54 • THE FEDERAL LAWYER • January/February 2015
The timing of an IPR request filing should be carefully analyzed vis-à-vis a particular defendant’s goals as well as risk tolerance. ANDA petitioners are not yet flocking towards IPR proceedings as an alternative or complement
to traditional ANDA litigation, but the waters have begun to be tested.
bY StephAnie e. o’bYrne
54 • THE FEDERAL LAWYER • January/february 2015
January/February 2015 • THE FEDERAL LAWYER • 55
IPRs and ANDA Litigation All a Matter of Timing
Competitor cases involving highly
profitable pharmaceutical products
are one of the most expensive vari-
eties of patent litigation. The average cost
through trial for Hatch-Waxman Act liti-
gation—patent infringement actions chal-
lenging a generic drug manufacturer’s filing
of an Abbreviated New Drug Application
(ANDA) with the Food and Drug Adminis-
tration—is in the $2.7 million to $4.5 mil-
lion range.1 Some practitioners have turned
to the new Inter Partes Review (IPR) pro-
cedure introduced by the America Invents
Act as one means of reducing or avoiding
the costs associated with ANDA litigation.The IPR procedure in general has proven to be tremendously
popular for other types of patent litigation. More than 1,400
IPR petitions have been filed with the Patent Trial and Appeals
Board (PTAB) of the U.S. Patent and Trademark Office to date,
with more than 100 petitions per month filed between April and
June 2014.2
An IPR offers undeniable cost advantages as compared
to traditional patent litigation. While data on counsel costs
for the new IPR procedures remain scarce, counsel costs for
comparable inter partes re-examinations (another procedure
before the patent office) through appeal are reported to average
$350,000 (in addition to request and post-institution fees total-
ing $23,000)—less than one-seventh the cost of a traditional
ANDA litigation through trial in the district courts.3 The cost
disparity is due in part to the limited nature of IPR, wherein the
validity of a patent may be challenged only on § 102 (anticipa-
tion) and 103 (obviousness) grounds with prior art patents and
printed publications.4
Despite these tremendous cost benefits, IPRs are rarely
utilized in ANDA cases. One reason is that both IPR and ANDA
litigation operate on very specific time lines. In an ANDA case,
the filing of the patent infringement action invokes a 30-month
stay on FDA approval of the ANDA.5 During this period, the
court is expected to hold trial in the action and issue its opinion
regarding infringement and validity. IPRs, on the other hand, are
required to proceed even more expeditiously. By statute, a deci-
sion on the petitioner’s request for an IPR must be made within
three months, and the patentee’s preliminary response is due
three months thereafter; the PTAB has one year from the date
of the institution of the IPR (with a possible six-month exten-
sion for good cause) to issue its written decision.6 Moreover, the
party bringing the IPR must institute it within 12 months of the
related district court case.7
56 • THE FEDERAL LAWYER • January/February 2015
Because of these time lines, IPRs may not always make sense in
ANDA cases. In many non-ANDA cases, one or both of the parties
will want to stay the litigation pending IPR to save litigation costs.
But in ANDA cases, the defendant ANDA applicant is generally
highly motivated to have the case decided as soon as possible so that
it may be permitted to market its product, if successful. Further,
some defendant ANDA applicants do not want to invalidate the
patent—they want to enter the market as a noninfringer but keep
other potential competitors out of the market. But in some situa-
tions, IPRs can be a good strategy for a defendant ANDA applicant
or hopeful ANDA applicant.
To that end, several IPR petitions have been filed on patents
involved in ANDA litigation. This article identifies several recent IPR
proceedings that were filed to accompany ANDA cases and analyzes
the IPR time lines vis-à-vis the concurrent district court litigation.
Timing ConsiderationsBoth the district court and PTAB are on expedited schedules to
issue decisions on patentability in drug cases. If running precisely
concurrently, there is only about a 12-month difference between the
decision deadline in an IPR (up to 18 months from institution) and
an ANDA case (30 months from filing suit). It has been suggested
that it can be advantageous for a generic drug company to file its
IPR early, before litigation begins, and even before the ANDA is filed
with the FDA.8 This would not only allow the possibility of settle-
ment before costly litigation but also avoid duplicative litigation on
the references already before the PTAB and allow a district court
the full 30 months to adjudicate the case should the patent claims
at issue survive IPR.
