A judge in Delaware has ruled against Astel­las Phar­ma and Gilead in a long-run­ning patent case over Pfiz­er-on­wed Hos­pi­ra’s gener­ic ver­sion of Lex­is­can.

The case kicked off in 2018, af­ter Hos­pi­ra sub­mit­ted an Ab­bre­vi­at­ed New Drug Ap­pli­ca­tion (AN­DA) for ap­proval to mar­ket a gener­ic ver­sion of Gilead’s Lex­is­can. The drug is used in my­ocar­dial per­fu­sion imag­ing (MPI), a type of nu­clear stress test.

Gilead and Astel­las al­leged that Hos­pi­ra’s AN­DA sub­mis­sion for re­gadeno­son in­fringed up­on sev­er­al patents, and sought a de­clara­to­ry judg­ment that Hos­pi­ra’s man­u­fac­tur­ing of the prod­uct would con­sti­tute a di­rect and in­duced in­fringe­ment. Hos­pi­ra de­nied the al­le­ga­tions, as­sert­ing in its de­fense that the patents are in­valid and fil­ing coun­ter­claims seek­ing judg­ments of non­in­fringe­ment.

Af­ter a three-day bench tri­al, Judge Colm Con­nol­ly ruled against Gilead and Astel­las. Con­nol­ly stat­ed that Gilead and Astel­las failed to prove any di­rect in­fringe­ment, and did not meet any bur­den to es­tab­lish that in­fringe­ment was breached. The par­ties are await­ing a fi­nal judge­ment.

The de­ci­sion comes as Astel­las wrote off more than half a bil­lion dol­lars in loss­es last month and gut­ted can­di­dates that were once thought to have mas­sive po­ten­tial. The com­pa­ny booked an “im­pair­ment loss” over two fis­cal quar­ters back in April, about a year af­ter writ­ing off $540 mil­lion fol­low­ing a clin­i­cal hold on its lead gene ther­a­py AT132.

For Gilead, while the com­pa­ny re­mains high on the For­tune 500 list, it suf­fered a set­back ear­li­er this year when the FDA slapped par­tial holds on stud­ies eval­u­at­ing ma­grolimab with azac­i­ti­dine. The FDA lift­ed its par­tial hold on those stud­ies last month, and Gilead said it’s on track for an in­ter­im read­out in 2023.

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Sorrento Therapeutics’ yearslong battle with NantCell and NANTibody has come to an arbitration award, but additional legal proceedings centered around a “catch-and-kill” scheme remain pending.

On Friday, the arbitrator in the dispute between Sorrento and NantCell and Immunotherapy NANTibody LLC issued an award that grants contractual damages and pre-award interest.

The arbitrator awarded NantCell (part of billionaire Patrick Soon-Shiong’s ImmunityBio) nearly $157 million and NANTibody close to $17 million. Post-award, prejudgment interest will accrue at 9% per annum, according to an SEC filing sent in by Sorrento.