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Biotechnology
January 19
January 2018 Biotech Buzz

Members of the Biotechnology Committee – You can view the latest issue of the Biotech Buzz below and access detailed information by clicking the names and other hyperlinks.  The more links below download the given article.  Click here to download the entire Biotech Buzz as a pdf file.
If you want to be active in the committee, click here  and indicate your interests, ideas, and contact information in your email. Alternatively, contact the Leader and Sub-Chair(s) of the particular subcommittee of interest.
  
January 2018
Dear Members of the Biotech Committee—Looking forward to the 2018 Midwinter meeting next week in sunny California (see Vice Chair Nick Landau’s and Community Leader Alice Martin’s announcements about the CLE program and the planned social event, below). 
Upcoming events include the next BCP meeting, tentatively planned for March 2018.  If you have any suggestions for topics of discussion please click on the envelope next to my name and email them to me. 
Also, see this month’s Featured Member’s spotlight on Melissa Pytel, below.
Vice Chair’s Notes – Nick Landau  
The Midwinter Institute Is Around the Corner—with Social and CLE!
Join the Biotech and Trademark Committees on Friday, Jan. 26 from 3:45-5:45 for a timely 2-hour CLE session on IP issues for the growing cannabis industry, “NOT JUST BLOWING SMOKE: THE PITFALLS AND OPPORTUNITIES FOR PROTECTING IP IN THE EMERGING U.S. CANNABIS INDUSTRY,” featuring Kristin Connarn moderating a panel of distinguished experts, including Reggie Gaudino, CSO of Steep Hill Labs, Kieran Doyle, from Cowan, Liebowitz & Latman, P.C., and Katherine Koenig from CHRISTOPHER & WEISBERG, P.A.  Please also join us for the Social event on Thursday.
Services Leader Carla Mouta
·        Ben Borson reports on Genzyme Corporation v. Dr. Reddy’s Laboratories Ltd. more
Issues Leader – Kristin Connarn
·        Laura Smalley reports on the Amgen v. Sandoz Filgrastim and Pegfilgrastim Litigation: The Federal Circuit rules that state law claims are preempted, and the district court dismisses Amgen’s infringement claims  more
Community Leader –Alice Martin
·        Please join us for the AIPLA BIOTECHNOLOGY COMMITTEE NO HOST SOCIAL THURSDAY JAN. 25, 2018, from 5-7 PM:  MEET IN THE TWENTY6 RESTAURANT BAR AT THE LA QUINTA RESORT (see below) - LOOK FOR THE AIPLA SIGN
 
FEATURED MEMBER’S SPOTLIGHT
This month’s Member Spotlightis on Melissa Pytel, Of Counsel at Medler Ferro Woodhouse & Mills.   Melissa is a long-standing attendee of AIPLA Annual Meetings and a recent volunteer on the Biosimilar Subcommittee of the Biotechnology Committee. 
 
MEMBER SPOTLIGHT:  MELISSA PYTEL, Of Counsel at Medler Ferro Woodhouse & Mills
Melissa notes:   I am a patent attorney with over 20 years of experience, both as an in-house attorney at a biopharmaceutical company and as outside counsel at boutique patent law firms.  I have a graduate degree in biochemistry and the focus of my practice has been in the areas of large and small molecule pharmaceuticals and medical devices.
 
Over the course of my practice I have regularly attending the AIPLA annual meeting in Washington DC, for the networking opportunities as well as the informative program sessions.  I recently decided to increase my involvement with AIPLA and become a member so that I could actively participate in the organization to help myself and others understand and influence the laws and policies that impact our clients and our world.
 
I joined the Biotech committee because Biotech patent law is an incredibly dynamic field.  Recent Supreme Court decisions and the implementation of new policies by the USPTO have greatly changed the practice of biotech patent law as has recent legislation in the area of biosimilars.  In this evolving environment, the AIPLA is an important resource and advocate for clients that rely on intellectual property to support their business objectives. 
 
