Plant­ing a fac­tory

Pa­tent pro­tec­tion en­cour­ages sig­nif­i­cant ad­vance­ment in biotech­nol­ogy

Finweek English Edition - - Spoor & fisher -

BIOTECH­NOL­OGY HAS BE­COME a sig­nif­i­cant field in the area of in­tel­lec­tual prop­erty over the past few decades, with a num­ber of South African de­vel­op­ments – rang­ing from the trial of HIV-vac­cines to new yeast fer­men­ta­tion tech­niques for the beer and wine in­dus­tries.

A typ­i­cal ex­am­ple that has sig­nif­i­cant pos­i­tive ram­i­fi­ca­tions is the map­ping of the hu­man genome, which has al­ready had nu­mer­ous med­i­cal spin-offs. An on­line en­cy­clopae­dia re­ports that the hu­man genome com­prises 24 dis­tinct chro­mo­somes with ap­prox­i­mately 3bn DNA base pairs con­tain­ing an es­ti­mated 20 000 to 25 000 genes. The Hu­man Genome Project pro­duced a ref­er­ence se­quence of the hu­man genome, now used world­wide in bio­med­i­cal sci­ences.

San­dra Clel­land, a part­ner at in­tel­lec­tual prop­erty law firm Spoor & Fisher, para­phrases US au­thor Bill Bryson in his book A Short His­tory of Nearly Ev­ery­thing that due to the genome-map­ping project “science now has a list of parts but still needs an op­er­at­ing man­ual to know how the genes all work.” In other words, much re­search still needs to be done.

“The SA Gov­ern­ment is very sup­port­ive of re­search in the field of biotech­nol­ogy and ac­cord­ingly has pro­vided sig­nif­i­cant fund­ing and sup­port for re­search and de­vel­op­ment.”

As a re­sult of the in­creas­ing amount of biotech­no­log­i­cal re­search be­ing con­ducted in SA, Spoor & Fisher es­tab­lished a di­vi­sion to ad­vise a wide spec­trum of com­pa­nies and in­sti­tu­tions on biotech­nol­ogy IP. Most of the R&D into biotech­nol­ogy, Clel­land says, is be­ing con­ducted at univer­si­ties, Gov­ern­ment-funded re­search or­gan­i­sa­tions, such as the Med­i­cal Re­search Coun­cil and the Coun­cil for Sci­en­tific and In­dus­trial Re­search (CSIR), and a num­ber of smal­land medium-sized private sec­tor com­pa­nies, many be­ing Cape-based.

While Clel­land says there are no pre­dom­i­nant trends or themes in biotech­nol­ogy, a sig­nif­i­cant amount of money is be­ing al­lo­cated to dif­fer­ent HIV/Aids re­search projects. “That’s such an im­por­tant area of re­search for Africa and we have a num­ber of world-renowned sci­en­tists in SA work­ing in dif­fer­ent ar­eas of Aids re­search, from di­ag­nos­ing and mon­i­tor­ing HIV in­fec­tion to de­vel­op­ing pos­si­ble HIV vac­cines.”

In ad­di­tion, some in­sti­tu­tions and or­gan­i­sa­tions are con­duct­ing re­search into in­dige­nous plants to es­tab­lish the ac­tive in­gre­di­ents used in tra­di­tional medicine so that com­mer­cial prod­ucts can be de­vel­oped. A typ­i­cal ex­am­ple is the ap­petite sup­pres­sant prop­erty qual­i­ties of the hoodia plant, used for thou­sands of years by the in­dige­nous San peo­ple of the Kala­hari. “The CSIR iso­lated the ac­tive in­gre­di­ent in hoodia a few years ago and filed pa­tent ap­pli­ca­tions for this com­pound in a num­ber of coun­tries world­wide. This in­ven­tion has now been li­censed to a large multi­na­tional com­pany and the San com­mu­nity will be re­ceiv­ing roy­alty pay­ments. So there’s been a pos­i­tive out­come for them too.”

Clel­land points to a num­ber of de­vel­op­ments where com­pa­nies are now try­ing to de­velop ge­net­i­cally mod­i­fied plants that will pro­duce the ac­tive in­gre­di­ents in cer­tain phar­ma­ceu­ti­cals. “For ex­am­ple, in the fu­ture a field of sun­flow­ers could be cul­ti­vated to pro­duce the ac­tive in­gre­di­ents of phar­ma­ceu­ti­cals rather than man­u­fac­tur­ing the ac­tive in­gre­di­ents in a tra­di­tional fac­tory. How­ever, there’s been a lot of op­po­si­tion to th­ese de­vel­op­ments by anti-GMO (ge­net­i­cally mod­i­fied or­gan­isms) groups.”

But GMO re­search has pro­duced many pos­i­tive spin-offs. For ex­am­ple, the Univer­sity of Cape Town is de­vel­op­ing drought tol­er­ant maize and Stel­len­bosch Univer­sity is pro­duc­ing a strain of yeast that will give white wine the same health ben­e­fits as red wine.

Pa­tent pro­tec­tion is es­sen­tial for both fun­ders and re­searchers, as it pro­vides a mech­a­nism pre­vent­ing oth­ers from du­pli­cat­ing the in­ven­tion with­out a li­cence. “It also gives the pa­tent owner bar­gain­ing power, as they can then li­cense their own pa­tent to an­other pa­tent holder in ex­change for a li­cence from the other pa­tent holder.”

Clel­land ac­knowl­edges that some par­ties take a phil­an­thropic approach to sci­en­tific in­ven­tion and ad­vance­ment, ad­vo­cat­ing against patents and rather be­liev­ing that in­ven­tions should be made avail­able to ev­ery­body.

How­ever, she points out that this approach can back­fire. “If an in­ven­tion isn’t patented it may be dif­fi­cult to in­ter­est a com­pany in de­vel­op­ing it to a point where it can be placed on the mar­ket. Take the de­vel­op­ment of a new phar­ma­ceu­ti­cal. It’s an ex­tremely ex­pen­sive process to de­velop and for­mu­late a new phar­ma­ceu­ti­cal com­po­si­tion, to con­duct the nec­es­sary tri­als and to then ob­tain reg­u­la­tory ap­proval. Con­se­quently, most com­pa­nies with the nec­es­sary re­sources are un­likely to un­der­take the de­vel­op­ment of a new phar­ma­ceu­ti­cal prod­uct un­less it’s patented.”

The pa­tent process can be lengthy and ex­pen­sive, she says, es­pe­cially if the in­ven­tor or de­vel­oper wants to pro­tect his prod­uct world­wide. A world­wide pa­tent ap­pli­ca­tion can cost be­tween R1m and R4m, so most in­ven­tors gen­er­ally only iden­tify a few coun­tries where they seek pa­tent pro­tec­tion. It’s very rare to file world­wide.”

Pa­tent pro­tec­tion nor­mally lasts 20 years from the fil­ing date of the pa­tent ap­pli­ca­tion to pro­vide suf­fi­cient time for own­ers of patents to re­coup their in­vest­ment and fil­ing costs – and, hope­fully, make a profit.

Much re­search still needed. San­dra Clel­land

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