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23 November 2016Patents

Four years of IPR: how life sciences companies have fared

Signed into law in September 2011, the America Invents Act introduced new procedures for challenging patent validity at the US Patent and Trademark Office (USPTO).

The following September, one of those procedures—the inter partes review (IPR)—became available, allowing any person to challenge a patent by filing a petition before a panel of administrative judges at the Patent Trial and Appeal Board (PTAB).

In 2013, Randall Rader, the former chief judge of the US Court of Appeals for the Federal Circuit, called the PTAB a “death squad” for patents.

To the end of September 2016 (ie, the end of the US government’s fiscal year 2016), 1,683 AIA petitions had been filed, with 13% covering the biopharmaceutical space, according to statistics from the USPTO. More than half of applications—55% (935 petitions)—were filed in the electrical/computer space. Of those 1,683 AIA filings, 1,565 were IPR-based.

According to Andrew Williams, partner at McDonnell Boehnen Hulbert & Berghoff, the PTAB has not turned out to be the death squad that was initially feared for life sciences patents.

Williams explains: “At first, if you had a petition filed against you, you could almost guarantee you’d lose your patent. That’s definitely not the case any more.”

He adds: “Any invalidation rate is going to look bad to a patent owner, but I think the rates have come down slightly over the past few years.”

However, as invalidation rates are still above 50%, invalidation is still a very real concern for patent owners.

“When the PTAB was created, and IPR procedures were first introduced, most of the patents being challenged through these proceedings were in the software, telecoms and electrical engineering fields. Only around 6% of patents being challenged were in the life sciences field,” Williams says.

Since then, this life sciences number has “risen dramatically” with the number of filings in 2014—92—increasing to 212 petitions by September this year (see Table 1).

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