Intellectual Property, Patents & Technology Transfer Sagar Manoli Shashidhar, Philippe Abdel-Sayed Responsible Conduct in Biomedical Research EPFL,

Overview The eligibility to patent genes Economical, Legal & Ethical considerations in Biotech IP

Example of claims in Biotech We managed to identify, purify and sequence the following new peptide sequence: GTEAATGAGMFLEATPMLSIPPE Moreover, we have demonstrated its function as an inhibitor of prostate cancer. What could we claim in this case?

Claims Answers 1.The peptide sequence: GTEAATGAGMFLEATPMLSIPPE 2.The nucleotide sequence coding the peptide according to claim 1 3.The vector comprising one or more copies of the sequence according to claim 2 4.The synthesis process of the peptide according to claim 1 characterized by the steps :...( chemical synthesis or recombinant peptide) 5.Peptide obtained by the process according to claim 4

Claims Answers 6. The pharmaceutical composition containing as active molecule the peptide according to claim 1 7. The peptide according to claim 1 as a drug 8. The use of the peptide according to claim 1, for the manufacture of a drug for the treatment of prostate cancer 9. The treatment method of prostate cancer characterized by the injection in patient of the pharmaceutical composition according to claim The kit comprising as active molecule the peptide according to claim 1 in combination with physiologic liquid and usage instructions

Eligibility to patent genes So far, – Plants and animals are in principle patentable – But, plant and animal varieties are not patentable – Isolated biological material (including an element isolated from the human body or otherwise produced by means of a technical process, including sequence or partial sequence of a gene) may be patentable even if identical to material in nature The New York Times, October 29, 2010 « U.S. Says Genes Should Not Be Eligible for Patents» by Andrew Pollack

« U.S. Says Genes Should Not Be Eligible for Patents» Genes are products of nature, not inventions, and should be common heritage of mankind. Criteria for patentability – New – Non-obvious – Useful

Discussion Human and other genes should not be eligible for patents because they are part of nature? This new position of the government would have a limited impact on biotech industry? Patenting system is vital to the development of Biotech industry?

Case study-Ruling on BRCA gene patents BRCA 1 &2 are tumour suppressor genes. They were patented by Myraid genetics, a molecular diagnostic company. Parts of the patent (only DNA sequence and NOT downstream products from it) were ruled invalid by district judge. Medical associations, doctors and patients were suing the company.

Reasons for invalidating the patent: 1)Because of long-standing concerns in scientific community that gene patents inhibit research and slow innovation. 2)Just diagnostics !! No development on the drug development was going on !! 3)Diagnostic cost went from $1600 to $3100 and denied women from getting tested because of inadequate insurance coverage. 4)Of course, it is a product of nature.

Consequences of invalidating the patent: Negatives: 1)Direct impact on the other companies having patents on genes associated with genetic tests. 2)Without IPR companies don’t get money and interesting discoveries sit on the shelf. Positives: 1)Further research and reduction in diagnostic costs 2)Sharing of individual test results with patients

Economical Issues Disagreement with gene patenting They restrain additional research because of dependency on patented genes. Delayed innovation and possible future litigation May impede the growth and development of new and uncharted areas in the emerging field, for ex Celera’s IP impeded 30% growth in research and product development. Agreement with gene patenting Critical to protect innovation Costs associated with imitating a product are extremely low relative to the innovator’s costs for discovering and developing it. Prevents doctors and geneticists from performing these tests for profit, or in a way that competes with the patent holder, without reimbursement to the inventors of those tests

Legal Issues Disagreement with gene patenting Nature’s products ! “The useful properties of a gene’s sequence are natural, inherent properties of the genes themselves”. Gene functions are obvious: can be predicted through in silico analysis on the basis of their homology to other genes.” Agreeing with gene patenting Many biotechnology products are built upon compounds existing in nature including antibiotics, interferons, interleukins, and insulin. Can be patented as long as inventor shows how to enable and use it.

Ethical Issues Disagree with gene patenting -Someone else is a owner of patient's genes. -Prevents access to the testing procedures. -Limitation of information exchange (the traditional pathway by which medical knowledge is advanced and shared) in the medical use. Agree with gene patenting -Person does not own any tissues or cells once they are outside the person’s body. -There is no evidence of patients unable to utilize existing genetic tests because of patents.

Thank You !