When I am not practicing law, I enjoy traveling, cooking, yoga and biking. 
 --Melissa
December 12
December 2017 - Biotech Buzz

 December 2017

 
 
Dear Members of the Biotech Committee—Lots of EXCITING news this month.  First, we’re kicking off the first installment of a new, recurring Member SpotlightFeature, as a way of introducing you to your fellow Committee members.  This month’s spotlight is on Vlad Drozdoff, Chief Patent Counsel at Cold Spring Harbor Laboratory, where he works in Technology Transfer and Business Development.   Vlad is a long-standing member of the Biotechnology Committee (over 10 years), where he serves as the co-subchair of the Tech Transfer and Licensing Subcommittee. 
 
MEMBER SPOTLIGHT:  VLAD DROZDOFF
 
Vlad notes:   I’ve been at CSHL for almost 10 years.  And over this time, I’ve had the good fortune of working in an intellectually stimulating and challenging place, supporting our efforts to make a positive impact on society and the public with the science and technology our investigators develop.   Working in a small, lean department, I often have many hats on.  But all under the general umbrella of helping my department work effectively as business agents for our scientists. Day to day, it’s always something different, which means the work rarely gets stale.  My role in all this ranges from managing IP, from a strategic level down to nuts and bolts drafting, providing legal support to our business development team and grants office, and also on the business side, working with our spin-out companies and our institutional and commercial partners.  What I can count on - an exciting and challenging mix of law, business and cutting edge science.
 
I’ve been attending AIPLA annual meetings, and have been on the Biotechnology Committee and Tech Transfer and Licensing subcommittee pretty much since I came to CSHL.  Probably the most valuable part of my involvement has been the opportunity to better understand and appreciate the different perspectives and challenges of those I interact with professionally outside of CSHL, and the chance to exchange ideas, advice and strategy on dealing with these challenges.  This has been especially valuable to me in being able to work effectively with outside organizations.
 
Outside of the AIPLA and CSHL, you will most likely find me on my Peloton, on a volleyball court or when I’m lucky enough, skating into the sun on a Nordic ski trail on some perfectly waxed, fast carbon core skis. --Vlad
 
 
Second, we’re eagerly anticipating the Midwinter Meeting next month, where the Biotech Committee is joining with the Trademark Committee to provide a 2-hour CLE session on IP issues for the growing cannabis industry, “NOT JUST BLOWING SMOKE: THE PITFALLS AND OPPORTUNITIES FOR PROTECTING IP IN THE EMERGING U.S. CANNABIS INDUSTRY.”  As federal and state governments battle it out over the legality of plants of the genus Cannabis for medical and recreational purposes, businesses in decriminalized states find themselves in a bind when it comes to the largely federal body of intellectual property law.  Issues Leader Kristin Connarn will moderate the panel of distinguished experts, including Reggie Gaudino, the Chief Science Officer of Steep Hill Labs, Kieran Doyle, from Cowan, Liebowitz & Latman, P.C., and Katherine Koenig from CHRISTOPHER & WEISBERG, P.A.
  
We’re also planning a happy hour/reception at the Midwinter meeting, with more details to follow.
 
If you have any suggestions, please feel free to send an e-mail to any of Committee Leaders by using the Leader’s email icon or send an email to all of us by clicking the envelope:  
 
Buzz Editor –Vicki G. Norton
 
Vice Chair Nicholas Landau
 
 
Issues Leader’s Notes Kristin A. Connarn
           Diagnostics & Gene Patenting SubcommitteeJohn E. Peterson and Charles W. Calkins
Mark Pidkowich and Thuy Nguyen report on The Canadian Intellectual Property Office’s problematic guidelines for Examination Practice Respecting Medical Diagnostic Methods ("PN 2015-02"), introduced in the summer of 2015.  While Canadian jurisprudence has yet to develop in the face of these guidelines, their implementation by examiners has begun to be better understood.  more
Ben Mahon reports on application of sovereign immunity to IPR proceedings in Covidien LP v. University of Florida Research Foundation Inc.  more
We’re planning a Happy Hour/Reception at the Mid-Winter meeting (stay tuned for details). 
  
November 13
November 2017 - Biotech Buzz

 BIOTECH BUZZ

November 2017
 
 
Dear Members of the Biotech Committee—As the new Chair of the Committee, I wanted to highlight how much the Leaders of the Committee are looking forward to continuing to working with you to make the Biotech Committee one of the most active, vibrant Committees at AIPLA.  As before, our goal is to serve as a value-added resource and forum for the Biotech IP Community.  If you have any recommendations for programs and resources you'd like to see offfered, or would like to get more involved in the Committee, feel free to send an e-mail to any of Committee Leaders.   
 
