Hatch-Waxman and BPCIA

Rx Drugs (new drugs)

• Identifying the application process for the approval of a new drug, i.e., small molecule, new chemical entities, etc.
• NDA (New Drug Application): definition, contents and regulatory overview
• INDA (Investigational New Drug Application) aka “IND”
  • How does it differ from an NDA?
• Accelerated approvals  
  • Defining eligibility criteria for accelerated approval and priority reviews
  • What portions of approval submissions might FDA release and when?
• Using advisory committees in the approval process

Biologics

• How does the approval process for a biologic differ from that of a drug?
• BLA (Biological Licensing Application): application and filing  
  • How does a biologic differ from a drug?
  • Which products require BLAs instead of NDAs?
• Why is it a “license,” rather than an “approved application”?

Patent Protections for Drug and Biologics

• Summarizing the patenting process for drugs and biologics
• Strategies for building patent protection for drugs and biologics
• Applying for and achieving extension of patent term for time spent in the drug approval process
• Patent Term Extension (“PTE”) / Patent Term Adjustment (“PTA”) synopsis
• Reviewing the 271(e)(1) “safe harbor” provision
• Distinguishing the patenting process for drugs from that of biologics

Trademark, Trade Name, and Trade Dress Protections

• Overview of selecting a brand name for a proposed drug product
• Roles of the USPTO and FDA in the drug naming process
• Identifying the PTO and FDA clearances necessary for trade name/trademark approval on your product
• Understanding the importance of trade dress
• How does the branding process work for your product

• What is the Orange Book, what does it contain, and why is it orange?  
  • FDA’s publication on Approved Drug Products with Therapeutic Equivalence Evaluations
• Understanding the role of Orange Book listings in patent life cycle management and patent portfolio management
• Exploring the continuing dilemma of which patents should be listed, delisted, and held in reserve
• Examining the FDA’s position on not listing a patent
• Understanding the FTC’s new de-listing authority
• Overcoming challenges associated with listing patented information in the product label and indications discovered in clinical testing
• Incorporating long term patent listing strategies into label negotiations with FDA
• Examining the skinny labeling and carve–out conundrum
• Assessing the scope of potential Orange Book listing controversies relative to:  
  • Device patents
  • Product-by-process claims
  • Metabolites; polymorphs; intermediates
  • Patents on unapproved uses

• Overview of Hatch-Waxman and reforms
• Comparing the NDA, 505(b)(2), and ANDA (Abbreviated New Drug Application) drug approval routes
• Reviewing fundamentals of applications
• Examining ANDA Standards for approval and the concepts of sameness and bioequivalence
• Special considerations: local acting drugs, labeling carve outs and other nuances
• Understanding the role of the Orange Book in the drug approval process
• Listings, de-listings and use codes
• Market exclusivities and protection
• Identifying the different types of exclusivities
• Regulatory exclusivity (FDA)/ (data) exclusivity
  • NCE (new chemical entity)
• 5 years data exclusivity  
  • Indication (new indication or use)
• 3 years marketing exclusivity  
  • NDF (new dosage formulation)
  • ODE (orphan drug exclusivity)
  • PED (pediatric exclusivity)

• Exploring the ANDA Paragraph IV Certification, and response to Notice Letters
  • Pre-suit considerations
  • Initial pleadings
  • Multiple ANDA filers
  • Declaratory judgments
• Typical Paragraph IV litigation scenarios -hypotheticals
• 30-month stay; patent extensions; ANDA filer exclusivity (180 day)
• Preparing for parallel litigation before the PTAB  
  • IPR overview
• Hot buttons in Hatch-Waxman litigation  
  • Settlements
  • Damages
• Double-patenting

• Overview of biosimilar legislation and regulations, i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA)
• Understanding the rationale for safety and efficacy concerns surrounding second generation biologics or aBLAs
• Exploring the concepts of “biosimilarity” or “interchangeability”
• FDA rulemaking and guidance relative to biosimilars
• Other points for consideration: substitution, naming, patents, and additional nuances
• The Purple Book: What is the book and what does it contain?
• FDA’s interpretation of what is included in the list
• Understand the obligations of Reference Product sponsors under Section 325 (“Biological Product Patent Transparency”), ‘The Purple Book Act’
• Evaluating how new requirements of including patent information will impact the ‘patent dance’
  
