I'm very excited about the all member call tomorrow and the chance to touch base and get your input on the Committee!
Also, please see the new issue of the Biotech Buzz, with some very interesting articles.
We're also looking forward to seeing those of you who are going to the Spring meeting in Seattle.
Dear Members of the Biotech Committee—Looking forward to the 2018 Midwinter meeting next week in sunny California (see Vice Chair Nick Landau’s blog announcement about the CLE program and the planned social event).
The latest issue of the Biotech Buzz is published. Click here to download the entire Biotech Buzz as a pdf file.
If you are interested in volunteering on the committee please let me know.
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.
This month’s Featured Member’s spotlight is on Melissa Pytel.
FEATURED MEMBER’S SPOTLIGHT
This month’s “Member Spotlight” is 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.
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.
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 Spotlight” Feature, 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.
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
● 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).
A Federal Register Notice regarding the IGC issued on March 24,
In the notice, the USPTO
representatives before the IGC requested input from patent practitioners
regarding issues to be discussed at upcoming IGC meetings. The notice is available HERE.
The deadline for submissions is May 23, 2016. Since written submissions are to be made
public, practitioners may also consider telephoning the USPTO representatives
to share their comments and/or stories. The notice states that comments regarding
the issues below would be particularly helpful to the USPTO:
Currently, several resources are available which
enable USPTO patent examiners to search prior art traditional knowledge and
medicine, many of which are also available to the public, and some of which are
available only to patent examiners through the USPTO Science and Technology
Are there additional databases with information
about genetic resources and traditional knowledge that patent examiners should
use to assess patentability?
What are the best practices for establishing
such a database?
Before such a database is made publicly
available, what steps should be taken to ensure that it does not include
What studies have been done regarding national
laws and practices that require patent applications to disclose the country of
source or origin for genetic resources or traditional knowledge that may be
implicated in the patent application?
The meeting is also expected to consider a wide
range of views among IGC delegations as to whether the intellectual property
system should play a role in ensuring that researchers obtain informed consent
before obtaining genetic resources or traditional knowledge from indigenous
What codes of conduct (e.g., University or industry
regarding research), practices (e.g., State park procedures to obtain prior
informed consent), and laws (e.g., tribal laws regarding sharing of culture and
granting prior informed consent) are relevant to the protection of genetic
resources and traditional knowledge?
What studies have been done regarding national
laws and practices requiring patent applications to disclose the country of
source or origin for genetic resources or traditional knowledge?
At various times, different IGC delegations have
referred to the Universal Declaration of Human Rights and to the United Nations
Declaration on the Rights of Indigenous Peoples.
How, if at all, should these Declarations inform
the discussions at the IGC?
At this point the leadership of the Biotech Committee does not
think that we will respond to the notice. However, if you wish to comment
please contact directly the USPTO representatives listed in the notice: Dom
Keating and Karin Ferriter. You may with to telephone them if you do not
want your comments to become part of the record. Their phone numbers are
listed in the Notice.
If the issues covered in the Federal Register regarding
databases for genetic resources are of concern to your clients, please let me
know. We are trying to collect as much information as we can on the topic
so we can best serve our membership.
These and other issues are sure to be discussed at the 30th IGC
that will be held in Geneva from May 30th to June 3rd. I am looking forward to attending as AIPLA’s
Request for Information Related to Intellectual
Property, Genetic Resources and Associated Traditional Knowledge, Federal
Register, Vol. 81, No. 57, Thursday, March 24, 2016.
As I reported in last
month’s Biotech Buzz, I attended the 29th session of the IGC in
February 2016 at WIPO in Geneva, Switzerland, which took place after a 1.5-year
hiatus. The topic around genetic
resources, traditional knowledge and folklore and benefit sharing has been in
discussions in various global fora for about fifteen years.
The discussion regarding having a disclosure requirement for the source
or origin of genetic resources, traditional knowledge and folklore
began in the Doha Round of negotiations at the World Trade Organization (WTO)
fifteen years ago, in 2001. The Doha Declaration was passed in 2001
in Doha, Qatar. It stated that each
member has the right to grant compulsory licenses and to determine the grounds
upon which such licenses are granted.