Buzz Editor –Vicki G. Norton
 
Vice Chair Nicholas Landau:
 
USPTO Relations Carla Mouta-Bellum
Carla Mouta-Bellum reports on the November 6 2017 BCP meeting more
 
Issues Leader’s Notes Kristin A. Connarn
Biosimilars – Kristin Connarn
Melissa Pytel reports on a letter from lawmakers urging USDA, FDA and EPA to Adopt a “Consistent, Science-Based” Approach to Regulating  Biotechnology more
Kristin Connarn reports that FDA’s naming convention rules for biosimilars and their biologic reference products’ names have been in place for ten           months but are not being applied more
Biotech Litigation – Bryan Diner, Patrice Jean and Laura Smalley
Laura Smalley reports on the Federal Circuit’s Denial of Writ of Mandamus Requesting Discovery of Non-Listed Patents under the Biologics Price Competition and Innovation Act, in Amgen v. Hospira more
           Diagnostics & Gene Patenting Subcommittee – John E. Peterson and Charles W. Calkins
John E. Peterson and Charles W. Calkins report on Athena v Mayo, a recent decision from D. Mass., holding that a method claim which the court held was directed to non-patentable subject matter is not “saved” by virtue of the use of a non-naturally occurring protein, such as radioactively labeled antibody or labeled antigen which make it possible to detect the presence or absence of antibody-antigen complexes, which are indicative of a diseased state.  The fact that antibodies and antigens labeled with radioactive iodine are not found in nature was deemed insufficient to transform the subject matter of the claim into patentable subject matter.  The case is presently on appeal to the CAFC more
Genetic Resources Subcommittee  – Debora Plehn-Dujowich, David Read and Holger Tostmann
Debora Plehn-Dujowich reports on AIPLA’s Statement made at the 2017 WIPO General Assembly Regarding Mandatory Disclosure Requirement for Genetic Resources and/or Traditional Knowledge in Geneva, Switzerland, October 2-11, 2017 more
Trade Secrets Subcommittee  – Noel Courage
 Noel Courage reports on International enforcement of trade secrets more
The social gathering during the Annual Meeting with the Electronic and Computer Law, Emerging Technologies and Food and Drug
Committees following the joint CLE program was a huge success, with great food and a standing room only.  Thanks again to our sponsors, and we look forward to seeing you at the get-together at the Mid-Winter meeting (stay tuned for details). 
 
 
October 02
September 2017 - Biotech Buzz

Members of the Biotechnology Committee – You can view the latest issue of the Biotech Buzz below and access detailed information by clicking the names and other hyperlinks.  The more links below download the given article.  Click here to download the entire Biotech Buzz as a pdf file.
 
If you want to be active in the committee, click here  and indicate your interests, ideas, and contact information in your email.  Alternatively, contact the Leader and Sub-Chair(s) of the particular subcommittee of interest.
 
September 2017
 
ANNOUNCEMENT:
 
·         Registration is open for the AIPLA Annual Meeting in DC.  To register please click HERE. 
·         Please see announcement below under “Regional/Social” for details on a Social Gathering to be held on Thursday October 19th at the Annual Meeting at Harry’s Pub in the Marriott from 5:30-7:30 pm.
 
Buzz Editor – Debora Plehn-Dujowich and Vicki Norton
 
Vice Chair Vicki Norton: The Federal Circuit Rejects the E.D. Texas District Court’s Flexible Post-TC Heartland Approach To Determining Venue, Ordering Transfer in In Re: Cray In Re Cray more  
 
Issues Leader’s NotesNicholas Landau
Biotech Litigation – Bryan Diner, Patrice Jean and Laura Smalley
Laura Smalley reports on In re Stepan Co. more
High Tech Biotech –Adrian Zahl
Daniel A. McKinley reports on Bioinformatics Inventions – Treatment Under Australian and New Zealand Patent Law more
 
Alice Martin reports that there will be a social gathering during the Annual Meeting on Thursday October 19 from 5:30-7:30 pm ET at Harry’s Pub in the Marriott more
David Read of Bartle Read IP reports on a position proposal by the European Commission on intellectual property rights post-Brexit more
Claire Gregg of Allens Patent & Trade Mark Attorneys reports on an Australian Full Federal Court decision that finds "Swiss-style" claims are not available for patent term extension more
Claire Gregg of Allens Patent & Trade Mark Attorneys reports on Australia's unique statutory 'best method' requirement that continues to get the better of patent applicants and patentees more
 
