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Building BRICS – The pharmaceutical industry in emerging markets. Chander M. Lall Lall & Sethi New Delhi India. Indian Pharmaceutical industry Three Important Periods. Indian Pharmaceutical Industry. Patents Act.
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Building BRICS – The pharmaceutical industry in emerging markets Chander M. Lall Lall & Sethi New Delhi India
Indian Pharmaceutical Industry Patents Act Source: Department of Pharmaceuticals, GoI
Export of Drugs & Pharmaceuticals from India Source: Directorate General of Foreign Trade Patents Act
Result : Many drugs patented internationally could be legally produced in India
Result : Many drugs patented internationally could be legally produced in India
Opportunities for future growth Generics Research & Development Contract Manufacturing
Opportunities for future growth Generics Research & Development Contract Manufacturing
Opportunities for Generics Prescription drugs worth US$ 40 billion in the U.S. and 26 billion in Europe lost their patents in the year 2008. In 2009, the global generic drug market was estimated to be US$ 84 bn, of which the US accounted for 42%. patented drugs constitute only 10% of the market. Rest are generics.
Opportunities for Generics In 2011 products worth more than $30 billion losing patent protection. This includes products like Lipitor, Plavix, Zyprexa and Levaquin. These products generated more than $15 billion in sales in 2010.
Opportunities for future growth Generics Research & Development Contract Manufacturing
Why the emerging economies ? “Eighty-five percent of the world's population lives in the emerging markets, and during the past 5 years, all real economic growth has come from these markets,” (Patrick Keohane, Vice President (VP) for R&D Asia Pacific at AstraZeneca)
“There is a lot of good talent at a much lower price in India. What I see happening now is manufacturing and even packaging and even formulation are moving to India. (Jim Worrell, the chief executive of Pharma Services Network, a Charlotte, N.C.-based consulting firm)
Other than China BRICS countries spend too little on R&D All BRICS countries have very few scientists per million population All BRICS countries need to increase R&D spend as percentage of GDP
HEALTHCARE R&D EXPENDITURE - ANNUAL US$ 7 billion + US$ 5 billion + US$ 4.5 billion + US$ 4 billion +
R&D PAYS BACK – Annual Sales of a product Sanofi US$ 9 bn + Astra Zeneca US$ 8 bn + GSK US$ 7 bn +
Products of the future Anticipated Sales 2014 Roche US$ 8 bn + Abbott US$ 8 bn + Pfizer US$ 8 bn +
THE LIPITOR EXAMPLE Pfizer purchased Warner Lambert for US$ 90.27 billion Annual Sales of LIPITOR US$ 13 billion + Losing patent in November 2011
MilimetOftho Industries versus Allergan Inc. (Supreme Court) Multinational corporations, who have no intention of coming to India or introducing their product in India should not be allowed to throttle an Indian Company by not permitting it to sell a product in India, if the Indian Company has genuinely adopted the mark and developed the product and is first in the market. Thus the ultimate test should be who is first in the market. The mere fact that the Respondents have not been using the mark in India would be irrelevant if they were first in the world market.
Cadila Health Care Ltd. vs. Cadila Pharmaceuticals Ltd.(Supreme Court) FALCIGO v FALCITAB "Exacting judicial scrutiny is required if there is a possibility of confusion over marks on medicinal products because the potential harm may be far more dire than that in confusion over ordinary consumer products ."
Cadila Health Care Ltd. vs. Cadila Pharmaceuticals Ltd.AIR 2001 SC 1952 FALCIGO v FALCITAB Drug Authorities directed to consider requiring an applicant to submit an official search report from the Trade Mark office pertaining to the trade mark in question which will enable the drug authority to arrive at a correct conclusion.
Cadila Health Care Ltd. vs. Cadila Pharmaceuticals Ltd.AIR 2001 SC 1952 FALCIGO v FALCITAB While examining cases in India, what has to be kept in mind is the purchaser of such goods in India who may have absolutely no knowledge of English language or of the language in which the trade mark is written and to whom different words with slight difference In spellings may sound phonetically the same.
Cadila Health Care Ltd. vs. Cadila Pharmaceuticals Ltd.AIR 2001 SC 1952 FALCIGO v FALCITAB Schedule "H" drugs are those which can be sold by the chemist only on the prescription of the Doctor but Schedule "L" drugs are not sold across the counter but are sold only to the hospitals and clinics. Nevertheless, it is not un-common that because of lack of competence or otherwise, mistakes can arise especially where the trade marks are deceptively similar.
SBL Ltd. v Himalaya Drug Co (Affirmed by Supreme Court VERSUS Nobody can claim exclusive right to use any word, abbreviation, or acronym which has become publicijuris. In the trade of drugs it is common practice to name a drug by the name of the organ or ailment which it treats or the main ingredient of the drug. Such organ, ailment or ingredient being publicijuris or generic cannot be owned by anyone for use as trade mark."
F. Hoffman La Roche versus Cipla Ltd. (Delhi High Court Appellate Bench) versus PRINCIPAL FINDINGS RESULT : Injunction declined PATENT : Erlotinib Hydrochloride (polymorphs A and B) FINDING : Patent can be challenged even after three levels of checks i.e. examination, pre-grant opposition and Post-grant opposition. FINDING : public interest over-rides other interests including encouraging innovation.
