Juneau comparative int_l_patent-pharma

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Juneau comparative int_l_patent-pharma

  1. 1. Comparative InternationalPatent Prosecution in the Pharmaceutical Arts By Todd L. Juneau
  2. 2. Talk Outline Patent Prosecution  U.S.  Brazil  Canada  Europe  Mexico
  3. 3. Proof of Principleis not enough An early filing date will defeat competitors’ patents and overcome prior art rejections Broad claims require more data to be in the patent application
  4. 4. ✴ “Heisenberg Uncertainty Principle” var.✴ Heisenberg: ✴ For subatomic particles, you can only know the position of it, OR ✴ the mass and velocity of it, but not both.✴ Juneau: ✴ For patent applications, you must balance getting an early filing date, OR ✴ waiting to add more data to support broad claims.✴ A decision to file must be made as soon as there is enough evidence to support commercially valuable claims 4
  5. 5. What is claimable in the U.S.?Compounds  Methodsof UseImprovements in Treatment  DiagnosticCompositions Methods andProcesses of Kits preparation  Devices
  6. 6. Compound Claims  A compound of the formula:in which R1 is alkyl containing 7 to 11 carbon atomsand R3 is lower alkyl1-hydroxy-4-methyl-6-cyclohexyl-2-pyridone US 3,883,545 (Hoechst-Ciclopirox)
  7. 7. Improvement Claims  A compound of the formula:and sodium and potassium salts thereof in which R1 is alkylcontaining 7 to 11 carbon atoms and R3 is lower alkyl1-hydroxy-4-methyl-6-cyclohexyl-2-pyridone and sodiumand potassium salts thereof US 3,883,545 (Hoechst-Ciclopirox)
  8. 8. Composition Claims A topical composition for the treatment of acne consisting essentially of: about 25-60% water; about 1.0-20.5% benzoyl peroxide; about 0.1-15% of an alpha hydroxy acid selected from the group consisting of glycolic acid…and mixtures thereof; about 0.1-10% of a moisturizer; about 0.05-10% of an alkyl ester of isosorbide; about 15-60% of a detergent. US 6,433,024
  9. 9. Biotechnology Inventions Antibodies Isolated & Purified DNA, RNA, Protein; i.e. amino acid sequences, nucleic acid sequences Genetically modified organism, i.e. plants, bacteria, yeast, animals, viral vectors “Anything under the sun made by man”
  10. 10. Process ClaimsA process for preparing zinc glycerolate by heating a mixture of zinc oxide, or zinc oxide precursor compound, with glycerol, characterized in that the reaction temperature is 15OC to 105OC. US 5,646,324
  11. 11. Method of Treatment ClaimsA method for the treatment of dermatological disorders comprising the administration of metronidazole in combination with one or more antimycotic agents. WO 97/47300
  12. 12. Diagnostic Method Claims A method for assaying invasiveness of a prostatic adenocarcinoma, comprising the steps of: (A) assaying for uteroglobin protein content in cells of a biopsy sample; and (B) comparing results of said assay for the content of uteroglobin protein in said biopsy sample with results in control cells selected from the group consisting of normal cells, benign tumor cells, and malignant tumor cells, wherein low invasiveness is indicated where the content of uteroglobin protein of the biopsy sample is typical of results obtained in the visualization of uteroglobin protein in normal control cells or of benign tumor control cells that stain strongly positive for uteroglobin protein. 
