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August 21
August Updates - BPCIA and Annual Meeting Planning

The PTAB, Biotech Litigation and Plant subcommittees continue to work on the joint Biotech-ITC CLE presentation at the Annual Meeting, in which outside counsel to Soteria will provide strategic advice on what Soteria needs to know about the pros and cons of enforcing patents in the ITC, as well as the impact of recent PTAB decisions and the need to reassess Soteria’s patents in view of recent cases holding biotechnology patents invalid as patent ineligible or lacking written description.  Laura Smalley also provided the following reports on the latest developments in biosimilars cases:

 
·         Laura Smalley  provided a Hot Biotech report on the Amgen v. Apotex case—the first in which the biosimilar manufacturer has complied with the “Patent Dance” under the BPCIA.  Amgen seeks to enjoin Apotex’s manufacture and distribution of a version of Amgen’s Neulasta® (pegfilgrastim) (Noel Courage and Vicki Norton, sub-chairs)
·         Laura Smalley  also provided a Biosimilar subcommittee report on the Federal Circuit’s ruling in Amgen v. Sandoz, affirming the district court’s ruling that the patent dance provisions of the Biologics Price Competition and Innovation Act (“BPCIA”) are not mandatory, but reversing the district court’s notice provision ruling to hold that the biosimilar applicant can only provide notice to the Reference Product Sponsor once its product is licensed by FDA  (Lynn Tyler and Kristin Connarn, sub-chairs)
 
All of the subcommittees also continue to welcome new members and volunteers to
assist with new projects, especially with postings to Soteria’s microsite.  We would love to have you join and appreciate your enthusiasm and willingness to get more involved. Please contact any Leader of the Biotech Committee or Co-Chairs of the subcommittees if you are interested in participating.
July 17
The Hot Biotech Subcommittee Reports on a Key Notice for Examination of Diagnostic Patents in Canada, and Issues Subcommittees Continue to Work on the Annual Meeting Joint CLE Presentation with the ITC

The PTAB, Biotech Litigation and Plant subcommittees continue to work on the joint Biotech-ITC CLE presentation at the Annual Meeting, in which outside counsel to Soteria will provide strategic advice on what Soteria needs to know about the pros and cons of enforcing patents in the ITC, including the low likelihood that the ITC will stay an action if a challenger files a PTAB proceeding, and the advantages of in rem jurisdiction.  The panel will also discuss the impact of recent PTAB decisions and the need to reassess Soteria’s patents in view of recent cases holding biotechnology patents invalid as patent ineligible or lacking written description.

 
The Hot Biotech subcommittee also provided a report on Canada’s recently published notice concerning examination of diagnostics patent claims:  
 
·         Noel Courage  provided a Hot Biotech report (Noel Courage and Vicki Norton, sub-chairs) on the Canadian Intellectual Property Office’s Diagnostics Patent Notice to Examiners regarding examination of diagnostic methods, (“Examination Practice Respecting Medical Diagnostic Methods – PN 2015-02”).  Noel reported that CIPO undertook a review of its diagnostics examination practices following the Federal Court of Appeal decision in the business methods patent case Canada v Amazon.com Inc., 2011 FCA 328.  Prosecution of some diagnostics applications, which had been postponed in the interim, will now be given priority, according to how long they have been waiting for a response.
 
All of the subcommittees also continue to welcome new members and volunteers to
assist with new projects, especially with postings to Soteria’s microsite.  We would love to have you join and appreciate your enthusiasm and willingness to get more involved. Please contact any Leader of the Biotech Committee or Co-Chairs of the subcommittees if you are interested in participating.
June 16
Issues Subcommittees Report on the Latest Biosimilars and PTAB Developments

The Biosimilars and PTAB Actions subcommittees report on key regulatory developments for biosimilars, and PTAB actions:

 
·         Lynn Tyler, co-subchair of the Biosimilar subcommittee (Lynn Tyler and Kristin Connarn, sub-chairs) reports on FDA’s follow-up draft guidance, which answers additional questions about implementation of the BPCIA, including FDA’s continuing consideration of the type of information sufficient to establish interchangeability.
·         Lynn Tyler  also reports on AbbVie’s Citizen Petition arguing the FDA should require clear labeling that the product is a biosimilar and that it is (or is not) interchangeable.  AbbVie also argues that biosimilar labels should include a better description of the data (or lack thereof) on which the biosimilar’s approval was based.
·         Robert Kappers of the PTAB Actions subcommittee (Herbert Hart and Malaika Tyson, sub-chairs) reports on PTAB’s first set of amendments to the Rules of Practice for Trials, which is a culmination of the Office’s ongoing attempt to maximize effectiveness of the Rules.
Work continues on the joint Biotech-ITC CLE presentation at the Annual Meeting, in which outside counsel to Soteria will provide strategic advice on patent enforcement proceedings at the ITC and district court, and strategy for PTAB proceedings. 
 
