US Life Sciences Market: Key Legal Features March 26, 2013 US FDA - - PowerPoint PPT Presentation

US Life Sciences Market: Key Legal Features

March 26, 2013

US FDA Update

Karl M. Nobert karl.nobert@squiresanders.com

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Navigating the U.S. Food and Drug Administration

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2012 FDA Organization

CDRH Center for Devices and Radiological Health

FDA

Center For Tobacco CFSAN Center for Food Safety and Applied Nutrition CBER Center for Biologics and Evaluation Research CVM Center for Veterinary Medicine CDER Center for Drugs and Evaluation Research

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2013 FDA Organization

Office of Global Regulatory Operations and Policy Office of Food and Vet Medicine Office of Medical Products and Tobacco Office of Operations FDA Office of Commissioner

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Regulatory Framework

• Federal Food, Drug, and Cosmetic Act (“FDC Act”)
• Code of Federal Regulations (“CFR”)
• Implements the statutory provisions of the FDC Act
• Title 21 – Covers FDA regulations on food and drugs in “Parts”
• Guidance Documents
• Compliance Manuals

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Regulatory Pathways for Market Entry

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Food Regulation

Key Agencies and Statutes

Food and Drug Administration

• Federal Food, Drug, and Cosmetic Act
• Fair Packaging and Labeling Act
• Bioterrorism Act of 2002

United States Department of Agriculture

• Food Safety and Inspection Service
• Federal Meat Inspection Act
• Federal Poultry Products Inspection Act
• Federal Egg Products Inspection Act
• Animal Plant Health Inspection Service
• Animal Health Protection Act
• Plant Variety Protection Act

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Food Regulation - Key Points

• Safe for Human Consumption
• Not Adulterated
• Not Misbranded (Properly

Labeled)

• Facility Registration

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Drug Regulation - The Basics

• The Center for Drug Evaluation and Research (“CDER”)
• Types of Drug Regulated:
• Rx (Branded and Generic)
• Over-the-Counter
• Homeopathic
• Drug Definition [21 U.S.C. § 321(g)(1)]:
• Official Compendia
• Intended for use in diagnosis, cure, mitigation, treatment, or

prevention of disease in man or other animals

• Intended to affect structure or function of body of man or

animal

• Any component of items 1-3 above.

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• Investigational New Drug (“IND”) Application
• New Drug Application (“NDA”)
• Pre-market review and approval
• Safety & Efficacy
• Current Good Manufacturing Practices

(“cGMPs”)

• User Fees

Drug Regulation - Approval Basics

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Medical Device Regulation - Classification

3 Classes of Medical Devices Based on Perceived Risk and Control Levels

• Class I (low risk)
• General Controls
• Class II (medium risk)
• Special Controls
• 510(k) Notification
• Class III (high risk and novel devices)
• Special Controls
• PMA

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Dietary Supplement Regulation - Definition

A product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

• Vitamins
• Minerals
• Herbs or other botanicals
• Amino acids
• Concentrate, metabolite, constituent, extract or

combination of above listed ingredients Under the Food, Drug and Cosmetic Act, dietary supplements are regulated as a category of foods, and have been since at least 1938

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Cosmetic Regulation – Characteristics

• Articles intended for Cleansing (except some soap)
• Beautifying
• Promoting Attractiveness
• Altering appearance

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Cosmetic Regulation - Products

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Introduction to Labeling, Marketing and Promotion

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• Immediate Container
• Package Insert
• Outer Packaging
• Shipping Label
• Client Information Sheet

The Product Label – What is Included?

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Product Labeling – What is it?

All marketing and promotional materials including:

• websites (product sites, meta tags)
• detailers / brochures
• trade show materials (handouts, posters)
• publications (journals, magazines)
• advertisements (TV and radio ads, internet pop-ups)

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The Standard for Adequate Substantiation

• Competent and Reliable Scientific Evidence
• FTC standard relied on by FDA

"tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results." See Vital Basics, Inc., C-4107 (Consent April 26, 2004); see also In Re Schering Corp., 118 F.T.C. 1030, 1123 (1994).

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Types of Claims & Risks

1) Disease Claims 2) Unsubstantiated Claims

• f Effectiveness

3) Fair Balance / Omission of Risk Information 4) Unsubstantiated Superiority Claims 5) Consumer Testimonials

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Enforcement Action and Mitigating Risk

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Avoiding FDA Enforcement Action

• Untitled Letter
• Warning Letter
• Seizure
• Injunction
• License Revocation
• Criminal Penalty
• Civil Money Penalty
• Disgorgement of Profits

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How Does FDA Find Out About Violations?