For a party seeking to invalidate a patent, an IPR has several
benefits when compared to district court litigation, including that
the standard of proof for invalidity before the PTAB (preponder-
ance of the evidence) is lower than that before the district court
(clear and convincing evidence).9 Taking the first shot under the
lower standard, however, comes at a high price. By reason of estop-
pel, an IPR requester cannot relitigate any ground of invalidity that
it raised or reasonably could have raised during the IPR in a subse-
quent civil action.10
By statute, a party that has been named in a civil action, e.g., an
ANDA defendant, may only file an IPR petition within 12 months of
the complaint in that action.11 Filing an IPR petition one year from
the initiation of suit may allow for counsel to vet the “best” patents
and printed publications for the IPR during the discovery process
in the civil case, test the patentee’s best validity arguments in
response to the asserted art, and in the best-case scenario, receive
guidance from the court itself all before the IPR request need be
filed. And even if the district court litigation moves quickly, the
PTAB is not bound by any decision by the court upholding the
patent’s validity, and the accused infringer can proceed to mount a
second challenge to the patent in the IPR with no estoppel consid-
erations—and under a lower standard of proof.
But filing an IPR after district court litigation is under way is
not without an opportunity cost. The client must elect to endure
the formidable expense of district court litigation, upon which the
cost of IPR will be layered, in addition to the cost of the appeals
stemming from both tracks. Moreover, under Fresenius USA Inc.
v. Baxter International Inc., a final decision of invalidity by the
PTAB, affirmed by the Federal Circuit, is immediately binding on
the district court.12 If filed at the same time, it is likely that the IPR
would reach the Federal Circuit first, potentially rendering moot the
district court’s decision.13
While a party to a civil action has a 12-month window in which to
file a petition for IPR, there is no deadline for generic drug companies
that have not yet filed an ANDA and provided a Paragraph IV notice
letter, i.e., triggered a Hatch-Waxman suit against them. In this regard,
a later market entrant has an option to wait out the patentee’s validity
defenses at trial, and potentially the district court’s decision, before
engaging the approval process.
Filing Strategies14
In reviewing recent IPRs on patents involved in ANDA litigation,15 it
is apparent that there has been no singular approach by generic drug
companies as to the timing of filing. It is possible, however, to illustrate
how the timing differences in filing IPRs have positioned generics vis-à-
vis contemporaneous litigation.
Filing an IPR petition early, before the 12-month deadline where
the IPR filer has been sued, gives the best possibility that the PTAB will
address validity before the court and, consequently, that the Federal
Circuit will decide the appeal from the PTAB first. This timing would
be most advantageous to an IPR filer securing an invalidity decision at
the PTAB under the lower burden of proof, because an affirmance by
the Federal Circuit would alleviate the burden of proving invalidity by
clear and convincing evidence in litigation. Yet in several cases, IPRs
have been requested by parties that have not been sued in the first
instance.
Several case examples illustrate that early IPR filings will result in a
first appeal from the PTAB. As a first example, an IPR request was filed
by Apotex Inc. days before the patent holder, Wyeth Holdings LLC,
asserted the patent in several litigations against ANDA filers seeking
approval for generic Tygacil®, an antibiotic medication. As the below
table demonstrates, the PTAB’s decision on Apotex Inc.’s IPR will issue
before the first court can try validity, months before the court can issue
Drug, Patents
WyethLLC
Tygacil®(antibiotic)
U.S.PatentNo.7,879,828
IPR/Lawsuit
ApotexInc.,IPRNo.2014-00115
InitiativeforResponsibilityinDrugPricingLLC,IPRNo.2014-01259
FreseniusKabiUSA,LLC,No.13-1893(D.Del.)
CFTPharmaceuti-calsLLC,No.14-781(D.Del.)andAurobindoPharmaLtd.andAurobindoPharmaUSAInc.,No.14-872(D.Del.)
