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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Sandoz’s announcement came shortly after the FDA released its draft guidance for industry entitled “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.”  The FDA had previously released three draft guidance documents outlining the FDA’s then-current thinking on important scientific and regulatory considerations relevant to submitting biosimilar applications,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.

Should You Incorporate Your Business? 07/23/2014

Posted by Morse, Barnes-Brown Pendleton in Venture Capital & Private Equity.
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By: Hillary PetersonCorporate Attorney Hillary Peterson

70% of all businesses in the country are organized as a sole proprietorship, but operating a business as an unincorporated entity is not without its disadvantages. Because of this, it is important for any business owner to consider forming a separate legal entity, such as a corporation, limited liability company or partnership, regardless of the size or nature of the business. There are a number of significant benefits to forming a corporation or LLC, including:

  • Protection of Personal Assets
  • Ability to Raise Capital
  • Perpetual Existence
  • Flexible Tax Treatment
  • Additional Credibility

Learn more here.

Massachusetts Enacts Biosimilar Substitution Law 07/22/2014

Posted by Morse, Barnes-Brown Pendleton in Intellectual Property, Life Sciences.
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Patent Attorney Stan ChalvireBy: Stanley Chalvire

Massachusetts recently enacted Chapter 143 of the Acts of 2014, entitled “An Act relative to the substitution of interchangeable biosimilars,” authorizing pharmacists to fill prescriptions that are written for brand name biological products with the corresponding and generally less expensive biosimilar product.  A biosimilar is a biological medicine that the U.S. Food and Drug Administration (FDA) has determined is highly similar to an FDA-approved biological product, notwithstanding minor differences in inactive components, for which there are no clinically meaningful differences between such biosimilar product and the reference biological product in terms of safety, purity and potency.

The Act defines “biological product” to include, for example, viruses, vaccines, blood components or derivatives and certain proteins that are applicable to the prevention, treatment or cure of a disease or condition of human beings.  An “interchangeable prescription biological product” is defined as a biosimilar that has been determined by the FDA to be substitutable with the prescribed reference biological product.

The Act generally tracks existing Massachusetts laws governing the substitution of generic drugs for prescribed brand name drugs.  In particular, the Act provides that:

  • A pharmacist filling a prescription for a biological product prescribed by its trade or brand name may substitute an interchangeable biological product;
  • The prescriber can instruct against substitution of an interchangeable biological product on a patient-specific basis;
  • The dispensing pharmacist or the pharmacist’s designee must notify the prescribing practitioner and the patient of the substitution;
  • The dispensing pharmacist or the pharmacist’s designee, the prescribing provider and administering practitioner shall retain a record of each substitution, for not less than 1 year from the date of the last entry in the profile record; and
  • In the event of noncompliance by a pharmacist or a practitioner, the purchaser or patient may inform the director of consumer affairs and business regulation of such noncompliance.

The FDA has yet to approve a biosimilar product, much less an interchangeable biosimilar product which pharmacists in Massachusetts would be permitted to substitute under the Act.  Massachusetts now joins Florida, North Dakota, Oregon, Utah, Virginia and Indiana on the forefront of states enacting laws governing the substitution of biosimilars.

For more information on the Act or biosimilars, please contact Stan Chalvire.

BRInvenTeam Brews up an Eco-Friendly Invention for EurekaFest 06/25/2014

Posted by Morse, Barnes-Brown Pendleton in Clean Tech, Client News, Events, Intellectual Property.
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By: Tracey Brenner

Lemelson-MIT hosted its eighth-annual EurekaFest June 20-21st, a celebration designed to empower the next generation of inventors by inspiring youth, honoring role models, and encouraging creativity and problem solving. Each EurekaFest Team, comprising high school students, educators and mentors, received up to $10,000 from the Lemelson-MIT Program to invent technological solutions to real-world problems of their own choosing.

Sixteen Teams, parsed into groups of four, presented their “pitch” to peers, teachers, and media in classrooms across the Stata Center at MIT the morning of June 20th. The young students, the most senior of which are now rising college freshmen, each handled themselves with youthful poise, enthusiasm, and eloquence.  Teams actively displayed a product prototype during the presentation. Prototypes included, from Benjamin Banneker Academic High School in Washington D.C., a safety device that attaches to a door to prevent it from opening in an emergency situation; from Elkin’s High School  in Missouri Texas, an automated disinfectant system for high-end 3D movie glasses; and from the School of Dreams Academy in Los Lunas, New Mexico, a system for detecting and alerting parked police officers of impending physical dangers.

