Dicer­na es­ca­lates war with Al­ny­lam over RNAi se­crets, claim­ing its ri­val wants a mo­nop­oly

Al­ny­lam made quite a splash in ear­ly 2014 when it an­nounced that it had ac­quired Mer­ck’s RNAi sub­sidiary Sir­na for $175 mil­lion. The deal to ac­quire Mer­ck’s group, which the phar­ma gi­ant had bagged in a $1.1 bil­lion buy­out in 2006, in­clud­ed some valu­able de­liv­ery tech that Al­ny­lam thought would ben­e­fit its GalNAc plat­form.

But there was a fly in that oint­ment that would dri­ve Al­ny­lam $AL­NY to sue RNAi ri­val Dicer­na $DR­NA 18 months lat­er in state court for al­leged­ly mis­ap­pro­pri­at­ing trade se­crets that dealt with that GalNAc tech. Ac­cord­ing to Al­ny­lam, Dicer­na had im­prop­er­ly swept up tech Al­ny­lam paid for when it hired a group of sci­en­tists oust­ed from Mer­ck af­ter the phar­ma gi­ant had de­cid­ed to shut it all down and of­fload the work. Af­ter a long se­ries of le­gal moves, that case is sup­posed to move for­ward to a tri­al in the spring of 2018.

Dicer­na, though, says it’s the vic­tim now. Al­ny­lam’s suit, the biotech says in a new law­suit filed in fed­er­al court in Boston this week, is noth­ing but a sham aimed at block­ing a ri­val pro­gram from beat­ing Al­ny­lam in the clin­ic, chill­ing po­ten­tial part­ner­ships while grab­bing a mo­nop­oly for it­self in the RNAi space. And Dicer­na wants a fed­er­al judge to put a stop to it un­der fed­er­al an­titrust laws in the Sher­man Act.

John Maraganore, Al­ny­lam

The crux of Dicer­na’s mo­nop­oly claims spot­lights an Achilles heel in trade se­crets that any bio­phar­ma ex­ec will want to pay close at­ten­tion to. It al­so pro­vides some com­pelling anec­dotes about how eas­i­ly re­search leaked out of Mer­ck af­ter the com­pa­ny de­cid­ed to punt their R&D flop. Dicer­na is claim­ing that Mer­ck ex­ec­u­tives prac­ti­cal­ly did every­thing but help car­ry suit­cas­es loaded with re­search out the door as they helped line up new jobs for the de­part­ing Sir­na staffers. And their case de­tails nu­mer­ous in­stances of just how help­ful they could be.

“Dur­ing the fi­nal months lead­ing up to the sale of its RNAi pro­gram Mer­ck al­lowed its ter­mi­nat­ed sci­en­tists to re­move in­for­ma­tion with­out any ef­fec­tive check on their ac­tiv­i­ties,” Dicer­na claims. There were no ex­it in­ter­views. No mon­i­tor­ing of the de­part­ing re­searchers. No ef­fort to pre­vent down­load­ing or cor­ral doc­u­ments.

“Mer­ck man­age­ment af­fir­ma­tive­ly en­cour­aged the ter­mi­nat­ed sci­en­tists to take slides and oth­er in­for­ma­tion with them” to help land new jobs. They even glad­ly told one of Dicer­na’s new hires to take in­fo need­ed for pub­li­ca­tions he was work­ing on. “In­deed, even af­ter Al­ny­lam sent a Jan­u­ary 26 let­ter to Dicer­na de­mand­ing the re­turn of al­leged trade se­crets, at least one Mer­ck em­ploy­ee con­tin­ued to send doc­u­ments to that sci­en­tist with in­for­ma­tion re­lat­ing to work he was do­ing on a man­u­script they hoped to pub­lish.”

Legal­ly, in or­der to claim that some­one mis­ap­pro­pri­at­ed trade se­crets, you have to show that the “se­crets” were prop­er­ly guard­ed. If you don’t take “rea­son­able” ef­forts to pro­tect it, it can’t be mis­ap­pro­pri­at­ed. In oth­er words, if you don’t guard the door, you can’t say any­one walk­ing out with your da­ta was steal­ing it. Al­ny­lam even ac­cused one of Dicer­na’s sci­en­tists with rolling out in­for­ma­tion in suit­cas­es with­out any­one at Mer­ck try­ing to stop him.

So why not just fight it out in state court?

Be­cause Dicer­na claims that Al­ny­lam’s re­al in­tent is to keep it un­der a cloud, chill­ing any part­ner­ships, li­cens­ing deals and al­liances which are the life blood of biotech. Two po­ten­tial part­ners walked away, Dicer­na’s suit claims, be­cause of the lit­i­ga­tion. At least one wouldn’t even talk to the com­pa­ny be­cause of the case.

That gives the big­ger Al­ny­lam an un­fair ad­van­tage, the suit al­leges, as they each try to steer ri­val pro­grams for pri­ma­ry hy­per­ox­aluria type 1 (PH1) through the clin­ic.

“By im­ped­ing Dicer­na’s com­pet­i­tive ef­forts, Al­ny­lam will be able to mo­nop­o­lize the mar­ket for the de­vel­op­ment (of) RNAi-based treat­ment of PH1,” Dicer­na says. That will stop their broad­er based pro­gram that in­cludes PH2 and PH3. Dicer­na wants a fed­er­al judge to stop the mo­nop­oly move rather than leave pa­tients with one or no choice, forc­ing them to pay more.

Here is the full doc­u­ment:

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

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