Bridging the Gap Between EU and U.S. Biotech Inventions Protection
Biotechnology companies both in the U.S. and Europe rely greatly on patents to protect their biotech inventions, especially during the research and development process. However, with the evolving economic landscape, and the rise of complex developments and innovation, protecting biotech inventions has become more difficult.
In this LIVE Webcast, a team of thought leaders and professionals brought together by The Knowledge Group will provide and present and in-depth analysis of the laws and regulations in the EU and U.S. concerning Biotech Inventions Protection. Speakers will also provide practical tips and strategies to maximize legal protection and to avoid risks and pitfalls while complying with applicable laws.
Key topics include:
- EU and U.S. Biotech Inventions Protection – Laws and Regulations
- Similarities and Differences
- Significant Court Rulings
- Trends and Legal Updates
- What Lies Ahead in 2018
Dean L. Fanelli
Seyfarth Shaw LLP
Thomas A. Haag
Seyfarth Shaw LLP
Speakers’ talking points:
1. Patentable Subject Matter in the U.S. in view of the Prometheus, Myriad, and Sequenom Cases;
2. Biosimilar Litigation in the U.S.; and
3. Overview of Biotech Proceedings/Statistics in front of the PTAB.
Jens Viktor Nørgaard
Speaker’s talking points:
Amendments - one of the biggest differences between US and EP practice. In a complex area as biotech, the amendments challenges, US applicants face in Europe are huge.
Priority – another area of huge difference between the US and Europe and partly related to amendments. I will talk about ways to overcome the challenges for US applicants.
Speaker’s talking points:
- Aspects of European opposition proceedings with a focus on biotech cases – a general overview of timelines, what to expect, differences to US PTAB and US district courts, tips and tricks, etc.
- Challenges faced by European applicants in the US with respect to double patenting, in particular in fields such as drug development where successive generations of an invention are sought to be patented, for example by different entities involved in a research collaboration.
- Antibody patenting in Europe and the US. The situation in Europe appears to be stable in contrast to the upheaval in the US after the CAFCs Amgen v Sanofi decision.
Elkington + Fife LLP
Speaker’s talking points:
Protection for antibodies in Europe:
Available claim types
What the EPO wants
What to included in the specification
SPCs for antibody inventions:
Is the product protected?
Boult Wade Tennant
Speaker’s talking points:
Second medical use claims
- How these differ from method of treatment claims in the US
- How these are interpreted in Europe
- The issues associated with enforcement of second medical use claims in Europe
Unitary European Patent and Unitary Patents Court
- General update
- Possible implications of Brexit
- Implications of the UPC for the interpretation of second medical use claims
Dean L. Fanelli, Ph.D. is a partner in the Intellectual Property Department of Seyfarth Shaw LLP’s Washington, D.C. office. Dr. Fanelli’s expertise lies in patent portfolio creation and management, counseling, technology transactions, due diligence, opinion work, including drafting novelty, freedom-to-operate, and invalidity opinions, and inter partes review and post grant review proceedings. Dr. Fanelli also has significant experience with the interplay between patent and FDA laws under the Hatch-Waxman Act, and he regularly handles IP issues attendant to mergers, acquisitions, and financing for life sciences companies as well as ANDA analyses associated with Hatch-Waxman paragraph IV litigation. Dr. Fanelli received his J.D. from The George Washington University Law School and received his Ph.D. in organic chemistry from Temple University, where he studied the syntheses of biologically active amino acids and amino acid derivatives under the supervision of Dr. Franklin A. Davis.
Dean L. Fanelli, Ph.D. is a partner in the Intellectual Property Department of Seyfarth Shaw LLP’s Washington, D.C. office. Dr. …
Thomas Haag is a partner in the Intellectual Property Department of Seyfarth Shaw LLP’s Washington D.C. office where he cochairs the firm’s chemical & life science patent team. His practice focuses on pharmaceutical and biotechnology patent counseling, due diligence and licensing/transactional matters; as well as Hatch-Waxman litigation and patent opinion work.
