Brief Overview of Hatch-Waxman Litigation
Presented at: CompanyMontreal, QC,
Date:
Presented by: Roy D. Gross
What This Presentation CoversqOverview of abbreviated regulatory pathways for drug
approvals under the Hatch-Waxman ActqBasics of Hatch-Waxman litigationsqTake Home Messages
Abbreviated Regulatory Pathways for Drug Approvals under the Hatch-
Waxman Act
Three Regulatory Pathways for Drug Approval Under the Hatch-Waxman Act
Preclinical, Clinical data, BA, PK-PD, etc.
Bridging studies as needed None
Reference listed drug (RLD) Similar drug Generic drugPatent Information Patent Information* NoneNone Referencing to RLD Referencing to RLDNone Patent Certification* Patent Certification*
None Para. IV Notice Letter Para. IV Notice Letter Exclusivity (typical 5 years)
Exclusivity(typical 3-5 years)
Exclusivity to a first filer (180 days)
Drug Approval Under FDC Act Hatch-Waxman Act of 1984
Abbreviated PathStandard Path
Std. NDA/505(b)(1) Paper NDA/505(b)(2) ANDA/505(j)
Basic Structure of the Hatch-Waxman Act>Orange Book Listings of NDA Drugs Containing:
>Market Exclusivity>Patents
Basic Structure of the Hatch-Waxman Act (cont’d)>Market Exclusivity – a first layer of protection to FDA-
approved products
New Chemical Entity 5 years
New Product (formulation or indication) 3 years
Orphan Drug designation 7 years
Pediatric Drug designation 6 months
Basic Structure of the Hatch-Waxman Act (cont’d)>Patents – a second layer of protection to FDA-Approved
Products>Expiration date can be found in the Orange Book>Calculations of a patent term can be complicated>Patent Term Extension – the patents terms of drug patents may be extended (up to 5 years) to compensate lost time in the FDA drug approval process
Basic Structure of the Hatch-Waxman Act (cont’d)>Patent Certification Requirements for all ANDA and
505(b)(2) Filers>Paragraph I, No Listed Patent
>Paragraph II, Patent has Expired
>Paragraph III, Will Wait for Patent to Expire
>Paragraph IV, Patent Not Valid or Not Infringed (and not enforceable)
>May Include “Section viii” Labeling Carve Out for Method of Treatment Patents
Basic Structure of the Hatch-Waxman Act (cont’d)
>Other Requirements Following Paragraph IV Certification>Notice Letter Sent to NDA and Patent Owners
>Last recipient of the Notice Letter triggers dates
>45 days for NDA and Patent Owner to Sue the Applicant
>If lawsuit filed, an automatic 30 Month Stay on Final FDA
Basic Structure of the Hatch-Waxman Act (cont’d)>Other Requirements (cont’d)
>Stay ends at the earlier of 30 months or when lawsuit is resolved
>Once stay ends before the lawsuit is over, Generic can launch “at risk.” NDA holders may:
>seek extension of the stay
>ask a 505(b)(2) or ANDA filer to give 6 months notice before launching product, or seek an injunction;
>seek money damages (profit, maybe attorney fees)
Basics of Hatch-Waxman Litigations
Facts about Hatch-Waxman Litigations>Hatch-Waxman cases are litigated in US district courts;
Different district courts have different local rules, which in turn may have separate patent litigation rules
>U.S. Court of Appeals for the Federal Circuit (“CAFC”) has a binding authority to a district court
>A district court decision is not binding to another district court
>New Jersey is one of the most popular jurisdictions for Hatch-Waxman litigations
Facts About Hatch-Waxman Litigation (cont’d)>Most cases settle
>The settlement can occur any time during the course of litigation
>If a loss occurs at trial, almost all losing parties appeal>The appeal court construes claims de novo. No deference to
the district court’s ruling
>If the patent at issue is being reexamined or subjected to Inter Parte Review at the USPTO, a district court may or may not stay a Hatch-Waxman case
Facts About Hatch-Waxman Litigation (cont'd)> Typical litigation costs include:
Attorney fees Deposition and hearing transcript fees
Court fees Legal research feesExpert fees Prior art search fees
Travel costs Fees for preparing exhibits for trials
Facts About Hatch-Waxman Litigation (cont'd)>Hatch Waxman litigation cost
>No good statistical information available
