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MBBP’s Jon Gworek on Panel for Harvard Law School Event: Careers in Venture Capital and Private Equity for J.D. Students 10/30/2014

Posted by Morse, Barnes-Brown Pendleton in Attorney News, Events, MBBP news, Venture Capital & Private Equity.
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Corporate Attorney Jonathan GworekHarvard Law School’s Office of Career Services is hosting an upcoming event, Careers in Venture Capital and Private Equity for J.D. Students on November 12th. MBBP Partner Jon Gworek will serve as a panelist at this event along with Deirdre Cummane of ATV Capital and David Kreisler of Weil Gotshal. This event will discuss topics such as the key differences between venture capital and private equity, a lawyer’s role in the field, and  strategies on how to embark on a career in the field.

For any questions regarding venture capital and private equity, please contact Jon Gworek

MBBP Supports MA Colleges and Universities in MITEF ‘Beantown Throwdown’ 10/23/2014

Posted by Morse, Barnes-Brown Pendleton in Events, Intellectual Property, MBBP news, New Resources, Telecommunications & Networking.
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2014-10-23_13-28-36MBBP joins MIT Enterprise Forum of Cambridge and CHEN PR in hosting the upcoming Beantown Throwdown in November.  Students from top colleges and universities in Massachusetts will pitch off their innovative ideas for start-up companies.  Students representing Babson, Berklee, Boston University, Boston College, Harvard, MIT, UMass Lowell, Northeastern and Wentworth will have 3 minutes to present their ideas to attendees who will then invest in their favorite companies with fake cash. The top three start-up companies with the most “money” invested will win various prizes and take part in a discussion panel the following evening.

 

To learn more about the Beantown Throwndown

MBBP Client Named to BBJ and MHT 2014 Innovation All-Stars List 10/21/2014

Posted by Morse, Barnes-Brown Pendleton in Client News, Computer Software & Hardware, Internet and E-Commerce, MBBP news.
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2014-10-20_13-58-38This month, the Boston Business Journal and Mass High Tech have published the list of 2014 Innovation All-Stars .  This year, two individuals and 15 companies will be honored. Among the companies named is MBBP client erecruit,  which was selected for the category of internet and business software.

Congratulations erecruit!

The full list of the 2014 Innovation All Stars can be read here

MBBP Client Results:Digital Acquired by MARC USA 10/06/2014

Posted by Morse, Barnes-Brown Pendleton in Client News, Computer Software & Hardware, Internet and E-Commerce, MBBP news.
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resultsdigMBBP Client Results:Digital, a Boston-based digital media agency, has been acquired by  a national marketing communications company. MARC USA is a  full-service marketing firm known for uncovering radical insights that incite powerful reactions through a deeper understanding of whole-brain behavior.  MARC USA offers many services, including advertising, strategic planning, and public relations. Results:Digital’s expertise lies in developing digital marketing solutions for large-scale B2C and B2B clients. The company focuses on understanding consumer behavior in order to uncover their unique insights, and from there decides how to successfully connect and influence consumers. The combination of the two companies will accelerate the growth of digital media offerings and services to better meet consumer needs.

“This acquisition gives us both expanded expertise in the fast-growing digital space as well as a new regional base in Boston, a city we believe has great potential for our combined agency,” said Tony Bucci, Chairman of MARC USA.

Results: Digital will be renamed  to MARC USA|Results:Digital and will then be fully-integrated within MARC USA’s media capabilities.

Congrats, Results:Digital!

To read the full article 

Newest Issue of Preferred Returns Released 10/06/2014

Posted by Morse, Barnes-Brown Pendleton in Attorney News, MBBP news, New Resources, Venture Capital & Private Equity.
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Corporate Attorney Jonathan GworekLast month, the most recent issue of Preferred Returns, the online publication of the American Bar Association’s Private Equity and Venture Capital Committee was released. This issue includes the Committee’s second annual survey of venture capital cases for 2013, which summarizes the most significant cases from last year.   The publication has a number of useful articles covering the latest legal development impacting the venture capital industry,  including cases covered by MBBP’s Mary Beth Kerrigan and Scott Bleier, as well as other developments of note.

