This generally deals with ANDA litigation in United states with Paragraph iv litigation generally. It also emphasizes on Cost involved in ANDA litigation with different methods for reducing the cost.and how many million or billion at stake when Generic and Branded drugs. It also covers the litigation part of District New Jersey that how and in what manner litigation with respect to Hatch-waxman act an is done along with the timelines and CAFC timelines.

1. PRESENTED BY: VIKRAM JEET SINGH 1
ANDA LITIGATION

2. Main Topics
• INTRODUCTION TO HATCH-WAXMAN ACT
• HISTORY
• TIMELINE
• HATCH-WAXMAN LITIGATION
• LITIGATION STEPS/PROCESS
• LOCAL PATENT RULES OF NEW JERSEY DISTRCIT COURT
• LOCAL PATENT RULES FOR HATCH-WAXMAN LITIGATION
• LITIGATION COST
• MEANS TO REDUCE LITIGATION COST
2

3. INTRODUCTION TO HATCH-WAXMAN ACT
• The Drug Price Competition and Patent Term Restoration Act 1984 (Hatch-Waxman Act).
The main purpose of this act was to:
– Strike a balance between two potentially competing policy interests which includes
pioneering development of pharmaceutical formulations and
– methods and facilitating efficient transition to a market with low cost, generic copies
of those pioneering inventions at the close of patent term.
3

4. HISTORY
• Late 1950s and early 1960s, thalidomide significantly increased the risk of birth defects.
• This scare Led to amendment in Food, Drug and Cosmetic act (FDCA) in year 1962 as before 1962, new drugs
were approved on basis of safety only.
• This amendment require all new drugs to be proven safe and effective prior to get approval from FDA.
• Proof of efficacy was made compulsory for marketing approval of a new drug based on Kefauver-Harris
amendments.
• Generic drug manufactures saw this as a discouraging entry
• Branded drug manufacturers pushed for additional protection against the entry by the manufacturers.
• In 1978, movement of Patent term restoration Started:
– to compensate for the time lost in review by extending the patent term.
• By 1983, debate over Drug price Competition act and patent term restoration raged in congress.
• In 1984, the Hatch-Waxman act was passed.
4

5. HATCH-WAXMAN ACT ENCOURAGES
– Manufacture of generic drugs by the pharmaceutical industry;
– Provide period of patent and marketing exclusivity to brand (innovator) drug
manufacturers to enable them to regain investment in drug development;
– established the modern system of government generic drug regulation;
– Provide consumers with benefit of rapid availability of lower priced generic versions
of innovator drugs.
– A unique patent litigation process triggered by a generic drug company’s submission
of an application for FDA approval.
5

6. DRUG APPROVAL
• FDA requires every new drug, including generic drugs, to be safe and effective which is
written in (21 U.S.C. § 355(a)) where it is written:
– “No person shall introduce or deliver for introduction into interstate commerce any
new drug, unless an approval of an application filed pursuant to subsection (b) or (j) of
this section is effective with respect to such drug”.
6

7. CHANGES BROUGHT BY HATCH-WAXMAN ACT
• For Branded Drug Manufacturer:
1. Patent term extension (35 USC 156).
2. 30-month stay (automatic injunction) – Orange Book listing.
3. ANDA filing - act of infringement (35 USC § 271(e)(2)).
• For Generic Drug Manufacture:
1. Use of safety and efficacy data developed by brands.
2. “Safe harbor” for bioequivalence test (35 USC § 271(e)(1)).
3. 180-day exclusivity to a first successful generic challenger.
7

8. CHANGES BROUGHT BY HATCH-WAXMAN ACT
• Term Extension
• Safe Harbor Provision: Allowed generics to perform the experiments and clinical
testing required for FDA approval prior to the patent’s expiration.
– Case Law: Roche v. Bolar Pharmaceuticals
• Exclusivity Periods: Exclusivity is exclusive marketing rights (EMR) granted by
the FDA upon approval of a drug and can run concurrently with a patent or not.
8

