Save the Date
Greenberg Traurig’s Life Sciences & Medical Technology Group will once again be hosting two events in San Francisco during the 2020 JP Morgan Healthcare Conference.
Wine Tasting and Networking Reception
Monday, January 13, 2020
6:00 p.m. – 9:00 p.m.
Fogo de Chão Brazilian Steakhouse
201 3rd Street | San Francisco, CA 94103
Lunch Workshop: Insiders’ Views of Deal Making
Tuesday, January 14, 2020
11:00 a.m. – 12:00 p.m. Networking and Lunch
12:00 p.m. – 2:00 p.m. Panel Discussion
Practising Law Institute
685 Market Street, Suite 100 | San Francisco, CA 94105
Seasoned executives from leading life sciences companies will share current trends, best practices, and pitfalls of deals including M&A, licensing, joint ventures, and strategic collaborations. Attendees will also hear predictions on what 2020 will hold for deal making.
Confirmed speakers include: Debbie Alexander, Director of Business Development at 23andMe; Shaun Grady, Senior Vice President of Business Development Operations at AstraZeneca; Jeremy Sohn, VP, Global Head of Digital Business Development & Licensing at Novartis; and Dr. Robert Mittendorff, Partner at Norwest Venture Partners.
Click here to view the evite to these exciting events.
Industry Articles & Alerts
FDA Toughens Enforcement of Homeopathic Products
By Eleanor (Miki) A. Kolton, Justin J. Prochnow, and Christopher M. Koepke (Washington, D.C., Denver, and Houston)
The FDA recently announced that it was taking two significant actions with respect to products marketed as homeopathic drugs, suggesting that increased enforcement related to these products is imminent. Homeopathy is a form of alternative medicine that is based on the idea that illnesses and their symptoms can be treated by small doses of ingredients that produce similar symptoms in healthy people. This alert highlights the FDA’s imminent changes in guidelines of homeopathic products.
Does Section 1782 Apply to Discovery in Private International Commercial Arbitration Proceedings?
By Thomas G. Allen, Tomás Leonard, Nicole Y. Silver, and Andrew Van Duzer (Washington, D.C., Shanghai, and Tokyo)
Life sciences companies should pay attention to an ongoing action in Delaware that could have implications for whether they can obtain (or be subjected to) U.S. discovery in international arbitration under 28 U.S.C. § 1782. Section 1782 is a powerful tool that permits litigants to obtain broad discovery in the United States for use in international arbitrations, which traditionally do not provide for or allow significant discovery. But U.S. courts have found that not all international arbitrations qualify under this statute. While courts have permitted Section 1782 to be used in connection with investor-State arbitration, they have wrestled with whether to apply the statute in the context of international arbitration between two private, commercial parties. This alert analyzes if Section 1782 applies to discovery in international arbitrations.
Funding Tips to Help Medtech Startups Cross the ‘Valley of Death’
By David J. Dykeman (Boston)
Medical technology research and development is fraught with challenges, including cost, time, and regulatory hurdles. As many entrepreneurs have learned, starting and growing a medtech company is a time-consuming and difficult process, but with careful planning that includes a strategic patent portfolio, innovators can thrive in the market. Seed stage funding, non-dilutive grants, and investment from strategics can help medtech companies cross the funding “valley of death” until the right time for VC investment.
4 Ways Medical Device Manufacturers Can Reduce Product Liability Risks
By Ginger Pigott and Michael R. Goodman (Los Angeles and Denver)
Medical device manufacturers have many goals, but central is the ability to improve or extend life, to add value to or improve medical treatment and/or be a benefit to patients.
In our world of litigation and exposure to potential company-ending liability, it is not only good intentions or successful execution of concept that win the day in court. To survive, to innovate and keep valuable products on the market means understanding and using the protections afforded by the regulatory framework and case law interpreting how prescription medical devices are to be treated in tort litigation.
Orthopedic Device Patent Strategies You Need for Success
By David J. Dykeman (Boston)
Patents are the currency of the orthopedic industry. In order to thrive, orthopedic device companies must distinguish themselves from their competitors through their intellectual property portfolios.
Strong patent portfolios are the key to success because they embody a well-reasoned business strategy, where each patent is a single strategic building block in a larger portfolio that reflects present and future business objectives. Patent portfolios are often the driving force for major events in the life cycle of an orthopedic company including venture capital investment, mergers and acquisitions, public offerings, strategic collaborations, joint ventures and litigation.
