Patent Reform

9:00  Opening  Remarks  and  Recap  of  Day   from the Conference Chairs

9:15    Preparing  for  Emerging  Patent  Challenges   Under  The  New  Post  Grant  Review  System

Teresa Stanek Rea Deputy 
Under Secretary of Commerce for Intellectual Property & Deputy  Director, 
United  States  Patent   and Trademark Office
(Alexandria, VA)

Scott P. McBride
Partner  
McAndrews  Held  &  Malloy  LTD.
(Chicago, IL)

Scott E. Kamholz, M.D., Ph.D.
Counsel  and  Chair  of  Patent  Reexamination and Post-GrantReview Practice  Group
Foley  Hoag  LLP 
(Boston,  MA)

•  Update  on  the  status  of  guidance  from  the  USPTO   on implementation of post grant proceedings-  What  discovery  will  be  needed?
-  How  will  petitions  be  selected  for  review  for  the  first   four  years?
-  Will  service  be  required  for  petitions  and  how  does  that  impact disclosure of claims for applications not selected for  review?-  Who  will  be  conducting  the  reviews  at  the  PTO?
•  Reviewing  the  requirements  for  the  PGR  system  set  forth   in the AIA Chapter 32
•  What  grounds  can  be  used  to  engage  in  PGR?-    What  grounds  cannot  be  used?
•  Preparing  the  necessary  documentation  for  the  PGR  in  the  short time available
-  Overcoming  the  unique  challenges  facing  the  life  sciences  industry resulting from the time constraints
•  Conducting  discovery
-  What  discovery  will  be  permitted?
-  What  discovery  can  actually  be  completed  in  the  short  time  frame?
-  What will a PGR discovery schedule look like? 
-  How  will  discovery  disputes  be  resolved,  should  they  arise?
•  The  risk  of  estoppel: How  do  the  estoppel  provisions  alter  your  analysis  of  whether  to  engage  in  the  PGR  system?-  What  can  be  considered  a  “ground  that  the  petitioner…  reasonably  could  have  raised  during  that  post-grant  review”  and  how  would  you  argue  for  or  against  this?-  Who  exactly  is  estopped  from  raising  the  claims  in litigation and how could collaboration between companies  develop  into  a  viable  PGR/litigation  strategy?
•  What  are  the  potential  ramifications  of  settlement   under  PGR?
•  How  does  the  PGR  system  positively  or  negatively  impact  smaller  and  start-up  companies?
•  Planning  your  PGR  strategy  now  to  ensure  you  are  prepared  when the system goes into effect
-  Anticipating  and  budgeting  for  the  costs  of  a  PGR
-  Identifying  what  patents  you  may  want  to  challenge  under  PGR  and  analyzing  the  benefits  and  consequences  of  using  the  PGR  route  as  opposed  to  litigation  down  the  road-  Recognizing  which  patents  may  be  vulnerable  to  a  PGR  and preparing in advance to defend important patents under this system

•  When  can  interferences  be  converted  to  PGR?•  Differentiating  the  requirements  for  European  opposition  practice  vs.  the  procedures  in  post-grant  review

10:45    Morning  Coffee  Break

11:00    The  Different  World  of  Inter  Partes  Review

John B. Pegram
Senior  Principal, 
Fish  &  Richardson
(New York, NY)

Mark D. Sweet
Partner  
Finnegan,  Henderson,  Farabow,  Garrett  &  Dunner,  LLP
(Washington,  DC)

•  Differentiating  the  requirements  of  inter  partes  review  from  post grant review
•  Reviewing  the  procedures,  conditions  and  appeal  process  for  an  IPR
•  Identifying  which  patents  are  most  susceptible  to  IPR  given  the limiting of the cancellation of the patent based only on challenges to prior art or printed publication grounds
•  Preparing  for  potential  inter  partes  review  of  patents  granted prior to November 1999
•  What  are  ramifications  of  settlement?
•  When  to  file  a  3rd  party  parallel  IPR?
•  How  to  bunt  the  IPR  process  for  crown  jewel  patents
•  How  and  when  to  use  expert  witnessess
•  Adapting  to  a  higher  threshold  of  proof  under  a  “reasonable  likelihood that the petitioner would prevail with respect to  at  least  1  of  the  claims  challenged  in  the  petition”  as opposed to the previous substantial new question of patentability standard-  Discussing  what  will  be  necessary  to  prove  the  reasonable  likelihood requirement
•  What  estoppel  provisions  are  associated  with  IPRs  and  how  are  these  different  from  the  inter  partes  reexamination  provisions?
•  What  are  the  options  for  a  second  tier  inter  partes  reexamination  review  after  a  post  grant  review?
•  How  do  pre-issuance  submissions  and  re-exam  affect   IPR  strategy?

