By Todd L. Juneau

1. juneaupartners.com Todd Juneau 2005 Comparative International Patent Prosecution By Todd L. Juneau

2. juneaupartners.com Todd Juneau 2005 Talk Outline Patent Prosecution U.S. Brazil Canada Europe Mexico

3. juneaupartners.com Todd Juneau 2005 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 “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 against 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. juneaupartners.com Todd Juneau 2005 What is claimable in the U.S.? Compounds Improvements Compositions Processes of preparation Methods of Use in Treatment Diagnostic Methods and Kits Devices

5. juneaupartners.com Todd Juneau 2005 Compound Claims A compound of the formula:

6. juneaupartners.com Todd Juneau 2005 Improvement Claims A compound of the formula:

7. juneaupartners.com Todd Juneau 2005 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

8. juneaupartners.com Todd Juneau 2005 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”

9. juneaupartners.com Todd Juneau 2005 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

10. juneaupartners.com Todd Juneau 2005 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

11. juneaupartners.com Todd Juneau 2005 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. US 6,054,320

12. juneaupartners.com Todd Juneau 2005 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

13. juneaupartners.com Todd Juneau 2005 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)

14. juneaupartners.com Todd Juneau 2005 What is claimable in Europe? Patentable: Compounds Compositions Devices Processes of preparing Use in the preparation of a medicament Kits Not Patentable: Diagnostic and Therapeutic Methods Business methods, software Genes or partial sequences w/o specific & credible technical effect

15. juneaupartners.com Todd Juneau 2005 “Method Claims” outside the U.S.: Use Claims Classic Use Claims Extended Use claims, also known as “reach through” claims

16. juneaupartners.com Todd Juneau 2005 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

17. juneaupartners.com Todd Juneau 2005 Classic Use Claim Format Compound X – normally defined by a structure Treatment – normally not further specified Disease Y – normally a well-defined medicinal condition

18. juneaupartners.com Todd Juneau 2005 Example: Classic Use Claim (Ciclopirox Genus) The use of 1-hydroxy-2-pyridones of the formula:

19. juneaupartners.com Todd Juneau 2005 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

20. juneaupartners.com Todd Juneau 2005 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)

21. juneaupartners.com Todd Juneau 2005 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)

22. juneaupartners.com Todd Juneau 2005 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

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29. juneaupartners.com Todd Juneau 2005 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)

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38. juneaupartners.com Todd Juneau 2005 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

39. juneaupartners.com Todd Juneau 2005 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

40. juneaupartners.com Todd Juneau 2005 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

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