BIOTECHNOLOGYCommittee Report and Workplan

January 2017

COMMITTEE LEADERSHIPDebora Plehn-Dujowich, Chair

Vicki Norton, Vice ChairMyra McCormack, Board Liaison

COMMITTEE LEADERSIssues Leader – Nick Landau

Community Leaders – Alice MartinServices Leader – Carla Mouta

Overall mission of the Committee as it relates toAIPLA’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 LiaisonsLaw Students – Kelly LuNew Lawyers – Wen Xi

Women in IP Law – Carine DoyleDiversity in IP Law – Roy Issac

Corporate – James J. Kelley

SUBCOMMITTEE SUB-CHAIRSBiosimilars – Kristin ConnarnBiotech Agents – Angie SeborBiotech Litigation – Bryan Diner, Patrice Jean, and Laura SmalleyBiotech Patent Education – Ryan B. Chirnomas Case Law Reviews – Melanie Szweras and Emily Curtis

H:\ADMIN\AIPLA BIOTECH\20151011 Biotech WorkPlan.docx

BIOTECHNOLOGY

Corporate – James J. Kelley and Angie SeborDiagnostics & Gene Patenting – John PetersonHigh Tech Biotech – Ashok K. Mannava and Adrian ZahlHot Biotech – Vicki NortonIndustrial Biotech – Judy Roesler and Melissa BraymanGenetic Resources – Debora Plehn-Dujowich, Holger Tostmann and David ReadInternational – David Read and Trevor DaviesLiaisons – James J. Kelley and Suzannah K. SundbyPlant Biotech – Alice Martin and Mark PidkowichPTAB Actions – Herbert Hart and Malaika TysonPublic Communications – Courtenay BrinckerhoffRegional/Social – Debora Plehn-Dujowich and Alice MartinSWAT – Brad DuftTechnology Transfer & Licensing – Eric Mirabel and Vladimir DrozdoffTrade Secrets – Noel CourageUSPTO Relations – Suzannah K. Sundby and Ron KamisWebinars – Carla Mouta

WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore

Biotech Committee Chair Debora Plehn-Dujowich attended the 29th IGC 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.

Upon returning to the U.S., Debora requested a vote of the Biotech Committee on whether the AIPLA should pass a resolution stating AIPLA’s opposition to a mandatory disclosure requirement of origin or source of genetic resources in patent applications. A majority of the voting members of the committee was in favor of the resolution. The AIPLA Board then passed the resolution. Debora read the resolution at the 30th IGC which will take place on May 30-June 3 at WIPO in Geneva, Switzerland.

AIPLA BOARD RESOLUTION ON IGC

2

BIOTECHNOLOGY

WHEREAS the World Intellectual Property Organization Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) has scheduled two meetings in 2016 to focus on the topic of genetic resources and benefit sharing, and WHEREAS the American Intellectual Property Law Association supports, in principle, the objectives of preserving sustainable biodiversity, and to provide for the fair and equitable sharing of benefits through the use of material transfer agreements between a user of newly identified genetic resource and the member state from which it is obtained to provide certainty to both parties, NOW THEREFORE, BE IT RESOLVED that the American Intellectual Property Law Association opposes a mandatory disclosure of origin or source requirement for genetic resources and/or traditional knowledge in patent applications

NEW SUBCOMMITTEE-GENETIC RESOURCESWe have created a new subcommittee named “Genetic Resources” to address issues relating to genetic resources and traditional knowledge such as those surrounding the Nagoya Protocol, the Convention on Biological Diversity and the Intergovernmental Committee on Genetic Resources and Traditional Knowledge that is taking place at WIPO.Co-subchair Holger Tostmann attended the IGC Seminar at WIPO in November 2016 as the AIPLA representative.

NEW SUBCOMMITTEE-TRADE SECRETSWe have created a new subcommittee named “Trade Secrets” to address issues relating to trade secrets in biotech and pharma.The subchair of the Trade Secrets Committee will be Noel Courage, who previously headed the Hot Biotech subcommittee. Hot Biotech will now be headed by Vicki Norton.

