Patent claims formulations

The patent claims in 3 of these patent lawsuits involved dmg substance claims, and the other 5 involved method of use and/or formulation claims. 

Platinol (Cisplatin) N/A, Paragraph HI Certification Formulation 1 Beginning 2 months prior to the last patent claiming the drug expired 30 months Between 100 and 250 million... 

The 463 patent claims a diltiazem formulation containing both slow-release heads, of the type found in Tiazac, and at least 1% free diltiazem. Because Tiazac is prior art to the 463 patent, the patent cannot cover Tiazac and he vahd See In re Buspirone Patent Litigation, 185 F. Supp. 2d at 360-62. 

Lyerly (Ref 6), in his patent claims use of the compd in a liq expl formulation having a deton vel of approx 18600ft/sec, with the following compn TMA 10, TNT 30, ammonium sulfate 27-6, Na nitrate 14 and w 18.4p... 

Patents have been granted for innovations involving the preparation and activities of broad-spectrum antimicrobial emulsions from 1977 (Sippos) to 2000 (Baker). All of these patents claim antibacterial activity, but all involve additives in the non-aqueous phase of the emulsion that are known to be antibacterial alone and before emulsification. Wide spectrum applications for these nanoemulsions have been claimed with positive results for bacteria, fungi, and viruses. The term nanoemulsion is used in US patents discussed below, but the generic term for the product of an emulsification (Gooch 2002, 1980) of a liquid within a liquid is an emulsion. United States patents 6,015,832 and 5,547,677 were examined and formulations in key claim statements were reproduced, and tested using standard methods for effectiveness. Additional patents listed in the reference section were reviewed as part of this study. 

A patent must end with one or more patent claims which describe the patented subject matter as unambiguously as possible. Patent claims may be considered as the definition of the patent scope for legal purposes. The precedent patent description has to justify all aspects of the patent claims and will be used for this purpose during the examination process. But only in cases of doubt will details of the patent description be used later on to interpret the patent claims. Thus, patent claims must be formulated with the utmost care. The three basic requirements novelty, non-obviousness and utility have to apply to... 

Process patents (i.e., patents claiming processes for making a drug compound or formulation) are not listed by the FDA in connection with approved drug formulations. Thus, process patents are not subject to... 

The silicide has been used in many expl formulations to increase sensy and power. An early patent claiming this action (Ref 2) incorporates 6—18% of various silicon compds including silicides, with the balance of the expl compn consisting of Amm Perchlorate, NC and TNT in the patents of Segay (Refs 3 and 4), AN and AN-TNT based expls incorporate from 13.8 to 27% calcium silicate and Pronk and Bower (Ref 5) include 15% Ca silicide in their patented Amm Perchlorate based formulations. However, the work of M dard (Ref 6) indicates that with the addn of from 5 to 30% Ca silicide to mixts with either PA or RDX as the principal constituents, an avg increase of only 6.6% in Trauzl (Pb block) expansion resulted when compared to the Traud results of neat samples of either expl. The work of Sartorius (Ref 8) is also pertinent at this point. He investigated expl compns consisting of 85 or 90% PA, PETN, RDX or TNT... 

Besides primary patents that are basic patents that cannot be circumvented and whose expiry has to be waited for, there are other categories of patents that may appear as severe hurdles. One example is the pharmaceutical formulation of therapeutic proteins, a dangerous minefield also for classical generics. Numerous patents claim distinct product-specific formulations. These inventions are related to a more advanced development stage, and they usually expire several years later. I believe that some of the biogeneric players are not fully aware of this difficult situation. Again, it requires specific experience to find a gap within a dense net of formulation patents. The biogeneric products will probably appear... 

The olefin complex (22 X,Y = F P,Q = Br) has also been prepared in low yield by a photochemical reaction of CFi CBra with pentacarbonyliron, together with a small amount of material formulated from its mass spectrum and an i.r. band at 1675 cm" as the fenacyclopentene (23). A Russian patent claims that bis(halogenoperfluoroalkene)iron derivatives can be prepared by heating Fe(CO)s with CF2 CFX (X = Br, CF3, or CFiCFj) in an autoclave at 125—280° for 23—38 h. ... 

The use of an oxidized starch acetate 180, urea 20, and water 200 as a gummed tape adhesive has been patented. The formulation of an acrylamide starch graft polymer is also claimed hydrolyzed low viscosity acrylamide-starch graft copolymer 67, canary dextrin 20, animal glue 10, urea 10, petrolatum 0.25, and sodium hexametaphosphate 0.1, are heated for 30 minutes at 185-205 F (85-96 C). ... 

Elsewhere, in a series of Japanese patents, mixtures of resorcinol + sodium nitrate, glycerine + sodium nitrate, lithium hydroxide + tungstate, etc., have been claimed to be effective. An example of the use of inhibited cooling mixtures of low toxicity is provided by a patent which describes a mixture of silicate-I- polyphosphate -I- a saccharide, e.g. sucrose or fructose, as the inhibitor formulation in a propylene glycol -I- potassium-hydrogen-carbonate mixture used in aluminium cooler boxes for ice-cream. 

Although IOS have not yet appeared in commercial formulations, several patents have claimed their use in LDLs and in other cleaning formulations. As an example, Kok et al. [8] have described the use of IOS containing 75% (3-hydroxysulfonate in a dishwashing detergent. Their patent also claims the use of IOS in granular and in liquid laundry detergents as well as in all-purpose cleaners. 

A number of azetidine-based compounds have been disclosed in patent applications from Aventis Pharma for CBi-modulated treatment of diseases such as obesity, Parkinson s disease, schizophrenia, respiratory and neurological diseases [330-334]. Compound (556) was specifically claimed for use in two formulation patent applications [330, 331] for a stable semi-solid composition and oral emulsion composition, respectively. The optional coadministration of an agent that activates norepinephrinergic and se-rotoninergic neurotransmission (for example, sibutramine) or dopaminergic neurotransmission was also claimed for the treatment of obesity. The optional use of a dopamine agonist (for example, levodopa) was claimed... 

Emorfazone has been launched as Pentoil, Pentoyl, Nandron. Synergistic analgesic formulations containing (3) and either acetaminophen (paracetamol), sulpyrine (dipyrone), grafinin or phenylbutazone were claimed in patents [68, 69], The combined use of emorfazone with different non-steroidal acidic antiinflammatory drugs has been reported to be beneficial [70, 71]. 

Patents Not Claiming the Approved Drug Substance, Drug Formulation or Use... 

Whether a brand-name company may appropriately list polymorph patents, or those claiming a use or formulation containing a polymorph, could be clarified through FDA regulation or guidance. This is the subjeet of the FTC Staff s Citizen Petition. 

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