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the development of certain fixed-combination drug products, the Food and Drug Administration (FDA) recently issued draft guidance revising its interpretation of the 5-year New Chemical Entity exclusivity provisions of the Federal Food, Drug and Cosmetic Act (FD&C Act).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

Massachusetts Life Sciences Center Accepting Applications for Tax Incentive Program 07/29/2013

Posted by Morse, Barnes-Brown Pendleton in Life Sciences.
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Massachusetts Life Sciences Center On July 23rd the Massachusetts Life Sciences Center (MLSC) announced that its 2013 Life Sciences Tax Incentive Program is now open. The Life Sciences Initiative authorizes the MLSC to award up to $25 million in tax incentives each year to qualified companies in an effort to expand life sciences-related employment opportunities, promote health-related innovations and stimulate research and development, manufacturing and commercialization in the life sciences. Applicants are generally companies that have transitioned or are transitioning from pure life sciences R&D to commercialization and manufacturing.

This is the fifth year that incentives will be provided under the program. Nearly 50 companies have active tax incentive awards totaling more than $75 million awarded during the past four program years. Those companies created a total of more than 1,800 jobs after receiving their tax incentives.

To be considered for tax incentives, please submit your application online via the MLSC’s website by October 24, 2013, at noon EDT. If you would like to learn more about this program, please visit the Mass Life Sciences Center.

SCOTUS Fails to Clear the Murky Hatch-Waxman Act Safe Harbor Waters 07/03/2013

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

Uncertainty over the extent to which the Hatch-Waxman Act’s safe harbor applies to post-approval activities remains as the Supreme Court declined to grant certiorari in two prominent cases involving the safe harbor this year. In particular, the Court both denied Momenta’s petition for certiorari of the Federal Circuit’s decision in Momenta v. Amphastar Pharmaceutical’s and denied GlaxoSmithKline’s petition for certiorari of the Federal Circuit’s decision in Classen v. GlaxoSmithKine. Whereas the Federal Circuit panel sitting en banc in Classen held that the safe harbor applies only to pre-approval activities, a different panel of the Federal Circuit sitting en banc more recently held in Momenta that the safe harbor applies to certain post-approval activities, such as quality control batch testing to comply with FDA regulations. The safe harbor is codified in 35 U.S.C. 271(e) (1), which provides that “it shall not be an act of infringement to make, use, offer to sell or sell … a patented invention … solely for uses reasonably related to the development and submission of information under a federal law which regulates the manufacture, use or sale of drugs or veterinary biological products.”

The Supreme Court’s refusal to grant certiorari in the Momenta case arguably means that the High Court is willing to accept that certain post-approval activities are protected under the safe harbor. The Court’s failure to opine on the issue, however, leaves interested stakeholders wondering exactly what types of post-approval activities are protected under the safe harbor. Given the divergence of opinions held by existing Federal Circuit justices, and the unresolved conflict between the Momenta and GlaxoSmithKline holdings, the Supreme Court will likely have another opportunity to clarify the types of post-approval activities that are protected under the safe harbor. In the meantime, industry stakeholders contemplating conducting post-approval activities that might infringe a patent would be well-advised to avoid extending the safe harbor beyond the facts of Momenta until the Supreme Court confirms that the safe harbor has indeed become a safe ocean.

To learn more about this topic, please contact David Fazzolare.

Mass Life Sciences Center Launches Accelerator Loan Program 01/07/2013

Posted by Morse, Barnes-Brown Pendleton in Events, Life Sciences.
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Massachusetts Life Sciences Center

On January 4, the Massachusetts Life Sciences Center announced it was launching the second year of its Accelerator Loan Program, in which early-stage life sciences companies apply for the opportunity to receive working capital to aid in the process of developing their science or technology, and to position these companies for subsequent investment. This year, loans for this program will be capped at $1 million per company. Applications are now being accepted and are due by February 8, 2013.

To date, the Accelerator Program has awarded $15.1  million in loans to 24 companies, six of which have paid back their Accelerator loans early with interest after generating more than $105 million in equity or acquisition proceeds.

To learn more or to apply for the Accelerator Loan Program, please visit Mass Life Sciences Center.

Information Session Life Sciences Tax Initiative Program 09/21/2012

Posted by Morse, Barnes-Brown Pendleton in Events, Legal Developments, Life Sciences.
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On Tuesday, October 2nd MBBP is hosting a joint event with McGladrey, LLP on the 2012 round of the MLSC Tax Program. In order to expand life sciences-related employment opportunities, promote health-related innovations and stimulate research and development, manufacturing and commercialization in the life sciences, the Massachusetts Life Sciences Center is offering tax incentives in 2012 to companies engaged in life sciences research and development, commercialization and manufacturing in Massachusetts. The Life Sciences Initiative authorizes the Center to award up to $25 million in tax incentives each year.