In addition to displaying prototypes, Teams also described the need based/market-driven iterative ideation and development process in which they engaged, and touched on some of the ways they executed key to-market strategies. For example, students described building a well-balanced founding team, raising supplemental funds, securing support from the community/stakeholders, and, in some cases, conducting patentability studies and pursuing intellectual property protection. Students also answered a plethora of eager questions from and offered tips and advice to their peers.

This Lemelson-MIT Program is an example of collaborative cross-disciplinary STEM education reaching to its highest heights. May it incite and inspire educator and entrepreneur alike.

MBBP client Bridgewater-Raynham Regional Highschool’s InvenTeam was one of the 16 high schools nationwide to be selected for a $9,200 grant out of 250 applicants. Through this grant, the BR team has invented a device that separates and stores the materials of single-serve coffee pods allowing proper recycling and composting.

Congratulations Bridgewater Raynham InvenTeam!

Visit Bridgewater-Raynham’s site to make a donation or to learn more about their invention.

 

Mary Beth Kerrigan to Speak on How to Raise Money from Family and Friends 05/30/2014

Posted by Morse, Barnes-Brown Pendleton in Attorney News, Events, Venture Capital & Private Equity.
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Corporate Attorney Mary Beth KerriganThe Enterprise Center at Salem State University is hosting an event titled “Raising Money from Friends and Family – How to Do it Right” on Friday, June 6th. MBBP Corporate Attorney Mary Beth Kerrigan is one of three speakers at the event who will provide an interesting discussion on early sources of funding, from both traditional and non-traditional sources, how to do it right, and the crucial pitfalls to avoid.

To learn more or to register for the event, please visit the Enterprise Center.

Do you have questions regarding seed funding? Feel free to contact Mary Beth.

Howard Zaharoff to Moderate Panel on Effective Partnerships & Conflict Avoidance in Life Sciences 05/16/2014

Posted by Morse, Barnes-Brown Pendleton in Events, Life Sciences.
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IP and Technology Licensing Attorney Howard ZaharoffTechSandBox, a Metrowest innovation center sponsored by MBBP, is hosting an upcoming program for its Life Sciences SIG titled “Effective Partnerships & Conflict Avoidance in Life Sciences“. MBBP IP and Licensing Attorney Howard Zaharoff will serve as moderator of the seminar which will discuss the importance of understanding what tools are available to life sciences companies that help manage conflict and disputes before they derail important relationships. The event takes place at TechSandBox’s space in Hopkinton, MA on Monday, May 19th.

To learn more or to register for the event, please visit TechSandBox.

Radio Entrepreneurs Interviews Shannon Zollo 04/28/2014

Posted by Morse, Barnes-Brown Pendleton in Attorney News, Corporate, Legal Developments, Venture Capital & Private Equity.
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Corporate Attorney Shannon Zollo

The Radio Entrepreneurs, a show that provides advice, information and connections for entrepreneurs, service providers and established companies, recently interviewed MBBP Corporate Attorney Shannon Zollo. Shannon was invited to discuss the Exit Planning Exchange (XPX) Boston, a community of trusted advisors to privately-held businesses and their owners who are focused on a successful path to the exit, and its annual Summit on May 2nd. The 2014 XPX Summit‘s theme is on growth and liquidity and helping business owners achieve both. To listen to the full discussion, please click the following link: Radio Entrepreneurs Interviews MBBP Attorney Shannon Zollo

Feel free to contact Shannon with any questions on exit planning or XPX.

Visit XPX Summit 2014 for more information or to register for the event.

Is Boston the new Cambridge for Tech Companies? 04/07/2014

Posted by Morse, Barnes-Brown Pendleton in New Resources, Venture Capital & Private Equity.
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Corporate Attorney Scott BleierBy: Scott Bleier

Blessed with two world-class research universities in Harvard and MIT and the annual parade of newly minted PhD’s and MBAs walking through their doors with dreams of entrepreneurship, Cambridge has long been the epicenter of the technology company/start-up community in the Greater Boston metropolitan area. However, according to recent statistics, the local tech landscape may be changing. CB Insights, a data services firm, recently published a report showing 2013 marked the first time that venture capitalists invested in more companies located in Boston than Cambridge. What does this mean for the local tech community? Read the full article to on our new VCs and Startups blog to find out.

Actifio Secures $100 Million Financing Round 04/01/2014

Posted by Morse, Barnes-Brown Pendleton in Client News, Computer Software & Hardware.
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actifio - Copy Data ManagementOn March 24 MBBP client Actifio announced a $100 million financing round, one of the largest investment deals for a privately held Boston-area technology firm in years. Actifio is an information technology and software company that delivers copy data virtualization to hundreds of global enterprise customers and service provider partners in more than 30 countries around the world. The new funding will be invested in the core IP and new features of its data virtualization platform as well as the continued expansion of Actifio’s market reach and surrounding ecosystem. Ash Ashutosh, CEO of Actifio, was recently quoted in Forbes discussing the financing:

All of last year, the simple focus was in scaling our business. The last three quarters we were figuring out how to scale, and the one factor that was a constraint was speed of time. Now this helps me grow as fast as possible.

