Hedge Fund IPR Challenges to Pharma Patents: Strategies to...
Transcript of Hedge Fund IPR Challenges to Pharma Patents: Strategies to...
Hedge Fund IPR Challenges to Pharma
Patents: Strategies to Strengthen
Patents to Withstand Attack
Today’s faculty features:
1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific
The audio portion of the conference may be accessed via the telephone or by using your computer's
speakers. Please refer to the instructions emailed to registrants for additional information. If you
have any questions, please contact Customer Service at 1-800-926-7926 ext. 10.
THURSDAY, MAY 28, 2015
Presenting a live 90-minute webinar with interactive Q&A
Thomas L. Irving, Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.
Barbara R. Rudolph, Ph.D., Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.
Amanda Murphy, Ph.D. Associate, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.
Rekha Bensal, Sr. Director of IP, Principia Biopharma, So. San Francisco, CA
Tips for Optimal Quality
Sound Quality
If you are listening via your computer speakers, please note that the quality
of your sound will vary depending on the speed and quality of your internet
connection.
If the sound quality is not satisfactory, you may listen via the phone: dial
1-866-819-0113 and enter your PIN when prompted. Otherwise, please
send us a chat or e-mail [email protected] immediately so we can address
the problem.
If you dialed in and have any difficulties during the call, press *0 for assistance.
Viewing Quality
To maximize your screen, press the F11 key on your keyboard. To exit full screen,
press the F11 key again.
FOR LIVE EVENT ONLY
Continuing Education Credits
In order for us to process your continuing education credit, you must confirm your
participation in this webinar by completing and submitting the Attendance
Affirmation/Evaluation after the webinar.
A link to the Attendance Affirmation/Evaluation will be in the thank you email
that you will receive immediately following the program.
For additional information about CLE credit processing call us at 1-800-926-7926
ext. 35.
FOR LIVE EVENT ONLY
Program Materials
If you have not printed the conference materials for this program, please
complete the following steps:
• Click on the ^ symbol next to “Conference Materials” in the middle of the left-
hand column on your screen.
• Click on the tab labeled “Handouts” that appears, and there you will see a
PDF of the slides for today's program.
• Double click on the PDF and a separate page will open.
• Print the slides by clicking on the printer icon.
FOR LIVE EVENT ONLY
Disclaimer
These materials have been prepared solely for educational and entertainment
purposes to contribute to the understanding of U.S. intellectual property law.
These materials reflect only the personal views of the authors and are not
individualized legal advice. It is understood that each case is fact specific, and
that the appropriate solution in any case will vary. Therefore, these materials
may or may not be relevant to any particular situation. Thus, the authors,
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (including Finnegan Europe
LLP, and Fei Han Foreign Legal Affairs Law Firm), and PRINCIPIA BIOPHARMA
cannot be bound either philosophically or as representatives of their various
present and future clients to the comments expressed in these materials. The
presentation of these materials does not establish any form of attorney-client
relationship with these authors. While every attempt was made to ensure that
these materials are accurate, errors or omissions may be contained therein, for
which any liability is disclaimed.
5
IPR Filings Have Risen Quickly
As of May 14, 2015. Source: http://www.uspto.gov/sites/default/files/documents/0514015_aia_stat_graph.pdf
6 PGRs filed so far; 2 settled prior to institution decision, 4 institution decision pending.
Tota
l AIA
Post-
Gra
nt
Fili
ngs P
er
Month
?
IPR: 2,894
CBM: 344
PGR: 6
DER: 11
Total: 3,255
Oct. 2012
Oct. 2013
Oct. 2014 Filings approximately doubled from Oct. 2013 to Oct. 2014
6
IPR Petitions by Technology
FY15 filings as of April 9, 2015. Source: http://www.uspto.gov/sites/default/files/documents/040915_aia_stat_graph.pdf
7
IPR Petitions by Technology (May 14, 2015)
FY15 filings as of May 14, 2015. Source: http://www.uspto.gov/sites/default/files/documents/051415_aia_stat_graph.pdf
Bio/Pharma petitions
rising?
8
Bio/Pharma IPR Petitions
7.8%
8.3%
8.4%
8.3%
7.5%
7.6%
7.7%
7.8%
7.9%
8.0%
8.1%
8.2%
8.3%
8.4%
8.5%
Bio/Pharma (TC1600)
9-Apr
23-Apr
7-May
21-May
FY15 filings as of April 9, 2015. Source: http://www.uspto.gov/sites/default/files/documents/040915_aia_stat_graph.pdf FY15 filings as of April 23, 2015. Source: http://www.uspto.gov/sites/default/files/documents/042315_aia_stat_graph.pdf FY15 filings as of May 7, 2015. Source: http://www.uspto.gov/sites/default/files/documents/050715_aia_stat_graph.pdf FY15 filings as of May 14, 2015. Source: http://www.uspto.gov/sites/default/files/documents/051415_aia_stat_graph.pdf
9
Petition Grant Rate is High!
Granted, 68% 1227/1800
Joinder, 7% 121/1800
Denied, 25% 452/1800
Decisions Whether to Institute (1800 Petitions)
Granted + joinder = 75%
As of May 14, 2015. Source: http://www.uspto.gov/sites/default/files/documents/051415_aia_stat_graph.pdf
10
Grant Rate Higher for Pharma/Chem/Bio IPR Petitions
Settled/ terminated
before decision, 9
Petition denied: 50
Petition partially
denied: 31
Instituted: 106
Pending: 136
Instituted on at least one challenged claim: 73% (137/187))
187 institution
decisions
Of 332 IPR petitions filed relating to TC1600 and TC1700, institution decisions
as of May 7, 2015. Source: Finnegan research.
11
And If IPR Instituted, Cancellation Rate is High!
As of April 1, 2015. Source: Finnegan research, with thanks to Dan Klodowski, Kai Rajan, Elliot Cook, and Joe Schaffner.
“Mixed outcome”: some instituted claims survived, some did not.
196 72.06%
44 16.18%
32 11.76%
IPR Results by Case
No Instituted or Substitute Claims Survived
Mixed Outcome
All Instituted Claims Survived
12
And If IPR Instituted, Cancellation Rate is High!
As of April 1, 2015. Source: Finnegan research, with thanks to Dan Klodowski, Kai Rajan, Elliot Cook, and Joe Schaffner.
2949 73.50%
792 19.74%
271 6.75%
IPR Results by Claim
Instituted Claims Cancelled by PTAB
Instituted Claims Survived
Instituted Claims Conceded by Owner
80% of claims do
not survive!