The primary goal of the Program is to incentivize life sciences companies to create new long-term jobs in Massachusetts. To qualify companies must receive certification from the Center and must demonstrate both the scientific and academic merit of their expansion plans.

You won’t want to miss this chance to get details and answers to your questions with Program speaker Brad Rosenblum, Chief Financial and Administrative Officer for the Massachusetts Life Sciences Center. Mr. Rosenblum is responsible for MLSC’s Finance, Information Technology, Human Resources, Risk Management and Facilities, and has over 20 years finance experience with public and private companies in various roles.

For more information, directions, or to register, please visit the event page: Information Session – Life Sciences Tax Incentive Program.

FDA to Hold Public Hearing on May 11th, 2012 to Obtain Input on Draft Biosimilars Guidance 03/15/2012

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

The Food and Drug Administration (FDA) plans to hold a public hearing on May 11, 2012, from 8:30 a.m. to 5 p.m., to gather feedback on its recently released draft biosimilars guidance documents.  The FDA’s release of the draft guidance documents is a significant milestone toward the implementation of the Biologics Price Competition and Innovation Act of 2009, which establishes an abbreviated path for the approval of biologic products that are biosimilar to, or interchangeable with, a reference product.  The FDA plans to finalize these draft guidance documents based on the information it receives during the hearing.

Individuals wishing to comment on the FDA’s draft biosimilars guidance may present at the hearing if they register by April 11, 2012, and may submit written comments until May 1, 2012.

The hearing will take place at the FDA’s White Oak Campus, which is located at 10903 New Hampshire Avenue, Building 31, Room 1503, in Silver Spring, Maryland.  The FDA is broadcasting a live webcast of the hearing for those who are unable to attend.  In addition, transcripts will become available no sooner than 30 days after the hearing.

Please review the FDA’s notice, or contact David A. Fazzolare for more information.

FDA Releases Long-Awaited Draft Guidance on Biosimilars 02/13/2012

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

The long-awaited guidance on biosimilar product development has finally been released by FDA. On Thursday, February 9th, FDA released three guidance documents on biosimilar product development which reflect the agency’s current thinking on important scientific and regulatory considerations pertinent to submitting biosimilar applications.

The first guidance document, entitled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product”, focuses on therapeutic protein products, and aims to help biosimilar applicants show that a biologic is biosimilar to a licensed biologic.

The second guidance document, entitled “Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product”, details analytical considerations (e.g., biological characterization) involved in evaluating biosimilarity.

The third guidance document, entitled “Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009”, addresses common questions biosimilar applicants may face in developing biosimilars, particularly in early product development stages.

FDA is expected to publish a request for public comments on the draft guidance documents in the Federal Register, and will consider such comments while finalizing its guidance.

Contact David A. Fazzolare for more information.

Expanded Track I Prioritized Examination of Patent Applications 01/26/2012

Posted by Morse, Barnes-Brown Pendleton in Legal Developments, Life Sciences.
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By: Stan Chalvire

The U.S. Patent and Trademark Office (USPTO) has issued final rules (75 Fed. Reg. 78566) extending the prioritized examination (Track I) provisions to patent applications in which a Request for Continued Examination (RCE) has been filed (see, Three Track Patent Examinations: USPTO Provides Further Guidance). The recently issued final rules provide patent applicants with the flexibility to accelerate the processing and examination of their applications in which an RCE has been filed by according such applications special status. An application that is accorded special status is placed on the Examiner’s special docket throughout its entire course of continued prosecution before the Examiner until a final disposition (e.g., the mailing of a notice of allowance or final office action, or the filing of a notice of appeal or subsequent RCE) is reached. The USPTO’s goal for handling applications under prioritized examination is to, on average, provide a final disposition of the application within twelve months of prioritized status being granted.

Requesting prioritized examination after the filing of an RCE requires that:

  1. The RCE be filed in an original utility or plant non-provisional application filed under 35 U.S.C. 111(a) or that has entered the national stage under 35 U.S.C. 371, accompanied by, among other things, a prioritized examination fee of $4,800 (which is subject to a fifty percent small entity discount);
  2. The request for prioritized examination be filed via the USPTO’s electronic filing system (EFS-Web) either concurrently with, or subsequently to, the filing of an RCE;
  3. Upon filing the request for prioritized examination, the application must contain or be amended to contain no more than four independent claims and no more than thirty total claims and no multiple dependent claims and, to the extent that an amendment is filed in an application that has been granted prioritized examination that exceeds these requirements, the prioritized examination will be terminated; and
  4. The request is filed prior to the USPTO’s acceptance of 10,000 requests for Track I prioritized examination under Sec. 1.102(e) in the fiscal year.

The final rules concerning the prioritized examination of applications in which an RCE has been filed became effective on December 19, 2011, and are applicable to any patent application in which an RCE has been filed before, on, or after December 19, 2011. For more information regarding prioritized examination, or to discuss other strategies for expediting the examination of your patent applications, please contact Stan Chalvire.

