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Apotex’s Second Biosimilar Application Accepted by FDA 02/26/2015

Posted by Morse, Barnes-Brown Pendleton in Industries, Life Sciences, New Resources.
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Patent Attorney Joanna Brougher Patent Attorney David FazzolareBy: David A. Fazzolare and Joanna T. Brougher

On February 18, 2015, Apotex Inc., announced that the Food and Drug Administration (FDA) had accepted its application for a biosimilar version of Amgen Inc’s Neupogen®. Apotex is second to Sandoz Inc. to propose a biosimilar version of Neupogen® (filgrastim), which is administered during chemotherapy to boost white blood cell counts and help fight infections. This is Apotex’s second biosimilar application, following Neulasta® (pelfilgrastim), a long-acting version of Neupogen®, filed last year. The approval of both Sandoz’s and Apotex’s Neuopogen(r) biosimilar applications could shed some light on the extent to which biosimilars will impact biologic sales.

Apotex hopes its biosimilar will be designated as an “interchangeable” product under the Biosimilars Act, which means that pharmacists filling prescriptions for Neupogen(r) could potentially substitute it without consulting the prescribing physician. However, it it is unclear whether it will benefit from the exclusivity period awarded to the first interchangeable product in view of Sandoz’s earlier filed Neupogen(r) biosimilar application. Even though Sandoz has publicly stated that it is not seeking interchangeability status for its Neupogen® biosimilar product, if the FDA nevertheless designates it as interchangeable Apotex would not be entitled to exclusivity for its Neupogen® biosimilar, and would have to wait until Sandoz’s exclusivity expired before the FDA would designate Apotex’s Neupogen® biosimilar as interchangeable.  On the other hand, if the FDA does not designate Sandoz’s Neupogen® biosimilar as interchangeable, then Apotex’s biosimilar could be designated as interchangeable, as well as benefit from the exclusivity awarded to the first biosimilar to receive designation as interchangeable.
For more information on this topic, please contact David A. Fazzolare or Joanna T. Brougher.

Forging Successful Strategic Alliances for Life Sciences Companies 02/25/2015

Posted by Morse, Barnes-Brown Pendleton in Corporate, Licensing & Strategic Alliances, Life Sciences, M&A, New Resources, Public Companies.
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M0744200When entering into an exclusive licensing arrangement, the odds of success are against most companies. Typically within the first twelve months of an arrangement, 2/3 of all alliances crumble.  If these ventures are so prone to failure, what preventative measures can a company employ to ensure success?

To learn how to achieve success when entering an alliance, read John Hession’s full article.

MBBP Client Demiurge Studios Acquired by SEGA Networks 02/20/2015

Posted by Morse, Barnes-Brown Pendleton in Client News, Computer Software & Hardware, Games & Interactive Entertainment, Intellectual Property, Legal Developments, Licensing & Strategic Alliances, New Resources, Public Companies, Publishing & Media.
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2015-02-19_10-29-40MBBP Client Demiurge Studios, an independent game developer out of Cambridge, Massachusetts, has been acquired by SEGA Networks, a multinational video game developer, publisher, and hardware development company. Founded in 2002, Demiurge Studios made the transition into mobile gaming in 2008 and found success with Marvel® Puzzle Quest™, a top 100 grossing app on the App Store and top 50 grossing apps on Google Play. Previously, they worked with world-class developers like BioWare™ and Irrational Games™ on AAA console and PC games, contributing to titles such as BioshockBorderlands, and Mass Effect. Demiurge Studios will continue to make games under the Demiurge Studios name.

Morse, Barnes-Brown & Pendleton serves as counsel to Demiurge Studios, and advised it in connection with the structuring, negotiation and documentation of this transaction.

Joe Martinez was the lead corporate attorney on MBBP’s team, which also included attorneys Mike Cavaretta, Diana Española and Hillary Peterson.

To learn more, read the full press release.

