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Biotechnology
Chair’s Notes
 
April 25
Federal Register Notice Regarding the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore

A Federal Register Notice regarding the IGC issued on March 24, 2016.[1]  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 Information Center. 

o   Are there additional databases with information about genetic resources and traditional knowledge that patent examiners should use to assess patentability?

o   What are the best practices for establishing such a database?

o   Before such a database is made publicly available, what steps should be taken to ensure that it does not include confidential information?

o   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 peoples.

o   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?

o   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.

o   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 representative.



[1] Request for Information Related to Intellectual Property, Genetic Resources and Associated Traditional Knowledge, Federal Register, Vol. 81, No. 57, Thursday, March 24, 2016.​

March 25
Overview of Convention on Biological Diversity, Nagoya Protocol and WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore

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:

 

1.    Conservation of biological diversity

2.    Sustainable use of its components

3.    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 corporations.

 

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 representative.​

February 28
Report from the WIPO 29th Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore

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:

 

1.    Whether there should be a disclosure requirement for the use of genetic resources and/or traditional knowledge; and

2.    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 patents.

 

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 resources. 

 

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 here.  ​ 
December 16
Report on AIPLA Trade Secrets Summit and Announcement regarding Mid-Winter Institute

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.

2.     Announcement 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.​

October 31
Annual Meeting Summary and Happy Halloween

Happy Halloween – Trick or Treat!

Dear Members of the Biotechnology Committee:
 
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.
 
Chair, Biotechnology Committee
 
 
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 N. Mensah of Medimmune acted as Soteria’s General Counsel. 
 
Vicki G. Norton of Duane Morris LLP acted as Soteria’s Director of IP. 
 
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
personal jurisdiction:
discovery from foreign manufacturers
may not be available
Process patents:
patents covering intermediates
(and methods of making them) enforceable
Process patents:
subject to 35 U.S.C. § 271(g)
Pace:
Time to trial ~ 9-10 months
Final decision ~ 17 months
Pace:
Time to trial ~ 17-46 months
Final decision ~ ??
IPRs:
IPR institution highly unlikely to
result in a stay of ITC litigation
(no cases stayed yet)
IPRs:
Odds of stay following
IPR institution ~ 65%
Injunction:
potentially faster route, if at least one sample of product was imported for a non-exempt purpose under § 271(e)(1)
Injunction:
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.
 
Finally, another special thanks to Evans Analytical Group and CHEMIR for sponsoring our informal Happy Hour with the Chemical Practice and Food and Drug Committees. 
 
 
1050 30th Street, NW
Washington, DC 20007
 
T: 202.486.8020
F: 202.540.8020
 
 
September 21
2015 Annual Meeting Information
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 HourFriday, 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 lrainey@eag.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.
 
July 31
​5 Items of Interest
 
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.
 
2.     The USPTO has issued an update to the Subject Matter Eligibility Guidelines.  The July 2015 Update can be found here.  Written comments on the July 2015 Update are due October 28, 2015, by email to: 2014_interim_guidance@uspto.gov
·         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.
 
Chair, Biotechnology Committee
May 04
Summary of 2015 Spring Session

The weather in LA was gorgeous – Sunny every day, which is perfect for growing Soteria Biosciences’ new plant varieties of Humurus sativa (common name: “Humor”).  Humor is a rare flowering plant within a large phylogenetic family of plants that have been generally used for fibers, seeds and seed oils, as foodstuffs, for medicinal purposes, and/or for various psychoactive effects it causes when consumed.  Humor plants contain various amoutns of humurbidiol (HBD; a chemical that has been associated with various beneficial medical effects, including anti-microbial properties, neurological, anti-inflammatory, and anti-psychotic effects) and tetrahydrohumurbinol (THH; a chemical that has been associated with various psychoactive effects), for use in agricultural and other biotechnology commercial applications. 

 
The joint CLE session entitled “Soteria Biosciences – The Early IP Adventures of an Agri-Biotech Startup Company as it Morphs into a Global Multidisciplinary Giant” with the Corporate Practice Committee was a hit. 
 
