BIODELIVERY SCIENCES INTERNATIONAL, INC.v.MONOSOL RX, LLC

Patent Trials and Appeals Board

Nov 13, 2013

10768809 - (D) (P.T.A.B. Nov. 13, 2013)

Trials@uspto.gov Paper 28
Tel: 571-272-7822 Entered: November 13, 2013

UNITED STATES PATENT AND TRADEMARK OFFICE

_______________

BEFORE THE PATENT TRIAL AND APPEAL BOARD

_______________

BIODELIVERY SCIENCES INTERNATIONAL, INC.
Petitioner

v.

MONOSOL RX, LLC
Patent Owner
_______________

Case IPR2013-00316
Patent 7,357,891
_______________

Before JACQUELINE WRIGHT BONILLA, SCOTT E. KAMHOLZ, and
CHRISTOPHER L. CRUMBLEY, Administrative Patent Judges.

KAMHOLZ, Administrative Patent Judge.

DECISION
Denying Institution of Inter Partes Review
37 C.F.R. § 42.108
Case IPR2013-00316
Patent 7,357,891

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I. INTRODUCTION
BioDelivery Sciences International, Inc. (“BioDelivery”) filed a petition
(Paper 5) on June 12, 2013, to institute an inter partes review of claims 10-28 of
U.S. Patent 7,357,891 (“the ’891 patent”). BioDelivery later filed a corrected
petition (Paper 10, “Pet.”). Patent Owner MonoSol Rx, LLC (“MonoSol”) filed
mandatory notices (Paper 17) and a preliminary response (Paper 22,
“Prelim. Resp.”). The Board, acting on behalf of the Director, has jurisdiction
under 35 U.S.C. § 314.
MonoSol asserted the ’891 patent against BioDelivery in a civil action styled
MonoSol Rx, LLC v. BioDelivery Sci. Int’l, Inc. et al., 10-cv-05695 (D.N.J.) (“the
’695 action”). Pet. 1; Prelim. Resp. 4. BioDelivery was served with a “Second
Amended Complaint” alleging infringement of the ’292 patent on September 27,
2011. Paper 17, 3. BioDelivery requested ex parte reexamination of the ’891
patent on January 20, 2012. Paper 17, 3; Ex. 2005, 44. Reexamination
No. 90/012,098 was ordered on March 1, 2012. Pet. 3. The reexamination
proceeding terminated August 21, 2012, upon issuance of a reexamination
certificate by which each of the original claims 1-9 was canceled and new claims
10-28 were added. Ex. 1002, 1-2. The parties represent that the ’695 action was
stayed pending resolution of the reexamination, and that it remains stayed. Pet. 2;
Paper 17, 4.
We deny the petition because it was not filed within the one-year period set
forth in 35 U.S.C. § 315(b).
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II. ANALYSIS
Section 315(b) of Title 35 of the United States Code provides:
(b) PATENT OWNER’S ACTION.—An inter partes
review may not be instituted if the petition requesting the
proceeding is filed more than 1 year after the date on
which the petitioner, real party in interest, or privy of the
petitioner is served with a complaint alleging infringe-
ment of the patent. The time limitation set forth in the
preceding sentence shall not apply to a request for joinder
under subsection (c).
We must decide whether 35 U.S.C. § 315(b) bars a petition filed more than
one year after a complaint alleging infringement was served on the petitioner, even
when the petition challenges claims amended by a reexamination certificate issued
after service of the complaint. We determine that it does.
BioDelivery contends that its petition is timely because it has not been
served with a complaint alleging infringement of the claims amended in
reexamination. Pet. 4-5. BioDelivery argues that issuance of the reexamination
certificate effectively created a new patent—the “ ’891C1” patent—in which none
of the claims is substantially identical to the claims in the original “ ’891B2”
patent. Id. BioDelivery argues that the “ ’891C1” patent did not exist before July
3, 2012, and has no retroactive effect, due to substantial changes to all claims.
Id. (citing 35 U.S.C. §§ 307(b) and 252 ¶ 1). BioDelivery asserts that, for these
reasons, service of the complaint alleging infringement of the “ ’891B2” patent
