Biotech and Diagnostic Patents Risks: What You Need to Know
In a two hour LIVE Webcast, a panel of key thought leaders and professionals assembled by The Knowledge Group will provide the audience with overview of the fundamentals as well as updates of this significant topic. The speakers aims to offer the audience with the best trends and practices to avoid the common pitfalls and risk issues in Biotech and Diagnostic Patents.
Key topics include:
- Biotech and Diagnostic Patent – An Overview
- Risks and Pitfalls in Biotech and Diagnostic Patent
- Composition and Method Claims in Biotech and Diagnostic Patent
- The cDNA Sequences
- DNA Polymerization Process
- Patent Protection under 35 U.S.C. § 101
SEGMENT 1: Lisa Pensabene, Partner
O'Melveny & Myers LLP
- Litigation risks
- Biosimilars will the industry dance
Kathleen M. Williams, Ph.D., J.D., Partner
Sunstein Kann Murphy & Timbers LLP
Denise M. Kettelberger, Ph.D., J.D., Counsel
Sunstein Kann Murphy & Timbers LLP
Application of 35 USC Section 101 Eligibility by the USPTO in examination of patent applications in the biotech and diagnostic industries:
- Two step approach of Mayo and Alice as defined by the Supreme Court, Federal Circuit
- USPTO Guidelines and Examples
- Responding to USPTO 101 rejections by:
- Asserting and factually supporting that the “claim as a whole” is drawn to more than a “law of nature”, is narrowly drawn to a particular use , does not preempt other uses
- Invention includes steps that alone and/or in combination are novel and non-obvious [a conflation of 101 and 102/103 – but addresses “conventional”]
- Requiring the Office to articulate with particularity the factual basis for finding claim as a whole and/or individual elements/steps “routine and conventional”
- Drafting claims that preempt a 101 rejection by narrowly focusing on particular, non-preemptive elements
- Examples of biotech/diagnostic patent claims recently allowed by USPTO over 101 rejection
- Court cases to watch (mention only)
- Ariosa Diagnostics v. Sequenom
- Ultramercial (Second Supreme Court bid)
Other Prosecution issues:
- “significantly more”
- Artificial additions to claims versus functional molecules
- Add a “label or marker” to a diagnostic method
- Add a treatment to a diagnostic method without adding another actor
- 101 mysteries
- Biosimilars – will the industry dance?
- Antitrust for withdraw from market in favor of new version
- Liability for off market and biosimilar use
- 12 years data exclusivity vs Biosimilars challenge
- Biobetters for evergreening – will BCPIA allow vs antitrust
- 101, 112 issues
- First in the target race
- Changing technologies – keeping pace
SEGMENT 3: Daniel Lev, Attorney
Pierce Atwood LLP
- 101 issues
Who Should Attend:
- Biotech and Diagnostic Patent Lawyers
- Medical Providers
- Biotech Professionals
- Healthcare Organizations
- Life Sciences Consultants and Professionals
- Health Industry Advisors
- Healthcare Facilities
- Other related/interested Professionals and Organizations
Lisa Pensabene is a partner at O’Melveny & Myers, LLP where she heads the Life Sciences Litigation practice. Lisa focuses her practice on high stakes patent litigation in the pharmaceutical and chemical industries. She has led trial teams in bench and jury trials, has argued to the Federal Circuit, and led briefing to the Supreme Court. Her experience in patent litigation includes technologies ranging from drugs and biologics for the treatment of cancer, diabetes and cardiovascular problems, cold symptoms, and glaucoma and pain, to agricultural chemicals, petroleum additives, carpet yarn, and semiconductor chips and processing. Lisa has been recognized as a leader in her field by numerous prominent publications and organizations including Euromoney and The Legal 500.
Lisa Pensabene is a partner at O’Melveny & Myers, LLP where she heads the Life Sciences Litigation practice. Lisa focuses …
Dr. Williams is an intellectual property attorney who specializes in complex legal issues surrounding the protection of discoveries in the life sciences. Her technology focus spans biology, chemistry, and materials sciences; molecular biology, biochemistry, medicinal chemistry, pharmacology, and devices in the areas of biotech, pharmaceuticals, therapeutics, diagnostics, nanotechnologies, bio-energy, cleantech and medicine. Kathy also handles complex patent interference and reexamination proceedings and has experience obtaining winning outcomes in patent litigations.
