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MEMORANDUM, INCLUDING
FINDINGS OF FACT
AND CONCLUSIONS OF LAW
7, 32, 74, and 84 of the '068 patent; and claims 19, 45, 82, 89,
115, and 145 of the '003 patent. Prior to litigation, both Teva
claims.
defendants' assertion that the '068, '003, and '244 patents are
invalid. They assert that the '068 and '003 patents are invalid
applications for those two patents before the U.S. Patent and
Trademark Office ("PTO") and that both the '068 and '003 patents
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inequitable conduct before the PTO during prosecution of the
I.
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The hexagonal shape at the left side of the compound is a phenyl
1991. The '068 patent issued on January 4, 2000 and will expire
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that patent's expiration coterminous with U.S. Patent No.
patent, both the '003 and '146 patents expire on December 14,
6. During trial, plaintiffs informed the court that the PTO had
granted plaintiffs' request to extend the term of the '068 patent
449 days from December 14, 2016 pursuant to 35 U.S.C. § 156. See
Merck & Co., Inc. v. Hi-Tech Pharmacal Co., Inc., 482 F.3d 1317,
1320-21 (Fed. Cir. 2007).
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calcimimetic compounds with a chemical structure similar to the
June 7, 1995, such as the '068, '003, and '146 applications, were
the date of issue or 20 years from the date the application was
Agreement Act, Pub. L. No. 103-465, 108 Stat. 4809, 4983 (1994),
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Plaintiffs filed the '541 application (application
July 15, 1997. Since the application was filed after June 7,
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enantiomer compounds, including two "most preferred" compounds.
the application was filed after June 7, 1995, the patent will
a beneficial effect.
Lyons & Lyons, the law firm NPS and Amgen retained as outside
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material to those prosecutions under 37 C.F.R. § 1.56, an
follows:
37 C.F.R. § 1.56.11
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company. It also forecasted that its sales of calcimimetic drugs
law firm of Trask, Britt & Rossa. The patent committee disclosed
law firm.
'003, and '244 applications. The '068, '003, '146, and '244
considering the '068, '003, and '146 applications were each aware
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some of the claims, and by arguing that three of the claims (as
foreign patents, and two U.S. patents held by Dr. Van Wagenen
the '244 examiner in his October 30, 1996 rejection. The patent
'146 application and the application that led to the '884 patent.
This office action returned the June 5, 1997 IDS with the '068
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According to letters exchanged between committee members, a
meeting was to occur on May 18, 1998 to discuss the '244 patent.
application." The CPA filed with the PTO omitted the first
quoted sentence.
recall, now some twelve years later, why the disclosure of the
'068, '003, and '146 applications went only to the '244 examiner,
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and not also vice versa. None of the four attorneys could
examiners because the '244 application was not prior art to those
applications, that is, that the '244 application was filed after
the '068 and '003 applications and was still pending when the
'068 and '003 patents issued. Dr. Heber testified that the '244
application was not disclosed because it was not prior art and
priority date. Dr. Ungemach also testified that his view of the
2016. As noted above, these disclaimers made the '068, '003, and
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Plaintiffs have listed the '068, '003, '146, and '244
Teva USA and Barr that each had filed an Abbreviated New Drug
(II) the patent has expired; (III) the patent is set to expire on
Corp., 276 F.3d 1368, 1371 (Fed. Cir. 2002). This certification
must be made for each patent listed in the FDA's Orange Book as
USA and Barr filed and served on plaintiffs are deemed acts of
12. By statute, any person seeking FDA approval for a drug must
notify the FDA of all patents "with respect to which a claim of
patent infringement could reasonably be asserted if a person not
licensed by the owner engaged in the manufacture, use, or sale of
the drug." 21 U.S.C. § 355(b)(1). The FDA lists such patents in
a volume called the Approved Drug Products With Therapeutic
Equivalence Evaluations, more commonly known as the "Orange
Book." See Andrx Pharm., Inc. v. Biovail Corp., 276 F.3d 1368,
1371 (Fed. Cir. 2002).
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infringement suit within 45 days. 21 U.S.C. § 355(j)(5)(B)(iii).
II.
If the infringer meets this burden, the court then balances the
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1463 (Fed. Cir. 1988) (quoting Colorado v. New Mexico, 467 U.S.
Assocs. Int'l, Inc., 522 F.3d 1279, 1297 (Fed. Cir. 2008)).13 It
v. Charles Mach. Works, 437 F.3d 1309, 1319 (Fed. Cir. 2006).
Appeals for the Federal Circuit ruled in July 1998 that one
148 F.3d 1380, 1382 (Fed. Cir. 1998). The Court of Appeals had
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application can be material to an earlier-filed copending
Total Containment, Inc., 329 F.3d 1358, 1367-68 (Fed. Cir. 2003).
F.3d at 1366.
'068 and '003 applications. Dr. Heber and both plaintiffs' and
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defendants' expert witnesses testified that the compound
claims.
of the prior art cited by the '244 examiner was also prior art to
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genus of compounds and species within that genus, the '068 and
the patent committee knew that the longest patent term available
patenting rejections from the '068 and '146 examiners over other
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applications as evidenced by disclosure of the '244 application.