13
Pharma/Chem/Bio IPR Case Outcomes in Terminated IPRs (137 Cases)
Adverse judgment: 8
8%
Mixed (some unpatentable, some
survived): 15 15%
All challenged claims unpatentable: 59
57%
All challenged claims survived: 13
13%
Settlement/ Terminated:
8 8%
Of 137 instituted IPRs filed relating to TC1600 and TC1700, as of May 7, 2015, 34 remain pending. 103 are terminated.
Source: Finnegan research.
14
Pharma/Chem/Bio IPR Case Outcomes in FWDs on the Merits (87 Decisions)
Mixed: 17% (15)
All challenged claims
unpatentable: 68% (59)
All challenged claims survived:
15% (13)
Of 87 instituted IPRs filed relating to TC1600 and TC1700, as of May 7, 2015, terminated on the merits.
Source: Finnegan research.
15
Pharma/Chem/Bio “Mixed” Results
Closer Look at the 15 “Mixed” Results By Claim: Most Claims Still Cancelled
Unpatentable: 68%
186/253
Survived: 32% 67/253
16
Why Petition for IPR?
Leverage for settlement
Lower burden of proof
Avoid or stay litigation
Faster resolution
•PTAB written decision within 12-18 months
•Appeal directly to Federal Circuit if losing party has Article III judicial standing
Lower cost
• Limited discovery and no live testimony
At present, general unavailability of Patent Owner amendment to
avoid cited prior art
To become an authorized generic and avoid Hatch-
Waxman Regime
Force forfeiture of 1st-
filer’s 180-day exclusivity
Any other reason?
17
New Threat
IPR PETITIONER PATENT OWNER
PATENT # SUBJECT MATTER CLAIMS PRODUCT FILED NOTES
IPR2015-00720
Coalition for Affordable Drugs, LLC
Acorda Therapeutics, Inc.
8,663,685 Sustained release aminopyridine composition
1-8 Ampyra® (MS)
(corr) 3/5/2015
Current H-W litigation
IPR2015-00817
Coalition for Affordable Drugs, LLC
Acorda Therapeutics, Inc.
8,007,826 Sustained release aminopyridine composition
1–3, 5–8, 10–41
(corr) 3/25/2015
IPR2015-00988
Coalition for Affordable Drugs, II, LLC
Shire, Inc. 6,773,720 Mesalazine controlled release oral pharmaceutical compositions
1-4 Lialda® (ulcerative colitis)
4/1/2015 Upheld as valid in district court litigation (2013)
IPR2015-01086
Coalition For Affordable Drugs, V, LLC
Biogen IDEC 8,759,393 Utilization of dialkylfumarates
1-13 Tecfidera® (MS)
4/22/2015
IPR2015-01136
Coalition For Affordable Drugs, V, LLC
Biogen MA Inc. 8,399,514 Treatment of MS 1-20 5/1/2015
18
New Threat
IPR PETITIONER PATENT OWNER
PATENT #
SUBJECT MATTER
CLAIMS PRODUCT FILED NOTES
IPR2015-01018
Coalition for Affordable Drugs, III, LLC
Jazz Pharms., Inc.
7,895,059 Sensitive drug distribution system and method
1-16 Xyrem® (narolepsy)
4/6/2015
IPR2015-01076
Coalition for Affordable Drugs, IV, LLC
Pharmacyclics, Inc.
8,754,090 Use of inhibitors of bruton's tyrosine kinase (Btk)
1-2 Imbruvica® (cancer)
4/20/2015
IPR2015-00990
Coalition for Affordable Drugs, II, LLC
NPS Pharms., Inc.
7,056,886 GLP-2 formulations 46-52 and 61-75
Gattex® (SBS)
4/1/2015 Same patent as -01093, same art
IPR2015-01093
Coalition for Affordable Drugs, II, LLC
NPS Pharms., Inc.
7,056,886 GLP-2 formulations 1-45 Gattex® (SBS)
4/23/2015 Same patent as -00990, same art
IPR2015-01241
Coalition for Affordable Drugs, VII, LLC
Pozen, Inc. 6,926,907 Pharmaceutical compositions for the coordinated delivery of NSAIDs
1-23 Vimovo® 5/21/2015
19
New Threat
IPR PETITIONER PATENT OWNER
PATENT # SUBJECT MATTER Claims Product FILED
IPR2015-01092
Coalition For Affordable Drugs, VI, LLC
Celgene Corp. 6,045,501 Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug
1-10 Thalomid® Revlimid®
4/23/2015
IPR2015-01102
Coalition for Affordable Drugs, VI, LLC
Celgene Corp. 6,315,720 Methods for delivering a drug to a patient while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug
1-32 Pomalyst® Revlimid®
4/23/2015
IPR2015-01103
Coalition for Affordable Drugs, VI, LLC
Celgene Corp. 6,315,720 Methods for delivering a drug to a patient while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug
1-32 Pomalyst® Revlimid®
4/23/2015
IPR2015-01096
Coalition for Affordable Drugs, VI, LLC
Celgene Corp. 6,315,720 Methods for delivering a drug to a patient while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug
1-32 Pomalyst® Revlimid®
4/23/2015
IPR2015-01169
Coalition for Affordable Drugs, VI, LLC
Celgene Corp. 5,635,517
Method of reducing TNFα levels with amino substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxo-and 1,3-dioxoisoindolines
1-10 Pomalyst® Revlimid®
5/7/2015
20
New Threat
IPR PETITIONER PATENT OWNER
PATENT #
SUBJECT MATTER
Claims Product FILED NOTES
IPR2015-00858
Ferrum Ferro Capital LLC
Allergan Sales, LLC
7,030,149 Combination of brimonidine timolol for topical ophthalmic use
4 Combigan® 3/9/2015 Upheld as valid in district court litigation (2013)
21
Ferrum Ferro Capital LLC v. Allergan Sales, LLC, IPR2015-00858
• U.S. Pat. No. 7,030,149: Combination of brimonidine timolol for topical
ophthalmic use.
• Issued April 18, 2006
• 4 claims
• 2 independent claims
• Only claim 4 challenged.
― Claim 4: A method of reducing the number of daily topical ophthalmic doses
of brimondine administered topically to an eye of a person in need thereof
for the treatment of glaucoma or ocular hypertension from 3 to 2 times a
day without loss of efficacy, wherein the concentration of brimonidine is
0.2% by weight, said method comprising administering said 0.2% brimonidine
by weight and 0.5% timolol by weight in a single composition.