9. Orphan Drug Exclusivity (ODE) – Exclusive rights up to 7 years
• Bars FDA from approving any other application (ANDA, 505(b)(2) or “full”
NDA or BLA) for the same drug for the same orphan disease or condition for
seven years.
New Chemical Exclusivity (NCE) - 5 years
• Bars FDA from accepting for review any ANDA or 505(b)(2) application for a
drug containing the same active moiety for:
• four years if an ANDA or 505(b)(2) is submitted containing a paragraph IV
certification to a listed patent
Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity
9

10. NDA (New Drug Application) and ANDA (Abbreviated New Drug
Application
NDA
• Branded Drug
• enough evidence on the drug's safety and
effectiveness has obtained, to meet the
FDA's requirements for marketing
approval.
• Branded manufacturer contact the FDA
and demonstrate that the new drug has a
particular quality and that the drug is safe
and effective.
• review is divided into sections on medical
analysis, chemistry, clinical pharmacology,
bio-pharmaceutics, pharmacology,
statistics, and microbiology
ANDA
• Generic Drug
• not required to include preclinical
(animal) and clinical (human) data to
establish safety and effectiveness.
• Generic applicant must scientifically
demonstrate that its product is
bioequivalent (i.e., performs in the same
manner as the original drug).
10

11. HATCH-WAXMAN ACT PROVISIONS
• Section 505 (j), which establishes the ANDA approval process.
• Four types of patent certifications:
– patent information has not been submitted to FDA called as "Paragraph I
Certification";
– That the patent has expired and called as "Paragraph II Certification";
– The date on which the patent will expire and called as "Paragraph III
Certification"; or
– Patent is invalid, unenforceable, or will not be infringed by the manufacture,
use, or sale of the drug product for which the abbreviated application is
submitted. The applicant shall entitle such a certification "Paragraph IV
Certification".
11

12. HATCH-WAXMAN LITIGATION
12

13. Hatch-Waxman Litigations (ANDA Litigation)
This includes:
• Patent litigation between brand name (innovator drug or
Blockbuster drug) and generic pharmaceutical companies.
• Fight between pharmaceutical company’s both innovator and
generic over the market for big-selling pharmaceutical products.
13

14. ADVANTAGES AND DISADVANTAGES OF HATCH-WAXMAN LITIGATION
• Litigation Incentives for Generic Firms:
– 180 days exclusivity
• Litigation Incentives for Innovator Firms: Innovator drug firms have little
to gain, and everything to lose.
– For example, Eli Lilly’s blockbuster drug Prozac generates
approximately $2 billion per year (i.e., $5.5 million per day)
– Barr’s filed a paragraph IV certification against Prozac patent
portfolio.
– Barr Laboratories successfully challenged the Prozac patent portfolio,
Eli Lilly’s stock price dropped by more than 30% in a single day.
14

15. LITIGATION STEPS/PROCESS & TIMELINES
• Fact discovery
▪ Document discovery,
 electronic discovery
▪ Depositions
• Expert discovery
• Summary Judgment
• Trial
15
Settlement between
parties can happen at
any time during
litigation process.

16. HATCH-WAXMAN LITIGATION ≠ NORMAL INFRINGEMENT SUIT
HATCH-WAXMAN LITIGATION
• No real act of infringement.
• No manufacturing or sale of accused
product.
• 30 month long time gap is there to
decide a case whether generic drug
manufacturer is infringing the
product or not.
• Jurisdiction is also an important
criterion for this. US district courts
are still not clear on this whether
jurisdiction in general or personal.
NORMAL INFRINGEMENT SUIT
• Infringement took place.
• Product is manufactured an as well
as available in market.
• Not time specified in any legislation
for civil suit
• Jurisdiction in civil suit is related
where the appellant is residing or
working at the time an action is
commenced.
• Personal jurisdiction exists in a
patent infringement case
16

