Client Alert: EU-U.S. Privacy Shield Adopted 07/15/2016Posted by Morse, Barnes-Brown Pendleton in Client News.
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The European Commission Has Adopted and Launched
the EU-U.S. Privacy Shield
By: Faith Kasparian
Earlier this week, the European Commission adopted the EU-U.S. Privacy Shield – a new framework for transatlantic data flows. The European Commission’s Press Release announcing the Shield promises that the new framework “protects the fundamental rights of anyone in the EU whose personal data is transferred to the United States” and brings “legal clarity for businesses relying on transatlantic data transfers.”
The EU-U.S. Privacy Shield replaces the Safe Harbor framework, which previously governed data transfers between the EU and the U.S. until it was declared invalid by the Court of Justice of the European Union on October 6, 2015. On February 2, 2016, the EU and the U.S. reached political agreement as to the new Privacy Shield. The European Commission’s “adequacy decision” implementing the Privacy Shield was approved on July 12. See our prior Alerts on this subject here and here.
Read the full alert which includes the principal elements of the Privacy Shield.
Tags: Corista, Corista DP3, Digital pathology, medical device
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Exciting news for MBBP client Corista as Johns Hopkins Medicine, one of the leading health care systems in the United States, has successfully installed Corista’s DP3 system. The DP3 is a digital pathology network platform that removes the physical boundaries from pathology and enables real-time remote expert diagnoses. It is a workflow solution integrating multiple facilities, scanners, physicians, patients and Laboratory Information Systems.
Johns Hopkins is standardizing this DP3 system as its centralized digital pathology platform in order to streamline workflows among its five hospital centers. The overall objective is to provide more efficient and accurate flow of information across core systems that manage diverse functions in the hospital system. Specifically, the system will help improve each hospital’s Tumor Board process, integration of existing systems including LIS, and global remote access.
Congratulations, Corista! MBBP serves as general counsel to Corista and assisted in negotiating its contract with Johns Hopkins. For more information, visit Corista News & Events.
Tags: app, apptomics, bbk worldwide, clinical trial, entrepreneur, neurologists, parkinson's disease, patient recruitment, patients, startup
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Firm client BBK Worldwide is partnering with Wellesley-based digital health app maker, Apptomics, as it prepares to launch a one-year clinical trial in September. Using a combination of apps (iMotor and MyPD), for monitoring patients with Parkinson’s disease, the trial will test the effectiveness of these tools in impacting the management of Parkinson’s disease and health outcomes. iMotor measures objectively patients’ motor function by combining several variables and MyPD focuses on collecting data related to symptoms, medications, side effects sleep quality, and emotional status. Data collected are transmitted in reports to patients’ neurologists.
BBK Worldwide is the foremost patient recruitment and engagement technology firm, providing a range of award-winning creative services and technology solutions to the world’s most innovative pharmaceutical and biopharmaceutical companies and their outsourced suppliers, such as CROs and eClinical providers. Apptomics works to achieve optimal management of chronic neurological conditions, including Parkinson’s, through scientifically validated mobile applications that allow collection of objective and patient reported data on disease progression. BBK Worldwide is now a minority investor in Apptomics, with BBK Principal Matthew Stumm serving on the Apptomics Board of Directors.
The two companies will work to develop a collection of apps aimed at monitoring patients with chronic neurological diseases and relaying the information to their doctors. Apptomics has already had success with the iMotor app through two studies that clearly demonstrated the scientific effectiveness of its data collection. The app also proved able to distinguish Parkinson’s patients from healthy individuals, and distinguished with high sensitivity the effects of treatment plans.
Congratulations to both companies on their new venture!
Tags: client, clinical study, ConforMIS, employment law, joint replacement implants, knee replacement, medical technology
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ConforMIS, Inc., a medical technology company that manufactures and sells joint replacement implants, received positive results from its iTotal CR study. The iTotal CR is a fully customized implant for use in total knee replacement, and the study found that 92% of patients were satisfied with the product in the year after receiving a knee replacement.
In developing, manufacturing, and selling joint replacement implants, ConforMIS uses its iFit Image-to-Implant technology, which allows for a customized implant specifically designed to fit an individual’s anatomy. The iTotal CR study included 300 patients in the United States, and is still ongoing. The interim study results were presented at the 2016 SICOT International Orthopaedic “Specialized Knee Surgery” Conference in Germany, which ran from June 30th to July 2nd.
The positive feedback is consistent with a previous study that showed that patients noted significantly higher satisfaction with the ConforMIS iTotal CR in their knee replacements, than with off-the-shelf implants. The positive results speak to the benefits of anatomically customized implants, and illustrate how ConforMIS’s products are making a positive and lasting impact in the joint replacement implant market.
