Strategic Patent Portfolio and Lifecycle Development for Pharma & Biotech Industries in 2016
Generic competition relentlessly poses a threat for pharma and biotech lifecycles. With its growing complexity, companies with poor product lifecycle management strategies are more likely to be exposed to legal challenges and revenue risks. Thus, it is crucial for companies to establish and maintain a robust life cycle management strategy to minimize possible loss and liabilities.
In a two-hour LIVE Webcast, a panel of key thought leaders, professionals and regulators assembled by The Knowledge Group will help the audience understand the most significant issues with respect to portfolio strategies in pharmaceutical and biotechnology patent lifecycle management and development. The panel will also share their expertise and insights on how to best maintain an effective and efficient patent portfolio in biotech and pharma lifecycle.
Key topics include:
- Pharmaceutical and Biotechnology Patent Life Cycles – An Overview
- Patent Term Adjustments for Biotech and Pharma
- Role of PTA in Biotech and Pharma Patent Life Cycle
- Patent Term Extensions, including SPCs in Europe
- Patentability and Implications for Life Sciences Innovation
- Portfolio Strategies
- Common Risks and Pitfalls
- Up-to-the-minute Regulatory Updates
Linda Chatwin (on behalf of MasterControl), Head of the North American Advisory Services group
Underwriters Laboratories (UL)
U.S. Patent law considerations - and moving globally
- Background case for patenting
- The first patent law was enacted in 1790.
- The patent laws underwent a general revision which was enacted July 19, 1952
- November 29, 1999, Congress enacted the American Inventors Protection Act of 1999 (AIPA), which further revised the patent laws. See Public Law 106-113, 113 Stat. 1501 (1999).
- America Invents Act – 2011
- Patent Terms
- Patent Term Extensions
- Practical considerations
- PTC filing
Janet S. Hendrickson, Ph.D., Partner
Senniger Powers LLP
- Double patenting jurisprudence has developed in the last several years.
- The policy considerations for double patenting include preventing the timewise extension of patent term and preventing harassment from issue of more than one patent on the same invention.
- The interplay between PTA, PTE, and double patenting can be complex.
- Restriction practice can vary widely between art units and individual examiners.
- The USPTO and Federal Courts do not necessarily apply a consistent double patenting standard.
Jill M. Browning, Partner
Greenblum & Bernstein, P.L.C.
P. Branko Pejic, Partner
Greenblum & Bernstein, P.L.C.
Section 101 – patentability in the Life Sciences Context
- Supreme Court Cases (Mayo-Alice- Myriad;
- Recent Federal Circuit Case (Ariosa Diagnostics)
- Addressing Claims going forward:
- Prevalence of 101 rejections;
- USPTO Interim Examination Guidance (2015);
- Tips for claim drafting
- Invalidating Life Sciences Patents
- In Court
- Section 101 -- How often?
- Other Defenses
- At the PTO
- In Court
Edward Oates, Partner
Carpmaels & Ransford LLP
- European life science patenting overview:
- New indications, delivery methods and dosage regimens
- Salts and solvates
- European SPCs – the basic principles.
Fiona Stevens, Partner
Gill Jennings & Every
- Combination SPCs
- Issues surrounding patenting new indications (including infringement of those claims in Europe)
Who Should Attend:
- Biotech/Pharma Industry Lawyers
- Patent Attorneys
- Patent Licensing Attorneys
- Patent Litigators
- Patent Consultants
- Medical Directors
- Medical Providers
- Pharmaceutical Company Executives
- Drug Manufacturing Executives
- Professionals from Biotech and Pharmaceutical Firms
- Other related/interested Professionals and Organizations
Ms. Chatwin has been involved with regulated medical products for over 30 years. She understands the global regulatory maze required to bring products to market, through years of watching regulations evolve and change. She holds a Regulatory Affairs Certification and is an attorney in the U.S. She has obtained product approvals for a wide range of products, and remains involved in changing requirements for medical devices worldwide. She has navigated many FDA inspections, and has negotiated favorable outcomes with FDA. Currently, she assists clients with regulatory issues and challenges, including implementation of UDI processes, performing mock audits, in-depth training on regulatory requirements and consulting on quality system development and improvement.
