Tags: CIO, consumer privacy, data breach, data privacy, Data Security, regulations
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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 08/19/2014Posted by Morse, Barnes-Brown Pendleton in Attorney News, Client News, Computer Software & Hardware, MBBP news.
Tags: blackboard, campus card services, cardsmith, mbbp, security solutions, technology
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MBBP 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.
For the full press release, please visit Blackboard’s website
MBBP Attorney Helps Fight Cancer: PMC 2014 08/19/2014Posted by Morse, Barnes-Brown Pendleton in Attorney News, Life Sciences, MBBP news, Nonprofit.
Tags: Cancer Research, Dana-Farber, Pan Mass Challenge, PMC, The Jimmy Fund
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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!
Tags: biologics, biosimilar, BPCI Act, celltrion, FDA, infliximab, remsima, Sandoz
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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 the 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.
Tags: Amgen, biosimilars, FDA, FDA Week, insiderhealthpolicy.com, patent, Sandoz
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On August 8th InsiderHealthPolicy.com’s FDA Week, an exclusive weekly report on Food and Drug Administration Policy, regulation and enforcement, published an article titled “Biosimilar ‘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.
Tags: application, biologic, Biologics Price Competition and Innovation Act, biosimilars, BPCI Act, drugmakers, FDA, PHS Act
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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 in 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.
Biosimilars Developers Watch Closely as FDA Accepts First Biosimilar Application from Sandoz 07/29/2014Posted by Morse, Barnes-Brown Pendleton in Intellectual Property, Life Sciences.
Tags: application, biologic, biosimilars, drugmakers, FDA, filgrastim, neupogen, Sandoz
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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 white 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.
Tags: amateur sleuths, boston globe, cold case, deborah halber, the skeleton crew
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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!”
Should You Incorporate Your Business? 07/23/2014Posted by Morse, Barnes-Brown Pendleton in Venture Capital & Private Equity.
Tags: business structure, corporation, entities, incorporation, llc, llp, sole proprietorship, state filings
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By: 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.
Tags: biological products, biosimilar, FDA, pharmacist, vaccines, viruses
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By: 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.
Tags: bridgewater-raynham, coffee pods, EurekaFest, innovation, inventeam, invention, lemelson-mit, MIT, STEM education
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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!
Tags: crowdfunding, enterprise center, family money, funding, salem state, seed money, startups
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The 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.
Radio Entrepreneurs Interviews Shannon Zollo 04/28/2014Posted by Morse, Barnes-Brown Pendleton in Attorney News, Corporate, Legal Developments, Venture Capital & Private Equity.
Tags: exit planning, radio entrepreneurs, shannon zollo, summit 2014, xpx
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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.
Tags: boston vs. cambridge, start-ups, vc financings, venture capital
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By: 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 04/01/2014Posted by Morse, Barnes-Brown Pendleton in Client News, Computer Software & Hardware.
Tags: actifio, data storage, data virtualization, financing round
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On 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.
Tags: glossary pilot program, patent applications, software, USPTO
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By: 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.
Tags: biotech, boston business j, IPO, public offering, stock
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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.
Tags: AIA, biologics, biosimilar, patent litigation, sandoz v. amgen
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By: 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.
Tags: drug products, FD&C Act, FDA, NCE, new drug application
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By: 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.