  13. 13. Kit Claims A kit for identifying prostatic intraepithelial neoplasia, which comprises: (A) a first reagent that binds specifically to an effector of arachidonic acid release in cells in a biopsy sample prepared for identification of said effector, and (B) a second reagent for detectably labelling said primary binding reagent bound specifically to cells in said biopsy sample, wherein the identification of said effector is diagnostic of said prostatic intraepithelial neoplasia. US 6,054,320
  14. 14. Device Claims Device for the production of phosgene from one or more selected from the group consisting of diphosgene and triphosgene, comprising: a storage vessel (1) for diphosgene and triphosgene and a reaction chamber (5) with a phosgene outlet (7), connected to the storage vessel (1) and containing the catalyst (3). US 6,399,822 (Dr. Eckert GmbH)
  15. 15. What is claimable in Europe? Patentable:  Not Patentable:  Compounds  Diagnostic and  Compositions Therapeutic Methods  Devices  Business methods,  Processes of software preparing  Genes or partial  Use in the sequences w/o specific preparation of a & credible technical medicament effect  Kits
  16. 16. “Method Claims” outside the U.S.: Use Claims Classic Use Claims Extended Use claims, also known as “reach through” claims
  17. 17. Classic Use Claims Classic:  The use of  a compound X  in the preparation of a medicament  for the treatment of disease Y.A 2nd and further medical indication is patentable in Europe
  18. 18. Classic Use Claim Format Compound X – normally defined by a structure Treatment – normally not further specified Disease Y – normally a well-defined medicinal condition
  19. 19. Example: Classic Use Claim (Ciclopirox Genus)  The use of 1-hydroxy-2-pyridones of the formula:for the production of a pharmaceutical for thetreatment of skin infections caused byantibiotic-resistant bacteria. EP 0 928 193 B1 (Aventis)
  20. 20. Extended Use Claims Objectives:  Obtain early protection  Obtain broader protection  Obtain longer protection Effects:  Threaten competition  Increase value of own portfolio  Keep attorneys and patent offices busy
  21. 21. Extended Use Claims Example 1 Use of (R)-fluoxetine, that is (R)-fluoxetine essentially without (S)-fluoxetine in the preparation of a medicament for treating a mammal suffering from or susceptible to a condition which can be improved or prevented by a selective occupation of the 5- HTIC receptor. EP 0 499 562 A1 (Eli Lilly)
  22. 22. Extended Use Claims Example 2 Use of taxol and sufficient medications to prevent severe anaphylactic reactions in the preparation of a medicament for simultaneous, separate, or sequential application for the administration of from 135 mg/m2 to 175 mg/m2 taxol over a period of about 3 hours or less as a means for treating cancer and simultaneously reduce neutropenia. EP 0 584 001 B1 (BMS)
  23. 23. III. Patent Prosecution – U.S. First to Invent (1st inventor to file) Groups, Art Units, SPE’s, Primary Examiners, Counts, Interviews Time Periods, Events, Costs:  Invent, Search, File Application  1 month= USSN;  9 mos.=Restriction/Search  12 mos.=Office Action (101,102,103,112)  15 mos. Interview, Response  18 mos. Notice of Allowance, Pay Issue Fee  21 mos. Grant Public search room
  24. 24. Patent Prosecution - PCT
  25. 25. Patent Cooperation Treaty Main reasons for using PCT filings: Defer translation costs Obtain a search & opinion Reserve patent rights in 119 countries while evaluating potential market of inventive subject matter Accelerate and standardize prosecution in some countries Can file in Chinese, English, French, German, Japanese, Russian, Spanish to obtain a search Can claim benefit of a U.S. provisional (21 years) Obtain a publication of the invention
  26. 26. Most frequent PCT users 1. Koninklijke Philips Electronics  11. The Procter & Gamble Company N.V. NL 1,922 US 536 2. Siemens Aktiengesellschaft  12. BASF Aktiengesellschaft DE 473 DE 1,268  13. Infineon Technologies AG DE 3. Robert Bosch GmbH DE 1,201 454 4. Telefonaktiebolaget L M  14. Honeywell International Inc. US Ericsson SE 870 422 5. Matsushita Electric Industrial  15. Mitsubishi Denki Kabushiki Co., Ltd. JP 838 Kaisha JP 421 6. Sony Corporation JP 676  16. Intel Corporation US 353 7. Nokia Corporation FI 651  17. International Business Machines 8. 3M Innovative Properties Corporation US 345 Company US 578  18. Qualcomm Incorporated US 320 9. Motorola, Inc. US 559  19. The Regents of the University of 10. Bayer Aktiengesellschaft DE California US 309 549  20. E.I. Du Pont de Nemours and Company US 279
  27. 27. PCT Basics Chapter I – thru 20th month, Chapter II – thru 30/31st month Demand previously required at 19th month is no longer required for most countries Unity of Invention is the standard – special technical feature
