Dorothy Whelan is principal in the
Twin Cities office of Fish & Richardson, and co-chairs
the firm’s post-grant practice group with Karl
As such, Whelan’s role has changed greatly
since the enactment of the America Invents Act (AIA) in 2011
and the advent of post-grant challenges at the Patent Trial and
Appeal Board (PTAB), which became available a year later.
"When the legislation that became the AIA was working its
way through Congress we just jumped on it, anticipating it, and
started to learn the new procedures," says Whelan.
"The post-grant work was actually a natural outgrowth of
re-examination but the post-grant proceedings have evolved in
ways that the re-examinations never did," she continues. "The
re-examination, even when you had another party, was really
between the patent owner and the examiner. The post-grant
proceedings under the AIA are much more adversarial. I call
them quasi litigation because you have many of the components
of district court litigation that were wholly absent from
Pharma PTAB challenges catch on
Whelan was surprised at just how popular PTAB proceedings
became. But pharmaceutical companies, Whelan’s
specialisation, were slower to catch on.
"Pharma was much later," she says. "Pharma had Hatch-Waxman.
Both generics and branded companies knew Hatch-Waxman
– it was like the devil you know – and really
were reluctant to plunge in. That started to change."
The pendulum swung when companies saw petitioners having a
lot of success at the PTAB. This emboldened some generic
"If you look at the statistics over the years the
institution rates have actually gone down, but I think
initially these generic manufacturers saw petitioners having
success and thought, 'Why not?’ They waded in and
some of them have had success. It's also become a good means
for gaining leverage in a settlement situation," says Whelan.
She adds that there have also been more challenges of
The nature of PTAB proceedings can be different for
pharmaceutical companies compared to technology companies.
Whelan says oftentimes pharma cases are true competitor suits
– a brand versus a generic – whereas on the
tech side one entity can sue a whole industry.
She adds that chemical and biological sciences are more
unpredictable than computer science or electrical work. "So the
way you frame arguments is different," she says. "You're often
looking for supporting data, and you have this unpredictability
about reasonable expectation of success that you just don't see
over in the tech side."
Pharmaceutical PTAB disputes also present a different
challenge to pharmaceutical cases in district court. PTAB
judges tend to be more technical, for example.
"The Board has got at least 15 judges who specialise in the
biopharma arts and you'll see at least one, and often all three
of them, are drawn from this group," says Whelan. "So they're
bringing expertise not only in the technology but also the laws
surrounding pharma, and they're familiar with the case law. For
example, they know how to do a lead compound analysis and all
the things that you see as part of the biopharma validity
An unfair system?
Pharmaceutical companies have a lot of concern about PTAB
proceedings. Many view them as unfair, and feel they have been
caught up in a system that was set up with technology companies
in mind. They also decry a situation that allows multiple
attacks of the same patent, with only one win being necessary
to take out a patent for a multi-billion dollar product.
"There is a sense that the whole Hatch-Waxman procedure was
really supposed to be the means for adjudicating validity,"
says Whelan. "The sense is it is not right that they be
subjected to attack both in a district court and in the Patent
Office, they feel that that's just not fair. There's also a
sense that they spend an awful lot of money developing these
drugs, and they don't see the PTAB as a balanced forum. As a
patent owner I think it is harder to get out your inventions
story. So there is a sense that they'd like to be in the
The PTAB has taken recent steps to make proceedings somewhat
fairer on patent owners. The Board in October designated
three decisions that address § 325(d) as informative.
Under § 325(d), the PTAB may reject a petition because
"the same or substantially the same prior art or arguments
previously were presented to the Office". The decisions make
clear the Board has authority to not consider evidence that was
previously considered in prosecution or re-examination. The
PTAB also in October designated as precedential its General
Plastic Industrial v Canon Kabushiki Kaisha decision, in which
the expanded panel decision provided a non-exhaustive list of
factors the Board considers in evaluating whether to permit
Whelan says the informative and precedential decisions help.
