BIOTECHNOLOGY
Committee Report and Workplan
November 2015
COMMITTEE LEADERSHIP
Debora Plehn-Dujowich, Chair
Vicki Norton, Vice Chair
Myra McCormack, Board Liaison
COMMITTEE LEADERS
Issues Leader – Nick Landau
Community Leader – Alice Martin and Ryan Chirnomas
Services Leader – Carla Mouta
Overall mission of the Committee as it relates to
AIPLA’s VISION, MISSION, and VALUES
To realize the promise of Biotechnology in health, energy, environment, and food
requires a reliable, global IP system that rewards innovation without inhibiting it and
protects investments in new products and new jobs. Biotechnology IP practitioners and
companies, however, face very significant challenges in helping the world realize this
promise. The overall mission of the Biotechnology Committee is to serve as resource,
educator, and advocate for its members, AIPLA, government institutions, and people
everywhere so that the promise of Biotechnology may be more fully realized globally.
Buzz Editor – Debora Plehn-Dujowich
Microsite Master – John Marquardt
TSC Liaisons
Law Students – Kelly Lu
New Lawyers – Wen Xi
Women in IP Law – Carine Doyle
Diversity in IP Law – Roy Issac
Corporate – James J. Kelley
SUBCOMMITTEE SUB-CHAIRS
Biosimilars – Lynn Tyler and Kristin Connarn
Biotech Agents – Angie Sebor
Biotech Litigation – Bryan Diner, Patrice Jean, and Laura Smalley
Biotech Patent Education – Ryan B. Chirnomas
Case Law Reviews – Melanie Szweras and Emily Curtis
Corporate – James J. Kelley and Angie Sebor
Diagnostics & Gene Patenting – George Yu and John Peterson
High Tech Biotech – Roy Issac and Ashok K. Mannava
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Hot Biotech – Noel Courage and Vicki Norton
Industrial Biotech – Judy Roesler and Gerald Swiss
International – David Read and Trevor Davies
Liaisons – James J. Kelley and Suzannah K. Sundby
Plant Biotech – Alice Martin and Mark Pidkowich
PTAB Actions – Herbert Hart and Malaika Tyson
Public Communications – Gene Quinn and Courtenay Brinckerhoff
Regional/Social – Debora Plehn-Dujowich and Alice Martin
SWAT – Brad Duft
Technology Transfer & Licensing – Eric Mirabel and Vladimir Drozdoff
USPTO Relations –Suzannah K. Sundby and Debora Plehn-Dujowich
Webinars – Carla Mouta
SOTERIA BIOSCIENCES
We have created a hypothetical biotech company named Soteria Biosciences. Soteria
Biosciences is a biotech company that grew from a small agro-bio startup into a
multidisciplinary global giant. Soteria Biosciences’ headquarters is based in the United
States and has offices and R&D facilities in other parts of the world. Our educational
programming (including our Biotech Buzz articles, webinars, and stated meetings) will
involve the IP issues Soteria Biosciences faces in the development, maintenance, and
enforcement of its IP portfolio. Examples of IP issues include initial phases, e.g.,
licensing and sponsored research agreements; international aspects, e.g., confidentiality,
privilege, ownership, foreign filing licenses; issues specific to life sciences, e.g.,
coordinating clinical trials with patent filings and PTA and PTE; and issues specific to
PTAB actions, ITC and district court litigation of patents in the life sciences.
The website for Soteria Biosciences is found at
http://www.aipla.org/committees/committee_pages/Biotechnology/Soteria/SitePages/H
ome.aspx where our educational materials involving Soteria Biosciences’ IP will be
found.
WEBINARS
We hosted a free webinar on “Patent Term Extension Around the World: India, China
and Korea” on Tuesday, May 12, 2015 at 12:30 PM ET. Our speakers were Tarun Gandhi
of Chadha & Chadha, Li Feng of Finnegan and Yoon Suk Shin of Lee International.
We also hosted a CLE webinar on “Biosimilars: Regulation, Litigation & New
Developments Patent Practitioners & Regulatory Attorneys Should Know” on Thursday,
August 27, 2015 at 12:30 PM ET. Our speakers were Jim Shehan of Hyman, Phelps &
McNamara, Sanya Sukduang of Finnegan and Debora Plehn-Dujowich of Prismatic Law
Group, PLLC.
We are hosting a CLE webinar with the Chemical Practice Committee on January 7,
2016 at 12:30 ET on functional claiming and written description. The speakers will be
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Suzannah K. Sundby of Canady + Lortz LLP, Robert D. Titus of Eli Lilly, and Kenneth
Jenkins of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo.
We are hoping to have webinar series on patent eligibility around the world, and we are
planning a webinar on written description issues and biologics.
