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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.

MBBP Event: Unfair Competition and False Advertising 07/30/2014

Posted by Morse, Barnes-Brown Pendleton in Events, Intellectual Property.
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Intellectual Property Attorney Sheri MasonOn August 12th MBBP is hosting a seminar on Unfair Competition/False Advertising: How the Supreme Court’s recent decisions impact false advertising claims against competitors. The Supreme Court recently issued two decisions, Lexmark International, Inc. v. Static Control Components, Inc. and POM Wonderful LLC v. Coca-Cola Co., which impact rights a party may have against competitors for false advertising claims under the Lanham Act. This seminar, presented by MBBP Trademark Attorney Sheri Mason, will discuss unfair competition and false advertising under the Lanham Act, the Lexmark International, Inc. v. Static Control Components, Inc.and POM Wonderful LLC v. Coca-Cola Co. decisions, and how these decisions may affect your rights against third parties.

To learn more or to register, please visit our events page.

For more information on false advertising, please feel free to contact Sheri directly.

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

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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.

Upcoming Seminars in Waltham & Cambridge! 07/16/2014

Posted by Morse, Barnes-Brown Pendleton in Corporate, Employment, Events, Intellectual Property, Legal Developments, MBBP news, Privacy and Data Security.
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The end of Summer and beginning of Fall are the perfect time to get back into the swing of things! Join us for timely, informative seminars on False Advertising, Sweepstakes & Contests, and Employment Law. Get the details below.

LIMITED SEATING – REGISTER TODAY!

8/12/14 – Unfair Competition / False Advertising: How the Supreme Court’s recent decisions impact false advertising claims against competitors. (Waltham, MA) – In this seminar, we will discuss unfair competition and false advertising under the Lanham Act, the Lexmark International, Inc. v. Static Control Components, Inc.and POM Wonderful LLC v. Coca-Cola Co. decisions, and how these decisions may affect your rights against third parties. Complimentary seminar!

9/18/14 – Playing a Game of ChanceUnderstanding the Differences Between Sweepstakes, Contests and Illegal Lotteries. (Cambridge, MA) – Sweepstakes and contests are a great way to promote your business. However, there is a fine line between conducting legal sweepstakes or contests and conducting an illegal lottery. In this seminar, we will discuss what constitutes an illegal lottery, ways to structure contests / sweepstakes to comply with federal & state laws, state registration requirements and penalties for conducting an illegal lottery. Complimentary seminar!

10/17/14 – The Morse CourseEmployment Law Compliance & Risk Prevention for Managers, Supervisors and HR Professionals. (Waltham, MA) – Learn practical information and valuable strategies for avoiding the many traps that lead to expensive and time-consuming HR problems and employment litigation. Group discount available!

Have a different topic in mind? Check our Events Page for additional seminars or email us.

Supreme Court Rules Aereo’s T.V. Streaming Services Violate Copyright Law 06/30/2014

Posted by Morse, Barnes-Brown Pendleton in Intellectual Property.
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Intellectual Property Attorney Sheri MasonBy: Sheri Mason

On June 25, 2014, the U.S. Supreme Court ruled that Aereo, Inc.’s T.V. streaming services violate U.S. copyright law, reversing the Second Circuit’s decision that held that Aereo’s system (which consists of tiny antennas housed in a centralized location) “amounted to nothing more than a cloud-computing version of old fashion rabbit ears – a private transmission within the home.”

In a decision written by Justice Breyer, the Court reasoned that Aereo’s system does not provide a “private performance” similar to an off-site digital video recorder, but rather provides a “public performance” within the meaning of the Copyright Act’s “Transmit Clause” in violation of the major television networks’ copyrighted works.  To reach this decision the Court determined, first, that Aereo “performs” broadcast works because it allows its paid subscribers to watch T.V. programs at virtually the same time they are being broadcast, like CATV companies.  Second, the Court determined that Aereo transmits these works to “the public” because it communicates its transmissions “to a large number of people who are unrelated and unknown to each other.”