Boston Area Claims Top U.S. Life Sciences Hub in New Report 12/16/2011

Posted by Morse, Barnes-Brown Pendleton in Life Sciences.
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Mass High Tech recently published an article describing a new global report released by real estate services firm Jones Lang LaSalle which names Boston the number one life sciences cluster spot in the United States. The US Life Sciences cluster rankings were based on scores in each of the following six categories:

  • High-Tech Research & Hospital/Medical Employment
  • Science & Engineering Graduate students
  • National Institute of Health Funding
  • VC Funding
  • Research and Development Spending as % of GDP
  • Academic and Research Institute Facilities

Boston ranked number one in five of the six methodology categories, beating out 13 other regions. The only area in which Boston did not take the top spot – in this case, claiming the number two ranking – was in venture capital funding.

To view the full report, please visit Jones Lang LaSalle.

MBBP’s Most Popular Articles of 2010 01/19/2011

Posted by Morse, Barnes-Brown Pendleton in Employment, Life Sciences, MBBP news.
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As we enter 2011, MBBP would like to share a look back on our 10 most popular articles of 2010:

For more information on what MBBP has to offer, please visit our website.

The ABCs for Life Sciences Entrepreneurs: From Start-Up to Exit 12/21/2010

Posted by Morse, Barnes-Brown Pendleton in Events, Life Sciences, MBBP news.
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Thinking about starting or joining a life sciences company, now or in the future? If so, please join Morse, Barnes-Brown & Pendleton for a series of engaging and interactive discussions on the basic topics with which entrepreneurs in the life sciences today must be familiar. There will be four sessions, each covering a different topic:

All sessions will be held at our Waltham office from 5:30 to 6:30 pm. Though inter-related, each session stands alone, so feel free to attend some or all of the sessions according to your interest. Complimentary refreshments will be provided.

For more information and to register, please contact Jaclyn Jefgood or 781-622-5930. Please provide the date(s) of the sessions you would like to attend.

Massachusetts Life Sciences Center Announces New Small Business Matching Grant Program 02/02/2010

Posted by Morse, Barnes-Brown Pendleton in Life Sciences.
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The Massachusetts Life Sciences Center (MLSC) has announced the launch of its new Small Business Matching Grant (SBMG) Program. The program is designed to support early-stage life sciences companies and grow employment opportunities, promote manufacturing and commercialization, and stimulate innovation across the Commonwealth.

The primary objective of the SBMG is to provide grants to commercialization-ready life sciences companies that have received at least the equivalent of a Phase II small business innovation research (SBIR) or small business technology transfer (STTR) grant from federal agencies such as the National Institutes of Health (NIH), National Science Foundation (NSF), Department of Defense (DOD), etc. Grants will provide “matching” support – capped at $500,000 per company — to Phase II or Post Phase II SBIR or STTR grants already received by applicant companies.

MLSC is targeting an FY ’10 investment of $3 million in the Small Business Matching Grant Program.

For more information on the program, please visit the Massachusetts Life Sciences Center.

Allegro Diagnostics Receives Grant From The National Cancer Institute 10/27/2009

Posted by Morse, Barnes-Brown Pendleton in Client News, Life Sciences.
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Allegro Diagnostics, Inc.MBBP client Allegro Diagnostics has received a $2.8 million Phase 1/2 Fast Track Small Business Innovation Research grant from The Cancer Institute to be used for a clinical study of its lung cancer diagnostic test, BronchoGen. Allegro Diagnostics, a Boston-based medical test developer, has enrolled 800 people throughout the United States to receive the BronchoGen test, which studies the RNA gene expression levels of patients’ airway-lining cells that are accessed during bronchoscopy.

The full article can be read here.

New Marketing Rules for Pharmaceutical and Med Dev Companies 07/20/2009

Posted by Morse, Barnes-Brown Pendleton in Legal Developments, Life Sciences.
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Patent Attorney Stan ChalvireMA Regulations Regarding Compliance with Pharmaceutical and Medical Device Manufacturer Code of Conduct Take Effect

By Stan F. Chalvire

On July 1, 2009 the recently enacted Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct regulations (the “Marketing Code of Conduct”) went into effect.  The Marketing Code of Conduct governs the behavior of both pharmaceutical and medical devices manufacturers that commercialize FDA-approved products in the Commonwealth (collectively “Manufacturers”), and in particular addresses the relationships between those Manufacturers and health care practitioners who are licensed to practice in the Commonwealth (“Practitioners”).

In implementing the Marketing Code of Conduct, the objectives of the Massachusetts Department of Public Health are, among other things, to minimize potential conflicts of interest, to enhance the transparency of relationships between Manufacturers and Practitioners and to preserve the independent judgment of Practitioners.  In furtherance of these objectives, the Marketing Code of Conduct imposes specific compliance requirements, marketing restrictions and disclosure obligations on Manufacturers that employ or contract with a sales representatives or agents to commercialize their products in the Commonwealth.

Click here to read more.

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