After the session, many attendees said the session helped them understand the in-house corporate side of R&D and IP management and with that understanding they will better be able to advise and assist their clients.
 
CLE Session Summary
(Note: When downloading the PPTs below, you will likely receive error pop ups.  Keep clicking okay and you would be able to obtain.)
 
Angela Sebor acted as Soteria Biosciences Chief Business Officer (Angela is really the Senior Director, Intellectual Property at GlobeImmune, Inc.).
 
Angela set forth the fact patterns and asked questions relating to Soteria Biosciences R&D, funding, IP ownership, domestic/foreign patent filings, due diligence, confidentiality, and privilege.  Read the facts behind these issues here.  The compiled slides for the session including the moderator slides can be obtained here
 
Debora Plehn-Dujowich of Drinker Biddle & Reath acted as the Chief Operating Officer and assisted Angela with putting together this awesome program.  Special thanks to Angela and Debora!
 
Section 1 Summary:
 
Soteria Biosciences met with its outside counsel to have a license strategy meeting to discuss its R&D and future plans and license negotiations with State A&M.  The in-depth CLE paper on the issues discussed in this section can be obtained here.
 
Lee Johnson of Wilson Sonsini Goodrich & Rosati, as outside counsel, informed Soteria Biosciences on the use of patent landscape analyses and potential risks involved.  For example, one should clearly set forth exclusionary limitations applied in the landscape search as later on, a client’s R&D may change and the client may find itself right in the middle of art which was never considered.  Lee’s presentation can be obtained here.
 
Mark Pidkowich of Smart & Biggar, as outside counsel, discussed further research considerations such as the importance of NDAs and MTAs with non-Soteria personnel and public use considerations.  Mark also cautioned that many foreign countries require biological deposits to be made on or before the filing date of the priority application.  Mark’s presentation can be obtained here.
 
Jennifer Zarutskie Sieczkiewicz played the role of Soteria Biosciences’ IP, Research & Business Development Counsel (Jennifer is really the Associate General Counsel, R&D Corporate, of Biogen Idec).  She explained how, as in-house counsel, she and her team advises Soteria Biosciences C-level executives and Board on IP acquisitions and due diligence at each stage of a deal.  Because of confidentiality and privilege issues, Jennifer recommends providing only a few high level PPT slides and verbal communications to avoid things in writing that could later be adverse to the company’s position.  Jennifer’s presentation can be obtained here.
 
Section 2 Summary:
 
After Section 1, we stepped into our time machine and found Soteria Biosciences a few years later seeking advice on their foreign filing issues.  The in-depth CLE paper on the issues discussed in this section can be obtained here.
 
Angela Domitrovich of Sheridan Ross and Joel Silver of Gilead Sciences discussed novelty and foreign filing requirements for countries around the world.  Unfortunately, because Soteria Biosciences did not know of certain filing requirements in foreign countries, the company forfeit the possibility of patent protection for some of their technology.  For example, because Soteria Biosciences has a research unit in China that developed IP that they wanted to protect but they failed to first file in China, they cannot obtain a patent in China.  Angela’s and Joel’s presentation can be obtained here.
 
Section 3 Summary:
 
We again stepped into our time machine and found Soteria Biosciences seeking advice from its outside counsel on their negotiations with BigPharma and the potential loss of confidentiality and privilege.  The CLE paper on privilege can be obtained here.  The CLE paper on drafting agreements related to confidentiality and privilege can be obtained here.
 
Bonnie Weiss-McLeod of Cooley acted as outside counsel and also pretended to be Carey Jordan of McDermott Will & Emery as Carey had an unexpected emergency.  Bonnie advised Soteria Biosciences on the difference between privilege and confidentiality, when one or the other applies, and how specific jurisdictions handle each.  Bonnie explained that some jurisdictions like the EU do not recognize privileged communications between in-house counsel and its employees as the communication must be with an external lawyer admitted to a bar of a member of the European Economic Area.  Bonnie also covered common interest agreements and NDAs and potential pitfalls.  Bonnie’s presentation can be obtained here.
 
