Unimed Pharmaceuticals LLC et al v. Perrigo Company et al

Filing 237

MEMORANDUM ORDER Granting MOTION to Dismiss and/or Strike Perrigo's Inequitable Conduct Counterclaims and Defenses, and Denying Motion for an Award of Attorneys' Fees (D.I. 201 ). Signed by Judge Richard G. Andrews on 1/6/2015. (nms)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
UNIMED PHARMACEUTICALS LLC,
et al.,
Plaintiffs,
Civil Action No. 13-236-RGA

V.

PERRIGO COMPANY, et al.,
Defendants.

MEMORANDUM ORDER

On July 23, 2014, I denied Perrigo's motion for leave to file an amended answer
including inequitable conduct allegations. (D.I. 153). On August 20, 2014, Plaintiffs filed an
amended complaint. (D.I. 164). Perrigo filed an answer-293 pages long- to the amended
complaint on September 29, 2014. (D.I. 185). Perrigo filed a separate answer - a modest 243
pages long- to a separate complaint. (D.I. 186). (The record is confusing because of the
consolidation of a number of cases.). Plaintiffs have responded with a motion to dismiss
Perrigo's inequitable conduct counterclaims and defenses. (D.I. 201). It has been briefed. (D.I.
202, 221, 235).
While Plaintiffs complain about Perrigo raising defenses that were previously rejected by
me, I do not see why Perrigo could not raise its defenses in response to new pleadings (including
newly asserted patents) by Plaintiffs. I ruled before that Perrigo could not amend its pleadings to
assert inequitable conduct. Perrigo does not need leave to file these answers and counterclaims;
indeed, it has to file answers. It may be that in the end, the issue for me is the same - whether

I
t

Perrigo has stated a claim - but its new pleadings are not verbatim 1 recitations of its old
pleadings, and the different procedural posture gives Perrigo a plausible reason for a second try.
That being said, Perrigo' s recitation of facts makes for impenetrable reading. The
allegations of inequitable conduct are about two and one-half times the length of a principal
opening brief in the courts of appeals. See Fed. R. App. P. 28.l(e)(2)(A)(i) (14,000 word limit).
It does not appear that there was any effort made to tell a comprehensible story. 2 Perrigo's

attorneys, apparently aware that the inequitable conduct allegations are nearly incomprehensible,
try to rehabilitate the pleading with a mixture of underlining and the use of bold, italic, and bold
italic fonts. It is as if Perrigo has dumped a pile of garbage in front of me, saying that there is a
golden ring in the garbage, while directing my attention to various flashing colored lights, the
point of which is unexplained.
Nevertheless, I tum to Perrigo's briefing to try to understand the inequitable conduct
allegations. The briefing has the same idiosyncratic combination of underlining and the use of
various fonts to try to make its message clearer. In order to support its arguments, it cites to the
answer, although the value of the citations is somewhat diminished when pages and pages of
paragraphs are cited to support a single sentence. 3 Nevertheless, the crux of Perrigo's argument
is summarized in its brief at pages 14-18. (D.I. 221at20-24). I now tum to it.
"An individual associated with the filing and prosecution of a patent application commits

1

By my count, Perrigo has reduced its verbiage on inequitable conduct from about 55,000
words to about 37,500 words. (D.I. 185, where the inequitable conduct allegations go from about
page 91 to page 278). As Plaintiffs admit, some editing has been done. (D.I. 202, p. 3).
2

By contrast, earlier today Perrigo made an admirably "to the point" Markman
presentation.
3

For reasons that are not obvious to me, Perrigo's sealed brief cites to the redacted
versions of its answers.