While there is concern that this ruling may impose copyright liability on other cloud-based technologies, the Supreme Court made clear that its ruling only applies to Aereo’s system and that Congress “did not intend to discourage or control the emergence or use of different kinds of technologies.”  Whether or not providers of other technologies violate the Transmit Clause – or other provisions of the Copyright Act – will need to be determined on a case-by-case basis.

The full opinion can be found here.

For more information on copyright law, please feel free to contact Sheri.

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

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

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

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

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

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

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

Congratulations Bridgewater Raynham InvenTeam!

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

 

Washington Redskins Trademark Canceled: What Does This Mean For the Team? 06/18/2014

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Intellectual Property Attorney Sheri MasonBy: Sheri Mason

The Trademark Trial and Appeal Board issued a decision today cancelling six of the Washington Redskins’ registered trademarks, finding that the marks disparage Native Americans. In 2006, five Native Americans filed a petition to cancel the marks, which were registered between 1967 and 1990, on the grounds that the marks disparage Native Americans. The T.T.A.B. agreed, finding that the marks were disparaging to Native Americans at the time the marks were registered.

If Pro Football, Inc. decides to appeal the decision, the T.T.A.B. will suspend cancellation of the registrations pending a decision by the court, which may take years. If they do not appeal, the registrations will be cancelled at that point.

What does this mean for the Washington Redskins? While the T.T.A.B. has authority to cancel the registrations of the marks, it does not have the authority to issue a ruling concerning the use of the marks. Therefore, even if Pro Football, Inc. does not appeal and the registrations are cancelled, the T.T.A.B.’s decision does not prevent the Pro Football, Inc. from continuing to use the Washington Redskins mark as the name of its professional football team.  This decision also does not mean that third parties may use the marks once the registrations are cancelled; Pro Football has well-established common law rights to the marks and can still prevent third-party use.

The full opinion can be found here.

For more information on trademarks, please feel free to contact Sheri.

Protecting Your Trademark: Top 10 Reasons To Register Your Trademark In The U.S. 06/17/2014

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Trademark Attorney Thomas DunnBy: Tom Dunn

Trademark registration is not required in the United States, however, owning a federal trademark registration enhances rights in a mark.  Here are the top ten reasons why you should register your mark with the United States Patent and Trademark Office:

  1. Prevention:  Registering your mark can prevent potential conflicts from arising. Prospective applicants or their counsel often search the USPTO’s free online trademark registry to determine whether a proposed mark is available. Prospective applicants who encounter your mark might be deterred some from filing a mark that conflicts with yours.
  2. Priority (U.S.): Upon registration, the filing affords you nationwide priority over all others who filed after you, except: (1) parties who used the mark before your filing date; and (2) parties who are entitled to an earlier priority filing date based on a foreign application.
  3. Priority (Foreign):  You have six months from your U.S. filing date within which to file in many foreign jurisdictions and claim as a priority filing date the date of your first-filed application in the U.S. for the same mark for use with the same goods and/or services. For example, if you apply in the U.S. on May 15, you may apply for the same mark for use with the same goods and/or services in China up to November 15 and claim a priority filing date in China of May 15.  Your application in China will take priority over all others who filed in China during those six months.
  4. Presumption:  Once on file, it is presumed your rights extend throughout the United States and its Territories.  Nationwide presumptive rights, as contrasted with geographic limitations inherent in unregistered marks, can be critically important in avoiding confusion in domestic markets in which you currently operate and into which you intend to expand.
  5. Protection:  Registering your mark protects against the registration of a third party’s confusingly similar mark for related goods and/or services by leveraging resources of the USPTO, which is charged with refusing registration of marks that conflict with prior pending and registered marks.
  6. Presentation:  Registration affords you the right to use the ® symbol when displaying your mark. Use of the ® symbol communicates to your current and prospective clients you are serious about protecting your intellectual property rights.  Use of the ® symbol is required at the time an enforcement action arises in order to recover profits and damages in federal court.
  7. Property: Your Certificate of Registration constitutes prima facie evidence of your exclusive ownership of the mark for use with the goods and/or services identified in the registration. After five years of continuous use your property right becomes “incontestable” by operation of law and can no longer be challenged by any third party claiming your mark is likely to cause or is causing confusion with their mark.
  8. Plaintiff:  Federal trademark registration grants you the right to sue for trademark infringement under federal law. Other claims might be available depending on the facts, such as unfair competition, false advertisement, etc., but Section 32 of the Trademark Act, which governs infringement claims, expressly provides for relief to “the registrant” only.
  9. Profits:  When a violation of any right of the registrant of a mark registered in the USPTO is established in a civil action, the registrant may recover certain statutory damages, including defendant’s profits. If you do not register your mark, you cannot recover lost profits.
  10. Ports:  You may record your federal trademark registration with U.S. Customs and Border Protection to block imports that infringe your mark or are counterfeits of your goods.