CFTPharmaceuti-calsLLC,No.2:14-00714(E.D.Wis.)
Date Filed
Nov.1,2013
Aug.8,2014
Nov.13,2013
June19,2014
July2,2014
June20,2014
Expected Decision
Oct.21,2015
Notyetinstituted.Ifinstituted,max.18monthsfrominstitu-tiondate(onoraboutAug.10,2016)
Followingbenchtrial,setforNovem-ber2015(likelybefore30-monthstaydeadline,April2,2016)
Followingbenchtrial,setforJune2016(likelybefore30-monthstaydeadline,Nov.18,2016)
t.b.d.
January/February 2015 • THE FEDERAL LAWYER • 57
its bench opinion.
In fact, the opinion in the first-filed case (against Fresenius
Kabi USA, LLC) may not issue until close to the expiration of the
30-month stay triggered by that case (April 2, 2016).16
As another example, three IPR requests were filed by Apotex
Corp. on patents listed in the Orange Book by Alcon Research,
Ltd. for Travatan Z®, an ophthalmic solution, before Alcon brought
suits on the patents against several ANDA filers. Again, the PTAB
is expected to decide validity almost half a year sooner than the
bench trial.
It is not clear when the court will issue its decision following the
November 2015 consolidated trial in these cases. Post-trial brief-
ing will not be completed by the expiration of the 30-month stay
deadline in the earliest-filed suit, just a month after trial (Dec. 13,
2015).17 Thus it is likely that the court will not issue its decision
until 2016, when the IPR determination may be on appeal.
An IPR petition need not be filed before litigation in order for
the PTAB to rule first. As another example, an IPR petition was
first filed by BioDelivery Sciences International (BDSI) on a pat-
ent listed in the Orange Book for Suboxone®, an opioid drug, four
months after BDSI was sued on the patent in district court in North
Carolina and six months before additional suits were filed against
other generic manufacturers in Delaware. As the below table indi-
cates, the IPR decision should issue after the bench trial but before
the expiration of the 30-month stay in the earliest-filed Delaware
action (Feb. 28, 2016). 18
In summary, BDSI’s IPR request was filed about six months after
the first Delaware action involving the patent was instituted, but the
IPR decision may still issue before the bench decision.
As noted above, filing an IPR request at the one-year mark allows
counsel the benefit of some discovery in the district court prior to
finalizing its “best” invalidity positions. At a minimum, it allows a
generic entrant additional time to search for and evaluate pertinent
prior art before filing its IPR request. In practice, there is no guar-
antee as to whether the district court or the PTAB will be first to
render a decision under these circumstances. For example, Amneal
Pharmaceuticals, LLC filed a first IPR request on a patent listed in
the Orange Book for Opana® ER, Endo Pharmaceuticals Inc.’s pain
management drug, 12 months after Amneal was sued by Endo in
the Southern District of New York. Amneal filed another IPR 12
months after a new patent was asserted by Endo via an amended
complaint in that action. As illustrated below, there is no trial cur-
rently scheduled in the district court, and it is likely that the PTAB
will issue its decision first.
In contrast, an IPR request was filed at the 12-month mark by
multiple requesters involved in litigation in the Delaware district
court based on ANDAs for Vimpat® solution, an anti-seizure drug.
If IPR is instituted, the PTAB’s decision will follow the scheduled
bench trial in the Delaware cases (in November 2015) and pos-
sibly follow the district court’s bench opinion (if issued before the
30-month stay deadline of April 28, 2016).19
Drug, Patents
PLAINTIFF
TravatanZ®(ophthalmicsolution)
U.S.PatentNos.8,268,299,8,323,630,8,388,941
IPR/Lawsuit
ApotexCorp.,IPRNos.2013-00428,2013-00429,2013-00430
MylanInc.andMylanPharmaceu-ticalsInc.,No.13-1332(D.Del.)
WockhardtBioAG,WockhardtLimited,andWock-hardtUSALLC,No.13-2040(D.Del.)
MicroLabsLimited,andMicroLabsUSAInc.,No.14-0014(D.Del.)