PLANS FOR ANNUAL MEETING
We presented a joint CLE program with the ITC Committee at the Annual Meeting which
discussed enforcement strategies for Soteria Biosciences’ IP portfolio.
The AIPLA time machine flashed forward to several years after Soteria Biosciences
discovered its Humor plant varieties and extracts, and successfully commercialized its
NoPainNoGain (“NPNG”) product, as discussed at the Spring Meeting 2015. Soteria’s
European subsidiary, Soteria AG discovered a new glycosylated polypeptide, which
provides the same pain relief without appetite stimulation as NPNG, but is also an
antagonist of the memory loss receptors, and therefore has no adverse effects on
memory. Soteria AG named the polypeptide NoPain/NoGain/Better Brain (NPGB).
Soteria AG also surprisingly found that NPGB is surprisingly efficacious for treating
neurodegenerative disorders.
Soteria further discovered that several Humor varieties produce NPGB with altered
glycosylation which decreases its immunogenicity and increases its accumulation in
plants.
Soteria obtained FDA approval for NPGB as Soterigen® NPGB 10 years ago, and learned
that SameGene Co. (“SameGene”), a European competitor with a U.S. subsidiary,
developed a biosimilar version of the NPGB product.
The CLE session at the 2015 Annual Meeting,
presented jointly with the ITC Committee, was
entitled “Whether to Pursue Enforcement of
Soteria Bioscience’s Patents Before the ITC
and/or District Court, and Preparing for PTAB
Challenges to Soteria’s Pre-AIA and Post-AIA
Patents.” The session featured a meeting
between Soteria in-house counsel, and its
outside litigation and PTAB counsel to discuss
its strategies and preparation to enforce its
patents.
CLE Session Summary
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Kwame N. Mensah acted as Soteria Biosciences’ General Counsel (Kwame is really
Intellectual Property Counsel at MedImmune and helped to put together the program).
Vicki G. Norton of Duane Morris LLP acted as Soteria’s Director of IP--she helped to put
together the program, including summarizing the facts behind the issues that the panel
will discuss. Read the facts behind these issues here.
Section 1 Summary:
This joint Biotech-ITC panel featured Brian Koo, an Investigative Attorney at the
ITC, and experts on ITC and district court litigation, as they advised Soteria
Biosciences, a hypothetical biotech company, on strategies for enforcing its
patents and preparing for PTAB challenges.
During Section 1, Brian B. Koo, an Investigative Attorney at the ITC, Maximilienne
Giannelli from Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, and Dallin G.
Glenn from Stern Kessler Goldstein Fox advised Soteria in-house counsel on what
patentees need 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, the advantages of in rem jurisdiction, and the possibility of side-stepping
the biosimilar patent dance through enforcement at the ITC.
Maximilienne Giannelli advised Soteria counsel on what makes the ITC an attractive
forum for biotech and chemical companies. Those advantages include quick resolution
at the ITC, the ability to more easily obtain discovery from foreign entities, and the
inapplicability at the ITC of the limitations in 35 U.S.C. § 271(g) for products that are
materially changed after manufacture by a process patented in the U.S., or that are a
trivial or nonessential component of an imported product.
Dallin Glenn addressed strategies for enforcement of Soteria’s biologic drug patents at
the ITC, including the ability for the patentee to sidestep the patent dance provisions of
the Biologics Price Competition and Innovation Act of 2009 by fling a Section 337 action
at the ITC.
Section 2 Summary:
Herbert D. Hart III, a partner at McAndrews Held & Malloy advised Soteria on strategies
for preparing for PTAB proceedings and post-grant challenges in “Facing The New Wolf
Pack: Preparing For Post-Grant Challenges At The Patent Trial And Appeal Board” Herb
discussed the timing and nature of potential PTO challenges to Soteria’s patents, the
impact of recent PTAB decisions for biopharma and pharma companies, and the need to
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reassess Soteria’s patents in view of recent cases holding biotechnology patents invalid
as patent ineligible or lacking written description.
The Biotech Committee also had an informal Happy Hour with the Chemical Practice
Committee at the Annual Meeting.
PLANS FOR MID-WINTER INSTITUTE
The Biotech Committee will join up with the Chemical Practice Committee and the
Licensing and Management of IP Assets Committee in presenting a case study on a
pioneering development, subsequently patented, and ultimately successfully launched
and marketed by a Fortune 100 company as a robust therapeutic for an advanced stage
disease - the result of collegial exchanges between US and non-US researchers
associated with different institutions, together with the efforts of a start-up company
whose mission is to develop life-saving products. Our panelists will address best
practices for portfolio management, institutional agreements, inventorship
determinations, due diligence, in-licensing, and the ultimate resolution of disputes which
can arise from the inception of research and development through various licensing
exchanges, with a promise to be stimulating, engaging, and enlightening.
