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5/4/16 – Life Sciences Series Panel 1: Business and IP Strategy 04/21/2016

Posted by Morse, Barnes-Brown Pendleton in Events, Intellectual Property, Life Sciences, MBBP news.
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reg now buttonJoin us at MBBP‘s Waltham office on Wednesday, May 4th at 7:00am for a look at Building Your Product & Patent Strategy from the Ground Floor. This is the first of four events in the 2016 Life Science Panel Series.

This lively panel of experts will discuss how to structure a well-crafted intellectual property portfolio. They have all built and analyzed multiple portfolios and will share their experiences on the do’s and don’ts in both organically growing an IP portfolio and in-licensing key properties.

Panelists include:

  • William Edelman Social Entrepreneur and C-Level Executive, Paragonix Technologies, NewVert, VitaThreads, Flexicath, First Light Biosciences
  • Molly Hoult Vice President, Fletcher Spaght Ventures
  • Michael McDonald, Ph.D. Director of Intellectual Property, bluebird bio

Seating is limited. Register today!

Sequenom Petitions Supreme Court to Clarify Scope of Mayo in Sequenom v. Ariosa 04/05/2016

Posted by Morse, Barnes-Brown Pendleton in Intellectual Property, Legal Developments, Life Sciences, Medical Devices.
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M0846516Late last month, Sequenom, Inc. filed a Petition for Writ of Certiorari requesting the United States Supreme Court to clarify the scope of its Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012) decision, as applied to Sequenom’s claimed inventions.  The Mayo decision, which held that a method correlating a drug dosage regimen and levels of the drug in the blood was an unpatentable law of nature, has had the profound effect of narrowing the scope of patent-eligible subject matter in the United States and has cast doubt on the validity and enforceability of previously-issued United States patents.

Sequenom’s discovery related to the discovery of cell-free fetal DNA circulating in maternal plasma, which was used to invent a test for detecting fetal genetic conditions in early pregnancy, and thereby avoid subjecting the mother to dangerous, invasive techniques such as amniocentesis.  The Federal Circuit agreed that Sequenom’s invention combined and utilized man-made tools of biotechnology in a new way that revolutionized prenatal care; however, in view of Mayo, such inventions were deemed patent-ineligible as a matter of law, since their new combination involved only a “natural phenomenon” and techniques that were “routine” or “conventional” on their own.

Despite the Federal Circuit’s reluctant holding that Sequenom’s claimed inventions were not patent-ineligible, multiple judges wrote separately to explain that while this result was probably not intended by Mayo, that decision controlled and only the Supreme Court could clarify Mayo’s reach to prevent a “crisis of patent law and medical innovation.”  Sequenom’s petition now asks the Supreme Court to clarify the scope of its Mayo decision in view of Sequenom’s claimed inventions, and to determine whether a novel method is patent-eligible where: (1) a researcher is the first to discover a natural phenomenon; (2) that unique knowledge motivates him to apply a new combination of known techniques to that discovery; and (3) he thereby achieves a previously impossible result without preempting other uses of the discovery.

If the Supreme Court grants certiorari it will have a compelling set of facts before it to clarify the scope of Mayo, and we patiently await its decision, which will have high stakes for the life sciences community.

For more information, contact Patent Attorney Stan Chalvire.

Survey Says: Top NINE Intellectual Property Developments of 2015 03/04/2016

Posted by Morse, Barnes-Brown Pendleton in Computer Software & Hardware, Intellectual Property, Licensing & Strategic Alliances, Life Sciences, Privacy and Data Security, Publishing & Media.
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happy-birthdayBy: Callie L. Pioli

2015 was another busy year in terms of intellectual property law, but luckily, MBBP has been carefully monitoring all of the important developments. There were many contenders for spots in our list, but only a select few could make the cut.

Get a recap on 2015 (and prepare for success in 2016) by reading our list.

We cover:

  1. Happy Birthday to All! – Marya v. Warner/Chappell Music, Inc.
  2. Google Books (Authors Guild v. Google, Inc.)
  3. Disparagement versus Free Speech: In re Tam
  4. Issue Preclusion & The TTAB: B&B Hardware, Inc. v. Hargis Indus., Inc.
  5. Patient Infringement Liability: Akamai Techs., Inc. v. Limelight Networks, Inc.
  6. Biosimilarity: Amgen v. Sandoz
  7. ­Patentability of Natural Phenomena: Ariosa Diagnostics, Inc. v. Sequenom, Inc.
  8. Computer Fraud & Abuse Act
  9. Safe Harbor Down, EU-US Privacy Shield Up

 

“Watch” it here: MBBP Client WatchRx wins Boston Scientific Connected Patient Challenge! 02/26/2016

Posted by Morse, Barnes-Brown Pendleton in Client News, Life Sciences, Medical Devices.
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MBBP client WatchRx, is an early stage startup founded while trying to help aging parents manage their medications and health conditions remotely. Current solutions available in the market, like mobile apps and pill caps/bottles, didn’t fit the need and only added to the confusion. WatchRx provides a a simple dedicated reminder solution. From voice reminders to GPS tracking this device addresses so many needs. The watch can even send alerts to family and caregivers.

