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Israel Connect
Legal Insight for Success in the US Market
Summer 2016
Welcome to our summer issue of Israel Connect — Mintz Levin’s quarterly newsletter highlighting the emerging trends and significant issues for Israeli companies operating in the US marketplace. In this issue, we cover an array of topics, from the most important considerations for securing trademark rights in the United States, to the latest regulatory developments in the medical device space, to the pioneering work of one of our clients, medCPU, which is partnering with companies in both Israel and the United States to help transform and streamline hospital communication systems.
We encourage you to explore any of these issues further by contacting us directly or visiting the Israel Practice section of our website. As it turns out, we've been off doing a bit of traveling and exploring ourselves, with Heidi and Adam visiting Israel in March to speak at the Tel Aviv Institutional Investment Conference and six additional members of our Israeli practice and the firm visiting over the course of the past quarter.
We hope you learn something new in this issue of Israel Connect, but, as always, we are also here to discuss your particular needs. Please contact Karen Sealine in Tel Aviv at 972.54.4706614 for direct assistance.
Happy reading,
Adam
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We are thrilled to have medCPU Inc. as the spotlight company for this month’s newsletter. medCPU is a health care technology company with offices in Tel Aviv, New York, and Pittsburgh. The company currently has 130 full-time employees in Tel Aviv and throughout the United States medCPU maintains a high clinician to non-clinician ratio with 70% clinicians and 30% non-clinicians — ensuring the solution remains at the highest level of development.
The company was founded in 2009 by Sonia Ben-Yehuda, President, and Eyal Ephrat, M.D., Chief Executive Officer, on the premise that clinical decision support solutions (DSS) based on precise technology, extensive evidence-based content, and expert services can significantly improve care delivery, safety, efficiency, and costs. medCPU develops and markets the innovative medCPU Advisor, a highly intelligent and accurate solution that provides real-time, actionable alerts at the point of care without interrupting clinicians’ workflow.
We advise medCPU on a range of projects from finance to trademarks ensuring that the company’s branding, policies, and procedures are compliant with applicable laws. Mintz Levin understands the unique nature of medCPU’s business and its place in the competitive landscape of health care decision support.
We are proud to be working with medCPU, which continues to rapidly expand its business — most recently in securing a $35 million investment led by the University of Pittsburgh Medical Center.
The company’s proven track-record of successfully implementing precise DSS in multisite hospital enterprises and improving quality health care delivery is why we’re excited to be working with this fantastic international team, which is executing a truly unique vision.
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In this article, Mintz Levin attorney Bethany Hills looks at what’s happening at the FDA, including developments concerning the National Evaluation System for Health Technology (NEST). Additional topics include the agency’s continuing focus on reimbursement as well as the upcoming deadline for implementation of the FDA’s Unique Device Identifier (UDI).
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Trademark rights exist on a country-by-country basis, and the laws in the United States differ in a number of significant ways from other markets. As a result, it is critical that before any non-US company seeks trademark protection in the United States, it first consider a number of potential obstacles. In this article, Mintz Levin attorney Elizabeth Kurpis flags the issues you need to consider to ensure your trademark is protected.
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The fiscal year that ended on April 2, 2016 was the most profitable in the firm’s history. In this article in The Am Law Daily, writer Nell Gluckman looks at the successful strategies behind the firm’s growth in the last fiscal year. Pertinent developments included, among others, the addition of more than two dozen accomplished attorneys in Intellectual Property, Health Law, Tax, and other practice areas as well as the firm’s successful representation of clients in high-profile transactions, particularly in the biotech sector.
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Mintz Levin’s attorneys blog on a broad range of legal issues affecting Israeli and international businesses. In this issue, we feature a post from our Securities Matters blog.
The new General Data Protection Regulation is effectively a “done deal” following the final trilogue meeting on December 15, 2015. One might assume based on UK media coverage that the biggest change in EU privacy law is that kids under 16 will need their parent’s consent to sign up for social media services and apps. As much consternation as that will cause at the breakfast table, it’s really the least of our worries.