22
Ferrum Ferro Capital LLC v. Allergan Sales, LLC, IPR2015-00858
• Drug – Combigan®
• Used to treat glaucoma or ocular hypertension.
• INDICATIONS AND USAGE – COMBIGAN® (brimonidine tartrate/timolol
maleate ophthalmic solution) 0.2%/0.5% is an alpha-adrenergic receptor
agonist with a beta-adrenergic receptor inhibitor indicated for the
reduction of elevated intraocular pressure (IOP) in patients with glaucoma
or ocular hypertension who require adjunctive or replacement therapy
due to inadequately controlled IOP; the IOP-lowering of COMBIGAN® dosed
twice a day was slightly less than that seen with the concomitant
administration of 0.5% timolol maleate ophthalmic solution dosed twice a
day and 0.2% brimonidine tartrate ophthalmic solution dosed three times
per day.
23
Ferrum Ferro Capital LLC v. Allergan Sales, LLC, IPR2015-00858
• Orange Book patents listed – Combigan (all OB-listed patents are in same
family)
• 7030149 expiration Apr 19, 2022 U – 849
• 7320976 expiration Apr 19, 2022 U - 849
• 7323463 expiration Jan 19, 2023
• 7642258 expiration Apr 19, 2022 U - 1024
• 8133890 expiration Apr 19, 2022 U - 1235
• 8354409 expiration Apr 19, 2022 U - 1371
• 8748425 expiration Apr 19, 2022 U - 1524
A delisting request
indicated on the OB
24
Ferrum Ferro Capital LLC v. Allergan Sales, LLC, IPR2015-00858
• Patent holder – Allergan, Inc., a global, multi-specialty health
care company.
• March 17, 2015: Actavis (NYSE:ACT) completed the acquisition
of Allergan, creating a $23 billion diversified global
pharmaceutical company and a leader in a new industry model
- Growth Pharma.
25
Ferrum Ferro Capital LLC v. Allergan Sales, LLC, IPR2015-00858
• Related litigation listed in the Ferrum petition:
• Allergan, Inc. v. Sandoz Inc., Case No. 2:09-cv-00097 (E.D. Tex)
• Allergan, Inc. v. High-Tech Pharmacal Co., Case No. 2:09-cv-00182
(E.D. Tex) and Allergan, Inc. v. Alcon Labs, Inc., Case No. 2:09-cv-
00348 (E.D. Tex)
• Allergan, Inc. v. Apotex Inc., Case No. 2:10—cv-00200 (E.D. Tex)
• Allergan, Inc. v. Watson Labs, Inc., Case No. 2:10-cv-00344 (E.D.
Tex)
26
Ferrum Ferro Capital LLC v. Allergan Sales, LLC, IPR2015-00858
• Previous litigation
• Allergan v. Sandoz, 726 F.3d 1286 (Fed. Cir. 2013)(PROST,
O’Malley, Dyk)(Dyk concurring-in-part and dissenting-in-part), pet.
for cert. denied, 134 S.Ct. 1764 (U.S., 2014)
• Sandoz asserted reference taught fixed combinations of alpha2-
agonists and beta-blockers for the treatment of glaucoma.
• At the time of the invention, both timolol and brimonidine were
commercially available drugs used for opthamalic conditions,
available in claimed concentrations, contained the preservative BAK,
and it was known that the serial administration of brimonidine and
timolol reduced intraocular pressure greater than either timolol or
brimonidine alone.
• Another reference “expressly provided a motivation to formulate
fixed combinations of alpha2-agonists and beta blockers, including
timolol, in order to increase patient compliance.”
27
Ferrum Ferro Capital LLC v. Allergan Sales, LLC, IPR2015-00858
• Previous litigation
• Allergan v. Sandoz, 726 F.3d 1286 (Fed. Cir. 2013)(con’t)
• Fed. Cir.: Majority held claim 4 of the ‘149 patent not invalid under
§103.
― No clear and convincing evidence of obviousness relating to reducing the
daily number of doses of brimonidine from 3 to 2 times a day without loss
of efficacy.
― Record firmly established “that when brimonidine is dosed twice per day
as opposed to three times per day, there is a loss of efficacy in the
afternoon—the so called, afternoon trough. Sandoz has failed to point to
evidence in the prior art that would allow us to conclude that the addition
of timolol to brimonidine dosed twice per day would eliminate the
afternoon trough issue.”
― Claims 1-3 summary judgment of non-infringement; no judgment on
validity.
28
Ferrum Ferro Capital LLC v. Allergan Sales, LLC, IPR2015-00858
• Previous litigation
• Allergan v. Sandoz, 726 F.3d 1286 (Fed. Cir. 2013)(con’t)
• Dissent: Would have held claim 4 invalid.
― “The majority’s outcome appears to rest, therefore, on the
notion that claim 4 was not obvious because it claims the result
of twice-a-day doing—avoiding ‘a loss of efficacy in the
afternoon.’ …. Avoiding a ‘loss of efficacy’ is not a separate step,
but rather a result of the claimed method…. We should
recognize in this case … that ‘[n]ewly discovered results of
known processes directed to the same purpose are not
patentable.’”
29
Ferrum Ferro Capital LLC v. Allergan Sales, LLC, IPR2015-00858
• Petitioner – Ferrum Ferro Capital, LLC
• Ferrum Ferro Capital, LLC is a privately-held venture focused on innovation,
application, and monetization.
• Led by Kevin Barnes
• U.S. 7,030,149
• Challenged patentability of one claim (claim 4)
• Claim 4 of the ‘149 patent. A method of reducing the number of daily
topical ophthalmic doses of brimondine administered topically to an
eye of a person in need thereof for the treatment of glaucoma or
ocular hypertension from 3 to 2 times a day without loss of efficacy,
wherein the concentration of brimonidine is 0.2% by weight, said
method comprising administering said 0.2% brimonidine by weight and
0.5% timolol by weight in a single composition.
• Challenged on one ground (§103 ).
30
Ferrum Ferro Capital LLC v. Allergan Sales, LLC, IPR2015-00858
• Note that claims 1-3 of the ‘149 patent were adjudged to be not
infringed in the Federal Circuit appeal.
• Unchallenged Claim 1 of the ‘149 patent: A method of treating
glaucoma or ocular hypertension by topical administration of about
0.2% brimonidine by weight to an eye of a person in need thereof,
said improvement comprising topically administering to said eye, in a
single composition, about 0.2% brimonidine by weight and about 0.5%
timolol by weight twice a day; as the sole active agents; wherein said
method is as effective as administration of 0.5% timolol twice a day
and 0.2% brimonidine three time a day to said eye, wherein the two
compounds are administered in separate compositions.