The Boston Scientific Connected Patient Challenge is an open competition focused on ideas and early-stage companies that improve patient care and/or drive down the cost of health care through the use of Remote Patient Monitoring using wearable, implantable or ubiquitous sensors. The top five ideas based on the online crowd voting and online judge scores were honored at a live event on February 25, 2016, where they presented their ideas to the Challenge Sponsors and fellow participants.  Arun Buduri, Founder and Chief Product Officer, presented for WatchRx and walked away the winner! Watch the pitch (skip to 56:45) and award (skip to 1:53:00) here.

WatchRx Video

This isn’t the only thing the Greater Boston-based company is celebrating. Just yesterday WatchRx Founder and CEO Jayanthi Narasimhan was awarded 2016 Women to Watch in Science & Technology by the Boston Business Journal.

Congrats to WatchRx. If you aren’t a client to “watch” we don’t know who is!

 

MBBP’s Life Sciences Vector, Fall 2015 11/30/2015

Posted by Morse, Barnes-Brown Pendleton in Client News, Life Sciences, MBBP news, New Resources.
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extU.S. INTRODUCTION TO THE HAGUE SYSTEM

For many years, non-U.S. parties have taken advantage of the Hague System to register their design patents, an important part of strengthening and differentiating your product and brand. On May 13, 2015, the Hague Agreement Implementation of the Patent Law Treaties Implementation Act of 2012 (PLT) went into effect in the U.S. As a result, the U.S. became a member of the Hague System, an international system of registration for design patents (also referred to as “industrial designs” internationally). Now, U.S. applicants wishing to register a design patent in the U.S. and abroad may submit a single application and pay a single fee to register such design patent in all or some of the 63 other Contracting Parties that participate in the Hague Agreement.

Click here to learn more.

4,500 COMPANIES REELING AS EU’S HIGHEST COURT INVALIDATES SAFE HARBOR

On October 6, the Court of Justice of the European Union (“CJEU”) issued a binding judgment invalidating the European Commission Decision (Commission Decision 2000/520, the “Safe Harbor Decision”) that authorized the EU-U.S. Safe Harbor arrangement. For the past fifteen years, this arrangement has been relied upon by many businesses to transfer personal data from the European Union to the United States in compliance with the EU Data Protection Directive (Commission Decision 95/46, the “Directive”). As a result of the CJEU’s judgment, self-certification under the Safe Harbor framework is no longer sufficient to comply with the Directive.

Read more on Page 5.

CONTROLLING THE DEBATE: ANTICIPATORY SELF-DILIGENCE IN BIOTECH BUSINESS DEVELOPMENT

By: Jonathan P. Gertler, Back Bay Life Science Advisors

Business development is the lifeblood of the biotech industry. This article focuses on internal decision making regarding portfolio prioritization, and external anticipatory diligence to maintain optimal control over negotiation dynamics (i.e. “controlling the debate”).

Read more on Page 3.

MBBP ADDS TWO ASSOCIATES

Registered Patent Attorney Erin E. Bryan handles a broad range of intellectual property issues in a number of technical areas. She currently works with a variety of clients, including universities, research organizations and start-ups in the chemical, pharmaceutical and biotechnology areas. She is also proficient in patent prosecution and provides assistance with various phases of IP litigation and counseling.

Corporate Attorney Erik S. Thompson provides services to a range of clients, including emerging businesses and private investment funds, and advises them on mergers and acquisitions, issuances of ISOs and equity options, and regulatory compliance. He also serves as outside counsel to numerous companies, attending Board meetings and advising them on corporate actions.

MBBP ATTORNEYS PRESENT “CONSTRUCTING A SOLID PROVISIONAL PATENT”

In October, Registered Patent Attorneys Sean D. Detweiler and Dr. Stanley F. Chalvire spoke at a program hosted by TechSandBox for its Life Sciences SIG. Joining Sean and Stan were two Life Science CEOs. The panel provided attendees with guidance on how to do a provisional patent, on your own, or on a low budget.

