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IPR issues with Biomedical Research

Group-16 Sudha Sunil (129278024)

Vipin Viswam (129278043)

Dinesh Nuti (129278049)

Introduction Biomedical Research

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Basic research, applied research, or translational research conducted to acquire knowledge in the field of medicine Discovers hidden diseases and treatments of these diseases Very expensive, time consuming and unpredictable in nature Medical devices, drugs, gene therapy solutions etc

Biomedical Research Preclinical research Feasibility, iterative testing and drug safety data is collected and analyzed Clinical Trial Testing in humans /animals Comparison test of a medication for a patient's condition

History of Medical Research

1543: The Structure of the Human Body 1628: Functions of the heart and the circulation of blood. 1675: Bacteria 1796: Vaccination 1842: Surgical anesthesia. 1895: X-ray beam 1907: How to grow living cells outside the body. 1912: Cholesterol was responsible for coronary artery disease 1928: Penicillin 1950-53: Study on DNA

Landmark cases in India

Novartis v. Union of India Glivec Case
April 2013

Bayer Nexavar Case

March 2013

Evergreening New Product? Did not pass novelty test Section 3(d) in the Patents Act

Compulsory License Nexavar - $5,181 Generic by Natco - $160 Section 84 of Indias Patents Act

Highlights and Issues in IPR with BMR

Highlights The number of patents is increasing on biomedical materials and processes, such as cell lines, and methods of replicating them, such as cloning. These patents have advantages, such as providing the funds needed to develop and distribute needed therapies.

They also have disadvantages, including driving up the cost of therapies and making them unaffordable to the poor.

Issues Ethical questions include the morality of commodifying the human body and the concern that patents could slow or prevent innovation by restricting access to important materials and processes. Many of the concerns about biomedical patents could be addressed by changing patenting and licensing practices.

Recommendations
Based on our research, we propose the following recommendations with respect to
the IPR issues in biomedical research Differentiate the laws on IPR clearly between a life-saving drug, generic drug and brand-name drugs make stringent laws towards life-saving drugs Governments to support the research of the private pharmaceutical companies in the

research and development of drugs which involve huge costs and long times to
develop; thus making available the drugs at affordable prices Agreement with the private pharmaceutical firms to supply the drugs at a lower rate for a certain period of time

Conclusion
Knowledge on IPR Through the judicial use of IPRs heavy investments poured in research and other business activities can be regained. In India more efforts are needed to create awareness about IPRs amongst the business and scientific community. Onus lies on the Govt. of India to provide more simplified and user friendly environment and processes for acquiring IP rights.

Privatization of BMR and the IPR that follow Promises to spur private investment but risks creating a tragedy of the anti-commons

Anti-commons in biomedical research may be more likely to endure because of the high transaction costs of
bargaining, heterogeneous interests among owners etc.

References
http://www.wabre.org/revolution-of-biomedical-research/ http://fbresearch.org/education/biomedical-research/

http://www.icmr.nic.in/ipr.htm
https://www.academia.edu/1908148/Intellectual_Property_in_the_Biom

edical_Sciences
http://www.sciencemag.org/content/280/5364/698.full