Beruflich Dokumente
Kultur Dokumente
______
Filed: April 23, 2015
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
___________________
COALITION FOR AFFORDABLE DRUGS VI LLC
PETITIONER
V.
CELGENE
PATENT OWNER
___________________
CASE NO.: UNASSIGNED
PATENT NO. 6,315,720
FILED: OCTOBER 23, 2000
ISSUED: NOVEMBER 13, 2001
INVENTORS: BRUCE A. WILLIAMS AND JOSEPH K. KAMINSKI
TITLE: 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
___________________
PETITION FOR INTER PARTES REVIEW
OF U.S. PATENT NO. 6,315,720
I.
INTRODUCTION ..................................................................................................... 1
II.
C.
IV.
V.
2.
3.
B.
1.
Consulted ......................................................................................................... 10
2.
3.
C.
2.
3.
4.
5.
6.
7.
8.
9.
B.
2.
3.
4.
5.
ii
iv
Description
Exhibit 1001
Exhibit 1002
Exhibit 1003
U.S. Patent No. 6,045,501 to Marc Elsayed and Bruce Williams, filed
on Aug. 28, 1998, and issued on Apr. 4, 2000 (Elsayed)
Exhibit 1004
Exhibit 1005
U.S. Patent No. 6,202,923 to Joseph H. Boyer et al., filed on Aug. 23,
1999, and issued on Mar. 20, 2001 (Boyer)
Exhibit 1006
Exhibit 1007
Exhibit 1008
Exhibit 1009
Exhibit 1010
Exhibit 1011
Exhibit 1012
Exhibit 1013
Description
Exhibit 1014
Exhibit 1015
Exhibit 1016
Exhibit 1017
Exhibit 1018
Exhibit 1019
Exhibit 1020
Exhibit 1021
Exhibit 1022
Exhibit 1023
Exhibit 1024
Exhibit 1025
vi
INTRODUCTION
Petitioner Coalition For Affordable Drugs VI LLC (CFAD), requests an Inter
Partes Review (IPR) of Claims 132 (collectively, the Challenged Claims) of U.S.
Patent No. 6,315,720 (the 720 Patent) (Ex. 1001) in accordance with 35 U.S.C.
31119 and 37 C.F.R. 42.100 et seq.
II.
available for IPR and that Petitioner is not barred or estopped from requesting IPR
challenging the claims of the 720 patent on the grounds identified in this Petition.
III.
A.
Affordable Drugs VI LLC (CFAD VI), Hayman Credes Master Fund, L.P.
(Credes), Hayman Orange Fund SPC Portfolio A (HOF), Hayman Capital
Master Fund, L.P. (HCMF), Hayman Capital Management, L.P. (HCM), Hayman
Offshore Management, Inc. (HOM), Hayman Investments, L.L.C. (HI), nXn
Partners, LLC (nXnP), IP Navigation Group, LLC (IPNav), J. Kyle Bass, and
Erich Spangenberg are the real parties in interest (collectively, RPI). The RPI
hereby certify the following information: CFAD VI is a wholly owned subsidiary of
Credes. Credes is a limited partnership. HOF is a segregated portfolio company.
HCMF is a limited partnership. HCM is the general partner and investment manager
1
been the subject of the following lawsuits: Celgene Corp. et al. v. Lannett Holdings, Inc. et
al., NJD-2-15-00697 (filed Jan. 30, 2015); Celgene Corp. v. Natco Pharma Ltd., NJD-2-10cv-05197 (filed Oct. 8, 2010); Celgene Corp. et al. v. Barr Laboratories, Inc. et al., NJD-22
42.103(a) and 42.15(a). If any additional fees are due during this proceeding, the
Office is authorized to charge such fees to Deposit Account No. 506293. Any
overpayment or refund of fees may also be deposited in this Deposit Account.
V.
IDENTIFICATION OF CHALLENGE
A.
The 720 Patent claims methods for delivering a drug to a patient, while
avoiding the occurrence of adverse side effects. (Id. at Abstract.) The 720 Patent
generally describes methods for the distribution to patients of drugs, particularly
teratogenic drugs, in ways wherein such distribution can be carefully monitored and
controlled. (Id. at 1:1316.) A teratogenic drug can cause severe birth defects when
administered to a pregnant woman. (Id. at 1:2729.) The 720 specification
acknowledges that prior [m]ethods for monitoring and educating patients to whom a
drug is distributed have been developed in connection with a known teratogenic
drug (isotretinoin), including a pregnancy prevention program. (Id. at 2:1320.)
