Sci­en­tists fear that EU could again block stem cell pa­tents

THE (Times Higher Education) - - NEWS - David.matthews@timeshigh­ere­d­u­ca­

Sci­en­tific acad­e­mies have warned that ad­vances in stem cell re­search could lead Euro­pean courts to put the le­gal brakes on patent­ing ways to use them, doom­ing the con­ti­nent to fall be­hind the United States and China in com­mer­cial­is­ing bio­med­i­cal break­throughs.

To the re­lief of many sci­en­tists, in 2014 the Euro­pean Union’s high­est court lifted a ban on patent­ing uses of stem cells be­cause, un­like a fer­tilised hu­man egg, they can start but not com­plete the process of de­vel­op­ing into a hu­man be­ing.

But re­cent sci­en­tific ad­vances mean that the prospect of stem cells be­ing able to fully de­velop into hu­mans is mov­ing closer, All Euro­pean Acad­e­mies (Al­lea) has warned, mean­ing that the courts could once again ham­per patent­ing in a cru­cial area of bi­o­log­i­cal in­no­va­tion.

Joseph Straus, an in­tel­lec­tual prop­erty ex­pert and chair of Al­lea’s work­ing group on IP rights, said that a num­ber of sci­en­tific pa­pers re­leased re­cently had brought the is­sue back on to the agenda. “Now they are talk­ing about de­vel­op­ing hu­man em­bryos from the Petri dish,” he said.

Un­like in the US and China, this could mean that Euro­pean courts re­strict the patent­ing of stem cell uses de­spite al­low­ing them to be used in re­search and oth­er­wise be com­mer­cially ex­ploited, he ar­gued, a po­si­tion that was “ab­so­lutely

in­con­sis­tent” and “not very en­cour­ag­ing” for Euro­pean sci­ence.

A bet­ter patent­ing sys­tem “would foster in­no­va­tion and re­ward in­ven­tors in­stead of pro­vid­ing con­di­tions for free rid­ing by com­peti­tors”, ac­cord­ing to Pa­tentabil­ity of In­ven­tions In­volv­ing Hu­man “Em­bry­onic” Pluripo­tent Stem Cells in

Eu­rope, a re­port from Al­lea re­leased last month, of which Pro­fes­sor Straus was the lead au­thor.

The ques­tion of whether the Euro­pean Court of Jus­tice would block fu­ture patent­ing of stem cell uses hinges on whether the cells could ever have the “in­her­ent ca­pac­ity of de­vel­op­ing into a hu­man be­ing”, a def­i­ni­tion set out by the court in 2014.

Mar­tin Pera, a pro­fes­sor at the Jack­son Lab­o­ra­tory, a bio­med­i­cal re­search net­work largely based in the US, and one of the sci­en­tists whose stem cell work has been cited by Pro­fes­sor Straus, said that there was “cer­tainly good ev­i­dence that hu­man pluripo­tent stem cells [those ca­pa­ble of de­vel­op­ing into many other cell types] can repli­cate some as­pects of early em­bry­onic de­vel­op­ment in a cul­ture dish”.

“How­ever, there is no ev­i­dence that hu­man pluripo­tent stem cells, or even mouse pluripo­tent cells, can give rise to a new in­di­vid­ual on their own,” he cau­tioned.

Ju­lian Hitch­cock, a life sciences

spe­cial­ist at the law firm Mar­riott Har­ri­son, said that he thought it was “rea­son­able” for Al­lea to raise con­cerns over fu­ture le­gal blocks on patent­ing, but was “rel­a­tively re­laxed” about the dan­ger, for sev­eral rea­sons.

For a start, re­search in this area, at least in the UK, was largely funded by pub­lic bod­ies not in­ter­ested in pa­tents, he said. “Busi­nesses do not want to throw money at em­bry­onic stem cell re­search be­cause you won’t get a re­turn,” he ar­gued.

He also thought that it was “ex­tremely un­likely” that sci­en­tists could “just leave them [the stem cells] and they turn into a hu­man”, mak­ing it un­likely that they would soon fit the EU court’s def­i­ni­tion of hav­ing “in­her­ent ca­pac­ity”. It would also be na­tional courts, not the EU, that would rule on this ques­tion in the fu­ture, he said.

But, he added, “the na­ture of sci­ence is that noth­ing is cer­tain” and was al­ways “con­tin­gent on the next ex­per­i­ment.”

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