Congratulations Actifio!

To learn more about this news, please see full articles in The Boston Globe and Forbes.

USPTO Announces Glossary Pilot Program to Expedite Software Patent Applications 03/28/2014

Posted by Morse, Barnes-Brown Pendleton in Computer Software & Hardware, Intellectual Property.
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Patent Attorney Sean DetweilerBy: Sean Detweiler

The USPTO recently announced the launch of a new pilot program called the Glossary Pilot Program, to run from June 2nd until December 31st.  The program is for software patent applications and requires an applicant to include a glossary section in the patent application specification to define terms used in the patent claims. Applications accepted into this pilot program will receive expedited processing and be placed on an examiner’s special docket prior to the first office action, and will have special status up to issuance of a first office action.  More information on the program can be found at USPTO.

If you wish to participate in this program, please contact Sean D. Detweiler.

Boston Business Journal Revisits Local Biotech IPO’s: “Where are They Now? 03/12/2014

Posted by Morse, Barnes-Brown Pendleton in Life Sciences, Public Companies.
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On March 7, the Boston Business Journal (BBJ) published an article titled “A year of biotech IPOs: Where is their stock price now?” which highlights fourteen local biotech companies that went public last year, ranking them by their stock increase seen since the close of their first day on the market until the March 6 close. A year ago this month, Enanta Pharmaceuticals and Tetraphase Pharmaceuticals, both of Watertown, MA, became the first two Massachusetts biotech firms to go public in what turned out to be the busiest biotech IPO boom in more than a decade.

To see the full list visit the BBJ.

Obtaining Early Biosimilar Patent Certainty in the Aftermath of Sandoz v. Amgen 03/11/2014

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

In December 2013, the court case of Sandoz v. Amgen became the first instance in which a court has been asked to interpret the patent litigation provisions of the Biologics Price Competition and Innovation Act (the “Biosimilars Act”), the outcome of which may have significant impact on future biosimilar development.

To learn what this means for biosimilar applicants, see the full article.

Please feel free to contact David with any questions on this topic.

FDA Revises Interpretation of 5-year NCE Exclusivity 03/11/2014

Posted by Morse, Barnes-Brown Pendleton in Intellectual Property, Life Sciences.
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Patent Attorney Stan ChalvireBy: Stanley Chalvire

In an effort to incentivize the development of certain fixed-combination drug products, the Food and Drug Administration (FDA) recently issued draft guidance revising its interpretation of the 5-year New Chemical Entity exclusivity provisions of the Federal Food, Drug and Cosmetic Act (FD&C Act).

Sections 505(c)(3)(E) and 505(j)(5)(F) of the FD&C Act provide the holder of an approved New Drug Application with the benefit of limited protection from certain competition (e.g., generic competition) in the marketplace.  In particular, newly approved drug products that contain an active ingredient that has not been previously approved by FDA (a so-called “new chemical entity”) are eligible for 5-years of New Chemical Entity (NCE) exclusivity and, with one exception, during such 5-year exclusivity period, third party applications referencing the newly-approved drug cannot be submitted to FDA.

Fixed-combination drug products are combinations of two or more active ingredients in a single dosage form or drug product.  FDA has historically interpreted the 5-year NCE exclusivity provisions of the FD&C Act such that fixed-combination drug products that contained a previously-approved drug product were not eligible for 5-year NCE exclusivity, irrespective of whether such fixed-combination drug product contained a new chemical entity.

Based on FDA’s recognition of the increasing prevalence of fixed-combination drug products in certain therapeutic areas (e.g., cancer and infectious diseases, such as HIV) and the role that such combination products play in optimizing adherence to dosing regimens and improving patient outcomes, FDA has revised its interpretation of the 5-year NCE exclusivity provisions.  As a result of FDA’s revised interpretation, a 5-year NCE exclusivity determination will be made on the basis of each active ingredient in a drug product, such that a drug product that includes a new chemical entity will be eligible for 5-year NCE exclusivity, regardless of whether that drug substance is approved alone or in a fixed-combination.  FDA is soliciting comments in response to its draft guidance until April 25, 2014.

For more information or to discuss FDA’s new interpretation of the NCE provisions, please contact Stan Chalvire.