MBBP Partner Jon Gworek is current chair of the ABA PEVC Committee

For more info, please contact Jon 

Jon Gworek Leads Private Equity and Venture Capital Committee at ABA Business Law Annual Meeting 09/29/2014

Posted by Morse, Barnes-Brown Pendleton in Attorney News, Events, Venture Capital & Private Equity.
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Corporate Attorney Jonathan GworekThe Private Equity and Venture Capital Committee of the Business Law Section of the American Bar Association met September 11-13th at this year’s annual meeting held in Chicago. As chair of the PEVC Committee, MBBP Partner Jon Gworek was integrally involved in the planning of the committee’s activities and cahired the full committee meeting in Chicago. The PEVC Committee sponsored two CLE events; “Drafting a Stronger Preferred Stock: Responses to Recent Case Law Developments”, and “How Inside and Outside Corporate Counsel Can Work Together to Maximize the Value of Corporate Legal Services”.

 

To learn more, please contact Jon Gworek.

BBK Worldwide raises $3M, eyes acquisitions 09/18/2014

Posted by Morse, Barnes-Brown Pendleton in Client News, Medical Devices.
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BBK WorldwideMBBP client BBK Worldwide has raised $3 million from a private, undisclosed investor and its two founders. The consultancy specializes in patient recruitment for the clinical R&D segments of the pharmaceutical, biotechnology, and medical device industries.

BBK moved from Newton to a new 15,000-square foot space in Needham earlier this year and has plans to grow its headcount by 10 percent before the end of the year.  BBK’s patient recruitment software is called TrialCentralNet, and its mobile app is My Clinical Study Buddy. The women-owned business says it has helped 23 of the world’s top 25 pharmaceutical companies to find patients for studied in the past year.

Read more in the Boston Business Journal.

Way to grow, BBK!

FDA Establishes “Purple Book” for Biosimilars 09/15/2014

Posted by Morse, Barnes-Brown Pendleton in Legal Developments, Life Sciences.
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By: David Fazzolare and Joanna Brougher

Patent Attorney David FazzolareOn September 9, 2014, the FDA announced the establishment of the “Purple Book” (formally entitled “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations”), which is the equivalent for biologics of the FDA’s “Orange Book.” Whereas the Orange Book lists all small molecule reference listed drugs and their counterpart generic drugs that have been approved by the FDA under the Hatch-Waxman Act, the Purple Book Patent Attorney Joanna Brougherlists all licensed biologics and will list the corresponding biosimilars when they are licensed by the FDA, and will designate whether the biosimilars are also interchangeable, under the Public Health Service Act (“PHSA”). The Purple Book will also provide the dates that the biologics were first licensed under section 351(a) of the PHSA, including whether the FDA has evaluated the biologic product for reference product exclusivity under section 351(k)(7) of the PHSA. Unlike the Orange Book, however, the Purple Book will not list patent information pertaining to licensed biologics.

Questions on the “Purple Book” can be directed to David or Joanna.

MBBP Attorney Stanley Chalvire to Speak at MDG Boston Forum 09/05/2014

Posted by Morse, Barnes-Brown Pendleton in Attorney News, Events, Intellectual Property, Internet and E-Commerce, Licensing & Strategic Alliances, MBBP news, Medical Devices.
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chalvireMedical Development Group (MDG), an organization for professionals in the medical device industry, is hosting an upcoming forum event entitled “Intellectual Property Approaches to Safeguard Value”. MBBP IP and Licensing Attorney Stanley F. Chalvire will serve as one of the speakers of this forum event, which will generally be directed to intellectual property strategies for creating and preserving value of medical devices.

 During the forum, some topics that Stan will address include:

  • Trade Secrets and the protections they can provide
  • Distinguish Trade Secrets and Patents
  • Discuss Strategic Considerations to Maintain Trade Secrets

The event takes place at Constant Contact headquarters in Waltham, MA on Wednesday October 1st.

 To register, please visit MDG Boston 

 

MBBP Client Hastings Equity Partners Completes Sale of Advanced Precision Products, Inc. 09/04/2014

Posted by Morse, Barnes-Brown Pendleton in Client News, Intellectual Property, Manufacturing, Retail & Service, MBBP news, Public Companies.
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Hastings Equity Partners, LLCMBBP client Hastings Equity Partners recently announced the sale of Advanced Precision Products, Inc. (APP) to Precision Engineered Products, LLC (PEP). Advanced Precision Products is a leading manufacturer of highly engineered components and products for oil & gas, medical, aerospace, automotive, military and commercial OEMs.  Morse, Barnes-Brown & Pendleton serves as counsel to Hastings Equity Partners, and advised it in connection with the structuring, negotiation and documentation of this transaction. Shannon Zollo was the lead corporate attorney on MBBP’s team, which also included attorneys Mark Tarallo and Jonathan Calla.