 
 
Feel free to send comments and recommendations to a Committee Leader using the Leader’s email icon or send an email the Chair, Vice Chair, and all Leaders by clicking the envelope: .
The Fine Print: These materials are public information and have been prepared solely for educational and entertainment purposes to contribute to the understanding of intellectual property law. These materials reflect only the personal views of the authors and are not a source of legal advice. It is understood that each case is fact specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, the authors and their organizations cannot be bound either philosophically or as representatives of their various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with the authors or their organizations. While every attempt was made to ensure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed.
 
 
August 30
August 2017 - Biotech Buzz

Members of the Biotechnology Committee – You can view the latest issue of the Biotech Buzz below and access detailed information by clicking the names and other hyperlinks.  The more links below download the given article.  Click here to download the entire Biotech Buzz as a pdf file.
 
If you want to be active in the committee, click here  and indicate your interests, ideas, and contact information in your email.  Alternatively, contact the Leader and Sub-Chair(s) of the particular subcommittee of interest.
 
August 2017
 
ANNOUNCEMENT:
 
·         Registration is open for the AIPLA Annual Meeting in DC.  To register please click HERE.  Please stay tuned for info on a joint Happy Hour with the Food and Drug Committee!
 
Buzz Editor – Debora Plehn-Dujowich and Vicki Norton
 
 
Carla Mouta-Bellum reports on upcoming webinars including one on September 20 entitled “Biotech and Emerging Technologies” which will be a reprise of the Spring Meeting panel more
 
Issues Leader’s NotesNicholas Landau
Biotech Litigation – Bryan Diner, Patrice Jean and Laura Smalley
Laura Smalley reports on Federal Circuit Addresses Obviousness under the Lead Compound Analysis in Holding that Velcade® Patent is not Obvious more
 
Janice Galvad and Ramon Pereira of Adams & Adams provide a review of the legislative landscape in South Africa relating to Traditional Knowledge (TK) and comment on the draft TK Bill more
Robin Bartle of Bartle Read reports on a significant decision by the UK’s Supreme Court establishing a doctrine of equivalents for the interpretation of claim language more
Beatriz San Martin, Nicole Jadeja and Hannah Smith-Willis report on The Future for European Supplementary Protection Certificates – is it in the balance? more
Holger Tostmann of Wallinger Ricker Schlotter Tostmann reports on “Early Certainty from Examination”-Initiative of European Patent Office Complicates Life Sciences Patent Prosecution in Europe more
 
 
 
Feel free to send comments and recommendations to a Committee Leader using the Leader’s email icon or send an email the Chair, Vice Chair, and all Leaders by clicking the envelope: .
The Fine Print: These materials are public information and have been prepared solely for educational and entertainment purposes to contribute to the understanding of intellectual property law. These materials reflect only the personal views of the authors and are not a source of legal advice. It is understood that each case is fact specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, the authors and their organizations cannot be bound either philosophically or as representatives of their various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with the authors or their organizations. While every attempt was made to ensure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed.
August 30
July 2017 - Biotech Buzz

Members of the Biotechnology Committee – You can view the latest issue of the Biotech Buzz below and access detailed information by clicking the names and other hyperlinks.  The more links below download the given article.  Click here to download the entire Biotech Buzz as a pdf file.
 
If you want to be active in the committee, click here  and indicate your interests, ideas, and contact information in your email.  Alternatively, contact the Leader and Sub-Chair(s) of the particular subcommittee of interest.
 
July 2017
 
ANNOUNCEMENT:
 
·         I will be attending the 2017 WIPO General Assembly in Geneva, Switzerland in October as AIPLA’s representative on the topic of Genetic Resources and Traditional Knowledge.  Please see my article below under the Genetic Resources Subcommittee heading for more info.
·         Registration is open for the AIPLA Annual Meeting in DC.  To register please click HERE. 
 
