Transcript
Comparative International Patent Prosecution in the
Pharmaceutical Arts
By Todd L. Juneau
Talk Outline
Patent Prosecution U.S. Brazil Canada Europe Mexico
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
✴ “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
What is claimable in the U.S.?
CompoundsImprovementsCompositionsProcesses of
preparation
Methods of Use in Treatment
Diagnostic Methods and Kits
Devices
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)
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)
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
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”
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
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
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
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
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)
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
“Method Claims” outside the U.S.: Use Claims
Classic Use ClaimsExtended Use claims, also known as
“reach through” claims
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
Classic Use Claim Format
Compound X – normally defined by a structure
Treatment – normally not further specified
Disease Y – normally a well-defined medicinal condition
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)
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
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)
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)
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
Patent Prosecution - PCT
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
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
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
PCT Regional PhaseEPO European Patent OfficeARIPO African Regional IP OfficeEAPO Eurasian Patent OfficeOAPI PO Oceania Asia Pacific Patent Office
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
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)
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
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
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.
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
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
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
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
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
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
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
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
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
Thank You
todd@juneaupartners.com
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