The Industrial Internet Consortium Announces Release of “Track and Trace” 02/18/2015

Posted by Morse, Barnes-Brown Pendleton in Client News, Industries, Manufacturing, Retail & Service.
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2015-02-12_12-25-14

MBBP client The Industrial Internet Consortium (IIC), a non-profit group whose mission is to accelerate growth of the Industrial Internet by identifying, assembling and promoting best practices, has announced the release of the Track and Trace testbed. The goal of this project is to manage handheld power tools in manufacturing and maintenance environments by efficiently tracking and tracing the usage of these tools for proper use. During this two year project, five Industrial Internet Consortium members will be lending their expertise to the testbed. With the Track and Trace testbed, companies will be able to enhance productivity, production quality, and work safety in manufacturing.

To read the full press release.

MBBP’s Carl Barnes on Panel for Boston University Law School Symposium: The Legal Challenges of Funding Startups 02/17/2015

Posted by Morse, Barnes-Brown Pendleton in Attorney News, Events, MBBP news, Venture Capital & Private Equity.
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Corporate Attorney Carl BarnesCarl Barnes will be a panelist at a symposium presented by the Boston University School of Law Review of Banking and Financial Law on Friday, February 27, 2015. The symposium will bring together legal scholars and practicing lawyers to discuss key financial issues that startup companies face, including crowdfunding, startup financing, and the tension between state and federal law.

For any questions regarding venture capital and start-up financing, please contact Carl Barnes.

Upcoming MBBP Event: Series A Venture Capital Financing: A Review of 2014 and What to Expect in 2015 02/12/2015

Posted by Morse, Barnes-Brown Pendleton in Events, MBBP news, Venture Capital & Private Equity.
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Cambridge Innovation Center (CIC)On Thursday, March 5th MBBP will host a VC event at the Cambridge Innovation Center discussing the various factors that need to be taken into consideration when pricing a venture capital transaction. We have gathered a panel of seasoned VCs that will discuss these factors and will share invaluable insight to entrepreneurs preparing for a fundraising.

Moderated by:
Scott Bleier, Senior Attorney, Morse, Barnes-Brown & Pendleton, PC


Panelists:
Luke Burns, Partner, Ascent Venture Partners
Rob Go, Cofounder, NextView Ventures
Paul Flanagan, Managing Director, Sigma Prime Ventures

This event is complimentary, but space is limited. Register today!
Please visit our event page for more details and to register.

MBBP Client Forge Worldwide Wins “Sweet” Partnership with Friendly’s 02/05/2015

Posted by Morse, Barnes-Brown Pendleton in Client News, Industries, Internet and E-Commerce, Public Companies, Publishing & Media, Telecommunications & Networking.
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forgelogoMBBP would like to congratulate client Forge Worldwide, a Boston-based advertising agency, for winning a partnership with Friendly’s Ice Cream.  Forge Worldwide will now oversee all television, radio, print and out-of-home advertising for Friendly’s as well as provide support to the Friendly’s team as it focuses on its re-brand and resurgence in core markets. Some other clients Forge Worldwide works with include Cisco, Rockland Trust, Brigham and Women’s Hospital, and Dragon Speech Recognition Software.

 

You can read the full announcement here.

Well done, Forge Worldwide!

FDA Recommends Approval of Sandoz’s Biosimilar Drug, a First 01/07/2015

Posted by Morse, Barnes-Brown Pendleton in Client News, Life Sciences, Medical Devices.
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By: David FazzolarePatent Attorney David Fazzolare

On January 5, 2015, the US Food and Drug Administration’s (“FDA’s”) Oncologic Drugs Advisory Committee (the “Committee”) announced its recommendation that the FDA approve Sandoz Inc.’s application to market Zarxio® (EP2006), a biosimilar version of Amgen, Inc.’s Neupogen® drug.  The Committee explained its recommendation in a 62-page, publicly-issued briefing document.  Zarxio® is the first drug reviewed by the Committee under new biosimilars provisions enacted as part of the Patient Protection and Affordable Care Act.  The Committee’s recommendation is therefore a key step forward not only for Zarxio®, but also for implementation of the new biosimilars provisions (known as the Biologics Price Competition and Innovation Act of 2009, or “BPCIA”).

Sandoz is not yet seeking interchangeability status for Zarxio®, a designation which allows pharmacists to substitute biosimilars in place of prescribed reference biologics—i.e., Zarxio® in place of Neupogen®.  Sandoz told the Committee it plans to file for interchangeability only after Zarxio® is fully approved as a biosimilar.