Buzz Editor – Debora Plehn-Dujowich and Vicki Norton
 
 
Adda C. Gogoris reports on Mylan Institutional LLC v. Aurobindo Pharma Ltd. more
Joan Wang reports on Emerachem Holdings, LLC v. Vokswagen Grp. Of Am., Inc. more
Carla Mouta-Bellum reports on upcoming webinars including one on August 15 entitled “Biotech IPRs: What have we learned?” and one on September 20 entitled “Biotech and Emerging Technologies” which will be a reprise of the Spring Meeting panel more
 
Issues Leader’s NotesNicholas Landau
Biotech Litigation – Bryan Diner, Patrice Jean and Laura Smalley
Noel Courage and Melanie Szweras report on Canada’s Supreme Court Moves Utility Test Back Towards the US and European Standards more
Genetic ResourcesDebora Plehn-Dujowich, Holger Tostmann and David Read
Debora Plehn-Dujowich reports on the upcoming 2017 General Assembly at WIPO and the discussion regarding genetic resources and traditional knowledge more
 
 
 
Feel free to send comments and recommendations to a Committee Leader using the Leader’s email icon or send an email the Chair, Vice Chair, and all Leaders by clicking the envelope: .
The Fine Print: These materials are public information and have been prepared solely for educational and entertainment purposes to contribute to the understanding of intellectual property law. These materials reflect only the personal views of the authors and are not a source of legal advice. It is understood that each case is fact specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, the authors and their organizations cannot be bound either philosophically or as representatives of their various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with the authors or their organizations. While every attempt was made to ensure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed.
 
June 26
June 2017 - Biotech Buzz

Members of the Biotechnology Committee – You can view the latest issue of the Biotech Buzz below and access detailed information by clicking the names and other hyperlinks.  The more links below download the given article.  Click here to download the entire Biotech Buzz as a pdf file.
 
If you want to be active in the committee, click here  and indicate your interests, ideas, and contact information in your email.  Alternatively, contact the Leader and Sub-Chair(s) of the particular subcommittee of interest.
 
June 2017
 
ANNOUNCEMENT: The next BCP meeting will be on August 2, 2017—for more info please see the announcement below by Suzannah Sundby under the USPTO Relations Subcommittee heading. 
 
Buzz Editor – Debora Plehn-Dujowich and Vicki Norton
 
 
 
USPTO Relations Suzannah Sundby and Ron Kamis
Suzannah Sundby Announcement: The next Biotechnology, Chemical, and Pharmaceutical Partnership Meeting will be held on August 2, 2017, from NOON to 5:00 PM EDT at the USPTO headquarters in Alexandria, VA and the Silicon Valley Regional Office.  More details to follow.  However, the proposed itinerary will primarily be on 101 (in)eligibility.  Thus, remember Happy Hour after at the Trademark Bar (Alexandria, VA), we will all probably need it.
Carla Mouta-Bellum reports on upcoming webinars including one on August 15 entitled “Biotech IPRs: What have we learned?” and one on September 20 entitled “Biotech and Emerging Technologies” which will be a reprise of the Spring Meeting panel more
 
Issues Leader’s NotesNicholas Landau
Kristin Connarn reports on Draft Biosimilar Interchangeability Guidance from FDA more
Biotech Litigation – Bryan Diner, Patrice Jean and Laura Smalley
Laura Smalley reports on Supreme Court Interprets the Biologics Price Competition in favor of Biosimilar Applicants more
Luke H. MacDonald, Ph.D., Li Feng, Ph.D. and Carla Mouta-Bellum, Ph.D., report on the Federal Circuit Considers the “Newly Characterized Antibody” Test in Amgen v Sanofi but Might Pass on a Ruling more
Mridula P. Sherin reports on In re U.S. Water Services Inc. more
 
Trade Secrets Noel Courage
Noel Courage and Nick Aitken report on Recent Cases Illustrate Civil vs Criminal Consequences for Taking Trade Secrets more
 
 
 
Feel free to send comments and recommendations to a Committee Leader using the Leader’s email icon or send an email the Chair, Vice Chair, and all Leaders by clicking the envelope: .
The Fine Print: These materials are public information and have been prepared solely for educational and entertainment purposes to contribute to the understanding of intellectual property law. These materials reflect only the personal views of the authors and are not a source of legal advice. It is understood that each case is fact specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, the authors and their organizations cannot be bound either philosophically or as representatives of their various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with the authors or their organizations. While every attempt was made to ensure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed.
 