Greenberg Traurig in the Industry
Jennifer Hermansky & Fang Xie Named Law360 Rising Stars
Jennifer Hermansky and Fang Xie, Ph.D., have been named to Law360’s 2019 Rising Stars. Hermansky and Xie, named an Immigration Rising Star and a Life Sciences Rising Star respectively, were recognized among 175 attorneys from 1,300 submissions, spanning 39 practice areas. The list highlights attorneys “whose legal accomplishments transcend their age,” according to Law360.
Hermansky, based out of Philadelphia, is internationally recognized for her counsel to clients worldwide regarding their employment-based immigration needs. She focuses in advising companies and real estate developers on the structuring of private equity funds seeking investment by foreign investors.
Xie, located in the firm’s Boston office, is a sought-after patent strategist and intellectual property transaction lawyer. She focuses her practice on establishing, defending, licensing, sharing, and monetizing intellectual property rights for life sciences companies.
Greenberg Traurig, Attorneys Shortlisted for Euromoney’s 2019 Rising Star Awards
Five attorneys from global law firm Greenberg Traurig, LLP were shortlisted for Euromoney’s 2019 Rising Star Awards. Marcella C. Ducca (ATL) was a finalist for Best in Product Liability and Fang Xie, Ph.D. (BOS) was a finalist for Best in Life Sciences. The firm was also shortlisted for Best International Mentoring Program and Best International Firm for Talent Management for the second consecutive year.
5 Greenberg Traurig Attorneys Recognized in IAM Strategy 300 – The World’s Leading IP Strategists 2019
The 2019 edition of the Intellectual Asset Management’s (IAM) Strategy 300 – The World’s Leading IP Strategists recognized five attorneys from global law firm Greenberg Traurig, LLP. According to the publication, the guide identifies the individuals leading the way in the development and implementation of strategies that maximize the value of IP portfolios.
The following firm shareholders were selected: David J. Dykeman, co-chair of Greenberg Traurig’s global Life Sciences & Medical Technology Group and the Boston Intellectual Property & Technology Group, Masahiro Noda, Chinh H. Pham, Andrew R. Sommer, Fang Xie, Ph.D.
18 Greenberg Traurig Attorneys Recognized in the 2019 Edition of IAM Patent 1000
The 2019 edition of Intellectual Asset Management’s (IAM) Patent 1000 – The World’s Leading Patent Professionals recognized 18 attorneys from global law firm Greenberg Traurig, LLP. The firm was also recognized in four regions for its patent litigation, prosecution, and transaction capabilities.
According to the publication, the guide identifies the top patent professionals in key jurisdictions around the globe. The patent professionals are identified after a 5-month, extensive research process. IAM conducts nearly 1,500 interviews with attorneys, patent attorneys, and in-house counsel. Recognized patent professionals have received sufficient positive feedback from peers and clients.
Greenberg Traurig’s Lori Cohen is the 2019 Benchmark Litigation Product Liability Attorney of the Year
Hard-hitting attorney Lori G. Cohen, co-chair of the Global Litigation Practice at Greenberg Traurig, LLP, was named ‘Product Liability Attorney of the Year’ by Benchmark Litigation at the publication’s seventh annual U.S. awards.
Past Events & Speaking Engagements
Greenberg Traurig was a sponsor of DeviceTalks West in Santa Clara, CA on December 9-10, 2019. The program explored the trends and technology that are shaping the future of the medical device industry. Greenberg Traurig Shareholders Ginger Pigott (LA), Vice Chair of the Pharmaceutical, Medical Device & Health Care Litigation, and Roman Fayerberg (BOS) were once again speakers at the event. Their panel, “Hot Topics: M&A, IP, and Products Liability Trends Impacting MedTech,” focused on trends within the IP and M&A industries and what medtech companies need to know about products liability litigation.
IP Due Diligence Considerations for the Life Science Industry: What You Should Know
Greenberg Traurig Shareholder Chinh H. Pham (BOS) presented on The Knowledge Group's live webcast, "IP Due Diligence Considerations for the Life Science Industry: What You Should Know," on Dec. 6. The webinar focused on key IP due diligence considerations, the implications of recent judicial developments, integrated IP strategies for Life Science companies, and best compliance practices.
