BIOTECHNOLOGYCommittee Report and Workplan

January 2016

COMMITTEE LEADERSHIPDebora Plehn-Dujowich, Chair

Vicki Norton, Vice ChairMyra McCormack, Board Liaison

COMMITTEE LEADERSIssues Leader – Nick Landau

Community Leaders – Alice Martin and Ryan ChirnomasServices 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-CHAIRSAcademia and Research Institutions – Mary TrachtaBiosimilars – Lynn Tyler and Kristin ConnarnBiotech Agents – Angie SeborBiotech Litigation – Bryan Diner, Patrice Jean, and Laura SmalleyBiotech Patent Education – Ryan B. Chirnomas

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Case Law Reviews – Melanie Szweras and Emily CurtisCorporate – James J. Kelley and Angie SeborDiagnostics & Gene Patenting – George Yu and John PetersonHigh Tech Biotech – Roy Issac and Ashok K. MannavaHot Biotech – Noel Courage and Vicki NortonIndustrial Biotech – Judy Roesler and Melissa BraymanInternational – 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 – Gene Quinn and Courtenay BrinckerhoffRegional/Social – Debora Plehn-Dujowich and Alice MartinSWAT – Brad DuftTechnology Transfer & Licensing – Eric Mirabel and Vladimir DrozdoffUSPTO Relations –Suzannah K. Sundby and Debora Plehn-DujowichWebinars – Carla Mouta

SOTERIA BIOSCIENCESWe have created a hypothetical biotech company named Soteria Biosciences. Soteria Biosciences is a biotech company that grew from a small agro-bio startup into a multidisciplinary global giant. Soteria Biosciences’ headquarters is based in the United States and has offices and R&D facilities in other parts of the world. Our educational programming (including our Biotech Buzz articles, webinars, and stated meetings) will involve the IP issues Soteria Biosciences faces in the development, maintenance, and enforcement of its IP portfolio. Examples of IP issues include initial phases, e.g., licensing and sponsored research agreements; international aspects, e.g., confidentiality, privilege, ownership, foreign filing licenses; issues specific to life sciences, e.g., coordinating clinical trials with patent filings and PTA and PTE; and issues specific to PTAB actions, ITC and district court litigation of patents in the life sciences.

The website for Soteria Biosciences is found at http://www.aipla.org/committees/committee_pages/Biotechnology/Soteria/SitePages/Home.aspx where our educational materials involving Soteria Biosciences’ IP will be found.

WEBINARS

We hosted a free webinar on “Patent Term Extension Around the World: India, China and Korea” on Tuesday, May 12, 2015 at 12:30 PM ET. Our speakers were Tarun Gandhi of Chadha & Chadha, Li Feng of Finnegan and Yoon Suk Shin of Lee International.

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We also hosted a CLE webinar on “Biosimilars: Regulation, Litigation & New Developments Patent Practitioners & Regulatory Attorneys Should Know” on Thursday, August 27, 2015 at 12:30 PM ET. Our speakers were Jim Shehan of Hyman, Phelps & McNamara, Sanya Sukduang of Finnegan and Debora Plehn-Dujowich of Prismatic Law Group, PLLC.

We 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 also have the following webinars planned:

§  Feb 25 (CLE): What’s Left Under 101 After Ariosa En Banc Denial

§  March 10: Patent Eligibility Around The World: Latin America

Luis Diego Castro (CASTRO & PAL ABOGADOS, Costa Rica)Ignacio Sanchez Echagüe (Marval, O'Farrell & Mairal, Argentina)Rodrigo Calderon (Uhthoff, Mexico)Leonor Magalhães Galvão (Magellan IP, Brazil)

§  March 16 (CLE): Trade Secrets in Biotech , Biosimilars and Medical Devices

Victoria Cundiff (Paul Hastings)Elizabeth Howard (Orrick)Austin Wang (Hologic)Debora Plehn-Dujowich (Prismatic Law Group, PLLC)

§  April 7: Biosimilars Around the World: Europe

§  May 25: Patent Eligibility Around The World: Europe and Australia

The list of speakers for the other Webinars is being finalized, but we have already received confirmation that the USPTO will have a representative speaker at the Feb 25, 2016 Webinar on Section 101. Debora Plehn (Prismatic Law Group, PLLC) will present at the March 16, 2016 Webinar on Trade Secrets and Holger Tostmann (WALLINGER RICKER SCHLOTTER

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TOSTMANN) will present at the April 7, 2016 Webinar on Biosimilars in Europe.

