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Comparative International Patent Prosecution in the Pharmaceutical Arts By Todd L. Juneau

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Page 1: Juneau comparative int_l_patent-pharma

Comparative International Patent Prosecution in the

Pharmaceutical Arts

By Todd L. Juneau

Page 2: Juneau comparative int_l_patent-pharma

Talk Outline

Patent Prosecution U.S. Brazil Canada Europe Mexico

Page 3: Juneau comparative int_l_patent-pharma

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

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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

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What is claimable in the U.S.?

CompoundsImprovementsCompositionsProcesses of

preparation

Methods of Use in Treatment

Diagnostic Methods and Kits

Devices

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Compound Claims A compound of the formula:

in which R1 is alkyl containing 7 to 11 carbon atoms and R3 is lower alkyl

1-hydroxy-4-methyl-6-cyclohexyl-2-pyridone

US 3,883,545 (Hoechst-Ciclopirox)

Page 7: Juneau comparative int_l_patent-pharma

Improvement Claims A compound of the formula:

and sodium and potassium salts thereof in which R1 is alkyl containing 7 to 11 carbon atoms and R3 is lower alkyl

1-hydroxy-4-methyl-6-cyclohexyl-2-pyridone and sodium and potassium salts thereof

US 3,883,545 (Hoechst-Ciclopirox)

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Composition ClaimsA 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

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Biotechnology InventionsAntibodies 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”

Page 10: Juneau comparative int_l_patent-pharma

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

Page 11: Juneau comparative int_l_patent-pharma

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

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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

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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

Page 14: Juneau comparative int_l_patent-pharma

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)

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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

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“Method Claims” outside the U.S.: Use Claims

Classic Use ClaimsExtended Use claims, also known as

“reach through” claims

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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

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Classic Use Claim Format

Compound X – normally defined by a structure

Treatment – normally not further specified

Disease Y – normally a well-defined medicinal condition

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Example: Classic Use Claim (Ciclopirox Genus)

The use of 1-hydroxy-2-pyridones of the formula:

for the production of a pharmaceutical for the treatment of skin infections caused by antibiotic-resistant bacteria.

EP 0 928 193 B1 (Aventis)

Page 20: Juneau comparative int_l_patent-pharma

Extended Use ClaimsObjectives:

Obtain early protection Obtain broader protection Obtain longer protection

Effects: Threaten competition Increase value of own portfolio Keep attorneys and patent offices busy

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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)

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Extended Use ClaimsExample 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)

Page 23: Juneau comparative int_l_patent-pharma

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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Patent Prosecution - PCT

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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

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Most frequent PCT users 1. Koninklijke Philips Electronics

N.V. NL 1,922 2. Siemens Aktiengesellschaft

DE 1,268 3. Robert Bosch GmbH DE 1,201 4. Telefonaktiebolaget L M

Ericsson SE 870 5. Matsushita Electric Industrial

Co., Ltd. JP 838 6. Sony Corporation JP 676 7. Nokia Corporation FI 651 8. 3M Innovative Properties

Company US 578 9. Motorola, Inc. US 559 10. Bayer Aktiengesellschaft DE

549

11. The Procter & Gamble Company US 536

12. BASF Aktiengesellschaft DE 473 13. Infineon Technologies AG DE

454 14. Honeywell International Inc. US

422 15. Mitsubishi Denki Kabushiki

Kaisha JP 421 16. Intel Corporation US 353 17. International Business Machines

Corporation US 345 18. Qualcomm Incorporated US 320 19. The Regents of the University of

California US 309 20. E.I. Du Pont de Nemours and

Company US 279

Page 27: Juneau comparative int_l_patent-pharma

PCT BasicsChapter I – thru 20th month, Chapter II –

thru 30/31st monthDemand previously required at 19th

month is no longer required for most countries

Unity of Invention is the standard – special technical feature

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PCT Regional PhaseEPO European Patent OfficeARIPO African Regional IP OfficeEAPO Eurasian Patent OfficeOAPI PO Oceania Asia Pacific Patent Office

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Patent Prosecution –EPO (year 2000)2600 examiners, 100 Board of Appeal

members142,000 applications in 2000; 53,000

searches; 45,000 examinations; 2,300 oppositions; and 1,200 appeals

www.european-patent-office.org

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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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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

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Perfecting an EP grant into the contracting statesTranslation 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

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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.

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Patent Prosecution - JapanFirst to file, absolute noveltyPublication at 18 monthsExamination must be requested within 3

years after filing (Y84,000 plus Y2000 per claim)

Patent term 20 yearsUtility Model term 6 yearsOpposition within 6 months after grant

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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

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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

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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

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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

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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

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Working RequirementsA 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

Page 41: Juneau comparative int_l_patent-pharma

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

Page 42: Juneau comparative int_l_patent-pharma

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

Page 43: Juneau comparative int_l_patent-pharma

Thank You

[email protected]