Paragraph IV Challenges: Exploring 2017 Trends, Developments and Updates
Since its enactment, the Hatch-Waxman Act has been continuously encouraging generic drug manufacturers to challenge active drug patent and gain market entry before the patents’ expected nominal expiration dates.
In the past years, the number of lawsuits involving paragraph IV challenges has significantly increased and the outcome of each litigation varies significantly according to the type of patent challenged.
In this LIVE Webcast, a team of thought leaders and professionals brought together by The Knowledge Group will provide the audience with an in-depth analysis of all the important issues and trends surrounding Paragraph IV challenges. Speakers will also present key strategies and practical tips to avoid common risks and pitfalls surrounding this significant topic.
Key topics include:
- Paragraph IV Challenges in the 2017 Landscape
- Recent Court Decisions
- Scope and Limitations
- Common Risks and Pitfalls
- Recent Trends, Developments, and Updates
Kilpatrick Townsend & Stockton LLP
- Broad Overview
- Helsinn, Eli Lilly case
- Teva 1
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
- TC / Heartland…Duke/Regeneron case a possibility
- Where to sue and safety suits
- Recent 103 decisions
Who Should Attend:
- Patent Legal Counsel
- Pharma Industry Lawyers
- Patent Licensing Attorneys
- FDA Attorneys
- Patent Litigators
- Pharmaceutical Company Executives
- Professionals coming from Biotech and Pharmaceutical Firms
- Professionals coming from Drug Manufacturing Companies
- Drug Manufacturing Executives
Alyson Wooten, PharmD, focuses her practice on patent litigation with a special emphasis on pharmaceutical patent litigation under the Hatch-Waxman Act. She has experience at all stages of the litigation process includes pre-filing investigations, discovery, expert witness preparation, Markman proceedings, dispositive motions, and settlement negotiations. She has argued Markman hearings, summary judgment, and discovery-related hearings in various United States courts. She also has experience in filing and conduct of Inter Partes Review proceedings, including proceedings co-pending with district court actions.
Registered as a patent attorney and pharmacist, Dr. Wooten also has broad experience in counseling clients on FDA regulatory matters, clinical trial management, early commercialization strategies, patent settlements and licenses regarding pharmaceuticals, drug product liability, and antitrust issues bearing on pharmaceutical patent settlements. Prior to joining Kilpatrick Townsend, Dr. Wooten worked for a leading pharmaceutical company focusing on FDA regulatory matters, clinical trial program for investigational new drugs, and patent litigation under the Hatch-Waxman Act.
Dr. Wooten was recognized in 2017 and the six years immediately preceding as a Georgia "Rising Star" in the area of Intellectual Property Litigation by Super Lawyers magazine.
Alyson Wooten, PharmD, focuses her practice on patent litigation with a special emphasis on pharmaceutical patent litigation under the Hatch-Waxman …
Joseph is an attorney in Mintz Levin’s Boston office. His practice focuses on intellectual property litigation and counseling on issues related to intellectual property rights. Joseph’s primary focus is in patent litigation, including the intricacies of Hatch-Waxman pharmaceutical litigation, and Inter Partes Review proceedings. He has extensive experience in every stage of litigation, from pre-suit investigations through appeal – including case initiation, fact and expert discovery, motion practice, and successful preparation for and participation in trials involving patent infringement allegations.
Joseph has represented clients across a wide range of technologies including pharmaceuticals, medical and mechanical devices, consumer products, and telecommunications services. He has also worked on numerous high-stakes Hatch-Waxman litigations for major pharmaceutical companies through trial and appeals.
Joseph is an attorney in Mintz Levin’s Boston office. His practice focuses on intellectual property litigation and counseling on issues …
Print and review course materials
Method of Presentation:
Experience in Patent Law
NASBA Field of Study:
Business Law - Technical
NY Category of CLE Credit:
Areas of Professional Practice
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About Kilpatrick Townsend & Stockton LLP
Kilpatrick Townsend is a full-service, international law firm with more than 620 lawyers in 18 offices worldwide. We have deep experience in the areas of intellectual property, litigation and corporate transactions. A close collaboration between the firm's practice areas ensures that we are well-positioned to serve all of our clients' needs. Offering the full range of services, Kilpatrick Townsend is one of the few general practice firms with a core commitment to intellectual property law. With more than 300 attorneys devoted to IP law, Kilpatrick Townsend offers clients specialization that exceeds even the most well-known boutique firms. For more information, please visit: www.kilpatricktownsend.com.
About Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Mintz Levin serves clients of all sizes and at all stages of growth, representing Fortune 500 companies, entrepreneurs, emerging growth and established companies, government agencies, and nonprofits. Mintz Levin’s IP Litigation team deals with all aspects of patents, trademarks, copyrights and trade secrets, including validity, infringement, enforceability and litigation of such rights. The life science IP litigators are thoroughly experienced with all aspects of IP litigation, and particularly Hatch-Waxman Litigation, which helps innovators protect their hard-earned inventions, which are so crucial to success in marketing new pharmaceuticals. The Hatch-Waxman litigation team works with clients to anticipate challenges to their patents, to prepare them for potential ANDA filings or other infringement issues, and to vigorously and efficiently protect these highly important patent rights. The team includes attorneys who are highly experienced in the space, have exceptional technical knowledge and training, and have achieved outstanding successes in cases such as Takeda v. Mylan, Takeda v. Alphapharm, and Mitsubishi Chemical v. Barr. The practice leaders have been recognized as Leading Practitioners in Managing Intellectual Property, Best Lawyers, and Super Lawyers, among others.