 
January 23
January 2017 - Biotech Buzz

Members of the Biotechnology Committee – You can view the latest issue of the Biotech Buzz below and access detailed information by clicking the names and other hyperlinks.  The more links below download the given article.  Click here to download the entire Biotech Buzz as a pdf file.

 

If you want to be active in the committee, click here  and indicate your interests, ideas, and contact information in your email.  Alternatively, contact the Leader and Sub-Chair(s) of the particular subcommittee of interest.

 

 BIOTECH BUZZ

January 2017

 

Chair’s NotesDebora Plehn-Dujowich:

ANNOUNCEMENT:

 

AIPLA Annual Mid-Winter Institute Social Gathering

Thursday, February 2, 2017

5:00-7:00 p.m.

Sea Level Bar

Marriott Harbor Beach Resort & Spa

 

REMINDER: 2017 Mid-Winter Institute—Please join us for a CLE panel with the Food and Drug Committee:

The theme for the MWI is “AIPLA TAPAS – Savory and Sweet Bites of Advanced IP Law and Practice.” In keeping with the theme, here are the presentations that we are planning:

 

Speakers:

Jeffrey Totten (Finnegan) will present: 3D Printing Menu – Tissues, Organs and Medical Devices

Irena Royzman (Patterson) will present: When Shall Means Shall: Lessons from Two Years of Biosimilar Litigation

Daphne Lainson (Smart & Biggar) will present: Clearly Canadian – Claim Drafting in view of Hatch-Waxman and Patenting Medicines Regulations

Matthew A. Pearson (Akin Gump) will present: Stay for Dinner – IPR stays during Hatch-Waxman cases

 

 

Moderator:

Malaika Tyson (McAndrews)

 

Buzz Editor – Debora Plehn-Dujowich and Vicki Norton

Microsite Master John Marquardt

Vice ChairVicki Norton:   more 

Services Leader’s NotesCarla Mouta

Case Law Reviews Melanie Szweras and Emily Curtis

D. Benjamin Borson, M.A., J.D., Ph.D. reports on In re Marcel van Os more

Webinars Carla Mouta

Carla Mouta reports on the upcoming January 24 webinar on Section 101 guidelines with June Cohan from the USPTO and Suzannah Sundby  more

 

 

Issues Leader’s NotesNicholas Landau

Announcement from Issues Leader Nick Landau – Volunteers Needed for various Biotech Committee positions more

Biosimilars – Lynn Tyler and Kristin Connarn

Kristin Connarn reports on FDA Guidance on Clinical Pharmacology Data Needed to Support Biosimilars more

Biotech Litigation – Bryan Diner, Patrice Jean and Laura Smalley

Laura Smalley reports on Supreme Court Agrees to Hear Case Regarding the Biologics Price Competition and Innovation Act of 2009 in Amgen v. Sandoz more

Carla Mouta, Ph.D., reports on Amgen’s Sweet Spot Sends Praluent Out of the Market: is the “Well-Characterized Antigen” Doctrine Supported by its Discovery? more

Plant Biotech Alice Martin and Mark Pidkowich

Sally Hemming and Mark Pidkowich report on Canada’s Patent Appeal Board Rejects Monsanto’s Claims to Use of Plants with a Specified Genotype in the Production of an Advantageous Seed Mix more

Tech Transfer & Licensing – Eric Mirabel, Vladimir Drozdoff and Ypsita Demunshi

Eric Mirabel and Vladimir Drozdoff report on CRISPR Licensing Strategies Offers Insights into Selection of Invalidation Procedures, and other Prosecution Strategies more

Kristin Neuman reports on CRISPR Patent Licensing: An Opportunity to Leverage Experience from Patent Pool Models to Help this Technology Reach its Full Potential more

 

 

Community Leader’s Notes Alice Martin

Regional/Social Debora Plehn-Dujowich and Alice Martin

Alice Martin reports that there will be a social gathering during the Mid-Winter Institute on Thursday February 2nd from 5-7 pm ET at the Sea Level Bar in the Marriott more

 

 

Feel free to send comments and recommendations to a Committee Leader using the Leader’s email icon or send an email the Chair, Vice Chair, and all Leaders by clicking the envelope: .

