Patent Subject Matter Eligibility – Impact on Litigation and Prosecution

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Personalized medicine relies on diagnostic technologies to accurately evaluate a patient’s clinical or genetic signature to guide treatment decisions. Protecting innovation by patenting the diagnostic methods and tools that inform clinical intervention and treatment has been the traditional means to protect investment in these important technologies. Recent U.S. Supreme Court decisions have challenged inventors’ ability to patent diagnostic innovations, notably the Supreme Court’s Prometheus, Myriad, and Alice decisions, by removing from the scope of patentable subject matter discoveries that broadly tie a medical marker, e.g., a biomarker or drug metabolite, to a therapeutic intervention (Prometheus), isolated products of nature such as mutated genes that are detected as individual biomarkers (Myriad) and abstract ideas that may integrate complex clinical information (Alice). Continue reading this entry

Breaking Through to Business Solutions for Personalized Medicine: A Thought-Provoking, Can’t-Miss Industry Event

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Just as with patient treatments, one size does not fit all when it comes to companies involved in personalized medicine. Each is unique in its mission, culture, and capabilities, so it should come as no surprise that each demands a distinct business strategy that can evolve alongside the industry. The annual Business of Personalized Medicine Summit is centered around helping attendees build just that.

While other forums for discussing personalized medicine have, for the most part, focused on relatively specialized areas such as underlying technologies, financing, regulatory pathways, or payment issues, the Summit seamlessly integrates thought leadership and networking into a one-day, one-of-a-kind forum that addresses cross-sections of such issues with a clear eye toward helping attendees build successful, sustainable industry business models.

And because the Summit is a must for all entities who are currently engaged in personalized medicine as well as those seeking to enter the space, it provides the perfect opportunity to connect with key players in this rapidly developing field. Through fresh discussions with key opinion leaders and each other, attendees can collect insights and arrive at solutions that will drive their individual growth and performance within personalized medicine as well as impact the overall future of health care.

The 2015 Summit, co-hosted by Foley & Lardner LLP, the Personalized Medicine Coalition, AmerisourceBergen, and the California Life Sciences Association, will take place on Wednesday, October 7, at the South San Francisco Conference Center in South San Francisco, California, the birthplace of biotechnology.

Who Should Attend

  • Business, legal, and health care professionals interested in industry leaders’ real-world experience on the current state of personalized medicine and where growth and opportunity exist
  • Business, legal, and health care professionals interested in discussions regarding the regulatory framework for diagnostics and targeted therapies
  • Executives and entrepreneurs interested in hearing diverse perspectives on both the development and delivery of personalized medicine therapies
  • Payors interested in current status and future possibilities regarding reimbursement of personalized medicine technologies
  • Corporate counsel in life sciences and health care provider organizations
  • Health care professionals working in the field of personalized medicine
  • Health care and life sciences investors
  • Researchers and academic personnel
  • Non-profit organizations

Featured Topics

  • Financing & Venture Capital: How investments, partnerships, and other transactions are impacting the business of personalized medicine
  • Payment: Strategies for identifying your target market, collecting evidence, and getting paid
  • FDA/Regulatory: The FDA’s proposed oversight of LDT’s, Obama’s Precision Medicine Initiative, and what to expect in the future as a result
  • Big Pharma: A look at the industry’s involvement and investment in personalized medicine
  • Intellectual Property: High-profile cases with significant implications in the personalized medicine space both at the R&D stage and downstream
  • Big Data: Driving development through complex bioinformatics and collaborative results analysis, plus a look at cybersecurity implications
  • Disruptive Innovation: How personalized medicine is being reshaped through innovative business models, technology applications, and information management
  • Clinical Adoption: Barriers to and solutions for effective understanding, acceptance, integration, and knowledge sharing throughout the personalized medicine life cycle

Register now to hear how some of the industry’s best and brightest are tackling today’s business challenges and what they envision for the future of personalized medicine. Plus, enjoy a special closing keynote presentation with John Parise, Director & Associate General Counsel at Genentech, and Steven Kafka, PhD, President & Chief Operating Officer at Foundation Medicine, as they highlight Roche’s $1 billion majority stake in the genomic cancer diagnostics firm.

For a complete speaker roster and program agenda, visit personalizedmedicinesummit.com.

Questions? Email BPMSummit@forumsmeetings.com or call 303.856.7018.

Nautilus Standard Sinks Dow Patents

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Dow Chemical Company (“Dow”) lost a ruling that competitor NOVA Chemical Corporation and NOVA Chemicals Inc. (collectively “NOVA”) infringed claims of two Dow patents when the Federal Circuit applied the U.S. Supreme Court’s new definiteness standard set forth in Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120 (2014)(“Nautilus”). Dow Chemical Co. v. NOVA Chemicals Corp. (Fed. Cir., August 28, 2015). The court held the claims indefinite under 35 U.S.C. § 112, and reversed the trial court’s award of supplemental damages. Continue reading this entry

AmerisourceBergen Guest Post: Solutions to Overcome Reimbursement Challenges in Personalized Medicine

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Guest Post by Amy Grogg, PharmD, Senior Vice President of Strategy and Commercialization, AmerisourceBergen Specialty Group

The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is for you.” The promise of personalized medicine holds allure for patients, providers, and payers alike by improving quality of care by targeting therapy, predicting disease course, mitigating risk, and reducing waste of scarce resources. However, several barriers remain that hinder adoption of PM across the globe, including industry incentive, regulatory pathways, reimbursement policies, and physician habits. In the U.S. market, there are challenges related to reimbursement, but manufacturers can take steps to overcome these barriers working with fellow stakeholders to unlock the full potential of personalized medicine. Continue reading this entry

Protecting Diagnostic Innovation – Two Actor Infringement Liability

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In Akamai Techs. Inc. v. Limelight Networks, Inc., (August 13, 2015 Fed. Cir.) an en banc Federal Circuit unanimously held that direct infringement under Section 271(a) can occur:

”where all steps of a claimed method are performed by or attributed to a single entity…Where more than one actor is involved in practicing the steps, a court must determine whether the acts of one are attributable to the other such that a single entity is responsible for the infringement. We will hold an entity is responsible for others’ performance or method steps in two sets of circumstances: (1) where that entity directs or controls others’ performance, and (2) where the actors form a joint enterprise.” Slip Op. at 4. Continue reading this entry