Welcome to Skilled in the Art. I'm Law.com IP reporter Scott Graham. We had a full slate of Federal Circuit arguments last week, and nearly half of them have already been decided without opinion. But it's not too late for a look back at how lawyers performed in a few high stakes cases. Plus, why the Federal Circuit should (but won't) video stream arguments.

As always, you can email me your feedback and follow me on Twitter.


Federal Circuit Judge Evan Wallach. (Photo: Diego Radzinschi/ALM)
|

Why Genentech and Janssen Didn't Get Opinions From the Federal Circuit

Fifty-four cases were argued last week at the Federal Circuit. So far, 24 have already been decided by Rule 36 summary affirmance. It didn't matter if you were the world's largest tech company trying to stamp out a patent that contributed to a $1 billion verdict, or a giant automaker trying to preserve a patent on improving exhaust systems. The court has other competing priorities these days (cough Arthrex en banc call cough).

Genentech and Janssen lost patent skirmishes over cancer treatment Herceptin and anti-inflammatory Remicade, respectively, without a word of explanation from the appellate court, for example. But it's not too hard to deduce the reasoning after listening to the oral arguments in the cases. That's especially true with Judge Evan Wallach on each panel. Wallach is a stickler for forthrightness and fair play, which let's just say doesn't always align 100% with drug company objectives.

Genentech had tried to preliminarily enjoin Amgen from launching Kanjinti, a biosimilar of Herceptin, last July. U.S. District Judge Colm Connolly refused partly on the ground that Genentech had waited until a week before Kanjinti's launch—even though Amgen had served its notice of commercial marketing in 2018, revealed a "fairly specific" launch date in April 2019, and obtained FDA approval in June. Genentech's actions were "contrary to the spirit and purpose" of the Biologics Price Competition and Innovation Act, which is designed to avoid chaotic last-minute stay motions, Connolly wrote.

Judge William Bryson sounded perplexed at Genentech pursuing Genentech v. Amgen. Trial is set for April 20, and Genentech has agreed that it will not block new patients who've already begun Kanjinti therapy from getting the drug. "So we're talking about five or six weeks, and only those patients who would [start] taking Amgen's drug between now and then," Bryson said. "I wonder if that is significant enough for the disruption that would occur upon stopping the Amgen drug from being sold, and then, if they win the case, starting it again six weeks hence."

Wilmer Cutler Pickering Hale and Dorr partner Bob Gunther, representing Genentech, said that's correct. "But remember, this is a huge drug," he said. And Amgen itself is projecting that it's going to become the market leader.

Then Wallach jumped in, ticking off some of the highlights of Connolly's ruling. "The way the court lays it out, it looks like an ambush on your part," he said.

"On their part?" Gunther hopefully clarified.

"On your part," Wallach repeated.

Gunther said that Amgen's witnesses would not commit to launching. "Every one we could get our hands on said in sworn testimony that while they were making sort of launch readiness plans, that there was no decision to actually launch the product," Gunther said.

That prompted MoloLamken partner Jeffrey Lamken, representing Amgen, to read some of the testimony from Amgen executives. "'Our plan is to launch some time in July.' That's Robert Jacobson," Lamken quoted. "Shane Hall: 'We're targeting being called to launch in July.' Dale Skeeters: 'We're targeting July 13th or 14th."

"We read it," Wallach assured him.

Gunther tried one more time in his rebuttal. "The district court felt that it was getting jammed. I get that," he said. "But I would ask your honors to consider whose fault is that? Is that our fault, or is that the fault of people who were telling him—"

Wallach didn't let him finish. "A) I don't buy your argument," he told him. "B) I think the district court is closer to the circumstances and knows who's jamming whom. And C) I think what you're representing to this court is not squarely on—I'm not saying you're making a misrepresentation—I'm just saying it's not squarely on where the district court is."

You could have forgiven Gunther for giving up then, but he tried one last Hail Mary, saying Judge Connolly had failed in his nine-page opinion to acknowledge and deal with the Amgen testimony that favors Genentech's position.

This time, Bryson, who has as long a fuse as any member of the court, sounded on the verge of losing it. "Given the time constraints, and given the fact that he has to deal with the heaviest patent docket in the country right now—250 patent cases per judge per year in Delaware—the fact that he was able to write as much as he wrote is remarkable," Bryson said. "And to hold him accountable for not having written something on every point that you made seems to me to be asking a lot."

"I think Judge Connolly's a terrific judge," Gunther said. "I am not suggesting that somehow Judge Connolly is lacking in terms of sort of ability—"

Again he didn't get to finish. "But you're suggesting he missed the ball on this issue," Bryson said. "And I'm suggesting that he wasn't required to swing at all the pitches."

Maybe it's a good thing for Genentech and Gunther that the court ruled without an opinion.

Janssen v. Celltrion followed a similar pattern. Celltrion had previously invalidated a Janssen patent covering the antibody infliximab, which is the active ingredient in Remicade. So Janssen tried to block Celltrion and joint venture partner Hospira from marketing their biosimilar versions of Remicade by asserting that they infringed Janssen's patented cell culture media—the material that's used to "feed" the genetically engineered cells that produce the drug.

Janssen sought more than $1 billion in damages and an injunction on the ground that Celltrion's media, while not identical to Janssen's, infringed under the doctrine of equivalents.