>For typical cases, between $1 million to $5 million
>Accurate estimate can be provided once the following information is known:
>Product - number of dosage forms
>Number of patents
>Number of experts needed
>District court rules
Hatch-Waxman Litigation Timeline
Notice Letter*
Complaint(start of litigation)
Answer,AffirmativeDefense, andCounterclaim
Plaintiff Answerto Counterclaim
SchedulingConference and Order
Fact and Expert Discovery*(longest –1.5 to 2 years)
(End of Discovery)MarkmanHearing*
SummaryJudgmentMotion*
PretrialConference
Trial
Appeal
(* Will be discussed later)
Notice Letter
>A Notice Letter to be served within 20 days after the filing of the application with FDA
>Important to develop your strategy when you file your ANDA or 505(b)(2) application
Notice Letter - Importance>Use of Certification and Notice Letters at Trial>Litigation arguments should be consistent with reasons
for non-infringement and invalidity given in Notice Letter>Inconsistency can be evidence of “bad faith”>“Bad faith” can result in Attorney Fees - exceptional
case>In Takeda v. Mylan, Mylan was found in bad faith and was
ordered to pay Takeda $17 million for the ANDA litigation
>Notice Letter can be evidence of non-willfulness infringement
Notice Letter (cont'd)
>Notice Letter to be sent to all NDA holders and patent owners or their representatives>Determining patent owners or representative can be tricky
>Timely send to anyone that you may think own the patents
>The 45 days and 30 months stay are triggered by the last recipient of the Notice Letter
Notice Letter (cont'd)
> Content of the Notice Letter>Detailed reasons why the patents are:
>Invalid
>Unenforceable
>Not infringed
>Offer of Confidential Access
Fact Discovery>Document production
>In U.S., each litigating party must produce relevant documents for discovery to the opposing party
>Applies even if some documents have unfavorable information
>Unrelated third parties may also be ordered to produce relevant documents
Fact Discovery (cont'd)>Exception: no need to produce if the documents are
protected by:>Attorney-Client (A-C) privilege, or>Work-Product (W-P) privilege
Fact Discovery (cont'd)>Document production includes information stored in an
electronic devices>Lawyers must review before sending to the other party
>To redact privilege information>To redact unrelated information
Fact Discovery (cont'd)>Practical tips:
>Keep one subject matter (i.e., one drug product) per an email (or per document), if possible
>Keep electronic files and documents organized or marked
>Makes it easy to isolate, search, and produce documents related only to the one drug product that is the subject of the lawsuit
>Be careful about what you put in writing about the brand’s product, whether it infringes/not, etc.
>Get lawyers involved earlier on:
>A-C and W-P privileges
Fact Discovery (cont'd)>Depositions
>Two types: >Corporate deposition (called 30(b)(6) deposition), and
>Fact witness deposition
>May need to travel to U.S. for depositions>Translators will be provided
Fact Discovery (cont'd)>Corporate deposition
>We can pick who will be deposed on behalf of the company
>Three types of topics:>Business decision regarding pursuing the ANDA or
505(b)(2) application - (business person may know this topic)
>Decision regarding how to formulate and develop the product - (R&D person may know this topic)
>Decision regarding regulatory filing of the ANDA or 505(b)(2) - (a regulatory person will know)
Expert Discovery>Retaining good experts is crucial>Experts submit an expert report, are deposed, and
testify at trial>Experts explain what claim terms mean to a person
having ordinary skill in the art
Markman Hearing>Unique to patent litigations>Held to determine the meaning of disputed claim
elements (claim construction) as a matter of law>Often use experts>The outcome can be critical to a patent litigation
Take Home Messages
>Involve Lawyers Early in Process>Be Prepared >Expect The Unexpected>There is Value in the Certainty of Settlement
Thank You !
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