• Claim 2 depends from claim 1 and adds the limitation that the composition further
comprises from 0.001% to 0.01% benzalkonium chloride.
• Claim 3 depends from claim 2 and adds the limitation that the composition further
comprises about 0.005% benzalkonium chloride.
31
Ferrum Ferro Capital LLC v. Allergan Sales, LLC, IPR2015-00858
• Obviousness ground asserted based on DeSantis in view of Timmermans, and further in view of Larsson
and/or Stewart.
• DeSantis and Larsson were both before the Federal Circuit. • According to Ferrum, “[t]he Federal Circuit already determined that the fixed combination of 0.5%
brimonidine and 0.2% timolol for glaucoma treatment would have been obvious when it invalidated the
composition claims of the related ’463 Patent. The Federal Circuit’s reasoning applies equally to method
claim 4 of the ’149 Patent.”
• DeSantis teaches the use of alpha-2 agonists and beta-blockers in fixed combinations for treatment of
glaucoma; discloses the beta-blocker timolol. • Provides motivation to combine the active ingredients into a fixed combination to increase patient
compliance through a simpler dosage regimen.
• Timmermans discloses alpha-2 agonists; discloses brimonidine.
• Larsson teaches twice daily serial administration of 0.2% brimonidine followed by 0.5% timolol after a five
minute period.
• Stewart also teaches twice daily serial administration of brimonidine and timolol, as well as no difference
in intraocular pressure effects of the twice daily dosing when compared to three times a day dosing.
• Before the ’149 Patent, there were three pharmaceutically acceptable alpha-2 agonists: clonidine,
apraclonidine, and brimonidine. • Of these three, brimonidine was favored for long-term treatment (as required for glaucoma)
32
Ferrum Ferro Capital LLC v. Allergan Sales, LLC, IPR2015-00858
• IPR Petition (con’t)
• Argument: Federal Circuit decision regarding the validity of claim
4 turned on the construction of “loss of efficacy,” but in this
proceeding, “broadest reasonable interpretation” (BRI) applies.
• Federal Circuit majority held “loss of efficacy” term was a claim
limitation.
• Federal Circuit dissent held “loss of efficacy” was not a claim
limitation – since the dissent’s view is the broader of the two, it
should apply here.
33
Ferrum Ferro Capital LLC v. Allergan Sales, LLC, IPR2015-00858
• IPR Petition (con’t)
• “Loss of efficacy” is merely an intended result.
• Expert declaration attests that POSITA would understand the term to be an intended result, not a step of the
claimed process.
• It would have been obvious to combine 0.5% brimonidine and 0.2% timolol in a fixed
combination for twice daily use in glaucoma treatment, and it would have been
obvious to dose the fixed combination twice daily.
• POSITA would be motivated to combine the two APIs in a fixed combination to
achieve better patient compliance.
• Objective evidence does not overcome prima facie case of obviousness. • Federal Circuit found long-felt need to be conclusory and without support;
• Federal Circuit rejected evidence of unexpected result of no loss of efficacy with twice daily
dosing. ― Objective evidence of an unexpected result tied to “without loss of efficacy” “is not a relevant
secondary consideration.”
34
Ferrum Ferro Capital LLC v. Allergan Sales, LLC, IPR2015-00858
• Status of IPR2015-00858
• Petition accorded filing date of March 9, 2015.
• No POPR filed yet (due no later than June 9, 2015).
• No institution decision yet (due no later than Sept. 9,
2015).
• No other IPR challenge
35
Coalition For Affordable Drugs III LLC v. Jazz Pharms., Inc.,
IPR2015-01018
• Petition filed April 6, 2015
• Claims 1-16 of U.S. Pat. No. 7,895,059
• Claim 1. A computerized method of distributing a prescription drug under exclusive control of an exclusive
central pharmacy, the method comprising:
• receiving in a computer processor all prescription requests, for any and all patients being prescribed the
prescription drug, only at the exclusive central pharmacy from any and all medical doctors allowed to
prescribe the prescription drug, the prescription requests containing information identifying patients,
the prescription drug, and various credentials of the any and all medical doctors;
• requiring entering of the information into an exclusive computer database associated with the exclusive
central pharmacy for analysis of potential abuse situations, such that all prescriptions for the
prescription drug are processed only by the exclusive central pharmacy using only the exclusive
computer database;
• checking with the computer processor the credentials of the any and all doctors to determine the
eligibility of the doctors to prescribe the prescription drug; confirming with a patient that educational
material has been received and/or read prior to shipping the prescription drug;
• checking the exclusive computer database for potential abuse of the prescription drug; mailing or
sending by courier the prescription drug to the patient only if no potential abuse is found by the patient
to whom the prescription drug is prescribed and the doctor prescribing the prescription drug;
• confirming receipt by the patient of the prescription drug; and generating with the computer processor
periodic reports via the exclusive computer database to evaluate potential diversion patterns.
36
Coalition For Affordable Drugs III LLC v. Jazz Pharms., Inc.,
IPR2015-01018
• Total Revenue 2014: $1172.9 M
• Net Income 2014: $527.6 M
• Key Products and Revenue: • XYREM® (sodium 4-hydroxy butyrate)
• Used to treat excessive daytime sleep and cataplexy associated with narcolepsy
• Total Revenue 2014: $778.6 M
• Schedule III drug
• Erwinaze®/Erwinase®
• Used to treat acute lymphoblastic leukemia (ALL)
• Total Revenue 2014: $199.7 M
• Defitelio®(defibrotide)
• Used to treat severe hepatic veno-occlusive disease (VOD) in patients over one
month of age undergoing hematopoietic stem cell transplantation (HSCT)
therapy
• Total Revenue 2014: $73.4M
• Patent Estate: 17 patents covering XYREM®
• Patents Listed in Orange Book: 15
37
Coalition For Affordable Drugs III LLC v. Jazz Pharms., Inc.,
IPR2015-01018
• Orange Book listings
38
Appl No Prod No Patent No Patent Expiration
Drug Substance Claim
Drug Product Claim
Patent Use Code
Delist Requested
N021196 001 6780889 Jul 4, 2020 Y
N021196 001 7262219 Jul 4, 2020 Y
N021196 001 7668730 Jun 16, 2024 U - 1110
N021196 001 7765106 Jun 16, 2024 U - 1069
N021196 001 7765107 Jun 16, 2024 U - 1070
N021196 001 7851506 Dec 22, 2019 U - 1101
N021196 001 7851506 Dec 22, 2019 U - 1102
N021196 001 7895059 Dec 17, 2022 U - 1110
N021196 001 8263650 Dec 22, 2019 Y U - 1101
N021196 001 8263650 Dec 22, 2019 Y U - 1102
N021196 001 8324275 Dec 22, 2019 U - 1101
N021196 001 8324275 Dec 22, 2019 U - 1102
N021196 001 8457988 Dec 17, 2022 U - 1110
N021196 001 8589182 Dec 17, 2022 U - 1110
N021196 001 8731963 Dec 17, 2022 U - 1110
N021196 001 8772306 Mar 15, 2033 U - 1532
N021196 001 8859619 Dec 22, 2019 Y
N021196 001 8952062 Dec 22, 2019 U - 1101
N021196 001 8952062 Dec 22, 2019 U - 1102
Yellow: Pharmaceutical composition, method of treatment patents. Last patent expires July 2020
Pink: Restricted distribution system for Xyrem. Six of these are being challenged by one or more ANDA filers in district court and in
IPR. Were also challenged under CBM but institution was denied by PTAB for failure to show the claims were CBM.
