American Conference
Institute (ACI) will be holding its next Paragraph IV Disputes conference on October
3-4, 2013 in Chicago, IL. The conference
will allow attendees to:
• Devise strategies
relative to the use of new PTO proceedings such as IPR in Hatch-Waxman
litigation;
• Understand how new 271(e)(1) controversies
under Claussen and Momenta may undo Roche v. Bolar;
• Decipher the implications of the Watson case for pharmaceutical patent
settlements;
• Assess how contradictory findings in the
federal courts and PTO relative to obviousness will impact primary compound and
composition claims;
• Formulate a plan of action for Markman hearings in view of the ongoing
intra-circuit discord at the CAFC on claim construction;
• Identify new challenges to market as well as
regulatory exclusivities;
• Appreciate how FDASIA, the GAIN Act, and
Generic User Fees Act will influence FDA regulatory redress in Hatch-Waxman
matters;
• Evaluate Orange Book-listed method of treatment
patents in view of new rulings on inducement and divided infringement; and
• Anticipate damages quantifications for at
risk launches vis-à-vis Protonix.
In particular,
ACI's faculty will offer presentations on the following topics:
• Identifying patents which may be ripe for
challenges of invalidity and non infringement: Offensive and defensive
strategies for brand names and generics;
• Use of IPR and other PTO proceedings in a
Paragraph IV challenge: Strategies for brand names and generics in navigating
new proceedings in alternate and parallel forums which may change the rules of
the Hatch-Waxman endgame;
• The start of the Paragraph IV litigation
countdown: The Paragraph IV certification and notice letter;
• Obviousness in review: Formulating assertions
and defenses in view of new substantive and procedural developments in the
Federal courts and PTO;
• Advanced strategies for drafting and
perfecting pleadings and effectively using dispositive motions in Paragraph IV
disputes;
• Of customs and courts: The importance of
mastering the requirements of local patent rules in Paragraph IV disputes;
• A view from the Bench;
• The end of Roche v. Bolar? --
Understanding how new 271(e) (1) controversies may alter the course of brand
name and generic strategies in Paragraph IV litigation relative to safe harbor
research exceptions;
• Mastering regulatory maneuvers in Paragraph
IV disputes: Seeking relief from the FDA in the course of Hatch-Waxman
litigation;
• New exclusivity challenges for brand names
and generics;
• Pay-for-delay and settlement drafting update;
• Continuing claim construction conundrums
impacting Markman strategies;
• Evolving theories of inducement and divided
infringement in Paragraph IV litigation concerning method treatment patents;
• Protonix -- Case study of an
at risk launch: Pros and cons analysis of launching at risk and survey of new
developments in seeking injunctive relief and damages; and
• Inequitable conduct: Ethical considerations for Paragraph IV matters
before the PTO and district court.
In addition, two pre-conference workshops will be offered on October 2, 2013. The first, entitled "Hatch-Waxman and BPCIA Master Class -- Perfecting Your IP and Regulatory IQ of Small and Large Molecules" will take place from 8:30 am to 12:00 pm, and the second, entitled "Post-Grant Review and Inter Partes Review Boot Camp: Essential Considerations for Brand Names and Generics Regarding the Use of These PTO Procedures in Paragraph IV Scenarios" will take place from 2:00 to 5:30 pm.
The agenda for the Paragraph IV Disputes conference can be found here. More information regarding the workshops and master class can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.
The registration
fee for the conference is $2,295 (conference alone), $2,895 (conference and one
workshop), or $3,495 (conference and two workshops). Those registering by September 9, 2013 will
receive a $200 discount. Patent Docs readers who reference the
discount code "PD 200" will receive $200 off the current price tier
when registering. Those interested in
registering for the conference can do so here,
by e-mailing [email protected], by calling 1-888-224-2480,
or by faxing a registration form to 1-877-927-1563.
Patent Docs is a media partner of the Paragraph IV Disputes conference.
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