Strategic Patent Portfolio and Lifecycle Development for Pharma & Biotech Industries: Significant Issues
In a highly competitive and constantly changing market of today, the pharmaceutical industry is looking for suitable ways to extend the profitability of its products up to and beyond patent expiry, so medical device IP Portfolios are becoming increasingly relevant for pharma. Due to the expensive cost associated with the Research and Development (R&D), it is becoming crucial to implement integrated Life Cycle Management (LCM) strategies that would maximize revenues and extend the lifespan of patent portfolios. In cases where patent extension is not an option, and the product is nearing patent cliff, drug innovators are increasingly relying upon medical device IP to decelerate the pace of revenue loss from generic competition.
Without strong product LCM strategies, pharmaceutical companies are more likely to be exposed to legal challenges and revenue risks. In this two-hour LIVE Webcast, a stellar panel assembled by The Knowledge Group will offer a discussion on the most significant issues involving patent portfolio and LCM strategies. The panel will also provide a roadmap through the R&D process and will help the audience understand the best practices in minimizing the risks associated with patent portfolio and lifecycle development.
- Pharmaceutical and Medical Device Patent Life Cycles – An Overview
- Patent Term Adjustments for Biotech and Pharma
- Role of PTA in Medical Device and Pharma Patent Life Cycle
- Patent Term Extension
- Patentability and Implications for Life Sciences Innovation
- Portfolio Strategies
- Common Risks and Pitfalls
- Up-to-the-minute Regulatory Updates
Christine G. Espino, PhD, Attorney
Proskauer Rose LLP
- Small Molecule Patent Lifecycle Management Post-Gilead
- US Exclusivity Strategies
- Portfolio Strategies – Further Considerations
- Flexibility May Have Costs*
- Terminal Disclaimer Practice Prior to Gilead
- Gilead Sciences Inc. v. Natco Pharma Ltd.
- Post-Gilead Developments and Unanswered Questions
- Current Post-Gilead Landscape
- Post-Gilead Strategies
Taylor Corbitt, Partner
Riley Safer Holmes & Cancila LLP
- After procurement, maintaining your pharma portfolio
- Defending IPRs in Hatch-Waxman cases
- Who is filing, what type of cases
- No first-filers, prospective ANDA filers or 3rd parties – means that defense of patents starts significantly earlier than traditional Hatch-Waxman cases
- Emerging as good route for patent challenges to biosimilars/BPCIA
- CBM attempts
- Success rates stats slide
- Evergreening – benefits and challenges in post-AIA world
- Who is filing, what type of cases
- Managing your portfolio through a merger or acquisition
- Stats slide on pharma/ chem company mergers in past 12 months – very high rate, one of biggest sea changes to pharmaceutical industry
- Lay of the land during merger or acquisition: turf insecurities, too many chiefs, pruning difficult, but wholistic evaluation of portfolio to represent new priorities imperative
- Tips for managing transition and minimizing continued outlay for less profitable patents (designate external “bad guy” to manage process; timeline management; priority consensus; managing IP conflicts)
- Defending IPRs in Hatch-Waxman cases
- After maintaining, monetizing your pharma portfolio
- Define project and end it when over – patents having high value almost always immediately apparent
- Non-OB patents vs. OB patents
Edward Arons, PH.D., Esq., Founding Partner
Weiss & Arons, LLP
- The patent value proposition
- Positioning the asset in the corporate portfolio
- The investor discussion (VC/strategic/in-house client)
- Diligence modeling
- Identifying foreign markets
- Technology model
- Technology timeline
- Laying the foundation for change
- Portfolio Development
- First inventor to file
- It's an IPR, IPR, IPR…world
- Practical reality
- Startup/corporate/in-house counsel
- Hard decisions
- Scaling up and outsourcing development
- Continuation practice
- Balance of US/OUS strategies
- The CIP fallacy
- Things to remember
- Title in corporate/international context
- Priority rights conveyance
- European combination theory
Who Should Attend:
- Biotech/Pharma Industry Lawyers
- Patent Attorneys
- Patent Licensing Attorneys
- Patent Litigators
- Patent Consultants
- Brand Managers from Biotech/Pharma Companies
- Pharmaceutical Company Executives
- Drug Manufacturing Executives
- Other related/interested Professionals and Organizations
Christine is an associate in the Litigation Department, and a member of the Life Sciences Patent practice. She works with clients at all stages of product development, from early-stage R&D through clinical trials and product commercialization. She brings the dual perspectives of scientist and attorney to her role as counsel on US and foreign patent prosecution, transactional due diligence, and freedom-to-operate and patentability analyses.
Prior to joining Proskauer Christine worked as an intellectual property associate at two leading Boston law firms, where she worked with large academic, institutional and corporate clients in all phases of product development and patent prosecution strategy. She drafted and prosecuted U.S. and foreign patent applications, assisted in due diligence for financing, and conducted freedom-to-operate and patentability analyses in the life sciences area.