17. TIMELINE OF PARAGRAPH IV LITIGATION
17

18. ANDA applicant files one or
more generics ANDA
application.
Within 20 days of the postmark on
the letter issued by FDA describing
acceptance of ANDA for review , the
generic drug firm must notify the
innovator drug firm of its application
Along with this notice, the
generic drug firm must
outline the basis for its
belief that the patent is
invalid or not
Generic drug filer is
also required to
make a confidential
offer of access to its
ANDA
Within 45 days of
receiving the generic’s
notice, the innovator
drug firm must file a
patent infringement
action if it wants the
advantage of the
thirty-month automatic
stay
18

19. NOTICE OF CERTIFICATION OF INVALIDITY OR NON-INFRINGEMENT OF A PATENT (21 CFR 314.95 )
Notice Letter
following FDA’s
Acceptance of
ANDA
which Includes Patent is invalid,
unenforceable, or
will not be
infringed,
Name and address of
the patent owner or
its representative
may be obtained
from the USPTO
PO
resides
in US
Name and Address of
the application holder or
its attorney, agent, or
authorized official may
be obtained from the
Orange Book Staff
PO not
resides
in US
Sending the notice
• FDA an acknowledgment
letter stating that its ANDA
is sufficiently complete to
permit a substantive review
• At the same time, the
applicant shall amend its
ANDA to include a
statement certifying that
the notice has been
provided to each person
• statement that FDA has
received an ANDA.
• application number
• Name of proposed drug
product
• active ingredient, strength,
and dosage form
• patent number and expiration
date
• detailed statement why the
claim is not infringed
• name and address of an agent
applicant shall include a copy of the
return receipt or other similar
evidence of the date the
notification was received
• FDA will presume the notice to be
complete and sufficient,
• will count the day following the
date of receipt of the notice by
the patent owner or its
representative 19

20. EXTENSIVE PATHWAY OF HATCH–WAXMAN LITIGATION
20

21. 21

22. THE LOCAL PATENT RULES FOR THE
DISTRICT OF NEW JERSEY: “THE RULES
• General provisions (Rules 2.1 – 2.4)
• Patent disclosures (Rules 3.1 - 3.5)
– Rule 3.1 - 3.4 - Infringement/Invalidity Contentions
– Rule 3.5 – Declaratory Judgment Cases
• Rule 3.6 - Hatch – Waxman Cases
• Rule 3.7 - Amendments to Disclosures
• Rule 3.8 - Advice of Counsel
• Rule 4 - Claim Construction Procedures
– Claim construction Issues (Rules 4.1 – 4.6)
22

23. Initial
Scheduling
conference
(ISC)
Disclosure of
Asserted claims and
infringement
contentions (DACIC)
Within
14 days
With DACIC party shall
file Document production
Accompanying Disclosure
Within 45 Days
of DACICServe a notice of Non-
infringement Contentions and
responses (NICR)
Invalidity
contentions (InvC)
Within
14 days
of InvC
Responses
to InvCWithin 14
days
Within 45
days of NICR
when validity
is not an
issue
Each Party shall serve on
each other party a list of
Claim terms construed by
Court
Exchange of Proposed Terms
for Construction
Party files a Complaint or
DJ not based on InvC
With in 14 days
after a party files
a Answer
Party Asserting
Patent Infringement
(NDA holder)
Send
23

24. Exchange of Proposed term
for construction
Within 21
days after
exchange of
lists
Exchange
Preliminary
Proposed
Construction (PPC)
Parties exchange their
respective “PCC” each
party shall also identify
all intrinsic evidence
Preliminary Claim
Construction
(PCC)
Within 14 days
of exchange of
PCC
Parties shall exchange
identification of all
evidence i.e. intrinsic
and extrinsic
Parties can meet and
confer purpose of
narrowing and resolving
issue and finalizing JCCPS
Preparation of Joint
Claim Construction and
Prehearing Statement
(JCCPS)
Within 30
days of
PCC
Complete and
file Joint Claim
Construction
and Prehearing
Statement
(JCCPS)
Complete All discover
related Claim
Construction
Within
30 days
24