WEBINARS

We hosted a CLE webinar with the Chemical Practice Committee on January 7, 2016 at 12:30 ET on functional claiming and written description. The speakers were 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 hosted a webinar on February 25, 2016 on What’s Left under 101 after Ariosa en banc denial? In this Webinar, participants learned the USPTO’s

3

BIOTECHNOLOGY

position on this question, as well as debated the consequences and hopes for patentable subject matter created by the decision and the denial for rehearing en banc. Together with the June Cohan from the USPTO, Alice Martin, Ph.D., J.D., of Barnes & Thornburg, and Carla Mouta, Ph.D., J.D., of Finnegan, explored the insightful opinions offered by several Federal Circuit Judges on the rehearing, agreeing to disagree with the Supreme Court’s position on the patent eligibility of inventions related to the discovery of natural laws, and whether or not the Court’s position mandates Mayo and the current state of the law. Potential antidotes to the “witches brew” created by combined decisions such as Ariosa and Mayo were proposed for discussion. Debora Plehn-Dujowich moderated the discussion.

We hosted a webinar on March 10, 2016 on Subject Matter Eligibility Around the World: Latin America. The speakers were:

Luis Diego Castro (CASTRO & PAL ABOGADOS, Costa Rica)Ignacio Sanchez Echagüe (Marval, O'Farrell & Mairal, Argentina)Leonor Magalhães Galvão (Magellan IP, Brazil)Eugenio Pérez P. (uhthoff, gómez vega & uhthoff, s.c., Mexico)

We hosted a CLE webinar on March 16, 2016 on Trade Secrets in Biotech, Biosimilars and Medical Devices. The speakers were:

Elizabeth Howard (Orrick)Debora Plehn-Dujowich (Prismatic Law Group)Austin Wang (Hologic)

We hosted a webinar on April 28, 2016 on Biosimilars Around the World: Europe. The speakers were:

Gareth Morgan (Olswang LLP)Holger Tostmann (WALLINGER RICKER SCHLOTTER TOSTMANN)

We hosted a webinar for May 25, 2016 on Subject Matter Eligibility Around the World: Europe and Australia. The speakers were:

Simon Wright (J A Kemp, CIPA)Hazel Ford (Finnegan)Trevor Davies (Allens)

We hosted a CLE webinar on July 27, 2016 regarding Building a Global Portfolio: Double Patenting and Unity of Invention Pitfalls in US, Europe, and Asia. The speakers were:

Yoon Suk Shin (Lee International IP & Law Group) (Asia) David Read (Bartle Read) (EPO) Bryan Diner (Finnegan) (US)

4

BIOTECHNOLOGY

We hosted a CLE webinar on September 27, 2016 entitled: Should you be losing sleep? Key Practice Tips in View of Recent Patent Exhaustion Court Decisions This webinar first discussed international exhaustion and the first sale doctrine in view of the 2016 en banc Federal Circuit decision in Lexmark International, Inc. v. Impression Products, Inc.  The webinar then covered patent exhaustion pitfalls for the unwary that apply to patent licensing in the biotechnology industry, including licensing strategies that take into account the possibility that the Supreme Court will overturn or limit Lexmark regarding the restricted sales exception to patent exhaustion.Jeremy McKown (Johnson & Johnson)Ron Kamis (Prismatic Law Group)Moderator: Eric Silverman (3M)

We hosted a CLE webinar on January 24, 2017, entitled: The 101 Guidelines & Case Law in Biotech & Precision Medicine: How far have we come? The impact of the most recent update of the USPTO Guidelines and Examples on subject matter eligibility.

June Cohan (USPTO)

Suzannah Sundby (Canady and Lortz)

Ben Jackson (Myriad)

Moderator: Carla Mouta (Finnegan)

Webinars Mission Statement:To present webinars for the Biotechnology Committee and the general AIPLA membership.