ActavisInc.,ActavisPharmaInc.,andWatsonLaboratoriesInc.,No.14-0647(D.Del.)
Date Filed
July5,2013
July26,2013
Dec.19,2013
Jan.9,2014
May20,2014
Expected Decision
July2,2015
Followingbenchtrial,setforNovem-ber2015
(30-monthstayinearliestcaseendsDec.13,2015)
Drug, Patents
PLAINTIFF
Suboxone®sublingualfilm(foropioiddependency)
U.S.PatentNo.8,475,832
IPR/Lawsuit
BDSI,IPRNo.2014-00325
BDSI,IPRNo.2014-00998
BDSI,No.5:13-760(E.D.N.C.)
MultipleANDAfil-ers,Nos.13-1461,13-1674,13-2003(D.Del.)
Date Filed
Jan.15,2014
June20,2014
Oct.29,2013
Aug.20,2013(earliest)
Expected Decision
Jan.29,2016
Notyetinstituted.Ifinstituted,max.18monthsfrominstitu-tiondate(onoraboutJuly1,2016)
(Nowclosed)
Followingbenchtrial,setforAugust2015(likelybefore30-monthstaydeadline,Feb.28,2016)
Drug, Patents
PLAINTIFF
Opana®ER(forpainman-agement)
U.S.PatentNos.7,851,482(’482pat-ent)and8,329,216(’216patent)
IPR/Lawsuit
Amneal,IPRNo.2014-00160(’482patent)
Amneal,IPRNo.2014-00360(’216patent)
Amneal,IPRNo.2014-01365(’216patent)
MultipleANDAfilers,Nos.12-8060,12-8115,12-8317,12-8318,12-8985,12-9261,13-435,13-436,13-3284,13-3288,13-4343,and13-8597(S.D.N.Y.)
Date Filed
Nov.18,2013
Jan.16,2014
Aug.22,2014
Nov.5,2012(earliest)
Nov.7,2012(Amneal)
Expected Decision
Jan.4,2016
Jan.25,2016
t.b.d.
t.b.d.
58 • THE FEDERAL LAWYER • January/February 2015
DiscussionThe timing of the IPR filing varies, as does how the timing
plays out vis-à-vis the scheduling of trial and the expiration of the
30-month stay (by which date it is presumed that the court will
render its opinion). While filing IPR at the 12-month deadline
gives the best possibility that the court will address validity
before the PTAB, the examples illustrate that these results are
not guaranteed.
The timing of the bench trial is a critical component in the
analysis. Yet predicting the scheduling of an ANDA trial is some-
times more of an art than a science, especially where suits con-
tinue to be initiated against later ANDA filers. Successive suits
may cause an initial delay in holding the scheduling conference to
set a consolidated trial date or may result in the later postpone-
ment of an originally set trial date to accommodate additional
defendants. Docket congestion and courts’ resultant practices of
double- and triple-booking of trials can also render scheduling
difficult to predict in advance. Amended pleadings and prelimi-
nary motions may also dramatically shift the time line of a case.
The scheduling of trial following the final IPR decision has an
advantage to the court, which may avoid trial altogether should
the patent(s) in IPR emerge invalid. It is not clear if the courts
are being made aware of copending IPRs or have been asked to
schedule trial before or after expected disposition dates. In the
Opana® ER case, the New York court was notified of Amneal’s
IPRs at least via a motion by Endo for clarification on whether
(and to what extent) Endo’s trial counsel could participate in
the IPR.20 Trial has yet to be scheduled, for at least two potential
reasons: (1) the ’216 patent is one of several Opana® ER patents
asserted against a dozen ANDA filers in that district; and (2) the
court must resolve Amneal’s currently pending motion to reduce
the number of total claims in its suit. In short, it is not clear if
the court purposefully scheduled trial following the PTAB’s deci-
sions on Amneal’s IPRs. Both the Opana® ER and Vimpat® case
examples demonstrate that coordinated cases involving multiple
ANDA defendants may take longer to reach trial. The possibility
of intervening motion practice is proportionally larger in cases
involving a large number of parties.