"Patent owners are concerned about harassment," she says. "That
was really the whole reason the whole estoppel provision is in
there in the first place because you don't want people being
able to take multiple swings at a patent – at some
point you have to enjoy quiet title. So the PTAB by issuing a
precedential decision and then several informative decisions is
actually signalling that it's going to be tougher on serial
She adds: "For patent owners now one of the first things you
look for in a petition is whether this the same art the
examiner already considered, and if it is that's good for
Whelan says a useful change from big pharma’s
viewpoint would be putting in a sur reply for the patent
"Right now it is petition, response, reply, so that a sur
reply might help," she says. "For big pharma, I think what
they'd like to see is a more level playing field for patent
owners. Honestly, a lot of them would just as soon see a
carve-out for pharmaceutical patents but I just
don’t see that happening."
A big Humira win
According to Docket Navigator, Whelan has been involved in
119 PTAB proceedings, both challenging and defending patents.
She has overseen about 30 IPRs in the past year alone,
including some high-profile PTAB disputes.
three IPR wins for Coherus BioSciences in May and June this
year, which invalidated three AbbVie patents of the blockbuster
arthritis drug Humira. These were the first-ever IPR decisions
that invalidated patents for the biologic, which was the
highest-selling drug in 2016 with $16 billion in global
Getting the win was not easy. "One of the biggest challenges
was the best art had been considered by an examiner," says
Whelan. "AbbVie had submitted expert declaration and all of
this had been before the examiner, who had considered it and
then decided to allow the claims anyway. So that meant a real
Whelan was able to demonstrate through her own experts that
the examiner didn't have the full picture. "There were other
compelling pieces of evidence and analysis we were able to do
through the experts to convince them that, you know what, this
dosing regimen would have been obvious," she says.
Whelan says another "interesting twist" on this case was
that Boehringer Ingelheim also filed two petitions on the same
patents a few months after Coherus. She says Boehringer
benefited from Coehrus deposing AbbVie’s
witnesses, which meant it could see the deposition testimony
and depose AbbVie’s witnesses. Boehringer was also
successful in getting an invalidation in a final written
Another interesting case for Whelan is representing
Greenwich Biosciences, a subsidiary of GW Pharmaceuticals, to
defend the first medical marijuana patent to be challenged at
the PTAB. GW’s patented plant-derived cannabinoid
therapeutics include Epidiolex (cannabidiol).
"It’s got the psychotropic chemicals removed,"
explains Whelan, "so it’s not what the teenagers
are buying up by around the corner. The patent that's being
challenged is used for epilepsy, and there are other uses for
it too. It's actually very interesting because there's just a
dearth of clinical trials out there. People weren't able to get
their hands on enough material to test. So we’ll
see how that goes."
The hottest topic at the PTAB at the moment is the pending
Oil States case at the Supreme Court, with oral argument set
for November 27. The case will address the constitutionality of
inter partes review so the stakes are high.
"We’re all looking to see what happens in the
Oil States case - should I take early retirement? Am I going to
have to learn to play golf?" Whelan asks, half-jokingly.
"Actually, I don't think that post-grant proceedings will be
held unconstitutional. For the industry it would be incredibly
disruptive just to get rid of them altogether. I'm not overly
worried that they're going to disappear and that
we’ll be left only with district court as the
option for challenging the validity. But it's possible that
they may prompt legislative changes or maybe even rule changes
to the proceedings themselves."
Women underrepresented at the PTAB
Whelan is one of the most-prominent women appearing before
the PTAB. She was also the first woman to serve on Fish &
Richardson’s management committee, and also served
on the firm’s compensation committee.
Research from Docket Alarm
published on the Patently-O blog in
September revealed that only 12% of attorney appearances at the
PTAB are female. Of the top 100 law firms, 55 have less than
10% female attorneys on cases, and eight firms have never had a
single female attorney work on their PTAB AIA-trial cases. When
representing patent owners, the percentage of female attorneys
is even lower – at 9.8%.
Whelan notes this is partly a result of PTAB practitioners
coming from male-dominated backgrounds. "If you look across IP,
and especially in the PTAB, people need some kind of science or
engineering degree," she says.
"Do I see it changing in near future? I hope so," she
continues. "I think firms are more sensitive to it these days
and I know there are a lot of women who are anxious to actually
do the oral argument. I try to find our female litigation
attorneys and say, 'Take the oral argument
Whelan says Fish is lucky because of its strong reputation
in the IP world
"With law school grads over 50% are women, and I think we do
have our fair shot at the best attorneys, period," she says.
"Then working here, we have women in upper levels of
management. I was on the management committee and I was on the
compensation committee. We have women on the management
committee now. So women are in prominent roles and some of most
highly paid people are women."