Goals for 2017:1. February 2017: Biotech IPRs: What have we learned?2. Mid-2017: Is the “Antibody Exception: Still Alive in Antibody

Patenting?3. Continue to report on important and newsworthy issues in biotech

and pharma, and on USPTO Guidelines

2016 SPRING MEETING

At AIPLA’s Spring 2016 meeting, the Biotech Committee joined forces with the FDA Committee to present an exciting, interactive CLE presentation on

5

BIOTECHNOLOGY

international IP and regulatory considerations for genetically modified organisms (GMOs), including exploring the final frontier of patent eligibility for GMOs on Mars.  Experts on patents, export control, biodiversity and regulation provided their insights into patent eligibility for GMOs, issues relating to FDA regulations for GMOs, and export control and biodiversity, including an update on WIPOs February 2016 meeting of the Intergovernmental Committee on Intellectual Property and Genetic Resources.  Our experts panelists included Marian T Flattery, Assistant Chief IP Counsel of DuPont Pioneer and DuPont Crop Protection, Professor Kan Wang, from the Department of Agronomy at Iowa State University, and Biotech Committee Chair Debora Plehn-Dujowich and John Ursu from Greene Espel.

2016 ANNUAL MEETING

At AIPLA’s 2016 Annual Meeting, experts from the Biotech Committee, Mergers & Acquisitions Committee and Antitrust Committee addressed biopharma patent issues, merger & acquisition issues and antitrust concerns relating to the development and commercialization of a Zika virus-vaccine. An FTC representative covered Bio and Pharma issues.

Speakers:Andrea Kamage-Johnson & JohnsonMary Trachta-UCLADaniel Walker-FTC

Moderator:Chuck Cappellari-Hologic

2017 MID-WINTER INSTITUTE

At AIPLA’s 2017 Mid-Winter Institute, the Biotech Committee will join forces with the Food and Drug Committee to cover “Food for Thought—Hot Topics in Food & Drug and Biotech.” Jeffrey Totten from Finnegan will cover “3D Printing Menu-Tissues, Organs and Medical Devices.” Irena Royzman from Patterson Belknap will present on “When Shall Means Shall: Lessons from Two Years of Biosimilar Litigation.” Daphne Lainson from Smart & Biggar will present “Clearly Canadina—Claim Drafting in view of Hatch-Waxman and Patenting Medicine Regulations.” Matthew Pearson from Akin Gump will cover “Stay for Dinner—IPR stays during Hatch-Waxman cases.” Malaika Tyson from McAndrews, Held & Malloy will moderate.

2017 SPRING MEETING

6

BIOTECHNOLOGY

At AIPLA’s Spring 2017 meeting, the Biotech Committee will joined forces with the Emerging Technologies Committee to present a panel discussion covering the technological convergence between biotechnology and emerging technology. Topics to be covered include personalized medicine, the use of drones in medicine, 3D printing, nanotechnology, the internet of things, neural networks and the use of artificial intelligence in diagnostics. IP and regulatory topics we will cover include Section 101 patent eligible subject matter, FDA regulation, standards, FCC regulation and FAA regulation.

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 EDUCATIONThe 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.

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 SERVICEThe 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.

7

BIOTECHNOLOGY

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 OUTREACHThe 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.

CHAIR’S BLOG

In her Chair’s blog, Debora Plehn-Dujowich reported on:

Report on AIPLA Trade Secrets Summit Report on the AIPLA Mid-Winter Institute Report from the WIPO 29th Intergovernmental Committee on

Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore

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

Report on Federal Register Notice Regarding the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore

VICE CHAIR’S BLOG

In her Vice-Chair’s blog, Vicki Norton reported on:

8

BIOTECHNOLOGY

Whether the Judicial Exception to Patent Eligibility Will Engulf Method of Treatment Claims (in light of the district court’s finding in Bristol Myers Squibb Co. v. Merck & Co. (Civil Action No. 15-560-GMS) that a method of treatment claim was directed to a natural phenomenon

Interstellar Intellectual Property Rights under the Outer Space Treaty of 1967

The Meaning of Life v. Promega—what constitutes a “substantial portion of components” of a patented combination under 35 U.S.C. § 271(f)(1)

In view of the DTSA, and rulings impacting patent eligibility and the scope of discovery under the BPCIA, biotech companies are re-weighing the benefits of trade secret protection against the risk of a competitor filing first for patent protection.  We provide practice tips for companies seeking to maximize trade secret protection for key technological developments maintained as trade secrets.