The invention of the 720 Patent was allegedly conceived in the context of the
FDA approval of thalidomidea teratogenic drug effective in treating a variety of
diseaseswhen the inventors were seeking methods to control the distribution of
[thalidomide] so as to preclude administration to foetuses. (Id. at 1:4664.)
The 720 Patents invention can be summarized as: (1) filling prescriptions only
after consulting a computer readable storage medium to confirm that the prescribers,
pharmacies, and patients are registered in a computer database; (2) assigning patients
to risk groups based on the risk that the drug will cause adverse side effects and
4
The 720 Patent has two independent claims and 30 dependent claims. Claim 1
is representative and is reproduced below.
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
5
Except for the prosecution history, exhibit cites herein are directed to the internal
page numbers of the exhibit, rather than to the Exhibits Bates numbers.
7
Consulted
Consulted means accessed and considered. (Ex. 1023 at 3; Ex. 1021 39.)
2.
Teratogenic effect
Teratogenic effect means any effect that disturbs the normal growth and
development of an embryo or fetus. (Ex. 1023 at 3; Ex. 1021 40.)
Petitioner notes that, in some instances, the patentee has defined claim terms apart
from their plain meaning. See Pacing Techs., LLC v. Garmin Intl, Inc., 778 F.3d 1021,
1024 (Fed. Cir. 2015). These terms include drug, computer readable storage
medium, patient risk groups, risk parameters, risk group assignment, likely to
occur, prescription approval code, counseled, risk avoidance measures, and
informed consent. (Ex. 1001 at 3:3538, 3:4548, 4:5456, 5:2933, 6:307:19,
8:4557, 9:826, 10:4146, 13:4464.)
10
Petitioner requests IPR under 35 U.S.C. 311 of Claims 132 of the 720
Patent, and cancellation of these 32 claims as unpatentable.
2.
Petitioner requests IPR of Claims 132 of the 720 Patent in view of the
following references, each of which is prior art to the 720 Patent under 35 U.S.C.
102(a) and (b) or 103. The Examiner did not reference any of the prior art listed in
the following chart in any Office Action. (See generally, Ex. 1002.) Claims 132 are
unpatentable under 35 U.S.C. 102(b) and 103(a):
Ground Proposed Rejections for the 720 Patent
1
Claims 132 are anticipated under 35 U.S.C.
Exhibit Number(s)
1006
Claims 132 are obvious under 35 U.S.C. 103(a) in 1006 and 1009
view of Thalomid PI (Ex. 1006) and Cunningham (Ex.
1009).
11
which can cause birth defectsneeded to be regulated. (See, e.g., Ex. 1007 at 90104;
Ex. 1011 at 10105.) The central regulatory goal was to avoid pregnancy in patients
treated with the drug. (See, e.g., Ex. 1011 at 101.) One notable case of a drug marketed
through methods to prevent its use in pregnant patients is isotretinoin, marketed
under the trade name Accutane. (See id. at 101.) Rather than remove this drug from
the market once its teratogenicity was realized, isotretinoin became part of a
manufacturer-sponsored Pregnancy Prevention Program (PPP). (Id. at 101.) The
program, among other features, included the distribution to physicians of a kit that
included informed consent documents and patient counseling information. (Id. at
101.) In particular, patients were warned against the teratogenic risk of isotretinoin
and the need to prevent pregnancy while taking the drug. (Id. at 105.) Patients were
also advised as to the proper methods of birth control available. (See id. at 103.)
Thalidomide is a drug that originated in Germany in 1957. (Ex. 1001 at 1:40
41.) Doctors initially prescribed the drug as a sedative, but quickly noticed its
effectiveness in treating a form of leprosy, erythema nodosum leprosum (ENL), as
well. (Ex. 1012 at 32021.) However, shortly after thalidomide came on the market,
doctors realized that the drug caused severe birth defects in infants whose mothers
took the drug while pregnant. (Ex. 1012 at 320.) As a result, thalidomide was generally
12
occurrence of an adverse side effect was known before October 23, 2000the earliest
possible priority date for the 720 Patentas evidenced by the THALOMID
(thalidomide) Capsules Revised Package Insert (15 July 1998) (Thalomid PI). (See
14
15
16
Claim 1 of the 720 Patent is written in Jepson format, meaning that the claim
first describes the scope of the prior art and then claims an improvement over the
prior art. Dow Chem. Co. v. Sumitomo Chem. Co., 257 F.3d 1364, 1368 (Fed. Cir. 2001).
