Patent Protection & Enforcement Masterclass - Wednesday, May 28, 2008

8:15 Continental Breakfast & Conference Registration

9:00 Chair’s Opening Remarks

9:15 PANEL: Effectively Maintaining Patent Protection And Enforcement In Light Of Upcoming Regulations
  Moderator:

Dr. Matthew Langer
Partner, Life Sciences, IP Counseling & Patents, Intellectual Property
Wilson Sonsini Goodrich & Rosati


  Heidi Berven
Senior Director of Intellectual Property
Concert Pharmaceuticals
Len S Smith
Senior Intellectual Property Counsel
Novo Nordisk
Esther Kepplinger
Director, Patent Operations
Wilson Sonsini Goodrich & Rosati

This keynote panel kicks off the pre-conference Masterclass by focusing on changes to rules and standards since the beginning of 2008. The expert panelists will focus on how to strategically take the path that provides the best avenue to maintain protection of portfolios and optimize patent life cycles.

10:00 Ensuring Optimal Lifecycle Extension By Assessing The Best Time To File
 
Thomas Bordner
Director Intellectual Property
Sanofi Pasteur

Thomas’ responsibilities include directing domestic and international patent prosecution and strategic portfolio development in a variety of vaccinal technologies including glycoconjugates. Thomas also counsels sanofi pasteur in the areas of copyrights and trade secret law. Prior to joining sanofi pasteur Thomas represented a range of biotech clients in patent and other matters while in private practice.

Drawing on this experience Tom sheds light on:

  • Understanding the needs of the business and aligning this with your filing strategies
  • Discussing what criteria to use when judging when to file applications
  • Effective strategies to determine which applications to file continuations for and how best to do this under the new regime
  • Should you file or not? Assessing trade secrets and other alternative strategies

10:45 Morning Refreshment And Networking Break

11:15 Cushioning the Dramatic Impact Of Changes To IDS Submission Rules
 
Marina Larson
Larson & Associates LLC
 

Since 1985 Marina Larson has been practicing all aspects of intellectual property law including patent prosecution and litigation on a wide variety of technical subjects. This has included the writing of numerous patent applications for inventions relating to biotechnology, pharmaceuticals, and organic and inorganic chemistry and chemical engineering.

OMB has now approved the PTO’s proposed changes to the IDS requirements. The final rules have not been published, but what is clear is that IDS submissions will need to focus on the most relevant references, and may still require additional disclosure depending on the number and size of the references.

Typically IDS are submitted after you file, but you are under the duty of disclosure throughout the life of the patent, the life of the prosecution and it applies as much to the attorneys as the inventors and those involved in the prosecution.

  • How will this change impact claims going forward and retroactively?
  • What are the implications for prosecution strategy?
  • While this is a prosecution issue, how does this impact potential litigation down the line?

12:00 Overcoming The Challenges Posed By Proposed Changes To Markush (Alternatives) Practice
 
  Heidi Berven
Senior Director of Intellectual Property
Concert Pharmaceuticals

Heidi has served as patent counsel for both large and small pharmaceutical companies, including Pfizer, Astra Zeneca, Praecis, and Epix Pharmaceuticals. Her specialties include small molecule patent preparation and prosecution, patent filing strategy, portfolio management, and client counseling.

The USPTO is proposing to revise the rules of practice pertaining to using alternative language to claim one or more species. However, this has been a fundamental way to protect products in a chemical genus. Drawing on her experience, Heidi will explore:

  • How will limiting claims to a single invention impact claiming overall?
  • Adapting claiming methodologies to overcome this
  • Submitting claims with alternatives in the new format

12:45 Networking Luncheon For All Conference Attendees

1:45 Prosecution Strategies Aimed At Avoiding A Charge Of Inequitable Conduct
 
  John Todaro
Assistant Counsel, Merck Patent Department
Merck

If you are accused of obtaining your patent through inequitable conduct and the courts agree, regardless of which part of your patent that would have been affected, your entire patent becomes unenforceable. John highlights how to prosecute patent applications to ensure that you don’t open up your patent to the threat of an IC challenge.

  • Analysis of key cases dealing with inequitable conduct including:
    • McKesson Information Solutions, Inc. v. Bridge Medical, Inc. 487 F.3d 897 (Fed. Cir. 2007).
    • Armament Systems and Procedures, Inc. v. IQ Hong Kong Ltd., Fed. Cir. App. No. 2008-1104, (E.D. Wis. 2007)(Griesbach, J.).
    • Novo Nordisk v. Bio-Technology General Corp. 424 F.3d 1347 (Fed. Cir. 2005)
  • Developing key practice steps when drafting and prosecuting applications to avoid inequitable conduct

2:30 An Indepth Analysis Of Patent Examiner Guidelines On Obviousness
 
Len S Smith
Senior Intellectual Property Counsel
Novo Nordisk

At Novo Nordisk, Len’s practice primarily involves biotechnology-related and pharmaceutical-related patent matters as well as management of US trademark and copyright issues. Prior to joining Novo Nordisk in August 2003, Len was an associate with the law firms of Leydig, Voit & Mayer (Chicago, IL and Washington, DC) and Synnestvedt, Lechner & Woodbridge (Philadelphia, PA and Princeton, NJ).

Examination guidelines for obviousness in view of the Supreme Court decision of KSR International v. Teleflex were released last year. This ruling will have similar impacts on prosecution as the dynamics of what you argue will change dramatically as there is no longer a clear TSM test. Len will detail how to adapt your prosecution strategies and the impact on what gets filed, what gets argued and what will hold up in court.

  • Shedding light of KSR on conditions for patentability and nonobvious subject matter
  • Detailed analysis of post-KSR case law at BPAI, Federal circuit and Federal courts
  • Resulting strategies for prosecution

3:15 Afternoon Refreshment And Networking Break

3:45 Interactive Roundtable Sessions
 

As you know much of the real value of attending a conference comes from the informal discussion with your industry peers. To ensure that you have an opportunity to leverage on the combined knowledge of your fellows, these roundtables are designed to be a continuation of the day’s content. This is an informal opportunity to brainstorm about what you’ve learned and what you need to know. Each 20 minute session will be focused on a specific theme within intellectual property.

Sample table themes include (but are not limited to):

  • Claim Drafting & Prosecution
  • Paragraph IV disputes
  • Regulatory Updates
Table 1: Topic "Expert Witnesses and Pharmaceutical Patent Litigation and Prosecution: A Scientific Viewpoint"
Erin DeCarlo
Registered Patent Attorney
O'Brien Jones
Dr. David Bugay
Managing Director
Aptuit Consulting

For more information on hosting a roundtable, call Brooke Kenna at 646-200-7546 or email at brooke.kenna@wbresearch.com.

*Check www.pharmabiotech-ip.com for updates on Moderators and table themes. 5:00 Welcome Cocktail


5:00 Welcome Cocktail Reception
  Kick off the PharmaBiotech IP Summit in style by enjoying informal networking and cocktails with your peers. This is an excellent opportunity to continue the keen debate of the day in a relaxed environment. There’s no better time to get to know your industry peers. Don’t forget to bring your business cards!

 



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