Is your patent be­ing worked?

Patent-hold­ers are not com­ply­ing with In­dia's law that re­quires them to work their patents in the coun­try

Down to Earth - - COLUMN -

Ilaws in­cor­po­rate some unique fea­tures IN­DIA'S PATENT that are in a class of their own.One such is Sec­tion 3d, the of Big Pharma,which has in­spired other coun­tries to emu­late it.This pro­vi­sion pro­hibits the patent­ing of a new form of a known mol­e­cule.Reams have been writ­ten on it and a num­ber of cases have been filed against it, but un­suc­cess­fully. Then, there are those sec­tions which al­low com­pul­sory li­cences (CLs) to be is­sued to In­dian com­pa­nies to over­ride patents that are not be­ing worked in In­dia or in sit­u­a­tions where vi­tal medicines are not avail­able to pa­tients. CLs are used world­wide but some fea­tures of Sec­tions 83 and 84 are cer­tainly unique to In­dia.

Now,the spot­light is on a less dis­cussed but crit­i­cal as­pect of the law that is em­bod­ied in Form 27. Sec­tion 146(2) of the Patents Act read with Rule 131 of the Patent Rules makes it manda­tory for ev­ery paten­tee and their li­censee to make an an­nual dis­clo­sure on how they are work­ing their patent com­mer­cially. It seeks full dis­clo­sure with de­tails of the quan­tum and value of the work­ing of the patented prod­uct. The for­mat for this manda­tory dis­clo­sure is Form 27.Paten­tees,how­ever,have been tak­ing Form 27 lightly and,shock­ingly,In­dia’s Patent Of­fice had been turn­ing a Nel­son’s eye on this vi­o­la­tion.

Mat­ters are now set to change. On Septem­ber 1, the Delhi High Court ad­mit­ted a Pub­lic In­ter­est Lit­i­ga­tion (pil) filed by le­gal scholar Sham­nad Basheer,who for­merly taught at the Na­tional Univer­sity of Ju­ridi­cal Sci­ences (nujs),Kolkata.He has sought the strict im­ple­men­ta­tion of the fil­ing of the “work­ing state­ment” in re­spect of all patents granted in In­dia. As far as I could make out, this re­quire­ment is not sought by any other coun­try.The court has given the gov­ern­ment till Novem­ber 17 to re­spond.

The pil is based on a study con­ducted by Basheer on the work­ing of patents granted in three sec­tors: phar­ma­ceu­ti­cals (specif­i­cally life-saving drugs), telecom­mu­ni­ca­tion and in­ven­tions em­a­nat­ing from pub­lic fund- ed re­search in­sti­tu­tions. Through hard-won Right to In­for­ma­tion (rti) ap­pli­ca­tions,the nujs pro­fes­sor found that about 35 per cent of the paten­tees had failed to dis­close the work­ing sta­tus of their patents dur­ing 2009-12. Worse, the Form 27s filed by th­ese com­pa­nies were in­com­plete,de­fec­tive or plain gob­bledy­gook,al­though fail­ure to file the state­ment or pro­vid­ing in­cor­rect in­for­ma­tion in­vites penalty of lakh.

The pe­ti­tion says gov­ern­ment in­ac­tion is egre­gious be­cause “the bla­tant non-com­pli­ance” was brought to its no­tice four years ago through a sim­i­lar in­ves­ti­ga­tion con­ducted by Basheer in a pub­lic re­port.

The Patent Of­fice’s fail­ure to strictly en­force Form 27 has a more se­ri­ous fallout: it ham­pers the right of those en­ti­ties which wish to ap­ply for CLs based on the work­ing sta­tus of the patent. One case il­lus­trates the im­por­tance of the work­ing of patent state­ment. When a small Hyderabad-based com­pany sought a CL on an mnc drug, it showed that the lat­ter was not work­ing the patent in the coun­try and even im­ports were of a lim­ited quan­tity.

The fact is most mncs,spe­cially those in pharma,have very lit­tle or no man­u­fac­tur­ing ca­pac­ity in In­dia.The pe­ti­tion says the statu­tory dis­clo­sure on the work­ing of patents is in­tended to foster trans­parency in the patent in­no­va­tion ecosys­tem be­cause Big Pharma and high-tech tele­com com­pa­nies are op­pos­ing this by cit­ing trade se­crecy con­cerns on their mar­kets for spe­cific prod­ucts.

There is a sig­nif­i­cant is­sue at stake here. While patent rights serve as an in­cen­tive for de­vel­op­ing new tech­nolo­gies and prod­ucts by pro­vid­ing monopoly con­trol over the newly cre­ated goods, in­no­va­tions are ex­pected to ben­e­fit so­ci­ety at large. The ar­gu­ment is that while in­no­va­tors should, in­deed, be re­warded, patents must be seen as tools for de­vel­op­ment that en­rich so­ci­ety through the widest pos­si­ble avail­abil­ity of goods,ser­vices and tech­nolo­gies.


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