Tag Archives: ipr

AbbVie’s Biggest Drug Gets Patent Setback; Stock Tumbles

Shares of big pharma AbbVie ( ABBV ) nosedived Monday after the U.S. Patent and Trademark Office agreed to review a challenge to a patent on its best-selling drug. The Patent Trial and Appeal Board accepted a request for inter partes review (IPR) by generic-drug startup Coherus Biosciences ( CHRS ) on patent 8,889,135, or the “methods” patent, for rheumatoid-arthritis treatment Humira. The patent is due to expire in 2025, but if Coherus is successful, it could launch its biosimilar version of Humira earlier. That might not happen too soon, though, since the review normally takes a year and is then open to appeal. AbbVie stock, which had opened flat on the stock market today , abruptly dropped 4% after the news came out mid-morning, to near 60, and ended Tuesday’s session at 60.23, down 3.6%. Coherus’ more lightly traded stock jumped 16%, to 18.85. AbbVie is No. 1 in its Industry Group — find out more at IBD Stock Checkup . Humira is currently the top-selling drug in the world, with $14 billion in sales last year. Coherus is one of several companies developing biosimilars of Humira — others include privately held Boehringer Ingelheim, which has some outstanding IPR requests on several different patents, and Amgen ( AMGN ), whose IPR request on a different Humira patent was denied back in January. Coherus has also filed IPR requests on two other patents. “Keep in mind AbbVie also has methods patents which cover other approved Humira indications, such as Crohn’s (disease), and we would expect additional IPRs/litigation to commence prior to potential biosimilar approvals (Amgen’s Humira biosimilar could be approved later this year),” wrote Evercore ISI analyst Mark Schoenebaum in an email. “Thus, these IPRs will likely be the first of many legal actions against AbbVie’s methods patent estate.”

Jazz Pharma Rises As Competitive Position Grows Stronger

Specialty drugmaker Jazz Pharmaceuticals ( JAZZ ) was trading up Wednesday morning as its lead drug staved off competition until the end of 2025, even though the company missed Q1 estimates late Tuesday. Jazz has been embroiled in litigation over its narcolepsy treatment Xyrem, as seven different generic-drug makers have been challenging its aging patents. On Tuesday’s earnings conference call with analysts, CEO Bruce Cozadd said that Jazz had reached a confidential settlement with two of them, Ranbaxy and Wockhardt Bio, which would allow them to start selling generic Xyrem, but not until Dec. 31, 2025. The news led Mizuho Securities analyst Irina Koffler to upgrade Jazz Pharma stock to buy from neutral, and raise the price target to 193 from 137. “Jazz’s announcement of its late 2025 Xyrem settlements was the upgrade signal we were looking for,” Koffler wrote in a research note. Bargaining From Strength Leerink analyst Jason Gerberry raised his price target to 198 from 137 while maintaining an outperform rating. He wrote that the patent launch was a year later than he’d been modeling, and came after last month’s favorable decision from the patent office declining to institute 18 claims Ranbaxy made against Jazz’s Xyrem patent, meaning that Ranbaxy would have to take Jazz to open court instead of banking on an inter partes review (IPR) ruling set for July. “Given favorable first-half developments in the IPR dispute … we believe Jazz is well positioned to entice the other challengers to accept similar settlement terms, eliminating an important stock overhang,” Gerberry wrote in his research note. The news lifted Jazz Pharma stock as much as 5.5% in early trading on the stock market today , though by midday shares were up just 1.5%, near 150, as Jazz reported a weak first quarter. Jazz’s earnings rose 14% over the year-earlier quarter to $2.26 a share, 5 cents short of analysts’ consensus, according to Thomson Reuters. Revenue climbed 9% to $336 million, missing consensus by almost $3 million. Jazz nonetheless added 20 cents to its 2016 EPS range, now $11.10 to $11.50, while affirmed revenue guidance of $1.49 billion to $1.55 billion. The earnings hike came entirely through share repurchases. Last year, the company made $9.52 a share on $1.325 billion in sales.

Biogen Wins Round In Patent Fight Vs. Kyle Bass

The U.S. Patent and Trademark Office ruled Wednesday against a patent challenge to Biogen’s (BIIB) blockbuster drug Tecfidera, holding out hope for denial of similar challenges against other drugs by hedge fund manager Kyle Bass. Biogen stock rose. The USPTO declined to hold a trial in response to Bass’s request for inter partes review (IPR) on Tecfidera’s patent with a number ending in 514, which expires in 2028. The office cited a “failure to