Lost in Transition: What does indefiniteness under Nautilus mean for claims reciting “consisting essentially of”?

SUBCOMMITTEE ACTIVITIESBiosimilars

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.

o Lynn C. Tyler reported on FDA Issues Draft Guidance on Formal Meetings with Biosimilar Sponsors.

o Lynn C. Tyler reported on Amgen, Inc. v. AbbVie Biotechnology Ltd., Case Nos. IPR2015-01514 and IPR2015-01517 (PTAB Jan. 14, 2016)

o Laura W. Smalley reported on Sandoz Petitions the Supreme Court for Review of Federal Circuit Decision in Amgen v. Sandoz Holding that FDA Approval is Required Before Giving 180-Day Notice of Commercial Marketing

o Christopher Persaud reports on Amgen, Inc. v. Sandoz, Inc., Case No. 2:16-cv-01276-SRC-CLW (D.N.J.)

o Kristin Connarn reported on “Deemed to be a License” Guidance from FDA

o Kristin Connarn reported on Biosimilar Product Labeling Guidance from FDA

o Lynn Tyler reported on FDA Approves First Biosimilar to a Monoclonal Antibody; Related Litigation is Progressing but Remains Pending

9

BIOTECHNOLOGY

o Kristin Connarn reports on Uptick in Biosimilar Approval Activity at FDAo Laura Smalley reports on Amgen Inc. v. Apotex Inc.: Federal Circuit

Holds that 180-Day Notice Must be Giveno Lynn Tyler reports on AbbVie Sues Amgen Over Biosimilar to HUMIRA®o Lynn Tyler reports on Dawn of the Biosimilar Era?o Lynn Tyler reports on District of Delaware Denies Hospira’s Motion to

Dismiss Amgen’s Claim for a Declaratory Judgment and Injunction Requiring an Effective Notice of Commercial Marketing

o Kristin Connarn reported on FDA Guidance on Clinical Pharmacology Data Needed to Support Biosimilars

Mission Statement: To monitor patent issues, litigation, and regulations pertinent to the development and commercialization of therapeutic and diagnostic biological products, including biosimilar and interchangeable products, provide the Biotechnology Committee leadership and members with periodic reports, and play a role in advocacy considerations, when pertinent, and coordinate with the Food and Drug Committee in monitoring and reporting on regulatory issues relevant to biological products. 

Goals for 2017:1.       Monitoring and reporting on patent issues, litigation and regulations pertinent to the development and commercialization of therapeutic and diagnostic biological products, including biosimilar and interchangeable products - Ongoing2.       Provide Committee leadership with periodic reports – Ongoing3.       Provide a webinar on ongoing developments in biotechnology litigation – Second or Third Quarter of 2017 4.       Provide program content for AIPLA Annual Meeting – Fourth Quarter of 2017

Biotech Litigationo Amgen Files Suit Against Sandoz Seeking to Enjoin its Etanercept

Biosimilaro Laura Smalley reports on Survey of U.S. Court of Appeals for the

Federal Circuit Decisions on Patent Obviousness in the Field of Biotechnology in 2015 and 2016

o Laura Smalley reports on U.S. District Court for the District of Delaware Holds that Discovery under the Biologic Price Competition and Innovation Act is Limited to Information Relevant to the Patents Asserted in the Litigation

10

BIOTECHNOLOGY

o Laura Smalley reports on AbbVie Files Suit Against Amgen Asserting Patent Infringement by Amgen’s Biosimilar to AbbVie’s HUMIRA® Biologic

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

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

 Mission Statement: The mission of the Litigation Subcommittee will be to monitor litigation issues pertinent to the development and commercialization of therapeutic and diagnostic biological products, particularly patent infringement litigation and Biologics Price Control and Innovation Act (“BPCIA”) litigation. The Subcommittee will provide Committee leadership and membership with periodic reports and play a role in advocacy considerations, when applicable.  The Subcommittee will provide updates for the Biotech Buzz and other publications on litigation-related issues.  Goals for 2017:1.       Monitoring and reporting on litigation issues pertinent to the development and commercialization of therapeutic and diagnostic biological products, particularly patent infringement litigation and BPCIA litigation2.       Provide Committee leadership with periodic reports3.       Provide a webinar on ongoing developments in biotechnology litigation 4.       Provide program content for AIPLA Annual Meeting

Biotech Patent Educationo 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."