Green: A method of treatment with Xyrem when patent is also taking valproate.
at issue in this IPR and
in DC litigation with ANDA filers
Coalition For Affordable Drugs III LLC v. Jazz Pharms., Inc.,
IPR2015-01018
39
Patent No
Patent Expiration
Other PTAB challenges of Patent at Issue in IPR2015-01018
District court challenges of Patent at Issue in IPR2015-01018
Notes
7895059 Dec 17,
2022 Par (IPR2015-00548), filed April 1, 2015
Watson Labs, Ranbaxy Labs., Amneal
Pharma, Par Parma, Roxanne Labs. Continuation of 7,668,730
Patent No
Patent Expiration
Other OB-listed patents: PTAB challenges
Other OB-listed patents: District court challenges
Notes
8457988 Dec 17,
2022 Par (IPR2015-00551) filed Jan. 8, 2015 Yes
Div of 13/013,680, abandoned, which is cont of patent
7,895,059 which is cont of 7,668,730
8589182 Dec 17,
2022
Amneal /Par (IPR2015-00545) filed Jan. 8, 2015
Yes
Cont. of 13/013,680, abandoned, which is cont of
patent 7,895,059 which is cont of 7,668,730
8731963 Dec 17,
2022
Cont. of 13/013,680, abandoned, which is cont of
patent 7,895,059 which is cont of 7,668,730
7668730 Jun 16, 2024
Amneal/Par (IPR2015-00554) filed Jan. 8, 2015
Yes
7765106 Jun 16, 2024
Amneal/Par (IPR2015-00546) filed Jan. 8, 2015
Yes Div of 7,668,730
7765107 Jun 16, 2024
Amneal/Par (IPR2015-00547)
filed Jan. 8, 2015 Yes Div of 7,668,730
Coalition For Affordable Drugs III LLC v. Jazz Pharms., Inc.,
IPR2015-01018
• Asserted references:
• U.S. Published Application No. 2004/0176985 to Lilly et al.
(“Lilly”) (§102(e) reference)
• Published transcript of an FDA Drug Advisory Committee
Meeting relating to Xyrem® (“the DAC Transcript”) (§102(b)
reference)
• U.S. Patent No. 6,587,829 (“Camarda”) (§102(b) reference)
• Published Preliminary Clinical Safety Review of the NDA for
Xyrem® (the “CSR”) (§102(b) reference)
40
Coalition For Affordable Drugs III LLC v. Jazz Pharms., Inc.,
IPR2015-01018
• Two grounds asserted, both §103.
• Claims 1-6, 9 and 12-14 obviousness over combination of Lilly in view of
the DAC Transcript and Camarda, because a POSITA would be motivated to
combine the teachings of these references to arrive at a method for
reducing the abuse of drug products such as Xyrem® and thus improve the
healthcare system while reducing healthcare costs.
• Lilly discloses a computerized system to assist pharmacies to distribute prescription drugs to
patients; store and obtain various types of data, including comparing new prescription to
medical history; desirable to reduce misure/abused prescriptions.
• DAC transcript discloses risk management program under which product, such as Xyrem®,
made available through a central pharmacy and shipped directly to patient at home via a
closed loop distribution system, with checks to determine if the physician is eligible to
prescribe Xyrem® and education about the risks and the appropriate use of the drug after the
first prescription is filled.
• Camarada teaches predicting which patients are most likely to fail to comply with their
prescription; report patient data to pharmacy.
41
Coalition For Affordable Drugs III LLC v. Jazz Pharms., Inc.,
IPR2015-01018
• Two grounds asserted, both §103 (con’t)
• Claims 7-8, 10-11 and 15-16 obviousness over combination of
above three references, in combination with the Preliminary
Clinical safety Review (CSR) reference which was part of FDA’s
approval process for Xyrem®
• CSR discloses that a patient’s prescription of Xyrem® may be shipped
to another pharmacy for patient’s pick up, rather than shipping it
directly to the patient.
42
Coalition Filed 5 IPRs Against Celgene
IPR PETITIONER PATENT OWNER
PATENT # SUBJECT MATTER Claims Product FILED
IPR2015-01092 Coalition For Affordable Drugs, VI, LLC
Celgene Corp. 6,045,501 Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug
1-10 Thalomid® Revlimid®
4/23/2015
IPR2015-01102 Coalition for Affordable Drugs, VI, LLC
Celgene Corp. 6,315,720 Methods for delivering a drug to a patient while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug
1-32 Pomalyst® Revlimid®
4/23/2015
IPR2015-01103 Coalition for Affordable Drugs, VI, LLC
Celgene Corp. 6,315,720 Methods for delivering a drug to a patient while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug
1-32 Pomalyst® Revlimid®
4/23/2015
IPR2015-01096 Coalition for Affordable Drugs, VI, LLC
Celgene Corp. 6,315,720 Methods for delivering a drug to a patient while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug
1-32 Pomalyst® Revlimid®
4/23/2015
IPR2015-01169 Coalition for Affordable Drugs, VI, LLC
Celgene Corp. 5,635,517
Method of reducing TNFα levels with amino substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxo-and 1,3-dioxoisoindolines
1-10 Pomalyst® Revlimid®
5/7/2015
43
Celgene Corp.
• Celgene: major global biopharmaceutical corporation.
