It’s
clear from the brief Abbott Laboratories filed in advance of last November’s en
banc hearing at the U.S. Court of Appeals for the Federal Circuit that the
drugmaker regarded the proceeding as a chance to make some new law. And if
you’re one of the patent lawyers breathing a sigh of relief at the strict
new standards for establishing misconduct that a six-judge Federal Circuit
majority handed down Wednesday, you can thank Abbott and its lead appellate
advocate John Whealan for sticking
with their position under some heavy judicial and fire. (Here’s the Reuter’s
story on the ruling, and here’s analysis
from Dennis Crouch at Patently-O.)
This
case was entirely a matter of principle. The Abbott blood glucose test strip
patent at issue in the underlying litigation with Becton Dickinson, Nova Biomedical, and Bayer was already dead by
the time the en banc argument took place. Judge William Alsup found key claims in the patent invalid back in the
federal district court proceeding, and a Federal Circuit panel affirmed
Judge Alsup’s finding in 2010. When the appellate court ordered an en banc
rehearing later in 2010, the Federal Circuit judges said they were only
interested in the issue of Abbott’s alleged misconduct in obtaining the patent,
which is known in IP cases as inequitable conduct.
The
financial stakes on both sides were pretty low. After finding that Abbott had
committed inequitable conduct in the district court, Judge Alsup had granted
Becton Dickinson about $6 million in attorneys fees. (Bayer was also granted
undisclosed fees.) The en banc rehearing put those fee awards in jeopardy.
But
the real issue for the lawyers presenting arguments for Abbott, Becton, and
Bayer was what the appropriate standard for inequitable conduct should be. By
most accounts, including that of the Federal Circuit majority in Wednesday’s
Therasense ruling, patent litigation has been swamped by a deluge of
inequitable conduct claims, in which infringement defendants argue that patent
holders deceived the U.S. Patent & Trademark Office in order to obtain
their patents. One academic study the Federal Circuit cited contends that as many
as 80 percent of federal patent suits include an assertion of inequitable
conduct.
And
why not? For the defense, an inequitable conduct finding is a veritable “atomic
bomb,” in the words of the Federal Circuit. If a trial judge finds evidence the
PTO was deceived, the entire patent is rendered unenforceable. Case over,
defense wins.
In
recent years, as an inevitable consequence of the flood of inequitable conduct
claims, lawyers who prosecute patent applications have taken to dumping huge
files on patent examiners, in the hopes that they won’t face subsequent
accusations of hiding something from the PTO. “Left unfettered,” said
Wednesday’s appellate majority opinion, written by Chief Judge Randall Rader, “the inequitable conduct
doctrine has plagued not only the courts, but the entire patent system.”
Abbott
and its lawyers decided to use the opportunity of the en banc hearing to put
forth a new vision of appropriate standards for inequitable conduct. “We felt
there was an important principle at stake,” said Abbott spokesman Scott Stoffel. “The inequitable conduct
standard had become unclear, watered down, and inconsistently applied.”
Abbott
had been represented in the first round of its Federal Circuit appeal by Munger, Tolles & Olson. For the en
banc hearing, the company supplemented its team with appellate specialists from
MoloLamken, as well as former PTO
solicitor general John Whealan,
who’s now an associate dean at George Washington University Law School.
Abbott’s lawyers went back to the U.S. Supreme Court cases that led to the
inequitable conduct doctrine. They concluded that all of high court inequitable
conduct cases involved egregious lies to the PTO. The Court acted, in each
instance, to protect the patent system and the public from outright patent
fraud.
From
those cases, Abbott developed the “but-for standard” Whealan argued eloquently
at the Nov. 9, 2011 hearing: Inequitable conduct should only be found when the
patent would not have been awarded but for intentional deception of the PTO.
Any other instances of attorneys lying about a detail or omitting a piece of
prior art, Whealan argued, can be handled through disciplinary proceedings.
Some
of the appellate judges, according to the
hearing transcript, questioned Whealan’s interpretation of the Supreme
Court cases and challenged his assurances that the but-for standard would not
result in a surge of lies to the Patent Office. Whelan stood firm, even
occasionally contradicting the judges on the law.
He
also reminded the court that well-intended lawyers have been running scared as
a result of inequitable conduct accusation. “I don’t know why we don’t think
patent lawyers tell the truth,” Whealan said. “People are presumed innocent
until proven guilty. For some reason we think patent attorneys are guilty until
proven innocent.”
All
of the other lawyers who spoke at the Nov. 9 hearing—Raymond Chen of the PTO; Rachel
Krevans of Morrison & Foerster
for Bayer; and Jim Badke of Ropes & Gray for Becton and Nova—advocated a standard
based on existing PTO rules, which say patent applicants cannot make material
misrepresentations to the Patent Office.
“The
rule was made after a lot of thought by an awful lot of people,” said Becton
counsel Badke of Ropes & Gray in an interview Thursday. “You have to give
deference to the agency that issues patents to determine what it needs to give
its job.” Badke said the overpleading of inequitable conduct isn’t due to an
unclear standard, but to inconsistent application of that standard by trial
court judges. “It’s a matter of implementation, of enforcing a uniform
standard,” he said.
But
the Federal Circuit majority disagreed. The appellate court adopted the
standard of intent that Abbott, Becton, and Bayer pretty much agreed on,
finding that there has to be clear and convincing evidence of an intent to
deceive the PTO. But on the question of materiality, the six judges in the
majority (with one separate concurrence and four dissents) agreed with Abbott:
To rise to the level of inequitable conduct, the fraud has to have been so
serious that the patent wouldn’t have been issued without it.
The
ruling sends the Abbott case back to the trial court for a determination of
whether Abbott’s alleged inequitable conduct meets the but-for standard.
Whealan
referred a call for comment to Abbott spokesman Stoffel. Badke said he believes
his side will be able to show Abbott engaged in inequitable conduct even under
the new standard, but says his client haven’t yet decided whether to appeal the
Federal Circuit ruling to the Supreme Court. Krevans declined to comment.
(Reporting by Alison Frankel)