Events
Duane Morris to Sponsor ACI Conference on Paragraph IV Disputes
May 3, 2011 | New York City
| Marriott New York Downtown
Duane Morris will be a sponsor of the American Conference Institute's conference on Paragraph IV Disputes, to be held on May 3-4, 2011, at the Marriott New York Downtown. Duane Morris partners Vincent L. Capuano, Ph.D., Robert M. Gould, Ph.D. and Richard T. Ruzich will be speakers at the event. Dr. Gould will speak on "Patent and Non-Patent Exclusivity" at the pre-conference workshop on May 2 at 1:45 p.m. Mr. Ruzich will participate in the panel "Invalid or Will Not Be Infringed: Re-Assessing the ANDA Applicant's Pre-Litigation Considerations and Obligations Under Paragraph IV vis-a-vis Microsoft v. i4i," to be held on May 3 at 9:30 a.m. Dr. Capuano will participate in the panel discussion "New Standards and Controversies in Double Patenting Type Obviousness: Repercussions for Paragraph IV Challenges," to be held on May 3 at 10:45 a.m.
About the Conference
Patents covering critical pharmaceutical products worth more than $30 billion annually are on the precipice of expiration. Conquer the litigation challenges that this patent onslaught will bring for brand name and generics in the Paragraph IV arena.
American Conference Institute’s Paragraph IV Disputes conference is the undisputed source for Hatch-Waxman litigation strategies for brand-names and generics. This event — which is widely recognized for setting the standards for Paragraph IV litigation and which also serves as the annual meeting place for the “who’s who” of pharmaceutical patent litigation — is now the single forum on which brand name and generic companies can rely for answers during this turbulent time in which the balance of power designed by the Hatch-Waxman Act may completely unravel. Come to this conference and get the up-to-the minute information that you need to prepare for the new litigation confrontations to come.
Brand name pharmaceutical companies are moving closer than ever to the edge of the patent cliff. However, generic manufacturers are facing their own hurdles as fewer opportunities for 180-day exclusivity will remain.
The industry has reached the long dreaded patent cliff of 2011. Brand name manufacturers are struggling to fill a drying pipeline and extend patent life through other statutory and regulatory conventions. Meanwhile, generics eye the ultimate Hatch-Waxman prize of 180-day exclusivity— knowing that such opportunities in the future may be short-lived as there will be few patented drug products worth coveting. These factors have turned Paragraph IV litigation into a no-holds barred fight and have raised the monetary ante to an unprecedented level.
New legislative developments, evolving case law and mounting enforcement actions are increasing this anxiety. Moreover, the passage of biosimilars legislation, the possible resurrection of patent reform and the never ending controversy surrounding reverse payment settlements have only added to the complexities surrounding this litigation. In this chaotic environment one thing is clear: it is more imperative than ever before for brand-name and generic drug manufacturers to have the offensive moves and defensive plays that they need to meet the evolving challenges of pharmaceutical patent endgame litigation.
An experienced faculty comprised of respected and renowned counsel for brand name and generic pharmaceutical companies will provide insights on all facets of Paragraph IV litigation: pre-litigation concerns – the commencement of suit – final adjudication – and every step in between. Sessions will address the key elements of Paragraph IV litigation in addition to some of the most pressing and recent controversies surrounding Paragraph IV cases, including:
- Possible re-evaluation of the Invalidity standard
- Double patenting obviousness
- Inducement of infringement
- Section 8 carve-outs
- Inequitable conduct
- Damages
We are also pleased to bring you the opportunity to hear from renowned federal jurists and a key official from the Federal Trade Commission. This will allow you to learn firsthand how the bench analyzes the theories of your case and what the FTC deems as “fair and foul” in the settlement of pharmaceutical patent disputes.
For more information or to register online, please visit the ACI website.