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Our very own Sue Foster, an international thought leader in licensing and commercial agreements, as well as the data compliance and privacy spheres, spoke at the Third Conference of the Israel Forum for Bio-Med In-House Counsel in Tel Aviv last month. The conference — entitled “Engaging Consultants in the Bio-Med Industry: IP and Compliance Aspects”—focused on the important considerations for companies considering engaging with service providers on the ground in Israel. For her presentation, Sue tapped her deep understanding of the international differences in intellectual property ownership to highlight and explain the contrasts between the situation in the United States and in Israel. You can contact Sue directly with your Information Privacy questions at [email protected]
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Bill Geary and Adam Samansky, both Boston-based Members of our Intellectual Property group, presented at the 4th Annual Best Practices in IP Conference at the end of May. They joined a host of other industry experts at the conference in Tel Aviv and shared their particular insights on topics including fast-track patents, the proper responses to data breaches, and strategies for marketing patent portfolios to venture capital investors, in addition to strategies for patent enforcement, defense, and litigation under the newly enacted Defend Trade Secrets Act. In addition to their presentations, both Bill and Adam served on panels and led luncheon discussions with colleagues from around the globe. Please contact Bill at [email protected] or Adam at [email protected] for your intellectual property questions — no matter the jurisdiction.
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In a busy month for conferences, Ivan Blumenthal and Merav Gershtenman attended the 15th Annual IATI-Biomed conference, also in May. Hosted in Tel Aviv, the three-day conference serves as the premier annual event of the Israeli life sciences industry. Ivan and Merav joined thousands of other industry professionals and experts for the roundtable discussions, panel presentations, and networking events at the conference. Please contact Ivan at [email protected] and Merav at [email protected] to discuss the latest trends in the US capital markets and the life sciences industry.
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On June 30th, we will be attending the annual US Independence Day Celebration event here in Israel at Ambassador Shapiro’s residence.
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Ran Zioni, an International Member in our Corporate & Securities Practice, will be in Israel from June 30th through July 7th and would be happy to meet you. You can contact Ran at [email protected]
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with Cynthia J. Larose
June 22, 2016
1:00 - 2:00 pm EST
The number one threat to a company's information (personal or confidential) is still its own employees. Data security and privacy training is the first line of defense against negligent employee behavior. We will explore why traditional training programs are falling short and what you can do to boost your efforts and counter top concerns regarding malicious and negligent employee handling of personal and confidential data.
This is an online event.
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This six-part webinar series was held from January 7, 2016 through May 5, 2016, and covered the following topics related to biosimilars and biologics:
- Part I: Legal and Regulatory Overview
- Part II: FDA/Regulatory Issues
- Part III: BPCIA Patent Litigation
- Part IV: Transactions and Patent Portfolios
- Part V: What Happens When Biosimilars Hit the US Market?
- Part VI: New Twists on Old Torts
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In an informative webinar, Mintz Levin attorney Adam Samansky reviewed recent US Supreme Court and Court of Appeals decisions and their impacts on patent strategy.
Specific topics included:
- The practical implications of Commil USA, LLC v. Cisco Systems, Inc. on opinion practice and litigation of indirect infringement claims
- The impact of Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. on appeals of claim construction orders to the Federal Circuit
- Structuring patent license (and other) agreements in view of Kimble v. Marvel Entertainment, LLC
- The broadening of means-plus-function limitations in view of Williamson v. Citrix Online, LLC
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Mintz Levin includes more than 500 attorneys serving clients worldwide. We have more than 15 years of experience working in Israel and serve more than 200 Israeli clients. Highly ranked and recognized by Chambers Global, our Israel Practice includes a multidisciplinary group of lawyers — including US-based Israeli attorneys — who know your political and business culture as well as Israel’s legal and regulatory landscape.
