Deadly Deadly decisiondecisions for s for People People living living with HIVwith HIV

Trans Pacific Trans Pacific FTAFTA

Kaletra - Kaletra - LPV/rLPV/r

Magic JohnsonMagic Johnson

$1.37 billion in sales $1.37 billion in sales (Abbott’s second-best (Abbott’s second-best seller after the arthritis seller after the arthritis drug Humira)drug Humira)

$8,000-13,000 in US per $8,000-13,000 in US per yearyear

130,00130,00

00peoplepeople

1111

Why is it available Why is it available generically?generically?

Pre-Grant oppositionPre-Grant oppositionMarch 2006 filing by AbbottMarch 2006 filing by Abbott2008 opposition by I-MAK( Medicines, Access & 2008 opposition by I-MAK( Medicines, Access & Knowledge) with Indian drugmakers Cipla, Knowledge) with Indian drugmakers Cipla, Matrix Laboratories and Okasa Pharmaceuticals Matrix Laboratories and Okasa Pharmaceuticals

Rejected under section 3(d) –Limited scope of Rejected under section 3(d) –Limited scope of patentabilitypatentability

does not represent a product which is new or does not represent a product which is new or novel “and hence not involving inventive step.” novel “and hence not involving inventive step.” 3(d) to patent for: “the mere discovery of a 3(d) to patent for: “the mere discovery of a new form of a known substance which does not new form of a known substance which does not result in the enhancement of the known result in the enhancement of the known efficacy of that substance or the mere efficacy of that substance or the mere discovery of any new property or new use for a discovery of any new property or new use for a known substance or of the mere use of a known known substance or of the mere use of a known process, machine or apparatus unless such process, machine or apparatus unless such process results in a new product or employs at process results in a new product or employs at least one new reactant.” least one new reactant.”

Trans Pacific FTA Trans Pacific FTA seeksseeks

Eliminate pre-grant oppositionEliminate pre-grant opposition““Party shall not make such proceedings Party shall not make such proceedings available before the grant of the patent.” available before the grant of the patent.”

Expand broadly scope of patentability… Expand broadly scope of patentability… “MUST” grant for“MUST” grant for

variations of existing chemical entitiesvariations of existing chemical entities

on new uses or methods of using existing on new uses or methods of using existing medicinesmedicines

on new formulations, dosages, and on new formulations, dosages, and combinationscombinations

even if there is no enhancement of even if there is no enhancement of therapeutic efficacy therapeutic efficacy

Broader Broader Pharma Pharma assaultassault

Lobbying: Lobbying: CEOs of seven of the world’s biggest CEOs of seven of the world’s biggest pharmaceutical companies met with the Indian Prime Minister pharmaceutical companies met with the Indian Prime Minister

Lawsuits: Lawsuits: Novartis, Bayer and Roche on 3(d) Novartis, Bayer and Roche on 3(d) Novartis vs. Union of India, Cancer Patients Aid Association Novartis vs. Union of India, Cancer Patients Aid Association ((Gleevec) Gleevec)

Buy Outs/Tie UpsBuy Outs/Tie UpsMatrix—first WHO and FDA approval for TDF and Lopnivir/RitonovirMatrix—first WHO and FDA approval for TDF and Lopnivir/Ritonovir

Ranbaxy Laboratories: $4.6 billion—many times the valuationRanbaxy Laboratories: $4.6 billion—many times the valuation

Aurobindo and Sun, tied into restrictive joint ventures: Pfizer and Aurobindo and Sun, tied into restrictive joint ventures: Pfizer and Merck Sharma, S. Merck Sharma, S.

Generics Generics expansion neededexpansion needed

Vietnam Vietnam (peg (peg interferoninterferon))

MalaysiaMalaysia

(Thailand, (Thailand, etc.)etc.)