The New USPTO Rules and their The New USPTO Rules and their Impact on Biomedical Patent Impact on Biomedical Patent ProsecutionProsecution

Mojdeh Bahar, J.D.,M.A.Mojdeh Bahar, J.D.,M.A.Technology Licensing SpecialistTechnology Licensing SpecialistOffice of Technology TransferOffice of Technology TransferNational Institutes of HealthNational Institutes of HealthU.S. Department of Health & Human ServicesU.S. Department of Health & Human Services

FLC MAR Annual MeetingOctober 2007

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Road MapRoad Map

NIH’s MissionNIH’s Mission NIH’s Patent Prosecution PolicyNIH’s Patent Prosecution Policy NIH’s Typical Patent Prosecution StrategyNIH’s Typical Patent Prosecution Strategy Very Brief Description of the New Rules Very Brief Description of the New Rules Possible ImpactsPossible Impacts Change in Prosecution StrategyChange in Prosecution Strategy

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NIH’s MissionNIH’s Mission

To uncover new knowledge To uncover new knowledge that will lead to improved that will lead to improved

public healthpublic health

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NIH’s Patent Prosecution NIH’s Patent Prosecution PolicyPolicySeek patent protection if:Seek patent protection if: facilitates availability of the technology for preventive, diagnostic, facilitates availability of the technology for preventive, diagnostic,

therapeutic, or other commercial usetherapeutic, or other commercial use further research and development is necessary to realize the further research and development is necessary to realize the

technology’s primary usetechnology’s primary use commercial or public health value of the technology warrants the commercial or public health value of the technology warrants the

expenditure of fundsexpenditure of funds research has a practical utility or a reasonable expectation of future research has a practical utility or a reasonable expectation of future

practical utilitypractical utility

Do Do notnot seek patent protection if: seek patent protection if: Commercialization and technology transfer can best be accomplished Commercialization and technology transfer can best be accomplished

without patent protectionwithout patent protection

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NIH’s Typical Patent NIH’s Typical Patent Prosecution StrategyProsecution Strategy Provisional Patent ApplicationProvisional Patent Application Initial Stage Foreign Filing (PCT Initial Stage Foreign Filing (PCT

Application)Application) National Stage Foreign FilingNational Stage Foreign Filing

– Includes U.S. Patent Application (non-Includes U.S. Patent Application (non-provisional)provisional)

Country validation or registrationCountry validation or registration– EPO ValidationEPO Validation

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NIH Typical Patent NIH Typical Patent Prosecution TimelineProsecution Timeline

1.1. Provisional Patent Application FiledProvisional Patent Application Filed2.2. 12 Months Later: Initial Stage Foreign 12 Months Later: Initial Stage Foreign

Filing (PCT)Filing (PCT)3.3. 18 months after PCT filing (30 months 18 months after PCT filing (30 months

after the filing of the provisional after the filing of the provisional application): National Stage Foreign and application): National Stage Foreign and US National Patent ApplicationUS National Patent Application

4.4. EPO Validation and RegistrationEPO Validation and Registration

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Types of ApplicationsTypes of Applications

CONCON– Continuation ApplicationContinuation Application

RCERCE– Request for Continued ExaminationRequest for Continued Examination

CIPCIP– Continuation in PartContinuation in Part

DIVDIVDivisional ApplicationDivisional Application

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A Typical A Typical Pharmaceutical/Biotech Pharmaceutical/Biotech ApplicationApplication Has more than 25 claimsHas more than 25 claims Will be subject to a restriction requirement Will be subject to a restriction requirement

necessitating the filing of one or more divisional necessitating the filing of one or more divisional applicationsapplications

Will have more than one CON, CIP or RCE for Will have more than one CON, CIP or RCE for each original or divisional application.each original or divisional application.

Has Markush claims (alternative embodiments of Has Markush claims (alternative embodiments of the invention)the invention)

They are generally filed at an earlier stage when They are generally filed at an earlier stage when compared to other arts, e.g., mechanical arts.compared to other arts, e.g., mechanical arts.

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Very Brief Description of the Very Brief Description of the New RulesNew Rules Applicants are limited to two continuations and Applicants are limited to two continuations and

one RCE as a matter of right.one RCE as a matter of right. Each application will be limited to five (5) Each application will be limited to five (5)

independent claims and twenty five (25) total independent claims and twenty five (25) total claims.claims.

Applicants need to disclose cases in which there Applicants need to disclose cases in which there are the same assignee, one common inventor, are the same assignee, one common inventor, and the applications have been filed within two and the applications have been filed within two months of one another. (except if present months of one another. (except if present application was filed before November 1, 2007).application was filed before November 1, 2007).

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Possible ImpactsPossible Impacts

The ability to use continuation practice to obtain the proper scope of The ability to use continuation practice to obtain the proper scope of protection necessary for commercial embodiments of early stage inventions protection necessary for commercial embodiments of early stage inventions will be limited.will be limited.a) analysis of applications and an understanding of the underlying a) analysis of applications and an understanding of the underlying technology will be more involvedtechnology will be more involvedb) decision points will be shiftedb) decision points will be shifted

Claim construction has become more important.Claim construction has become more important.

Thorough knowledge of restriction practice is now paramount.Thorough knowledge of restriction practice is now paramount. Compliance with these rules for entities with large patent portfolios is a Compliance with these rules for entities with large patent portfolios is a

daunting task.daunting task. The Markush Rules (proposed, but not yet finalized) further complicate The Markush Rules (proposed, but not yet finalized) further complicate

matters.matters. There are many unknowns in these rules: required showing for filing There are many unknowns in these rules: required showing for filing

additional continuations, impact on the overall cost of prosecution, additional continuations, impact on the overall cost of prosecution, applicant submissions and prosecution estoppel, etc.applicant submissions and prosecution estoppel, etc.

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Changes in Prosecution Changes in Prosecution StrategyStrategy More interactions with the inventors at the More interactions with the inventors at the

beginning of the patenting process.beginning of the patenting process. Exploring all possible directions that the Exploring all possible directions that the

research may take, in which the inventor is research may take, in which the inventor is interested.interested.

Conducting marketing campaigns in the first Conducting marketing campaigns in the first thirty months of an invention’s life.thirty months of an invention’s life.

Having the prosecution strategy more closely Having the prosecution strategy more closely follow the scientific development. follow the scientific development.

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OTT/NIH ContactsOTT/NIH Contacts

NIHNIH http://www.nih.govhttp://www.nih.gov

OTTOTT http://www.ott.nih.govhttp://www.ott.nih.gov

Science. Ideas. Breakthroughs.

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Any Questions?Any Questions?

Thank you for your kind attentionThank you for your kind attention