Hastings Equity Partners is a Waltham, MA-based, private investment firm that acquires and grows small to mid-sized enterprises.

Please visit Hastings Equity Partners for more information.

MBBP’s Joanna Brougher 2014 National Law Journal Rising Star 09/02/2014

Posted by Morse, Barnes-Brown Pendleton in Attorney News, Intellectual Property, Life Sciences, MBBP news, Medical Devices.
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9-2-2014 10-08-43 AM MBBP’s Joanna Brougher was selected for the 2014 National Law Journal’s list of Boston’s Rising Stars. The National Law Journal Rising Stars program recognizes the region’s 40 most promising lawyers age 40 and under.  Joanna graduated from the University of Rochester with a B.S. in Microbiology, a B.A. in German, and a masters in public health. Joanna received her J.D. from Boston College Law School in 2008.  She is a biotech, pharma, medical device and intellectual property consultant, and is also a adjunct lecturer at Harvard School of Public Health where she teaches a course on intellectual property and health technologies.

Congrats, Joanna!

More info on Boston’s Rising Stars

MBBP Client Implant Sciences Corporation Achieves Milestone With QS-B220 09/02/2014

Posted by Morse, Barnes-Brown Pendleton in Client News, Computer Software & Hardware, Industries, Intellectual Property, MBBP news.
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9-2-2014 12-36-18 PMMBBP client Implant Sciences Corporation, a company that develops and manufactures explosive trace detection sensors and systems, announced that its QS-B220 desktop explosives trace detector has successfully completed the certification process for the United States Transportation Security Administration’s (TSA) Explosive Trace Detection (ETD) qualification requirements for aviation checkpoint and checked baggage screening.

This announcement marks a major milestone for the company; having the QS-B220 added to the TSA’s Qualified Product List is one of the highest levels of recognition in the security industry and one of the most difficult to achieve,” according to Todd Silvestri, Implant Sciences’ Vice President of Technology.

President and CEO, Glenn D. Bolduc, stated    “We’re very proud to be able to deliver this innovative product for the protection of travelers in our country. Every member of the Implant Sciences team has done a phenomenal job of getting us to this point.”

 

 You can read Implant Sciences’ complete announcement here.

 Well done, Implant Science Corporation!

 

 

Want To Stay Employed as a CIO? Better Get Privacy Right 08/25/2014

Posted by Morse, Barnes-Brown Pendleton in Computer Software & Hardware, Intellectual Property, Internet and E-Commerce, Legal Developments, Privacy and Data Security.
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Consumer privacy is emerging into a big headache for companies — and the CIO is bearing the brunt. Most companies analyze customer data in some way, and there are increasing amounts of legislation around how such data handling should be performed. Breaking the rules can land a company in hot water — and leave the CIO out of a job. Sensitive information is often copied from system to system by staff with little understanding of  privacy issues and risks surrounding sensitive data. As a result, it falls to the CIO to make sure that a customer privacy strategy is in place. To properly ensure consumer privacy, the CIO should make sure their company is complying with existing regulations, but also be prepared for possible data breaches.

To read the full article

Understanding the rapidly changing landscape of privacy and data security laws is critical for any business. For more information on how MBBP counsels clients in this area, visit our Privacy & Data Security practice or check out our related resources.

MBBP Client Acquired by Blackboard 08/19/2014

Posted by Morse, Barnes-Brown Pendleton in Attorney News, Client News, Computer Software & Hardware, MBBP news.
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cardsmithMBBP client CardSmith, the industry’s leading cloud provider of campus card solutions and turn-key card program management services, has been acquired by Blackboard, the world’s leading education technology company. Blackboard offers campus card services and integrated campus commerce and security solutions to hundreds of institutions. CardSmith joins Blackboard’s growing set of student identification services and will broaden the credentialing deployment options the company offers to schools and institutions.

MBBP Attorneys Chip Wry, Joe Martinez and Jonathan Calla were the attorneys on this deal.

For the full press release, please visit Blackboard’s website

MBBP Attorney Helps Fight Cancer: PMC 2014 08/19/2014

Posted by Morse, Barnes-Brown Pendleton in Attorney News, Life Sciences, MBBP news, Nonprofit.
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cavaretta2

This year, MBBP Partner Mike Cavaretta completed his tenth Pan Mass Challenge.  The PMC is a two-day 194-mile bike ride across Massachusetts from Sturbridge to Provincetown to raise money for The Dana-Farber Cancer Institute.