The Convention on
Biological Diversity (CBD) is a separate treaty. It is an environmental treaty separate from
WTO or WIPO. CBD allows for countries to
sustain and have sovereignty over their genetic resources. The US participates as an observer in
CBD. The US signed but never ratified
the treaty. However, if US companies do
business in any country that is party to the treaty they must comply with its
provisions. The full text of the treaty
is available at: https://www.cbd.int/convention/text/
The main goals of CBD are:
Conservation of biological diversity
Sustainable use of its components
Fair and equitable sharing of benefits
arising from genetic resources
The Nagoya Protocol on
Access to Genetic Resources and the Fair and Equitable Sharing of Benefits
Arising from their Utilization is a supplementary agreement to the CBD. It was adopted on October 29, 2010 and
entered into force on October 12, 2014.
The focus of the Nagoya Protocol is on access and benefit sharing (ABS)
for genetic resources. Developing
countries having genetic resources want to obtain a benefit from granting
access to those genetic resources to other countries or to foreign
The discussions on whether
there should be a disclosure requirement for the source of origin of genetic
resources in patent applications shifted to WIPO and the Intergovernmental
Committee on Intellectual Property and Genetic Resources, Traditional Knowledge
and Folklore (IGC).
In general, developing
countries such as India and Brazil are in favor of a mandatory disclosure
requirement, and developed countries such as the US, Canada, Japan and Korea
are opposed to it. Some developing
countries propose that the remedies available for failure to disclose genetic
resources include the revocation of the patent.
The US is opposed to any remedy that would include the invalidation of a
patent. The US delegation before the IGC
is composed of USPTO representatives and State Department representatives, both
of which are opposed to any mandatory disclosure requirement and to any remedy
that would include the invalidation of a patent.
The EU supports in
principle a disclosure requirement (See HERE),
as long as violation of the disclosure requirement does not invalidate a patent.
Discussion on these and
other topics will continue during the 30th Intergovernmental
Committee, which will take place at WIPO in May, 2016.
For more information
regarding the conference, and to download conference documents, click here. For a summary of the decisions of the 29th
IGC and an Annex with a list of outstanding issues to be tackled at the next
IGC, click here.
The 30th IGC
will meet at WIPO in May 2016, and is anticipated to be more substantive. I am looking forward to attending as AIPLA’s
I attended the conference
at WIPO in Geneva, Switzerland as AIPLA’s representative from February 15-19,
2016. During the conference, attendees
focused on the following two issues:
Whether there should be a disclosure
requirement for the use of genetic resources and/or traditional knowledge; and
Whether databases should be set up
where patent offices (and possibly applicants) could search for genetic
resources and/or traditional knowledge to prevent the erroneous granting of
Discussion centered around
what form the disclosure would take, and whether the disclosure should be
mandatory or voluntary, or if disclosure should even be necessary at all. Developing countries and indigenous groups
were most in favor of the disclosure requirement, but expressed reservations
regarding the use of databases.
The issue of databases is
separate from the issue of disclosure. The
delegations of the US, Canada, Norway, Republic of Korea and Japan put forward
a joint recommendation regarding databases (See Document
WIPO/GRTKF/IC/29/5 available here).
They propose that Member States should facilitate, as appropriate, the
creation, exchange and dissemination of, and access to, databases of and/or
regarding genetic resources and traditional knowledge associated with genetic
They also propose the following:
Member States should
provide legal, policy or administrative measures, as appropriate and in
accordance with national law, to prevent patents from being granted erroneously
with regard to claimed inventions that include genetic resources and traditional
knowledge associated with genetic resources where, under national law, those
genetic resources and traditional knowledge associated with genetic resources:
(a) Anticipate a claimed
invention (no novelty); or
(b) Obviate a claimed
invention (obvious or no inventive step).
Developing countries and
indigenous groups expressed reservations regarding the use of databases because
they feared that they would encourage free dissemination of the information
contained therein. At the end of the conference, no agreement was reached
regarding either the disclosure requirement or the implementation of databases. Discussion on these and other topics will
continue during the 30th Intergovernmental Committee, which will
take place at WIPO in May, 2016.
For more information
regarding the conference, and to download conference documents, click
I am very happy and honored
to be the new Chair of the Biotech Committee.
I would like to thank and welcome our Leaders Carla Mouta, Nick Landau,
Ryan Chirnomas and Alice Martin, as well as my terrific Vice Chair Vicki
Norton. I would also like to thank all our new Subchairs and our former Chair Suzannah Sundby. Below are some updates and
announcements. I look forward to seeing
many of you at the Mid-Winter Institute in La Quinta.