All of the subcommittees also continue to welcome new members and volunteers to assist with new projects, especially with postings to Soteria’s microsite.  Please contact any Leader of the Biotech Committee or Co-Chairs of the subcommittees if you are interested in participating.
June 17
Highlighting Technology Transfer & Licensing Piece of Platform Tech

The Technology Transfer & Licensing Subcommittee Reports on an Exemplary Collaboration to Identify Lead Products Using a Platform Technology

 
This month, as part of their ongoing project to summarize terms in exemplary agreements and to note trends in licensing, the Technology Transfer & Licensing Subcommittee summarizes an exemplary collaboration agreement to identify lead products using a platform technology, and compares the terms in that agreement to the terms in an agreement for a product and research & development collaboration between a small biotech and a large pharmaceutical company:
 
Eric Mirabel, Ypsita Demunshi and Vladimir Drozdoff summarize an exemplary collaboration agreement to identify lead products using a platform technology more
 
The subcommittees continue to monitor and report on issues of interest to biotech
patent practitioners.  For example, the Diagnostics & Gene Patenting subcommittee continues to monitor for any updates to the PTO’s March 4, 2014 guidance memorandum for examining claims for subject matter eligibility.  The Hot Topics subcommittee also continues to monitor several cases expected to have an impact on Biotech patent practitioners. 
 
All of the subcommittees including the technology transfer & licensing subcommittee continue to welcome new members and volunteers to assist with these and other exciting projects. We would love to have you join and appreciate your enthusiasm and willingness to get more involved. Please contact any Leader of the Biotech Committee or Co-Chairs of the subcommittees if you are interested in participating.
 
April 16
Spotlight on the Industrial Biotech Subcommittee

Please see the report on the Butamax v Gevo biofuel case by the new Industrial Biotech Subcommittee (Judy Roesler  and Gerald F. Swiss, sub-chairs).  The subcommittee monitors issues relating to “white biotechnology,” including the use of bioproducts (e.g., biocatalysts and microorganisms) to produce industrial goods, such as renewable energy fuels and biomaterials sourced from renewable sources (including bioplastics and bike tire innertubes!).  

The Biosimilars, High Tech Biotech, Hot Topics, and the Diagnostics and Gene Patenting Subcommittees also provide updates on the latest developments impacting those practice areas.

For more information see

http://www.aipla.org/committees/committee_pages/Biotechnology/il/public/Documents/Issues_Buzz_201404.pdf

March 10
See the Latest Reports on Biosimilars, and on the PTO Guidance on Subject Matter Eligibility
This month, the Issues Subcommittees (Diagnostics & Gene Patenting, working with Hot Topics) provide a Hot Biotech Report on the closely monitored PTO’s Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena & Natural Products.  In addition, the Biosimilars Subcommittee reports on an upcoming Guidance by the European Medicines Agency (”EMEA”) on the limitations of biosimilar data comparison methodologies to evaluate biosimilarity for biosimilars, as well as President’s Obama latest Fiscal budget (2015) to propose decreasing biologic product regulatory exclusivity from 12 years to 7 years. 
 

January 14
See the Latest reports from the PTAB, Litigation and Diagnosticis Subcommittees

In the January 2014 Buzz, the PTAB Subcommittee Reports on PTAB decisions instituting inter partes review in three companion proceedings to ANDA litigations. the Biotech Litigation Subcommittee Provides Tips on Litigating Non-Obviousness in view of the Federal Circuit’s decisions in Institut Pasteur and Galderma, and the Diagnostics and Gene Patenting Subcommittee reports the results of the AIPLA Biotech Commitee Myriad survey

For more news about Issues Subcommittee activities, please read the complete summary at http://www.aipla.org/committees/committee_pages/Biotechnology/il/public/Documents/Issues_Buzz_201401.pdf

December 12
Tech Transfer and Licensing Subcommittee Report on New FTC Rules
Ypsita Demunshi and Vlad Drozdoff of the Technology Transfer and Licensing Subcommittee (Vlad Drozdoff and Eric Mirabel, sub-chairs) report on the New FTC Rules for Pre-Notification and Review of Licensing in the Biotech and Pharmaceutical Industries.  See the full article at the link below. 
 
 

http://www.aipla.org/committees/committee_pages/Biotechnology/licensing/Shared%20Documents/Licensing_Buzz_201312.pdf

November 20
Hot Topics Subcommittee Reports on Senate Bill to Regulate "Trolls"

The Hot Topics Subcommittee (Noel Courage and William Simmons, Co-Chairs), with Ypsita Demunshi reporting, provides a hot report on the latest bill to address false patent troll claims, which was introduced in the Senate on November 18th, on the heels of a hearing on the House's Goodlatte "Anti-Troll" bill.

You can read the report at:

http://www.aipla.org/committees/committee_pages/Biotechnology/hot/Shared%20Documents/20121120%20HotBiotech%20Senate%20NPE%20bill.pdf

Or join the discussion on Linked In.​

November 20
PTAB Subcomittee (Herb Hart, Chair) Reports on BioDelivery Sciences v MonoSol Rx

Robert K. Kappers, Herb Hart and Malaika Tyson of McAndrews, Held and Malloy report on the PTAB's denial of BioDelivery Sciences International, Inc.'s petition for inter partes review of MonoSol Rx, LLC's's U.S. Patent 7,425,292.  They report that the PTAB held that 35 U.S.C. sec. 315(b) bars petitions filed less than one year after service of a complaint asserting infringement but less than one year after claims are amended by reexamination certificate.  This comes as a follow up to the Board's decision in St. Jude Medical, Cardiology Division, which was previously reported by Robert, Herb and Malaika.

 

Please see the complete article, which will appear in the December issue of the Buzz at:

 

http://www.aipla.org/committees/committee_pages/Biotechnology/ptab/Shared%20Documents/PTAB_Buzz_201312.pdf

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