Dorothy Whelan is principal in the Twin Cities office of Fish & Richardson, and co-chairs the firm’s post-grant practice group with Karl Renner.
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 re-examination.”
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 companies especially.
“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 biosimilars patents.
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 analysis.”
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 district court.”
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 follow-on petitions.
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 petitions.”
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 patent owners.”
Whelan says a useful change from big pharma’s viewpoint would be putting in a sur reply for the patent owner.
“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.
She secured 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 sales.
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 uphill battle.”
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 decision.
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 now.’”
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.”