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

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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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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

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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.

Howard Zaharoff to Moderate Panel on Effective Partnerships & Conflict Avoidance in Life Sciences 05/16/2014

Posted by Morse, Barnes-Brown Pendleton in Events, Life Sciences.
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IP and Technology Licensing Attorney Howard ZaharoffTechSandBox, a Metrowest innovation center sponsored by MBBP, is hosting an upcoming program for its Life Sciences SIG titled “Effective Partnerships & Conflict Avoidance in Life Sciences“. MBBP IP and Licensing Attorney Howard Zaharoff will serve as moderator of the seminar which will discuss the importance of understanding what tools are available to life sciences companies that help manage conflict and disputes before they derail important relationships. The event takes place at TechSandBox’s space in Hopkinton, MA on Monday, May 19th.

To learn more or to register for the event, please visit TechSandBox.

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

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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

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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

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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

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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

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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.

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