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 !