Specifically, the Claim 1 preamble recites:
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
17
22
Claims 710 depend from Claim 1, and merely add limitations anticipated by
Thalomid PI. Claim 7 requires that the information to be obtained from said patient,
25
27
Claims 1114, and 2125 depend from Claim 1, and merely add limitations
anticipated by Thalomid PI. Claims 11, 12, and 13 respectively require that the drugs
associated side effect is likely to arise in said patient, is likely to arise in a foetus
carried by said patient, and is likely to arise in a recipient or a foetus carried by a
recipient of the bodily fluid of said patient, while Claim 14 requires that the Claim
12 recipient is a sexual partner of said patient. (Ex. 1001 at 19:19.) Claim 22
requires that the drug is thalidomide. (Ex. 1001 at 19:3435.) Claim 21 requires that
the drugs associated side effect comprises a teratogenic effect, while Claims 23
and 24 respectively require that the Claim 21 teratogenic effect is likely to arise in a
foetus carried by said patient, and is likely to arise in a foetus carried by a recipient
of the bodily fluid of said patient. Claim 25 requires that the Claim 24 recipient of
the bodily fluid of said patient is a sexual partner of said patient. (Ex. 1001 at 19:32
33, 3642.) Claim 20 requires providing said patient with a contraceptive device or
formulation. (Ex. 1001 at 19:3031.)
Thalomid PI explicitly discloses that thalidomides side effects arise in the
patient taking the drugin the case of peripheral neuropathy, and also in a fetus
carried by the patient taking the drugin the case of teratogenicity, anticipating
Claims 11, 12, 21, 22 and 23. (Ex. 1006 at 1, 2, 8, 9, 10; Ex. 1021 14950.)
Thalomid PI also explicitly discloses that thalidomide side effects likely arise in a
sexual partner and recipient of bodily fluid of a male treated with the drug,
28
29
Claims 1617 depend from Claim 1, and merely add limitations anticipated by
Thalomid PI. Claim 16 requires that the Claim 15 second set of information
comprises a survey regarding said patients behavior and compliance with said risk
avoidance measures, while Claim 17 requires that the Claim 16 survey is conducted
telephonically using an integrated voice response system. (Ex. 1001 at 19:1924.)
With respect to Claim 16s requirement of a survey regarding said patients
behavior and compliance with said risk avoidance measures, Thalomid PI teaches the
importance of compliance with risk avoidance measures, as well as pre-treatment
31
Claims 1819 and 2627 ultimately depend from Claim 1, and merely add
limitations anticipated by Thalomid PI. Claim 18 requires that, where the patient is a
female of childbearing potential, the Claim 15 second set of information collected on
a periodic basis comprises the results of a pregnancy test, while Claim 19 requires
that the periodic interval for the Claim 18 pregnancy test comprises about 28 days.
(Ex. 1001 at 19:2529.) Claim 26 similarly requires that, where the drug has a
teratogenic effect, the information to be obtained from said patient includes the
results of a pregnancy test, while Claim 27 adds to the requirements of Claim 26 that
said prescription is filled for no more than about 28 days. (Ex. 1001 at 19:4320:2.)
Thalomid PI explicitly discloses that, in light of thalidomides teratogenicity,
[b]efore starting treatment, women of childbearing potential should have a
pregnancy test within the 24 hours prior to beginning therapy, as required by
Claim 26. (Ex. 1006 at 2; see also Id. at 9, 1112, 20.)
Thalomid PI further anticipates the Claim 18 and 19 requirements for obtaining
periodic pregnancy test results every about 28 days by requiring that the patient
acknowledge I know that I must have a pregnancy test done every week during the
first 4 weeks of THALOMID therapy. I will then have a pregnancy test every 4 weeks
33
Claim 28, although an independent claim, merely repeats the language of Claim
1 with a single added limitation anticipated by Thalomid PI. Claims 2932 depend from
Claim 28, and similarly add limitations already known in the field and anticipated by
Thalomid PI. In addition to the exact requirements of Claim 1, Claim 28 requires that
said adverse side effect is likely to arise in patients who take said drug in combination
with at least one other drug. (Ex. 1001 at 20:331.) Claims 29 and 30 respectively
require that the information to be obtained from said patient is also probative of
the likelihood that said patient may take said drug and said other drug in
combination, and includes the results of diagnostic testing, while Claims 31 and
32 respectively require that the Claim 30 diagnostic testing comprises testing for
34
Element
1pre. 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
Prior Art
Thalomid PI teaches a method for delivering thalidomide to a
patient in need of the drug, while avoiding the occurrence of an
adverse side effect:
Ex. 1006 at 2 (THALOMIDTM (thalidomide) may be
prescribed only by licensed prescribers who are registered in the
S.T.E.P.S. program and understand the risk of teratogenicity if
thalidomide is used during pregnancy.);
Id. at 1 (Thalidomide is contraindicated in WOMEN of
36
;
Id. at 21
38
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;
.
