Dai­ichi Sankyo is go­ing back af­ter Seagen in the lat­est bout of patent in­fringe­ment ac­cu­sa­tions.

The Japan­ese phar­ma an­nounced Fri­day that the US Patent and Trade­mark Of­fice (PTO) has agreed to the com­pa­ny’s re­quest to restart a post-grant re­view of a Seagen patent.

A post-grant re­view (PGR) is when the patent of­fice’s board — called the Patent Tri­al and Ap­peal Board — ex­am­ines at least one claim from an ex­ist­ing patent in a bid to de­ter­mine if that claim is ca­pa­ble of be­ing patent­ed.

The patent in ques­tion, no. 10,808,039, cov­ers cer­tain me­chan­ics of an­ti­body-drug con­ju­gates, a sweet spot of the Seat­tle biotech.

Ac­cord­ing to Dai­ichi’s state­ment, the Japan­ese phar­ma filed with the US Patent and Trade of­fice in Dec. 2020 ask­ing for a post-grant re­view as it was look­ing to con­test the “patentabil­i­ty of cer­tain claims of the ‘039 patent.” The patent of­fice start­ed the ini­tial post-grant re­view in April 2022.

Three months lat­er, the of­fice re-heard the de­ci­sion to grant Dai­ichi’s re­view per Seagen’s re­quest — lat­er shut­ting down the post-grant re­view. Fi­nal­ly, the orig­i­nal PGR pan­el was in­struct­ed on Feb. 7 to de­cide whether or not to restart the pan­el.

“We are very pleased that the PGR will be re­in­sti­tut­ed giv­en the PTO’s de­ter­mi­na­tion that our pe­ti­tion pre­sent­ed com­pelling ev­i­dence of un­patentabil­i­ty of the ’039 patent,” Dai­ichi gen­er­al coun­sel Nao­to Tsuk­aguchi said in a state­ment.

The row is cen­tered around En­her­tu, the block­buster on­col­o­gy ADC at the heart of a 2019 col­lab that saw As­traZeneca pay $1.35 bil­lion up­front to Dai­ichi to part­ner on. The ther­a­py was first ap­proved by FDA lat­er that year, with its most re­cent ap­proval in Au­gust of 2022.

Dai­ichi lost a court ver­dict re­lat­ed to En­her­tu ear­li­er last year, when a Texas ju­ry found Dai­ichi guilty of in­fring­ing on Seagen’s ‘039 patent, dat­ing back to 2005 and in­volv­ing Seagen’s pro­tease-cleav­able link­ers. Four months lat­er, an ap­peal from Dai­ichi to push back a $42 mil­lion fine failed in fed­er­al court.

Dai­ichi said af­ter the failed ap­peal that it would con­tin­ue to con­test the rul­ing, in­clud­ing a de­tail that Seagen could be award­ed roy­al­ties from En­her­tu.

Ed­i­tor’s note: This sto­ry has been cor­rect­ed to re­flect a change in the sto­ry. En­her­tu was first ap­proved in 2019. End­points re­grets the er­ror.

Belgian biotech Confo Therapeutics has landed $183 million, plus potential royalties, in a drug-discovery deal with Daiichi Sankyo.

Early Thursday, Confo Therapeutics put out word of the deal that will be focused on small molecule antagonists to go after an undisclosed target that the company says is associated with CNS diseases.

Confo CEO Cedric Ververken told Endpoints News that Daiichi originally reached out to learn about the biotech’s technology. He added that Confo, founded in 2015, will use its platform to drug a GPCR target that Daiichi has struggled with internally.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.