The Fine Print: These materials are public information and have been prepared solely for educational and entertainment purposes to contribute to the understanding of intellectual property law. These materials reflect only the personal views of the authors and are not a source of legal advice. It is understood that each case is fact specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, the authors and their organizations cannot be bound either philosophically or as representatives of their various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with the authors or their organizations. While every attempt was made to ensure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed.

 ​

December 20
December 2016 - Biotech Buzz

Members of the Biotechnology Committee – You can view the latest issue of the Biotech Buzz below and access detailed information by clicking the names and other hyperlinks.  The more links below download the given article.  Click here to download the entire Biotech Buzz as a pdf file.

 

If you want to be active in the committee, click here  and indicate your interests, ideas, and contact information in your email.  Alternatively, contact the Leader and Sub-Chair(s) of the particular subcommittee of interest.

 

 BIOTECH BUZZ

December 2016

 

Chair’s NotesDebora Plehn-Dujowich:

2017 Mid-Winter Institute—Please join us for a CLE panel with the Food and Drug Committee:

The theme for the MWI is “AIPLA TAPAS – Savory and Sweet Bites of Advanced IP Law and Practice.” In keeping with the theme, here are the presentations that we are planning:

 

Speakers:

Jeffrey Totten (Finnegan) will present: 3D Printing Menu – Tissues, Organs and Medical Devices

Irena Royzman (Patterson) will present: When Shall Means Shall: Lessons from Two Years of Biosimilar Litigation

Daphne Lainson (Smart & Biggar) will present: Clearly Canadian – Claim Drafting in view of Hatch-Waxman and Patenting Medicines Regulations

Matthew A. Pearson (Akin Gump) will present: Stay for Dinner – IPR stays during Hatch-Waxman cases

 

 

Moderator:

Malaika Tyson (McAndrews)

 

ANNOUNCEMENT - Don’t forget to sign up for Biotech Committee during AIPLA Committee Open Season:

It is currently “open season” for signing up for AIPLA committees.  Please remember to re-sign up for the Biotech Committee so that you continue to receive amazing benefits like the Biotech Buzz. Please also consider signing up as a “voting member” of the Biotech Committee. This will allow you to participate in votes on important issues such as which comments AIPLA will submit to the USPTO on issues such as the proposed ST26 sequence listing standard, the Section 101 Examples, etc.  To sign up, go to the AIPLA website (aipla.org) and click on the tab “Committee Center” then click on “Update Committee Selections” in the drop-down menu.  You must be logged in to make selections.

 

Buzz Editor – Debora Plehn-Dujowich and Vicki Norton

Microsite Master John Marquardt

 

Vice ChairVicki Norton:   more 

Vicki Norton writes about Lost In Transition:  What does indefiniteness under Nautilus mean for claims reciting “consisting essentially of”? more

Services Leader’s NotesCarla Mouta

Case Law Reviews Melanie Szweras and Emily Curtis

Hui-Shan Sandra King reports on In re Efthymiopoulos more

Adda C. Gogoris reports on In re NuVasive more

USPTO Relations Suzannah Sundby and Ron Kamis

Ron Kamis reports on the BCP meeting of October 19 more

Webinars Carla Mouta

Carla Mouta reports on the upcoming January 24 webinar on Section 101 guidelines with June Cohan from the USPTO and Suzannah Sundby  more

 

 

Issues Leader’s NotesNicholas Landau

Genetic Resources – Debora Plehn-Dujowich, Holger Tostmann and David Read

Holger Tostmann reports on WIPO activities regarding Intellectual Property Relating to Genetic Resources and Traditional Knowledge more

PTAB Actions – Herb Hart and Malaika Tyson

Manuela Cabal Carmona reports on Patent Agent-Client Privilege in PTAB Proceedings: USPTO’s Proposed Rule Amendment more

 

Community Leader’s Notes Alice Martin

International David Read and Trevor Davies

David Read reports on EPO referring questions concerning the allowability of ‘undisclosed disclaimers’ to its Enlarged Board of Appeal more

Robin Bartle reports on EPO’s enlarged board of appeal ordering antidote to poisonous priorities more

 

 

Feel free to send comments and recommendations to a Committee Leader using the Leader’s email icon or send an email the Chair, Vice Chair, and all Leaders by clicking the envelope: .