25. After
Filing
JCCPS
File and serve their
opening Markman
briefs and any
evidence (OMS)
Within 45 days
of JCCPS
Declaration must be
concluded if given by
expert witness
Within 30
days of
OMS
File and serve
responding
Markman
Briefs (MB)
Within 60
days of
OMS
Counsel shall confer and
propose to court for Claim
Construction hearing (CCH)
Within two Weeks
of Submission of
MB
Summary
Judgment
Pre-Trial
Submission
TRIALPost trial
Hearing
Court
Decision/Beginning
of Appeal Process
CAFC Decision
Claim
construction
order by
court
25

26. HATCH-WAXMAN (LOCAL PATENT RULES)
26

27. • Each party who is an ANDA filer shall produce to each party asserting patent infringement the entire
ANDA or NDA.
• ISC serve on all parties a “Disclosure of Asserted Claims”.
• ISC shall provide written basis for its “Invalidity Contentions (InvC)” with all
disclosures.
• “Invalidity Contentions (InvC)” shall be accompanied by the production of documents.
• InvC Response to invalidity contentions must be served.
• ISC provides written basis for its “Non-Infringement Contentions” (NIC).
Within 7 Days
Within 14 days
27

28. • Non-Infringement Contentions shall be accompanied by the production of any document.
• NIC NDA filer must provide each opposing party with a “Disclosure
of Infringement Contentions” (DACIC).
• DACIC must be enclosed with documents.
• ANDA Applicant Notify the FDA of any and all motions for injunctive
relief after the date on which such a motion is filed
• When privilege is claimed for request of documents , ANDA Applicant
whose application is pending with FDA provide a copy of all correspondence
between itself and FDA to NDA applicant
Within 07 days
28

29. MODIFICATION OF LOCAL PATENT RULES
• Court may modify the obligations or deadlines.
• Based on the circumstances of any particular case, including,
without limitation, the simplicity or complexity of the case as shown
by the patents, claims, products, or parties involved.
29

30. PRETRIAL SUBMISSIONS
• Most common type of pretrial motion is the motion in limine.
• seeks to exclude certain evidence or arguments at trial on the grounds that the
evidence is irrelevant, prejudicial, likely to confuse the jury, or otherwise
improper
• Common motions in limine include motions to preclude:
– undisclosed or belatedly disclosed prior art,
– an expert from offering opinions not disclosed in expert reports, and
– evidence that the accused infringer has its own patents.
30

31. TRIAL
• Single most important event.
• Time constraint is there for judges as well as patent trial lawyer also.
• Patent and ANDA case litigation are most commonly same.
• The trial lawyer must have thorough mastery of technical knowledge of case
as well complexities of law related to patent.
31

32. Timeline During Trial
• How trails are planned?
• How trial is conducted including opening statements?
• The order of proof
• Examination of fact
• Expert witness
• Presentation of documentary
• Physical evidence
• Trial motions
• Closing arguments
32

33. AFTER TRIAL
• Decision: May take up-to 06 to 16 months
• Post-trial Motions
– Motion for Pre-trial
• Appeal: Within 30 days after the entry of a final
judgment, file a notice of appeal with the district
court .
33

34. SETTLEMENTS AFTER TRIAL
• Settlements are possible at any time, but are more common after
district court trial.
• Terms of settlement may include:
– Generic API supply to patentee/NDA holder
– Agreements to toll exclusivity and to license upon market
entry (“authorized generics”)
• Co-promotion agreements
34