• Inspections
• Random Sampling
• Adverse Event Reports
• International Cooperation
• Trade Complaints by Competitors

IP Portfolio Protection

Rahul Pathak, Ph.D. J.D. rahul.pathak@squiresanders.com

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Patentability - Outline

• Patents are awarded to subject matter that is:
• Patentable subject matter
• Useful
• Novel
• Non-obvious
• Described and enabled

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Patentable Subject Matter

• Categories
• Processes, machines, manufactures, compositions of matter

– Excludes

» Transitory signals » Naturally occurring organisms » Human beings

• Exceptions
• Laws of nature, physical phenomena, abstract ideas
• Unless

– Practical application of an exception

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Useful Subject Matter

• Criteria
• Credible

– Accepted by one of ordinary skill in the art

• Specific

– Specific to subject matter claimed, not to class of the invention

• Substantial

– Real world use

• Examples
• Treating or preventing microbial infection
• DNA fragment
• Uncharacterized protein
• Isolated protein for treating Alzheimer’s disease

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Novel Subject Matter – Effective March 16

• All elements of subject matter are not in the prior art
• Prior art
• All patents, printed publications, public uses, on sale, or available to

the public

– Before filing date of patent application

• All patents and published patent applications by another worldwide

– With earlier effective filing dates – “Worldwide” differs from EP practice

• Exceptions
• Disclosure by or from inventor within one year of filing
• Commonly owned patents and patent applications
• Both differ from EP practice

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Non-Obvious Subject Matter – March 16

• Differences between the claimed invention and the prior art
• Claimed invention as a whole would have been non-obvious to a

person of ordinary skill in the art

• Substantial differences from prior art
• Insubstantial differences, with evidence of unexpected results
• Prior art includes patent applications earlier filed
• Differs from EP practice

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Patent Application

• Claims, claims, claims
• Detailed description
• How to make and use the invention
• Best mode

– Differs from EP practice

• Drawings
• Optional

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Patent Examination

• Subject matter
• Utility
• Novelty
• Non-obviousness
• Often contentious
• Description and enablement
• Also often contentious

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Post-Grant Proceedings – March 16

• Ex parte reexamination
• Post grant review
• Novelty, obviousness, written description, enablement, indefiniteness,

subject matter

• Trial at the Patent Trial and Appeal Board
• 12-18 months
• Inter partes review
• Prior patents or printed publications
• Trial at the Patent Trial and Appeal Board
• 12-18 months
• Transitional program for covered business methods
• Method or apparatus for data processing

– Except for technological inventions

• May be filed by party charged with infringement
• Any grounds of unpatentability

Dynamics of the Research and Development / Clinical Trials Market in the US

Maureen Bennett maureen.bennett@squiresanders.com

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Dynamics of US R&D/Clinical Trials

• Global Dynamics
• Continued Impact of Patent Cliffs
• Continued Impact of Health Care Reform/Pricing Pressures
• Consolidation of In-house R&D resources
• Increased in Industry Joint Development Programs
• Increased outsourcing to CROs/AROs/Specialty Providers
• Variable availability of capital from financial markets
• Variable Availability of Government Funding/NIH in the US

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Dynamics of US R&D/Clinical Trials

• New Models of Innovation
• Transcelerate
• Industry/AMC Broad Collaboration Platforms
• Target Validation Consortium
• State Programs
• Personalized Medicine/Unmet Needs
• Social Media Recruitment

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Dynamics of US R&D/Clinical Trials

• Recent US Regulatory Developments Affecting Clinical Trials
• New HITECH Regulation-Flexibility in Authorizing Future Research
• FDA Approval of Remote Clinical Trial Monitoring
• HHS Consideration of Centralized IRBs
• FDA Final Guidance re: Financial Disclosures
• Physician Payment in the Sunshine Act

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Dynamics of US R&D/Clinical Trials

• Negotiating Clinical Trial Agreements with US

AMCs/hospitals/physician practices

• Contrast with UK System
• No model agreements like NHS Trust
• Variation in budget formats
• IRBs
• No regulatory requirement for insurance, but…
• Indemnity negotiations
• PI Oversight Issues

For questions regarding CLE credit, please contact:

Robin Hallagan robin.hallagan@squiresanders.com

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Worldwide Locations

• Cincinnati
• Cleveland
• Columbus
• Houston
• Los Angeles
• Miami
• New York
• Northern Virginia
• Palo Alto
• Phoenix
• San Francisco
• Tampa
• Washington DC
• West Palm Beach
• Bogotá+
• Buenos Aires+
• Caracas+
• La Paz+
• Lima+
• Panamá+
• Santiago+
• Santo Domingo
• Beirut+
• Berlin
• Birmingham
• Bratislava
• Brussels
• Bucharest+
• Budapest
• Frankfurt
• Kyiv
• Leeds
• London
• Madrid
• Manchester
• Moscow
• Paris
• Prague
• Riyadh
• Warsaw
• Beijing
• Hong Kong
• Perth
• Seoul
• Shanghai
• Singapore
• Sydney
• Tokyo

North America Latin America Europe & Middle East Asia Pacific

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