RECENT FINANCINGS IN HEALTHCARE / LIFE SCIENCES

  • NED Biosystems closed a $1.5 million Series B Preferred financing with First Round Capital and angel investors. NED Biosystems provides a adjunct therapy of natural supplements designed to enhance chemotherapy with less toxic side effects.
  • Criscot Inc. closed an $800,000 extension of its Series A-2 Preferred Stock financing. Criscot provides a novel, proprietary applicator for delivery of drug compounds, resulting in more exact dosage without toxicity effects.
  • First Light Biosciences Inc. closed a $3.0 million Series B Preferred Stock financing. First Light Biosciences provides a patented instrument for early and swift detection of pathogens during the hospital admissions process, reducing the risk of hospital-acquired infections.

SELVITA ESTABLISHES FIRST U.S. OPERATIONS  IN GREATER BOSTON AREA

MBBP client, Selvita, recently announced an expansion into the Boston-area biotechnology and pharmaceutical market, as they open a fully-owned US subsidiary, Selvita Inc., headquartered in Cambridge, Massachusetts. Selvita is a leading global drug discovery company and the largest drug discovery company in Central and Eastern Europe. The new office, located at 485 Massachusetts Ave., will focus largely on expanding the company’s existing clients for its drug discovery services, as well as exploring and developing partnering opportunities.

Read more.

HENKE-SASS, WOLF A SO-CALLED “HIDDEN CHAMPION”

Every day, people all over the world use products and solutions produced by Henke-Sass, Wolf – often without even realizing it, as most of our products have the brand and label of our customers and not ours. As a medium-sized international company, and a technological leader in the medical endoscopy sector, we are sometimes considered a “hidden champion” – but certainly not “hidden” from our longstanding business partners and loyal customers.

Read more.

MBBP Client Selvita Establishes First U.S. Operations in Greater Boston Area 09/25/2015

Posted by Morse, Barnes-Brown Pendleton in Client News, Life Sciences.
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MBBP client, Selvita, recently announced an expansion into the Boston-area biotechnology and pharmaceutical market, as they open a fully-owned US subsidiary, Selvita Inc., headquartered in Cambridge, Massachusetts. Selvita is a leading global drug discovery company and the largest drug discovery company in Central and Eastern Europe. The new office, located at 485 Massachusetts Ave., will focus largely on expanding the company’s existing clients for its drug discovery services, as well as exploring and developing partnering opportunities.

“We are excited to celebrate the official opening of Selvita’s new office in Cambridge,” said Mike Kennealy, Acting President & CEO of the Massachusetts Life Sciences Center, a state-funded investment agency that worked closely with Selvita on their location decision. “The company’s presence here will enable Selvita to make important contributions to the Massachusetts life sciences community and to drug development, in the world’s leading ecosystem for life sciences innovation and growth.”

Read the full news release here.

Team Wine or Team Tequila? Upcoming TUGG 9th Annual Tech Charity Wine and Tequila Party 04/13/2015

Posted by Morse, Barnes-Brown Pendleton in Clean Tech, Events, Industries, Life Sciences, MBBP news, Nonprofit, Public Companies, Telecommunications & Networking, Venture Capital & Private Equity.
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2015-04-13_8-13-29On Thursday, April 16th, MBBP will be sponsoring the TUGG 9th Annual Wine and Tequila Party. Join 1,500+ of Boston tech’s entrepreneurs, venture capitalists, and philanthropists as we raise $400K+ to support six local nonprofits, while enjoying top-shelf wine and tequila. The non profits at this year’s party will consist of three returning favorites from the TUGG portfolio, and three new and promising ones. Meet and mingle with representatives from these nonprofits and hear their stories during the event. Then cast your votes for your favorite returning and your favorite new nonprofit. The winning non profit will be awarded up to $50,000. 

 

Don’s miss out! Learn more and register for the TUGG 9th Annual Wine and Tequila Party.

MBBP Managing Partner Lisa Warren Panelist at MassBio Annual Meeting 03/20/2015

Posted by Morse, Barnes-Brown Pendleton in Life Sciences, MBBP news.
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M0164549On Thursday, March 26th MBBP Managing Partner Lisa Warren will sit as part of a panel at The MassBio Annual Meeting.  The discussion will be on the topic of Externalizing Pharma R&D.

The MassBio Annual Meeting is a two day event that focuses on the most timely and critical challenges facing the Massachusetts biotechnology industry. As MassBio’s largest event, drawing close to 400 industry leaders, the meeting program is compiled by a Steering Committee and includes keynote presentations, plenary discussions, two panel tracks (Better Business and Trends in Science), and extensive networking opportunities.

For more information contact MassBio.

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.

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.

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.

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

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

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

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

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

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

Congrats, Joanna!

More info on Boston’s Rising Stars

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

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

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

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

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

Congrats, Mike! Well done!

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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