35. REVIEW OF SETTLEMENT AGREEMENTS
• Under 2003 changes in the law, the following must reviewed by the FTC and the
DOJ (Department of Justice):
– Agreements between ANDA Paragraph IV filer and Brand Company
regarding:
(i) Manufacture, marketing or sale of brand name drug or generic drug or
(Ii) 180-day exclusivity period
• Agreements between multiple ANDA Paragraph IV filers regarding 180- day
exclusivity
• Agreements must be filed by each party prior to a first commercial marketing of
a drug and within 10 business days of execution.
35

36. FEDERAL CIRCUIT PROCEDURE
Within of : CAFC dockets the case
Appellant’s opening brief due
Appellee’s responsive brief due
Appellant’s reply brief due
Joint Appendix due
an oral argument will be scheduled
Oral arguments are usually 30 minutes per case, 15
minutes per side
After oral argument, a decision, if published and
precedential, usually issues in 6-12 months
Filing notice of
appeal7-10 days
Within 60 days of docketing:
Within 40 days of service of opening brief
Within 14 days of service of responsive
brief
Within 7 days of service of reply brief
Within 3-4 months of filing Joint Appendix
(CAFC’s stated goal is 3 months of
oral argument) 36

37. LITIGATION COST
37

38. • Bear their own litigation cost. This is a thumb rule.
• Court costs include fees for the clerk of the court, court reporters, witnesses,
copying, and translation.
• In this case involved Levaquin® (levofloxacin) and was filed back in 2002 in
West Virginia.
– After three years of litigation, the District Court and Court of Appeals
concluded that the patent at issue was valid and infringed.
– The prevailing party Daiichi asked the Court to award court costs of $2.2M,
and after reducing part of the request, the Court granted Daiichi an award
of court costs of $1.3M.
38

39. LITIGATION COST AT EVERY STAGE
• Discovery (Costliest part)
– Strategy and preparation
– Case Starts
– Document request and Production
• Interrogatories
– Expert Discovery
• Depositions
• Subpoenas of Third parties
E-Discovery
39

40. E-discovery
Sr. No. Document type (Storage) Quantity (Pages)
1 1 Megabyte (MB Averages 75 pages
2 1 Gigabyte (GB Averages 75,000 pages
3 1 Terabyte (TB) Averages 75,000,000 pages
4 Email Averages 1-2 pages each
5 Word Processing Averages 5-8 pages each
6 Spreadsheets Averages 15-30 pages each
7 Presentation Averages 12-24 pages each
8 Graphic Averages 1 page each
9 Adobe PDF Averages 35 pages each
10 CD (640 MB – 800 MB) Averages 48,000-64,000 pages
11 DVD (4.7 GB – 17 GB) Averages 350,000-1.3 million pages
12 Fire-wire USB “flash” drive (120 GB) Averages 10,500,000 pages
13 Hard Drive (20 GB and over) Over 1.5 million pages
14 Back-up Tape (200 GB compressed) Approximately 17,500,000 pages 40

41. HOW TO REDUCE DISCOVERY COST?
• Estimate volume of electronic and paper discovery.
– search documents,
– research documents,
– drug development documents,
– compositions,
– preclinical studies data, and
– clinical studies data
THIS ALL REQUIRED HUGE AMOUNT OF STORAGE DEVICE.
• Identify potential vendors to handle discovery.
– Potential vendor who can handle this large bulk amount of data.
– In-experienced vendor, which may lead to lose the case.
• Contract attorneys for document review
– Contract attorneys are best person to asses the data as they are
experienced.
41

42. ATTORNEY FEES
In 35 U.S. Code § 285, “The court in exceptional cases may award reasonable
attorney fees to the prevailing party.”
In this case involving Actos®(pioglitazone), Takeda prevailed in a case
against two ANDA filers, and the district court awarded $16.8M worth of
attorney fees, expert fees, and expenses.
U.S. follow what is sometimes called the “American Rule.” The American Rule
calls for each party in a lawsuit win or lose, to pay for their own attorney fees.
42