PLANS FOR SPRING MEETING
We are working on a joint CLE program with the Food and Drug Committee for the
Spring Meeting in Minnesota which will cover topics that are relevant to the geographic
region, such as agrosciences, GMOs, animal feed and/or food chemistry. We hope to
involve local industries and to include local speakers.
PLANS FOR COORDINATION AND COMMUNICATION
Every month, the Chair, Vice Chair, and Leaders have a “Leaders telecon” to discuss
various activities and plans. The Leaders then coordinate, e.g., by telecon or email, with
the subchairs of the subcommittees they oversee. Some subcommittees have regularly
scheduled subcommittee telecons. In addition to the Leaders telecons, we coordinate
and communicate by email, the Biotech Buzz, blog postings, and LinkedIn.
The Chair and Vice Chair regularly communicate with the Board Liaison by telephone,
email, and Committee Cluster telecons arranged by the Board Liaison.
ADVOCACY AND PUBLIC EDUCATION
The Biotechnology Committee is increasing its advocacy and public education efforts
through the activities of our various subcommittees.
Barbara Fiacco and Timothy Meigs put together a Biotech Patent Law Roadshow in
Boston on September 10, 2015, which provided regular and ethics CLE credits to its
many attendants.
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We hope to organize future Roadshows and to coordinate them with social events for
our members across the US. We hope to work with BIO to provide joint programming
and services that will be mutually beneficial to our members. Thus, we hope to provide
additional programming and services to our members by collaborating with BIO.
MEMBER SERVICE
The Biotechnology Committee continues to serve its members by publishing a monthly
newsletter, the Biotech Buzz. The Biotechnology Committee uses its LinkedIn group and
Leaders’ Blogs to disseminate information important to its members. All the
subcommittees have been essential in providing useful information to its members.
The TSC liaisons have been providing regular summaries on other AIPLA committees’
activities. Our TSC liaisons for New Lawyers and Law Students Committees prepared
guides on how members can participate in the New Lawyers Committee and the Law
Students Committee. The Biotechnology Committee prepared a Biotechnology
Volunteer Guide which other AIPLA committees may disseminate to their interested
members. Our TSC liaisons for Women in IP Law, Diversity in IP Law, and the Corporate
Committees are working on similar guides.
GLOBAL OUTREACH
The International Subcommittee’s activities have significantly expanded the global reach
of the Biotechnology Committee. The involvement of our international (non-US)
members has increased substantially. The educational articles on foreign IP laws that
are written by our international members are a valuable resource for our US-members.
For example, the International subcommittee has published a series of articles on patent
term extension around the world, which were followed by a series of webinars on the
same topic. These were very well attended and and well received. The Biotechnology
Committee will continue to assist all its members by being a leading resource on
intellectual property law in the biotechnology sector around the world.
SUBCOMMITTEE ACTIVITIES
Biosimilars
o Lynn C. Tyler reported on Sandoz’s Zarxio biologic approval status, FDA’s CDER
Plans to Issue Four Biosimilars Guidance Documents in 2015, and the new
biosimilar case filed by Janssen Biotech against Celltrion and Hospira over the
biosimilar to Remicade®.
o Laura Smalley provided a follow up to her Hot Biotech report with an in depth
article on the Amgen v. Sandoz decision.
o Noel Courage reported on the latest European guidance on biosimilars, this time
addressing clinical and non-clinical issues.
Biotech Patent Education
o Jennifer A. Fleischer wrote the first article of a series that will examine “patent
profanity” and other terms and phrases. Jennifer’s article examined the use of
"i.e." as compared to "e.g."
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o Stacey Farmer and Martin Grund discussed one peculiarity of European practice
which is the "poisonous" divisional. They examined the situations in which this
problem may arise, some potential countermeasures, and a hint of relief which
may be coming soon.
Case Law Reviews
o Melissa D. Schwaller reported on the Federal Circuit’s decision in Promega Corp.
v LifeTech Inc. and to be wary of “comprising” language.
o Matthew A, Chivvis reported on the Federal Circuit’s recent ruling upholding
plant patents in Delano Farms Co. et al. v. The California Table Grape
Commission.
o Lynn Tyler reviewed Enzo Biochem Inc. v. Applera Corp., Case No. 2014-1321,
2015 U.S. App. LEXIS 4064 (Fed. Cir. Mar. 16, 2015) on the issue of claim
construction.
o Sung Park reviewed Senju Pharma. Co. v. Lupin, Ltd., No. 13-1630 (Fed. Cir. Mar.
20, 2015) on the issue of obviousness of a re-examined patent.
High Tech Biotech
o Roy Issac, Atabak R. Royaee, and James J. Aquilina analyzed the USPTO’s 2014
Interim Guidance on patent eligibility, and its impact on high tech biotech,
including its impact on bioinformatics, biosensors & microfluidics, and
telemedicine patents.