Areas of regulatory expertise:
- Developing international regulatory strategy
- US FDA 510(k) and other regulatory submissions
- Remediation efforts from audit findings
- Quality system construction and improvement
- Training to QSR, Risk management, RoHS and safety standards
- Risk management file construction and maintenance
- Gap assessments to various certification standards
- Performing FDA Mock Audit and other outside auditing
- Managing FDA inspections
- Developing, implementing and mitigating design control processes
- Coordinating corporate legal activities and General Counsel duties
- Review, negotiation and structure of agreements involving technology and licensing, as well as other commercial matters
- Providing legal and practical business advice, including medical device classification, marketing plans, real estate matters, employment, technology and risk management
- Writing protocols, obtaining IRB approval and provided oversight in clinical trial for pharmaceutical product development
Ms. Chatwin has been involved with regulated medical products for over 30 years. She understands the global regulatory maze required …
Janet S. Hendrickson is a Partner at Senniger Powers LLP in St. Louis, Missouri. She specializes in intellectual property law, particularly, in patent related issues, including the development, management, and enforcement of worldwide patent portfolios for pharmaceutical, chemical, and biotech companies. Dr. Hendrickson also frequently prepares opinions on infringement and validity and counsels her clients on freedom to operate involving their commercial products. Dr. Hendrickson speaks frequently on a variety of IP related topics and is currently serving on the Council, the policy-making body, of the Intellectual Property Law Section of the American Bar Association (ABA). Dr. Hendrickson received her J.D. from the University of Toledo, her Ph.D. in Chemistry from the University of Colorado at Boulder, and her B.A. in Chemistry from Cornell College. She is admitted to practice in the state of Missouri and before the U.S. Patent and Trademark Office.
Janet S. Hendrickson is a Partner at Senniger Powers LLP in St. Louis, Missouri. She specializes in intellectual property law, …
Jill M. Browning is a partner with Greenblum & Bernstein. She holds a bachelor of science from the University of Virginia in chemistry with a specialization in biochemistry as well as a law degree from the University of Virginia School of Law. After graduating, Ms. Browning clerked for the “Rocket Docket” otherwise known as the U.S. District Court for the Eastern District of Virginia. Currently, Ms. Browning’s practice focusses on contested matters before the U.S. Patent and Trademark Office as well as patent litigations in U.S. District Courts, including Hatch-Waxman ANDA litigations. She has both first and second chair experience at trial and has argued many cases before the U.S.P.T.O. Patent Trial and Appeal Board. Ms. Browning has also negotiated and drafted numerous IP agreements and routinely counsels clients on managing their patent portfolio.
Jill M. Browning is a partner with Greenblum & Bernstein. She holds a bachelor of science from the University of …
Mr. Pejic is a partner in Greenblum & Bernstein’s litigation and trial practice group. Prior to joining the firm in 1999, Mr. Pejic clerked for U.S. District Court Judge H. Dale Cook in the Northern District of Oklahoma, and since then, he routinely litigates Hatch-Waxman ANDA litigations in U.S. District Courts country-wide; most recently invalidating a patent for a blockbuster drug in a bench trial in Delaware. Mr. Pejic has also argued appeals before the Court of Appeals for the Federal Circuit, advised clients on patent portfolio management matters, and been involved in negotiations for acquisition, sale and in/out licensing of patent portfolios, as part of transactions involving pharmaceutical patents, business divisions and products. He has also spoken on patent valuation and monetization. Mr. Pejic holds a bachelor of science in Chemical Engineering from the University of Arkansas, a J.D. from the University of Tulsa and an LLM in International and Comparative Law (with focus on international trade and intellectual property protection) from the Georgetown University Law Center.
Mr. Pejic is a partner in Greenblum & Bernstein’s litigation and trial practice group. Prior to joining the firm in …
Ed practises in the life sciences field, with a particular focus on pharmaceuticals, from small molecule inventions through to later stage developments. He has worked on numerous marketed products across a variety of fields, including some of the world’s most commercially successful medicines of recent times.
When not prosecuting patents or engaged in contentious work, Ed uses his knowledge of the pharmaceutical industry and his experience on big-ticket cases to give practical advice to life sciences clients of all sizes in relation to IP matters. This includes freedom-to-operate advice and transactional support, such as due diligence.
One of Ed’s areas of special interest is patent lifecycle management, and he advises clients on supplementary protection certificates (SPCs), paediatric extensions and regulatory exclusivities. He has an extremely detailed knowledge of SPC law, and has coordinated many complex pan-European SPC portfolios.
Ed practises in the life sciences field, with a particular focus on pharmaceuticals, from small molecule inventions through to later …
Fiona Stevens is a European Patent Attorney at Gill Jennings & Every and handles a wide variety of work in the pharmaceutical, chemical and biotechnology fields. She has a Masters degree in Natural Sciences (chemistry, pharmacology and physiology) from the University of Cambridge.
The majority of Fiona’s clients are UK SMEs, primarily in the Biotechnology and Pharmaceutical industries. She has extensive experience helping companies create and shape their IP strategies and worldwide patent portfolios, and specialises in helping her clients get “due diligence ready”. Fiona has guided her clients through multiple fund-raising rounds and partnering processes, helping them raise well in excess of £200 million in the last two years alone. Fiona ardently believes that there is no “one size fits all” approach to IP strategy, but rather helps tailor the strategy according to the business plan.
Fiona has a particular interest in protecting re-profiled drugs via second medical use patents, and is on a mission to educate big pharma and investors as to their value, which is commonly misunderstood. Fiona has obtained many second medical use patents (and supplementary protection certificates) on compounds that are now successful drugs.