For more information on trademark registration and other trademark topics, please contact Tom Dunn.

USPTO Proposes Reducing Fees for Trademark Applications and Renewals Filed Electronically 05/20/2014

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Trademark Attorney Thomas DunnBy: Thomas Dunn

The USPTO has issued a notice of proposed rulemaking relating to the reduction of fees for trademark applications and trademark renewals filed electronically.

Currently the per-class fees for filing an application for registration of a trademark are set at $375 for filing a paper application, $325 for filing electronically using the regular Trademark Electronic Application System (TEAS) form, and $275 for filing electronically using TEAS Plus form, which involves additional requirements. The per-class fee for renewal of a trademark registration is currently $400.

The USPTO proposes to reduce by $50 the fee for an application filed using the regular TEAS application form from $325 to $275 per class if the applicant authorizes email communication and agrees to file all responses and other documents electronically during the prosecution of the application. This option will be known as a TEAS Reduced Fee (‘‘TEAS RF’’) application. The USPTO also proposes to reduce by $50 the fee for a TEAS Plus application for registration from $275 to $225 per class and reduce by $100 the fee for a TEAS application for renewal of a registration from $400 to $300 per class.

The filing fee of $375 per class for trademark applications filed on paper will not be changed. The filing fee of $400 per class for renewal of a trademark registration filed on paper will likewise not be changed.

The full notice is available here. The comment period closes on June 23, 2014. We expect the reduced fee structure will be implemented shortly thereafter.

Trademark attorneys at Morse, Barnes-Brown and Pendleton file every application and renewal electronically, authorize email communication with the USPTO, and file all responses and other documents electronically during the prosecution of an application.  By meeting these requirements, we are positioned to help reduce filing costs for our clients. We invite you to talk with us about how we can meet your trademark needs in a cost-efficient manner.

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

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

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

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

Intellectual Property Today Names MBBP a 2013 Top US Patent Firm 03/18/2014

Posted by Morse, Barnes-Brown Pendleton in Intellectual Property, MBBP news.
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In the March 2014 issue of Intellectual Property Today, Morse, Barnes-Brown & Pendleton was named to the list of 2013 Top Patent Firms in the United States. The list is composed of law firms and individual representatives, ranked according to the number of utility patents issued in 2013 where the firm is listed as the legal representative on the issued patent. The number of patents issued in 2013 for which MBBP was identified as the representative law firm increased by 47.4%, ranking MBBP 20th out of 286  in growth, relative to 2012, and landing MBBP at #253 in absolute numbers.

MBBP has had a strong focus on building its patent practice over the last few years and is pleased to have earned placement on this list. Keep an eye out for MBBP’s continued growth in the patent arena.

For the full list, please click here.

Visit our website for more information on our patent practice!

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.

