estate for the claimed technology?The historical estate was technically meaningful because high-molecular-weight PEO is central to many expandable osmotic systems. The claim also avoided dependence on a specific drug, giving it potential application across multiple products. Its present legal strength is zero as an enforceable U.S. patent because the patent has expired. Its historical scope was subject to several constraints:
The expired patent can still matter as prior art against later applications, particularly where a later applicant seeks claims to similar PEO-based osmotic compositions. It may also limit the ability to obtain broad, overlapping claims for the same technical concept. What generic-entry risks exist today?Patent 5,030,456 creates no current generic-entry risk. The relevant risk for an osmotic product is the remaining estate around the marketed product, not this expired patent. A generic or follow-on developer should evaluate:
Biosimilar risk is normally inapplicable because osmotic tablets and capsules generally contain small-molecule drugs rather than biologic products. The relevant regulatory pathway is usually an ANDA under section 505(j), not a biosimilar application under section 351(k). What licensing and litigation issues are associated with the patent?ALZA historically licensed and commercialized osmotic delivery technology across multiple pharmaceutical products. A license analysis must distinguish Patent 5,030,456 from broader ALZA platform rights and from product-specific agreements. Because the patent expired in 2008, a current license to this patent alone would have little or no prospective U.S. patent value. Historical agreements may still matter for:
No current litigation conclusion should be drawn from the patent number without a docket-specific review. Expiration generally removes the patent from active infringement litigation, but it does not by itself resolve historical disputes, contractual claims, or foreign counterparts. How does Patent 5,030,456 compare with competing osmotic technologies?The claim is narrower than a general osmotic-device claim because it requires a defined PEO molecular-weight range. It is broader than a drug-specific formulation claim because it does not limit the active ingredient.
A design-around could use a different polymer, a PEO grade outside the claimed range, a non-osmotic expansion mechanism, or a device architecture that does not use the composition to deliver the drug over a prolonged period. Each route would require analysis under literal infringement and the doctrine of equivalents. What is the geographic coverage?U.S. Patent 5,030,456 covers only conduct within the territorial scope of U.S. patent law. It does not itself protect products made, sold, or used outside the United States. International protection would depend on corresponding foreign applications and granted patents. Patent families for osmotic systems may have different filing dates, claim scope, expiration dates, maintenance status, and enforcement histories in Europe, Canada, Japan, Australia, and other markets. A U.S. expiration date cannot be used to infer that every foreign counterpart expired on the same date. Key Takeaways
FAQsCan a company sell high-molecular-weight PEO for osmotic drug delivery today?Yes, Patent 5,030,456 is expired in the United States. Other patents, trade secrets, contractual restrictions, or foreign rights may still affect a specific commercial product. Does using PEO with a molecular weight of 7,500,000 automatically infringe the patent?Historically, that value would fall within the express molecular-weight range. Current U.S. infringement is not possible under this expired patent, although the patent may remain relevant as prior art. Does the patent cover OROS products generally?No. It covers a defined composition used in an osmotic device. OROS products may also be subject to separate patents covering membranes, drug layers, orifices, manufacturing, and active-ingredient formulations. Is Patent 5,030,456 relevant to an ANDA filed today?Not as an unexpired blocking patent. A current ANDA analysis should focus on unexpired listed patents and applicable FDA exclusivity for the reference product. Can a non-PEO polymer avoid the claim?A non-PEO polymer would not satisfy the express PEO limitation. Historical equivalents analysis could still have been relevant before expiration, but the patent has no current U.S. enforcement term. References
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Drugs Protected by US Patent 5,030,456
| 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 |
International Family Members for US Patent 5,030,456
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Austria | 402689 | ⤷ Start Trial | |||
| Austria | A242288 | ⤷ Start Trial | |||
| Australia | 2293888 | ⤷ Start Trial | |||
| Australia | 615215 | ⤷ Start Trial | |||
| Belgium | 1001101 | ⤷ Start Trial | |||
| Canada | 1317550 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
