Deadly decisions for People living with HIV Trans Pacific FTA

Kaletra - LPV/r Magic Johnson $1.37 billion in sales (Abbott’s second-best seller after the arthritis drug Humira) $8,000-13,000 in US per year

130,000 people 130,000 people 11

Why is it available generically? Pre-Grant opposition March 2006 filing by Abbott 2008 opposition by I-MAK( Medicines, Access & Knowledge) with Indian drugmakers Cipla, Matrix Laboratories and Okasa Pharmaceuticals Rejected under section 3(d) –Limited scope of patentability does not represent a product which is new or novel “and hence not involving inventive step.” 3(d) to patent for: “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such process results in a new product or employs at least one new reactant.”

Trans Pacific FTA seeks Eliminate pre-grant opposition “Party shall not make such proceedings available before the grant of the patent.” Expand broadly scope of patentability… “MUST” grant for variations of existing chemical entities on new uses or methods of using existing medicines on new formulations, dosages, and combinations even if there is no enhancement of therapeutic efficacy

Broader Pharma assault Lobbying: CEOs of seven of the world’s biggest pharmaceutical companies met with the Indian Prime Minister Lawsuits: Novartis, Bayer and Roche on 3(d) Novartis vs. Union of India, Cancer Patients Aid Association (Gleevec) Buy Outs/Tie Ups Matrix—first WHO and FDA approval for TDF and Lopnivir/Ritonovir Ranbaxy Laboratories: $4.6 billion—many times the valuation Aurobindo and Sun, tied into restrictive joint ventures: Pfizer and Merck Sharma, S.

Generics expansion needed Vietnam (peg interferon) Malaysia (Thailand, etc.)