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.

o Ryan B. Chirnomas reported on the Trans-Pacific Partnership Agreement in U.S.

Mission Statement:

11

BIOTECHNOLOGY

To educate biotech patent practitioners on best practices for planning, obtaining, and leveraging strong patent portfolios for clients in a rapidly-changing legal environment; to serve as a clearing house for ideas on adapting strategies in view of important PTAB, Federal Circuit, and Supreme Court opinions; and to foster the exchange of information and ideas relating to best practices for patent prosecution of inventions in the life sciences. 

Goals for 2017:To publish articles in the Biotech Buzz relating to informing Biotech Committee members of best practices for planning, obtaining, and leveraging strong patent portfolios for clients.

Case Law Reviewso 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.

o Gideon Eckhouse and Andreas Baltatzis report on Purdue Pharma L.P. et al v. Epic Pharma LLC et al.

o Lynn C. Tyler and Sean M. Phipps reported on Acorda Therapeutics Inc. v. Mylan Pharm. Inc., No. 2015-1456, 2016 WL 1077048 (Fed. Cir. 2016)

o D. Benjamin Borson reported on Genetic Technologies Limted v Merial L.L.C., Bristol-Meyers Squibb Company 2015-1202, 2015-1203 (Fed. Cir. April 8, 2016)

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

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

o Adda Gogoris reports on Vanda Pharmaceuticals Inc. v. Roxane Labs., Inc., No. 2015-1456, 2016 WL 1077048 (D. Del. 2016)

o Hui-Shan Sandra King reported on In re Efthymiopouloso Adda C. Gogoris reported on In re NuVasiveo D. Benjamin Borson, M.A., J.D., Ph.D. reports on In re Marcel van Os

12

BIOTECHNOLOGY

Mission Statement:To provide summaries of legal developments relevant to intellectual property that affects biotechnology both in the United States, and worldwide; to include informed commentary that spurs on further discussion; and to provide a simple way for our members to increase their involvement in AIPLA’s work.

Goals for 2017:The case law review subcommittee would like to continue providing updated case law information regarding cases relevant to the Biotechnology Committee members. We would also like to encourage engagement of the committee members by working with volunteers to summarize relevant cases.

Diagnostics and Gene Patentingo In a joint report from Diagnostics and Gene Patenting and Hot Biotech,

Laura N. Arneson reported on the PTO’s May 4, 2016 Life Sciences Subject Matter Eligibility Examples

o Alice Martin reported on Sequenomo Alice Martin reports on RAPID LITIGATION MANAGEMENT LTD. V.

CELLZDIRECT, INCo John E. Peterson, Judith Roesler, and Vicki G. Norton reported on FDA’s

two July 6, 2016 draft guidance documents laying out FDA’s proposed oversight of Next Generation (“Next Gen”) sequencing technology for performing In-Vitro Diagnostic (“IVD”) tests, containing non-binding recommendations for stakeholders and FDA staff.

Mission Statement:To monitor and report on domestic and international laws relating to the intellectual property protection of inventions involving genetic materials, diagnostic products, and methods utilizing such, especially those relating to personalized medicine.

Goals for 2017:1)     Continue to monitor, and provide reports and comments on court decisions, and PTO guidance relating to patent eligibility of biotechnology inventions.2)     Monitor district court decisions relating to patent eligibility of diagnostic and gene inventions. Notify the amicus committee of decisions to watch.3)     Generate and submit at least one Buzz article in 2017 on a topic relevant to the subcommittee.

13

BIOTECHNOLOGY

Genetic Resourceso Holger Tostmann reported on WIPO activities regarding Intellectual

Property Relating to Genetic Resources and Traditional Knowledge.

Mission Statement:To report on issues relating to genetic resources and traditional knowledge such as those surrounding the Nagoya Protocol, the Convention on Biological Diversity and the Intergovernmental Committee on Genetic Resources and Traditional Knowledge that is taking place at WIPO.

