December 4, 2012 | 9:15-10:15 a.m. PT | San Francisco
MBHB partner Paul Tully is a featured presenter at a two-day conference entitled, “Paragraph IV Disputes” set to take place Dec. 4-5, 2012 in San Francisco. Sponsored by American Conference Institute, the event is described as a “must-attend event for litigators from brand name and generic companies to share insights into increasingly high-stakes and complicated Hatch-Waxman litigation.” Mr. Tully’s presentation is as follows:
Analyzing Invalidity & Non-Infringement Assertions In Light of the ANDA Applicant’s Pre-Litigation Obligations and Assertions
- Reexamining the initial obligations
- NDA applicant under Paragraph IV in light of the Supreme Court’s ruling in Microsoft v. i4i
- when is there “clear and convincing” evidence that patent is invalid and therefore not infringed
- assessing the consequences of not meeting this burden of proof
- Weighing your options in light of the burden: should you file a Paragraph IV certification or choose another ANDA route?
- Choosing which Orange Book patents to challenge
- compounds; formulations
- The Research Foundation of State University of New York v. Mylan Pharmaceuticals, Inc.
- AstraZeneca AB et al v. Hanmi USA, Inc.
- process; methods of use
- extended release
- In re Cyclobenzaprine
- AstraZeneca Pharmaceuticals LP v. Torrent Pharmaceuticals Ltd.
- Sunovian Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc.
- factoring “forfeiture” into your Orange Book strategy
- skinny labeling and carve-out considerations via Caraco
- obviousness assessments
- How Patent Reform may impact Orange Book patent challenges
- elimination of Best Mode defense
- prior user rights
- exploring new Post Grant Review and Inter Partes Review as another mechanism for invalidating an Orange Book patent
- Understanding the role of non-Orange Book patents in your PIV ANDA strategies
- innovator / non-innovator
- Procuring legal opinions on invalidity and non-infringement-
- performing cost effective due diligence and freedom to operate analysis before filing an ANDA
- assessing when opinions are needed
- opinion of in-house v. outside counsel
- questions of privilege
- Rule 26 (b) (4) revisions regarding expert opinions
- Filing the ANDA
- fulfilling requirements for FDA approval:
- pharmaceutically equivalent; bioequivalent
- identifying triggers which may necessitate new bioequivalence studies
- Contents of the Paragraph IV certification
McDonnell Boehnen Hulbert & Bergoff LLP (Chicago, IL)
Sandoz Inc. (Princeton, NJ)
Morrison Foerster (San Diego, CA)
Sponsored by: American Conference Institute
Register online at at http://americanconference.com/paragraphIVSNF/overview.