 
Future of Soteria Biosciences
 
Because of the positive feedback we received, we hope to follow-up with a 3-part webinar series in which each of the issues discussed during the Spring Meeting will be addressed in greater depth.  So stay tuned!
 
Meanwhile please periodically check Soteria Biosciences website at http://www.aipla.org/committees/committee_pages/Biotechnology/Soteria/SitePages/Home.aspx for further information as we will continue to post additional resources. 
 
Also, plan on joining us again at the Annual Meeting in October when Soteria Biosciences seeks advice on enforcing its various patents in district court and the ITC.
 
 
Finally, if you missed the Thursday Morning panel entitled “Track 1 Patent Prosecution: Patent Eligibility – What’s Left to Patent?”  You can obtain my PPT presentation which provides examples of claim limitations and arguments which overcame 101 rejections for diagnostic assay claims here.
 
Chair, Biotechnology Committee
December 15
101, Open Season, and Soteria Biosciences

Revised 101 Guidance

The USPTO Revised Interim 101 Guidance will be officially published on December 16, 2014.  An advanced copy of the Revised Guidance can be obtained here.  The official version will be available here. 
The Revised Guidance supersedes the March 2014 Mayo/Myriad Guidance.  As expected, the factor-based analysis where an ineligibility factor can outweigh a pro-eligibility factor has been withdrawn and replaced with a two-part analysis.  Additionally, the test for determining whether a claim is directed to a “product of nature” exception is separated from the analysis of whether the claim includes significantly more than the exception.  Further, the markedly different analysis is no longer limited to structure only, and instead can include functional differences as compared to its naturally occurring counterpart in its natural state.
The webpage has been updated and provides Nature-Based Product Examples and information on the upcoming Eligibility Forum on January 21, 2015.  The USPTO has not provided diagnostic assay examples as they are waiting for at least two pending Federal Circuit cases (Univ. of Utah Research Foundation and Sequenom).
Comments on the Revised Guidance and claim example sets may be submitted by email to 2014_interim_guidance@uspto.gov.  The comment period ends March 16, 2015.
Over the next several months, the Biotechnology Committee will provide various articles with detailed analyses of the Revised Guidance and its impact on a variety of technologies in the life sciences sector.
101 Legislative Reform – If you have any thoughts and suggestions for 101 legislative reform, please email Suzannah by clicking here Please clearly identify in the subject matter of your email “AIPLA Biotech – 101 Legislative Reform” so I can readily keep track of everyone’s comments on this topic.
Committee Open Season – It is open season to select your committees.  This means you must re-select your voting status and make any changes to your selected committees by January 31, 2015.  Click here for how-to information.
Soteria Biosciences – Our hypothetical company is Soteria Biosciences.  Soteria’s webpage, currently under development is here.  During the AIPLA’s 2015 Spring Meeting, we are planning a joint CLE session with the Corporate Committee.  The CLE session will be a panel discussion on the cultivation of Soteria’s early IP roots.  The panel will also cover confidentiality and attorney-client privilege in the context of the early stages of the company’s development.  Our educational programming over the next year will explore all the issues surrounding Soteria’s first steps, such as the early stages of R&D, funding and ownership, through foreign filing, and worldwide patent enforcement.  Please check Soteria’s website for future educational programming.
Suzannah
November 14
November 2014 Chair's Notes

Hypothetical Biotech Company – We have some exciting plans for our committee’s educational programming.  In particular, we are creating a hypothetical biotech company and will follow the company’s IP issues.  Click here to read more about it and click here to vote on the company’s name.  Voting will close on November 21, 2014.

Committee Open Season – It is open season to select your committees.  This means you must re-select your voting status and make any changes to your selected committees by January 31, 2015.  Click here for how-to information.
Biotechnology Subcommittees – We have had a few changes to our subcommittee subchairs and added a new subcommittee, Biotech Patent Agents.  The subcommittees and subchairs are provided below.  If you would like to be more active in the Biotechnology Committee, please click here to find out how and contact the subchairs of the subcommittees of interest and tell them you want to be involved.
Biotech Agents Angie Sebor
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