United States Drug Patent 7,270,800: Claim Scope, Expiration, FDA Status, and Amyloid-Imaging Patent Landscape

U.S. Patent No. 7,270,800 covers radiolabeled and non-radiolabeled amyloid-binding compounds, pharmaceutical compositions, amyloid-imaging methods, ex vivo tissue assays, quantitative amyloid measurement, and methods directed to selective binding of amyloid plaques over neurofibrillary tangles. The patent is associated with the Pittsburgh amyloid-imaging platform, including compounds related to Pittsburgh Compound B, or PiB.

The patent is expired and does not create a current U.S. blocking right for commercial development. It also does not appear to correspond to an FDA-approved drug product or an Orange Book-listed product. Current commercial risk therefore depends on later patents covering specific radiotracers, formulations, manufacturing processes, regulatory use, or branded amyloid-imaging agents rather than on Patent 7,270,800 itself.

What does U.S. Patent 7,270,800 cover?

The patent covers five principal subject-matter groups:

Claim group	Covered subject matter	Commercial relevance
Claims 1-2, 20	Amyloid-binding chemical compounds and isotopically substituted analogs	Core chemical and radiotracer scope
Claims 3, 6-11	In vivo amyloid detection, including PET, SPECT, MRI and MRS	Diagnostic-imaging use
Claims 4	Radiolabeling methods using trialkyltin precursors and halogenating agents	Radiotracer manufacturing
Claim 5	Pharmaceutical compositions containing the compounds	Injectable imaging products
Claims 12-18	Ex vivo tissue staining, quantification and plaque-selective binding	Pathology, research and biomarker applications

The issued claims identify structures numbered 1-34, 36, and 38-45. The supplied claim text does not reproduce the chemical drawings. Exact molecule-by-molecule mapping therefore depends on the patent figures and specification, not solely on the textual claim transcription.

What chemical structures are claimed?

Claims 1 and 2 define amyloid-binding compounds selected from specified chemical structures. Claim 2 expands the scope by permitting replacement of substituents with:

Positron-emitting isotopes, including carbon-11, fluorine-18 and bromine-76.
Gamma-emitting isotopes, including iodine-123, iodine-125, iodine-131 and bromine-75.
Tritium and carbon-14.
Fluorinated, halogenated and alkyl substituents.
Ether, ester, amide, nitrile, trifluoromethyl and related carbon-containing groups.
Phenyl groups with specified substituents.
Technetium-99m chelating groups.

The claims therefore extend beyond a single clinical tracer. They attempt to cover a platform of amyloid-binding compounds capable of use in PET, SPECT, autoradiography, microscopy and quantitative tissue assays.

Claim 20 specifically recites a compound under claim 2 in which a substituent is carbon-11. That limitation is directed to short-lived PET tracers, including compounds prepared for rapid synthesis and administration in a nuclear-medicine setting.

Does the patent cover Pittsburgh Compound B?

The patent is closely associated with the Pittsburgh amyloid-imaging technology and compounds in the PiB family. PiB is generally identified as carbon-11-labeled 2-[4'-(methylamino)phenyl]-6-hydroxybenzothiazole.

The patent’s practical significance is broader than PiB alone. The claim language covers a set of substituted amyloid-binding structures and radiolabeled versions. Whether a particular PiB analog falls within an issued claim requires comparison against the structural drawings, claim dependencies and prosecution history.

How broad are the method-of-use claims?

The method claims are broad in modality, patient population and testing environment.

In vivo imaging

Claims 3 and 6 cover administration of a claimed compound or composition followed by detection of binding to amyloid deposits. Claim 6 expressly includes:

Gamma imaging.
Magnetic resonance imaging.
Magnetic resonance spectroscopy.

Claim 9 narrows gamma imaging to PET or SPECT. Claim 10 specifies intravenous administration. Claim 7 places the deposits in the brain, while claim 8 identifies patients suspected of having:

Alzheimer’s disease.
Familial Alzheimer’s disease.
Down syndrome.
Homozygosity for the apolipoprotein E4 allele.

The claims are framed around detecting amyloid deposits rather than treating disease. They do not claim an amyloid-reducing therapeutic mechanism.