Hot Biotech
o Laura W. Smalley provided an update on the Amgen v. Sandoz Litigation and
reported on the ruling in Amgen v Sandoz that the patent dance provisions of
BPCIA are not mandatory.
o Noel Courage reported on FDA’s approval of the first biosimilar product under
the Biologics Price Competition and Innovation Act.
Industrial Biotech
o Judy Roesler reported on the impact of the Supreme Court’s ruling in Teva v
Sandoz on the petition for writ of certiorari in in Butamax Advanced Biofuels LLC
v. Gevo Inc.
International
o Michaela Elbel of Pateris providesd an outline of recent changes to patent law in
Germany.
o Duncan Ribbons and Maeve Lynch of Redd Solicitors provided a summary of the
CJEU’s decision on parthenotes which has now issued following the Advocate
General’s opinion.
o Li Feng of Finnegan, Henderson, Farabow, Garrett & Dunner LLP, Jiancheng Jiang
and Yuan Wang of Peksung Intellectual Property Ltd in Beijing provided a brief
comparison of the scope of experimental use exemption in the United States and
China.
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o David Read of Bartle Read reported on Morocco’s unique agreement with the
European Patent Office regarding the validation of EP patents.
o Glyn Truscott of Carpmaels & Ransford LLP highlighted the importance in the UK
of ensuring that an Applicant has the right to claim priority from an earlier
application.
o David Read of Bartle Read reported on the first case in the UK that relates to the
interpretation of Swiss form second medical use claims.
o Clare Young and Rebecca Sadleir of Allens reported that, based on a recent
Australian court decision, if a licensee is not a true 'exclusive licensee', it will have
no standing to sue for infringement, and will not be able to claim damages or
any other remedy.
o Tarun Gandhi of Chadha & Chadha provided a summary of a Delhi High Court
decision confirming that though any violation of the requirement under section 8
to provide information on corresponding foreign patent applications may result
in revocation of the patent.
o David Read of Bartle Read reported on two decisions regarding the patentability
of plants in Europe.
o Chris Bown, Glen Deleavey, and Trevor Newton of Gowlings reported on CIPO’s
Revised Examination Guidance on Methods of Medical Treatment and Dosage
Regimens.
o Trevor Davies and Linda Govenlock of Allens Patent & Trade Mark Attorneys
provided a further detailed report on the Australian High Court appeal finding
that Myriad Genetics' patent claims to isolated nucleic acid encoding BRCA1
polypeptide were not patentable subject matter. more
o Chong-Yee Khoo of Cantab Cantab LLP reported that the Intellectual Property
Office of Singapore has announced plans to make it no longer possible to
request supplementary examination to rely on the grant of a foreign
corresponding application for Singapore patent applications filed on or after 1
January 2017. more
o Duncan Ribbons and Maeve Lynch of Redd Solicitors LLP reported on a decision
clarifying the ‘mental element’ required for infringement of Swiss second medical
use claims in the UK.
Plant Biotech
o Ann De Clercq reported on a decision by the EPO’s Enlarged Board of Appeal
that paves the way for patentability of claims to plants in Europe.
PTAB Actions
o Erin M. B. Leach and Malaika Tyson reported on PTAB’s trio of final written
decisions upholding three of Supernus Pharmaceuticals, Inc.’s patents covering
once-daily formulations of doxycycline with a “delayed-release” component;
provide an update on recent PTAB petitions.
o Mark J. Stewart reported on the unintended consequences of a liberal IPR
standing requirement.
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o Malaika Tyson and Robert Kappers provided an update on the unintended
consequences of the liberal IPR standing requirement, and on the PTAB decision
in Aker Biomarine v. Neptune Techs.
Public Communications
o Courtenay Brinckerhoff reported on the PTAB’s institution of the Kyle Bass IPR
against the Lialda® patent.
Technology Transfer & Licensing
o Ypsita Demunshi reported on Kimble v. Marvel Enterprises, and notes potential
implications for biotech IP holders if Kimble, a Spider-Man toy inventor,
successfully challenges the Brulotte rule’s restriction on post-expiration royalties.
USPTO Relations
o Suzannah K. Sundby summarized the USPTO’s Biotech/Chemical/Pharmaceutical
Customer Partnership meeting held April 7, 2015.
o The USPTO Relations subcommittee notifies our members of scheduled USPTO
Customer Partnership Meetings relating to the life sciences.
o The next USPTO’s Medical Device Customer Partnership Meeting is scheduled
for Tuesday, June 2, 2015. The Partnership Meeting will be followed on June
3rd by a Medical Technology Fair. If you would like to present a topic or
would like to suggest a topic for discussion, please contact the customer
partnership team at
Medical_Device_Customer_Partnership_TC3700@uspto.gov.
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