1. Report on AIPLA Trade Secrets Summit: I was honored to present on
Biosimilars at the AIPLA Trade Secrets Summit that was held in Boston on
November 12-13, 2015. I presented as
part of a panel on Using Trade Secrets Law In The Bio Tech and Medical Device Arena For a brief “take home” on
trade secrets protection please click on the link to my Chair’s Notes.
regarding Mid-Winter Institute Licensing/Biotech/Chem Committees CLE:
The Licensing and IP Management of Assets,
Biotechnology, and Chemical Practice Committees will present 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.
Happy Halloween – Trick or Treat!
No trick, but my two-year term is up and today is my last day as Chair of the Biotechnology Committee. It has been a real treat, a true honor, to serve you.
Many thanks to all who wrote articles for the BIOTECH BUZZ, were speakers for our many webinars and CLE sessions, and helped lead this Committee as Leaders and Subchairs. You are what makes our Committee the committee it is.
Debora Plehn-Dujowich will be Chair and Vicki Norton will be Vice Chair and so I have no doubt the Committee is in great hands.
I will continue as a co-subchair of the USPTO Relations and Liaisons Subcommittees. I am also continuing as a member of AIPLA’s Special Task Force on Subject Matter Eligibility. So, I’ll still be around and active in AIPLA.
Please read and see my One Last Plea as Chair and a Summary of Annual Meeting CLE session below.
One Last Plea:
During the last few years, we have watched the judicial exceptions to subject matter eligibility become the rule rather than the exceptions they were meant to be and we are beginning to see this era of ineligibility dampen innovation and economic growth. The courts are consistently invalidating patents under Section 101 and, horrifyingly, many patent examiners are rejecting certain claimed inventions ineligible even where the courts have been silent – where the courts have not decided certain technologies fall within a judicial exception and are not patent eligible.
Therefore, I implore you to write articles and submit comments to the USPTO and provide the scientific and legal reasoning why certain inventions, which have yet to be considered by the courts, are patent eligible. As an example, please see my recent comment letter that explains why “combination” and “weighted” biomarker assay claims should be properly found by the USPTO to be patent eligible.
Numerous times, the USPTO has said they welcome comments even if after a given comment period deadline. The Biotechnology Committee will publish well-founded and reasoned articles in its BIOTECH BUZZ, and many bloggers would be happy to publish guest posts. Such comments and articles can help stop this 101 nightmare from becoming worse.
Summary of Annual Meeting:
At the Annual Meeting in October, the Biotechnology and the International Trade Commission Committees provided a joint CLE session 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. Read the facts behind these issues here. You can obtain the PowerPoint Presentation and CLE papers here.
Kwame and Vicki were moderators and helped put together the session.
Maximilienne Giannelli of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, and Dallin Glenn of Stern Kessler Goldstein Fox advised Soteria Biosciences’ 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 advised Soteria counsel on the advantages of ITC proceedings over district court litigation for biotech, chemical, and pharmaceutical patents. The 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 trivial or nonessential components of imported products. These advantages and others are summarized in the following table:
Potential ITC Advantage
District Court Comparison
in rem jurisdiction:
discovery from any foreign
entity named as a respondent
discovery from foreign manufacturers
may not be available
patents covering intermediates
(and methods of making them) enforceable
subject to 35 U.S.C. § 271(g)
Time to trial ~ 9-10 months
Final decision ~ 17 months
Time to trial ~ 17-46 months
Final decision ~ ??
IPR institution highly unlikely to
result in a stay of ITC litigation
(no cases stayed yet)
Odds of stay following
IPR institution ~ 65%
potentially faster route, if at least one sample of product was imported for a non-exempt purpose under § 271(e)(1)
actions based on § 271(e)(2) are
subject to the limitations and requirements of 42 U.S.C. § 262
Dallin 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. Dallin noted that (1) filing at the Commission does not require a filed biosimilar application, receipt of a notice of intent to market, or participation in the patent dance, and (2) with the right facts and strategic timing, an injunction may be obtained at the ITC to prevent the biosimilar launching in the U.S.