To read more about the study and ConforMIS’s technology, read the full article.
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MBBP’s Employment Law Group just released a follow-up Employment Law Alert on noncompetition reform. In the prior alert, clients were informed about a proposed bill, H. 4323, imposing strict new requirements on the use of employee noncompetition agreements in MA. Yesterday, the Massachusetts House of Representatives unanimously approved a slightly modified bill, H. 4434.
Learn more in our Employment Law Blog.
Tags: acquisition, biologic, biopharmaceutical, biotechnology, blue stream, charles river laboratories, clinical development, merger, merger and acquisition, pharmaceutical
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MBBP client Blue Stream Laboratories, an analytical contract research organization supporting the development of complex biologics and biosimilars, was acquired by Charles River Laboratories. Charles River Laboratories is a provider of essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts.
According to Blue Stream, “The synergy of combining Blue Stream’s core expertise with Charles River’s existing broad portfolio of biopharmaceutical clinical development and supporting services creates a well-established services entity which can fully support biologic and biosimilar development.”
Morse, Barnes-Brown & Pendleton served as counsel to Blue Stream Laboratories and advised them in connection with the structuring, negotiation and documentation of this transaction. Shannon Zollo was the lead corporate attorney on MBBP’s team.
For more information, read the full news release.
Ad Network to pay $950,000 in civil penalties for alleged privacy misrepresentations and alleged COPPA violations 06/22/2016Posted by Morse, Barnes-Brown Pendleton in Client News, Internet and E-Commerce, New Resources.
Tags: Childrens online privacy act, deceptive trade practice, FTC, InMobi, privacy laws, settlement
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The Federal Trade Commission (FTC) today announced a settlement with InMobi, a Singapore-based mobile advertising network. The FTC alleged that InMobi engaged in deceptive trade practices in violation of Section 5(a) of the FTC Act by misrepresenting its practices regarding online consumer tracking and collection of information from children. The FTC also alleged that InMobi violated the Children’s Online Privacy Protection Act (COPPA) by failing to comply with COPPA’s notice requirements and failing to obtain verifiable parental consent before collecting and using personal information (including geolocation information) from children under the age of 13.
The penalties imposed were $4 million (suspended to $950,000 based on the company’s financial condition). This case underscores the importance of ensuring that privacy representations are accurate and complying with COPPA. Please contact Faith Kasparian if you have questions about privacy representations and/or whether COPPA applies to your business and how to comply.
MBBP Client Valeritas, Inc. Announced Positive Results for V-Go® Disposable Insulin Delivery Device 06/16/2016Posted by Morse, Barnes-Brown Pendleton in Client News.
Tags: client, insulin, insulin delivery, Life Sciences, medical devices, patient care
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MBBP client Valeritas, Inc. has recently announced positive results for four studies on their flagship product. Valeritas is a commercial-stage medical technology company focused on developing innovative solutions to improve health and quality of life of people with Type 2 diabetes.
Their flagship product is the V-Go® Disposable Insulin Delivery Device which is a small, wearable, disposable insulin delivery solution for the delivery of basal-bolus insulin therapy in adults with Type 2 diabetes.
The four studies were as followed:
Study 1: Evaluating the Impact on Diabetes Control with V-Go® For Patients with Diabetes not Achieving Optimal Control: A Retrospective Cohort Analysis in a Large Endocrine and Specialized Diabetes System
Study 2: Evaluating V-Go® In Patients 65 Years of Age or Older with Poorly Controlled Diabetes: A Health Outcome and Economic Analysis from an Endocrine and Diabetes Specialty System
Study 3: Optimizing Insulin Therapy in Older Adults in Long-Term Care: A Com parative Retrospective Analysis of V-Go® vs. Standard of Care
Study 4: Improved Glycemic Control in Patients with Type 2 Diabetes Switching to the V-Go® Insulin Delivery Device: A Prospective Study Utilizing Continuous Glucose Monitoring
These studies showed that when using, or switching to V-Go®, patients with diabetes experienced improved glycemic control, a reduction in A1C and cost savings when compared to comparison treatments. Overall, Dr. David Sutton remarks, “The studies that I am involved with provide data that continues to support the real-world clinical value of using V-Go® in patients that require insulin. Importantly, the data presented at ADA shows the value of V-Go® in older patients that require both a clinically-effective and cost-effective therapy.”
Great work, Valeritas, Inc.!
For more information, read Valeritas press release.
Tags: infringement, patent, patent law, seagate, supreme court
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The U.S. Supreme Court has just issued a decision in two unrelated cases that overturns the 2007 Federal Circuit ruling, known as “Seagate”. The Supreme Court considers Seagate to be “unduly rigid” and overly limiting as to the potential for enhanced damages in patent infringement cases.