  28. 28. PCT Regional Phase EPO European Patent Office ARIPO African Regional IP Office EAPO Eurasian Patent Office OAPI PO Oceania Asia Pacific Patent Office
  29. 29. Patent Prosecution –EPO (year 2000) 2600 examiners, 100 Board of Appeal members 142,000 applications in 2000; 53,000 searches; 45,000 examinations; 2,300 oppositions; and 1,200 appeals www.european-patent-office.org
  30. 30. Patent Prosecution - Europe Novelty, Inventive Step, Clarity, Industrial Use First to File Registration only, need to perfect in each member country 18 month publication Request examination within 6 months of publication Opposition at EPO Validity, Enforcement locally AT, BE, BG, CY, CZ, DE, DK, EE, ES, FI, FR, GR, HU, IE, IT, LI, LU, MC, NE, PT, RO, SK, SI, SE, CH, TR, UK Extensive search capabilities (SE, DK)
  31. 31. EPO grant Must request exam within 6 months after EPO search report published (extendible by 1 month) Usually receive multiple office actions Receive Rule 51(4) Request for Approval of Text; answer due within 4 months (extendible by 2 months) Upon receipt of approved text, 3 months to pay grant fees and provide translation of priority documents if necessary EP patent effective upon publication in Eur.Pat. Bulletin Opposition period for 9 months thereafter
  32. 32. Perfecting an EP grant into thecontracting states Translation of claims required within 3 months: Austria, Belgium, Denmark, France, Germany, Greece, Italy, Netherlands, Portugal, Spain, Sweden, Switz./Lch, United Kingdom Translation of claims within 6 months: Ireland
  33. 33. EPO and the European Market Austria, Belgium, Bulgaria, Cyprus, Czech, Switzerland, Germany, Denmark, Estonia, Spain, Finland, France, The United Kingdom, Greece, Hungary, Ireland, Italy, Liechtenstein, Luxembourg, Monaco, The Netherlands, Portugal, Romania, Slovenia, Slovakia, Sweden, and Turkey. Extension States: Albania, Latvia, Lithuania, Macedonia Market Size: about 485 million people.
  34. 34. Patent Prosecution - Japan First to file, absolute novelty Publication at 18 months Examination must be requested within 3 years after filing (Y84,000 plus Y2000 per claim) Patent term 20 years Utility Model term 6 years Opposition within 6 months after grant
  35. 35. Patent Prosecution - Australia First to file, absolute novelty Publication at 18 months Examination - must be requested within 6 months after receiving notice to do so, usually within 1 or 2 years after filing Standard Patents - Examined, opposition available, 20 year term, no online application Innovation Patents - Not examined, less costly, opposable, 8 year term, can apply online, unenforceable in Court until examined Opposition within 3 mos. of grant
  36. 36. Patent Prosecution - Brazil 18 month publication Request examination within 36 months of earliest filing date Application examined for form, substance, and novelty Third parties can file observations between publication and conclusion of examination Limited search Room
  37. 37. Patent Prosecution - Canada Novelty, unobviousness; limited exam First to File Patent application open to public inspection 18 months from the earliest filing date Request examination within 5 years of earliest filing date Before a patent is granted a third party can file an opposition to the patent Web-site search possible
  38. 38. Patent Prosecution - Mexico 18 month publication No request for examination is required; the application is examined after publication Patent Office may accept examinations performed by foreign patent offices, or may request technical assistance from other national institutes No public search capability
  39. 39. Patent Renewal Fees Annuity or maintenance fees must be paid to avoid patent abandonment:  U.S. maintenance fees due 4, 8, and 12 years after patent grant  Europe annuity fees due every year starting 3 years after filing
  40. 40. Working RequirementsA patentee is sometimes required to “work” the invention once it is patented If the invention is not worked within a specified time period, the patentee must compulsory license the patent at a specified government royalty A patent may not be used as the basis for a lawsuit if it is not worked
  41. 41. Triggers to Compulsory Licenses Germany-if it is “in the public interest”; very rare UK, Italy, Belgium-lack of sufficient use of the patent France, Spain, Austria-both in the public interest and lack of sufficient use U.S.-no compulsory license In general, not greatly used
  42. 42. UK filing vs. U.S. provisional UK filing Inexpensive Can obtain a search within 6 months Can obtain a refund of amounts paid against the EPO filing U.S. provisional Inexpensive Effective date under 102(e) both against prior art and against other applicants 21 year term
  43. 43. Thank Youtodd@juneaupartners.com

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