The Committee’s recommendation, while a milestone for the drug and the FDA, does not automatically clear the way for approval of Zarxio®.  The Committee noted that the lack of comparative data available left some “residual uncertainty about whether ADA [anti-drug antibodies] incidence is similar in subjects administered [Zarxio®] and … Neupogen®.”  On January 7, 2015, the FDA will take testimony from experts, who may weigh in on this issue, and provide their own recommendations as to whether the FDA should approve Zarxio® as a Neupogen® biosimilar.  The FDA will then undertake a full review of Zarxio®.  In the background is Amgen’s pending federal lawsuit against Sandoz, brought on October 24, 2014, which alleges Sandoz’s conduct violated the procedures required by the BPCIA.  Amgen also submitted a citizen’s petition to the FDA on October 29, 2014, asking that the FDA require biosimilar applicants to fully comply with all BPCIA procedures.  How the Committee’s recommendation will affect these filings remains unclear.

For more information, please contact David Fazzolare.

Q3 VC Data Reported in MBBP’s VC Spotlight Newsletter 12/19/2014

Posted by Morse, Barnes-Brown Pendleton in Client News, Venture Capital & Private Equity.
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MBBP’s Q4 VC Spotlight newsletter just published over on our Venture Capital and Start-Up Blog!

We’re reporting on Q3 2014 First Institutional Rounds; how the SEC’s suggested changes to the definition of which investors constitute “accredited investors”  might affect you; and a recent financing completed by our client, MA-based OYO Sports.

Get the details here.

Federal Circuit in Sandoz v. Amgen Upholds District Court Ruling on Standing Requirements in Biosimilars Cases 12/19/2014

Posted by Morse, Barnes-Brown Pendleton in Legal Developments, Life Sciences, Medical Devices, New Resources.
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Patent Attorney David FazzolareBy: David A. Fazzolare

The recent back and forth between Amgen and Sandoz took another dramatic turn on December 5, 2014, when the Federal Circuit affirmed the district court’s dismissal of Sandoz’s declaratory judgment lawsuit against Amgen because Sandoz’s alleged injury did “not meet the requirements of immediacy and reality” necessary for standing. Regarding immediacy, Judge Taranto noted that Sandoz had brought the suit at a time when it was years away from completing its Phase III clinical trials for its Enbrel® biosimilar. Obtaining FDA approval would further push back the earliest possible date on which Sandoz could hope to market its drug. Regarding reality, Judge Taranto further opined that it was possible that Sandoz’s biosimilar would never infringe the patents licensed to Amgen. For example, Sandoz’s drug could fail completely in Phase III trials and never be approved by the FDA; the drug might also require modifications making it dissimilar enough from Enbrel® as to prevent infringement, even while remaining biosimilar. For those reasons, Judge Taranto concluded Sandoz could not demonstrate that either of these possibilities was “so unlikely to arise” that Sandoz could show it had a concrete injury in the pipeline.

While seemingly fact-specific, the Federal Circuit’s decision may have larger ramifications for future cases involving the BPCIA. Judge Taranto noted in his opinion: “The biosimilarity approval standard is new; indeed, the FDA has not yet applied the new standard to complete its review of and approve any product under the BPCIA.” Yet elsewhere in the opinion, Judge Taranto suggested that the Federal Circuit, at least, had an idea of how courts should evaluate BPCIA cases. He wrote: “Our conclusion is consistent with our cases under the Hatch–Waxman Act. As noted above, we have found no justiciability where a declaratory-judgment plaintiff had not filed an application for the FDA approval required to engage in the arguably infringing activity. On the other hand, where we have found a case or controversy in the Hatch–Waxman setting, we have focused on the presence of an application for the required FDA approval.” Thus Sandoz’s failure to submit a biosimilar application to the FDA before filing seeking its declaratory judgment seems to have played a role in the outcome of the case.

The Federal Circuit’s decision to consider this BPCIA ruling’s conformity with Hatch–Waxman may be due to the fact that the BPCIA provision under which Sandoz’s brought suit was directly “borrow[ed] from” Hatch–Waxman. Whether other courts hearing BPCIA cases will look to Hatch–Waxman or view this part of the Federal Circuit opinion as dicta remains to be seen.