CJP Health Professions Annual Breakfast
On Nov. 17, 2019, Greenberg Traurig sponsored the Combined Jewish Philanthropies (CJP) Health Professions Annual Breakfast. The event featured a Healthcare Innovations Network pre-reception and a keynote address on "How Innovation is Improving Delivery of Medical Care - Creating Value for Patients and Investors." Greenberg Traurig Shareholder David J. Dykeman (BOS) was a co-chair of the event.
ACI 3rd Annual Summit on Life Sciences IP Due Diligence
David J. Dykeman (BOS) presented at the American Conference Institute’s (ACI) 3rd Annual Summit on Life Sciences IP Due Diligence Nov. 14-15, 2019. Dave moderated the panel, “Avoiding Missteps During the Chain of Title Review: Understanding Ownership Rules,” which addressed patent ownership questions related to the valuation of proprietary life sciences technology.
Medical Devices, Market Trends & Opportunities – Educational Breakfast
Greenberg Traurig hosted a Medical Devices Market Trends & Opportunities Educational Breakfast on Tuesday, Nov. 12 from 7:30 am - 10:30 am at the firm's Boston office. The event addressed trends in the MedTech industry, identified opportunities for innovators to develop IP, examined the energy and power management for medical devices, and discussed the requirements and constraints that originate from patients, physicians, and regulatory agencies. David J. Dykeman (BOS) was a panelist and Chinh H. Pham (BOS) delivered welcome remarks.
Insiders’ Views of Deal Making in the Life Sciences Sector Seminar
Greenberg Traurig’s global Life Sciences & Medical Technology Group co-hosted the seminar, “Insiders’ Views of Deal Making in the Life Sciences Sector,” with German biotech strategy consulting firm, Catenion. The seminar took place from on Oct. 25, 2019, at Greenberg Traurig’s Tokyo office. Speakers from Greenberg Traurig and Catenion discussed best practices and practical tips in deal making, as well as pitfalls in M&A, licensing, joint ventures, and strategic collaborations. Presentations were followed by a panel discussion about recent trends and challenges involving international deal-making in the life sciences sector. Co-chair of Greenberg Traurig’s Japan Practice Koichiro Ohashi delivered the program's opening remarks and David J. Dykeman (BOS) and Wayne H. Elowe, co-chair of Greenberg Traurig’s global Life Sciences & Medical Technology Group and co-chair of the firm’s Corporate Group in Atlanta, were speakers.
Collaboration in Global Life Sciences Seminar
On Oct. 22, 2019, Greenberg Traurig’s global Life Sciences & Medical Technology Group co-hosted the seminar, “Collaboration in Global Life Sciences,” with Korean law firm, Jipyong LLC, and German biotech strategy consulting firm, Catenion. The event gathered Korean biotech, pharma, medical device, and medical technology companies for a series of presentations and a panel discussion focused on opportunities for collaboration in the emerging field of bioconvergence. Specific topics addressed the key factors in structuring and negotiating collaboration deals, IP and regulatory issues companies need to address in deal negotiations, and Korean legal issues that need to be considered when closing these deals. Shareholders David J. Dykeman (BOS) and Wayne H. Elowe (HOU) were presenters during the seminar.
Greenberg Traurig shareholders Kate Black (MIA/SF) and Daniel Smulian (NY) presented on “Innovation, Regulation, and Adaptation: Emerging Legal Issues in Digital Health” as part of the MedTech Conference on Sept. 25, 2019. The session focused on the convergence of digital and health care technologies to promote efficient health care and personalized medical treatment. It provided an overview of assistive technologies like robotics in surgical procedures, artificial intelligence, mobile health and telemedicine. Kate and Daniel shared an overview of the evolving legal landscape for companies that make these technological advancements possible by examining the existing regulatory framework, from FDA and other governmental actors, to the ways that courts are adapting with traditional defenses and doctrines.
Trevor Chaplick Presents AIPLA Webinar on Startup Investments
Greenberg Traurig Shareholder Trevor J. Chaplick co-presented the American Intellectual Property Law Association (AIPLA) CLE Webinar entitled “Startup Investments: A Primer for IP Attorneys” on Sept. 19, 2019. The webinar provided an overview of corporate considerations for startup investments. Chaplick’s presentation focused on choice of entity, key documents (from invention assignments to purchase agreements), and select IP due diligence topics.