12:00    Audience  Q&A  Open  Forum  for  Discussion   on  the  New  Procedural  Provisions  and  the   Impact  on  Life  Sciences  Companies12:30    Networking  Luncheon

1:45    Examining  the  Potential  Ramifications  of  Patent  Reform  on  Hatch  Waxman  Litigation  and  the  Brand/Generic  Wars

Timothy X. Witkowski
Executive  Director  &  Executive  Counsel,   Intellectual  Property
Boehringer  Ingelheim  Pharmaceuticals,  Inc. 
(Ridgefield,  CT)

Stephen M. Hankins
Partner,  IP  Group  Leader, 
Schiff  Hardin  LLP
(Washington,  DC)

Lisa Barons Pensabene
Partner, 
Fitzpatrick,  Cella,  Harper  &  Scinto
(New York, NY)

Jeremy C. Lowe
Partner,  Axinn,  Veltrop  &  Harkrider  LLP
(Hartford, CT)

Given  the  myriad  strategic  considerations  that  companies  need  to  take  into  account  prior  to  engaging  in  Paragraph  IV  litigation, the addition of patent reform has further complicated the already complex world of brand/generic wars. Both branded and generic companies are already analyzing the AIA to ascertain the  effect  on  Hatch-Waxman  litigation  and  debating  how  post-grant review could potentially impact the playing field for life sciences companies. Add the potential for biosimilars litigation into the mix, and the theoretical possibilities and strategic chess moves  are  mind-bending.  In  this  session,  your  expert  speakers  will use hypothetical situations to explore the implications of  patent  reform  on  PIV  and  biosimilars  litigation  as  well  as  provide guidance on what you should be doing now to prepare for the costly and convoluted litigation that is likely to come.

3:15    Afternoon  Networking  Break3:30 Specific  Considerations  for  Universities,   Non-Profit  Institutions  and  Micro-Entities
       
Ralph A. Loren
Partner, 
Edwards  Wildman  Palmer  LLP
(Boston, MA)

Kathleen A. Denis, PhD, CLP
Associate  Vice  President, 
Office  of  Technology  TransferThe Rockefeller University
(New York, NY)

Lee Heiman
2012  AUTM  Eastern  Co-Chair
Registered  Patent  Attorney
Intellectual  Property  Consulting
(Washington,  DC)

•  How  does  the  university  patenting  model  differ  overall   from  the  corporate  strategy?
-  Use  of  antedating  applications-  Volume  of  applications  filed  and  timing  of  research
-  Public  use  and  on  sale  activity
•  What  impact  will  the  switch  to  the  first-to-file  system   have  on  academic  entities  and  innovation?
-  Changes  to  analysis  and  requirements  for  funding   for  start-ups  and  research?
•  Analyzing  the  implications  for  licensing  and  collaborations  between academia and industry
-  The  exception  of  a  prior  user  right  defense  for  academics
-  What  will  happen  to  the  value  of  research  tool  patents?
•  How  will  funding  for  start-ups  and  research  change   as  a  result  of  the  new  requirements?
•  What  qualifies  as  a  micro-entity  and  how  do  micro  entities  take advantage of the new fee reduction provisions available to  them

4:30    Analyzing  the  Potential  Impact  of  the  “Miscellaneous  Provisions”  on  Life  Sciences  CompaniesRonald I EisensteinPartner,  Co-Leader,  PatentsNixon  Peabody  LLP(Boston, MA)

Nick Seay
Chief Technology Officer
Cellular  Dynamics  International,  Inc.
(Madison, WI)

•  Debating  how  the  interpretation  of  “no  patent  may  issue  on  a  claim  directed  to  or  encompassing  a  human  organism”  could impact life sciences inventions specifically-  Application  to  stem  cells?
•  The  impact  on  the  value  of  patent  opinions  given  the  “Advice  of  Counsel”  provision  -  Comparison  to  Seagate  and  the  current  standards  regarding the role of opinions in litigation as it relates  to willful infringement
•  Limitations  to  joinder  of  parties  per  the  Act  and  how  it  may  apply to infringement cases in the life sciences sector
•  What  is  the  intention  behind  the  study  on  genetic  testing  and how could the results impact gene sequencing and diagnostic  method  patents?  -  How  does  this  study  relate  to  Myriad?  
•  Understanding  the  changes  to  false  marking  and  virtual  marking and the potential impact, if any, on life sciences

5:15    Conference Concludes