Fiona Stevens is a European Patent Attorney at Gill Jennings & Every and handles a wide variety of work in …
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About Underwriters Laboratories (UL)
MasterControl is a committed team of quality, regulatory and software experts who work to empower regulated companies to get their products to market faster. MasterControl’s quality management software solutions reduce overall costs, increase efficiency and accelerate compliance, creating a significant competitive advantage for customers. Drawing upon unparalleled industry experience, MasterControl offers a suite of seamlessly integrated and scalable software solutions for quality management, document control, product lifecycle management, supplier management, audit management, training management and much more. MasterControl’s complete quality management solution is designed for easy implementation, validation and use, continually improving on the promise of Compliance Accelerated. For more information about MasterControl, visit www.mastercontrol.com or call 1.800.825.9117 (U.S.); +44 (0) 1256 325 949 (Europe); +81 (03) 5422 6665 (Japan); or +61 (3) 9717 9727 (Australia).
About Senniger Powers LLP
Senniger Powers is the largest intellectual property law firm in Missouri. We specialize in the preparation and prosecution of patents, copyrights and trademarks, and related litigation, representing all types of businesses from Fortune 500 companies to small start-ups, in each of the core technology areas – chemical, life sciences, mechanical and electrical. The diverse technical capabilities of our professionals help serve clients in a wide array of industries including pharmaceuticals, life sciences, chemicals, mechanical arts, electronics, computer systems and software. The firm has an active litigation practice including several full-time intellectual property litigators, and many others in supporting roles. Our collaborative approach, combined with our technical experience, allows us to deliver insightful counsel, unique solutions and exceptional client service. Therefore, we are able to help our clients achieve a competitive advantage through strategic management of their IP portfolios.
About Greenblum & Bernstein, P.L.C.
Greenblum & Bernstein specializes exclusively in intellectual property law, particularly concentrating in patents, trademarks and copyrights. G&B maintains an active docket in all aspects and stages of intellectual property practice surrounding the life sciences (both biotechnology and pharmaceuticals), including patent prosecution and licensing, post-grant procedures, interferences, derivation proceedings, litigation, and Hatch-Waxman.
G&B’s Pharmaceutical And Biotechnology Practice Group, including Ms. Browning and Mr. Pejic – both former law clerks to U.S. District Court Judges, is highly experienced with all aspects of Biosimilars and Hatch-Waxman, including developing patent strategies for pharmaceutical companies, preparing Notice Letters, litigation, and negotiating settlements. Not content to work within rigid confines, G&B attorneys have the flexibility to employ creative methods to resolve disputes, including cooperative and creative negotiations; use of FDA citizen petitions; and post-grant procedures.
Our team is uniquely qualified to represent petitioners and patent owners in Inter Partes Review proceedings (IPR), and Post Grant Review proceedings (PGR). Our team is one of only a few firms that have filed a PGR petition (which is the only PGR to date on a pharmaceutical patent).
In addition to our patent practitioners who have significant and longstanding experience representing patentees and petitioners in post-grant proceedings, our team includes several former administrative patent judges of the Board of Patent Appeals and Interferences (now the “Patent Trial and Appeal Board”), whose experience is directly applicable to the Board’s handling the post-grant proceedings. Further, our team includes practitioners with significant experience handling interference proceedings.
G&B represents a broad range of clients spanning a spectrum of technical areas, ranging from large and established multinational corporations to start-up companies seeking intellectual property guidance for the first time. Our client base spans the globe, with major clientele around the world, including the United States, India, Europe and Japan.
About Carpmaels & Ransford LLP
Carpmaels & Ransford LLP is a leading firm of European patent attorneys. At the vanguard of intellectual property for over 200 years, our pioneering roots in London now extend to Munich and around the globe.
We have been at the forefront of biotechnology right from the start when we started prosecuting cases originating mainly from the West Coast of the US.
Our broad-based technical expertise is organised into dedicated teams with key technical and professional skills specific to both emerging and established industries. Each team represents a pool of specialist knowledge where developments in the law and technology are closely followed. We believe it’s the depth of our expertise, the range of our experience, the huge pride in what we deliver to our clients and our supportive approach to problem solving that marks us out.
For more information, please see www.carpmaels.com.
About Gill Jennings & Every LLP
Gill Jennings & Every LLP is a leading European intellectual property firm based in London. It represents the patent, trade mark and design interests of many prominent British, European and global corporations and helps guide high-growth SMEs as they seek to establish a presence in fiercely competitive markets. It understands the strategic importance of intellectual property to any business by providing clear, creative and expert advice and assists businesses in protecting, exploiting and managing IP assets to maximise their true market value.
Gill Jennings & Every is consistently recognised by the leading UK legal directories, Chambers, Legal 500 and Managing Intellectual Property as a top tier 'go-to' firm, which is a testament to the quality of advice and support it provides to its clients.