ACI Maximizing Pharmaceutical Patent Lifecycles Conference

American Conference Institute (ACI) will be holding its 9th Annual Maximizing Pharmaceutical Patent Lifecycles conference on October 15-16, 2008 in New York.  At the conference, ACI's faculty will offer presentations on the following topics:

• Clarifying the evolving meaning of 'patent life cycle' for the pharmaceutical business;
• Constructing, adjusting, and executing a pharmaceutical patent life cycle management plan;
• View for the FTC;
• Navigating the complexity of structuring patent settlement options between brand name and generic pharmaceutical patent cases;
• Eye on the bench: Identifying judicial trends in pharmaceutical patent cases;
• Mastering the intricacies of the 180-day generic market exclusivity;
• Penetrating the complexitites of non-patent/FDA exclusivities;
• Plotting a course into safe harbor for branded pharma;
• View from the FDA;
• Slicing through the complex spectrum of declaratory judgment actions in pharmaceutical patent cases; and
• Factoring the role, challenges, and impact of Orange Book listings and de-listings in patent portfolio management.

Attendees can also elect to attend a branded or generic master class on October 17, 2008.  The branded master class, entitled: "Overpowering the challenges in increasing the pharmaceutical patent life cycle through patent extensions," will address the following topics:

• Defining the benchmarks in the drug’s development;
• Determining eligibility for patent term extension;
• Mastering the regulatory review period determinations;
• Calculating the patent term restoration;
• Adjusting the patent term because of delays, glitches, and obstacles in prosecuting patents at the USPTO;
• Calculating the effect of patent term extensions outside the U.S.;
• Obtaining extensions through FDA Pediatric Exclusivity and Orphan Drug Exclusivity;
• Measuring the import of second-generation patents; and
• Incorporating non-US filing strategies into the life cycle plan for pharmaceutical patents.

The generic master class, entitled: "Adding value to Paragraph IV certifications and notice letters," will address the following topics:

• Defining the four types of patent certifications;
• Clarifying the obligations of the ANDA applicant;
• Probing the impact of the declaratory judgment and counter claim provisions;
• Applying the 30-month stay effectively;
• Incorporating the benefits, costs, and impact of the 180-day exclusivity;
• When will forfeiture of exclusivity be triggered?
• Forecasting consequences of inadequate notice letters;
• When should disclosure of technical information about the ANDA and proposed generic product occur?
• Identifying exceptional cases where attorney's fees may be awarded; and
• Illuminating the procedural and substantive requirements of Paragraph IV letters.

The agenda for the Maximizing Pharmaceutical Patent Lifecycles Conference conference can be found here.  A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.

The registration fee for the conference alone is $1,895 (the registration fee for the branded or generic master classes has not yet been set).  Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media sponsor of ACI's Maximizing Pharmaceutical Patent Lifecycles Conference conference.

Comments

[Rahul Rajpal]

Hi,

Evalueserve did a follow up on the IP China article with the patent filing trends in the Indian IT, Pharma and Auto Industry. Since your articles deal with patents, I think you will also be interested in the attached short studies. They talk about the low patenting activity among domestic IT and Pharma companies in India.

The complete report (Patenting Landscape in India) has been published on our website and can be accessed at http://www.evalueserve.com/Media-And-Reports/WhitePapers.aspx.

Do let me know if you need any additional information.

Regards,

Rahul Rajpal