Posts
Drug life cycle management involves the US patent system, since sales of brand name drugs are mostly increased by patent extension strategies. These strategies work because the number of items related to a proprietary medicine that are considered novel and therefore eligible for patent monopoly protection increased from five in the 1980s to 18 in the 1990s. After the initial patent grant, the patent holder immediately starts work on these items, resulting in a series of overlapping 20 year intellectual property monopolies that delay the market entry of lower-priced generic versions of the brand name drug. People who see this as an abuse of the patent system's intent view it as one of the legal and business strategies that are included under the title evergreening. The pharmaceutical industry has strong objections to even the use of this term, and you can read them in the PDF version of GlaxoSmithKline's policy position paper of August 2011. Judge for yourself, I will only add a link to a couple of case studies that present more common scenarios than the case study presented by GSK.
Patent law is an international affair of numerous agreements, but the patent systems of other countries nevertheless illustrate alternatives to the US system. India is a country with a strong generic drug industry noted for sale of inexpensive medications to poorer nations because their patent law is designed to prevent patenting minor changes in medications or patent extensions. Novartis has been battling the Indian system and is about to go to trial again in the Indian Supreme Court because a patent for a new salt form of its cancer drug Gleevec has been denied because of patent office and court rulings that the new form of the drug is not any more effective than the old form. This is an entirely different standard than those applied in the US. The Indian court system has already ruled that this standard does not conflict with The Agreement on Trade Related Aspects of Intellectual Property Rights.
Patent law is an international affair of numerous agreements, but the patent systems of other countries nevertheless illustrate alternatives to the US system. India is a country with a strong generic drug industry noted for sale of inexpensive medications to poorer nations because their patent law is designed to prevent patenting minor changes in medications or patent extensions. Novartis has been battling the Indian system and is about to go to trial again in the Indian Supreme Court because a patent for a new salt form of its cancer drug Gleevec has been denied because of patent office and court rulings that the new form of the drug is not any more effective than the old form. This is an entirely different standard than those applied in the US. The Indian court system has already ruled that this standard does not conflict with The Agreement on Trade Related Aspects of Intellectual Property Rights.
No comments:
Post a Comment