Duck Dynasty or Patent Dynasty? 03/06/2014

Posted by Morse, Barnes-Brown Pendleton in Intellectual Property, New Resources.
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Patent Attorney Sean DetweilerBy: Sean Detweiler

If you are reading this because the title caught your eye, then there is a good chance that you are aware of the recently popular Duck Dynasty® television show on A&E Television Networks, which is in its 5th season as I write this article. The frequent promotion for the show states, “meet the Robertsons; they turned duck calls into a multi-million dollar empire.”What you may not realize is that the family patriarch, Phil Robertson, is also a patent holder. He is listed as the inventor on at least two patents related to duck calls.

The cost of filing for, and obtaining, patent protection is not trivial. Independent inventors, startup companies, and small companies alike all have a common issue with which to grapple at the genesis of their own developing back stories. As a patent attorney, I repeatedly hear the same question, “Should we file a patent application to cover our invention, or should we put that money into the company for manufacturing and/or marketing or other areas to build the business?” My response to these questions usually is, “What is the value of your idea?”

Mr. Robertson made the tough choice early on in a market where there were a lot of competitors making duck calls. He invested in patents when he was just starting his company and making duck calls by hand in a shed in Louisiana. So what is the value of those two Phil Robertson duck call patents? Should you patent your idea? Read the full article to find out.

For more information about how MBBP’s Patent Practice can assist you, please contact Sean D. Detweiler.

Howard Zaharoff Interviewed for HoGo Blog Piece 03/04/2014

Posted by Morse, Barnes-Brown Pendleton in Attorney News, Intellectual Property.
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IP and Technology Licensing Attorney Howard ZaharoffOn March 4 MBBP IP Technology and Licensing Attorney Howard Zaharoff was featured in a blog post by HoGo, a DRM (digital rights management) platform that lets users copy-protect, distribute and manage PDF files. The blog post titled “Ten Questions with… Howard Zaharoff (Part One)” shares his legal perspective on copyrights and copy protection with readers of HoGo Blog Confidential.

Visit HoGo to see the first half of Howard’s interview.

Please feel free to contact Howard with any of your own questions on IP and Copyright law.

Trends: Top 10 Intellectual Property Developments of 2013 02/10/2014

Posted by Morse, Barnes-Brown Pendleton in Client News, Intellectual Property, Legal Developments, New Resources.
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Top 10 Intellectual Property  Developments of 2013Looking back at 2013, there were many interesting developments in intellectual property. In an effort to keep our contacts and clients up-to-date with the most recent IP law changes and court decisions, MBBP has compiled our Top 10 Intellectual Property Developments of 2013:

  1. AIA Institutes “First Inventor to File” System
  2. Association for Molecular Pathology v. Myriad Genetics
  3. Bowman v. Monsanto
  4. Apple and Samsung
  5. Federal Trade Commission v. Actavis, Inc.
  6. Already, LLC v. Nike, Inc.
  7. Kirtsaeng v. John Wiley & Sons, Inc.
  8. The Authors Guild, Inc. v. Google, Inc.
  9. COPPA Rule Amendments
  10. New Top Level Domain Names

For more information on these developments, please view the full article here.

Changes To Implement the Patent Law Treaty 12/19/2013

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

On Wednesday, December 18, 2013, new U.S. Patent and Trademark Office (USPTO) final rules addressing the implementation of the Patent Law Treaties Implementation Act of 2012 (PLTIA) took effect, revising the rules of practice pertaining to patent cases.  The final rule was issued on October 21, 2013 pursuant to title II of the PLTIA, which amends U.S. law to implement the provisions of the Patent Law Treaty (PLT). The PLT, an international treaty to which the U.S. is a signatory, aims to harmonize and streamline formal procedures pertaining to the filing and processing of patent applications.

Some of the final rule’s notable changes to U.S. patent law generally pertain to: (i) the restoration of patent rights following the unintentional abandonment of patent applications and the unintentional delay of the payment of certain fees; (ii) the restoration of foreign priority or domestic benefit claims after the expiration of the priority period; and (iii) the extension of the time periods for responding to certain USPTO communications.  A copy of the final rules can be accessed at 78 Fed. Reg. 62368.

For more information or to discuss the PLTIA or how the new rules affect your patents or patent applications, please contact Stan Chalvire.

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