inequitable conduct when he or she (1) makes an affirmative misrepresentation of a material fact,
fails to disclose material information, or submits false material information to the PTO; (2) with
the specific intent to deceive the PTO. Star Scient(fic, Inc. v. R.J. Reynolds Tobacco Co., 537
F.3d 1357, 1365 (Fed. Cir. 2008)." Wyeth Holdings Corp. v. Sandoz, Inc., 2012 WL 600715, *5
(D. Del. Feb. 3, 2012), adopted, 2012 WL 749378 (D. Del. Mar. 1, 2012). Perrigo's pleadings
and arguments must be evaluated in light of this standard.
Four individuals are named as having committed inequitable conduct.
The first is an expert witness - Dr. Weiner- hired by Plaintiffs. The allegations against
him are summarized by seven bulleted points. (D.I. 221 at 21). 4 Three of the bulleted points(##1, 3, and 5) are unexceptional. Perrigo cites 22 paragraphs for the proposition that Dr. Weiner
"knew [his] affidavits ... contained false and misleading statements." (D.1. 221at21, citing D.I.
[185], iMJ 403-24). The essence of these paragraphs are allegations that: (1) Dr. Weiner
submitted two affidavits to the PTO which discussed data from Example 1 of the patent then
being prosecuted; (2) the data came from an in vitro study; (3) Dr. Weiner claimed that the data
showed unexpectedly therapeutic results in treating a human; (4) thus meaning that Dr. Weiner
was asserting that in vitro studies had value in predicting in vivo results; and (5) in contrast with
the last allegation, Dr. Weiner is on record, both before and after the submission of the two
affidavits at issue, as stating that in vitro tests are neither predictive nor correlative of in vivo
results.
Perrigo quotes Dr. Weiner's actual (supposedly false or misleading) statements in~ 403.
4

There is also a diversionary argument that Dr. Weiner failed "to disclose his extensive
employment for Plaintiffs." (D.I. 221, at 16). Perrigo does not then cite where its allegations
about this are in the Answer. I do not see any basis for concluding that Dr. Weiner's
involvement in the "l % Antitrust Litigation" or "l % Patent Litigation" as being something that
was independently required to be disclosed.

He stated that the data '"are an indication"' of efficacy. (D.I. 185, if403(a)). He further stated
that "'[i]t is also possible that at some level"' [the therapeutic benefits would end]. (D.1. 185,
if403(b)). It seems to me that, contrary to the use of the word "false," there is no allegation of
falsity here. How could there be, given the hesitancy used in expressing Dr. Weiner's positions?
There is barely even an allegation that Dr. Weiner's argument is "misleading." Rather, the
argument is that he should not have used the in vitro studies to make an argument that the results
disclosed in the patent at issue were '"surprising and unexpected."' (D.1. 185, if403(c)). It is not
alleged that Dr. Weiner said one place, In vitro results do not predict in vivo results, and said to
the PTO, In vitro results predict in vivo results. The argument is that what he said to the PTO
had the unstated premise that in vitro results predict in vivo results. It seems to me that stating
that in vitro results provide "indications" or "possibilities" about in vivo results is not the same
thing as saying that they predict the results. One is significantly more tentative than the other.
Further, common sense says that in vitro studies can provide "indications" or "possibilities" for
in vivo studies. Why else would they be done? Therefore, I do not think Perrigo has plausibly
alleged a false or misleading or deceptive statement by Dr. Weiner in his affidavits.
It follows that the fourth bulleted point fails, as it essentially says that Dr. Weiner did not

disclose materials (D.I. 185, iMf 416-31) that would support Perrigo's argument that the affidavits
were false. The sixth and seventh bulleted points (D.I. 185, ifif 425-92) fail, for essentially the
same reasons.
The second individual accused of inequitable conduct is the inventor, Malladi. The
allegations against Malladi are the same as the arguments directed at Dr. Weiner, or variations
thereof, and are similarly without plausibility.
The third and fourth individuals accused of inequitable conduct are two prosecuting

attorneys. The allegations against them are essentially the same as those against Dr. Weiner, and
fail for the same reasons. 5
Plaintiffs' Motion to Dismiss and/or Strike Perrigo's Inequitable Conduct Counterclaims
and Defenses (D.I. 201) is GRANTED. Plaintiffs' Motion for an Award of Attorneys' Fees (D.I.
201) is DENIED.

~

IT IS SO ORDERED this V a y of January 2015.

5

Inasmuch as I do not think Perrigo has alleged a false statement or a failure to disclose a
material fact, I do not need to reach Plaintiffs' other arguments for dismissal.