Defendants argue that the '068 and '003 examiners would have
March 1998, when the one-way disclosure was made, the patent
committee could foresee that the '068 and '003 prosecutions would
could foresee that patents resulting from the '068 and '003
of issue and thus extend beyond October 2015, when the expected
'244 patent (which would have a twenty year term from the date of
and '003 examiners and which would anticipate the claims to the
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filed "before the invention thereof by the applicant for patent."
material even though it was not prior art. Akron Polymer, 1995
WL 620148, at *6. The parties have not directed the court to any
appeal of the same case. 148 F.3d at 1382. The 1995 Akron
Polymer opinion does not cite any earlier case law for the
application but not the other way around. The patent committee
14. This version of § 102 had been in effect since 1975. See An
Act to Carry into Effect Certain Provisions of the Patent
Cooperation Treaty, and for Other Purposes, Pub. L. No. 94-131,
§ 5, 89 Stat. 685 (1975) (amending subsection (e)).
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applications that were not prior art, including later-filed
136815; Akron Polymer, 148 F.3d at 1383-84. The law is clear that
15. Although Dayco was not decided until 2003, the Court of
Appeals for the Federal Circuit found that its opinion in that
case did not create a new obligation to disclose the opinions of
examiners considering related copending applications. In Dayco,
the Court of Appeals applied that duty to a patent claiming
priority to a 1989 application. See McKesson Info. Solutions,
Inc. v. Bridge Medical, Inc., 487 F.3d 897, 922-23 (Fed. Cir.
2007).
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same references to the '068 examiner as prior art. The letter
III.
16. The court has considered the wording differences between the
draft CPA disclosing the '068, '003, and '146 applications and
the final version submitted to the PTO. Those differences are
inconsequential.
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patent that are not patentably distinct from claims in a commonly
owned earlier patent." Eli Lilly & Co. v. Barr Labs., Inc., 251
F.3d 955, 967 (Fed. Cir. 2001) (emphasis supplied). This long-
considers the claims in the earlier patent and the later patent
Inc., 518 F.3d 1353, 1363 (Fed. Cir. 2008). Next, the court
In re Kaplan, 789 F.2d 1574, 1577-80 (Fed. Cir. 1986); see Eli
Lilly & Co. v. Zenith Goldline Pharm., Inc., 364 F. Supp. 2d 820,
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and attempt to patent a novel, useful, and nonobvious variation
terms as of June 8, 1995, the '068 and '003 patents on the genera
'244 patent on the species. Defendants argue that the '068 and
1995 and expired in October 2019, seventeen years from its issue.
owned two other patents, the '511 and '945 patents, the
applications for which were filed after June 7, 1995. The '511
of compounds within the genus of the '012 patent. The '511 and
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'945 species patents will expire October 2015, four years before
that the '511 and '945 patents could serve as double patenting
references for the '012 patent even though they issued later in
time and expired earlier. The Board reasoned that the '012
patent prevented the public from practicing the art taught in the
'511 and '945 patents beyond the terms of those two patents,
doctrine. In the Board's view, it is the patent term and not the
when or if the PTO might grant each of the three patents, the
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would have longer terms than the '244 species patent. As
the later species patent term will expire after the earlier genus
genus.
'244 patent would have extended beyond the '068 and '003 patent
IV.
17. Of course, had the '244 patent issued before the '068 and
'003 patents, the '244 patent would have anticipated and
invalidated the '068 and '003 patents (or required common
ownership and terminal disclaimers).
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or patent to the '244 examiner during prosecution. As noted
2015. Defendants argue that the '541 patent was material because
examiner been aware of the '541 patent, the '244 examiner would
Jensen worked for the patents' assignees. Thus, the court will
infer that they were aware of the '541 prosecution and patent.
have not adduced clear and convincing evidence, however, that Dr.
Van Wagenen, Dr. Ungemach or Mr. Jensen withheld the '541 patent
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Inc., 417 F.3d 1230, 1238 (Fed. Cir. 2005); FMC Corp. v. Hennessy
Indus., Inc., 836 F.2d 521, 526 n.6 (Fed. Cir. 1987). A party
L.P. v. Stryker Sales Corp., 267 F.3d 1370, 1382 (Fed. Cir.
2001).
Dr. Warburg and Dr. Heber worked for a firm other than
the '541 patent, which did not issue as a patent until more than
his time at Lyon & Lyon. There is no evidence that Dr. Heber
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owed or breached a duty to inquire. Star Scientific, 537 F.3d at
1366.
V.
v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1366 (Fed. Cir.
Containment, Inc., 329 F.3d 1358, 1368 (Fed. Cir. 2003). The
the reference must permit one skilled in the art "to practice the
1075, 1083 (Fed. Cir. 2008); Metabolite Labs., 370 F.3d at 1367.
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A patent to a genus of compounds anticipates a
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A district court is required to construct properly all
S.A. v. Rolabo, S.L., 353 F.3d 928, 933 (Fed. Cir. 2003). As
group (F3C) on the left side phenyl ring's meta position, as does
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permitted right-side substituents to describe a total class of 45
preferred compounds.
the relevant art would not "at once envisage" cinacalcet from the
'541 patent.
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IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
ORDER
Applications Nos. 90-476 and 90-539 filed with the Food and Drug
Administration.
BY THE COURT: