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Pick Up the (Patent Process) Pace! 03/07/2017

Posted by Morse Barnes-Brown Pendleton in Attorney News, Intellectual Property, Life Sciences.
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LMW Headshot Photo 2015 (M0846622xB1386)A common frustration for patent applicants is the incredibly slow pace at which an application proceeds from filing to receipt of a substantive examination report to allowance. On average it takes 15.7 months for a patent application to receive even a first substantive examination report! The Patent Office has recognized this problem and implemented several initiatives which attempt to address the problem from different angles. Lisa Warren, MBBP Managing Partner and Patent Attorney, discusses the Patent Prosecution Highway and the Track One program in her new article.

Interested in moving your patent application into the fast lane? Contact Lisa directly.

Is Software Patentable? 03/03/2016

Posted by Morse Barnes-Brown Pendleton in Computer Software & Hardware, Intellectual Property, Legal Developments.
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M0846496By: Brian J. Assessor

On June 19, 2014, the Supreme Court’s decision in Alice Corp. v. CLS Bank International sent shockwaves through many areas of patent law and, as a result of that decision, patent attorneys, inventors, and companies working in the computer and software space are wondering “is software patentable?” and, if so, “what type of software is patentable?”. The impact of this case should be a primary consideration for anyone filing a patent application related to software, even those who were not previously aware of the Alice Corp. decision.

Read the full article.

Learn more about our Patent Team.

USPTO Reduces Certain Trademark Filing Fees 01/29/2015

Posted by Morse Barnes-Brown Pendleton in Intellectual Property, Legal Developments.
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By: Tom Dunn

Trademark Attorney Thomas DunnOn January 17, 2015, the USPTO reduced certain trademark filing fees and introduced a new electronic application filing option.

The fee for both the TEAS Plus application and the TEAS Regular application are reduced by $50. The TEAS Reduced Fee (TEAS RF) application is a new filing option, and one may still submit a paper filing, as well:

Application for registration, per international class
(paper filing)
$375
Application for registration, per international class
(electronic filing, TEAS application)
$325
Application for registration, per international class
(electronic filing, TEAS RF application)
$275
Application for registration, per international class
(electronic filing, TEAS Plus application)
$225

Each of the three TEAS options comes with a set of requirements; the lower the fee, the higher the number of requirements. (TEAS is an acronym for Trademark Electronic Application System.)

For example, to take advantage of the $225 fee per class of goods/services in the TEAS Plus application, one must meet the following requirements: include an e-mail address and authorization for the USPTO to send application-related e-mail correspondence; agree to file related submissions, such as responses to Office actions, electronically via TEAS; select an identification of goods/services from the USPTO Trademark ID Manual; pay all fees at the time of filing; and provide certain statements regarding the mark in the application as-filed, if applicable (e.g., translation statement, claim of ownership, color claim and description).

Only a subset of the foregoing requirements pertains to the TEAS RF application, while none pertain to the TEAS application.

If one files a TEAS Plus or TEAS RF application but does not satisfy the relevant requirements the applicant will be required to submit an additional processing fee of $50 per class of goods or services, and the application will then be handled as a TEAS application.

The fee to electronically renew a trademark registration has been reduced by $100, to $300 per class of goods/services, as well.

Please see the Reduced Fee FAQs page for more information about the new filing fees and the Trademark Fee Information page for information on payment options and a listing of other trademark fees.

To discuss trademark filing options and related matters, please contact Tom Dunn by email at tdunn@mbbp.com or by phone at (781) 697-2248.

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.

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