should not bar a petition challenging claims of the “ ’891C1” patent. Id. 5.
We reject BioDelivery’s argument that reexamination results in the issuance
of a new patent. It does not. A reexamination certificate merely “incorporat[es] in
the patent any proposed amended or new claim determined to be patentable.”
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35 U.S.C. § 307(a) (emphasis added). The reexamination certificate itself states:
“The patent is hereby amended as indicated below.” Ex. 1002, 2 (emphasis
added). Accord Aspex Eyewear, Inc. v. Marchon Eyewear, Inc., 672 F.3d 1335,
1341-42 (Fed. Cir. 2012) (“Unlike reissue, reexamination does not result in the
surrender of the original patent and the issuance of a new patent.”). The identical
reference in § 315(b), to the “the date on which the petitioner . . . is served with a
complaint alleging infringement of the patent” (emphasis added), indicates that the
timeliness analysis is to be made with reference to “the patent.”
BioDelivery’s arguments concerning the effects of reexamination as set forth
in 35 U.S.C. §§ 307(b) and 252 are not persuasive. BioDelivery does not explain
why these provisions, which specify the effect of an “amended or new claim” in a
reexamined patent, should have any bearing on the applicability of § 315(b). In
particular, BioDelivery does not explain how § 307(b) or § 252 nullifies service of
MonoSol’s “Second Amended Complaint” alleging infringement of the ’891
patent. Those sections do not state or imply that an infringement complaint is to be
treated as if it never had been served, when the asserted patent is afterward
amended by reexamination. Whatever the effects of the amended claims of the
’891 patent, the complaint still stands and bars institution of inter partes review.
BioDelivery argues also that they have not had a full year to evaluate the
claims as amended by the reexamination certificate, a period Congress deemed
important when enacting the legislation. Pet. 5-6 (citing 157 CONG. REC. S5429
(daily ed. Sep. 8, 2011) (statement of Sen. Kyl)). This argument is not persuasive,
because BioDelivery had its year to evaluate the claims, as discussed above. That
year ended September 27, 2012. BioDelivery itself manufactured any supposed
reduction in its evaluation time by requesting ex parte reexamination.
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BioDelivery argues that Fresenius USA, Inc. v. Baxter Intern., Inc., 721 F.3d
1330 (Fed. Cir. 2013), rendered after BioDelivery filed its petition, “is directly on
point to the issue to the contested issue of standing.” Paper 26, 2. We disagree.
Fresenius addressed a situation in which all claims at issue in a complaint
subsequently were cancelled during reexamination. Fresenius, 721 F.3d at
1334-35. The Federal Circuit held that cancellation of all claims during
reexamination was binding on a pending district court infringement litigation
because no court had rendered a sufficiently “final” judgment. Id. at 1346-
47. That is not the situation before us now.
BioDelivery was served with MonoSol’s complaint alleging infringement of
the ’891 patent on September 27, 2011. The petition was filed more than one year
after that date and is, therefore, barred.
III. CONCLUSION
The Board denies the petition because it was not filed within the time limit
imposed by 35 U.S.C. § 315(b).
IV. ORDER
For the reasons given, it is
ORDERED that the petition challenging the patentability of claims 1-55 of
U.S. Patent 7,357,891 is denied.

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For PETITIONER:

Danielle L. Herritt
Kia L. Freeman
McCarter & English, LLP
dherritt@mccarter.com
IPR891@mccarter.com

For PATENT OWNER:

Harold H. Fox
Steptoe & Johnson LLP
hfox@steptoe.com

Daniel A. Scola, Jr.
Michael I. Chakansky
Hoffman & Baron, LLP
dscola@hbiplaw.com
mchakansky@hbiplaw.com