PLANS FOR ANNUAL MEETING

We presented a joint CLE program with the ITC Committee at the Annual Meeting which discussed enforcement strategies for Soteria Biosciences’ IP portfolio.

The AIPLA time machine flashed forward to several years after Soteria Biosciences discovered its Humor plant varieties and extracts, and successfully commercialized its NoPainNoGain (“NPNG”) product, as discussed at the Spring Meeting 2015. Soteria’s European subsidiary, Soteria AG discovered a new glycosylated polypeptide, which provides the same pain relief without appetite stimulation as NPNG, but is also an antagonist of the memory loss receptors, and therefore has no adverse effects on memory. Soteria AG named the polypeptide NoPain/NoGain/Better Brain (NPGB). Soteria AG also surprisingly found that NPGB is surprisingly efficacious for treating neurodegenerative disorders.

Soteria further discovered that several Humor varieties produce NPGB with altered glycosylation which decreases its immunogenicity and increases its accumulation in plants.

Soteria obtained FDA approval for NPGB as Soterigen® NPGB 10 years ago, and learned that SameGene Co. (“SameGene”), a European competitor with a U.S. subsidiary, developed a biosimilar version of the NPGB product.

The CLE session at the 2015 Annual Meeting, presented jointly with the ITC Committee, was entitled “Whether to Pursue Enforcement of Soteria Bioscience’s Patents Before the ITC and/or District Court, and Preparing for PTAB Challenges to Soteria’s Pre-AIA and Post-AIA Patents.” The session featured a meeting between Soteria in-house counsel, and its outside litigation and PTAB counsel to discuss its

strategies and preparation to enforce its patents. 

CLE Session Summary

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Kwame N. Mensah acted as Soteria Biosciences’ General Counsel (Kwame is really Intellectual Property Counsel at MedImmune and helped to put together the program).

Vicki G. Norton of Duane Morris LLP acted as Soteria’s Director of IP--she helped to put together the program, including summarizing the facts behind the issues that the panel will discuss.  Read the facts behind these issues here. 

Section 1 Summary:

This joint Biotech-ITC panel featured Brian Koo, an Investigative Attorney at the ITC, and experts on ITC and district court litigation, as they advised Soteria Biosciences, a hypothetical biotech company, on strategies for enforcing its patents and preparing for PTAB challenges.

During Section 1, Brian B. Koo, an Investigative Attorney at the ITC, Maximilienne Giannelli from Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, and Dallin G. Glenn from Stern Kessler Goldstein Fox advised Soteria in-house counsel on what patentees need to know about the pros and cons of enforcing patents in the ITC, including the low likelihood that the ITC will stay an action if a challenger files a PTAB proceeding, the advantages of in rem jurisdiction, and the possibility of side-stepping the biosimilar patent dance through enforcement at the ITC.

Maximilienne Giannelli advised Soteria counsel on what makes the ITC an attractive forum for biotech and chemical companies. Those advantages include quick resolution at the ITC, the ability to more easily obtain discovery from foreign entities, and the inapplicability at the ITC of the limitations in 35 U.S.C. § 271(g) for products that are materially changed after manufacture by a process patented in the U.S., or that are a trivial or nonessential component of an imported product.

Dallin Glenn addressed strategies for enforcement of Soteria’s biologic drug patents at the ITC, including the ability for the patentee to sidestep the patent dance provisions of the Biologics Price Competition and Innovation Act of 2009 by fling a Section 337 action at the ITC.