Greenberg Traurig sponsored the 2019 DeviceTalks Minnesota on Sept. 9-10. This year's conference explored the trends and technology that are shaping the future of the medical device industry. On Sept. 9, David J. Dykeman (BOS) moderated the “Hot Topics: M&A, IP, and Products Liability Trends Impacting MedTech” session, with Shareholders Stephen Baird (MSP) and Marcella C. Ducca (ATL) serving as panelists. The panel focused on the pressing issues currently facing medtech communities, including M&A trends from the perspective of both acquirer and seller and products liability litigation - what every medtech company needs to know.
Lori Cohen Speaks at the ACI Women Leaders in Life Sciences Law Conference
Lori G. Cohen, co-chair of the Global Litigation Practice of Greenberg Traurig, LLP, spoke at the American Conference Institute's (ACI) Women Leaders in Life Sciences Law Conference at the OMNI Parker House Boston on July 25-26. Greenberg Traurig was a sponsor of the sixth annual career development and networking event and hosted a cocktail reception July 25.
ACI's Women Leaders in Life Science Law Conference is an annual educational and networking event that brings together in-house and private practice professionals from the biotech, medical device, and pharmaceutical industries. This year's event focused on strategies for increasing the prominence of women in the life sciences legal field through substantive legal discussion, professional development, and woman-to-woman networking.
Greenberg Traurig was a sponsor of the National Bar Association's Annual Convention on July 20-26, 2019 in New York. The convention offered a series of exhibits, continuing legal education seminars, think tanks, symposiums, and forums. The National Bar Association Annual Convention is the premier venue for black lawyers to increase their profiles and networks.
On June 25, 2019, Greenberg Traurig’s Health Care & FDA Practice hosted a networking reception in conjunction with the American Health Lawyers Association (AHLA) Annual Meeting. Guests enjoyed an evening of cocktails and conversation while taking in the view from Greenberg Traurig’s Boston’s roof deck.
Greenberg Traurig sponsored the 2019 DeviceTalks Boston on June 5-6, 2019. DeviceTalks is the premier industry event for the medtech community fostering the exchange of ideas, insight and technology among the pioneers of the medical technology industry and the engineering behind it. On June 5, David J. Dykeman (BOS) moderated the “Hot Topics: M&A, IP, and Products Liability Trends Impacting MedTech” session, with Shareholders Trevor J. Chaplick (DC) and Evan Holden (ATL) serving as panelists. The panel focused on the pressing issues currently facing medtech communities, including M&A trends from the perspective of both acquirer and seller and products liability litigation - what every medtech company needs to know.
CJP Lifesciences L’chaim Reception
On April 4, 2019, David J. Dykeman (BOS) moderated a panel at the Combined Jewish Philanthropies (CJP) Lifesciences L’chaim Reception discussing the latest Life Science industry trends.
William Paterson University Bioethics Course
On April 2, 2019, Barry J. Schindler (NJ), Chair of Greenberg Traurig's Global Patent Prosecution Group, was a guest lecturer speaking on bioethics - specifically how patents and biomedical product development play a major role in the fast-moving world of biotechnology.
Maximizing Value from Strategic Partnering in Clinical Development Seminar – Tokyo, Japan
Greenberg Traurig and Catenion hosted the Maximizing Value from Strategic Partnering in Clinical Development Seminar on March 1 in Tokyo. The program provided an in-depth look at the life cycle of an early stage biotech company that has developed an exciting new drug candidate and is evaluating its options for commercializing the product and obtaining the returns on its investment. Speakers discussed the key issues that both the companies developing new drug products and those seeking new candidates for commercialization should consider when choosing partners and successfully partnering. Greenberg Traurig Shareholder Koichiro Ohashi (Tokyo) delivered the program's opening remarks, and Catenion Founder and Senior Partner Christian Elze led a discussion on "Developing a value-maximizing clinical development and partnering strategy" with contributions from Wayne H. Elowe (ATL). Wayne also spoke with David J. Dykeman (BOS) about "Identifying the right partner, negotiating a deal and implementing it," with contributions from Catenion's Christian Elze.
On January 24, 2019, David J. Dykeman (BOS) moderated the Massachusetts Biotechnology Council (MassBio) symposium panel entitled “Building an IP Fence Around Your Drug Device Combination Product." The panel addressed how combination products today blend drugs, devices, and services to improve patient outcomes, and how device IP can add further value and protection.