Goals for 2017:1. To attend meetings and seminars of the Intergovernmental

Committee on Genetic Resources and Traditional Knowledge that is taking place at WIPO and to report back to AIPLA.

2. To write articles for the Biotech Buzz on issues relating to genetic resources and traditional knowledge.

High Tech Biotecho 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.

Mission Statement:To advise and report on issues specific to biotech inventions involving software and computer implementations such as biosensors, microfluidics, bioinformatics, and telemedicine, and to advocate for laws and policies that help stimulate further innovation and growth in these areas by promoting strong and valid intellectual property protection for such inventions.  The High Tech Biotech subcommittee will focus on patent law issues that are important to both information technology and biotechnology companies and provide a forum for practitioners in these areas.

Goals for 2017:To write articles for the Biotech Buzz reporting on issues specific to biotech inventions involving software and computer implementations such as biosensors, microfluidics, bioinformatics, and telemedicine, and to advocate for laws and policies that help stimulate further

14

BIOTECHNOLOGY

innovation and growth in these areas by promoting strong and valid intellectual property protection for such inventions. 

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.

o Alice Martin reported on the Ariosa en banc denial.

Mission Statement:To track important, breaking issues and provide timely “news you can use” updates.

Goals for 2017:- tracking important, breaking issues, such as subject matter issues re diagnostic methods- provide timely “news you can use” updates to Biotech Committee members- decide on new mechanism to distribute news updates, to replace use of postings in LinkedIn Group

Industrial Biotecho 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.

o Judith Roesler reported on Roquette Frères v. Solazymeo Melissa Brayman reported on Federal Circuit Affirms Unpatentability of

Gevo, Inc. Biofuel Patent

Mission Statement:To monitor patent issues, litigation, and regulations pertinent to the development and commercialization of biotechnology for industrial purposes, including manufacturing, alternative energy white biotechnology, including alternative energy such as biofuels, and biomaterials (“white biotechnology”); to provide periodic reports and contributions to the Biotech Buzz for key intellectual property events involving white biotechnology; and to provide advice to the Biotechnology Committee leadership in matters involving in advocacy and promoting the value of intellectual property in this emerging area.

Goals for 2017:

15

BIOTECHNOLOGY

To write articles for the Biotech Buzz reporting on issues specific to the development and commercialization of biotechnology for industrial purposes. 

Internationalo Michaela Elbel of Pateris provided 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.

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. 

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

16

BIOTECHNOLOGY

a foreign corresponding application for Singapore patent applications filed on or after 1 January 2017. 

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.

o Gisella Barreda of Brda Abogados reported on TPP – Most important changes in the Peruvian Patent Law are really subject to the Andean Community’s permission

o Juan Rodrigo Pimentel of Arochi & Lindner reported on Opportunities for Mexico in Biotechnology Upon the Entry to the TPP

o Yoichi Watanabe, Partner of Seiwa reported on Trans-Pacific Partnership – Patent and regulatory implications for Japan

o Noel Courage and Melanie Szweras of Bereskin and Parr reported on Protecting Life Science Innovations in Canada – A Year in Review

o David Read of Bartle Read reports on Contributory infringement in Europe: Actavis goes the extra mile and Eli Lilly loses in latest instalment of Alimta saga

o Yoon Suk Shin of Lee International reported on the Korean Patent Acto Yoon Suk Shin of Lee International reported on Legislation Updates -

Revisions to the Korean Patent Acto David Read of Bartle Read reported on Brexit—the implications so faro David Read reports on EPO referring questions concerning the

allowability of ‘undisclosed disclaimers’ to its Enlarged Board of Appealo Robin Bartle reports on EPO’s enlarged board of appeal ordering

antidote to poisonous priorities

Mission Statement:To report on biotech patent issues, laws, and best practices around the world and bring together the global biotech patent community.

Goals for 2017:To write articles for the Biotech Buzz reporting on patent issues from around the world. To participate in “Around the World” webinar series on Patent Term Extension and other topics.

Plant Biotecho 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.

o Humphrey Foote reported on Australia issues new Myriad Guidelines.