“Why do I do it? Some people might say it’s because I’m crazy. Others might say it’s for the free beer (Harpoon!). And still others might say it’s for the challenge and the camaraderie. They’d all be right. But the main reason I do it is to help wipe out cancer”

The Pan Mass Challenge has raised more money for charity than any other event in the country. Their goal this year is to raise $40 million dollars by October 2014, 100% of which will go to Dana-Farber and the Jimmy Fund. To donate on Mike’s (or other riders’) behalf please visit the PMC website.

Congrats, Mike! Well done!

Second Biosimilar Application Filed Under BPCI Act by Celltrion 08/13/2014

Posted by Morse, Barnes-Brown Pendleton in Intellectual Property, Life Sciences.
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Patent Attorney David FazzolareBy: David Fazzolare and Joanna Brougher

On August 8, 2011, Celltrion announced that it filed a biosimilar application under the Biologics Price Competition and Innovation Act (BPCI Act) for its infliximab biosimilar.  Celltrion’s infliximab biosimlar is already marked in over 50 countries worldwide, including Europe, Canada and Japan, under the brand name of Remsima®.  Celltrion’s announcement comes shortly after Sandoz’s recent announcement that thePatent Attorney Joanna Brougher FDA had accepted its application for a filgrastim biosimilar application, and marks the second biosimilar application known to be filed under the BPCI Act, as well as the first application for a biosimilar mAb.

For more information on this topic, contact David or Joanna.

David Fazzolare Quoted in FDA Week Biosimilar Article 08/12/2014

Posted by Morse, Barnes-Brown Pendleton in Attorney News, Intellectual Property, Legal Developments, Life Sciences.
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Patent Attorney David FazzolareOn August 8th InsiderHealthPolicy.com’s FDA Week, an exclusive weekly report on Food and Drug Administration Policy, regulation and enforcement, published an article titledBiosimilar ‘Patent Dance,’ Litigation Could Coincide With Possible Approval. The article discusses the FDA’s recent acceptance of the first biosimilar application from Sandoz for a biosimilar filgrastim, a version of Amgen’s Neupogen. This acceptance of Sandoz’s application has also set off a series of deadlines outlined in statute that will determine which patents the two companies will litigate. MBBP Patent Attorney David Fazzolare was quoted in the article discussing the patent exchange process including several other deadlines before possibly resulting in litigation. David stated:

The earliest that I see anything publicly happening, absent any press releases from Sandoz and Amgen, is March of next year.

The same two companies are currently engaged in litigation over patents related to a different product, Enbrel, which is currently on appeal in the U.S. Court of Appeals for the Federal Circuit and oral arguments are slated for Sept. 10.

For more information on this topic, please contact David Fazzolare.

FDA Releases Guidance for Determining Biologic Exclusivity Under the BPCI Act 08/08/2014

Posted by Morse, Barnes-Brown Pendleton in Intellectual Property, Life Sciences.
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Patent Attorney David FazzolareBy: David Fazzolare & Joanna Brougher

On August 4, 2014, the Food & Drug Administration (FDA) released its latest guidance in a series of guidance documents issued as part of its ongoing effort toward implementing a biosimilar approval pathway under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).  In contrast to previously released guidance which dealt with the scientific and regulatory considerations involved inPatent Attorney Joanna Brougher reviewing biosimilar applications, such as the clinical pharmacology data required to demonstrate biosimilarity to a licensed biologic, this latest guidance outlines the FDA’s current thinking with respect to determining whether a licensed biologic is entitled to the exclusivity provided for in Section 351(k)(7)(C) of the Public Health Service Act (PHS Act), as amended by the BPCI Act.

To spur the development of innovative and lifesaving biologic medicines, the BPCI Act amended the PHS Act to award periods of exclusivity to certain licensed biologics during which the FDA is prohibited from taking certain actions with respect to an application for a biosimilar version of those licensed biologics.  The Act provides two relevant exclusivity periods which are both calculated from the date on which a licensed biologic was first licensed.  The guidance refers to this date as the date of “first licensure.”  Section 351(k)(7)(C) provides that licensure of an application for a biosimilar or interchangeable product under the BPCI Act may not be made effective until 12 years after, or submitted to the FDA for review until 4 years after, the date of first licensure of the licensed biologic referenced in the biosimilar application. Thus, establishing the date a licensed biologic was first licensed is critical to determining when the licensed biologic’s exclusivity ends and thus when biosimilar and interchangeable products may enter the market.

