1. The New USPTO Rules and their Impact on Biomedical Patent Prosecution Mojdeh Bahar, J.D.,M.A. Technology Licensing Specialist Office of Technology Transfer National Institutes of Health U.S. Department of Health & Human Services FLC MAR Annual Meeting October 2007

2. 2 Road Map NIH’s Mission NIH’s Mission NIH’s Patent Prosecution Policy NIH’s Patent Prosecution Policy NIH’s Typical Patent Prosecution Strategy NIH’s Typical Patent Prosecution Strategy Very Brief Description of the New Rules Very Brief Description of the New Rules Possible Impacts Possible Impacts Change in Prosecution Strategy Change in Prosecution Strategy

3. 3 NIH’s Mission To uncover new knowledge that will lead to improved public health

4. 4 NIH’s Patent Prosecution Policy Seek patent protection if: =facilitates availability of the technology for preventive, diagnostic, therapeutic, or other commercial use =further research and development is necessary to realize the technology’s primary use =commercial or public health value of the technology warrants the expenditure of funds =research has a practical utility or a reasonable expectation of future practical utility Do not seek patent protection if: =Commercialization and technology transfer can best be accomplished without patent protection

5. 5 NIH’s Typical Patent Prosecution Strategy Provisional Patent Application Provisional Patent Application Initial Stage Foreign Filing (PCT Application) Initial Stage Foreign Filing (PCT Application) National Stage Foreign Filing National Stage Foreign Filing –Includes U.S. Patent Application (non- provisional) Country validation or registration Country validation or registration –EPO Validation

6. 6 NIH Typical Patent Prosecution Timeline 1. Provisional Patent Application Filed 2. 12 Months Later: Initial Stage Foreign Filing (PCT) 3. 18 months after PCT filing (30 months after the filing of the provisional application): National Stage Foreign and US National Patent Application 4. EPO Validation and Registration

7. 7 Types of Applications CON CON –Continuation Application RCE RCE –Request for Continued Examination CIP CIP –Continuation in Part DIV DIV Divisional Application

8. 8 A Typical Pharmaceutical/Biotech Application Has more than 25 claims Has more than 25 claims Will be subject to a restriction requirement necessitating the filing of one or more divisional applications Will be subject to a restriction requirement necessitating the filing of one or more divisional applications Will have more than one CON, CIP or RCE for each original or divisional application. Will have more than one CON, CIP or RCE for each original or divisional application. Has Markush claims (alternative embodiments of the invention) Has Markush claims (alternative embodiments of the invention) They are generally filed at an earlier stage when compared to other arts, e.g., mechanical arts. They are generally filed at an earlier stage when compared to other arts, e.g., mechanical arts.

9. 9 Very Brief Description of the New Rules Applicants are limited to two continuations and one RCE as a matter of right. Applicants are limited to two continuations and one RCE as a matter of right. Each application will be limited to five (5) independent claims and twenty five (25) total claims. Each application will be limited to five (5) independent claims and twenty five (25) total claims. Applicants need to disclose cases in which there are the same assignee, one common inventor, and the applications have been filed within two months of one another. (except if present application was filed before November 1, 2007). Applicants need to disclose cases in which there are the same assignee, one common inventor, and the applications have been filed within two months of one another. (except if present application was filed before November 1, 2007).

10. 10 Possible Impacts The ability to use continuation practice to obtain the proper scope of protection necessary for commercial embodiments of early stage inventions will be limited. The ability to use continuation practice to obtain the proper scope of protection necessary for commercial embodiments of early stage inventions will be limited. a) analysis of applications and an understanding of the underlying technology will be more involved b) 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 daunting task. Compliance with these rules for entities with large patent portfolios is a daunting task. The Markush Rules (proposed, but not yet finalized) further complicate matters. The Markush Rules (proposed, but not yet finalized) further complicate matters. There are many unknowns in these rules: required showing for filing additional continuations, impact on the overall cost of prosecution, applicant submissions and prosecution estoppel, etc. There are many unknowns in these rules: required showing for filing additional continuations, impact on the overall cost of prosecution, applicant submissions and prosecution estoppel, etc.

11. 11 Changes in Prosecution Strategy More interactions with the inventors at the beginning of the patenting process. More interactions with the inventors at the beginning of the patenting process. Exploring all possible directions that the research may take, in which the inventor is interested. Exploring all possible directions that the research may take, in which the inventor is interested. Conducting marketing campaigns in the first thirty months of an invention’s life. Conducting marketing campaigns in the first thirty months of an invention’s life. Having the prosecution strategy more closely follow the scientific development. Having the prosecution strategy more closely follow the scientific development.

12. 12 OTT/NIH Contacts NIHhttp://www.nih.gov http://www.nih.gov OTThttp://www.ott.nih.gov http://www.ott.nih.gov Science. Ideas. Breakthroughs.

13. 13 Any Questions? Thank you for your kind attention