Thus far, almost as often as not, IPR requests on pharmaceuti-
cal patents have been made by parties that are not involved in
concurrent litigation. There has not yet been a court ruling on a
motion to stay an ANDA case in favor of IPR. In the Suboxone®
case example, BDSI responded to the suit against it with its
IPR request, a motion to dismiss the district court action, and
a motion to stay the case in favor of its IPR. BDSI’s motion to
dismiss was ultimately successful and mooted the stay motion.
ANDA defendants utilizing IPR have presumably done so in
order to secure a faster resolution on validity (under a lower
standard of proof). The examples illustrate that this timing is
possible even where an IPR request is filed at the 12-month
deadline, negating the need for a stay motion in most cases.
Notwithstanding, a stay motion may help mitigate against the
risk that the district court will issue a decision first and may be
a useful tool in some cases.
ConclusionThe timing of an IPR request filing should be carefully analyzed
vis-à-vis a particular defendant’s goals as well as risk tolerance.
ANDA petitioners are not yet flocking towards IPR proceedings as
an alternative or complement to traditional ANDA litigation, but
the waters have begun to be tested. The relative infrequency of
IPR proceedings in pharmaceutical disputes renders it difficult to
describe particular “trends” at this juncture. As IPR proceedings
are still rather new, and final decisions are just beginning to roll
out of the PTAB, the timing, as well as the result, of IPR decisions
on patents involved in ANDA litigation merit continued review.
Stephanie O’Byrne is counsel at the bou-
tique litigation firm Shaw Keller LLP.
Previously, she served as law clerk to
Judge Sue L. Robinson of the U.S. District
Court for the District of Delaware. The
opinions expressed herein are solely
those of the author and do not necessar-
ily reflect the opinions of Shaw Keller
LLP or of any of its attorneys or clients.
Endnotes1See 2013 AIPLA Rep. of the Econ. Survey, at I-143.2See www.uspto.gov/aia_implementation/statistics.jsp. More than
160 IPR petitions were filed in June 2014, the largest monthly total
to date. 3See Id. at I-192; cf. 2013 AIPLA Rep. of the Econ. Survey, at
I-143. 4See 35 U.S.C. § 311(b) (2013).5A generic drug manufacturer may submit an ANDA with a
Paragraph IV certification or a certification that any patents
listed in the FDA publication “Approved Drug Products with
Therapeutic Equivalents” (the “Orange Book”) are invalid or not
infringed. See 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (2011). Filing an
ANDA with a Paragraph IV certification is an act of infringement
pursuant to 35 U.S.C. § 271(e)(2)(A). Notice must be provided
to the New Drug Application holder, such that an infringement
action may be brought in district court. See 21 U.S.C. §§ 355(j)
(2)(B)(i)(I), (j)(5)(B)(iii)(2011). The initiation of suit also
serves to trigger a 30-month stay under which, without a court
judgment, the FDA may not proceed to process and approve the
ANDA application. 21 U.S.C. § 355(j)(5)(B)(iii) (2011).6See 35 U.S.C. § 314(b); 37 C.F.R. § 42.107(b); 35 U.S.C.
§ 316(a)(11) (2013). 7See 35 U.S.C. § 315(b)(2013). 8See Scott A. McKeown, Generic Pharma Leverages PTAB,
Drug, Patents
PLAINTIFF
Vimpat®solution(forepilepticseizures)
U.SPatentNo.RE38,551
IPR/Lawsuit
MultipleANDAfil-ers,Nos.13-1206to13-1220(D.Del.)
MultipleD.Del.ANDAsuitdefen-dants,IPRNo.2014-01126
Date Filed
July10,2013(earliest)
July10,2014
Expected Decision
Followingbenchtrial,setforNovem-ber2015(likelybefore30-monthstaydeadline,April28,2016)
Notyetinstituted.Ifinstituted,max.18monthsfrominstitu-tiondate(onoraboutJuly25,2016)
January/February 2015 • THE FEDERAL LAWYER • 59
Patents POst grant blOg (Mar. 20, 2014), www.patentspostgrant.
