The India 1999 Patents Amendment Act Sample Clauses

The India 1999 Patents Amendment Act. Following the decision of the Appellate Body in the India – Mailbox case, India amended its Patents Act in 1999 to add a mechanism for the filing of patent appli- cations with respect to pharmaceutical products,149 as well as a mechanism for the grant of exclusive marketing rights.150 It added a new Chapter IVA to the Patents Act titled “Exclusive Marketing Rights”. That new Chapter provided that the Con- troller General of Patents would not refer an application regarding a medicine or drug to a patent examiner until December 31, 2004. However, if an application was made for the grant of EMRs, it would be referred to an examiner for the purposes of preparing a report as to whether it fell within the scope of claimed inventions otherwise excluded from patentability in India,151 such as the mere dis- covery of a scientific principle,152 or an invention claiming a new use for a known substance.153 If the report does not conclude that the invention should be rejected as outside the subject matter scope of patenting (this report is not an examination as to whether the claimed invention satisfies the criteria of patentability), then the Controller may grant exclusive marketing rights under the specified conditions.154 The 1999 Amendment Act enumerated the preconditions set out in Article 70.9 (i.e., that a patent was filed for and granted in a Paris Convention country on or after 1 January 1995, a patent had been granted in that country, and “the approval to sell or distribute the article or substance on the basis of appropriate tests con- ducted on or after the 1st day of January, 1995, in that country has been granted on or after the date of making a claim for a patent covered under [the provision refer- ring to medicines or drugs].” If those conditions are met, and marketing approval for the medicine or drug has been granted in India, “then, he shall have the exclusive right by himself, his agents or licensees to sell or distribute in India the article or substance on and from the date of approval granted by the Controller in this behalf till a period of five years or till the date of grant of patent or the date of rejection of application for grant of patent, whichever is earlier.”155 The 1999 Amendment Act provides for a prior user’s right in the following terms: 149 India’s Patents Act did not at that time exclude patenting of agricultural chemical products. Also, the Patents Act permitted the patenting of processes relating to pharmaceutical products. See...
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