CERN Big Bang Experiment 10 September 2008 Gravitons and Bosons Missing Dark Matter Higgs particles .

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FarmaPatent Limited http://www. farmapatent CERN "Big Bang“ Experiment 10 September 2008 Gravitons and Bosons "Missing Dark Matter“ Higgs particles. IPTS 2008 Pharmaceutical Patents Dr.Ecz . PINAR BULUT. Electronic Orange Book. Patent Data *. Exclusivity Data
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FarmaPatent Limited http://www. farmapatent CERN "Big Bang" Experiment 10 September 2008 Gravitons and Bosons "Missing Dark Matter" Higgs particles IPTS 2008 Pharmaceutical Patents Dr.Ecz . PINAR BULUT

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Electronic Orange Book Patent Data * Exclusivity Data There is no unexpired eliteness for this item. * GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE

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Marketing Exclusivity Codes: New Combination New Chemical Entity New Dosage Form New Ester or Salt of an Active Ingredient New Product New Route New Strength The licenses that FDA views as guaranteeing these medication licenses are : 1) Patents that claim the dynamic fixing (s) 2) Drug item patent, which incorporate plan/arrangement licenses 3) Use licenses for a specific affirmed sign or strategy for utilizing the item .

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Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the making of a supplementary insurance endorsement for therapeutic items Article 3 . Conditions for acquiring a declaration A testament should be allowed if, in the Member State in which the application alluded to in Article 7 is submitted and at the date of that application: (a) the item is secured by a fundamental patent in drive ; Article 1 . Definitions For the reasons for this Regulation: \'therapeutic item\' implies any substance or mix of substances exhibited for treating or averting sickness in people or creatures … .. ; (b) "item" implies the dynamic fixing or blend of dynamic elements of a restorative item; (c) \'essential patent\' means a patent which ensures an item as characterized in (b) thusly, a procedure to acquire an item or an utilization of an item , and which is assigned by its holder with the end goal of the system for concede of an endorsement;

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SPC number : SPC/GB02/049 Patent No: EP0347066 ( New Enantiomers and Their Isolation ) Community authorisa tion: Sweden (7 December 2001) Product portrayal: Escitalopram oxalate Supplementary Protection Certificate (SPC)

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SPC number : SPC/GB01/053 Patent No: EP 0397831 (Treatment of Obesity ) Community authorisa tion: Germany (14 January 1999) Product depiction: Sibutramine hydrochloride monohydrate Supplementary Protection Certificate Claims The utilization of N,N-dimethyl-1-[1-(4-chlorophenyl)cyclobutyl]-3-methylbutylamine hydrochloride in the make of a medicament for the treatment of corpulence. The utilization of N,N-dimethyl-1-[1-(4-chlorophenyl)cyclobutyl]-3-methylbutylamine hydrochloride monohydrate in the fabricate of a medicament for the treatment of heftiness.

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CAUTION ! * For most Generic Drug Developments, Molecule Patent expiry dates are the \'Tip of the Iceberg\' * Presented by Leighton Howard – ICSE2005 , Madrid

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Drug Substance Polymorph s Salt/Hydrate/Solvate Prodrug, Metabolite Impurity Profile , Substantially immaculate Physicochemical properties Particle measure Synthetic Route New intermediates, Starting materials, Catalysts Purification Method Assay Technique Drug Product Formulation/Composition Combination Manufacturing strategy Excipients Packaging Medical Use Route of Administration Dosing Regimen Secondary Patent s (Evergreening)

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POLYMORPH PATENTS (Donepezil – EISAI) Claims 1. Donepezil hydrochloride … .. as polymorph (III) , being determined … X-beam diffraction design and … infrared retention spectra … .

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POLYMORPH PATENTS (Rosiglitazone – SKB) Claims A polymorphic type of … maleic corrosive salt ( the Polymorph ) described in that it gives : an infrared range containing tops at … . ; and/or a Raman range containing tops at … . ; and/or a strong - state 13C NMR range containing crests at … ; and/or a XRPD design …

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PSEUDOPOLYMORPH (Hydrate) - (Rosiglitazone – SKB)

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Scientific Considerations of Polymorphism in Pharmaceutical Solids: Abbreviated New Drug Applications * POLYMORPHISM IN PHARMACEUTICAL SOLID DRUG SUBSTANCE AND THE ISSUE OF "SAMENESS" A medication substance in a non specific medication item is for the most part thought to be the same as the medication substance in the reference recorded medication on the off chance that it meets similar norms for personality . Much of the time, the gauges for character are portrayed in the USP despite the fact that FDA may endorse extra benchmarks when vital. Since medication item execution relies on upon the item detailing, the medication substance in a proposed bland medication item require not have similar physical frame (molecule size, shape, or polymorph shape) as the medication substance in the reference recorded medication. * FDA