• Total Revenue 2014: $7,670.4 M
• Net Income 2014: $1,999.9 M
• Products and Revenue: • ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound)
― Used to treat breast cancer, pancreatic cancer, and non-small cell lung cancer
― Total Revenue 2014: $848.2 M
• ISTODAX® (romidespsin)
― Used to treat cutaneous T-cell lymphoma and peripheral T-cell lymphoma
― Total Revenue 2014: $65.6 M
• OTEZLA® (apremilast)
― Used to treat psoriatic arthritis and psoriasis
― Total Revenue 2014: $69.8M
• POMALYST® (pomalidomide)
― Used to treat multiple myeloma and systemic sclerosis
― Total Revenue 2014: $679.7 M
• REVLIMID® (lenalidomide)
― Used to treat hematological malignancies (multiple myeloma and myelodysplastic syndromes)
― Total Revenue 2014: $4,980.0 M
• THALOMID® (thalidomide)
― Used to treat multiple myeloma and erythema nodosum leprosum
― Total Revenue 2014: $221.2 M
• VIDAZA® (azacitidine - pyrimidine nucleoside analog)
― Used to treat myelodysplastic syndromes
― Total Revenue 2014: $611.9 M
44
Orange-Book Listed Patents for POMALYST® (pomalidomide)
use of pomalidomide to inhibit the secretion of
pro-inflammation cytokines, including tumor
necrosis factor alpha
use of pomalidomide while preventing the
exposure of a fetus or other contraindicated
individual to pomalidomide
use of pomalidomide while preventing the exposure of a fetus or other contraindicated individual
to pomalidomide
45
Orange-Book Listed Patents for REVLIMID® (lenalidomide)
use of lenalidomide to inhibit the secretion of pro-
inflammatory cytokines, including tumor necrosis
factor alpha
use of lenalidomide while preventing the exposure of a
fetus or other contraindicated individual to lenalomide
use of lenalidomide while preventing the exposure of a
fetus or other contraindicated individual to lenalomide
46
Orange-Book Listed Patents for THALOMID® (thalidomide)
approval for marketing only under a special restriction program approved by FDA
called “System for Thalidomide Education and
Prescribing Safety”
use in combination with dexamethasone is indicated for the treatment of patients
with newly diagnosed multiple myeloma
use in combination with dexamethasone is indicated for the treatment of patients
with newly diagnosed multiple myeloma
method for delivering a drug to a patient in need of
the drug, while avoiding the
occurrence of an adverse side effect
known or suspected of being caused by
said drug
47
Coalition For Affordable Drugs VI LLC v. Celgene Corp.,
IPR2015-01092
• U.S. Pat. No. 6,045,501
• Claim 1. A method for delivering a teratogenic drug to patients in need of the
drug while avoiding the delivery of said drug to a foetus comprising:
• a. registering in a computer readable storage medium prescribers who are qualified to
prescribe said drug;
• b. registering in said medium pharmacies to fill prescriptions for said drug;
• c. registering said patients in said medium, including information concerning the ability
of female patients to become pregnant and the ability of male patients to impregnate
females;
• d. retrieving from said medium information identifying a subpopulation of said female
patients who are capable of becoming pregnant and male patients who are capable of
impregnating females;
• e. providing to the subpopulation, counseling information concerning the risks attendant
to fetal exposure to said drug;
• f. determining whether patients comprising said subpopulation are pregnant; and
• g. in response to a determination of non-pregnancy for said patients, authorizing said
registered pharmacies to fill prescriptions from said registered prescribers for said non-
pregnant registered patients.
• Patent expires: Aug. 28, 2018.
48
Coalition For Affordable Drugs VI LLC v. Celgene Corp.,
IPR2015-01092
• 2 Grounds asserted, both §103.
• Petition combines references that discuss the importance of
monitoring and counseling patients regarding the risks of pregnancy
while taking teratogenic drugs, such as thalidomide, with references
teaching such computer-based programs for other drugs.
• Petition argues keeping records in a computer readable storage
medium would have been obvious to a person of ordinary skill in the
art, as a matter of routine optimization.
• None of asserted references was before the Examiner during
prosecution.
49
Coalition For Affordable Drugs VI LLC v. Celgene Corp.,
IPR2015-01092
• Related litigation
• Celgene Corp. v. Lannett Holdings, Inc., 2-15-cv-00697 (NJD) (filed
January 30, 2015) - pending (Briefing on Motion to Dismiss for Lack of
Jurisdiction and Improper Venue).
• Celgene Corp. v. Natco Pharma Ltd., 2-10-cv-05197 (NJD) (filed October
8, 2010) - Current status: Order regarding infringement entered May 7,
2014.
• Celgene Corp. v. Barr Labs., Inc., 2-08-cv-03357 (NJD) (filed July 3, 2008);
Celgene Corp. v. Barr Labs., Inc., 2-07-cv-05485 (NJD) (filed November 14,
2007); Celgene Corp. v. Barr Labs., Inc., 2-07-cv-04050 (NJD) (filed
August 23, 2007); Celgene Corp. v. Barr Labs., Inc., 2-07-cv-00287 (NJD)
(filed January 18, 2007) - cases consolidated and dismissed w/out
prejudice on May 26, 2010.
50
Coalition For Affordable Drugs VI LLC v. Celgene Corp.,
IPR2015-01102, -01103, -01096
• U.S. Pat. No. 6,315,720
• Claim 1. In a method for delivering a drug to a patient in need of the drug, while avoiding
the occurrence of an adverse side effect known or suspected of being caused by said drug,
wherein said method is of the type in which prescriptions for said drug are filled only
after a computer readable storage medium has been consulted to assure that the
prescriber is registered in said medium and qualified to prescribe said drug, that the
pharmacy is registered in said medium and qualified to fill the prescription for said drug,
and the patient is registered in said medium and approved to receive said drug, the
improvement comprising: • a. defining a plurality of patient risk groups based upon a predefined set of risk parameters for said
drug;
• b. defining a set of information to be obtained from said patient, which information is probative of
the risk that said adverse side effect is likely to occur if said drug is taken by said patient;
• c. in response to said information set, assigning said patient to at least one of said risk groups and
entering said risk group assignment in said medium;
• d. based upon said information and said risk group assignment, determining whether the risk that
said adverse side effect is likely to occur is acceptable; and
• e. upon a determination that said risk is acceptable, generating a prescription approval code to be
retrieved by said pharmacy before said prescription is filled.
• Patent expires: Oct. 23, 2020.
51
Coalition For Affordable Drugs VI LLC v. Celgene Corp.,
IPR2015-01102, -01103, -01096
• -01096 Petition
• Challenges all 32 claims
• 2 Grounds: §102 and §103.