U.S. District Judge Mark Wolf ruled Janssen's hypothetical equivalent would have been "ensnared" by prior art—specifically, that a POSA would have had the ability and motivation to combine familiar ingredients from prior art cell culture media to produce the invention.

Patterson Belknap Webb & Tyler of counsel Gregory Diskant argued that Wolf had used impermissible hindsight analysis in reaching his conclusion. It "runs through the district court's decision from top to bottom," Diskant said.

But Wallach wanted to know why Janssen was telling the Federal Circuit that a prior art reference known as Field taught away from the invention, when the company had told Wolf during the trial court proceedings, "You can disregard it, Judge."

"How … can you possibly rely on Field in good faith after saying you can disregard it?" Wallach asked.

Diskant said he'd told Wolf to disregard the reference in a specific context. But when the judge assessed the prior art as a whole, the reference should have been included.

"It was unfair of him to disregard it, is what you're saying," Wallach said.

"I think it was incorrect of him to disregard it," Diskant said.

"Incorrect, even though you said, quote, 'You can disregard it,'" Wallach said.

"I did for purposes of our affirmative argument," Diskant said. "But then the district court in my view—and you may disagree, I assume you do—

"Oh thank you," Wallach interjected, maybe not 100% sincerely.

Kirkland & Ellis, which also got the antibody patent invalidated, argued last week's appeal for Celltrion and Hospira. Partner Jim Hurst told the court that ensnarement "follows from black letter law laid down by KSR." He said the improvement Janssen claimed in its hypothetical claimed culture was no more than the predictable use or prior art elements according to their established functions. "Here, there's no alleged improvement," he told the court.


Federal Circuit Judge Pauline Newman (Photo: Stacey Cramp)
|

Belated Reexaminations and Willful Infringement

As previewed here briefly last week, Finnegan, Henderson, Farabow, Garrett & Dunner partner Michael Jakes presented a smorgasbord of arguments for why the Federal Circuit should unwind a $268 million judgment on back telemetry patents related to implanted hearing aids.

Most of the court's questioning in Alfred E. Mann Foundation v. Cochlear focused on U.S. District Judge Fernando Olguin's decision to double the original $134 million award for willfulness, in part because Jakes' client, Cochlear, filed for an ex parte reexamination of one of the patents after the 2014 verdict and while other issues were up on appeal.

"The court must have not understood what ex parte reexams are," Jakes told the court. "There's a statutory right that says the party can file a reexam any time during the enforceability period. And somehow this was litigation misconduct."

"The reexam was filed seven years into the litigation?" Judge Richard Linn asked.

"It was filed post-verdict, yes," Jakes said. But the Federal Circuit has vacated judgments in the past when the patent office invalidated claims, post-verdict, on reexamination. "It has happened," he said.

When it was Morgan, Lewis & Bockius partner Tom Peterson's turn to defend the judgment, Judge Pauline Newman threw down the gauntlet. "Explain to us what's wrong with exercising your right to challenge a patent in the patent office," she said.

Peterson said it wasn't just the request for reexamination that Olguin had found harassing, it was also Cochlear's demand that the Alfred E. Mann Foundation hire new attorneys and bring them up to speed on years of litigation, only then to drop its demand at the last minute.

The judge had other criticisms too, including what he called "a kitchen sink approach to the litigation," Peterson said.

"Yes, the judge thought it was strange that you have all these paths of attacking the patent," Newman said. "I agree. I think it's very strange. But it's in the law."


EFF Wants to Bring Cameras to Federal Circuit

I like the sentiment behind EFF's motion Monday to video stream next month's Federal Circuit arguments in Uniloc 2017 v. Apple. But never have I been more certain that a motion will be denied.

The Federal Circuit makes audio recordings of its hearings available on its website, typically within a few hours of the arguments, which is tremedously helpful for the bar, the public and the media. But it could go further by providing a video feed, as (for example) the Ninth Circuit and the California Supreme Court do.

In Uniloc v. Apple, EFF is intervening on behalf of the public to support U.S. District Judge William Alsup's order unsealing confidential documents in the case, including some hundred license agreements Uniloc has with third parties. Alsup reasoned that Uniloc had tried to hide far too many documents, including some public court opinions, and that patent owners use secrecy surrounding licenses to demand "vastly bloated" figures compared to what they've actually earned.

Uniloc has argued that, if nothing else, the third parties Uniloc has negotiated its licenses with expect their agreements to remain confidential.

In its motion Monday, EFF says videotaping and webcasting the April 8 argument would "send a powerful message about this Court's commitment to protecting the public's right of access in patent cases."

I agree. Opening a window into the arguments and the judges' questioning could also help the public (and stakeholders) move the dialogue past "Patent troll! Patent Troll!" or "Inventors are being stripped of the property rights!"

But the odds of this motion being granted strike me as zero. The Federal Circuit judges are extremely media-shy—for some, including having their pictures taken—even by federal judge standards. Uniloc has indicated that it will oppose the motion.

So good luck EFF. I hope the court has had a change of heart, or that you've drawn a panel that feels comfortable presenting itself to the public. My experience of the court is that the judges always come prepared with serious, thoughtful questions. It would reflect well on the Federal Circuit, in my view, for the public to see for itself how diligently the court approaches its responsibilities.


That's all from Skilled in the Art this week. This briefing will be on hiatus Friday, but I'll see you all again on Tuesday.