43. HOW MANY MILLIONS ARE AT STAKE?
PART OF TIMELINE YEAR
2005 2011
Less than $ 1 million at risk End of Discovery
$350,000 $350,000
All cost
$850,000 $650,000
$1 to $25 million at risk End of Discovery
$1.25 million $1.5 million
All cost
$2 million $2.5 million
More than $25 million at risk End of Discovery
$3 million $3 million
All cost
$4.5 million $5 million
43

44. Patent Infringement (all varieties)
Amount in Controversy End of Discovery Through Trial
< $1M $530K $970K
$1M-$10M $1.2M $2.1M
$1M-$25M $1.7M $2.8M
$10M-$25M $2.2M $3.6M
>$25M $3.6M $5.9M
44

45. Patent (defending against NPEs (non-
practicing entities))
Amount in Controversy End of Discovery Through Trial
< $1M $516K $820K
$1M-$10M $988K $1.6M
$1M-$25M $1.3M $2.0M
$10M-$25M $1.7M $2.7M
>$25M $2.9M $4.4M
45

46. HOW TO REDUCE LITIGATION COST?
46

47. MAIN PURPOSE OF EVERY CLIENT IS TO MAINTAIN
• Efficiency
• Cost predictability
• Transparency
• Targeted advice
• Increased use of Alternative Fee Arrangements
• Value
47

48. Alternative Fee Arrangements (AFA) for Paragraph IV Litigation
• Patent cliff
• Generic pharmaceutical companies are looking for ways to save
costs as profit is less.
What needs to be consider in AFA?
• Financial risk of the litigation
• What is the advantage to client?
• Advantage to Law firm?
48

49. Hourly Fee
Arrangement
Blended Rate Fee
Arrangement
Success Fee Partial Contingency
Arrangement
Straight Contingency
Fee
Definition Law firm bills the
client for each hour
of time
Law firm agrees
to bill every
attorney at the
same rate.
Attorneys bill only a
fraction of their hourly
fees, foregoing their full
hourly fee.
Similar to a success
fee arrangement
except that the
reward is some
percentage of the
recovery in the
litigation
Law firm
essentially works
for free and takes
a percentage of
the recovery if
they are successful
Who will bear
Financial Risk?
Law firm bears no
financial risk in the
litigation. entire
risk of the litigation
is borne by the
client
The law firm risks a
percentage of its actual
fees and the reward is a
multiplier of those
deferred fees at the
end of the litigation.
(more financial risk)
the law firm bears
some risk of losing
and, therefore, if
the law firm is
successful, it shares
in the profits of
that success
the law firm bears
almost the entire
financial risk of the
litigation and that
does not come
without a cost.
Popularity Not well-used or
popular
Advantage to
client
Actual legal bills are
less
the out-of-pocket
costs of the
litigation are less
Advantage of
costing the client
very little money
Disadvantage it is often difficult
to control costs
If the law firm is
successful, the
client will pay more
in compensation to
the law firm.
a large portion of
the recovery goes
to the law firm
49

50. Number of ANDA Cases filed per year
203
218
261
291 294
239
264
432
0
50
100
150
200
250
300
350
400
450
500
2007 2008 2009 2010 2011 2012 2013 2014
Total
Total
50

51. CONCLUSION
• Generic Market is increasing day-by-day.
• Local Patent rules are paradise for Hatch-Waxman
litigation.
• Number of litigation increasing per year.
• Discovery Cost is also increasing.
51

52. 52

53. 53

54. ADDRESS for Communication
Name- Vikram Jeet Singh
Address: Vikram Jeet Singh, B-403, Bhim Rao Ambedkar Hall of
Residence, IIT Kharagpur, Kharagpur, Paschim
Medinipur, Kolkata-Pincode-721302
Mobile number: +917076607759, +919582150890
Email-id: Vikramjeet790@gmail.com
54