Section 2 Summary:

Herbert D. Hart III, a partner at McAndrews Held & Malloy advised Soteria on strategies for preparing for PTAB proceedings and post-grant challenges in

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“Facing The New Wolf Pack: Preparing For Post-Grant Challenges At The Patent Trial And Appeal Board” Herb discussed the timing and nature of potential PTO challenges to Soteria’s patents, the impact of recent PTAB decisions for biopharma and pharma companies, and the need to reassess Soteria’s patents in view of recent cases holding biotechnology patents invalid as patent ineligible or lacking written description.

The Biotech Committee also had an informal Happy Hour with the Chemical Practice Committee at the Annual Meeting.

PLANS FOR MID-WINTER INSTITUTEThe Biotech Committee will join up with the Chemical Practice Committee and the Licensing and Management of IP Assets Committee in presenting a case study on a pioneering development, subsequently patented, and ultimately successfully launched and marketed by a Fortune 100 company as a robust therapeutic for an advanced stage disease - the result of collegial exchanges between US and non-US researchers associated with different institutions, together with the efforts of a start-up company whose mission is to develop life-saving products. Our panelists will address best practices for portfolio management, institutional agreements, inventorship determinations, due diligence, in-licensing, and the ultimate resolution of disputes which can arise from the inception of research and development through various licensing exchanges, with a promise to be stimulating, engaging, and enlightening.

Speakers:Robert D. Titus from Eli LillyCasie Kelly from University of California IrvineD.C. Toedt from The Law Office of D.C. ToedtLisa Haile from DLA PiperJ. Michael Warner from Pfizer

PLANS FOR SPRING MEETING

We are working on a joint CLE program with the Food and Drug Committee for the Spring Meeting in Minnesota which will cover topics that are relevant to the geographic region, such as agrosciences, GMOs, animal feed and/or food chemistry. We hope to involve local industries and to include local speakers.

PLANS FOR COORDINATION AND COMMUNICATION

Every month, the Chair, Vice Chair, and Leaders have a “Leaders telecon” to discuss various activities and plans. The Leaders then coordinate, e.g., by telecon or email, with the subchairs of the subcommittees they oversee. Some subcommittees have regularly scheduled subcommittee telecons. In

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addition to the Leaders telecons, we coordinate and communicate by email, the Biotech Buzz, blog postings, and LinkedIn.

The Chair and Vice Chair regularly communicate with the Board Liaison by telephone, email, and Committee Cluster telecons arranged by the Board Liaison.

ADVOCACY AND PUBLIC EDUCATION

The Biotechnology Committee is increasing its advocacy and public education efforts through the activities of our various subcommittees.

Barbara Fiacco and Timothy Meigs put together a Biotech Patent Law Roadshow in Boston on September 10, 2015, which provided regular and ethics CLE credits to its many attendants.

We hope to organize future Roadshows and to coordinate them with social events for our members across the US. We hope to work with BIO to provide joint programming and services that will be mutually beneficial to our members. Thus, we hope to provide additional programming and services to our members by collaborating with BIO.

MEMBER SERVICE

The Biotechnology Committee continues to serve its members by publishing a monthly newsletter, the Biotech Buzz. The Biotechnology Committee uses its LinkedIn group and Leaders’ Blogs to disseminate information important to its members. All the subcommittees have been essential in providing useful information to its members.

The TSC liaisons have been providing regular summaries on other AIPLA committees’ activities. Our TSC liaisons for New Lawyers and Law Students Committees prepared guides on how members can participate in the New Lawyers Committee and the Law Students Committee. The Biotechnology Committee prepared a Biotechnology Volunteer Guide which other AIPLA committees may disseminate to their interested members. Our TSC liaisons for Women in IP Law, Diversity in IP Law, and the Corporate Committees are working on similar guides.

GLOBAL OUTREACH

The International Subcommittee’s activities have significantly expanded the global reach of the Biotechnology Committee. The involvement of our international (non-US) members has increased substantially. The

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educational articles on foreign IP laws that are written by our international members are a valuable resource for our US-members. For example, the International subcommittee has published a series of articles on patent term extension around the world, which were followed by a series of webinars on the same topic. These were very well attended and and well received. The Biotechnology Committee will continue to assist all its members by being a leading resource on intellectual property law in the biotechnology sector around the world.

