Several thousand executives, analysts, bankers, venture capitalists, and lawyers journey to San Francisco each January for the highly anticipated JPMorgan Healthcare Conference.
Coinciding with JPMorgan’s 34th annual conference, Morgan Lewis held a roundtable on January 12 for general counsel and other senior legal officers focusing on the challenges that pharmaceutical, biotech, and medical device companies face. Trending topics included international tax planning for life sciences companies, US Food and Drug Administration (FDA) and European Union regulatory trends, and biosimilars and intellectual property (IP) trends. Our guests interacted with Morgan Lewis Princeton partner Randy Sunberg; Santa Monica/Washington, DC, partner Richard de Bodo; San Francisco partner Ben Pensak; Silicon Valley partner John Ryan; Washington, DC, partners Kathy Sanzo and Bob Smyth; and London consultant Paul Ranson.
Our firm held its annual wine reception after the roundtable. Taking place this year at San Francisco’s Sir Francis Drake Hotel, the reception drew more than 600 guests, including executives from local and international life sciences and healthcare companies, investors, private equity firms, and consultants, many of whom we count as clients.
Randy, who serves as co-chair of the Morgan Lewis life sciences interdisciplinary group with San Francisco partner Jeff Mann, spoke to us about the year ahead and how our interdisciplinary teams are poised to assist companies in achieving their business objectives.
Members of our life sciences team collaborate with colleagues in various specialties. What is the hallmark of the practice?
Our life sciences industry sector is a boutique within our global law firm that focuses on the life sciences and healthcare industry and spans all the relevant practice areas in almost every one of our offices worldwide. We team among our intellectual property, FDA/regulatory, transactional, and litigation groups to bring cutting-edge industry knowledge to our clients’ mission-critical deals and cases.
Life sciences companies in the United States, Europe, and elsewhere face multifaceted challenges to their business plans, from consolidation to pricing pressures, to health reform and growing regulation. What are the top client concerns globally as 2016 unfolds?
Top concerns for our life sciences clients include optimizing their tax strategies in the global marketplace; the advent of personalized medicine and companion diagnostics; combination therapies, such as immuno-oncology; and the IP and regulatory challenges and opportunities of biosimilars.
How do you help clients stay ahead of regulations coming out of the European Union?
We work with our colleagues in London, Brussels, Paris, and Frankfurt to keep ahead of developments in the EU, as well as with our colleagues in Dubai, to understand how trends in the Middle East and North Africa can affect the EU and surrounding areas. To bring this knowledge to our clients, we have offered webinars and publications, such as Medicines Pricing and Reimbursement: Demonstrating Value and Sharing Risk in the EU and United States and our London team’s LawFlash, International Life Sciences Data Transfers After Schrems. We do the same for China and Japan, as well.
In fall 2015, US regulators tightened rules on so-called “tax inversions” in which corporations pursue overseas mergers that lead to, among other things, tax benefits. What keeps clients up at night specific to this topic or in the realm of international tax planning more broadly?
Our clients’ tax environment has become more global as they expand their research and development, manufacturing, and commercial operations into new markets. We follow developments in the United States and international tax rules so we can advise clients on inversions that are still possible, as well as the state of the art in transfer pricing and other issues that affect the taxability of their business activities.
Last year also brought many important developments in the biosimilars industry, including the FDA’s approval of its first biosimilar application. What are some of the unique challenges that clients will face in 2016 in this growing area?
Companies seeking to introduce new biosimilar products as well as companies combating biosimilar entry will all face a rapidly changing legal, patent, and regulatory environment and issues of first impression in 2016. Our biosimilars team includes lawyers who have already litigated issues under the recently enacted Biologic Price Competition and Innovation Act (BPCIA), successfully challenged and overturned patents in the US Patent Office that were intended to block biosimilar entry, and worked with the FDA to get biosimilar applications approved. As a result, we are well qualified to assist companies seeking to launch biosimilars as well as companies with existing biologics drugs that want to oppose biosimilar entry.