Jonathan Gworek Panels ABA Event on Great Hill Equity Partners Case 03/03/2014

Posted by Morse, Barnes-Brown Pendleton in Attorney News, Venture Capital & Private Equity.
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Corporate Attorney Jonathan GworekOn January 27th, MBBP Corporate Partner and Chair of the Private Equity and Venture Capital Committee of the American Bar Association, Jonathan Gworek, moderated a webinar on the implications of the recent Great Hill Equity Partners case. In this case the Delaware Court of Chancery held that under Section 259 of the DGCL, all privileges—including the attorney-client privilege—pass from the acquired corporation to the surviving corporation in a merger.

In October, Jon moderated a similar webinar on the recent In re Trados Inc. Shareholder Litigation opinion, in which the Delaware Court of Chancery found that a sale of the venture backed company was entirely fair notwithstanding the fact that the common stockholders received none of the merger consideration.

Materials from both panel discussions can be found here.

Please feel free to contact Jonathan Gworek with any questions on these topics.

Joe Martinez to Speak At Equity Crowdfunding Symposium 02/24/2014

Posted by Morse, Barnes-Brown Pendleton in Attorney News, Events, Venture Capital & Private Equity.
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Corporate Attorney Joseph MartinezOn Thursday, April 24, MBBP Corporate Attorney Joseph Martinez will sit as a panelist for Quincy College Symposium on Equity Crowdfunding. With the passage of the Jumpstart Our Business Startups (JOBS) Act of 2012, the world of Equity Crowdfunding promises to stir the pot for investors and entrepreneurs alike. Joe will help lead a discussion that focuses on new and traditional sources of business capital including equity crowdfunding, bank loans, government loans, vendors and more.

For more details or to register visit the event page.

Please feel free to contact Joe with any questions on raising capital.

Jonathan Gworek Published in Business Law Today 02/13/2014

Posted by Morse, Barnes-Brown Pendleton in Attorney News, M&A, Venture Capital & Private Equity.
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Corporate Attorney Jonathan GworekMBBP Corporate Attorney and Chair of the Private Equity and Venture Capital Committee of the American Bar AssociationJonathan Gworek, was recently published in the January edition of Business Law Today, a publication by the American Bar Association. Jonathan’s article, “The Threat of Social Media Diligence on the Confidentiality of the M&A Process“, covers the very practical impact of the Internet and “social media diligence” on the confidentiality in M&A transactions and suggests certain practices that the parties might adopt to both mitigate and more fairly allocate this risk.

Visit Business Law Today to read the full article.

For more information on the M&A process, please feel free to contact Jon.

Joseph Marrow to Speak At Boston College 02/11/2014

Posted by Morse, Barnes-Brown Pendleton in Attorney News, Venture Capital & Private Equity.
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Corporate Attorney Joseph MarrowOn Tuesday, February 18th MBBP Corporate Attorney Joseph Marrow will be a guest lecturer for the Carroll Graduate School of Management at Boston College. Joe will be discussing venture capital term sheets for an Entrepreneurial Finance class.

Please feel free to contact Joe with any questions on VC term sheets.

For more information on term sheets visit our resources page.

MBBP Publishes Articles on Data Privacy 11/27/2013

Posted by Morse, Barnes-Brown Pendleton in Games & Interactive Entertainment, Privacy and Data Security, Publishing & Media.
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IP Licensing and Trademark Attorney Faith KasparianMBBP has published two articles on Data Privacy, both written by licensing and intellectual property attorney Faith Kasparian. The first article, FTC’s Recommended Best Practices for Mobile Privacy Disclosures, discusses the Federal Trade Commission‘s report on privacy recommendations for mobile platforms, app developers, advertising networks (other third parties), as well as app developer trade associations including academics, usability experts, and privacy researchers. For the full article, please click here.

Faith’s second article, FTC Finds Privacy Practices Lacking in Mobile Apps for Kids, covers a report released by the FTC which raises concerns with the current lack of privacy practices and disclosures for apps directed toward children. The report also announced the launch of nonpublic investigations to determine compliance with the Children’s Online Privacy Protection Act and the Federal Trade Commission Act. For the full article, please click here.

For more information on either of these topics, please feel free to contact Faith.

MBBP Hosts Goldenseeds Boston Office Hours 11/19/2013

Posted by Morse, Barnes-Brown Pendleton in Venture Capital & Private Equity.
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Golden Seeds On Thursday, November 14th MBBP hosted the first of many Golden Seeds Boston Office Hours in which experienced private investors lead a presentation on the basics of angel funding and the Golden Seeds investment process. Following the presentation, attending entrepreneurs had the ability to meet one-on-one with investors, receiving feedback on their business venture and  answers to questions about the angel investing process.

Golden Seeds is an investment firm that pursues above market returns through the empowerment of women entrepreneurs and the people who invest in them.

To learn more about Boston Office Hours, please visit Golden Seeds.

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