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Scientific Considerations of Polymorphism in Pharmaceutical Solids: Abbreviated New Drug Applications * An ANDA candidate is required to show that the proposed item meets the gauges for personality , displays adequate solidness and is bioequivalent to the reference recorded medication. Throughout the years FDA has endorsed numerous nonexclusive medication items based upon a medication substance with various physical shape from that of the medication substance in the separate reference recorded medication (e.g., warfarin sodium, famotidine, and ranitidine ). Additionally numerous ANDAs have been endorsed in which the medication substances varied from those in the comparing reference recorded medications concerning solvation or hydration state (e.g., terazosin hydrochloride, ampicillin, and cefadroxil). * FDA

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CASE 1: RANITIDINE 1. Shape 2 ranitidine hydrochloride portrayed by an infra-red range as a reflect in mineral oil demonstrating the accompanying fundamental pinnacles:

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RANITIDINE: Patents and Generics

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PATENT ACT (INDIA) Amendment (fifth April 2005) INVENTIONS NOT PATENTABLE 3. What are not creations " (d) the insignificant revelation of another type of a known substance which does not bring about the upgrade of the known viability of that substance or the negligible disclosure of any new property or new use for a known substance or of the unimportant utilization of a known procedure, machine or contraption unless such known process brings about another item or utilizes no less than one new reactant. Clarification – For the motivations behind this statement, salts, esters, ethers, polymorphs, metabolites, immaculate frame, molecule measure, isomers, blends of isomers, buildings, mixes and different subsidiaries of known substance should be thought to be similar substance , unless they vary significiantly in properties concerning adequacy ."

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RESULT LIST Approximately 662 results found in the Worldwide database for: polymorp * in the title or unique AND wo as the production number AND C07D as the IPC arrangement Search International Patent Applications Results of looking in PCT for: AB STRACT: POLYMORPH OR POLYMORPHS OR POLYMORPHISM P RIORITY COUNTRY: IN DIA I P C : C07D 99 records

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Search International Patent Applications Results of scanning in PCT for: AB STRACT: POLYMORPH OR POLYMORPHS OR POLYMORPHISM IPC: A61K APPLICANT: TEVA 7 records APPLICANT: PFIZER 12 records APPLICANT: ROCHE 3 records Results of Search in US Patent Collection db for: (ACLM/( crystalline AND f orm ) AND a61k ): 184 licenses .

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ISOMERIC FORM, SALT and HYDRATE Claims 1. The magnesium salt of (- )- 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl]-1H-benzimidazole ( Mg-salt of the (- ) enantiomer of omeprazole ) Claims 1. The magnesium salt of S-omeprazole trihydrate

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IMPURITY Claims 1. Utilization of escitalopram involving under 3% w/w of R-citalopram for the arrangement of a pharmaceutical creation.

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FDA TALK PAPER Feb. 27, 1998 SELDANE AND GENERIC TERFENADINE WITHDRAWN FROM MARKET Hoescht Marion Roussel and Baker Norton Pharmaceuticals have willfully stopped appropriation and showcasing of all terfenadine-containing antihistamine product offerings in the United States. Terfenadine-containing items ,, for example, Seldane and Seldane-D, have been connected with uncommon, yet genuine heart issues when brought with certain different medications, including certain anti-toxins and antifungals. In January 1997, FDA proposed expelling all terfenadine items from the commercial center in view of the endorsement of a more secure option sedate: Allegra ( fexofenadine hydrochloride ).

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SUBSTANTIALLY PURE 13. A HPLC strategy containing the means of: joining a R-Tolterodine tartrate test with a blend of acetonitrile: water … (b) infusing the arrangement into a … . section … (c) slope eluting the specimen from the segment at around 8 min utilizing a blend of … (d) measuring the debasement content in the applicable example with an UV identifier … .. I . R-Tolterodine tartrate having not exactly around 0.5% zone by HPLC of aggregate polluting influences.

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FORMULATIONS – COMPOSITIONS - EXCIPIENTS Clopidogrel bisulfate tablet plan 1. A pharmaceutical tablet which involves clopidogrel bisulfate and an ointment chose from the gathering comprising of zinc stearate , sodium stearyl fumarate and stearic corrosive. Dry Mix Formulation for Bisphosphonic acids 1. A pharmaceutical structure involving from 0.5 to 40% by weight of 4-amino-1-hydroxybutylidene - 1,1-bisphosphonic corrosive or a pharmaceutical worthy salt thereof and from 60 to 99.5% by weight of excipients , said excipients containing a diluent chose from anhydrous lactose or hydrous quick stream lactose , a

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