He has extensive experience strategically managing large patent portfolios, drafting and negotiating biomedical patent licenses, asset purchase agreements and joint development agreements. Dr. Haag’s technical expertise is in molecular biology related technologies including those in the fields of immuno-oncology, cancer/infectious disease vaccines, nucleic acid-based therapeutics, stem-cell therapeutics, gene editing and therapy, epigenetics, transgenic plants, next generation sequencing (NGS), biologics and biosimilars.
Previously, Dr. Haag was a Founding Partner and Chair of Fanelli Haag PLLC. Fanelli Haag was acquired by Seyfarth Shaw LLP in October 2016. Fanelli Haag was a leading intellectual property boutique law firm focused on issues facing the biotechnology, pharmaceutical, nanotechnology and chemical industries.
Thomas Haag is a partner in the Intellectual Property Department of Seyfarth Shaw LLP’s Washington D.C. office where he cochairs …
Jens Viktor has worked as patent attorney since 1998 in private practise and the biotech industry. He is now a partner and team leader for the Life-sciences team at HØIBERG.
Jens Viktor counsels on IPR strategy, IPR organization and management of companies, business development, license agreements, freedom-to-operate, validity of patents, oppositions and appeals before the EPO (European Patent Office), in addition to drafting and prosecution of patent applications. Jens Viktor has extensive experience in representing clients at oral proceedings before the EPO Examining Divisions, Opposition Divisions and Boards of Appeal. Jens Viktor has earned experience as technical judge at Oslo County Court in Norway.
Jens Viktor is a respected and experienced speaker/teacher in Denmark and internationally. He has given lectures for several years at morning meetings in Medicon Valley Alliance and international conferences about biotech patenting and teaches European patent practice to US patent attorneys in the US.
Jens Viktor has worked as patent attorney since 1998 in private practise and the biotech industry. He is now a …
Niklas Mattsson is a European patent attorney, and has been with Awapatent since 1999. He drafts and prosecutes patent applications worldwide, and provides IP strategies and IP-related business advice for SMEs, in particular in the life sciences.
Niklas also establishes infringement, validity and freedom-to-operate opinions, e.g. focusing on scope of protection and expiry strategies in pharma life cycle management. He has expertise in the procedures for SPCs for pharmaceuticals throughout the EU. Niklas frequently gives presentations on these subjects.
His specialist technical expertise is within areas such as protein engineering, biochemistry, genetics, biotechnology research tools and bioinformatics. Niklas is a member of Awapatent’s specialist groups for Life Sciences and Pharma.
Since 2011, Niklas is the elected representative of Sweden in epi’s Biotechnology Committee, and in 2016, he was appointed to the AIPPI Standing Committee on Pharma and Biotechnology.
Niklas Mattsson is a European patent attorney, and has been with Awapatent since 1999. He drafts and prosecutes patent applications …
Glyn is a European and UK Patent attorney whose practice spans a wide range of biotechnology subject-matter, from combination immunotherapies to PCR-based diagnostic assays. The majority of his work involves the drafting and prosecution of patent applications, and the handling of post-grant opposition proceedings, before the European Patent Office. In recent years, he has handled numerous high-value EPO oppositions and appeals involving biologics, immuno-oncology and cellular therapies, in addition to coordinating corresponding litigations in the High Court of England & Wales and elsewhere in Europe. Accordingly, he has an acute sense of the necessity of expert representation before the EPO, aligned with an integrated approach to patents, SPCs and regulatory data protection.
Glyn is a European and UK Patent attorney whose practice spans a wide range of biotechnology subject-matter, from combination immunotherapies …
Jennifer, Partner at Boult Wade Tennant, is a Chartered Patent Attorney and European Patent Attorney in the Biotechnology and Life Sciences Group. She has experience prosecuting patent applications before the European Patent Office in all aspects of biotechnology, with particular focus on PEGylation technologies, antibodies, immunology and Alzheimer’s Disease.
Jennifer also has experience in both attacking and defending patents during Opposition Proceedings before the European Patent Office, managing clients’ international patent portfolios, advising on filing strategies and prosecuting patent applications before the UKIPO. She has been extensively involved in the filing of SPC applications throughout Europe. She is also a member of the BIA Cell & Gene Therapy Advisory Committee.