• §102: Petition cites discussion in Thalidomide Package Insert of the
special restricted distribution program approved by the FDA, and
argues the claimed step of generating a prescription approval code is
inherent in the system disclosed in the Package Insert.
• §103: Petition argues that if the step of generating a prescription
approval code is not inherent in the Package Insert, it is obvious over
the teachings of another cited reference.
52
Coalition For Affordable Drugs VI LLC v. Celgene Corp.,
IPR2015-01102, -01103, -01096
• -01102 Petition
• Challenges all 32 claims.
• 1 ground: §103
• Essentially combines the arguments of -01092 and -01096 Petitions.
• -01103 Petition
• Challenges all 32 claims.
• 1 ground: §103
• Essentially combines the arguments of -01092 and -01096 Petitions.
53
Coalition For Affordable Drugs VI LLC v. Celgene Corp.,
IPR2015-01102, -01103, -01096
• Related litigation (same as for U.S. Pat. No. 6,045,501 at issue in IPR2015-
01092)
• Celgene Corp. v. Lannett Holdings, Inc., 2-15-cv-00697 (NJD) (filed January 30,
2015) - pending (Briefing on Motion to Dismiss for Lack of Jurisdiction and
Improper Venue).
• Celgene Corp. v. Natco Pharma Ltd., 2-10-cv-05197 (NJD) (filed October 8, 2010)
- Current status: Order Regarding Infringement entered May 7, 2014
• Celgene Corp. v. Barr Labs., Inc., 2-08-cv-03357 (NJD) (filed July 3, 2008);
Celgene Corp. v. Barr Labs., Inc., 2-07-cv-05485 (NJD) (filed November 14,
2007); Celgene Corp. v. Barr Labs., Inc., 2-07-cv-04050 (NJD) (filed August 23,
2007); Celgene Corp. v. Barr Labs., Inc., 2-07-cv-00287 (NJD) (filed January 18,
2007) - cases consolidated and dismissed w/out prejudice on May 26, 2010.
54
Coalition For Affordable Drugs VI LLC v. Celgene Corp.,
IPR2015-01169
• U.S. Pat. No. 5,635,517
• Claim 1: The method of reducing undesirable levels of TNFα in a mammal
which comprises administering thereto an effective amount of a compound of
the formula:
• in which in said compound one of X and Y is C=O and the other of X and Y is C=O
or CH2.
• Patent expires:
• October 4, 2019 for drug substance claims relating to lenalidomide.
• July 24, 2016 for all other claims.
55
Coalition For Affordable Drugs VI LLC v. Celgene Corp.,
IPR2015-01169
• 3 grounds asserted, all §103.
• Ground 1: Petition argues it would have been obvious to use the claimed
thalidomide analogs for reducing TNFα production because the cited
references show that the parent molecule (thalidomide) and other analogs
have that property.
• Ground 2: Petition argues that the cited combination of references shows
a direct link between structure and function among thalidomide analogs,
and establishes an expectation that structurally similar analogs of
thalidomide will behave like their parent compounds.
• Ground 3: Petition argues that two of the cited references establish a
“lead compound” and the remaining references provide motivation to
make the claimed modifications, which were known to maintain the anti-
inflammatory activity of thalidomide and to increase solubility.
• Asserted references – one considered during prosecution.
56
Coalition For Affordable Drugs VI LLC v. Celgene Corp.,
IPR2015-01169
• Related litigation
• Celgene Corp. v. Natco Pharma Ltd., 2-12-cv-04571 (NJD) (filed
July 20, 2012) – pending.
• Celgene Corp. v. Natco Pharma Ltd., 2-10-cv-05197 (NJD) (filed
October 8, 2010) – pending.
57
What Can Innovative Pharma Do Today To Strengthen Their
Patents To Enhance The Chance Of Survival In IPR,
Irrespective Of The Identity Of The Petitioner
58
Reminder of Standards Unfavorable to Patent Owner
ISSUE PGR/CBM PGR/IPR DISTRICT COURT
Burden of proof Preponderance of the
evidence Clear and convincing
evidence
Presumption of Validity?
No Yes
Claim construction Broadest reasonable Interpretation (BRI)*
Phillips/Markman framework: analyze claims, specification,
and prosecution history to determine how claims would
be understood by one of ordinary skill in the art
Decision maker Patent Trial and
Appeal Board (APJs) District court judge or jury
* and no attempt to preserve patentability; also not bound to follow district court’s construction, if it exists.
59
25% of the Institution Decisions Have Been Denials
Patent Owner’s best outcome is a denial
60
Institution Decision Non-Appealable
• 35 U.S.C. § 314(d): NO APPEAL.—The
determination by the Director whether
to institute an inter partes review
under this section shall be final and
nonappealable.
61
Federal Circuit Treatment So Far
• In re Cuozzo Speed Technologies, LLC, 778 F.3d 1271 (Fed. Cir. 2015)
• No jurisdiction to review PTAB’s IPR institution decision (See 35 U.S.C. § 314(d)).
• Affirm PTAB’s Final Written Decision in full (all instituted claims unpatentable as obvious)
• No error in PTAB’s application of BRI claim construction standard;
• No error in obviousness determination; and
• No error in denial of Cuozzo’s motion to amend.
― Lack of written description support;
― Improper broadening
62 62
Federal Circuit Using Rule 36 Affirmances for PTAB Appeals Note: Affirmance Rate is 100%
• Rule 36 non-precedential decisions affirming PTAB decisions:
• Softview LLC v. Kyocera Corp., No. 2014-1599, 592 Fed.Appx. 949 (Fed. Cir. Feb. 9, 2015) (same) (IPR2013-00004)
(joined)
• Softview LLC v. Kyocera Corp., No. 2014-1599, 592 Fed.Appx. 949 (Fed. Cir. Feb. 9, 2015) (same) (IPR2013-00257)
(joined)
• Softview LLC v. Kyocera Corp., No. 2014-1600, 592 Fed.Appx. 947 (Fed. Cir. Feb. 9, 2015) (same) (IPR2013-00007)
(joined)
• Softview LLC v. Kyocera Corp., No. 2014-1600, 592 Fed.Appx. 947 (Fed. Cir. Feb. 9, 2015) (same) (IPR2013-00256)
(joined)
• Board Of Trustees Of The University Of Illinois v. Micron Technology, Inc., No. 2014-1509, __Fed. Appx. __ (Fed. Cir.