• Examining biosimilar exclusivities

• Deciding when to provide notice of commercial marketing
• Addressing contentions and controversies in the aBLA information exchange
• Understanding how biosimilar applicants can command the stride of litigation under the BPCIA
• Evaluating what is “manufacturing information”
• Appreciating the limitations on declaratory judgment actions
• Analyzing the biosimilar and innovator perspectives when deciding whether to dance

• Defining bioequivalence in drugs and biologics  
  • Drugs v. biologics
• What an ANDA-filer must demonstrate for bioequivalence?  
  • Bioequivalence and dosage form – oral tablet/capsule, injection, nasal sprays, topical, nasal sprays
  • Same active ingredient
• What must the aBLA filer demonstrate?  
  • Exploring bioequivalency with biosimilars
• Defining interchangeability and understanding how it relates to bioequivalency
• Determining interchangeability for biosimilars
• How does bioequivalence relate to patents?  
  • Patenting of bioequivalence characteristics – extended-release drug products
  • Bioequivalence v. Doctrine of Equivalents – what is the difference?
  • Arguments about bioequivalence raised in Paragraph IV patent litigation
  • Infringement, copying (non-obviousness)

• Understanding 180-day generic market exclusivity under the Hatch-Waxman Act  
  • What are the qualifying criteria for exclusivity?
• How can an ANDA applicant really determine who is “first-to-file” and win 180 –day exclusivity?
• Identifying triggers for the running of the 180-day exclusivity period
• Deciphering the FDA’s new interpretation of pre- and post- MMA 180 day exclusivity  
  • What are the implications of this interpretation for products having ANDA’s filed prior to the enactment of the MMA?
• Exploring the interplay between the 30-month stay and 180-day exclusivity
• Forfeiture provisions: identifying circumstances under which exclusivity is forfeited  
  • Other circumstances that may trigger the loss of 180-day exclusivity
• When can the 180-day exclusivity period be transferred to another ANDA applicant?
• Evaluating when the 180-day exclusivity period can be relinquished, and exploring the consequences defining “shared exclusivity”

• Understanding which drug products are eligible for regulatory exclusivity  
  • Small biologics v. biologics
• The different modes and methods of regulatory exclusivity (non-patent)
• NCE (new chemical entity): 5 years marketing exclusivity/5 years data exclusivity
• indication (new indication or use): 3 years marketing exclusivity
• NDF (new dosage formulation)
• ODE (orphan drug exclusivity)
• PED (pediatric exclusivity)
• FD&C 505b2 (alternate pathway to ANDA) a/k/a paper NDA
• What role does the FDA play in regulating these modes of exclusivity?
• When are each of these methods sought?
• Using trade dress as means of exclusivity

• Exploring the safe harbor of the Hatch-Waxman Act 35 USC § 271(e)(1)
• Understanding the safe harbor’s scope of protection for otherwise infringing activities
• Examining the safe harbor protections afforded to research tool patents
• Identifying safe harbor protections relative to:
  • Basic R&D
  • New product screening
  • Optimization
  • Pre-clinical testing
  • Post-approval testing

• Extension of patent term under 35 U.S.C. § 156 and 37 CFR 1.710 – 1.791
• Exploring the viability of extension applications to:  
  • Basic and combination compounds; secondary patents
• Important benchmarks in the drug’s development and patent timelines
• Eligibility for patent term extension
• Regulatory review period determinations
• How to calculate the patent term restored
  • Respective roles of the FDA and PTO in granting patent extensions
  • Third-party challenges — “diligence”
• Patent term extensions outside the U.S.
• Examining patent term adjustment due to delays in prosecution before the USPTO   
  • Strategies for:  
    • Diligence in prosecution by the patent applicant
    • Calculating the adjustment period
• Understanding the link between patent extensions and exclusivity  
  • Extensions obtained through FDA Pediatric Exclusivity and Orphan Drug Exclusivity
• Obtaining patent coverage for pharmaceuticals using second-generation patents, e.g.,  
  • Maintaining patent position for second-generation products
  • Approaches taken by pharmaceutical companies in obtaining second-generation patents
  • Enforcement of second-generation patents