Since 2007, under the now-overturned-Seagate-analysis, a patent infringer could more easily avoid paying treble, or otherwise enhanced damages for their infringing activity, by simply demonstrating that they had not acted in an “objectively reckless” manner regarding their infringing activities. This essentially meant that a patent infringer could escape paying higher damages as long as they could present virtually any form of explanation or reason as to why they did not consider their activity to be infringing. This could even, in some instances, include asserting a defense during the patent infringement trial that they ultimately lost, with nothing else such as a non-infringement opinion or other legal analysis.
Now in 2016, based on this overturned decision, a court can assess enhanced damages under 35 U.S.C. §284, including treble damages, for patent infringement activities at the discretion of the court. This decision eliminates the more rigid test requirements of Seagate, which means courts can now assess enhanced damages more often for less egregious infringing activities.
How does this affect you? The Supreme Court decision did not go so far as to specify whether willful infringement is required for an enhanced damages award (vs. a requirement that the infringement be “egregious”). As such, in a patent infringement case where infringement is found, the court will take into account all evidence and at its discretion decide at the end of a trial whether the patent infringer should be on the hook for enhanced damages or not. Many had interpreted the Seagate ruling of 2007 as reducing the need for non-infringement opinions to be drafted by attorneys as a protection against enhanced damages should infringement be found.
Whether or not you had that view in 2007, it is clear that now with Seagate being overruled you may want to more carefully consider whether you should obtain at least a legal memorandum or analysis, if not a full-fledged legal opinion, from your patent attorney if you are concerned about a competitor patent and whether your product may infringe. If nothing else, it appears that in light of this Supreme Court decision such documents from your attorney will now do more to protect you from enhanced damages, including treble damages, if you are found to infringe another’s patents.
For more information concerning this issue, please contact Sean D. Detweiler.
 Halo Electronics, Inc. v. Pulse Electronics, Inc., U.S., No. 14-1513, 6/13/2016; Stryker Corp. v. Zimmer, U.S., No. 14-1520, 6/13/2016
 In re Seagate Technology, LLC, 497 F. 3d 1360
Tags: data, investment firm, investsoft, morningstar, risk, software, workflow
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MBBP Client InvestSoft Technology, a provider of innovative software solutions designed to streamline workflow, reduce risk and harness the value of data throughout an organization, was acquired by Morningstar, Inc. (NASDAQ: MORN), a leading provider of independent investment research.
Todd Roitfarb, chief executive officer of InvestSoft, said, “InvestSoft understands the real-time needs of investment firms, and we pride ourselves on the speed and accuracy of our calculations and the seamlessness of our data processing. Now that we are part of Morningstar, we can reach and better serve more investors who need high-quality fixed-income analytics.”
MBBP has served as counsel to InvestSoft since 2009, and advised it in connection with the structuring, negotiation and documentation of this transaction. Jon Gworek was the lead attorney on MBBP’s team, which also included attorneys Howard Zaharoff and Matthew Loecker.
For more information, read the full news release here.
PULSE@Mass Challenge Now Open in Boston! 06/10/2016Posted by Morse, Barnes-Brown Pendleton in Client News, Life Sciences, Medical Devices.
Tags: biotechnology, digital health, entrepreneur, entrepreneurs, innovation, Life Sciences, MassChallenge, research
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PULSE@MassChallenge officially opened in Boston last week, adding to the already increasing number of digital health companies in the area. MBBP’s Peter Barnes-Brown attended the ribbon cutting ceremony.
Read more about Peter’s thoughts on the growing digital health industry and about the company on our VCs & Startups Blog.
Tags: acquisitions, indemnification provisions, MCLE, mergers, mergers and acquisitions, termination provisions, transactions, warranties
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Carl Barnes will be featured as a panelist on the upcoming MCLE program “Representations, Warranties, Indemnification and Termination Provisions: Drafting and negotiating to allocate risk in business transactions”.
For more detail and for information on how to register, visit our M&A Today blog.
Tags: acquiring, acquisition, client, logistics, M&A transactions, SaaS, trademark, transportation
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Firm client Kewill announced that as of June 1, 2016, its acquisition of LeanLogistics is closed. The acquisition will allow the two companies to better serve their customers’ supply chain logistics needs.
Kewill specializes in enabling its clients to efficiently move their information and goods across the global supply chain through its logistics software.
LeanLogistics’ is a software as a service (SaaS) company with a cloud-based transportation management system.
Kewill’s acquisition of LeanLogistics creates “the most expansive and largest carrier network feeding into the most sophisticated Transportation Management platform available in North America.” Congratulations to both companies on the acquisition!