com/lang/en/2014/03/generic-pharma-eyes-ptab.9Compare 35 U.S.C. § 316(e)(2014) with 35 U.S.C. § 282(a)
(2014).10See 35 U.S.C. § 315(e)(2)(2014). 11See 35 U.S.C. § 315(b)(2013). While most pioneer drug companies
institute ANDA litigation within the statutory period following the
Paragraph IV notice letter, and it is unusual for a generic drug company
to institute a declaratory judgment action, it should be noted that an
IPR may not be instituted if the requesting party filed a civil action
challenging validity before the IPR, and any such case filed after the
IPR petition would be subject to an automatic stay. 35 U.S.C. §§
315(a)(1), (2) (2013).12721 F.3d 1330 (Fed. Cir. 2014). Commentators have stated
that the Fresenius holding allows a “second bite at the apple”
for unsuccessful Hatch-Waxman litigants in district court. See H.
Keeto Sabharwal & Joshua N. Mitchell, IPR: A 2nd Bite at the
Apple for Hatch-Waxman Litigants, Law 360 (Mar. 11, 2014),
www.law360.com/articles/515476/ipr-a-2nd-bite-at-the-apple-for-
hatch-waxman-litigants.13See Gleaton et al., Inter Partes Review in Generic
Drug Litigation—Why the USPTO Should Exercise Its
Discretion to Deny IPR Petitions in Appropriate Hatch-
Waxman Act Disputes, PharMaPhOruM.cOM (Mar. 7, 2014),
www.pharmaphorum.com/articles/inter-partes-review-in-generic-
drug-litigation%E2%80%94why-the-uspto-should-exercise-
its-discretion-to-deny-ipr-petitions-in-appropriate-hatch%E2
%80%93waxman-act-disputes.
14Shaw Keller LLP represents (or formerly represented) several
defendants in the civil actions discussed in this section, or in
actions related thereto, including Accord Healthcare Inc. and Intas
Pharmaceuticals Ltd., No. 13-1206 (D. Del.), Alvogen Group, Inc.,
and Alvogen Pine Brook Inc., No. 13-2003 (D. Del.). No confidential
information was accessed by the author or utilized in any way in
drafting this overview. 15This article focuses on IPRs filed in Hatch-Waxman cases filed
through and including August 2014, and excludes other actions
for infringement of pharmaceutical patents filed pursuant to other
sections of 35 U.S.C. § 271.16No. 13-1893 (D. Del.), D.I. 3.17No. 13-1332 (D. Del.), D.I. 3.18No. 13-1674 (D. Del.), D.I. 3.19No. 13-1206 (D. Del.), D.I. 8.20No. 12-8115 (S.D.N.Y.), D.I. 87.
AUTO | HOME
Distinctive auto insurance—just because you belong.
Did you know that as a Federal Bar Association member, you could save up to $427.96 or more on Liberty Mutual Auto Insurance?1 You could save even more if you also insure your home with us. Plus, you’ll receive quality coverage from a partner you can trust, with features and options that can include Accident Forgiveness2, New Car Replacement3, and Lifetime Repair Guarantee.4
#1#Discounts are available where state laws and regulations allow, and may vary by state. Figure reflects average national savings for customers who switched to Liberty Mutual’s group auto and home program. Based on data collected between 9/1/12 and 8/31/13. Individual premiums and savings will vary. To the extent permitted by law, applicants are individually underwritten; not all applicants may qualify. #2#For qualifying customers only. Subject to terms and conditions of Liberty Mutual’s underwriting guidelines. Not available in CA and may vary by state. #3#Applies to a covered total loss. Your car must be less than one year old, have fewer than 15,000 miles and have had no previous owner. Does not apply to leased vehicles or motorcycles. Subject to applicable deductible. Not available in NC or WY. #4#Loss must be covered by your policy. Not available in AK. Coverage provided and underwritten by Liberty Mutual Insurance Company and its affiliates, 175 Berkeley Street, Boston, MA. ©2014 Liberty Mutual Insurance
VISIT YOUR LOCAL OFFICE
CONTACT US TODAY TO START
SAVING
800-981-2372 CLIENT #121875
LIBERTYMUTUAL.COM/FBA
VISIT YOUR LOCAL OFFICE
