LSPN 19: Two bites at the apple here to stay, says Alkermes director
Petitioners will continue to be able to launch litigation simultaneously before both the district court and the Patent Trial and Appeal Board (PTAB), effectively having two bites at the apple, according to John Kirkland, director of IP at biopharmaceutical company Alkermes.
Kirkland participated on the “US Patent Prosecution & Protection Outlook” panel yesterday, April 25, at the Life Sciences Patent Network in Boston.
“It’s tough to tell from the current trends what’s going to happen in the future, because everything is changing so quickly with Andrei Iancu [director of the US Patent and Trademark Office],” said Kirkland.
However, Kirkland did say that estoppel (which stops issues that were litigated in a prior proceeding from being re-tried) was “finally getting some teeth”, citing a recent decision in the US District Court for the District of Delaware where a judge stopped a party that was unsuccessful in its inter partes review (IPR) petition with respect to obviousness from asserting that again in the district court.
He also said that the PTAB is finally beginning to use its discretion to deny follow-on petitions (multiple, staggered filings of petitions), where petitioners have not only a second but a third or fourth bite at the apple.
Ha Kung Wong, partner in the New York office of Venable Fitzpatrick and panel moderator, provided statistics on the use of IPRs.
“Since their inception in 2012, the use of IPRs has grown steadily for Orange Book drug patents and biologic drug patents. It’s starting to level off now, but it’s still significant,” he said.
Wong also noted that there’s been an increase in the overlap of IPRs and district court litigation for biologic drug patents, up from 10% in August 2017 to 57% in April 2019.
Institution rates for biologics and Orange Book patents have also fallen from what Wong called “death squad” rates of more than 75% in 2013, to the 50/60% range.
Ahmed Mousa, vice president, general counsel and corporate secretary of Boston-headquartered Pieris Pharmaceuticals, added: “When IPRs were first instituted in 2012, a lot of folks didn’t view them as a particularly significant threat.”
But times have changed since then, and there’s an increasing trend for petitioners to make use of IPR and other American Invents Act proceedings.
Mousa believes that there are trends both pushing people away from and back towards the IPR regime, but that the PTAB’s willingness to look with a scrutinising eye towards secondary considerations of non-obviousness arguments is likely to encourage to maintain a steady level of petitions.
“There’s still a silver lining for innovator companies as about 80% of patents that enter this system, ultimately survive,” added Mousa.
All participants were speaking in a personal capacity.
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