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In re Armodafinil Patent Litigation Inc. (‘722 Patent Litigation), MDL No. 10-md-2200-GMS (D. Del. Mar. 30, 2013)

In re Armodafinil Patent Litigation Inc. (‘722 Patent Litigation), MDL No. 10-md-2200-GMS (D. Del. Mar. 30, 2013)

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IN THE UNITED STATES DISTRICT COURTFOR THE DISTRICT OF DELAWAREIN RE: ARMODAFINIL PATENT LITIGATIONINC. ('722 PATENT LITIGATION)CEPHALON, INC., CEPHALON FRANCE, andTEVA SANTE SAS,Plaintiffs,
v.
WATSON LABORATORIES, INC.,Defendant.CEPHALON, INC., CEPHALON FRANCE, andTEVA SANTE SAS,Plaintiffs,
v.
SANDOZ, INC.,Defendant.CEPHALON, INC., CEPHALON FRANCE, andTEV A SANTE SAS,Plaintiffs,
v.
LUPIN LIMITED,Defendant.CEPHALON, INC., CEPHALON FRANCE, andTEVA SANTE SAS,Plaintiffs,
v.
APOTEX, INC.,Defendant.
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MDL No. 10-md-2200 (GMS)Civil Action No. 10-cv-007 (GMS)Civil Action No. 10-cv-055 (GMS)Civil Action No. 11-cv-782 (GMS)Civil Action No. 10-cv-210 (GMS)Civil Action No. 10-cv-695 (GMS)Civil Action No. 10-cv-1078 (GMS)
 
MEMORANDUMI. INTRODUCTION
In this consolidated patent infringement action, plaintiffs Cephalon, Inc. and CephalonFrance (collectively, "the plaintiffs" or "Cephalon") allege that pharmaceutical products proposed
by
defendants Apotex, Inc., Lupin Limited, Sandoz, Inc., and Watson Laboratories, Inc.(collectively, "the defendants"), infringe the asserted claims
ofthe
patents-in-suit. (D.I.
1.)
Thecourt held a four-day bench trial in this matter
on
July 17 through July 20, 2012. (D.I. 304-307.)Presently before the court are the parties' post-trial proposed findings
of
fact and conclusions
of
law concerning the validity
of
the patents-in-suit.
1
(D.I. 314; D.I. 319.)Pursuant to Federal Rule
of
Civil Procedure 52(a), and after having considered the entirerecord in this case and the applicable law, the court concludes that: (1) the asserted claims
of
thepatents-in-suit are not invalid as anticipated under 35 U.S.C. § 102(b); and (2) the asserted claims
of
the patents-in-suit are not invalid as obvious under 35 U.S.C. § 103. These findings
of
fact andconclusions
of
law are set forth in further detail below.
II. FINDINGS OF FACT
A.
The Parties
2
1
The defendants stipulated to infringement
of
the asserted claims
of
the patents-in-suit. (D.I. 258 at
~
3;
Pretrial Order
at~~
40-43.) The court also notes that the defendants had alleged that certain claims
of
the '570 Patentlacked written description. However, the defendants did not include this defense as an issue for trial in the Pretrialorder, which excluded it from the case.
See
Pretrial Conference (June 25, 2012) Tr. at 42:13-15. In addition, theplaintiffs note that, after trial, in an email correspondence dated July 27, 2012, counsel for Watson confmned on behalf
of
all defendants that "[d]efendants are no longer asserting lack
of
inventorship as a defense to the '570 patent-insuit." Accordingly, the court does not address these issues in this Memorandum.
2
Prior
to
trial, the parties submitted an exhibit
of
uncontested facts in conjunction with their Pretrial Order.(D.I. 258.) The court takes most
of
its findings
of
fact from the parties' uncontested facts. Where necessary, the courthas overruled objections to the inclusion
of
hese facts. The court has also reordered and renumbered some paragraphs,corrected some spelling and formatting errors, and made minor edits for the purpose
of
concision and clarity that itdoes not believe alters the meaning
of
the paragraphs from the Pretrial Order. Otherwise, any differences betweenthis section and the parties' statement
of
uncontested facts are unintentional.The court's fmdings
of
fact with respect to matters that were the subject
of
dispute between the parties areincluded in the Discussion and Conclusions
of
Law section
of
this opinion, preceded by the phrase "the court fmds"or "the court concludes."
2
 
1.
Plaintiff Cephalon, Inc. ("Cephalon") is a Delaware corporation having its corporateoffices and principal place
ofbusiness
at
41
Moores Road, Frazer, Pennsylvania 19355.
2.
Plaintiff Cephalon France ("Cephalon France") is a societe par action simplifiee ("SAS")under the laws ofFrance, is a wholly-owned subsidiary ofCephalon, Inc., and is located at 20 RueCharles Martigny, 94701 Maisons-Alfort Cedex, France.3. Defendant Watson Laboratories, Inc. ("Watson") is a corporation organized and existingunder the laws
of
Nevada, with a principal place
of
business at Morris Corporate Center III, 400Interpace Parkway, Parsippany, New Jersey 07054.4. Defendant Sandoz, Inc. ("Sandoz") is a corporation organized and existing under the laws
of
Colorado, with a principal place
ofbusiness
at 506 Carnegie Center, Suite 400, Princeton, NewJersey 08540.
5.
Defendant Lupin Limited ("Lupin") is a corporation organized and existing under the laws
of
India, with a principal place
ofbusiness
at B/4 Laxmi Towers Bandra Kurla Complex, Bandra(E), Mumbai 400 051, India.
6.
Defendant Apotex, Inc. ("Apotex") is a corporation organized and existing under the laws
of
Canada, with a principal place
of
business at 150 Signet Drive, Toronto, Ontario M9L 1T9,Canada.
7.
Apotex, Lupin, Sandoz, and Watson will be collectively referred to as "defendants."
B. Background
8.
Armodafinil is a chemical compound known asdiphenylbenzhydrylsulphinyl)]acetamide and has the following chemical structure:
.to
S..::::::.
0
(-)-2-[R-(-
9.
Armodafinil is also known
by
other names, including 2-[(R)(diphenylmethyl)sufinyl]acetamide, CRL 40982,
(-
)-benzhydrylsulfinylacetamide,
(-
)-modafinil,and the levorotatory or laevorotatory enantiomer
of
modafinil.10. Armodafinil is also known as the R-enantioer
of
modafinil. Modafinil is a racemic mixturecontaining equal amounts
of
both the R-enantiomer and S-enantiomer ofmodafinil.3

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