Cerebellar comparison

Claim 11 covers comparison of tracer binding in a brain region other than the cerebellum with binding in the cerebellum. This reflects the diagnostic use of cerebellar tissue as a reference region because it generally has lower levels of fibrillar beta-amyloid deposition than cortical regions in Alzheimer’s disease.

Claim 17 applies a similar ratio concept to biopsy or post-mortem tissue. It recites a threshold under which Alzheimer’s disease is determined when the suspected subject’s ratio is above 90% of the ratios obtained from normal subjects. The wording is unusual and should be interpreted against the specification and prosecution history.

Plaque selectivity

Claims 18 and 19 address selective binding to amyloid plaques rather than neurofibrillary tangles.

Claim 18 specifies an in vitro concentration below 10 nM. Claim 19 refers to maintaining blood concentration below 10 mM, although the surrounding technical context strongly suggests that the intended concentration may have been 10 nM. The issued patent controls for infringement analysis, while the specification and prosecution history may affect construction of the limitation.

What manufacturing methods are protected?

Claim 4 covers synthesis of radiolabeled compounds by reacting a trialkyltin derivative with a halogenating agent containing a selected radioisotope.

The claim is relevant to radiotracer production because aromatic trialkyltin precursors are commonly used in radiohalodestannylation. The claimed process is directed to introduction of iodine, bromine or fluorine isotopes into the amyloid-binding scaffold.

Potentially relevant process limitations include:

A precursor based on one of the specified amyloid-binding structures.
A trialkyl tin substituent on that precursor.
A halogenating agent containing the selected isotope.
Formation of the radiolabeled final compound.

A manufacturer using a different precursor, a different radiolabeling route or a different chemical transformation would require a separate claim analysis. Process claims can remain commercially relevant even when broad composition claims have expired, but claim 4 of Patent 7,270,800 is no longer enforceable after patent expiration.

What is the patent term and current legal status?

Item	Information
Patent	U.S. Patent No. 7,270,800
Title	Amyloid binding compounds and methods of use thereof
Patent type	Utility patent
Technical field	Amyloid-binding agents and diagnostic imaging
Filing and priority	The patent belongs to the earlier Pittsburgh amyloid-imaging patent family
Issue date	September 18, 2007
Current status	Expired
Current blocking effect	None from the expired patent
FDA product linkage	No identified Orange Book-listed approved product

The patent’s enforceable term ended after the applicable 20-year patent term calculation, including any applicable patent-term adjustment. Public patent records classify the patent as expired by term. The expiration removed the patent’s ability to block U.S. manufacture, use, sale or importation of products that would otherwise fall within its claims.

The expiration of this patent does not eliminate later patents in the same field. A product can be outside the scope of Patent 7,270,800 and still infringe a later patent covering a specific tracer, formulation, synthesis route, imaging indication or commercial product.

What is the Orange Book status of Patent 7,270,800?

Patent 7,270,800 is not an Orange Book patent for an FDA-approved drug product.

The relevant amyloid PET agents were approved as diagnostic radiopharmaceuticals under separate FDA applications:

Product	Active tracer	FDA approval
Amyvid	Florbetapir F 18 injection	2012
Vizamyl	Flutemetamol F 18 injection	2013
Neuraceq	Florbetaben F 18 injection	2014

Patent 7,270,800 predates these approvals and is not itself the Orange Book-listed patent protecting those branded products. Its claims are directed to the underlying amyloid-binding technology and diagnostic methods rather than to an approved NDA product.

There is no conventional small-molecule generic pathway associated with PiB as an approved reference drug because PiB is not an FDA-approved commercial therapeutic or diagnostic product. For approved amyloid PET agents, an abbreviated new drug application strategy would depend on the reference product, dosage form, radiochemical identity, labeling, manufacturing controls and relevant exclusivity or patent barriers.

Which competing amyloid-imaging patent estates matter?

The principal competing technology estates concern the three FDA-approved fluorine-18 amyloid PET tracers.