The Federal Circuit ultimately declined to review the district court’s alternative grounds for dismissal involving Sandoz’s failure to comply with BPCIA procedures, limiting the extent of its holding. While Sandoz may appeal this decision to the Supreme Court, it is clear for now that parties must continue to carefully evaluate standing prior to bringing a patent infringement suit under the BPCIA.

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

Upcoming MBBP Event: Get Your Head in the Cloud 12/12/2014

Posted by Morse, Barnes-Brown Pendleton in Computer Software & Hardware, Events, Industries, Internet and E-Commerce, MBBP news.
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On Tuesday, January 13, 2015, MBBP will host the Women’s Bar Association event entitled Get Your Head in the Cloud. A panel of experts will lead a discussion on the basics of cloud computing, how corporations are integrating it into their business, and the benefits involved.

Panelists Include:
Howard Zaharoff, Partner, MBBP
Anne W. Hulecki, Principal, Law Office of Anne W. Hulecki

To learn more or to register for this event, please visit the WBA website.

2013 Data Privacy Report 11/24/2014

Posted by Morse, Barnes-Brown Pendleton in Attorney News, Computer Software & Hardware.
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In September 2014, the Massachusetts Office of Consumer Affairs and Business Regulation released its 2013 Data Privacy Report, which includes an in-depth analysis of data breaches of personal information of Massachusetts residents during the year of 2013.

The report identifies the type of breaches reported (88% involving electronic records; 12% paper, faxes/mail/e-mail, both paper/electronic) and the industries most affected.  Not surprisingly, the financial services industry reflected the most significant activity and accounted for 85% of the total reported breaches, followed by the health care industry (5%).  As for the industry with the biggest increase in the number of those affected by data breaches, the education industry saw a massive 611% jump from 5,208 Massachusetts residents affected in 2012 to 31,780 in 2013.

The report also underscores the need for businesses to comply with the Massachusetts data security regulations that came into effect in 2010. Among other requirements, the regulations require any person or entity that owns or licenses personal information of Massachusetts residents to develop and implement a Written Information Security Plan (“WISP”).  In addition to further requirements, businesses acting in accordance with a WISP must: (1) designate an individual to maintain and be responsible for the program; (2) identify any reasonably foreseeable data security risks; (3) protect and restrict access to paper and electronic forms of any personal information; and (4) oversee any third party service providers and ensure that those service providers comply with the regulations. More information about the Massachusetts data security regulations can be found in our past client alerts from March 9, 2009March 17, 2009 and February 17, 2012.

When discussing possible liability of a business related to a data breach, the 2013 Data Privacy Report stated that a business’ “WISP and documentation of steps taken to guard and protect the personal information it retains or entrusts to a third party vendor and its response will be paramount in assessing its degree of culpability in the incident.”

In a year that has seen data breaches of several major corporations, this report serves as a reminder for all businesses to take a proactive approach by: (1) promoting a culture of security within their organizations; (2) committing to the protection of personal information by instituting mechanisms to ensure compliance with all applicable privacy and data protection laws, many of which require the implementation of reasonable administrative, technical, and physical safeguards to protect the confidentiality, and prevent the unauthorized interception, of personally identifiable information; and (3) being prepared to address the effects of a data breach in the event that one occurs.

 

For additional information, or to have a WISP prepared, reviewed, or revised to ensure compliance with the Regulations, please contact Faith KasparianMichael Cavaretta, or Howard Zaharoff.

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 OYO Sports Acquires New Investors 10/20/2014

Posted by Morse, Barnes-Brown Pendleton in Client News, Games & Interactive Entertainment, Industries, Intellectual Property, Manufacturing, Retail & Service, MBBP news.
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OYO Sportstoys, Inc.MBBP client OYO Sports is getting noticed by investors and making strides towards innovative toys for kids. OYO, based in Acton, makes plastic “minifigure” toys that resemble star athletes, similar to the popular Lego toys. The local toy start-up company has raised $14 million in funding in the last year and has recently acquired a new investor. OYO’s newest investor is Mandalay Sports Media, a company chaired by Hollywood executive Peter Guber, who is also an owner of the Los Angeles Dodgers and the NBA’s Golden State Warriors. Local OYO investors include Atlas Venture and Boston Seed.

Learn more about where OYO came from and where they’re going in these recent articles by the Boston Globe and The Boston Business Journal.

Way to go, OYO!

 

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!

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