March 12, 2015) (same) (IPR2013-00005)
• Board Of Trustees Of The University Of Illinois v. Micron Technology, Inc., No. 2014-1510, __Fed. Appx. __ (Fed. Cir.
March 12, 2015) (same) (IPR2013-00006)
• Board Of Trustees Of The University Of Illinois v. Micron Technology, Inc., No. 2014-1511, __Fed. Appx. __ (Fed. Cir.
March 12, 2015) (same) (IPR2013-00008) • Clearlamp, LLC v. LKQ Corp., 594 Fed.Appx. 687 (Fed. Cir. Feb. 18, 2015)
• In re Zillow, Inc., --Fed. Appx. __ (Fed. Cir. March 12, 2015)
• Helferich Patent Licensing, LLC v. CBS Interactive, Inc., --Fed. Appx. __ (Fed. Cir. April 8, 2015)
• Also written decisions affirming PTAB decisions: • In re Cuozzo Speed Technologies, LLC, 778 F.3d 1271 (Fed. Cir. 2015)
• Belden Inc. v. Berk-Tek LLC, 2015 WL 1781484 (Fed. Cir. Apr. 17, 2015) (affirmed in written decision) (IPR2013-
00058)(non-precedential)
• Belden Inc. v. Berk-Tek LLC, 2015 WL 1781484 (Fed. Cir. Apr. 17, 2015) (affirmed in written decision) (IPR2013-
00069)(non-precedential)
63
What Are Some Examples Of The Bases Of These Denials?
• Failure to name real-party-in-interest as required by 35 U.S.C. §312(a)(2) and 37 C.F.R. §42.8(b)(1). • Very fact-dependent. • This is one area where we are seeing motions for additional discovery granted.
• Time-barred under 35 U.S.C. §315(b)
• Same or substantially the same prior art/arguments under 35 U.S.C. §325(d)
• “Same or substantially the same prior art or arguments” during prosecution • “Same or substantially the same prior art or arguments” in another IPR petition
• Claim construction
• Insufficient evidence to meet threshold for institution
• 35 U.S.C. §314(a): “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.”
• Objective evidence of nonobviousness
• Reference is not prior art
64
Filing POPR Is Optional, But More Petitions Denied When POPR Filed:
Sample from Pharma/Chem IPR Petitions
POPR filed in denied petition,
47
No POPR filed in denied
petition, 3
POPR filed in partially
denied petition, 25
No POPR filed in
partially denied
petition, 6
In 94% (47/50) of cases where petition denied, POPR was filed.
In 81% (25/31) of cases where petition partially denied, POPR was filed.
“Partially denied” indicates institution on fewer than all claims challenged in the petition.
Source: Finnegan research. As of May 13, 2015.
65
Filing POPR Is Optional, But More Petitions Denied When POPR Filed:
Sample from Pharma/Chem IPR Petitions
Source: Finnegan research. As of May 13, 2015. “Denied-in-Part” indicates institution on fewer than all claims challenged in the petition.
73 50%
25 17%
47 33%
POPR Filed (145 cases)
Instituted Denied-in-Part Denied
33 79%
6 14%
3 7%
POPR Not Filed (42 cases)
Instituted Denied-in-Part Denied
66
Use the POPR to Tell PTAB Why Petition Should Be Denied
• Do not make PTAB figure it out.
• PTAB just does not have time.
• PTAB looking for the concise, compelling
argument.
67
“Front-load” to Maximize Chance of Success at Institution Stage
• Institution decision is substantive
• Don’t hold back arguments:
• Actavis, Inc. v. Research Corporation Technologies, Inc., IPR2014-
01126, Paper 21 (PTAB Jan. 9, 2015):
• “Therefore, based on the record before us, we determine that Petitioner has
not provided competent evidence to qualify the LeGall thesis as a “printed
publication” under § 102(b). Petitioner may have recognized this deficiency.
Indeed, in a footnote, Petitioner states that it “reserves the right to
supplement this Petition with additional evidence that the LeGall thesis was
accessible to a POSA well before” the critical date. Pet. 36 n. 3. But a party
may only submit supplemental information after a trial has been instituted
(37 C.F.R. § 42.123) while we must decide whether to institute a trial based
on “the information presented in the petition” (35 U.S.C. § 314(a)). Because
the Petition and the accompanying evidence are insufficient to qualify the
LeGall thesis as a § 102(b) prior art, we deny the Petition regarding this ground.
(emphasis added)
68
Suggestions
• Claim construction is critical.
• If the Patent Owner has not made it clear in
specification and claims, it could be a tough go for
the Patent Owner.
• Lack of specification definition/claim clarity
could force PTAB to rely on dictionary
definitions.
69
Take-Away
• Drafting and prosecution
• Define terms judiciously, considering dual objectives of
patentability and proving infringement.
• Once defined, use terms consistently.
• Lay basis for Patent Owner’s desired claim construction, both
at PTAB and in district court litigation, and enhance chances
of PTAB denial of institution.
• Probably want range of claims from broad to narrow, but
consider what limits you want on broad claims so that the
broadest reasonable interpretation (BRI) is not unreasonable.
• Rely on such a specification in POPR when attacking
Petitioner’s proposed BRI! 70
Practitioner Drafting And Prosecution Tools To Strengthen Potentially Important Patent Applications
and Increase Chances of IPR Denial
o Build up specification and file history during drafting and
prosecution.
Patent Owners cannot present newly-generated declaration
evidence in a Patent Owner's Preliminary Response (POPR);
Solidify novelty, non-obviousness, enablement, and written
description positions.
Consider declarations during prosecution, but be mindful of
inequitable conduct attacks in litigation.
71
Declarations to Provide Foundation for Denial
• Declarations need to be as solid as possible. PTAB has found that defective declarations relied on for patentability during prosecution can form an independent basis for instituting an IPR.
• K-40 Electronics, LLC v. Escort, Inc., IPR2013-00203, Paper 6 (PTAB Aug. 29, 2013)
― Board reviewed a § 1.131 declaration from the prosecution, found it
deficient, and reapplied the prior art the declaration had antedated, instituting the IPR.
― Case also had live testimony from inventor at oral hearing. ― One might want declarations from the inventor during prosecution that
can then by referred to by the Patent Owner in the optional Preliminary Response to try to ward off institution.
• Therasense always a consideration with declarations.
72
Thank You!
Contact Information:
Tom Irving
202.408.4082
Barbara Rudolph, Ph.D.
202.408.4346
Amanda Murphy, Ph.D.
202.408.4114
Rekha Bensal
650.416.7711
73