SUBCOMMITTEE 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 Biosimilar Naming.

o Dr. Holger Tostmann reported on HumiraTM (Adalimumab) Dosage Patents in Opposition Proceedings before the European Patent Office (EPO)

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

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 Kristin A. Connarn reported on Pharmaceuticals and the Trans-Pacific Partnership Agreement in U.S.

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

Case Law Reviews

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o Melissa D. Schwaller reported on the Federal Circuit’s decision in Promega Corp. v LifeTech Inc. and to be wary of “comprising” language.

o Matthew A, Chivvis reported on the Federal Circuit’s recent ruling upholding plant patents in Delano Farms Co. et al. v. The California Table Grape Commission.

o Lynn Tyler reviewed Enzo Biochem Inc. v. Applera Corp., Case No. 2014-1321, 2015 U.S. App. LEXIS 4064 (Fed. Cir. Mar. 16, 2015) on the issue of claim construction.

o Sung Park reviewed Senju Pharma. Co. v. Lupin, Ltd., No. 13-1630 (Fed. Cir. Mar. 20, 2015) on the issue of obviousness of a re-examined patent.

o Robert A. Shulman reported on Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc.

Diagnostics and Gene Patentingo Paul Cole reported on the Federal Circuit’s denial of en banc rehearing

in Ariosa v. Sequenom—Through the Looking Glass: A Path to the Supreme Court (Down a Rabbit Hole?)

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.

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 Laura Smalley reported on District Court grants injunction requiring Apotex to provide 180-day notice before the date of first commercial marketing of pegfilgrastim.

o Alice Martin reported on the Ariosa en banc denial.

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 Butamax Advanced Biofuels LLC v. Gevo Inc.

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Internationalo Michaela Elbel of Pateris providesd an outline of recent changes to

patent law in Germany.o Duncan Ribbons and Maeve Lynch of Redd Solicitors provided a

summary of the CJEU’s decision on parthenotes which has now issued following the Advocate General’s opinion.

o Li Feng of Finnegan, Henderson, Farabow, Garrett & Dunner LLP, Jiancheng Jiang and Yuan Wang of Peksung Intellectual Property Ltd in Beijing provided a brief comparison of the scope of experimental use exemption in the United States and China.

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 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.

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o Andrew Kaikai of Ridout & Maybee LLP reports on pharmaceuticals and the Trans-Pacific Partnership Agreement in Canada.

o Archana Shanker Senior Partner & Head (Patents & Designs) of Anand and Anand reports on two recent pharmaceutical patent decisions in India.

o Tarun Gandhi, Partner of Chadha & Chadha IP reports on the Indian Draft Patents Amendment Rules, 2015 being proposed to bring the present law in line with recent judicial pronouncements and to deal with the several problems faced during patent prosecution, grant, opposition and revocation proceedings.

o Trevor Davies, PhD of Allens Patent & Trade Mark Attorneys and Sally Page of Allens reported on implications of the Trans-Pacific Partnership Agreement to the current patent laws and regulatory procedures in Australia and New Zealand.

o Trevor Davies, PhD of Allens Patent & Trade Mark Attorneys reported on the Australian Patent Examination Guidelines issued by IP Australia following High Court Decision in D'Arcy v Myriad Genetics Inc

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.

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.

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.

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

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

Bass IPR against the Lialda® patent.

Regional and Socialo Alice Martin reported on there will be a Biotech Committee karaoke

outing during the Mid-Winter Institute.

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 Beyond Hybrid Licenses -- Strategies for Post Patent Expiration Payments.

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 USPTO’s Medical Device Customer Partnership Meeting was

held on Tuesday, June 2, 2015. The Partnership Meeting was 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 in the future, please contact the customer partnership team at Medical_Device_Customer_Partnership_TC3700@uspto.gov.

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