Adam Sisitsky
Chair, Israel Practice
Adam focuses on business and securities litigation, internal investigations, and US government enforcement actions. He represents clients in SEC investigations and enforcement proceedings as well as in civil litigation. Adam routinely counsels public and private companies and others in matters involving compliance issues, including matters arising under the US Foreign Corrupt Practices Act (FCPA). Read more.
Merav Gershtenman, 212.692.6806
Associate, Corporate & Securities Practice
Merav represents issuers and underwriters in capital market transactions, including IPOs, follow-on offerings, PIPEs, and At-the-Market offerings. Merav also concentrates her practice on providing, on an ongoing basis, counsel to public companies with respect to compliance and disclosure obligations under the securities laws, corporate governance matters, listing and compliance with various trading markets, including NYSE, NASDAQ, and OTC markets. Read more.
Tom Burton
Chair, Energy Technology Practice
Tom founded and chairs the firm’s Energy Technology Practice, which has completed more than 350 transactions totaling over $7 billion. He is ranked by Best Lawyers in America in the Corporate Law section and recognized by The Legal 500 United States as “rising to the fore” in energy technology for Venture Capital and Emerging Companies. Read more.
Bill Geary
Member
Bill is an experienced patent and trademark attorney with a particular background in medical technology, polymers and advanced materials, and chemicals. He is recognized in Chambers USA (Massachusetts — Intellectual Property) and was recognized for 10 consecutive years in Massachusetts Super Lawyers. For the past two years, he has also been named an IP Star by Managing Intellectual Property.
Read more.
Adam Samansky
Member
Adam’s practice focuses on IP litigation. His core practice includes patent and trade secret litigation involving complex technologies in the pharmaceutical, medical, high-tech, and defense industries. Adam has tried cases before multiple US District Courts, briefed and argued cases before the US Court of Appeals for the Federal Circuit, and briefed bet-the-company issues before the US Supreme Court. Read more.
Susan Berson
Managing Member, DC office
Susan has advised some of the largest government health programs and negotiated some of the largest pharmacy service agreements in the United States. She has been listed in Chambers USA for three consecutive years and is recognized by The Legal 500 United States. Susan is also a recipient of the International Law Office and Lexology’s Client Choice Award for Healthcare & Life Sciences.
Read more.
Bethany Hills
Member
Bethany leverages deep FDA regulatory experience and exceptional knowledge of the health care delivery system to help international and US health technology companies enter and navigate the US health care market. Bethany represents a large variety of health care provider businesses in a range of regulatory, reimbursement, and US and international compliance matters.
Read more.
Ran Zioni
International Member
Ran represents companies in mergers and acquisitions, venture capital, and private equity financing transactions as well as in technology licensing and outsourcing transactions. In addition to his work with Israeli companies, Ran advises US clients on matters involving Israeli law and on issues relevant to US participants in Israel’s venture capital and high-tech industries. Read more.
Doug Hauer
Member
Doug is a Member in the firm's Corporate & Securities Practice and Immigration Practice. On the corporate side, he focuses on private offerings and related securities work. Doug serves as counsel to developers and businesses seeking capital through the EB-5 investor visa program. He also counsels lenders, private equity firms, and EB-5 Regional Centers on all aspects of EB-5 financing. In the immigration law space, Doug represents corporate, institutional, and individual clients in routine and complex immigration matters. He has in-depth experience advising companies on the immigration consequences of corporate restructuring. He also advises businesses on the legal aspects of establishing new offices and operations in the US. Read more.
Mitch Danzig
Member
Mitch has extensive experience in employment law and in intellectual property litigation and complex commercial litigation. He has also served as a member of the firm's Policy Committee. His work has focused on litigation in the areas of trade secrets, complex commercial litigation, employee mobility, wrongful termination, discrimination, harassment, contracts, defamation, wage and hour, and unfair competition. As part of his counseling practice, Mitch has performed management training for employers and rendered employment advice on employment-related issues, including those associated with hiring employees, terminating employees, workplace investigations, discrimination, protection of trade secrets, leaves of absence, reductions-in-force, and compliance with wage and hour laws, among others. Read more.
Karen Sealine, 972.54.4706614
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