Biotech Patents

Day 1: Wednesday, November 30, 2011

INTERACTIVE WORKING GROUP SESSION

8:30am – 11:30am (Registration & Continental Breakfast at 7:45am)

A Integrating Changes at the PTO into Biotech Patent Practices

Daniel Sullivan, Ph.D.
Supervisory Patent Examiner
US Patent & Trademark Office (Alexandria, VA)

Gary Nickol, Ph.D.
Supervisory Patent Examiner
US Patent & Trademark Office (Alexandria, VA)

Esther Kepplinger
Chief Patent Counselor
Wilson, Sonsini, Goodrich & Rosati, PC (Washington, DC)

Michele Cimbala, Ph.D.
Director
Sterne Kessler Goldstein & Fox, P.L.L.C. (Washington, DC)

The already complex task of patent prosecution for biotech innovations is now measurably more difficult thanks to a flood of new court decisions that have been issued in recent years. What’s more, this process will shortly be complicated even further thanks to the impending issuance of FDA regulations for biosimilar approval and the imminent passage of patent reform legislation. The resulting, broad changes at the PTO will create a perfect storm of unpredictability, uncertainty, and complexity. ACI’s faculty of present and former PTO examiners will walk you through the most recent changes in PTO guidelines and consider the implications that various reforms will have on examination. The upcoming changes will be among the most sweeping the PTO has seen in half a century. You will not get this sort of one-on-one experience with PTO experts anywhere else. Stay on the cutting edge of patent prosecution and sign up today.

• The maturation of obviousness post-KSR in examination
  • what are the newest standards in PTO examination regarding obviousness?
  • what language should be employed to avoid obviousness rejections at the PTO?
  • how should a response to an obviousness rejection be crafted?
• Notes on the Patent Prosecution Highway (PPH)
  • how often is the PPH employed?
  • detailing the advantages and disadvantages of the PPH
• Outlining the PTO’s use of restrictions in examination
  • describing the PTO’s reasoning in restrictions in biotech patents
  • how does the unity of invention rule interact with the PTO’s restriction practice?
  • methods for getting around the PTO’s propensity to restrict
• A review of recent PTO proposed and fi nal rulemakings and other prosecution initiatives

Friday, December 2, 2011

POST-CONFERENCE MASTER CLASS

9:00am – 12:00pm (Registration & Continental Breakfast at 8:30am)

B Successful and Practical Strategies for Patenting Antibodies

Deirdre E. Sanders
Principal
Hamilton Brook Smith & Reynolds, P.C. (Concord, MA)

Matthew Beaudet, Ph.D.
Patent Attorney
Novartis Institutes for BioMedical Research, Inc. (Cambridge, MA)

Antibody innovations are central to the biotechnology industry and in light of uncertainty in patenting genes, protecting this intellectual property is more important than ever. Nevertheless, the difficulties of antibody patenting have been drastically amplified in recent years. Between the narrowing of allowable claims by KSR and its progeny, the “obvious to try” strictures of In re Kubin, and now the schism between courts and the USPTO present in the Centocor opinion, the rules for obtaining an antibody patent are as convoluted as ever. ACI’s faculty of industry leaders will present the process of obtaining an antibody patent, share the latest best practices with you, and give you the chance to brainstorm with peers. Do not miss this opportunity to keep your clients on the cutting edge.

• Drafting antibody claims after Centocor
  • investigating the growing conflict between USPTO guidelines and court decisions and their effects on antibody claims
• dissecting the CAFC’s distinction between its holding in Centocor and Noelle v. Lederman
• handling enablement and written description issues now
• Addressing the evolving obviousness standard and its effect on antibody patenting
• Draft guidelines for monoclonal antibodies when fi ling in Europe
• Analyzing recent developments in antibody technology
• Tackling claim construction issues with antibody patents
• Understanding the types of antibody claims being issued
• Determining how antibody claims are being construed

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