Jennifer has an MBiochem from the University of Oxford. In her final year she studied bacterial replication, focusing on chromosome segregation.
Jennifer, Partner at Boult Wade Tennant, is a Chartered Patent Attorney and European Patent Attorney in the Biotechnology and Life …
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Method Of Presentation:
Basic Knowledge in Biotech Inventions Protection Laws
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About Seyfarth Shaw LLP
Seyfarth Shaw LLP has more than 850 attorneys and provides a broad range of legal services in the areas of intellectual property, labor and employment, employee benefits, litigation, corporate and real estate. With offices in Atlanta, Boston, Chicago, Houston, London, Los Angeles, Melbourne, New York, Sacramento, San Francisco, Shanghai, Sydney and Washington, D.C., Seyfarth’s clients include over 300 of the Fortune 500 companies and reflect virtually every industry and segment of the economy. A recognized leader in delivering value and innovation for legal services, Seyfarth’s acclaimed SeyfarthLean client service model has earned numerous accolades from a variety of highly respected third parties, including industry associations, consulting firms and media. For more information, please visit www.seyfarth.com.
HØIBERG is well-established in the Medicon Valley with offices in Copenhagen, Lund, and Aarhus. All of the patent attorneys at HØIBERG hold advanced degrees from international universities and work in all fields of technology.
The core values of HØIBERG lie in:
• long-lasting client relationships;
• intelligent and creative IP strategies;
• value-based solutions.
HØIBERG provides expert IPR knowledge in thefields ranging from biotech, pharma, medtech, nanotech, chemistry and cleantech to software, electronics and mechanics to support your business.
HØIBERG has the largest group of life science patent attorneys in Medicon Valley. We have first-hand experience from courtrooms when we assist life science clients in litigation in Europe and the US. We are very experienced in all types of proceedings at the European Patent Office.
The AWA Group is a leading consultancy group in intellectual property (IP) with presence in both Europe and Asia.
Our clients are innovation-intensive companies, ranging from startups to owners of the world’s most well-known brands and patent portfolios. We help them turn their ideas and innovations into business opportunities.
Our 165 patent attorneys, attorneys-at-law and other IP pros are experts in IP strategy and legal services as well as patents, trademark, design, and copyright.
Awapatent was founded in 1897. In 2011, AWA IPro was established to provide services, strategy and partnering solutions in commercialization of IP and other revenues from innovation. In 2015, AWA Asia was founded to support Western clients with IP expertise in Asia and Asian clients with IP expertise in Europe.
The Group has 300 employees at 16 offices in Sweden, Denmark, Germany and China. In 2015 we reported sales of EUR 63.4 million.
About Elkington + Fife LLP
Elkington + Fife is a firm of patent and trademark attorneys based in Holborn, central London, and Sevenoaks in Kent (UK). Established in 1927, it has a long-standing reputation for delivering high-quality IP services to our clients.
E+F is consistently recognised for excellence – the Legal 500, for example, cites its “outstanding team” – and the firm prides itself on giving its clients the reassurance that comes from knowing their business interests are in safe hands.
Elkington and Fife’s team has an unparalleled command of all aspects of IP. The bulk of its work is focused on patent and trade mark protection, but it is also well-known for advising on other types of IP, such as supplementary protection certificates, plant variety rights, registered designs, domain names and copyright protection.
About Boult Wade Tennant
Boult Wade Tennant is a specialist patent and trade mark firm. It exists to help individuals and businesses protect, manage and enforce their intellectual property rights on a global scale. The firm looks after the multi-jurisdictional IP issues of major industrial and commercial companies worldwide, as well as portfolio management for a wide range of SME’s, academic institutions, and independent research and development organisations.
Their attorneys are renowned for being committed to helping their clients succeed and for providing a service that is focussed and aligned with the clients’ commercial objectives. Services cover the full range of intellectual property requirements; from filing and prosecuting Patent and Trade Mark applications to the managing of large and complex portfolios; from advocacy at Opposition and Appeal hearings to due diligence work and the provision of opinions.