By
Andrew Williams —
Last
week, in Hoffmann-La Roche Inc. v. Apotex
Inc., the Federal Circuit affirmed the denial of a request for a
preliminary injunction from the U.S. District Court for the District of New
Jersey related to the sale of Roche's osteoporosis drug Boniva®. The lower court had found that Roche failed
to establish a reasonable likelihood that it would prevail against the
obviousness challenges from the ANDA filers in the case. Because the majority of the three-judge panel
of the Federal Circuit believed that the lower court did not abuse its
discretion in denying the request, the decision was affirmed. However, Judge Newman dissented because she
believed, in part, that the lower court and the majority did not properly
consider the equities in the case. The dissent
summed up the case with the statement: "[t]he only issue on this appeal is
whether to preserve the status quo during this litigation, or whether to change
it irretrievably." Judge Newman
disagreed with the majority because, according to her, not only did the
equities favor an injunction for Roche, but if the lower court had not ignored
the evidence of unpredictable results in the art, it would have found that
Roche had established a reasonable likelihood of defending the validity of its
patents.
Boniva®,
the drug at issue in this case, is approved by the FDA as a once-monthly
treatment of osteoporosis in post-menopausal women. The active ingredient is ibandronate, the use
of which was already known in the art for the treatment for osteoporosis. However, when administered on a continuous
basis, it can cause skin irritations and result in side effects in the
digestive tract. Roche's scientists
discovered that instead of daily dosings, a once-monthly dose of 150 mg could
also be effective without causing the adverse conditions. Based on this work, Roche owns two patents,
U.S. Patent Nos. 7,410,957 and 7,718,634, with method of treatment claims that
cover the FDA-approved use. In 2007,
Apotex, Watson Laboratories, Inc., and Mylan Inc. filed separate ANDAs to
engage in the commercial manufacture, use, or sale of generic versions of
once-monthly ibandronate products to treat osteoporosis. The present action was brought in the New
Jersey District Court, and during the pretrial proceedings, Roche filed the
present motion for preliminary injunction. The lower court denied this motion for the sole reason that Roche failed
to establish a reasonable likelihood that it would prevail against an
obviousness challenge from the Defendants in view of six prior art references. Roche appealed.
The
majority began its discussion by pointing out that the grant or denial of a
preliminary injunction is within the sound discretion of the lower court, and
that reversal is appropriate if one or more of the findings were clearly
erroneous, such that the lower court could be said to have abused its
discretion. To receive such a request, Roche
needed to establish that there was "a reasonable likelihood of success on
the merits," which in this case was a likelihood that Roche would
withstand an obviousness challenge in light of the burdens and presumptions
that inure at trial. In fact, the
majority pointed out that Roche did not challenge the framework employed by the
lower court. Instead, Roche challenged
the lower court's decision because it believed that the court applied an "obviousness
to try" standard, and that the court failed to consider evidence of
unexpected results.
The
majority disagreed with both of Roche's criticisms of the lower court's
analysis. First, the majority pointed
out that the District Court carefully evaluated each of the six references and
the testimony of Roche's own expert. The
lower court determined that the prior art evidenced a trend towards
intermittent (such as once-monthly) dosing of ibandronate based on the total
amount of ibandronate dosed in the same period under continuous (for example,
once-daily) administration. In fact, Roche's
expert conceded: (1) that one of the references provided a motivation to investigate
monthly dosing of ibandronate, (2) that in the 2000-02 timeframe, the art was
trending towards longer interval dosing, (3) that by the critical date, a
skilled artisan would have had reason to investigate once-monthly treatment,
(4) that determining a dose within a given broad range is a relatively routine
matter, and (5) that by May 2002, one of skill in the art would have had a
reasonable expectation that a once-monthly dose of ibandronate would have had
some effectiveness. With regard to the
objective evidence of non-obviousness, the lower court had found that Roche
failed to detail its position, much less substantively point out the
evidence. Instead, Roche apparently "incorporated
by reference" its summary judgment pleading, which itself apparently only
contained a few conclusory sentences with citation to the record. As a result, the lower court apparently did
not consider this information. In siding
with the District Court on this issue, the majority cited to the 7th
Circuit Court of Appeals in noting that district court judges "are not
archaeologists," and that it is not a district court's burden to "excavate
masses of papers in search of revealing tidbits."
Finally,
in response to the dissent's criticisms, the majority found that it owed
deference to the lower court. Ultimately,
the majority found no evidence of any clearly erroneous findings, much less any
abuse of discretion on behalf of the lower court in denying the request for the
preliminary injunction. Of note, during
this appeal, the District Court concluded in May on a motion for summary
judgment that the claims of one of the patents would have been obvious in view
of the same art (plus three additional references), and made a similar finding
with regard to the claims of the second patent earlier this month. Of course, even though it is interesting that
Roche was ultimately unsuccessful in fending off the obviousness challenge at
the lower court, those judgments are still subject to appeal, and appropriately
played no role in the majority's decision.
Judge
Newman in dissent complained that the equities in this case were not properly
weighed, because if they had been, the result would have been the preservation
of the status quo — in other words, the ANDA filers would not have been allowed
to market their products regardless of the expiration of the 30-month
stay. Judge Newman pointed out the "panoply
of biological and clinical evaluations" needed to bring an effective and
safe drug to market, and the "millions of dollars" consumed to obtain
regulatory approval. She noted that
bringing a drug to market required a "heavy risk-laden investment," one
which the defendants were now trying to enjoy with no cost or risk of
failure. The problem with this analysis
is that this criticism applies in every ANDA case, and therefore following this
logic, an NDA holder would always get a preliminary injunction to maintain its
exclusive rights until at least the conclusion of litigation. Whereas there is some appeal to this position,
because it takes into account the substantial costs and risks of brining a drug
to market, the Hatch Waxman statute clearly contemplates the ability of an ANDA
filer to get approval at the end of the 30-month stay, and to "launch at
risk" should the litigation still be ongoing at the time. In other words, Congress contemplated that
not all preliminary injunctions would be granted, so the mere fact that a
generic manufacturer files an ANDA should not be the sole determining factor
whether an injunction should issue.
Judge
Newman also criticized the lower court's refusal to consider Roche's evidence
of unpredictable results. She pointed
out that, apparently, both parties had cited to their respective summary
judgment briefs in their filings for the present action. Nevertheless, Roche had the burden of
establishing that it deserved a preliminary injunction, so if the parties were
at fault for this practice, it should disproportionally affect Roche. Judge Newman also stressed the clear and
convincing standard required to invalidate an issued patent, and that this
burden was even greater in this case because the cited references were
considered by the examiner and rejected.
Therefore, in the end, Judge Newman believed that because of the
equities in this case and the presumption of validity of the patents, "the
fair and just action [would have been] to preserve the status quo during the
litigation."
Hoffmann-La Roche Inc.
v. Apotex Inc. (Fed. Cir. 2012)
Nonprecedential
disposition
Panel: Circuit Judges Newman, Lourie, and O'Malley
Opinion
by Circuit Judge Lourie; dissenting opinion by Circuit Judge Newman
Patent Docs 