Christine’s technical experience includes small molecules, pharmaceutical formulations, crystalline polymorphs, polymers for drug delivery, and protein-drug and antibody-drug conjugates. She performed her post-doctoral research in organic and polymer chemistry at M.I.T., where she developed transition-metal mediated strategies for preparing novel conjugated polymers and extended aromatic structures. As a graduate research fellow at Stanford University, Christine developed a new methodology for synthesizing highly functionalized amine derivatives, which culminated in a novel, commercially available catalyst. As an undergraduate research assistant at Harvard University, she delineated the substrate scope of the enantioselective aluminum-catalyzed addition of HCN to imines as a route to non-natural a-amino acids.
Christine has served as an attorney mentor in the Boston Lawyers Group Mentor Program since 2014.
Christine is an associate in the Litigation Department, and a member of the Life Sciences Patent practice. She works with clients …
Taylor Corbitt is an intellectual property and patent litigator at Riley Safer Holmes & Cancila LLP. Taylor has nearly a decade of experience with patent portfolio planning and counselling, managing prosecution of chemical, biotech and pharmaceutical portfolios, clearance and freedom-to-operate opinions, IP due diligence, pre-litigation analysis, litigation, and proceedings before the Patent Trials and Appeal Board of the U.S. Patent and Trademark Office. Taylor’s practice focuses on chemical and pharmaceutical technologies, but she also represents clients in patent litigation concerning technologies related to consumer products, mechanical devices, and computer methods. Taylor is a graduate of DePaul University College of Law. She received a degree in molecular biology from the University of Virginia. Taylor has been named an Emerging Lawyer in Intellectual Property Law and Patent Law by Law Bulletin Publishing Company’s Leading Lawyers in 2015 and 2016.
Taylor Corbitt is an intellectual property and patent litigator at Riley Safer Holmes & Cancila LLP. Taylor has nearly a …
Ted Arons' distinctive combination of law and engineering expertise is invaluable to his clients. With 15 years of highly technical experience in engineering and applied mathematics prior to his legal career, Ted brings an unparalleled level of knowledge and practical solutions to every case. Clients can count on his immediate and thorough understanding of their advanced technology products as well as their short- and long-term business needs.
He is highly regarded for providing new ways of looking at technical issues and client advice regarding their products, product pipeline development, acquisitions and licensing. Drawing on his wide-ranging experience in technical areas, guides companies through IP aspects of transactions, including fundraising, renders legal opinions, provides product clearance advice and helps businesses achieve optimal IP positions for corporate growth and fundraising.
Ted's combination of broad and deep scientific background and extensive legal experience enables him to respond to the many intellectual property concerns of his clients. His practice is fully supported by an outstanding staff that works collaboratively on cutting- edge legal issues.
Key to his success are strategies to protect the value of IP assets in today's business and legal climate, whether in the U.S. or abroad. Ted brings this integrated approach to transactional work including due diligence, patent portfolio strength assessment and risk management counseling.
Ted Arons' distinctive combination of law and engineering expertise is invaluable to his clients. With 15 years of highly technical experience …
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About Proskauer Rose LLP
Proskauer is a leading international law firm focused on creating value. Founded in 1875 and with over 700+ lawyers active in virtually every major market worldwide, the firm is recognized not only for its legal excellence, but also its dedication to client service. Their clients include many of the world’s top companies, financial institutions, investment funds, not-for-profit institutions, governmental entities and other organizations across industries and borders. They have offices in New York, Boston, Beijing, Chicago, Hong Kong, London, Los Angeles, Paris, São Paulo and Washington, D.C., as well as Boca Raton, Newark and New Orleans.
Proskauer's collaborative Life Sciences Patent practice has industry experience in the life sciences area that is second to none, with members having worked at companies such as Amgen, Chiron, Life Technologies, Affymetrix, Millennium Pharmaceuticals and Wyeth. The group focuses on partnering with leading pharmaceutical, biotechnology and medical device clients to meet their business objectives and develop and execute practical solutions to their problems throughout the full life cycle of the patent process. Their deep knowledge of the most important therapeutic areas, such as immunology, oncology and neurology, has allowed them to successfully represent their life sciences clients against some of the industry’s most aggressive companies and institutions, employing comprehensive strategies that draw from their extensive experience with patent prosecution, patent litigation, contested patent office proceedings, FDA regulations, patent transactions, including licenses and assignments, and patent litigation.
About Riley Safer Holmes & Cancila LLP
Riley Safer Holmes & Cancila LLP is a diverse, service-oriented and technically sophisticated national litigation practice committed to providing legal and client service at the highest levels in the profession. Our partners offer decades of experience and feature leaders in class action, white collar, intellectual property, product liability, employment law and general litigation. Our teams of seasoned and capable attorneys in Chicago, San Francisco and New York, represent and serve the interests of valued clients around the world.
About Weiss & Arons, LLP
Weiss & Arons LLP is an intellectual property law firm that represents clients that range from small businesses to private equity and from start-ups to multi-billion dollar international corporations. We provide IP risk management advice in connection with technology-based transactions, whether acquisition- or license-based, product development strategy and competitive market positioning. Our scientific expertise and institutional knowledge cover the fields of medtech, electrical engineering, telecommunications, software, material properties, heat transfer and thermodynamics, optics, geophysical exploration, high-energy particle applications and consumer products. The firm is entrusted with IP matters that go before the U.S. Patent and Trademark Office, including the Patent Trials and Appeals Board, the U.S. District Courts and, through decades of collaboration with trusted foreign associates worldwide, courts and rightsgranting agencies throughout the world.