Novartis gleevec case


Novartis:

• Novartis International AG is a Swiss multinational pharmaceutical company based in Basel, Switzerland, ranking number two in sales (46.806 billion US$) among the world-wide industry in 2010
• Novartis was created in 1996 from the merger of Ciba-Geigy and Sandoz Laboratories, both Swiss companies

Gleevec:
Gleevec, also known as STI571, is a new drug that was approved by the Food and Drug Administration in 2001 for the treatment of chronic myeloid leukemia (CML), a cancer of white blood cells, and for the treatment of a rare form of stomach cancer called gastrointestinal stromal tumor (GIST) in 2002.

Generic drug:

• a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use.
• any drug marketed under its chemical name without advertising.
• A generic drug must contain the same active ingredients as the original formulation
• Although they may not be associated with a particular company, generic drugs are subject to the regulations of the governments of countries where they are dispensed. 
• Generic drugs are labeled with the name of the manufacturer and the adopted name (nonproprietary name) of the drug.
• Generic drugs are usually sold for significantly lower prices than their branded equivalents. One reason for the relatively low price of generic medicines is that competition increases among producers when drugs no longer are protected by patents.
• Generic manufacturers do not incur the cost of drug discovery.
• When a pharmaceutical company first markets a drug, it is usually under a patent that, until it expires, allows only the pharmaceutical company that developed the drug (or its licensees) to sell it. 
• Generic drugs can be produced without patent infringement for drugs where:                                                                             
  1) the patent has expired,
  2) the generic company certifies the brand company's patents are either invalid, unenforceable or will not be infringed,
  3) for drugs which have never held patents, or
  4) in countries where the drug does not have current patent protection. Patent lifetime differs from country to country; typically an expired patent cannot be renewed.

Challenge to India's patent law:

• In 2006, Novartis launched a court case against India seeking to prohibit the country from developing generic drugs based on patented medicines.
• Novartis had challenged a law that allows India to refuse to recognize a patent for an existing medicine if there is a modified formula resulting in a re-patent of the drug.
• India claimed that "If Novartis wins millions of people living in poverty world wide could be deprived of affordable medicines"
• In a decision on April 1, 2013 the decision of the high court relating to the anti-cancer drug imatinib was upheld.

PROS AND CONS OF CASE:

• had raised the serious question of future investments and research by foreign pharmas in India and may have repercussions on India’s attempts to attract foreign investment.
• it’s likely to make way for home-grown pharma firms to provide affordable drugs to cancer patients
• India need to regulate the country’s $ 26 billion generic drug industry, the generic drug manufacturers should be pinned down to strict quality standards.