BIO 2018: Former judge weighs in on differing patent standards
Why has the US Supreme Court never granted certiorari on the issue of differing standards required to prove patent invalidity at district courts and at the US Patent and Trademark Office (USPTO)?
This was one of the questions raised by former district judge Faith Hochberg, who also asked “how can Congress justify a different standard of proof?” at the 2018 BIO International Convention yesterday, June 5. Hochberg added that she was surprised the “highest court hasn’t got to that issue yet”.
Hochberg was taking part in the panel discussion called “Hatch-Waxman ANDA Cases and IPRs”. She was joined by James Harrington, senior vice president and chief IP counsel at Shire Pharmaceuticals, and Jason Lief, special counsel at Cooley, who moderated the panel.
There’s an “extraordinary difference” in the standards to prove invalidity under USPTO proceedings and the standards for the district courts, said Lief.
In an inter partes review (IPR), a preponderance of the evidence must be demonstrated in order to prove invalidity, while in court, a clear and convincing argument must be made.
“It’s the most fundamental thing of everything we do—treat like cases alike. But as the US Court of Appeals for the Federal Circuit said [in Novartis v Noven Pharmaceuticals], the Patent Trial and Appeal Board properly may reach a different conclusion based on the same evidence,” added Lief.
Hochberg said that she was surprised the “highest court hasn’t got to that issue [of differing standards] yet” but that the USPTO has no power to control the standard of proof.
“Either the courts have to change their [standard of proof] or Congress has to change [the USPTO’s],” she added.
Last month, in a bid to standardise proceedings, the USPTO proposed to replace the broadest reasonable interpretation standard for construing unexpired and proposed patent claims in America Invents Act (AIA) trials with the standard that is applied in federal district court and International Trade Commission proceedings.
Harrington added that the USPTO’s chief judge has been “bending over backwards” to get feedback from industry on these issues.
“They’re aware of the problem of inconsistencies and they’re really making an effort to standardise proceedings,” he said.
The panel also asked the audience whether they thought the introduction of AIA trials had led to less expensive litigation costs. No one said yes.
Harrington agreed, noting that in Shire’s experience, increasingly almost every one of its Hatch-Waxman cases comes with at least one IPR, so that when a generic company files an ANDA, the company usually also files an IPR.
Hochberg added: “I thought the whole goal was to make [the system] more congruent with the rest of the world. I’m not sure why we went beyond that.”
Turning to settlement options, Hochberg claimed that the best time for settlement is when “multiple balls are in the air”, which means before any decision has been handed down.
“Once a decision is reached by any entity, one party has the power,” she said, adding that “the longer you wait, the longer you’re gambling on the unknown.”
The 2018 BIO International Convention is taking place in Boston between Monday, June 4 and Thursday, June 7.
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