Thalomid PI discloses that the patient is assigned to one of the
risk groups and this information is entered into the S.T.E.P.S.
database:
Ex. 1006 at 3 (Thalidomide is contraindicated in WOMEN of
childbearing potential unless alternative therapies are considered
inappropriate AND the patient MEETS ALL OF THE
FOLLOWING CONDITIONS (i.e., she is essentially unable to
become pregnant while on thalidomide therapy).);
Id. at 4 (Thalidomide is contraindicated in sexually mature
MALES unless the PATIENT MEETS ALL OF THE
FOLLOWING CONDITIONS: he is capable of complying
with the mandatory contraceptive measures that are appropriate
for men, patient registration, and patient survey as described in
the S.T.E.P.S. program.);
Id. at 1 (UNDER THIS RESTRICTED DISTRIBUTION
PROGRAM, ONLY PRESCRIBERS AND PHARMACISTS
REGISTERED WITH THE PROGRAM ARE ALLOWED
TO PRESCRIBE AND DISPENSE THE PRODUCT. IN
ADDITION, PATIENTS MUST BE ADVISED OF, AGREE
TO, AND COMPLY WITH THE REQUIREMENTS OF
THE S.T.E.P.S. PROGRAM IN ORDER TO RECEIVE
PRODUCT.);
Id. at 21
39
.
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
2. The method of
claim 1 wherein, in
response to said
risk group
assignment, said
patient is counseled
as to the risks of
taking said drug
and advised as to
risk avoidance
measures.
3. The method of
claim 2 wherein
said counseling
comprises full
disclosure of said
risks.
4. The method of
claim 3 wherein
said prescription is
filled only
following said full
disclosure and
7. The method of
claim 1 wherein
said set of
information
includes the results
of diagnostic
testing.
8. The method of
claim 7 wherein
said diagnostic
testing is probative
of the onset of said
adverse side effect.
9. The method of
claim 7 wherein
said diagnostic
testing is probative
of the
concentration of
said drug in a tissue
of said patient.
10. The method of
claim 7 wherein
said diagnostic
testing comprises
genetic testing.
11. The method of
claim 1 wherein
said side effect is
likely to arise in
said patient.
g. obtaining said
second set of
information from
said patient; and
h. entering said
second set of
information in said
medium before
B.
was filed in 1995 and granted in 1998. (Ex. 1009 at Cover.) During the prosecution of
the 720 Patent, the examiner did not consider this reference. (See Ex. 1001 at Cover.)
3
For all claim elements not specifically discussed under Ground 2, those claim
Claims 1(e) and 28(e) 4 of the 720 Patent require that, upon a determination
that said risk is acceptable, generating a prescription approval code to be retrieved by
said pharmacy before said prescription is filled. (Ex. 1001 at 18:4042.) This
mechanism would have been obvious to a person of ordinary skill in the art, upon
reading Thalomid PI, which discloses that a prescription may not be filled until the
risks are deemed acceptable and the prescription has been approved:
THALOMIDTM (thalidomide) may be prescribed only by licensed
prescribers who understand the risk of teratogenicity if thalidomide is
used during pregnancy. A prescription for thalidomide for a woman
53
Claim 5 requires that said risk group assignment and informed consent is
verified by said prescriber at the time that said patient is registered in said computer
54
58
All Thalomid PI disclosures are listed in the Ground 1 claim chart above.
Element
1e./28e. upon a
determination that
said risk is
acceptable,
generating a
prescription
approval code to
be retrieved by said
pharmacy before
said prescription is
Prior Art
Cunningham discloses an approval code lockout system for a
pharmacy:
Ex. 1009 at 11:68, 1723 (If authenticity is not established, it
follows that the participating pharmacy cannot dispense
corresponding pharmaceutical product. However, if
authenticity is established then the pharmac[ys] terminal dials
the central computing station and data and information from
the pharmac[ys] authorization media and personal identification
is uploaded to the database of the central computing station 12.
Assuming full validation, the central computing station
59
VII. CONCLUSION
Thus, Petitioners respectfully request inter partes review of Claims 132 of U.S.
Patent No. 6,315,720.
Respectfully Submitted,
/Sarah E. Spires/
Sarah E. Spires (Reg. No. 61,501)
SKIERMONT PUCKETT LLP
2200 Ross Ave. Ste. 4800W
Dallas, Texas 75201
P: 214-978-6600/F: 214-978-6601
Lead Counsel for Petitioner
60
/Sarah E. Spires/