November 4-6, 2019 | North Bethesda, MD

Legal Learning Track

GRx+BIOSIMS
LEGAL LEARNING
TRACK

AAM’s Karin Hessler provides an inside look at the GRx+Biosims 2019 legal track. For legal professionals in the generic and biosimilars industry, this is a perfect opportunity for attendees to receive CLE accreditations through our interactive breakout sessions.

Legal Issues Currently Facing the Industry
Be a part of the discussions on a wide variety of topics, including drug pricing, state challenges, GDUFA, FDARA and the latest proposals coming from the Trump Administration. We’ll also explore emerging IP issues, Paragraph IV litigation and “Biosimilars at the Bar”.

GRx+Biosims Legal Learning Track:

Emerging State Legal Issues
Increasingly, states are wrestling with ways to address drug pricing in order to maintain a sustainable health care system. Most legislative proposals will impact generics and biosimilars. Unfortunately, many of the solutions offered at the state level focus on “price transparency” or price limitations with no recognition of the important differences between the brand industry that drives higher prices and the generic industry that drives savings. Additionally, policymakers often emphasize percentage increase when looking at prices while neglecting to consider true costs and the overall deflationary pricing trend—price decreases—for the vast majority of generic medicines. Finally, new legislative concepts appear each year that, if enacted, will have a greater impact on reducing access to and delaying market entry of generic and biosimilar medicines.

This panel offers a frank and insightful discussion of state legislative proposals.

Emerging State Legal Issues
Unfortunately, many of the solutions proposed at the state level have focused only on “price transparency” or pricing limitations with no recognition of the differences between the brand industry that drives higher prices and the generic industry that drives savings. In addition, some policymakers emphasize isolated price spikes in terms of percentage increase, while neglecting to mention the overall deflationary pricing trend—price decreases—for the vast majority of generic medicines.

The Changing Landscape of Patents, Hatch-Waxman, and the BPCIA
Patents have been perhaps the hottest topic in Congress this year. This session is a can’t-miss opportunity for members of the biosimilars and generic manufacturing community to discuss the opportunities and challenges brought about by current legislation. We will cover patent settlements, the biosimilar patent dance, attempts to curb patent abuse, patent damages law, and the impact of potential changes to 180-day exclusivity on patent challenges.

The Changing Landscape of Patents and Hatch-Waxman
Destructive abuses of the system governing generic and biosimilar medicines are keeping affordable medicines from patients longer. This session is a can’t-miss opportunity for members of the biosimilars and generic manufacturing community to discuss the opportunities and challenges brought by changes to current legislation.

Rebalancing U.S. Trade Policy
U.S. trade policy has too often reflected the interests of the branded pharmaceutical industry, eschewing a balanced approach that would both reward innovation and ensure a competitive marketplace for generic and biosimilar medicines. This policy reflects a well-resourced, concerted effort by the branded industry to tie U.S. trade leadership and economic success directly to expanded intellectual property (IP) rights protections that extend far beyond World Trade Organization (WTO) obligations. To counter this, the generic and biosimilar industry must develop a focused narrative that demonstrates the industry’s value to the U.S. economy and its healthcare system.

This panel brings together global IP and trade experts to explore how the generic and biosimilar industry can change U.S. trade policy and influence the on-going debate around trade, IP protection, access to medicines, and economic growth.

Biosimilars at the Bar
There’s never been a more meaningful moment for biosimilars. We’ll explore the themes that will shape the industry in the coming months and years. This session provides an update on labeling carve-outs, the Purple Book, interchangeability, biobetters, and other current obstacles and opportunities for bringing more biosimilars to market.

Who should attend:

About GRx+Biosims 2019

GRx+Biosims 2019 is the premier scientific and regulatory event for the U.S. generics and biosimilars industries, featuring timely programming relevant to technical, regulatory, policy and legal professionals. Top officials and subject matter experts share their knowledge and best practices to help attendees understand how to succeed in generic and biosimilar development, the regulatory process and approvals and the evolving policy landscape.

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