The Fine Print: These materials are public information and have been prepared solely for educational and entertainment purposes to contribute to the understanding of intellectual property law. These materials reflect only the personal views of the authors and are not a source of legal advice. It is understood that each case is fact specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, the authors and their organizations cannot be bound either philosophically or as representatives of their various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with the authors or their organizations. While every attempt was made to ensure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed.

 ​

July 20
July 2016 - Biotech Buzz

Members of the Biotechnology Committee – You can view the latest issue of the Biotech Buzz below and access detailed information by clicking the names and other hyperlinks.  The more links below download the given article.  Click here to download the entire Biotech Buzz as a pdf file.

 

If you want to be active in the committee, click here  and indicate your interests, ideas, and contact information in your email.  Alternatively, contact the Leader and Sub-Chair(s) of the particular subcommittee of interest.

 

 BIOTECH BUZZ

July 2016

 

Chair’s NotesDebora Plehn-Dujowich:

We are busy planning a wonderful CLE panel presentation together with the M&A and Antitrust Committees for the 2016 AIPLA Annual Meeting:

Experts from the Biotech Committee, Mergers & Acquisitions Committee and Antitrust Committee will address biopharma patent issues, merger & acquisition issues and antitrust concerns relating to the development and commercialization of a Zika virus-vaccine.  An FTC representative will cover Bio and Pharma issues.

Stay tuned for more details.

 

Buzz Editor – Debora Plehn-Dujowich and Vicki Norton

Microsite Master John Marquardt

 

Vice ChairVicki Norton: writes about The Meaning of “Life” 2:  The Court’s Grant of Life’s Petition for Certiorari on What Constitutes “A Substantial Portion of Components” of a Patented Combination in 35 U.S.C. § 271(f)(1)? … more 

 

 

Services Leader’s NotesCarla Mouta

Case Law Reviews Melanie Szweras and Emily Curtis

Lisa Mandrusiak reports on Genzyme Therapeutic Prods. Ltd. P’ship v. Biomarin Pharm. Inc. more

Lynn C. Tyler and Sean M. Phipps report on Gilead Sciences., Inc. v. Merck & Co, Inc.  more

USPTO Relations Suzannah Sundby and Ron Kamis

Suzannah Sundby and Ron Kamis report on the BCP meeting of June 30 more

Webinars Carla Mouta

Carla Mouta reports on there will be a CLE webinar on July 27 regarding Building a Global Portfolio: Double Patenting and Unity of Invention Pitfalls in US, Europe, and Asia.   more

 

 

Issues Leader’s NotesNicholas Landau

Biosimilars – Lynn Tyler and Kristin Connarn

Kristin Connarn reports on Uptick in Biosimilar Approval Activity at FDA more

Laura Smalley reports on Amgen Inc. v. Apotex Inc.: Federal Circuit Holds that 180-Day Notice Must be Given more

Diagnostics & Gene Patenting – George Yu and John Peterson

Alice Martin reports on Sequenom more

Alice Martin reports on RAPID LITIGATION MANAGEMENT LTD. V. CELLZDIRECT, INC more

PTAB Actions – Herb Hart and Malaika Tyson

Ben J. Mahon reports on Genzyme Therapeutic Products Ltd Partnership v. Biomarin Pharmaceutical Inc., Fed. Cir. 2015-1720 more

Tech Transfer & Licensing – Eric Mirabel, Vladimir Drozdoff and Ypsita Demunshi

Eric Mirabel and Vladimir Drozdoff report on The Federal DTSA and Its Advantages over Related State Court Relief more

 

Community Leader’s NotesRyan Chirnomas and Alice Martin

International David Read and Trevor Davies

David Read of Bartle Read reports on Brexit—the implications so far more

 

 

Feel free to send comments and recommendations to a Committee Leader using the Leader’s email icon or send an email the Chair, Vice Chair, and all Leaders by clicking the envelope: .

The Fine Print: These materials are public information and have been prepared solely for educational and entertainment purposes to contribute to the understanding of intellectual property law. These materials reflect only the personal views of the authors and are not a source of legal advice. It is understood that each case is fact specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, the authors and their organizations cannot be bound either philosophically or as representatives of their various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with the authors or their organizations. While every attempt was made to ensure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed.

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