Herbert D. Hart III of McAndrews Held & Malloy advised Soteria on strategies for preparing for PTAB proceedings and post-grant challenges. Herb discussed the timing and nature of potential PTAB challenges to Soteria’s patents, 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. Herb noted that it is never too early to prepare for a post grant challenge at the PTAB; in fact, preparation should be an ongoing process. He also explained that there are plenty of options for strengthening a patent portfolio, and choosing wisely can pay big dividends.
Brian B. Koo, an Investigative Attorney with Office of Unfair Import Investigations (OUII) of the International Trade Commission (ITC), played himself (and his comments are his own and shall not be attributed to the ITC, etc.). Brian recommended that complainants take the opportunity to review their draft complaints with OUII. He explained that OUII has an active role prior to institution of an investigation and, in most cases, after institution and that OUII is an independent party that represents the public interest. Two key takeaways from Brian’s presentation are: 1) If you plan to bring a Section 337 case at the ITC, prepare as much of your case as possible (discovery requests, testing of accused products, experts, claim charts, preparation of domestic industry evidence, consideration of discovery needed from third parties, etc.) before filing the complaint; and 2) Communicate with the OUII attorney in your investigation, if one is assigned as OUII attorneys can often help the private parties resolve issues without having to resort of motions practice.
1050 30th Street, NW
Washington, DC 20007
1. CLE Session – During the Annual Meeting in October, we have an awesome CLE program planned with the International Trade Commission Committee. The Joint CLE program is Thursday, October 22, 2015, 3:30-5:50 PM. Vicki Norton and Kwame Mensah are moderating and ITC staff attorney Brian Koo along with Maximilienne Giannelli and Daniel Yonan will discuss whether Soteria Biosciences should enforce its patents before the ITC or in district court, and Herbert Hart is going to address what Soteria Biosciences should do to prepare for the PTAB challenges that will likely ensue.
2. Informal Happy Hour – Friday, October 23, 4:30-7 PM at Stone’s Throw (Lobby Bar), the Chemical Practice and Biotechnology Committee are having another informal Happy Hour sponsored by Evans Analytical Group and CHEMIR. You can pick up your tickets after the Biotech/ITC CLE meeting or after the Chemical Practice meeting. Alternatively, contact Laura Rainey at email@example.com to receive your tickets by mail.
Evans Analytical Group and CHEMIR have been providing scientific data for legal cases for over 50 years. If it involves failure analysis, chemical testing, physical testing, or materials characterization, Evans Analytical Group and CHEMIR are a go-to lab! Find them on www.eag.com/mc.
1. The USPTO’s BCP Customer Partnership Meeting is scheduled for Monday, September 14, 2015. The meeting will be an all-day event. Attendees can participate in-person at either the Alexandria campus or the Detroit Satellite Office. Tentative topics include:
· Cooperative Patent Classification (CPC) Overview
· Trends in Subject Matter Eligibility for Biotechnology Inventions (A Customer Perspective)
· Third Party Submission
· AIA 130 Declaration
· PCT National Stage Filing Tips
· Double Patenting
More details will be posted here when available.
· The USPTO is still working on additional guidance and examples for diagnostics and other biotech claims. One may want to take this opportunity to submit additional comments on such, especially in view of decisions, e.g., Ariosa, rendered after the 2014 Interim Guidance.
3. Our Webinar on “Biosimilars: Regulation, Litigation and New Developments Patent Practitioners and Regulatory Attorneys Should Know” is Thursday, August 27, 2015, 12:30-2 PM ET. Click here for details and registration information.
4. Don’t forget about the Biotech Patent Law Roadshow in Boston on September 10, 2015. For details and to register, click here.
5. Registration for the Annual Meeting opens today! Click here. The Annual Meeting is October 22-24 in Washington DC.
· The Biotechnology Committee and the ITC Committee have an awesome CLE program planned for Thursday, October 22nd 3:30-5 PM. The joint Biotech-ITC panel features Brian Koo, an Investigative Attorney at the ITC, and experts on ITC, district court, and PTAB proceedings as they advise Soteria Biosciences, a hypothetical biotech company, on strategies for enforcing their patents and preparing for PTAB challenges. The panel will discuss 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, 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 Law Practice Management Committee has a FREE breakfast meeting planned Thursday, October 22nd at 7 AM. The topic of the breakfast is: “Business Development - Creating, Cultivating, and Maintaining Client Relationships that Generate IP Work”. Tickets to this event are limited (<150) and are first come, first served.