Developments in Pharmaceutical and Biotech Patent Law 2010 (Groupcast Location)

Overview

Co-Sponsored by New Jersey Institute for Continuing Legal Education

Why You Should Attend

This year’s program is totally new! Pharmaceutical and biotech patent law is an important and rapidly changing practice area and the program is designed to give you the information you need to maintain your practice edge, concentrating on new developments from 2010 and placing them in the context of constantly evolving areas of the law.

Technological innovation, Federal Circuit appellate oversight, and Supreme Court decisions continue to drive significant changes in the law. Several different perspectives on many of the most pressing issues will be offered from experienced in-house and outside counsel.

Do not miss this opportunity to fully understand the impact of new appellate decisions on your pharmaceutical and biotechnology patent practice.

What You Will Learn

• Top pharmaceutical and biotech decisions from 2010
• Continued developments in the law governing the patentability of active pharmaceutical products from the Federal Circuit and District Court perspectives
• Section 112 developments regarding enablement and written description requirements and how they apply to compounds, antibodies, nucleic acids, methods of treatment and pharmaceutical compositions
• Section 101 developments on utility and patentable subject matter
• Integrating changes in the law from 2010 into prosecution strategies and practices

Who Should Attend

Attorneys, whether in-house counsel or practicing at law firms, who are responsible for pharmaceutical and biotech patent prosecution, patent litigation, and patent transactions and strategies, will benefit from attending this program.

Special Bonus to all Registrants

All attendees receive a complimentary copy of PLI's comprehensive Course Handbook. This softcover, bound volume was written to augment this program and to stand alone as a permanent reference. PLI's Course Handbooks represent the definitive thinking of the nation's finest legal minds, and are often the standard reference in the field.

PLI Group Discounts

Groups of 4-14 from the same organization, all registering at the same time, for a PLI program scheduled for presentation at the same site, are entitled to receive a group discount. For further discount information, please contact membership@pli.edu or call (800) 260-4PLI.

Cancellations

All cancellations received 3 business days prior to the program will be refunded 100%. If you do not cancel within the allotted time period, payment is due in full. You may substitute another individual to attend the program at any time.

Schedule

Morning session:  9:00 a.m. - 12:30 p.m.

9:00  Program Overview

David K. Barr, Daniel L. Reisner

9:15  Section 101:  Redefining Patentable Subject Matter and Utility and the Impact on Pharmaceutical and Biotech Patents

Section 101 of the Patent Code defines the scope of patentable subject matter, including the requirement that to be patentable, inventions must be "useful".  Recent cases cast a spotlight on the scope of patentable subject matter and the utility requirement and will have a significant impact on pharmaceutical and biotech patents.  This segment will include the following:

• Analysis of the impending Supreme Court's decision in Bilski and how it may affect the scope of patent protection
• Review of how the Federal Circuit applied its Bilski decision in Prometheus Labs v. Mayo Collaborative Services
• Consideration of how the district court decision in Association for Molecular Pathology v. USPTO holding claims to isolated DNA sequences as covering unpatentable subject matter impact similar patent claims
• Determining whether the Federal Circuit heightened the standard for satisfying the utility requirement in view of its decision in In re '318 Patent Infringement Litigation

David K. Barr

10:15  The Age of Written Description and Enablement

The Federal Circuit's en banc decision in Ariad has finally resolved the decade-long debate over the applicability of the written description requirement to originally filed claims.  The Court has also increasingly found patents invalid as a matter of law under the enablement requirement.  The time is ripe to consider the impact of these two section 112 requirements on pharmaceutical and biotech patents.

• Written Description is here to stay (Ariad)
• Enablement may have more teeth
• Application of the written description and enablement requirements to different types of claims:
  - compounds
  - methods of treatment
  - genes
  - proteins
  - antibodies

11:15  Networking Break

11:30  Navigating Follow-on Biologics Legislation

Earlier this year, the Biologics Price Competition and Innovation Act was signed into law as part of health care reform legislation (H.R. 3590), creating a pathway for FDA approval of so-called generic biologics or biosimilars. Learn the ins and outs of the Act and how it departs significantly from the Hatch-Waxman framework for generic small molecule therapeutics:

• Who will pursue the FOB pathway and under what circumstances?
• Will the lengthy market exclusivity period make patent litigation less likely?
• What does it mean to be biosimilar and how will that impact non-infringement positions?
• What issues have historically been litigated in innovator vs. innovator biologics cases and will they differ for generic biologics?

Jennifer Gordon

12:30  Lunch Break

Afternoon session:  1:45 p.m. - 5:00 p.m.

1:45  Maximizing Patent Term: Pointers and Pitfalls

Patent exclusivity is of the utmost importance to pharmaceutical and biotech products.  This topic will explore how patent terms can either be extended or shortened, thus affecting the valuation of pharmaceutical and biotech products.  You learn about:

• The "A-B-Cs" of Patent Term Adjustment
• Patent term extensions under Hatch-Waxman
• The impact of terminal disclaimers
• "Overextending" patent term-double patenting concerns

Patricia A. Carson

2:45  Networking Break

3:00  Recent Developments in the Law of Patent Remedies

The Supreme Court's MedImmune v. Genentech and Ebay decisions have spawned a new body of case law on declaratory judgment, injunctions and damages in pharmaceutical and biotech patent cases. This segment will consider these and other recent developments in the law of patent damages and preliminary injunctions, including:

• Outcomes of preliminary injunction motions in recent ANDA cases
• Recent cases apply the MedImmune standard
• post-Ebay injunctions in ANDA and biotech cases
• Federal Circuit's recent tightening of evidentiary standards in damages cases

Colleen Tracy

4:00  Recent Changes in Patent Prosecution Practice

• Changes to the USPTO count system 
  - What are the implications of changes to the USPTO count system for biotech & pharma prosecutors?  
  - How could the changes impact RCE practice?
• Changes to BPAI appeal practice
  - How will PTO's changes streamline BPAI appeal practice? 
  - How will changes impact appeals from TC 1600?
• Proposed changes to missing parts practice to allow for 12 month extension for provisional patent applications
  - Do the proposed changes really provide a 12-month extension to the 12-month provisional application period? 
  - Can the proposed changes be used to extend patent term for pharmaceutical applications?  
• In re Tanaka (BPAI)
  - Is the addition of narrower claims a valid reason for filing a reissue if applicant does not also allege that one or more of the broader patent claims is overly broad? 
  - Can reissue applicant add specific species compound claims without also alleging broader genus claims are invalid?

5:00  Adjourn

Faculty

Co-Chair(s)

Speaker(s)

Program Attorney(s)

CLE Credit

Travel Information

New Jersey Groupcast Location

New Jersey Institute for Continuing Legal Education, One Constitution Square, New Brunswick, NJ 08901-1520. 732-249-5100.