Tags: biotech, biotechnology, boston, employers, Life Sciences, medical labratories, medical research, patent, research
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The Boston Business Journal just announced that at the annual Biotechnology Innovation Organization meeting, Boston was recognized as the city with the largest number of employers in the field of research testing and medical laboratories. The BBJ explains that from biotech giants such as Biogen to Genzyme to research labs at the prestigious Harvard and MIT, the city is booming in life science employment and early stage development.
Furthermore, MassBio CEO and President Bob Coughlin explains how, “The research shows Massachusetts shines at the earliest stages of industry, with high levels of academic research, NIH and venture capital investments, as well as number of patents earned by our institutions…” Specifically, MA had $9.5 billion in VC investment in a three year term and ranked just behind California in the number of life science patents awarded.
MBBP is proud to represent life sciences companies throughout the greater Boston area (and beyond), in fields including biotechnology, pharmaceuticals and medical devices, along with institutions and investors in a wide range of sophisticated legal matters that arise in connection with the development, protection and commercialization of their diagnostic and therapeutic solutions.
Register Now! Laying the Firm Foundation for Growth: Entity & Equity – Life Sciences Series – Panel 2 05/31/2016Posted by Morse, Barnes-Brown Pendleton in Attorney News, Client News, Events, Intellectual Property, Life Sciences, MBBP news.
Tags: entrepreneurs, equity, Intellectual Property, Life Sciences, llc, llc formation, startup
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Join us at our Waltham office on June 22nd for the second panel in our Life Sciences Series, Laying the Firm Foundation for Growth: Entity & Equity.
Our expert panel will discuss whether a corporation or a limited liability company is more suitable for building an emerging company, and how to maximize the equity compensation of your team with restricted stock, stock options, or profits interests.
The event will take place from 7-9:30am. A light breakfast will be provided. Seating is limited – please register here.
Eric Lander of MBBP Client Whitehead Institute for Biomedical Research Receives MIT’s Killian Award 05/19/2016Posted by Morse, Barnes-Brown Pendleton in Client News, Life Sciences.
Tags: biology, client, Eric Lander, genome, MIT, President's Council of Advisors on Science and Technology, research, science, science and technology, Whitehead Institute for Biomedical Research
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MIT’s 2016-2017 James R. Killian Jr. Faculty Achievement Award was presented to biology professor Eric Lander. Lander, of MBBP client Whitehead Institute for Biomedical Research, is a renowned biologist recognized for his research in mapping the human genome. The Killian Award, established in 1971, honors faculty members who demonstrate extraordinary professional achievements.
Lander led the international Human Genome Project from 1990 to 2003, which included the development of techniques to map the human genome. He has taught his MIT introductory biology course for over 20 years. In addition to these achievements, Lander serves as co-chair of the White House’s President’s Council of Advisors on Science and Technology.
Lander joined the Whitehead Institute for Biomedical Research in 1986. The Whitehead Institute is a non-profit research facility that works to improve human health through biomedical research.
The Killian Award committee explained that “unlocking the information in genomes has been one of the defining scientific revolutions of the past quarter century. With the Killian Award, the committee acknowledges the transformative effect Professor Lander has had on the study of biology and medicine. We honor Professor Eric S. Lander for these extraordinary contributions, and for his roles as a gifted leader, teacher, mentor, and public advocate for science at the highest levels.”
In response, Lander stated that he is “tremendously honored, especially because this is an award conferred by my faculty colleagues at MIT. There is no higher recognition.”
Tags: entrepreneaurship, entrepreneurs, Germany, healthcare, investors, Life Sciences, science, Summit
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John Hession, Co-Chair of both the Corporate Department and the Life Science Task Force at Morse Barnes-Brown & Pendleton, PC, will be the Moderator of the prestigious Charité Entrepreneurship Summit 2016-Rethink & Transform Healthcare being held in Berlin, Germany May 26th & 27th. This is the 4th time John finds himself in this role, and he proclaims it as being one of his favorite and most rewarding “extra- curricular” activities.
Among the largest life sciences and health care industry conferences held in Western Europe each year, the Charité Summit brings together over 400 international entrepreneurs, scientists, investors and healthcare industry professionals. This year’s agenda features such diverse and relevant topics as the digitalization of health care, the prospects of genome editing, and the growing understanding of the compelling impact of gender differences on research and in the practice of medicine.
John says the role of Summit moderator is one he relishes with particular enthusiasm because it affords him the opportunity to interact with both the learned speakers and the diverse audience of life sciences and healthcare professionals. As he remarked, “The insights are scintillating and informative, the speakers animated and trenchant, and the networking before, during and after the program – in the Berlin beer halls- robust and gregarious.” Hession is the only American to repeat as Moderator in its 9 year history.