Tracer	Brand	Sponsor or commercial holder	Primary commercial issue
Florbetapir F 18	Amyvid	Eli Lilly through Avid Radiopharmaceuticals	Product-specific composition, formulation, synthesis and labeling rights
Flutemetamol F 18	Vizamyl	GE Healthcare	Tracer manufacturing, kit and diagnostic-use rights
Florbetaben F 18	Neuraceq	Bayer and commercialization partners	Composition, manufacturing and diagnostic-use rights
Carbon-11 PiB	Research-use tracer	Academic and research institutions	Short half-life, on-site cyclotron requirement and lack of FDA commercial approval

These products are not automatically covered by Patent 7,270,800 merely because they bind amyloid. Infringement depends on the exact chemical structure and the surviving claims. Later patents commonly narrow the technology to a named tracer, a particular stereochemical form, a formulation, a synthetic intermediate, a radiolabeling process or an approved imaging indication.

What generic entry risks exist after expiration?

The patent-expiration risk is low for the specific claims of Patent 7,270,800 because the patent has expired. Market-entry risk remains in four areas.

Later composition patents

A later patent may claim the exact active tracer or a narrower analog. Such claims can remain enforceable after expiration of an earlier genus patent if the later patent has a valid priority date and satisfies novelty and nonobviousness requirements.

Formulation patents

Radiopharmaceuticals can have formulation claims directed to:

Injectable aqueous solutions.
Stabilizers and antioxidants.
Buffer systems.
Specific pH ranges.
Radiochemical purity.
Container and administration systems.
Shelf-life or synthesis-to-injection conditions.

A generic or compounded radiopharmaceutical may avoid an expired composition claim but still encounter a formulation patent.

Method-of-use patents

Later patents may claim interpretation of amyloid PET scans, patient-selection criteria, quantitative thresholds, disease staging, or use in combination with anti-amyloid therapies. Such claims are distinct from the broad detection methods in Patent 7,270,800.

Manufacturing and quality-control patents

Commercial PET production requires validated radiosynthesis, precursor supply, automated synthesis modules, quality-control testing and tightly controlled release specifications. Patent rights may cover the precursor, cassette, synthesis sequence or purification process.

How strong was the patent estate for commercial enforcement?

The estate was technically broad but commercially constrained.

Strengths

It covered multiple amyloid-binding chemical scaffolds.
It included radioactive and nonradioactive isotopes.
It addressed PET, SPECT, MRI and MRS.
It included in vivo and ex vivo applications.
It reached synthesis methods and pharmaceutical compositions.
It targeted the central diagnostic concept of detecting amyloid deposits.

Limitations

The structural drawings are essential to determine the exact chemical boundaries.
Some claims depend on unusual concentration, threshold or comparative-ratio limitations.
The claims are directed to a broad research and diagnostic platform rather than a single FDA-approved product.
Commercial products launched years later could rely on separate, narrower patent families.
Short-lived isotopes impose operational constraints independent of patent rights.
Patent expiration removed the principal exclusionary value of this patent.

The patent was more important as an originating platform patent than as a current commercial barrier.

Are biosimilar risks relevant?

No. Biosimilar law does not apply to these products because the claimed agents are small-molecule radiopharmaceuticals, not biologic products.

The relevant regulatory competition is generic, hybrid, compounded or new-drug competition. For FDA-approved fluorine-18 agents, applicants must address chemical identity, radiochemical purity, sterility, dosimetry, imaging performance and manufacturing controls. The abbreviated pathway may be more complex than for a conventional tablet because the product is radioactive, often produced near the imaging site and tied to a diagnostic interpretation framework.

What litigation or settlement issues affect the patent?

Patent 7,270,800 does not provide a current basis for U.S. infringement litigation because it is expired. Any historical enforcement, licensing, university commercialization or settlement activity would need to be assessed against the patent’s term and the specific accused product.

The principal current litigation risk is more likely to arise from later patents associated with:

Amyvid.
Vizamyl.
Neuraceq.
Radiopharmaceutical manufacturing platforms.
Amyloid imaging interpretation.
Anti-amyloid therapeutic monitoring.

A Paragraph IV challenge directed specifically to Patent 7,270,800 would have no practical present value after expiration. A Paragraph IV notice could still be relevant to a later patent listed for an approved product, but not to this expired patent standing alone.

What geographic coverage does the patent provide?