Typically, the date of first licensure is the initial date a given biologic product is licensed under 351(a).  Not every licensure of a biological product under 351(a), however, is considered a “first licensure” that gives rise to its own exclusivity period.  To assist stakeholders and reviewers at the FDA in determining whether licensure of a biologic product under 351(a) gives rise to its own exclusivity period, the guidance outlines circumstances in which a licensure would not be considered a “first licensure.”  For example, the date of first licensure does not include the date of licensure for a supplement for the biological product that is the reference product, or a subsequent application by a biologic manufacturer or sponsor (or related entity) for a change to a licensed biologic that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength, or a modification to the structure of the biological product that does not result in a change in safety, purity, or potency.  In other words, for the date of licensure of a modified version of a biologic licensed under 351(a) to be considered the date of first licensure, there must be a modification to the structure of the biologic that results in a change in safety, purity, or potency.

The guidance notes that the FDA intends to determine on a case-by-case basis, based on data submitted by the sponsor, whether a structural modification to a licensed biologic results in a change in safety, purity, or potency that is sufficient to trigger its own exclusivity period.  However, the guidance does not elaborate on how significant those changes must be for the modified biologic to obtain its own exclusivity period.  In this manner, the guidance falls short of providing much needed certainty on the topic.  It is important to remember, however, the guidance has not yet been finalized by the FDA and is subject to change.  Moreover, in releasing the guidance that the FDA passed another major milestone toward implementing the biosimilar approval pathway created by the BPCI Act and shed some light on the topic of biologic exclusivity.

For more information on this topic, contact David or Joanna.

Biosimilars Developers Watch Closely as FDA Accepts First Biosimilar Application from Sandoz 07/29/2014

Posted by Morse, Barnes-Brown Pendleton in Intellectual Property, Life Sciences.
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Patent Attorney David FazzolareBy: David Fazzolare & Joanna Brougher

Sandoz, a Novartis Group company, announced on July 24, 2014 that the US Food and Drug Administration (FDA) has accepted for review its application for a biosimilar version of filgrastim. The reference product, Neupogen®, which brought maker Amgen Inc. $1.4 billion in sales in 2013, is a biologic used to prevent
infections in cancer patients getting certain treatments that result in a decrease in infection-fighting whitePatent Attorney Joanna Brougher blood cells.  Sandoz’s application for filgrastim is the first biosimilar application known to have been accepted by the FDA for review since the Biologics Price Competition and Innovation Act (BPCIA) established an approval pathway for biosimilars in 2009.  Sandoz’s biosimilar filgrastim has already been approved in more than 40 countries outside the US under the brand name Zarzio®, including in Japan and Europe, and could be the first biosimilar approved in the US under the BPCIA.  Such biosimilars could offer patients more affordable alternatives to existing biologic medicines similar to the way that generic drugs approved under the Hatch Waxman Act offer patients more affordable alternatives to their brand-name counterparts.

Sandoz’s announcement came shortly after the FDA released its draft guidance for industry entitled “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.”  The FDA had previously released three draft guidance documents outlining the FDA’s then-current thinking on important scientific and regulatory considerations relevant to submitting biosimilar applications, however, none of the industry guidance documents have yet been finalized.  More importantly, none of the guidance documents provide clarity on the evidentiary thresholds required by the FDA to obtain interchangeability status for a biosimilar, which is required before an approved biosimilar can be substituted for a prescribed biologic without first consulting the prescribing physician.  Although it is unclear whether Sandoz is pursuing interchangeability status for its biosimilar version of fligrastim, the FDA’s review of Sandoz’s application could provide much needed clarity on this as well as other issues related to the approval pathway for biosimilars.  As the FDA weighs approval of Sandoz’s application, drugmakers are certain to gain insights on how the FDA will review future biosimilar applications.

For more information on this topic, contact David or Joanna.

MBBP Client Deborah Halber Publishes First Book 07/23/2014

Posted by Morse, Barnes-Brown Pendleton in Client News, Publishing & Media.
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Congratulations to MBBP client Deborah Halber on the publication of her first book, The Skeleton Crew: How Amateur Sleuths are Solving America’s Coldest Cases (Simon & Schuster, 2014)! Publishers Weekly calls this “A lively study that’s … eminently entertaining and will be devoured by armchair detectives.” The Boston Globe says that Deborah writes “vividly and engagingly” and calls the book “captivating.” We say “Way to go, Deborah!”

To read an excerpt from The Skeleton Crew and complete reviews, visit Deborah’s website. To hear her July 1 On Point interview with Tom Ashbrook, click here.

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