17

BIOTECHNOLOGY

o Frances Salisbury reported on the Revocation of the Melon Patent in Europe

o Frances Salisbury gave an update on the Revocation of the Melon Patent in Europe

o Mia Unson and Mark Pidkowich gave an update on Managing Fees For Applications Involving Large Sequence Listings

o Mark Pidkowich-Announcement: Registration remains open for the Ag Innovation Showcase, being held in St. Louis, MO from September 12-24, 2016

o Katherine D. Koenig reports on USDA Declines Regulation of CRISPR-Edited Mushroom

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

Mission Statement:To foster awareness of competing global interests that affect advances in plant biotechnology, and how intellectual property protection affects those interests; to investigate key patent issues that influence innovative plant research, product development and commercialization; to be a resource for domestic and international patent practitioners who work in plant biotechnology and the patenting of plants; and to advocate for policies that support the promise of plant biotechnology.

Goals for 2017:To write articles for the Biotech Buzz reporting on plant and agro patent issues. To participate in live AIPLA meetings by contributing panelists.To participate in a webinar on Plant Biotech.

PTAB Actionso 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.

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.

18

BIOTECHNOLOGY

o Chad Stroud reported on Inguran, LLC v. Premium Genetics, PGR2015-00017 (PTAB)

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

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

Mission Statement:To monitor post-grant trial proceedings at the PTAB pertaining to, or selectively impacting, biotechnology; to provide Committee leadership and membership with periodic reports, and play a role in advocacy considerations, when pertinent.

Goals for 2017:To write articles for the Biotech Buzz reporting on PTAB issues. To report on PTAB decisions.To participate in the Mid-Winter Institute CLE panel.

Public Communicationso Courtenay Brinckerhoff reported on the PTAB’s institution of the Kyle

Bass IPR against the Lialda® patent.o Courtenay C. Brinkerhoff reported the Proposed USPTO Patent

Prosecution Fee Changes.

Mission Statement:To tell the pro-patent innovation story; one that explains the truth so that it can be understood by average citizens and dispel factually incorrect information disseminated by biased parties.

Goals for 2017:To write articles for the Biotech Buzz informing the public on Biotech and Pharma news.

Regional/Socialo Debora Plehn-Dujowich and Alice Martin reported that there was a

Biotech Committee karaoke outing during the Mid-Winter Institute. o Debora Plehn-Dujowich and Alice Martin reported that there will be a

Biotech Committee karaoke outing during the Spring Meeting. o Alice Martin reported that there will be a social activity during the

Annual Meeting at Harry’s Pub

19

BIOTECHNOLOGY

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

Mission Statement:To provide more opportunities for our members to network and have fun in local regions.

Goals for 2017:To organize social events and networking opportunities for Biotech Committee members, for example during AIPLA meetings.

Technology Transfer & Licensingo 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.

o Eric Mirabel and Vladimir Drozdoff reported on Beyond Hybrid Licenses -- Strategies for Post Patent Expiration Payments.

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

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

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

Mission Statement:To define the various licenses and other commercial relationships among industry and institutions, and business considerations that play a primary role in shaping these licenses and relationships; and to advise on trends and best practices and recommend changes in current practices, if needed.

Goals for 2017:To participate in the AIPLA Forms project with the AIPLA Licensing Committee.To continue writing articles for the Biotech Buzz reporting on licensing issues.To continue participating in webinars on licensing issues.

20

BIOTECHNOLOGY

USPTO Relationso 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.

o Ron Kamis reported on USPTO activities such as the BCP meeting on April 26

o Suzannah Sundby and Ron Kamis reported on the BCP meeting of June 30

o Ron Kamis reported on the BCP meeting of October 19

Mission Statement:To maintain and strengthen the relationship between our members, biotech patent practitioners, and the USPTO, and to increase the quality of biotech patents by monitoring and commenting on USPTO notices, rulemaking, and guidance materials that may impact the protection of inventions in the life sciences. 

Goals for 2017:To attend all BCP meetings at the USPTO and report back to the AIPLA Committee through articles in the Biotech Buzz.To continue writing articles for the Biotech Buzz reporting on USPTO issues.To continue participating in webinars on USPTO issues such as the Section 101 Guidelines.To provide written comments to the USPTO on Sequence Listing Guidelines.

21