The patent provided U.S. rights only. Corresponding international applications or national-phase patents may have existed in other jurisdictions, but U.S. expiration does not determine the status of foreign family members.

For a global launch, the relevant review must separately cover:

European Patent Office and individual European validations.
Canada.
Japan.
Australia.
China.
South Korea.
Major radiopharmaceutical production markets.

Foreign rights may have different filing dates, prosecution outcomes, patent-term adjustments, supplementary protection certificates or national expiration dates. A U.S. freedom-to-operate conclusion cannot be extended automatically to Europe or other jurisdictions.

Key Takeaways

Patent 7,270,800 covers a broad amyloid-imaging platform, including radiolabeled compounds, pharmaceutical compositions, synthesis methods and in vivo or ex vivo detection methods.
The claims are closely associated with Pittsburgh amyloid-binding technology and compounds related to PiB, but exact chemical coverage requires review of the missing structural drawings.
Claims 6-11 focus on in vivo amyloid detection, including PET, SPECT, MRI and MRS, with particular emphasis on brain deposits and cerebellar comparison.
Claims 12-18 cover tissue staining, quantitative amyloid measurement and plaque-selective binding.
Claim 4 covers radiolabeling through trialkyltin precursors and isotope-containing halogenating agents.
The patent is expired and does not impose a current U.S. exclusionary right.
Patent 7,270,800 is not an Orange Book-listed patent for Amyvid, Vizamyl or Neuraceq.
Current competitive risk lies in later patents covering specific tracers, formulations, manufacturing processes, imaging interpretation and approved-product indications.
These products are small-molecule radiopharmaceuticals, so biosimilar analysis is not applicable.
A commercial launch still requires a separate review of later U.S. and foreign patent families, FDA requirements, radiopharmaceutical manufacturing rights and product-specific exclusivity.

FAQs

Is Pittsburgh Compound B still patent protected in the United States?

Patent 7,270,800 no longer protects Pittsburgh amyloid-binding compounds in the United States because the patent has expired. Later patents covering specific derivatives or manufacturing processes must be reviewed separately.

Can a company commercialize carbon-11 PiB after Patent 7,270,800 expires?

Patent expiration removes the blocking effect of this patent. Commercialization would still require compliance with FDA requirements for the proposed product, radiopharmaceutical manufacturing controls, site licensing, human-use research or marketing authorization, and any surviving later patent rights.

Does Patent 7,270,800 cover amyloid monoclonal antibodies?

No. The patent covers small-molecule amyloid-binding compounds and related imaging methods. It does not cover biologic anti-amyloid antibodies or biosimilar versions of those antibodies.

Does the patent cover tau imaging?

The claims supplied are directed to amyloid deposits and distinguish amyloid plaques from neurofibrillary tangles. They do not establish broad coverage of tau imaging agents.

Are PET interpretation methods covered after the patent expires?

The interpretation methods in Patent 7,270,800 are no longer enforceable because the patent is expired. Later patents may cover specific quantitative PET interpretation methods, patient-selection rules or therapy-monitoring applications.

References

U.S. Patent No. 7,270,800. (2007). Amyloid binding compounds and methods of use thereof. United States Patent and Trademark Office.
United States Code, 35 U.S.C. §§ 154, 271, 282. Patent term, infringement and validity provisions.
U.S. Food and Drug Administration. (2012). Amyvid (florbetapir F 18 injection) prescribing information.
U.S. Food and Drug Administration. (2013). Vizamyl (flutemetamol F 18 injection) prescribing information.
U.S. Food and Drug Administration. (2014). Neuraceq (florbetaben F 18 injection) prescribing information.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. Orange Book.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1611115	⤷ Start Trial	CA 2015 00009	Denmark	⤷ Start Trial
European Patent Office	1611115	⤷ Start Trial	C300724	Netherlands	⤷ Start Trial
European Patent Office	1611115	⤷ Start Trial	15C0005	France	⤷ Start Trial
European Patent Office	1611115	⤷ Start Trial	C20150004 00139	Estonia	⤷ Start Trial
European Patent Office	1334091	⤷ Start Trial	PA2015001	Lithuania	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 7,270,800

Summary for Patent: 7,270,800