Other Use Without Authorization of The Right Holder: Nexavar (Treatment of Kidney and Liver Cancer

 

Compulsory licensing (CL) is when a government allows someone else to use the patented invention without the consent of the patent owner owner.. The Indian IP scene has seen great excitement with respect to CLs, and the score of successful ones stands as 11 till date, with pending decisions in the pipeline. This write up !rie"# highlights the histor# and the present state of a$airs of CLs in India and around the world. The history CLs as enabled by the TRIPS agreement% &rug licensing practices !# 'outh frica and ra*il were highl# critici*ed !# the +' uptill earl# ---. owever, in a +turn move as an aftermath of the nthrax scare, post the /011 attacs, the +' revisited its own CL polic# and Lin). ). 3ventuall# in 4ovem!er --1 5T6IP' secured a discount on a#er2s Cipro Cipro (  (Lin greement7s "exi!ilities in connection with health2 were added to the agenda of the 8T97s :th ;inisterial Conference at &oha (&eclaration on the T6IP' greement and Pu!lic ealth). Paragraph < of this declaration rea=rmed rticle >1, recogni*ing the authorit# of mem!er states to grant CLs, to determine the grounds for CLs, to ?determine what constitutes a national emergenc#,@ and to deAne its own licensing regime without challenge. rticle >1 of the T6IP' agreement, ? Other Use Without Authorization of the Right Holder ” allows compulsor# licensing and government use of a patent without the authori*ation of its owner. It can !e done onl# under conditions aimed at protecting the legitimate interests of the patent holder% Article 31b% Compan# appl#ing for the CL must have Arst attempted to unsuccessfull# o!tain a voluntar# license from the patent right holder on reasona!le commercial terms. o  This reBuirement can can !e waived of in case of a ?national ?national emergenc#@ or ?other circumstances of extreme urgenc#@ or in cases of ?pu!lic noncommercial use@. Article 31h% If a compulsor# licence li cence is issued, adeBuate remuneration must still !e paid to the patent holder. holder. Paragraph  of the declaration sought to address the production capacit# issue. It was responded !# the 8T9 in ugust -->, with a waiver allowing pharmaceuticalproducing nations to issue a CL for the export of pharmaceutical •

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products to nations with insu=cient pharmaceutical production capa!ilities (third-party licensing). In &ecem!er --<, the 8T9 announced its intention to mae the >- ugust --> waiver a permanent amendment, which is #et to !e passed (31 December 2013 pending deadline). Link

CLs in India%  The following two applications, related related to Section 8 of the Patent ct, 1/D-, have !een made !# private manufacturers to The Controller Eeneral of patents.  The controller can issue CLs CLs to these manufacturers, manufacturers, provided certain grounds grounds are met. !e"a#ar% India2s Arst CL was granted to 4atco Pharma for a#er2s Nexavar  (treatment  (treatment of idne# and liver cancer  Lin) Lin) !# the Controller in ;arch -1. 4atco !egan sale of 4exavar !# Ful# -1. The decision was challenged with the IP in ugust -1 (Lin ( Lin). ). The IP upheld the ). a#er has challenged the IP2s controller2s decision in ;arch -1> (Lin ( Lin). order at the om!a# igh court whose hearing was held at 9cto!er /. •

 

Cost of therap# !# a#er% 6s. ,G-, :G0 month (6s. >>, <, 1>0 #ear) o Cost of therap# proposed !# 4atco% 6s. G,G--0 month $asatinib % India2s second CL application was Aled !# &6 pharmaceuticals in ;arch -1> for ;'2s Dasatinib Dasatinib (anti  (anti cancer drug% expir# in --). It was recentl# reHected !# the controller in 9cto!er -1> (Lin) Lin) o ;' sells &asatini! at 6s 1,G,---0 month o

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&6 has o$ered to sell it at 6s G1-In Fanuar# -1>, the government announced its plans to initiate the process of issuing CLs for three anticancer drugs Trastuzumab (Herceptin), (Herceptin), Dasatinib  Dasatinib    Ixabepilone under Section %& (issued !# the government on the grounds of a pu!lic health emergenc#)  Lin. Lin. 'ection / is a faster and simpler route to attaining a CL. +nlie the 'ection G: decision, the 'ection / decision cannot !e challenged in a court of law. In Ful# -1>, the &IPP turned down the CL plea for Trastuzumab Trastuzumab.. owever, this was followed !# the revocation of the Trastuzumab Trastuzumab patent  patent under section  of the Indian Patents ct ct (rarest of the rare case% lin) lin) •

CLs in other countries' part from India there are other countries who have issued compulsor# licenses for pharma products in the past% (alaysia% In 9cto!er -->, the ;ala#sian government issued government use authorisation for didanosine didanosine (;'),  (;'), zidovudine  zidovudine (E'J)  (E'J) and lamivudine/zidovudine (E'J). lamivudine/zidovudine  (E'J). ConseBuentl# the patent holders o$ered signiAcant price reductions, leading to average cost per patient dropping from a!out >G-- +'& to D-- +'& (The Elo!al Politics of Pharmaceutical ;onopol# Power, •

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Thailand % In 4ovem!er --, Thailand granted Eoverment +se (E+) orders on (erc) 2s 2s Efavirenz  (an  (an antiretroviral used for treating I&'). This was followed !# a E+ on another antiretroviral !# Abott  (lopinavir/ritonavir  )  ) and a E+ on ;'2s clopidogrel (a heart disease drug) in Fanuar# --D.  The Efavirenz  E+  E+ expired in -11, and the Thai government recentl# announced its plans to issue a CL on it o

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 The licenses were issued for a -.< K ro#alt# of the the total sales of the generic product  The generic Efavirenz  was  was purchased from Ranba"y at a <-K reduced price ( The  The Elo!al Politics Politics of Pharmaceutical Pharmaceutical ;onopol# ;onopol# Pow Power, er, oen --/) *ra+il% In ;a# --D, the ra*ilian government also granted a CL for Efavirenz  for  for ?pu!lic interest@. Lin  This was the result result of an exhaustive negot negotiation iation (1 meetings) with patent o,ner (erc) , who made its !est o$er of >-K to the -K proposed !# the government  The license was issued for Ave #ears and 1.< percent percent ro#alties to ;erc as remuneration Lin # --/, the local manufacturer armanguinhos !rought the generic to the maret, despite the lac of technical information  information  provided !# ;erc (onl# as patent documents)  The estimated savings until until -1 have !een .S/ &30 millions 'uch CLs and E+s have also !een granted !# 'outh frica, Jen#a, 6wanda etc. and even developed nations such as Canada (CL on Tamiu Tamiu to  to *iolyse  Lin Lin)) o

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CLs related to industries other than pharma •

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Tai,an% In Ful# --:, the Taiwan Intellectual Propert# 9=ce (TIP9) granted a CL to Eigastorage for the patented technolog# of Philips for C&s. Lin))  The decision was eventuall# reversed reversed in the high court in --G ((Lin .S (  (Lin Lin)% )% o In --<, +' &9F opposed inHunctive relief for infringement of patents relating to lac!err# email services (government use under G +'C 1:/G) o In Fune --, a court granted ;icrosoft a compulsor# license to use two patents owned !# *: Technologies Technologies relating to &igital 6ights ;anagement s#stems used !# ;icrosoft for its 8indows and ;' 9=ce software programs o In 'eptem!er --, a court granted Fohnson and Fohnson a compulsor# license to use three of &r. Fan oda2s oda2s patents on guidingcatheters medical devices for performing angioplast#