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SAFE HARBOR/EXPERIMENTAL USE, INHERENCY, OBVIOUSNESS
AND UTILITY

Resolving Uncertainty In Biotechnology Patent Law

Sponsored with the Boston Patent Law Association and the
Intellectual Property Law Concentration

Please Note: This course has already been held.

Date: Friday, November 18, 2005

Location: Suffolk University Law School, 120 Tremont St., Boston, MA
Time: 09:00 AM - 04:00 PM

Faculty
Schedule/Agenda
Registration Information

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Biotechnology patent law may be entering an era of uncertainty. Legal practitioners, scientists, scholars, licensing officers, and industry leaders alike are striving to define standards, clarify boundaries, and establish practices in the wake of Merck v. Integra, and other landmark decisions.

Resolving Uncertainty in Biotechnology Patent Law will focus on the issues of the statutory safe harbor exemption, common law experimental use, utility, written description, obviousness and anticipation. Attendees will apply their working knowledge of patent law to recent Federal Circuit and U.S. Supreme Court decisions that are defining the direction of biotechnology patent law.

Distinguished panels will lead discussions, which address the statutory safe harbor exemption and common law experiment use exception, Merck’s new standard of “reasonably related,” implications with respect to offshore alternatives. Other topics will include patent prosecution in view of recent Federal Circuit decisions regarding written description, inherency, and obviousness standards of patentability.

You will benefit from a session featuring relevant Federal Circuit and Supreme Court decisions and will gain valuable insight as leading United States Patent and Trademark Office (USPTO) officials offer an inside peek at trends and initiatives of the USPTO.

  F A C U L T Y

  N. Scott Pierce, Esq., Principal
  Hamilton, Brook, Smith & Reynolds, P.C., Concord, MA
   
  Kenneth J. Burchfiel
  Patent Attorney
Sughrue Mion, PLLC, Washington, D.C.
   
  Kristina L. Burgard
  Chief Intellectual Property Counsel
Sepracor Inc., Marlborough, MA
   
  Denise W. DeFranco
  Patent Attorney
Foley Hoag, LLP, Boston, MA
   
  John F. Duffy
  Professor of Law
The George Washington University Law School
Washington, D.C.
   
  Michael R. Dzwonczyk
  Patent Attorney
Sughrue Mion, PLLC, Washington, D.C.
   
  Janice Klunder
  Patent Counsel
Millennium Pharmaceuticals, Cambridge, MA
   
  Stephen Walsh
  Associate Solicitor for the US Patent and Trademark Office, Alexandria, VA
   
  John M. Whealan
  Deputy General Counsel for Intellectual Property and Solicitor for the US Patent and Trademark Office, Alexandria, VA
   
  Mary K. Murray, Esq.
  Patent Attorney
Hamilton, Brook, Smith & Reynolds, P.C., Concord, MA
   
  S C H E D U L E / A G E N D A

8:30 REGISTRATION AND CONTINENTAL BREAKFAST

9:00 WELCOME AND INTRODUCTIONS

9:10 DESIGNING AROUND, EXPERIMENTAL USE, AND PRACTICAL CONSIDERATIONS AFTER MERCK v. INTEGRA
  • The Merck standard of “reasonably related”
  • Overview/designing around in the pharmaceutical and biotechnology industries
  • What level of experimental use is permitted after Merck?
  • Does experimental use need to be judicially rehabilitated after Embrex, Madey and Merck?
  • Re-evaluating unlicensed technology after Merck
  • How is experimental use different than de minimus infringement, accidental (unintended) infringement, and unavoidable (inherent) infringement?
  • Implications with respect to offshore alternatives
Panel: Kenneth J. Burchfiel, Kristina L. Burgard, Denise W. DeFranco and
John M. Whealan



10:45 BREAK

11:00 FEDERAL CIRCUIT AND SUPREME COURT UPDATE

12:00 LUNCHEON WITH GUEST SPEAKER: ATTORNEY KENNETH J. BURCHFIEL
Sponsored by Hamilton, Brook, Smith & Reynolds, P.C.

For more than 25 years Kenneth J. Burchfiel has protected and enforced intellectual property rights through litigation before the federal courts, interferences, and appeals. Mr. Burchfiel has expertise in the chemical arts, with particular focus on biotechnology and general organic chemistry. Thousands have benefited from his publishing and teachings in the area of patent law and procedure. He is nationally recognized in this area as he also testifies as an expert witness on patent law and USPTO practice and procedure. Mr. Burchfiel was the first American patent lawyer admitted to practice in Japan under the reciprocal foreign law practice statute. He is a Partner with Sughrue Mion PLLC.



1:30 DEFINING INVENTION: PATENT PROSECUTION IN VIEW OF RECENT DECISIONS AFFECTING WRITTEN DESCRIPTION, INHERENCY, OBVIOUSNESS AND UTILITY CONSIDERATIONS
  • Written description and enablement
  • The limits of statutory subject matter
  • Considerations for patent prosecution
Panel: John F. Duffy, Michael R. Dzwonczyk, Janice Klunder and Stephen Walsh



3:00 BREAK

3:15 AN INSIDE PEEK AT THE UNITED STATES PATENT AND TRADEMARK OFFICE
Panel: John M. Whealan and Stephen Walsh



4:00 CONCLUDING REMARKS
Reception immediately following, generously sponsored by the Boston Patent Law Association



  G E N E R A L   I N F O

Date:  

Friday, November 18, 2005

Tuition:  

Tuition is $249; $199 for Suffolk alumni, attorneys admitted to the Bar after 2002 and BPLA members. The course book and continental breakfast are included in the tuition charge. A limited number of partial scholarships are available. Please submit a written request via fax 617-305-3099.



Walk-Ins:  

Space is limited. Registrations at the door are welcome, but please register in advance to reserve a seat and your written course materials or call to confirm space availability.



Refunds:  

Written requests for cancellations received via fax or email 24 hours prior to the program will be granted a refund, minus a $15 charge. If you cannot attend, you can send a substitute, otherwise you will receive the written course materials.



Location:  

Suffolk University Law School, 120 Tremont St., Boston, MA



Credit:  

Approved for CLE Credit in RI, NH, VT & ME.



Special
Needs:
 

If you have special needs addressed by the Americans with Disabilities Act, please notify us as soon as possible.




Directions to the Law School.

 

Unable to attend but are interested in the course materials?
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