Dr. Williams has extensive experience helping life sciences companies avoid roadblocks and lay the groundwork for new commercial efforts. She advises clients on patent portfolio creation and management, patentability of inventions and commercialization in view of third-party patents, patent prosecution and patent life cycle management, and intellectual property due diligence for corporate transactions such as investments, licenses, acquisitions, and initial public offerings. Dr. Williams works closely with companies to ensure that effective intellectual property strategies are devised, adapted and executed. Her clients include start-up as well as mature life sciences companies, companies which serve the life sciences industry, research institutions and investors.
Dr. Williams is an intellectual property attorney who specializes in complex legal issues surrounding the protection of discoveries in the …
Dr. Kettelberger is a patent attorney with deep experience in bioscience industries, including biotechnology, agricultural biotech, medical devices, and pharmaceuticals. She has special expertise in IP procurement and enforcement strategies, portfolio management and review, IP analysis and opinions, including freedom to operate, infringement, and validity, and litigation support.
Dr. Kettelberger handles strategic management of complex IP portfolios and prepares due diligence opinions and assessments of intellectual property estates. She is responsible for evaluating new product launches while addressing associated potential infringement concerns and licensing opportunities. Dr. Kettelberger also participates in litigation as a strategist and has been responsible for reexamination of US patents and the evaluation of the new post-grant procedures. Dr. Kettelberger holds a Ph.D. in cell biology from the University of Maryland, School of Medicine and an undergraduate degree in biology.
Dr. Kettelberger is a patent attorney with deep experience in bioscience industries, including biotechnology, agricultural biotech, medical devices, and pharmaceuticals. …
Dan Lev focuses his practice on IP prosecution and counseling, patent litigation, and IP and technology transactions. Dan works with life science companies to develop U.S. and international patent portfolios. He counsels pharmaceutical and biotech companies regarding issues at the intersection of regulatory law and patent law. Dan regularly conducts IP due diligence and prepares non-infringement and invalidity opinions for pharmaceutical and biotech clients.
Dan has litigated patent cases before U.S. district courts and the International Trade Commission concerning diverse technologies, including biotechnology and pharmaceuticals, medical devices and diagnostics, LEDs, and semiconductors.
Dan also has extensive experience conducting and negotiating various life science transactions, including IP licenses, research and development collaborations, strategic partnerships, and joint ventures.
Dan Lev focuses his practice on IP prosecution and counseling, patent litigation, and IP and technology transactions. Dan works with …
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About O'Melveny & Myers LLP
With approximately 700 lawyers in 15 offices worldwide, O’Melveny & Myers LLP helps industry leaders across a broad array of sectors manage the complex challenges of succeeding in the global economy. O’Melveny is a values-driven law firm, guided by the principles of excellence, leadership, and citizenship. Its commitment to these values is reflected in the firm’s dedication to improving access to justice through pro bono work and championing initiatives that increase the diversity of the legal profession. For more information, please visit www.omm.com .
About Sunstein Kann Murphy & Timbers LLP
Sunstein Kann Murphy & Timbers LLP has an outstanding record of important wins for our technology and life sciences clients through litigation, patent and trademark prosecution, intellectual property portfolio development and business transactions. We emphasize early identification of business goals and strategic planning to achieve them. We have a long track record of success in protecting and enforcing our clients’ patent, trademark, copyright and other IP-related assets.
About Pierce Atwood LLP
There’s a reason why informed decision makers nationwide turn to Pierce Atwood LLP. The reason is not just that we deliver exceptional service and value to our clients. It’s “how” we do it. We start by attracting and retaining superb legal talent. We add to that a cost structure and a partnership system that allows us to put our clients first in all instances and to offer a reasonable rate structure including options for alternative fee arrangements, in addition to the billable hour.
By rewarding our attorneys for teamwork and collaboration, rather than "originations," our clients get the right lawyer for the right job. Pierce Atwood is a member of The Bridge Group, a network of law firms in the United States, England, France, Belgium and Germany. The Bridge Group firms call upon each other to cover far reaching geographic areas and to address different areas of expertise in order to provide the highest level of quality and service to our clients.
We are a team of responsive, creative, collaborative and hard-working professionals who serve our clients from offices located in four New England states, the District of Columbia and Stockholm, Sweden. Pierce Atwood is the only New England-based law firm to be named to the National Law Journal’s “Midsize Hot List” four years in a row.