Beruflich Dokumente
Kultur Dokumente
ROAD MAP
Overview of GATT and WTO TRIPS and Intellectual Property Rights Patents and its importance Developing concept of Patentability Patents and its enforcement Status of Patent Act Pharmaceutical Industry as an case study
Discoveries are not patentable Ideas are not patentable Laws of nature Physical Phenomena Abstract ideas
Test was not whether they were living, but whether they were produced by human intervention.
PATENT RIGHTS
Right to exclude others A patent is not a grant of a right to make use or sell. Quid pro quo of Patent protection- grant of patent in return for full disclosure
COCEPTS OF PATENTABILITY
Utility Anticipation Obviousness Enablement Best mode
UTILITY
Level of utility to be disclosed by pharmaceuticals patents In vitro activity Animal tests Does not have to prove safety or efficacy of the drug in human beings Reasonable correlation between the activity in question and the asserted utility Function of the FDA and patent office are distinct
The invention was known or used or patented or described in a printed publication before the invention thereof by the applicant for patent
OBVIOUSNESS
If the difference between the subject matter sought to patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains Definition of one of Ordinary skill in the art Combining two or more prior art references Motivation to combine Some teaching, suggestions, or motivation to modify or combine found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art
ENABLEMENT
35 U.S.C. 112 The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set for the the best mode contemplated by the inventor of carrying out his invention
INFRINGEMENT
Making, using, selling or offering for sale Importing Experimental use defense Bolar exemption is not an experimental use defense
FDA
Regulatory approval-time and cost Focus of FDA approval process-safety and efficacy Difference between the conditions for patentability and approval Only one out of every 2,500 patents make it to the market
PARA CERTIFICATIONS
Section 505(j)(2)(A)(vii) (I) That such patent information has not been filed; (II) That such patent has expired; (III) That the proposed drug will not be marketed until expiration of the patent. (IV) That either the proposed generic drug does not infringe the patent or the patent is invalid (known as Paragraphs IV certification)
CONCLUSION
Protection of Intellectual property is at most important for knowledge based industry Exploitation of patent landscape would be a driving factor for expanding business.
CARRIER OPPORTUNITIES IN IP
Intellectual Property Management Generic business IPM - Drug discovery Business Development Strategic Development IP Law firms KPO (Knowledge Processing Organization)
THANKS ..
mahendrat@drreddys.com